21 CFR 74.1710 D&C Yellow No. 10.
(a) Identity. (1) The color additive D&C Yellow No. 10 is a mixture
of the sodium salts of the mono- and disulfonic acids of
2-(2-quinolinyl)-1H-indene-1,3 (2H)-dione consisting principally of the
sodium salts of 2-(2,3-dihydro-1,3-dioxo-1H-indene-2-yl)esulfonic acid
and 2-(2,3-dihydro-1,3-dioxo-1H-indene-2-yl)-8-quinolinesulfonic acid
with lesser amounts of the disodium salts of the disulfonic acids of
2-(2-quinolinyl)-1H-indene-1,3(2H)-dione (CAS Reg. No. 8004-92-0). D&C
Yellow No. 10 is manufactured by condensing quinaldine with phthalic
anhydride to give the unsulfonated dye, which is then sulfonated with
oleum.
(2) Color additive mixtures made with D&C Yellow No. 10 for drug use
may contain only those diluents that are suitable and that are listed in
part 73 of this chapter as safe for use in color additive mixtures for
coloring drugs.
(b) Specifications. The color additive D&C Yellow No. 10 shall
conform to the following specifications and shall be free from
impurities other than those named to the extent that such other
impurities may be avoided by current good manufacturing practice:
Sum of volatile matter at 135 C (275 F) and chlorides and sulfates
(calculated as sodium salts), not more than 15 percent.
Matter insoluble in both water and chloroform, not more than 0.2
percent.
Total sulfonated quinaldines, sodium salts, not more than 0.2
percent.
Total sulfonated phthalic acids, sodium salts, not more than 0.2
percent.
2-(2-Quinolinyl)-1H-indene-1,3 (2H)-dione, not more than 4 parts per
million.
Sum of sodium salts of the monosulfonates of
2-(2-quinolinyl)-1H-indene-1,3 (2H)-dione, not less than 75 percent.
Sum of sodium salts of the disulfonates of
2-(2-quinolinyl)-1H-indene-1,3 (2H)-dione, not more than 15 percent.
2-(2,3-Dihydro-1,3-dioxo-1H-indene-2-yl)-6, 8-quinolinedisulfonic
acid, disodium salt, not more than 3 percent.
Diethyl ether soluble matter other than that specified, not more than
2 parts per million, using added 2-(2-quinolinyl)-1H-indene-1,3
(2H)-dione for calibration.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
Total color, not less than 85 percent.
(c) Uses and restrictions. The color additive D&C Yellow No. 10 may
be safely used for coloring drugs generally in amounts consistent with
current good manufacturing practice.
(d) Labeling. The label of the color additive and any mixtures
prepared therefrom and intended solely or in part for coloring purposes
shall conform to the requirements of 70.25 of this chapter.
(e) Certification. All batches of D&C Yellow No. 10 shall be
certified in accordance with regulations in part 80 of this chapter.
(48 FR 39219, Aug. 30, 1983, as amended at 49 FR 8432, Mar. 7, 1984)
21 CFR 74.1711 D&C Yellow No. 11.
(a) Identity. (1) The color additive D&C Yellow No. 11 is
principally 2-(2-quinolyl)-1,3-indandione.
(2) Color additive mixtures, for drug use made with D&C Yellow No.
11 may contain only those diluents that are suitable and that are listed
in part 73 of this chapter as safe for use in color additive mixtures
for coloring externally applied drugs.
(b) Specifications. D&C Yellow No. 11 shall conform to the
following specifications and shall be free from impurities, other than
those named, to the extent that such other impurities may be avoided by
good manufacturing practice:
Volatile matter (at 135 C), not more than 1 percent.
Ethyl alcohol-insoluble matter, not more than 0.4 percent.
Phthalic acid, not more than 0.3 percent.
Quinaldine, not more than 0.2 percent.
Subsidiary colors, not more than 5 percent.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
Total color, not less than 96 percent.
(c) Uses and restrictions. D&C Yellow No. 11 may be safely used in
externally applied drugs in amounts consistent with good manufacturing
practice.
(d) Labeling. The label of the color additive and any mixtures
prepared therefrom intended solely or in part for coloring purposes
shall conform to the requirements of 70.25 of this chapter.
(e) Certification. All batches of D&C Yellow No. 11 shall be
certified in accordance with regulations in part 80 of this chapter.
21 CFR 74.1711 Subpart C -- Cosmetics
21 CFR 74.2101 FD&C Blue No. 1.
(a) Identity. The color additive FD&C Blue No. 1 is principally the
disodium salt of ethyl(4-(p-(ethyl(m-sulfobenzyl)amino)- henyl)
benzylidene)-2,5-cyclohexadien-1-ylidene)(m-sulfobenzyl)ammonium
hydroxide inner salt with smaller amounts of the isomeric disodium salts
of ethyl(4-(p-(ethyl(p-sulfobenzyl)amino)-
idene)-2,5-cyclohexadien-1-ylid ene)(p-sulfobenzyl)ammonium hydroxide
inner salt and ethyl(4-(p-(ethyl(o-sulfobenzyl)amino)-
-(o-sulfophenyl)benzylidene)-2,
5-cyclohexadien-1-ylidene)(o-sulfobenzyl)ammonium hydroxide inner salt.
Additionally, FD&C Blue No. 1 is manufactured by the acid catalyzed
condensation of one molecule of sodium 2-formylbenzene-sulfonate with
two molecules from a mixture consisting principally of
3-((ethyl-phenylamino)methyl)benzenesulfonic acid, and smaller amounts
of 4-((ethylphenylamino)methyl)
benzenesulfonic acid and 2-((ethyl-phenylamino)methyl)benzenesulfic
acid to form the leuco base. The leuco base is then oxidized with lead
dioxide and acid, or with dichromate and acid to form the dye. The
intermediate sodium 2-formylbenzenesulfonate is prepared from
2-chlorobenzaldehyde and sodium sulfite.
(b) Specifications. The color additive FD&C Blue No. 1 shall
conform in specifications to the requirements of 74.101(b).
(c) Uses and restrictions. FD&C Blue No. 1 may be safely used for
coloring cosmetics generally in amounts consistent with current good
manufacturing practice.
(d) Labeling. The label of the color additive shall conform to the
requirements of 70.25 of this chapter.
(e) Certification. All batches of FD&C Blue No. 1 shall be
certified in accordance with regulations in part 80 of this chapter.
(47 FR 42565, Sept. 28, 1982)
21 CFR 74.2104 D&C Blue No. 4.
(a) Identity and specifications. The color additive D&C Blue No. 4
shall conform in identity and specifications to the requirements of
74.1104(a)(1) and (b).
(b) Uses and restrictions. D&C Blue No. 4 may be safely used for
coloring externally applied cosmetics in amounts consistent with good
manufacturing practice.
(c) Labeling. The label of the color additive shall conform to the
requirements of 70.25 of this chapter.
(d) Certification. All batches of D&C Blue No. 4 shall be certified
in accordance with regulations in part 80 of this chapter.
21 CFR 74.2151 D&C Brown No. 1.
(a) Identity. The color additive D&C Brown No. 1 is a mixture of
the sodium salts of 4((5-((dialkylphenyl)-
azo)-2,4-dihydroxyphenyl)azo)-benzene sulfonic acid. The alkyl group is
principally the methyl group.
(b) Specifications. D&C Brown No. 1 shall conform to the following
specifications and shall be free from impurities other than those named
to the extent that such other impurities may be avoided by good
manufacturing practice:
Sum of volatile matter (at 135 C) and chlorides and sulfates
(calculated as sodium salts), not more than 16 percent.
Water-insoluble matter, not more than 0.2 percent.
Sulfanilic acid, sodium salt, not more than 0.2 percent.
Resorcinol, not more than 0.2 percent.
Xylidines, not more than 0.2 percent.
Disodium salt of 4((5-((4-sulfophenyl)-azo)-2,4-dihydroxy)
benzenesulfonic acid, not more than 3 percent.
Monosodium salt of 4((5-((2,4-dimethyl-phenyl)azo)
-2,4-dihydroxyphenyl)azo) benzenesulfonic acid, not less than 29 percent
and not more than 39 percent.
Monosodium salt of 4((5-((2,5-dimethyl-phenyl)azo)
-2,4-dihydroxyphenyl)azo) benzenesulfonic acid, not less than 12 percent
and not more than 17 percent.
Monosodium salt of 4((5-((2,3-dimethyl-phenyl)azo) -
2,4-dihydroxyphenyl)azo) benzenesulfonic acid, not less than 6 percent
and not more than 13 percent.
Monosodium salt of 4((5-((2-ethylphenyl)-azo)-2,4-dihydroxyazo)
benzenesulfonic acid, not less than 5 percent and not more than 12
percent.
Monosodium salt of 4((5-((3,4-dimethyl-phenyl)azo)
-2,4-dihydroxyphenyl)azo) benzenesulfonic acid, not less than 3 percent
and not more than 9 percent.
Monosodium salt of 4((5-((2,6-dimethyl-phenyl)azo)
-2,4-dihydroxyphenyl)azo) benzenesulfonic acid, not less than 3 percent
and not more than 8 percent.
Monosodium salt of 4((5-((4-ethylphenyl)
azo)-2,4-dihydroxyphenyl)-azo) benzenesulfonic acid, not less than 2
percent and not more than 8 percent.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
Total color, not less than 84 percent.
(c) Uses and restrictions. D&C Brown No. 1 may be safely used for
coloring externally applied cosmetics in amounts consistent with good
manufacturing practice.
(d) Labeling. The label of the color additive shall conform to the
requirements of 70.25 of this chapter.
(e) Certification. All batches of D&C Brown No. 1 shall be
certified in accordance with regulations in part 80 of this chapter.
21 CFR 74.2203 FD&C Green No. 3.
(a) Identity and specifications. The color additive FD&C Green No.
3 shall conform in identity and specifications to the requirements of
74.203(a)(1) and (b).
(b) Uses and restrictions. The color additive FD&C Green No. 3 may
be safely used for coloring cosmetics generally in amounts consistent
with current good manufacturing practice.
(c) Labeling. The label of the color additive shall conform to the
requirements of 70.25 of this chapter.
(d) Certification. All batches of FD&C Green No. 3 shall be
certified in accordance with regulations in part 80 of this chapter.
(47 FR 52144, Nov. 19, 1982)
21 CFR 74.2205 D&C Green No. 5.
(a) Identity and specifications. The color additive D&C Green No. 5
shall conform in identity and specifications to the requirements of
74.1205 (a)(1) and (b)(2).
(b) Uses and restrictions. D&C Green No. 5 may be safely used for
color cosmetics generally except in the area of the eye in amounts
consistent with current good manufacturing practice.
(c) Labeling requirements. The label of the color additive shall
conform to the requirements of 70.25 of this chapter.
(d) Certification. All batches of D&C Green No. 5 shall be
certified in accordance with regulations in part 80 of this chapter.
(47 FR 24285, June 4, 1982)
21 CFR 74.2206 D&C Green No. 6.
(a) Identity and specifications. The color additive D&C Green No. 6
shall conform in identity and specifications to the requirements of
74.1206 (a) and (b).
(b) Uses and restrictions. D&C Green No. 6 may be safely used for
coloring externally applied cosmetics in amounts consistent with good
manufacturing practice.
(c) Labeling requirements. The label of the color additive shall
conform to the requirements of 70.25 of this chapter.
(d) Certification. All batches of D&C Green No. 6 shall be
certified in accordance with regulations in part 80 of this chapter.
(47 FR 14146, Apr. 4, 1982, as amended at 21 FR 9784, Mar. 21, 1986)
21 CFR 74.2208 D&C Green No. 8.
(a) Identity and specifications. The color additive D&C Green No. 8
shall conform in identity and specifications to the requirements of
74.1208(a)(1) and (b).
(b) Uses and restrictions. D&C Green No. 8 may be safely used for
coloring externally applied cosmetics in amounts not exceeding 0.01
percent by weight of the finished cosmetic product.
(c) Labeling. The label of the color additive shall conform to the
requirements of 70.25 of this chapter.
(d) Certification. All batches of D&C Green No. 8 shall be
certified in accordance with regulations in part 80 of this chapter.
21 CFR 74.2254 D&C Orange No. 4.
(a) Identity and specifications. The color additive D&C Orange No.
4 shall conform in identity and specifications to the requirements of
74.1254 (a)(1) and (b).
(b) Uses and restrictions. D&C Orange No. 4 may be safely used for
coloring externally applied cosmetics in amounts consistent with good
manufacturing practice.
(c) Labeling. The label of the color additive shall conform to the
requirements of 70.25 of this chapter.
(d) Certification. All batches of D&C Orange No. 4 shall be
certified in accordance with regulations in part 80 of this chapter.
(42 FR 52396, Sept. 30, 1977)
21 CFR 74.2255 D&C Orange No. 5.
(a) Identity and specifications. The color additive D&C Orange No.
5 shall conform in identity and specifications to the requirements of
74.1255 (a)(1) and (b).
(b) Uses and restrictions. D&C Orange No. 5 may be safely used for
coloring mouthwashes and dentifrices that are ingested cosmetics in
amounts consistent with current good manufacturing practice. D&C Orange
No. 5 may be safely used for coloring lipsticks and other cosmetics
intended to be applied to the lips in amounts not exceeding 5.0 percent
by weight of the finished cosmetic products. D&C Orange No. 5 may be
safely used for coloring externally applied cosmetics in amounts
consistent with current good manufacturing practice.
(c) Labeling. The label of the color additive shall conform to the
requirements of 70.25 of this chapter.
(d) Certification. All batches of D&C Orange No. 5 shall be
certified in accordance with regulations in part 80 of this chapter.
(47 FR 49635, Nov. 2, 1982, as amended at 49 FR 13342, Apr. 4, 1984)
21 CFR 74.2260 D&C Orange No. 10.
(a) Identity and specifications. The color additive D&C Orange No.
10 shall conform in identity and specifications to the requirements of
74.1260(a)(1) and (b).
(b) Uses and restrictions. D&C Orange No. 10 may be safely used for
coloring externally applied cosmetics in amounts consistent with good
manufacturing practice.
(c) Labeling requirements. The label of the color additive shall
conform to the requirements of 70.25 of this chapter.
(d) Certification. All batches of D&C Orange No. 11 shall be
certified in accordance with regulations in part 80 of this chapter.
(46 FR 18954, Mar. 27, 1981)
21 CFR 74.2261 D&C Orange No. 11.
(a) Identity and specifications. The color additive D&C Orange No.
11 shall conform in identity and specifications to the requirements of
74.1261(a)(1) and (b).
(b) Uses and restrictions. D&C Orange No. 11 may be safely used for
coloring externally applied cosmetics in amounts consistent with good
manufacturing practice.
(c) Labeling requirements. The label of the color additive shall
conform to the requirements of 70.25 of this chapter.
(d) Certification. All batches of D&C Orange No. 11 shall be
certified in accordance with regulations in part 80 of this chapter.
(46 FR 18954, Mar. 27, 1981)
21 CFR 74.2304 FD&C Red No. 4.
(a) Identity and specifications. The color additive FD&C Red No. 4
shall conform in identity and specifications to the requirements of
74.1304(a)(1) and (b).
(b) Uses and restrictions. FD&C Red No. 4 may be safely used for
coloring externally applied cosmetics in amounts consistent with good
manufacturing practice.
(c) Labeling. The label of the color additive shall conform to the
requirements of 70.25 of this chapter.
(d) Certification. All batches of FD&C Red No. 4 shall be certified
in accordance with regulations in part 80 of this chapter.
21 CFR 74.2306 D&C Red No. 6.
(a) Identity and specifications. The color additive D&C Red No. 6
shall conform in identity and specifications to the requirements of
74.1306 (a)(1) and (b).
(b) Uses and restrictions. The color additive D&C Red No. 6 may be
safely used for coloring cosmetics generally in amounts consistent with
current good manufacturing practice.
(c) Labeling requirements. The label of the color additive shall
conform to the requirements of 70.25 of this chapter.
(d) Certification. All batches of D&C Red No. 6 shall be certified
in accordance with regulations in part 80 of this chapter.
(47 FR 57688, Dec. 28, 1982)
21 CFR 74.2307 D&C Red No. 7
(a) Identity and specifications. The color additive D&C Red No. 7
shall conform in identity and specifications to the requirements of
74.1307 (a)(1) and (b).
(b) Uses and restrictions. The color additive D&C Red No. 7 may be
safely used for coloring cosmetics generally in amounts consistent with
current good manufacturing practice.
(c) Labeling requirements. The label of the color additive shall
conform to the requirements of 70.25 of this chapter.
(d) Certification. All batches of D&C Red No. 7 shall be certified
in accordance with regulations in part 80 of this chapter.
(47 FR 57688, Dec. 28, 1982)
21 CFR 74.2317 D&C Red No. 17.
(a) Identity and specifications. The color additive D&C Red No. 17
shall conform in identity and specifications to the requirements of
74.1317(a)(1) and (b).
(b) Uses and restrictions. D&C Red No. 17 may be safely used for
coloring externally applied cosmetics in amounts consistent with good
manufacturing practice.
(c) Labeling. The label of the color additive shall conform to the
requirements of 70.25 of this chapter.
(d) Certification. All batches of D&C Red No. 17 shall be certified
in accordance with regulations in part 80 of this chapter.
21 CFR 74.2321 D&C Red No. 21.
(a) Identity and specifications. The color additive D&C Red No. 21
shall conform in identity and specifications to the requirements of
74.1321(a)(1) and (b).
(b) Uses and restrictions. The color additive D&C Red No. 21 may be
safely used for coloring cosmetics generally in amounts consistent with
current good manufacturing practice.
(c) Labeling requirements. The label of the color additive shall
conform to the requirements of 70.25 of this chapter.
(d) Certification. All batches of D&C Red No. 21 shall be certified
in accordance with regulations in part 80 of this chapter.
(47 FR 53846, Nov. 30, 1982)
21 CFR 74.2322 D&C Red No. 22.
(a) Identity and specifications. The color additive D&C Red No. 22
shall conform in identity and specifications to the requirements of
74.1322(a)(1) and (b).
(b) Uses and restrictions. The color additive D&C Red No. 22 may be
safely used for coloring cosmetics generally in amounts consistent with
current good manufacturing practice.
(c) Labeling requirements. The label of the color additive shall
conform to the requirements of 70.25 of this chapter.
(d) Certification. All batches of D&C Red No. 22 shall be certified
in accordance with regulations in part 80 of this chapter.
(47 FR 53846, Nov. 30, 1982)
21 CFR 74.2327 D&C Red No. 27.
(a) Identity and specifications. The color additive D&C Red No. 27
shall conform in identity and specifications to the requirements of
74.1327 (a)(1) and (b).
(b) Uses and restrictions. D&C Red No. 27 may be safely used for
coloring cosmetics generally in amounts consistent with current good
manufacturing practice.
(c) Labeling requirements. The label of the color additive shall
conform to the requirements of 70.25 of this chapter.
(d) Certification. All batches of D&C Red No. 27 shall be certified
in accordance with regulations in part 80 of this chapter.
(47 FR 42568, Sept. 28, 1982)
21 CFR 74.2328 D&C Red No. 28.
(a) Identity and specifications. The color additive D&C Red No. 28
shall conform in identity and specifications to the requirements of
74.1328 (a)(1) and (b).
(b) Uses and restrictions. D&C Red No. 28 may be safely used for
coloring cosmetics generally in amounts consistent with current good
manufacturing practice.
(c) Labeling requirements. The label of the color additive shall
conform to the requirements of 70.25 of this chapter.
(d) Certification. All batches of D&C Red No. 28 shall be certified
in accordance with regulations in part 80 of this chapter.
(47 FR 42568, Sept. 28, 1982)
21 CFR 74.2330 D&C Red No. 30.
(a) Identity and specifications. The color additive D&C Red No. 30
shall conform in identity and specifications to the requirements of
74.1330 (a)(1) and (b).
(b) Uses and restrictions. D&C Red No. 30 may be safely used for
coloring cosmetics generally in amounts consistent with current good
manufacturing practice.
(c) Labeling requirements. The label of the color additive shall
conform to the requirements of 70.25 of this chapter.
(d) Certification. All batches of D&C Red No. 30 shall be certified
in accordance with regulations in part 80 of this chapter.
(47 FR 22511, May 25, 1982)
21 CFR 74.2331 D&C Red No. 31.
(a) Identity and specifications. The color additive D&C Red No. 31
shall conform in identity and specifications to the requirements of
74.1331(a)(1) and (b).
(b) Uses and restrictions. D&C Red No. 31 may be safely used for
coloring externally applied cosmetics in amounts consistent with good
manufacturing practice.
(c) Labeling. The label of the color additive shall conform to the
requirements of 70.25 of this chapter.
(d) Certification. All batches of D&C Red No. 31 shall be certified
in accordance with regulations in part 80 of this chapter.
21 CFR 74.2333 D&C Red No. 33.
(a) Identity and specifications. The color additive D&C Red No. 33
shall conform in identity and specifications to the requirements of
74.1333(a) (1) and (b).
(b) Uses and restrictions. The color additive D&C Red No. 33 may be
safely used for coloring cosmetic lip products in amounts not to exceed
3 percent total color by weight of the finished cosmetic products. D&C
Red No. 33 may be safely used for coloring mouthwashes (including
breath fresheners), dentifrices, and externally applied cosmetics in
amounts consistent with current good manufacturing practice.
(c) Labeling requirements. The label of the color additive and any
mixtures prepared therefrom intended solely or in part for coloring
purposes shall conform to the requirements of 70.25 of this chapter.
(d) Certification. All batches of D&C Red No. 33 shall be certified
in accordance with regulations in part 80 of this chapter.
(53 FR 33120, Aug. 30, 1988)
21 CFR 74.2334 D&C Red No. 34.
(a) Identity and specifications. The color additive D&C Red No. 34
shall conform in identity and specifications to the requirements of
74.1334(a)(1) and (b).
(b) Uses and restrictions. D&C Red No. 34 may be safely used for
coloring externally applied cosmetics in amounts consistent with good
manufacturing practice.
(c) Labeling. The label of the color additive shall conform to the
requirements of 70.25 of this chapter.
(d) Certification. All batches of D&C Red No. 34 shall be certified
in accordance with regulations in part 80 of this chapter.
21 CFR 74.2336 D&C Red No. 36.
(a) Identity and specifications. The color additive D&C Red No. 36
shall conform in identity and specifications to the requirements of
74.1336 (a)(1) and (b).
(b) Uses and restrictions. The color additive D&C Red No. 36 may be
safely used for coloring cosmetic lip products in amounts not to exceed
3 percent total color by weight of the finished cosmetic products. D&C
Red No. 36 may be safely used for coloring externally applied cosmetics
in amounts consistent with current good manufacturing practice.
(c) Labeling requirements. The label of the color additive shall
conform to the requirements of 70.25 of this chapter.
(d) Certification. All batches of D&C Red No. 36 shall be certified
in accordance with regulations in part 80 of this chapter.
(53 FR 29031, Aug. 2, 1988)
21 CFR 74.2340 FD&C Red No. 40.
(a) Identity and specifications. (1) The color additive FD&C Red No.
40 shall conform in identity and specifications to the requirements of
74.340(a)(1) and (b) of this chapter.
(2) The listing of this color additive includes lakes prepared as
described in 82.51 and 82.1051 of this chapter, except that the color
additive used is FD&C Red No. 40 and the resultant lakes meet the
specification and labeling requirements prescribed by 82.51 or 82.1051
of this chapter.
(b) Uses and restrictions. FD&C Red No. 40 may be safely used in
coloring cosmetics generally subject to the following restrictions:
(1) The color additive may be used in amounts consistent with good
manufacturing practice.
(2) The color additive shall not be exposed to oxidizing or reducing
agents which may affect the integrity of the color or any other
conditions which may affect the integrity of the color.
(c) Labeling. The label of the color additive shall conform to the
requirements of 70.25 of this chapter.
(d) Certification. All batches of FD&C Red No. 40 shall be
certified in accordance with regulations in part 80 of this chapter.
21 CFR 74.2602 D&C Violet No. 2.
(a) Identity and specifications. The color additive D&C Violet No.
2 shall conform in identity and specifications to the requirements of
74.1602(a)(1) and (b).
(b) Uses and restrictions. The color additive D&C Violet No. 2 may
be safely used for coloring externally applied cosmetics in amounts
consistent with good manufacturing practice.
(c) Labeling. The label of the color additive shall conform to the
requirements of 70.25 of this chapter.
(d) Certification. All batches of D&C Violet No. 2 shall be
certified in accordance with regulations in part 80 of this chapter.
21 CFR 74.2602a Ext. D&C Violet No. 2.
(a) Identity. The color additive Ext. D&C Violet No. 2 is
principally the monosodium salt of 2-((9,10-dihydro-4-hydroxy
-9,10-dioxo-1-anthracenyl) amino)-5-methyl-benzenesulfonic acid.
(b) Specifications. Ext. D&C Violet No. 2 shall conform to the
following specifications and shall be free from impurities, other than
those named, to the extent that such other impurities may be avoided by
good manufacturing practice:
Sum of volatile matter (at 135 C) and chlorides and sulfates
(calculated as sodium salts), not more than 18 percent.
Water-insoluble matter, not more than 0.4 percent.
1-Hydroxy-9,10-anthracenedione, not more than 0.2 percent.
1,4-Dihydroxy-9,10-anthracenedione, not more than 0.2 percent.
p-Toluidine, not more than 0.1 percent.
p-Toluidine sulfonic acids, sodium salts, not more than 0.2 percent.
Subsidiary colors, not more than 1 percent.
Lead (as Pb), not more than 20 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
Total color, not less than 80 percent.
(c) Uses and restrictions. The color additive Ext. D&C Violet No.
2 may be safely used for coloring externally applied cosmetics in
amounts consistent with good manufacturing practice.
(d) Labeling. The label of the color additive shall conform to the
requirements of 70.25 of this chapter.
(e) Certification. All batches of Ext. D&C Violet No. 2 shall be
certified in accordance with regulations in part 80 of this chapter.
21 CFR 74.2705 FD&C Yellow No. 5.
(a) Identity. The color additive FD&C Yellow No. 5 is principally
the trisodium salt of
4,5-dihydro-5-oxo-(1-4-sulfophenyl)-4-((4-sulfophenyl)azo)-1H-pyrazole-
3-carboxylic acid (CAS Reg. No. 1934-21-0). To manufacture the additive,
4-aminobenzenesulfonic acid is diazotized using hydrochloric acid and
sodium nitrite. The diazo compound is coupled with
4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1H-pyrazole-3-carboxylic acid or
with the methyl ester, the ethyl ester, or a salt of this carboxylic
acid. The resulting dye is purified and isolated as the sodium salt.
(b) Specifications. FD&C Yellow No. 5 shall conform to the
following specifications and shall be free from impurities other than
those named to the extent that such other impurities may be avoided by
good manufacturing practice:
Sum of volatile matter at 135 C (275 F) and chlorides and sulfates
(calculated as sodium salts), not more than 13 percent.
Water-insoluble matter, not more than 0.2 percent.
3
4,4 -(4,5-Dihydro-5-oxo-4-((4-sulfopheny-diyl)bis(benzenesulfonic acid),
trisodium salt, not more than 1 percent.
1
4-((4 ,5-Disulfo(1,1 -biphenyl)-2-yl)hyd-(4-sulfophenyl)-1H-pyrazole-3-
carboxylic acid, tetrasodium salt, not more than 1 percent.
Ethyl or methyl
4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-((yl)hydrazono)-1H-pyrazole-3-car
boxylate, disodium salt, not more than 1 percent.
Sum of 4,5-dihydro-5-oxo-1-phenyl-4-((4-sulfophe-3-carboxylic acid,
disodium salt, and 4,5-dihydro-5-oxo-4-(phenylazo)-1-(4-sul-3-carboxylic
acid, disodium salt, not more than 0.5 percent.
4-Aminobenzenesulfonic acid, sodium salt, not more than 0.2 percent.
4,5-Dihydro-5-oxo-1-(4-sulfophenyl)-1H-pyrazole-3-carboxylic acid,
disodium salt, not more than 0.2 percent.
Ethyl or methyl 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-1H-parboxylate,
sodium salt, not more than 0.1 percent.
4,4 -(1-Triazene-1,3-diyl)bis(benzenesulfonic acid), disodium salt,
not more than 0.05 percent.
4-Aminoazobenzene, not more than 75 parts per billion.
4-Aminobiphenyl, not more than 5 parts per billion.
Aniline, not more than 100 parts per billion.
Azobenzene, not more than 40 parts per billion.
Benzidine, not more than 1 part per billion.
1,3-Diphenyltriazene, not more than 40 parts per billion.
Lead (as Pb), not more than 10 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
Total color, not less than 87 percent.
(c) Uses and restrictions. FD&C Yellow No. 5 may be safely used for
coloring cosmetics generally in amounts consistent with current good
manufacturing practice.
(d) Labeling. The label of the color additive shall conform to the
requirements of 70.25 of this chapter.
(e) Certification. All batches of FD&C Yellow No. 5 shall be
certified in accordance with regulations in part 80 of this chapter.
(50 FR 35782, Sept. 4, 1985, as amended at 51 FR 24524, July 7, 1986)
21 CFR 74.2706 FD&C Yellow No. 6.
(a) Identity and specifications. The color additive FD&C Yellow No.
6 shall conform in identity and specifications to the requirements of
74.706 (a)(1) and (b).
(b) Uses and restrictions. FD&C Yellow No. 6 may be safely used for
coloring cosmetics generally in amounts consistent with current good
manufacturing practice.
(c) Labeling. The label of the color additive shall conform to the
requirements of 70.25 of this chapter.
(d) Certification. All batches of FD&C Yellow No. 6 shall be
certified in accordance with regulations in part 80 of this chapter.
(51 FR 41782, Nov. 19, 1986)
21 CFR 74.2707 D&C Yellow No. 7.
(a) Identity and specifications. The color additive D&C Yellow No.
7 shall conform in identity and specifications to the requirements of
74.1707(a)(1) and (b).
(b) Uses and restrictions. D&C Yellow No. 7 may be safely used for
coloring externally applied cosmetics in amounts consistent with good
manufacturing practice.
(c) Labeling. The label of the color additive shall conform to the
requirements of 70.25 of this chapter.
(d) Certification. All batches of D&C Yellow No. 7 shall be
certified in accordance with regulations in part 80 of this chapter.
21 CFR 74.2707a Ext. D&C Yellow No. 7.
(a) Identity and specifications. The color additive Ext. D&C Yellow
No. 7 shall conform in identity and specifications to the requirements
of 74.1707a (a)(1) and (b).
(b) Uses and restrictions. Ext. D&C Yellow No. 7 may be safely used
for coloring externally applied cosmetics in amounts consistent with
good manufacturing practice.
(c) Labeling. The label of the color additive shall conform to the
requirements of 70.25 of this chapter.
(d) Certification. All batches of Ext. D&C Yellow No. 7 shall be
certified in accordance with regulations in part 80 of this chapter.
21 CFR 74.2708 D&C Yellow No. 8.
(a) Identity and specifications. The color additive D&C Yellow No.
8 shall conform in identity and specifications to the requirements of
74.1708(a)(1) and (b).
(b) Uses and restrictions. D&C Yellow No. 8 may be safely used for
coloring externally applied cosmetics in amounts consistent with good
manufacturing practice.
(c) Labeling. The label of the color additive shall conform to the
requirements of 70.25 of this chapter.
(d) Certification. All batches of D&C Yellow No. 8 shall be
certified in accordance with regulations in part 80 of this chapter.
21 CFR 74.2710 D&C Yellow No. 10.
(a) Identity and specifications. The color additive D&C Yellow No.
10 shall conform in identity and specifications to the requirements of
74.1710(a)(1) and (b).
(b) Uses and restrictions. The color additive D&C Yellow No. 10 may
be safely used for coloring cosmetics generally in amounts consistent
with current good manufacturing practice.
(c) Labeling. The label of the color additive shall conform to the
requirements of 70.25 of this chapter.
(d) Certification. All batches of D&C Yellow No. 10 shall be
certified in accordance with regulations in part 80 of this chapter.
(48 FR 39220, Aug. 30, 1983, as amended at 49 FR 8432, Mar. 7, 1984)
21 CFR 74.2711 D&C Yellow No. 11.
(a) Identity and specifications. The color additive D&C Yellow No.
11 shall conform in identity and specifications to the requirements of
74.1711(a)(1) and (b).
(b) Uses and restrictions. D&C Yellow No. 11 may be safely used for
coloring externally applied cosmetics in amounts consistent with good
manufacturing practice.
(c) Labeling. The label of the color additive shall conform to the
requirements of 70.25 of this chapter.
(d) Certification. All batches of D&C Yellow No. 11 shall be
certified in accordance with regulations in part 80 of this chapter.
21 CFR 74.2711 Subpart D -- Medical Devices
21 CFR 74.3045 (Phthalocyaninato(2-)) copper.
(a) Identity. The color additive is (phthalocyaninato(2-)) copper
(CAS Reg. No. 147-14-8) having the structure shown in Colour Index No.
74160.
(b) Specifications. The color additive (phthalocyaninato(2-)) copper
shall conform to the following specifications and shall be free from
impurities other than those named to the extent that such impurities may
be avoided by current good manufacturing practice:
Volatile matter 135 C (275 F), not more than 0.3 percent.
Salt content (as NaC1), not more than 0.3 percent.
Alcohol soluble matter, not more than 0.5 percent.
Organic chlorine, not more than 0.5 percent.
Aromatic amines, not more than 0.05 percent.
Lead (as Pb), not more than 40 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
Total color, not less than 98.5 percent.
(c) Uses and restrictions. (1) The color additive
(phthalocyaninato(2-)) copper may be safely used to color polypropylene
sutures, polybutester (the generic designation for the suture fabricated
from 1,4-benzenedicarboxylic acid, polymer with 1,4-butanediol and
alpha-hydro-omega-hydroxypoly(oxy-1,4-butanediyl), CAS Reg. No.
37282-12-5) nonabsorbable sutures for use in general and ophthalmic
surgery, polybutylene terephthalate nonabsorbable monofilament sutures
for general and ophthalmic surgery, and polymethylmethacrylate
monofilament used as supporting haptics for intraocular lenses, subject
to the following restrictions:
(i) The quantity of the color additive does not exceed 0.5 percent by
weight of the suture or haptic material.
(ii) The dyed suture shall conform in all respects to the
requirements of the U.S. Pharmacopeia.
(2) The color additive (phthalocyaninato(2-)) copper may be safely
used for coloring contact lenses in amounts not to exceed the minimum
reasonably required to accomplish the intended coloring effect.
(3) Authorization for these uses shall not be construed as waiving
any of the requirements of section 510(k), 515, or 520(g) the Federal
Food, Drug, and Cosmetic Act with respect to the medical device in which
(phthalocyaninato(2-)) copper is used.
(d) Labeling. The label of the color additive shall conform to the
requirements of 70.25 of this chapter.
(e) Certification. All batches of (phthalocyaninato (2-)) copper
shall be certified in accordance with regulations in part 80 of this
chapter.
(48 FR 34947, Aug. 2, 1983, as amended at 50 FR 16228, Apr. 25, 1985;
51 FR 22929, June 24, 1986; 51 FR 28930, Aug. 13, 1986; 51 FR 39371,
Oct. 28, 1986; 52 FR 15945, May 1, 1987; 55 FR 19620, May 10, 1990)
21 CFR 74.3106 D&C Blue No. 6.
(a) Identity. The color additive D&C Blue No. 6 is principally
(D2,2 -biindoline)-3,3' dione (CAS Reg. No. 482-89-3).
(b) Specifications. D&C Blue No. 6 shall conform to the following
specifications and shall be free from impurities other than those named
to the extent that such impurities may be avoided by good manufacturing
practice:
Volatile matter at 135 C (275 F), not more than 3 percent.
Matter insoluble in N,N-dimethylformamide, not more than 1 percent.
Isatin, not more than 0.3 percent.
Anthranilic acid, not more than 0.3 percent.
Indirubin, not more than 1 percent.
Lead (as Pb), not more than 10 parts per million.
Arsenic (as As), not more than 3 parts per million.
Mercury (as Hg), not more than 1 part per million.
Total color, not less than 95 percent.
(c) Uses and restrictions. (1) D&C Blue No. 6 may be safely used at
a level --
(i) Not to exceed 0.2 percent by weight of the suture material for
coloring polyethylene terephthalate surgical sutures for general
surgical use;
(ii) Not to exceed 0.25 percent by weight of the suture material for
coloring plain or chromic collagen absorbable sutures for general
surgical use;
(iii) Not to exceed 0.5 percent by weight of the suture material for
coloring plain or chromic collagen absorbable sutures for ophthalmic
surgical use;
(iv) Not to exceed 0.5 percent by weight of the suture material for
coloring polypropylene surgical sutures for general surgical use; and
(v) Not to exceed 0.5 percent by weight of the suture material for
coloring polydioxanone synthetic absorbable sutures for ophthalmic and
general surgical use.
(2) Authorization for these uses shall not be construed as waiving
any of the requirements of sections 510(k), 515, and 520(g) of the
Federal Food, Drug, and Cosmetic Act with respect to the medical device
in which the color additive is used.
(d) Labeling. The label of the color additive shall conform to the
requirements of 70.25 of this chapter.
(e) Certification. All batches of D&C Blue No. 6 shall be certified
in accordance with regulations in part 80 of this chapter.
(49 FR 29956, July 25, 1984; 49 FR 34447, Aug. 31, 1984, as amended
at 50 FR 30698, July 29, 1985)
21 CFR 74.3206 D&C Green No. 6.
(a) Identity. The color additive D&C Green No. 6 shall conform in
identity to the requirements of 74.1206(a).
(b) Specifications. The color additive D&C Green No. 6 for use in
medical devices shall conform to the specifications of 74.1206(b).
(c) Uses and restrictions. (1) The color additive D&C Green No. 6
may be safely used at a level
(i) Not to exceed 0.03 percent by weight of the lens material for
coloring contact lenses;
(ii) Not to exceed 0.75 percent by weight of the suture material for
coloring polyethylene terephthalate surgical sutures, including sutures
for ophthalmic use;
(iii) Not to exceed 0.1 percent by weight of the suture material for
coloring polyglycolic acid surgical sutures with diameter greater than
U.S.P. size 8-0, including sutures for ophthalmic use;
(iv) Not to exceed 0.5 percent by weight of the suture material for
coloring polyglycolic acid surgical sutures with diameter not greater
than U.S.P. size 8-0, including sutures for ophthalmic use; and
(v) Not to exceed 0.21 percent by weight of the suture material for
coloring poly(glycolic acid-co-trimethylene carbonate) sutures (also
referred to as 1,4-dioxan-2,5-dione polymer with 1,3-dioxan-2-one) for
general surgical use.
(2) Authorization for these uses shall not be construed as waiving
any of the requirements of sections 510(k), 515, and 520(g) of the
Federal Food, Drug, and Cosmetic Act with respect to the medical device
in which D&C Green No. 6 is used.
(d) Labeling. The label of the color additive shall conform to the
requirements of 70.25 of this chapter.
(e) Certification. All batches of D&C Green No. 6 shall be
certified in accordance with regulations in part 80 of this chapter.
(48 FR 13022, Mar. 29, 1983, as amended at 51 FR 9784, Mar. 21, 1986;
51 FR 37909, Oct. 27, 1986)
21 CFR 74.3230 D&C Red No. 17.
(a) Identity and specifications. The color additive D&C Red No. 17
shall conform in identity and specifications to the requirements of
74.1317(a)(1) and (b).
(b) Uses and restrictions. (1) The substance listed in paragraph (a)
of this section may be used as a color additive in contact lens in
amounts not to exceed the minimum reasonably required to accomplish the
intended coloring effect.
(2) Authorization for this use shall not be construed as waiving any
of the requirements of section 510(k), 515, and 520(g) of the Federal
Food, Drug, and Cosmetic Act with respect to the contact lens in which
the color additive is used.
(c) Labeling. The label of the color additive shall conform to the
requirements of 70.25 of this chapter.
(d) Certification. All batches of D&C Red No. 17 shall be certified
in accordance with regulations in part 80 of this chapter.
(55 FR 22898, June 5, 1990)
21 CFR 74.3602 D&C Violet No. 2.
(a) Identity and specifications. The color additive D&C Violet No.
2 shall conform in identity and specifications to the requirements of
74.1602(a)(1) and (b).
(b) Uses and restrictions. (1) The color additive, D&C Violet No.
2, may be safely used for coloring contact lenses in amounts not to
exceed the minimum reasonably required to accomplish the intended
coloring effect.
(2) D&C Violet No. 2 may be safely used for coloring sutures for use
in surgery subject to the following conditions:
(i) At a level not to exceed 0.2 percent by weight of the suture
material for coloring polyglactin 910 (glycolic-lactic acid polyester)
synthetic absorbable sutures for use in general and ophthalmic surgery;
and
(ii) At a level not to exceed 0.3 percent by weight of the suture
material for coloring polydioxanone synthetic absorbable sutures for use
in general and ophthalmic surgery.
(3) The color additive, D&C Violet No. 2, may be safely used for
coloring polymethylmethacrylate intraocular lens haptics at a level not
to exceed 0.2 percent by weight of the haptic material.
(4) Authorization for these uses shall not be construed as waiving
any of the requirements of sections 510(k), 515, and 520(g) of the
Federal Food, Drug, and Cosmetic Act with respect to the medical devices
in which the color additive is used.
(c) Labeling. The label of the color additive shall conform to the
requirements of 70.25 of this chapter.
(d) Certification. All batches of D&C Violet No. 2 shall be
certified in accordance with regulations in part 80 of this chapter.
(52 FR 19722, May 27, 1987, as amended at 55 FR 18868, May 7, 1990)
21 CFR 74.3710 D&C Yellow No. 10.
(a) Identity. The color additive D&C Yellow No. 10 shall conform to
the identity requirements of 74.1710(a).
(b) Specifications. The color additive D&C Yellow No. 10 for use in
contact lenses shall conform to the specifications of 74.1710(b).
(c) Uses and restrictions. (1) The color additive D&C Yellow No. 10
may be used for coloring contact lenses in amounts not to exceed the
minimum reasonably required to accomplish the intended coloring effect.
(2) Authorization for this use shall not be construed as waiving any
of the requirements of sections 510(k), 515, and 520(g) of the Federal
Food, Drug, and Cosmetic Act with respect to the contact lens in which
the color additive is used.
(d) Labeling. The label of the color additive shall conform to the
requirements of 70.25 of this chapter.
(e) Certification. All batches of D&C Yellow No. 10 shall be
certified in accordance with regulations in part 80 of this chapter.
(52 FR 28690, Aug. 3, 1987)
21 CFR 74.3710 Pt. 74, App. A
21 CFR 74.3710 Appendix A to Part 74 -- The Procedure for Determining
Ether Soluble Material in D&C Red Nos. 6 and 7
The dye is dissolved in glacial acetic and 8 N hydrochloric acids
(1.33:1) and extracted with diethyl ether. Sulfonated moieties,
including the color additive, are discarded in subsequent aqueous
extractions of the ether. Carboxylated moieties are removed from the
ether by extraction with 2% (w/w) NaOH. The ether is evaporated to near
dryness, ethanol (95%) is added, and the solution is analyzed
spectrophotometrically in the visible range. The absorbance at each
wavelength must not exceed 150% of the absorbance similarly obtained for
D&C Red No. 6 Lot AA5169.
(A) Spectrophotometer (Cary 118 or equivalent).
(B) Separatory funnels -- one 1000 mL and one 500 mL.
Note: Use distilled water when water is required.
(A) Glacial Acetic Acid (ACS grade).
(B) Diethyl ether (Anhydrous) -- Note and follow safety precautions
on container.
(C) 8 N HCl -- Pour 165 mL H2O into a 500 mL graduate. Place the
graduate in hood, then add HCl conc. to bring to volume. Carefully
pour this solution into a 500 mL Erlenmeyer flask, Stopper and shake.
Label the flask.
(D) 2% (w/w) NaOH -- Pour ca 190 mL H2O into a 250 mL mixing
graduate. Add 8 g. (5.23 mL) of 50% (w/w) NaOH, bring to 200 mL volume
with water, stopper and mix. Pour this solution into a glass bottle,
label and stopper with a polytetrafluoroethylene top.
(E) Ethanol (95%).
Weigh a 250 mL beaker to tenths of a mg and add 100 mg of dye.
Record weight to tenths of a mg.
Note: The following work must be performed in the hood.
Add 75 mL of 8 N HCl and 100 mL of glacial acetic acid to the beaker
and stir.
Place the beaker on a hot plate and heat with stirring, until all of
the dye is in solution.
Remove the beaker from the hot plate, cover with a watch glass and
allow to cool to room temperature (1-2 hrs).
When the dye solution is at room temperature, transfer the solution
to a 1000 mL separatory funnel.
Rinse the beaker three times with 50 mL portions of H2O, transferring
each rinse to the 1000 mL funnel.
Add 150 mL of ether to the funnel, stopper and shake for 10 seconds,
then invert funnel and open stopcock to remove gas buildup.
Shake the funnel for one minute, opening the stopcock a few times
while the funnel is inverted to remove gas buildup. (Use this shake
procedure throughout method.)
Allow the funnel to stand until the layers have separated.
Transfer the bottom (aqueous) layer to a 500 mL separatory funnel,
add 100 mL of ether, stopper and shake for one minute.
When the layers have separated, drain off the bottom layer into a
waste beaker.
Pour the ether layer in the 500 mL separatory funnel into the 1000 mL
separatory funnel.
Rinse the 500 mL sep. funnel with 100 mL H2O, then transfer it to
the 1000 mL sep. funnel, stopper and shake for one minute.
When the layers have separated, drain off the bottom aqueous layer
into the waste beaker.
Rinse the 500 mL funnel at least three times (total) and repeat the
100 mL water washes until no color is present in the aqueous layer.
Discard the bottom aqueous layer to the waste beaker after each
separation.
Shake the ether layer twice more with 100 mL portions of H2O,
discarding the bottom aqueous layer after each separation.
Remove the unsulfonated subsidiary color from the ether by shaking
the ether layer for one minute with 20 mL of 2% (w/w) NaOH.
Appropriately label a 100 mL beaker. After the layers separate, drain
the aqueous alkaline layer into the beaker and save for the
determination of 3-hydroxy-4-((4-methylphenyl)
azo)-2-naphthalenecarboxylic acid, sodium salt.
If there is any color left in the ether, shake for one minute with
another 20 mL portion of 2% (w/w) NaOH. After the layers have
separated, drain off the aqueous alkaline layer into the 100 mL beaker.
If color remains in the ether layer, repeat the above step for a
total of three washes of the ether with 2% (w/w) NaOH. Note: Three
washes is usually sufficient to remove the unsulfonated subsidiary.
With the stopper removed, gently swirl the ether layer in the sep.
funnel twice to separate the remaining aqueous base. Drain this into
the 100 mL beaker.
Appropriately label a 250 mL beaker. Pour the ether layer into the
beaker. Allow the ether to evaporate to near dryness. Cool to room
temperature. Add ca 8 mL ethanol (95%). Swirl beaker to mix contents.
Quantitatively transfer to a 25 mL graduate using ethanol (95%) rinses.
Add ethanol (95%) to bring volume to 15 mL.
Spectrophotometer Parameters:
Scan Range: 400-700 nm
Scan: 50 nm/in; 5.0 nm/sec.
Absorbance Range: 0-1 AUFS
Cell length: 1 cm (Note: Reference and Sample cells)
(1) Record the visible spectrum of a blank. Fill the reference cell
with distilled water and the sample cell with ethanol (95%).
(2) Rinse the sample cell with 2-3 mL of the ether soluble material
(in ethanol solution); then fill the cell. Record the visible spectrum
of the ether soluble material.
(3) Compare the spectra obtained to the spectra attached. The
attached spectra represents 150% of the absorbance at each wavelength
for similarly analyzed D&C Red No. 6 Lot AA5169.
The spectra of the current sample must not exceed the attached
spectra at any wavelength in order to pass test.
Insert illus. 0433
(47 FR 57688, Dec. 28, 1982; 48 FR 3946, Jan. 28, 1983; 48 FR 7438,
Feb. 22, 1983; 48 FR 10811, Mar. 15, 1983)
21 CFR 74.3710 PART 80 -- COLOR ADDITIVE CERTIFICATION
21 CFR 74.3710 Subpart A -- General Provisions
Sec.
80.10 Fees for certification services.
21 CFR 74.3710 Subpart B -- Certification Procedures
80.21 Request for certification.
80.22 Samples to accompany requests for certification.
80.31 Certification.
80.32 Limitations of certificates.
80.34 Authority to refuse certification service.
80.35 Color additive mixtures; certification and exemption from
certification.
80.37 Treatment of batch pending certification.
80.38 Treatment of batch after certification.
80.39 Records of distribution.
Authority: Secs. 701, 706 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 371, 376).
Source: 42 FR 15662, Mar. 22, 1977, unless otherwise noted.
21 CFR 74.3710 Subpart A -- General Provisions
21 CFR 80.10 Fees for certification services.
(a) Fees for straight colors including lakes. The fee for the
services provided by the regulations in this part in the case of each
request for certification submitted in accordance with 80.21(j)(1) and
(2) shall be 25 cents per pound of the batch covered by such requests,
but no such fee shall be less than $160.00.
(b) Fees for repacks of certified color additives and color additives
mixtures. The fees for the services provided under the regulations in
this part in the case of each request for certification submitted in
accordance with 80.21(j)(3) and (4) shall be:
(1) Fees for straight colors including lakes. 25 cents per pound of
the batch covered but not less than $160.
(2) Repacks of certified color, color additives, and color additive
mixtures. (i) 100 pounds or less -- $25.
(ii) Over 100 pounds but not over 1,000 pounds -- $25 plus 6 cents
for each pound over 100 pounds.
(iii) Over 1,000 pounds -- $79 plus 2 cents per pound for each pound
in excess of 1,000 pounds.
(c) Advance deposits. Any person regularly requesting certification
services may deposit funds in advance of requests as prepayment of fees
required by this section.
(d) Method of payment. All deposits and fees required by this
section shall be paid by money order, bank draft, or certified check,
drawn to the order of the Food and Drug Administration, collectable at
par at Washington, DC. All such deposits and fees shall be forwarded to
the Division of Color Technology, HFF-430, Center for Food Safety and
Applied Nutrition, Food and Drug Administration, 200 C St. SW.,
Washington, DC 20204, whereupon after making appropriate records
thereof, they will be transmitted to the Treasurer of the United States
for deposit to the special account ''Salaries and Expenses,
Certification, Inspection, and Other Services, Food and Drug
Administration.''
(e) Refunds from advance deposits. Whenever in the judgment of the
Commissioner the ratio between fees collected (which are based upon
experience and the best estimate of costs and the best estimate of
earnings) and the costs of providing the service during an elapsed
period of time, in the light of all circumstances and contingencies,
warrants a refund from the fund collected during such period, he shall
make ratable refunds to those persons to whom the services were rendered
and charged, except that no refund shall be made where the computed
ratable amount for the elapsed period is less than $5.00.
(42 FR 15662, Mar. 22, 1977, as amended at 47 FR 24692, June 8, 1982;
54 FR 24890, June 12, 1989)
21 CFR 80.10 Subpart B -- Certification Procedures
21 CFR 80.21 Request for certification.
A request for certification of a batch of color additive shall:
(a) Be addressed to the Commissioner of Food and Drugs.
(b) Be prepared in the manner set forth in paragraph (j) of this
section.
(c) Be submitted in duplicate.
(d) Be signed by a responsible officer of the person requesting
certification of the batch. In the case of a foreign manufacturer, the
request for certification must be signed by a responsible officer of
such firm, and, by his agent who resides in the United States.
(e) Show the name and post office address of the actual manufacturer
in case such manufacturer is not the person requesting certification of
the batch.
(f) Be accompanied by the fee prescribed in 80.10 unless the person
has established with the Food and Drug Administration an advanced
deposit to be used for prepayment of such fees. In no case shall the
Commissioner consider a request for certification of a batch of color
additive if the fee accompanying such request is less than that required
by 80.10 or if such fee exceeds the amount held in the advance deposit
account of the manufacturer submitting such request for certification.
(g) Be accompanied by the sample prescribed in 80.22 consisting of:
(1) Four ounces in the case of straight colors and lakes.
(2) Two ounces in the case of repacks and mixtures.
A sample accompanying a request for certification must be submitted
under separate cover and should be addressed to the Color Certification
Branch.
(h) The name of a color additive shall be given in the following
manner:
(1) The name of a straight color shall be the name of the color as
listed in parts 74 and 81 of this chapter.
(2) The name of a lake shall be the name derived in the manner
described in part 82 of this chapter.
(3) The name of a mixture shall be the name given to such mixture by
the person requesting certification.
(4) The name of a repack shall be the name described in paragraph
(h)(1), (2), or (3) of this section, whichever is applicable.
(i) The information and samples enumerated in paragraphs (a) to (h),
inclusive, of this section are the minimum required. Additional
information and samples shall be submitted at the request of the Food
and Drug Administration when such additional information and samples are
necessary to determine compliance with the requirements of 80.31 for
the issuance of a certificate.
(j) The form for submission of the application shall be one of the
following, depending upon whether the color additive is a straight
color, a lake, a repack of a previously certified color additive, or a
color additive mixture.
(1) Request for certification of a batch of straight color additive.
Date --------------------
Division of Color Technology,
HFF-430, Center for Food Safety and Applied Nutrition,
Food and Drug Administration,
200 C St., SW.,
Washington, DC 20204
In accordance with the regulations promulgated under the Federal
Food, Drug, and Cosmetic Act, we hereby make application for the
certification of a batch of straight color additive.
Name of color
(As listed in 21 CFR part 74)
Batch number
(Manufacturer's number)
Batch weighs ---------------------- pounds
Batch manufactured by -------------------- at ------------------
(Name and address of actual manufacturer)
How stored pending certification
--
(State conditions of storage, with kind and size of containers,
location, etc.)
Certification requested of this color for use in
-- -- (State proposed uses)
Required fee, $ ------ (drawn to the order of Food and Drug
Administration).
The accompanying sample was taken after the batch was mixed in
accordance with 21 CFR 80.22 and is accurately representative thereof.
(Signed) --------------------
By --------------------
--------------------
(Title)
(2) Request for certification of a batch of color additive lake.
Date --------------------
Division of Color Technology,
HFF-430, Center for Food Safety and Applied Nutrition,
Food and Drug Administration,
200 C St. SW.,
Washington, DC 20204
In accordance with the regulations promulgated under the Federal
Food, Drug, and Cosmetic Act, we hereby make application for the
certification of a batch of color additive lake.
Name of color
Batch number
(Manufacturer's number)
Batch weighs ------------------------ pounds
Name of color used
Quantity ---------------------------- pounds
Lot number
(When certification of the lake
for use in foods is requested)
Precipitant used
Substratum used
Quantity ---------------------------- pounds
Batch manufactured by -------------------- at ------------------
(Name and address of actual manufacturer)
How stored pending certification
--
(State conditions of storage, with kind and size of containers,
location, etc.)
Certification requested of this color for use in
-- -- (State proposed uses)
Required fee, $ ------ (drawn to the order of Food and Drug
Administration).
The accompanying sample was taken after the batch was mixed in
accordance with 21 CFR 80.22 and is accurately representative thereof.
(Signed) --------------------
By --------------------
--------------------
(Title)
(3) Request for certification of a repack of a batch of certified
color additive.
Date --------------------
Division of Color Technology,
HFF-430, Center for Food Safety and Applied Nutrition,
Food and Drug Administration,
200 C St. SW.,
Washington, DC 20204
In accordance with the regulations promulgated under the Federal
Food, Drug, and Cosmetic Act, we hereby make application for the
certification of a batch of color additive repack.
Name of color
(As listed in regulations and as certified; or repacker's name, if a
mixture)
Original lot number
Certified color content
This color obtained from
Batch number
Batch weighs ------------------------ pounds
How stored pending certification
--
(State conditions of storage, with kind and size of containers,
location, etc.)
Certification requested for use in
-- -- (State proposed uses)
Required fee, $ ------ (drawn to the order of Food and Drug
Administration).
The accompanying sample was taken after the batch was mixed in
accordance with 21 CFR 80.22 and is accurately representative thereof.
(Signed) --------------------
By --------------------
--------------------
(Title)
(4) Request for certification of a batch of color additive mixture.
Date --------------------
Division of Color Technology,
HFF-430, Center for Food Safety and Applied Nutrition,
Food and Drug Administration,
200 C St. SW.,
Washington, DC 20204
In accordance with the regulations promulgated under the Federal
Food, Drug, and Cosmetic Act, we hereby make application for the
certification of a batch of color additive mixture.
Name of mixture
(Manufacturer's trade name)
Batch number
(Manufacturer's number)
Weight of batch -------------------- pounds
Volume of batch -------------------- (If liquid) gallons
Batch manufactured by
Constituents of the mixture:
1. Color(s). (List separately each color and each lot number.)
Name of color
as certified Lot number
-- --
Quantity used
(in pounds) Obtained from
-- --
2. List of diluents. (List separately each diluent.)
-- --
By volume
By weight (if liquid)
-- --
Batch mixed as follows
(Describe in detail)
How stored pending certification
--
(State conditions of storage, with kind and size of containers,
location, etc.)
Certification requested for use in
-- -- (State proposed uses)
Required fee, $ ------ (drawn to the order of Food and Drug
Administration).
The accompanying sample was taken after the batch was mixed in
accordance with 21 CFR 80.22 and is accurately representative thereof.
(Signed) --------------------
By --------------------
--------------------
(Title)
(42 FR 15662, Mar. 22, 1977; 44 FR 17658, Mar. 23, 1979; 44 FR
22053, Apr. 13, 1979, as amended at 54 FR 24890, June 12, 1989)
21 CFR 80.22 Samples to accompany requests for certification.
A sample of a batch of color additive which is to accompany a request
for certification shall:
(a) Be taken only after such batch has been so thoroughly mixed as to
be of uniform composition throughout.
(b) Held under the control of the person requesting certification
until certified.
(c) Be labeled to show:
(1) The name of the color additive.
(2) The manufacturer's batch number.
(3) The quantity of such batch.
(4) The name and post-office address of the person requesting
certification of such batch.
(5) Be accompanied by any label or labeling intended to be used.
21 CFR 80.31 Certification.
(a) If the Commissioner determines, after such investigations as he
considers to be necessary, that:
(1) A request submitted in accordance with 80.21 appears to contain
no untrue statement of a material fact;
(2) Such color additive conforms to the specifications and any other
conditions set forth therefor in parts 81 and 82 of this chapter.
(3) The batch covered by such request otherwise appears to comply
with the regulations in this chapter, the Commissioner shall issue to
the person who submitted such request a certificate showing the lot
number assigned to such batch and that such batch, subject to the terms,
conditions, and restrictions prescribed by part 74, 81, and 82 of this
chapter, is a certified batch.
(b) If the Commissioner determines, after such investigation as he
considers to be necessary, that a request submitted in accordance with
80.21, or the batch of color additive covered by such request, does not
comply with the requirements prescribed by paragraph (a) of this section
for the issuance of a certificate, the Commissioner shall refuse to
certify such batch and shall give notice thereof to the person who
submitted such request, stating his reasons for refusal. Any person who
contests such refusal shall have an opportunity for a regulatory hearing
before the Food and Drug Administration pursuant to part 16 of this
chapter.
21 CFR 80.32 Limitations of certificates.
(a) If a certificate is obtained through fraud or misrepresentation
of a material fact, such certificate shall not be effective, and a color
additive from the batch on which such certificate was issued shall be
considered to be from a batch that has not been certified in accordance
with the regulations in this part. Whenever, the Commissioner learns
that any certificate has been obtained through fraud or material
misrepresentation, he shall notify the holder of the certificate that it
is of no effect.
(b) If between the time a sample of color additive accompanying a
request for certification is taken and the time a certificate covering
the batch of such color additive is received by the person to whom it is
issued, any such color additive becomes changed in composition, such
certificates shall not be effective with respect to such changed color
additive and such changed color additive shall be considered to be from
a batch that has not been certified in accordance with the regulations
in this part.
(c) If at any time after a certificate is received by the person to
whom it is issued any color additive from the batch covered by such
certificate becomes changed in composition, such certificate shall
expire with respect to such changed color additive. After such
expiration, such color additive shall be considered to be from a batch
that has not been certified in accordance with this part; except that
such color additive shall not be so considered when used for coloring a
food, drug, or cosmetic, or for the purpose of certifying a batch of a
mixture in which such color additive was used as an ingredient, or for
use in preparing a batch of a mixture for which exemption from
certification has been authorized, if such change resulted solely from
such use.
(d) A certificate shall expire with respect to any color additive
covered thereby if the package in which such color additive was closed
for shipment or delivery is opened. After such expiration such color
additive shall be considered to be from a batch that has not been
certified, except that such color additive shall not be so considered
when the package is opened;
(1) and such color additive is used, subject to the restrictions
prescribed by paragraphs (f), (g), and (h) of this section, in coloring
a food, drug, or cosmetic;
(2) for the purpose of certifying a batch made by repacking such
color;
(3) for the purpose of certifying a batch of a mixture in which such
color is used as an ingredient; or
(4) for the purpose of preparing a batch of a mixture for which
exemption from certification has been authorized; or
(5) when the package is reopened solely for repackaging by the person
to whom such certificate was issued.
(e) A certificate shall not be effective with respect to a package of
color additive and such color additive shall be considered to be from a
batch that has not been certified if such package is shipped or
delivered under a label which does not bear all words, statements, and
other information required by 70.25 of this chapter to appear thereon.
(f) A certificate shall not be effective with respect to a package of
color additive, and such color additive shall be considered to be from a
batch that has not been certified if:
(1) Such package has not been sealed in accordance with 70.20 of
this chapter.
(2) Such package has been sealed in accordance with 70.20 of this
chapter and the seal has been broken, intentionally or accidentally,
unless such seal has been broken for the purpose of using color additive
in accordance with 80.38, or, such package has been opened by a duly
authorized representative of the Administration or Department in the
performance of his official duties, and he has immediately resealed the
package in conformance with 70.20 of this chapter.
(g) A certificate shall not be effective with respect to a package of
color additive and such color additive shall be considered to be from a
batch that has not been certified if such color additive is used in any
manner other than that for which it was certified.
(h) When the listing or the specifications for a color additive are
revoked or amended, the final order effecting the revocation or
amendment may specify, in addition to its own effective date, a date on
which all certificates for existing batches and portions of batches of
such a color additive theretofore issued under such revoked or amended
regulations shall cease to be effective; and any such lots of the color
additive shall be regarded as uncertified after the date specified
unless a new certificate can be and is obtained in conformance with the
new regulations. When a certificate thus ceases to be effective for a
color additive, any certificates previously issued for a color additive
mixture containing that color additive shall cease to be effective on
the same date. Use of such color additive or color additive mixture
after such specified date without the new certificate in preparing
foods, drugs, or cosmetics will result in such food, drugs, or cosmetics
being adulterated. When a certified color additive has been used in
food, drugs, or cosmetics and the status of the color additive is
thereafter changed by amendment or revocation of its listing or
specification regulations, such food, drugs, and cosmetics will not be
regarded as adulterated by reason of the use of such color additive,
unless the hazard to health is such that existing stocks of the foods,
drugs, or cosmetics cannot be safely used, in which cases findings to
that effect will be made and regulations appropriate for such special
cases will be issued.
21 CFR 80.34 Authority to refuse certification service.
(a) When it appears to the Commissioner that a person has:
(1) Obtained, or attempted to obtain, a certificate through fraud or
misrepresentation of a material fact.
(2) Falsified the records required to be kept by 80.39; or
(3) Failed to keep such records, or to make them available, or to
accord full opportunity to make inventory of stocks on hand or otherwise
to check the correctness of such records, as required by 80.39; or
(4) Refused to permit duly authorized employees of the Food and Drug
Administration free access to all manufacturing facilities, processes,
and formulae involved in the manufacture of color additives and
intermediates from which such color additives are derived; he may
immediately suspend certification service to such person and may
continue such suspension until adequate corrective action has been
taken.
(b) Any person who contests suspension of service shall have an
opportunity for a regulatory hearing before the Food and Drug
Administration pursuant to part 16 of this chapter.
21 CFR 80.35 Color additive mixtures; certification and exemption from
certification.
(a) Color additive mixtures to be certified. Any color additive
mixture that contains one or more straight colors listed in part 74 of
this chapter, together with any diluents listed in such subparts for use
with such straight colors, shall be certified if intended for use in
foods, drugs, or cosmetics, or in coloring the human body, as the case
may be, subject to any restriction prescribed in parts 70 and 71 of this
chapter.
(b) Color additive mixtures exempted from certification. A color
additive mixture prepared from a previously certified batch of one or
more straight colors, with or without any diluent that has been listed
in part 73 of this chapter for use in mixtures, shall be exempt from
batch certification if the straight color used has not changed in
composition in any manner whatsoever since its certification and if it
is simply mixed with the approved diluents for exempt mixtures. The
label of such color additive mixtures shall not bear the lot number
assigned by the Food and Drug Administration to the certified straight
color components, but shall bear the manufacturer's control number
through which the history of the straight color can be determined.
(c) Additions to the list of diluents. A person requesting additions
to the list of diluents authorized for the purposes described in
paragraphs (a) and (b) of this section shall submit a petition in
accordance with the provisions of 71.1 of this chapter. Each such
petition shall be accompanied by the fee prescribed in 70.19 of this
chapter, unless there is an advance deposit to be used for prepayment of
such fees.
Note: The provisions of 80.35 with respect only to diluents for use
in cosmetic color additive mixtures were stayed, until a regulation is
effected listing safe diluents for cosmetic use, including cosmetics
which color the human body, 29 FR 18495, Dec. 29, 1964.
21 CFR 80.37 Treatment of batch pending certification.
Immediately after the sample that is to accompany a request for
certification of a batch of color additive is taken, the batch shall be:
(a) Stored in containers of such kind as to prevent change in
composition.
(b) Held under the control of the person requesting certification
until certified.
(c) Marked, by labeling or otherwise, in a manner such that there can
be no question as to the identity of the batch and no question that it
is not to be used until the requested certificate has been issued.
21 CFR 80.38 Treatment of batch after certification.
(a) Immediately upon notification that a batch of color additive has
been certified, the person requesting certification thereof shall
identify such batch, by labeling, with the certified lot number.
(b) The person requesting certification shall maintain storage in
such manner as to prevent change in composition until such batch has
been packaged and labeled as required by 70.20 and 70.25 of this
chapter, except that the person requesting certification may use such
color additive for the purpose of coloring a food, drug, or cosmetic.
21 CFR 80.39 Records of distribution.
(a) The person to whom a certificate is issued shall keep complete
records showing the disposal of all the color additive from the batch
covered by such certificate. Upon the request of any officer or
employee of the Food and Drug Administration or of any other officer or
employee acting on behalf of the Secretary of Health and Human Services,
such person, at all reasonable hours until at least 2 years after
disposal of all such color additive, shall make such records available
to any such officer or employee, and shall accord to such officer or
employee full opportunity to make inventory of stocks of such color
additive on hand and otherwise to check the correctness of such records.
(b) The records required to be kept by paragraph (a) of this section
shall show:
(1) Each quantity used by such person from such batch and the date
and kind of such use.
(2) The date and quantity of each shipment or delivery from such
batch, and the name and post-office address of the person to whom such
shipment or delivery was made.
(c) The records required to be kept by paragraph (a) of this section
shall be kept separately from all other records.
21 CFR 80.39 PART 81 -- GENERAL SPECIFICATIONS AND GENERAL RESTRICTIONS
FOR PROVISIONAL COLOR ADDITIVES FOR USE IN FOODS, DRUGS, AND COSMETICS
Sec.
81.1 Provisional lists of color additives.
81.10 Termination of provisional listings of color additives.
81.30 Cancellation of certificates.
81.32 Limitation of certificates.
Authority: Secs. 701, 706 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 371, 376, 376 note).
21 CFR 81.1 Provisional lists of color additives.
The Commissioner of Food and Drugs finds that the following lists of
color additives are provisionally listed under section 203(b) of the
Color Additive Amendments of 1960 (sec. 203(b), 74 Stat. 405 (21 U.S.C.
376 note)). Except for color additives for which petitions have been
filed, progress reports are required by January 1, 1968, and at 6-month
intervals thereafter. Specifications for color additives listed in
paragraphs (a), (b), and (c) of this section appear in the respective
designated sections. The listing of color additives in this section is
not to be construed as a listing for surgical suture use unless color
additive petitions have been submitted for such use or the Commissioner
has been notified of studies underway to establish the safety of the
color additive for such use. The color additives listed in paragraphs
(a), (b), and (c) of this section may not be used in products which are
intended to be used in the area of the eye. The color additives listed
in paragraphs (a), (b), and (c) of this section are provisionally listed
until the closing dates set forth therein.
(a) Color additives previously and presently subject to certification
and provisionally listed for food, drug, and cosmetic use.
(b) Color additives previously and presently subject to certification
and provisionally listed for drug and cosmetic use.
(c) Color additives previously and presently subject to certification
and provisionally listed for use in externally applied drugs and
cosmetics.
(42 FR 15665, Mar. 22, 1977)
Editorial Note: For Federal Register citations affecting 81.1, see
the List of CFR Sections Affected in the Finding Aids section of this
volume.
21 CFR 81.10 Termination of provisional listings of color additives.
(a) Ext. D&C Yellow Nos. 9 and 10. These colors cannot be produced
with any assurance that they do not contain -naphthylamine as an
impurity. While it has been asserted that the two colors can be
produced without the impurity named, no method of analysis has been
suggested to establish the fact. -Naphthylamine is a known carcinogen;
therefore, there is no scientific evidence that will support a safe
tolerance for these colors in products to be used in contact with the
skin. The Commissioner of Food and Drugs, having concluded that such
action is necessary to protect the public health, hereby terminated the
provisional listing of Ext. D&C Yellow No. 9 and Ext. D&C Yellow No.
10.
(b) (Reserved)
(c) FD&C Red No. 1. Results of recent feeding tests of this color
additive have demonstrated it to be toxic upon ingestion:
(1) Groups of 50 rats are being fed diets containing FD&C Red No. 1
at levels of 5 percent, 2 percent, 1 percent, 0.5 percent, and 0
percent. At this stage of the tests, which have now been in progress
for from 15 months to 18 months, 116 animals from the 250 being fed FD&C
Red No. 1 at various levels and 27 of the 100 controls have died. Of
these, 11 being fed at the 5 percent level, 16 being fed at the 2
percent level, 11 being fed at the 1 percent level, and 2 being fed at
the 0.5 percent level, have shown liver damage. None of the controls
that have died have shown liver damage.
(2) Groups of 100 mice are being fed diets containing 2 percent, 1
percent, 0.5 percent, and 0.1 percent FD&C Red No. 1, with 400 mice as
controls. All mice on dosage levels of 2 percent and 1 percent died
before the seventieth week. Gross liver damage has been observed in all
groups fed at the 0.5 percent diet and above.
(3) Groups of 4 dogs are being fed diets containing 2 percent, 1
percent, 0.25 percent, and 0 percent FD&C Red No. 1. Three of the dogs
on the 2 percent dosage level died before 32 weeks; the other is
living. Three of the dogs on the 1 percent dosage level died or were
sacrificed within 13 months. All deceased or sacrificed dogs have shown
liver damage grossly and/or microscopically. Deceased dogs on the 1
percent and 2 percent dosage level showed poor physical condition.
The Commissioner of Food and Drugs having concluded that ingestion of
this color additive over a long period of time would be unsafe, and in
order to protect the public health, hereby terminates the provisional
listing of FD&C Red No. 1 for use in foods, drugs, and cosmetics.
(d) FD&C Red No. 4. Feeding tests of this color additive have been
conducted with three species:
(1) Rats of the Osborne-Mendel and Sprague-Dawley strains were fed
FD&C Red No. 4 for 2 years at levels of 5 percent, 2 percent, 1
percent, and 0.5 percent of the diet. No effect was found.
(2) Mice of the C3Hf and C57BL strains were fed FD&C Red No. 4 for 2
years at levels of 2 percent and 1 percent of the diet. No effect was
found.
(3) Dogs were fed FD&C Red No. 4 at levels of 2 percent and 1
percent of the diet. Adverse effects were found at both levels in the
urinary bladder and in the adrenals. Three dogs of five fed on the
2-percent level died after 6 months, 9 months, and 5 1/2 years on the
test. Two of the dogs on the 2-percent level and all five of the dogs
on the 1-percent level survived to the completion of the 7 year study.
The Commissioner of Food and Drugs has concluded that available data
do not permit the establishment of a safe level of use of this color
additive in food, ingested drugs and ingested cosmetics. In order to
protect the public health, the Commissioner hereby terminates the
provisional listing of FD&C Red No. 4 for use in food and ingested
drugs. The Commissioner has previously terminated the provisional
listing of FD&C Red No. 4 for use in ingested cosmetics. FD&C Red No.
4 is listed for use in externally applied drugs and cosmetics by
74.1304 and 74.2304 of this chapter, respectively. Section 82.304 of
this chapter is retained in part 82 of this chapter to permit the use of
lakes of FD&C Red No. 4 in externally applied drugs and cosmetics.
(e) FD&C Violet No. 1. The Commissioner of Food and Drugs, in order
to protect the public health, hereby terminates the provisional listing
of FD&C Violet No. 1 for use in foods, drugs, and cosmetics.
(f) FD&C Red No. 2. The Commissioner of Food and Drugs, in order to
protect the public health, hereby terminates the provisional listing of
FD&C Red No. 2 for use in food, drugs, and cosmetics.
(g) Carbon black (prepared by the ''impingement'' or ''channel''
process). The Commissioner of Food and Drugs, in order to protect the
public health, hereby terminates the provisional listing of carbon black
(prepared by the impingement or channel process) for use in food, drugs,
and cosmetics.
(h) D&C Red Nos. 10, 11, 12, and 13. The petition for these color
additives was withdrawn so that there no longer exists a basis for their
continued provisional listing. In addition, the Commissioner has
learned of the possible contamination of D&C Red No. 10, D&C Red No.
11, D&C Red No. 12, and D&C Red No. 13 with -naphthyl- amine. The
Commissioner concludes that these colors cannot be produced with any
reasonable assurance that they will not contain -naphthylamine as an
impurity or not yield -naphthylamine from the metabolism of subsidiary
colors present in them. -Naphthylamine is a known carcinogen;
therefore, there is no scientific evidence that will support a safe
tolerance for these colors in drugs or cosmetics. The Commissioner of
Food and Drugs, upon withdrawal of the petition for their use and in
order to protect the public health, hereby terminates the provisional
listing of D&C Red No. 10, D&C Red No. 11, D&C Red No. 12, and D&C
Red No. 13 for use in drugs and cosmetics, effective December 13, 1977.
(i) Ext. D&C Yellow No. 1. The Commissioner has learned of the
contamination of Ext. D&C Yellow No. 1 with 4-aminobiphenyl. The
Commissioner concludes that this color cannot be produced with any
reasonable assurance that it will not contain 4-aminobiphenyl as an
impurity or not yield benzidine from the decomposition of a subsidiary
reaction product that might be present in the color. 4-Aminobiphenyl
and benzidine are known carcinogens; therefore, there is no scientific
evidence that will support a safe tolerance for these colors in drugs or
cosmetics. In addition, insufficient data have been submitted to permit
establishment of appropriate specifications for the batch certification
of the color. The Commissioner of Food and Drugs, in order to protect
the public health, hereby terminates the provisional listing of Ext.
D&C Yellow No. 1 for use in externally applied drugs and cosmetics,
effective December 13, 1977.
(j) Graphite. Data have been developed that show the contamination
of graphite with polynuclear aromatic hydrocarbons (PNA's). There is no
reasonable assurance this color can be produced so that it will not
contain PNA's as an impurity. The presence of certain PNA's in graphite
would indicate that PNA's known to be carcinogenic to animals and humans
may also be present. Therefore, there is no scientific evidence that
will support a safe tolerance for this color in drugs or cosmetics. The
Commissioner of Food and Drugs, in order to protect the public health,
hereby terminates the provisional listing of graphite for use in
externally applied cosmetics, effective November 29, 1977.
(k) Ext. D&C Green No. 1. The Commissioner concludes that there are
inadequate analytical methods to permit certification of the color
additive Ext. D&C Green No. 1. In addition, the Commissioner has found
that there was a failure to comply with the conditions attached to the
postponement of the closing date in accordance with section 203(a)(2) of
the transitional provisions of the Color Additive Amendments of 1960.
The Commissioner of Food and Drugs hereby terminates the provisional
listing of Ext. D&C Green No. 1 for use in externally applied drugs
and cosmetics, effective November 29, 1977.
(l) (Reserved)
(m) D&C Orange Nos. 10 and 11. In the absense of a petition to list
D&C Orange No. 10 and D&C Orange No. 11 for use in ingested drugs and
cosmetics, there no longer exists a basis for provisional listing for
such uses. Therefore, FDA is terminating the provisional listing of D&C
Orange No. 10 and D&C Orange No. 11 for use in ingested drugs and
cosmetics, effective April 28, 1981.
(n) D&C Blue No. 6. The Commissioner of Food and Drugs, having
concluded that unresolved questions remain concerning the chemistry of
unidentified minor components, hereby terminates the provisional listing
of D&C Blue No. 6 for use in drugs and cosmetics.
(o) D&C Green No. 6. In the absence of a petition to list D&C Green
No. 6 for use in ingested drugs and cosmetics, there no longer exists a
basis for provisional listing for such uses. Accordingly, the
Commissioner of Food and Drugs hereby terminates the provisional listing
of D&C Green No. 6 for use in ingested drugs and cosmetics, effective
March 27, 1981.
(p) (Reserved)
(q)(1) D&C Red No. 19 and D&C Red No. 37. Having concluded that,
when ingested, D&C Red No. 19 causes cancer in rats and mice, the
agency hereby terminates the provisional listings of D&C Red No. 19 and
chemically related D&C Red No. 37 for use in ingested drugs and
ingested cosmetics, effective February 4, 1983.
(2) D&C Red No. 37. In the absence of a petition to list D&C Red No.
37 for external uses, there no longer exists a basis for provisional
listing for such uses. Accordingly, the Commissioner of Food and Drugs
hereby terminates the provisional listings of D&C Red No. 37 for use in
externally applied drugs and cosmetics, effective June 6, 1986.
(r) (Reserved)
(s) D&C Orange No. 17. Having concluded that, when ingested, D&C
Orange No. 17 causes cancer in rats and mice, the agency has terminated
the provisional listing of D&C Orange No. 17 for use in ingested drugs
and ingested cosmetics, effective March 31, 1983.
(t) D&C Red No. 8 and D&C Red No. 9. In the absence of a petition
to list D&C Red No. 8 and D&C Red No. 9 for mouthwash, dentifrices,
and ingested drugs, except ingested drug lip products, there no longer
exists a basis for provisional listing for such uses. Accordingly, the
Commissioner of Food and Drugs hereby terminates the provisional
listings of D&C Red No. 8 and D&C Red No. 9 for use in mouthwash,
dentifrices, and ingested drugs, except ingested drug lip products,
effective January 6, 1987.
(u) FD&C Red No. 3. Having concluded that FD&C Red No. 3 causes
cancer in rats, the agency hereby terminates the provisional listing of
FD&C Red No. 3 for use in cosmetics and externally applied drugs and
the provisional listing of the lakes of FD&C Red No. 3 for use in food,
drug, and cosmetic products, effective January 29, 1990.
(42 FR 15665, Mar. 22, 1977)
Editorial Note: For Federal Register citations affecting 81.10, see
the List of CFR Sections Affected in the Finding Aids section of this
volume.
21 CFR 81.30 Cancellation of certificates.
(a) Certificates issued heretofore for colors being removed from the
provisional list ( 81.10(a)) are cancelled and of no effect after
December 1, 1960, and use of such color additives in drugs or cosmetics
after that date will result in adulteration.
(b)(1) Certificates issued heretofore for the color additive
designated FD&C Red No. 1 are cancelled as of the date of the
publication of this Order, and use of this color additive in the
manufacture of foods, drugs, or cosmetics after that date will result in
adulteration.
(2) The Commissioner finds that no action needs to be taken to remove
foods, drugs, and cosmetics containing this color additive from the
market on the basis of the scientific evidence before him, taking into
account that the additive is not an acute toxic substance and that it is
only used in small amounts in foods, drugs, and cosmetics.
(c) Certificates issued for FD&C Red No. 4 and all mixtures
containing this color additive are cancelled and have no effect after
September 23, 1976 insofar as food, ingested drugs, and ingested
cosmetics are concerned, and use of this color additive in the
manufacture of food, ingested drugs, and ingested cosmetics after this
date will result in adulteration. The certificates shall continue in
effect for the use of FD&C Red No. 4 in externally applied drugs and
cosmetics. The Commissioner finds, on the basis of the scientific
evidence before him that no action has to be taken to remove from the
market food, ingested drugs and ingested cosmetics containing the color
additive.
(d) Certificates issued for the following color additives and all
mixtures containing these color additives are canceled and have no
effect after October 4, 1966, and use of such color additives in the
manufacture of foods, drugs, or cosmetics after that date will result in
adulteration:
FD&C Green No. 1.
FD&C Green No. 2.
D&C Green No. 7.
D&C Red No. 5.
D&C Red No. 14.
D&C Red No. 18.
D&C Red No. 24.
D&C Red No. 29.
D&C Red No. 35.
D&C Red No. 38.
D&C Orange No. 3.
D&C Orange No. 8.
D&C Orange No. 14.
D&C Orange No. 15.
D&C Orange No. 16.
D&C Blue No. 7.
D&C Black No. 1.
Ext. D&C Yellow No. 5.
Ext. D&C Yellow No. 6.
Ext. D&C Red No. 1.
Ext. D&C Red No. 2.
Ext. D&C Red No. 3.
Ext. D&C Red No. 10.
Ext. D&C Red No. 11.
Ext. D&C Red No. 13.
Ext. D&C Red No. 14.
Ext. D&C Red No. 15.
Ext. D&C Blue No. 1.
Ext. D&C Blue No. 4.
Ext. D&C Orange No. 1.
Ext. D&C Orange No. 4.
(e) Certificates issued for the following color additives and all
mixtures containing these color additives are canceled and have no
effect after July 1, 1968, and use of such color additives in the
manufacture of drugs or cosmetics after that date will result in
adulteration:
Ext. D&C Yellow No. 3.
Ext. D&C Red No. 8
Ext. D&C Orange No. 3.
(f) Certificates issued for D&C Yellow No. 11 and all mixtures
containing this color additive are canceled and have no effect after
April 30, 1968, insofar as ingested use is concerned. Use of this color
additive in the manufacture of ingested drugs or cosmetics subject to
ingestion after that date will result in adulteration.
(g) Certificates issued for D&C Red No. 17, D&C Red No. 31, D&C Red
No. 34, D&C Orange No. 4, and D&C Violet No. 2, and all mixtures
containing these color additives, are canceled and have no effect after
December 31, 1968, insofar as ingested use is concerned. Use of these
color additives in the manufacture of ingested drugs or cosmetics
subject to ingestion after that date will result in adulteration.
(h)(1) Certificates issued for FD&C Violet No. 1 and all mixtures
containing this color additive are canceled and have no effect after
April 10, 1973, and use of such color additive in the manufacture of
foods, drugs, or cosmetics after that date will result in adulteration.
(2) The Commissioner finds that no action needs to be taken to remove
foods, drugs, and cosmetics containing this color additive from the
market on the basis of the scientific evidence before him.
(i) Certificates issued prior to July 1, 1968, for D&C Brown No. 1
and Ext. D&C Violet No. 2 and all mixtures containing these colors are
canceled and have no effect. This cancellation does not apply to
certificates issued after March 15, 1973, for D&C Brown No. 1 and Ext.
D&C Violet No. 2, which are provisionally listed in 81.1(b) and (c)
respectively for coloring externally applied cosmetics.
(j)(1) Certificates issued for FD&C Red No. 2 and all mixtures
containing this color additive are canceled and have no effect after
January 28, 1976, and use of this color additive in the manufacture of
food, drugs, or cosmetics after this date will result in adulteration.
(2) The Commissioner finds, on the basis of the scientific evidence
before him, that no action has to be taken to remove from the market
food, drugs, and cosmetics containing the color additive.
(k)(1) Certificates issued for D&C Red No. 10, D&C Red No. 11, D&C
Red No. 12, and D&C Red No. 13, their lakes and all mixtures
containing these color additives or their lakes are cancelled and have
no effect after December 13, 1977, and use of these color additivies in
the manufacture of drugs or cosmetics after this date will result in
adulteration.
(2) The Commissioner finds, on the basis of the scientific evidence
before him, that no action has to be taken to remove from the market,
drug and cosmetic products containing the color additives.
(l)(1) Certificates issued for Ext. D&C Yellow No. 1 and all
mixtures containing this color additive are cancelled and have no effect
after December 13, 1977, and use of this color additive in the
manufacture of drugs or cosmetics after this date will result in
adulteration.
(2) The Commissioner finds, on the basis of the scientific evidence
before him, that no action has to be taken to remove from the market
drugs and cosmetics containing the color additive.
(m)(1) Certificates issued for Ext. D&C Green No. 1 and all
mixtures containing this color additive are cancelled and have no effect
after November 29, 1977, and use of the color additive in the
manufacture of drugs or cosmetics after this date will result in
adulteration.
(2) The Commissioner finds, on the basis of the scientific evidence
before him, that no action has to be taken to remove from the market
drugs and cosmetics containing the color additive.
(n)(1) Certificates issued for D&C Orange No. 10, D&C Orange No.
11, their lakes, and all mixtures containing these color additives are
cancelled and have no effect as pertains to their use in ingested drugs
and cosmetics after April 28, 1981 and use of these color additives in
the manufacture of ingested drugs or cosmetics after this date will
result in adulteration.
(2) The agency finds, on the basis of the scientific evidence before
it, that no action has to be taken to remove from the market drugs and
cosmetics to which the color additives were added on or before April 28,
1981.
(o)(1) Certificates issued for D&C Blue No. 6 and all mixtures
containing this color additive are cancelled insofar as its use in drugs
and cosmetics is concerned and have no effect after December 13, 1977,
and use of the color additive in the manufacture of drugs or cosmetics
after this date will result in adulteration. The color will continue to
be certified for use in the coloring of surgical sutures.
(2) The Commissioner finds, on the basis of the scientific evidence
before him, that no action has to be taken to remove from the market
drugs and cosmetics containing the color additive.
(p)(1) Certificates issued for D&C Green No. 6, its lakes and all
mixtures containing this color additive are cancelled and have no effect
as pertains to their use in ingested drugs and cosmetics after May 4,
1982 and use of the color additive in the manufacture of ingested drugs
or cosmetics after this date will result in adulteration.
(2) The agency finds, on the basis of the scientific evidence before
it, that no action has to be taken to remove from the market ingested
drugs and cosmetics containing the color additive.
(q) (Reserved)
(r)(1) Certificates issued for D&C Red No. 19 and D&C Red No. 37,
their lakes, and all mixtures containing these color additives are
cancelled and have no effect as pertains to their use in ingested drugs
and cosmetics after February 4, 1983, and use of these color additives
in the manufacture of ingested drugs or cosmetics after this date will
result in adulteration.
(2) The agency finds, on the scientific evidence before it, that no
action has to be taken to remove from the market ingested drugs and
cosmetics to which D&C Red No. 19 and D&C Red No. 37 were added on or
before February 4, 1983, or externally applied drugs and cosmetics to
which D&C Red No. 37 was added on or before June 6, 1986.
(3) Certificates issued for D&C Red No. 37, its lakes, and all
mixtures containing this color additive are cancelled and have no effect
as pertains to its use in externally applied drugs and cosmetics after
June 6, 1986, and use of this color additive in the manufacture of
externally applied drugs or cosmetics after this date will result in
adulteration.
(4) Certificates issued for D&C Red No. 19, its lakes, and all
mixtures containing this color additive are cancelled and have no effect
as pertains to its use in externally applied drugs and cosmetics after
July 15, 1988, and use of this color in the manufacture of externally
applied drugs or cosmetics after this date will result in adulteration.
(5) The agency finds, on the scientific evidence before it, that no
action has to be taken to remove from the market externally applied
drugs and cosmetics to which D&C Red No. 19 was added on or before July
15, 1988.
(s)(1) Certificates issued for D&C Red No. 8 and D&C Red No. 9,
their lakes, and all mixtures containing these color additives are
canceled and have no effect as pertains to their use in mouthwash,
dentifrices, and ingested drugs, except ingested drug lip products,
after January 6, 1987, and use of these color additives in the
manufacture of mouthwash, dentifrices, and ingested drugs, except
ingested drug lip products, after this date will result in adulteration.
(2) The agency finds, on the basis of the scientific evidence before
it, that no action has to be taken to remove from the market mouthwash,
dentifrices, and ingested drugs to which the color additives were added
on or before January 6, 1987. Ingested drug lip products, however, are
regulated for use in 74.1308 and 74.1309.
(3) Certificates issued for D&C Red No. 8, and D&C Red No. 9, their
lakes, and all mixtures containing these color additives are cancelled
and have no effect as pertains to their use in ingested drug and
cosmetic lip products and in externally applied drugs and cosmetics
after July 15, 1988, and use of these color additives in the manufacture
of ingested drugs and cosmetic lip products and in externally applied
drugs and cosmetics after this date will result in adulteration.
(4) The agency finds, on the basis of the scientific evidence before
it, that no action has to be taken to remove from the market ingested
drug and cosmetic lip products and externally applied drugs and
cosmetics to which the color additives were added on or before July 15,
1988.
(t)(1) Certificates issued for D&C Orange No. 17, its lakes, and all
mixtures containing this color additive are cancelled and have no effect
as pertains to its use in ingested drugs and ingested cosmetics after
March 31, 1983 and use of this color additive in the manufacture of
ingested drugs or ingested cosmetics after this date will result in
adulteration.
(2) The agency finds, on the scientific evidence before it, that no
action has to be taken to remove from the market drugs and cosmetics to
which the color additive was added on or before March 31, 1983.
(3) Certificates issued for D&C Orange No. 17, its lakes and all
mixtures containing this color additive are cancelled and have no effect
as pertains to its use in externally applied drugs and cosmetics after
July 15, 1988, and use of this color in the manufacture of externally
applied drugs or cosmetics after this date will result in adulteration.
(4) The agency finds, on the scientific evidence before it, that no
action has to be taken to remove from the market externally applied
drugs and cosmetics to which D&C Orange No. 17 was added on or before
July 15, 1988.
(u)(1) Certificates issued for FD&C Red No. 3 and all mixtures
containing this color additive are cancelled and have no effect as
pertains to their use in cosmetics and externally applied drugs after
January 29, 1990. Certificates issued for FD&C Red No. 3 lakes and all
mixtures containing these lakes are cancelled and have no effect as
pertains to their use in food, drugs, and cosmetics after January 29,
1990. Certificates issued for D&C Red No. 3 lakes and all mixtures
containing those lakes are cancelled and have no effect as pertains to
their use in drugs and cosmetics after January 29, 1990. Use of this
color additve in the manufacture of cosmetics and of externally applied
drugs and any use of the lakes of FD&C Red No. 3 (including the lakes
of D&C Red No. 3) after this date will result in adulteration.
(2) The agency finds, on the scientific evidence before it, that no
action must be taken to remove from the market food, drugs, and
cosmetics to which the provisionally listed color additive or its lakes
were added on or before January 29, 1990.
(42 FR 15665, Mar. 22, 1977)
Editorial Note: For Federal Register citations affecting 81.30, see
the List of CFR Sections Affected in the Finding Aids section of this
volume.
21 CFR 81.32 Limitation of certificates.
Certificates issued for the color additives listed in 81.25 and for
all mixtures containing these color additives are limited to the
conditions stated in 81.25. The use of these color additives in drugs
and cosmetics in any other manner will result in adulteration. Each of
these color additives shall bear a label statement of the tolerance and
use limitations applicable to it.
(44 FR 48966, Aug. 21, 1979)
21 CFR 81.32 PART 82 -- LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONS
21 CFR 81.32 Subpart A -- General Provisions
Sec.
82.3 Definitions.
82.5 General specifications for straight colors.
82.6 Certifiable mixtures.
21 CFR 81.32 Subpart B -- Foods, Drugs, and Cosmetics
82.50 General.
82.51 Lakes (FD&C).
82.101 FD&C Blue No. 1.
82.102 FD&C Blue No. 2.
82.203 FD&C Green No. 3.
82.304 FD&C Red No. 4.
82.705 FD&C Yellow No. 5.
82.706 FD&C Yellow No. 6.
21 CFR 81.32 Subpart C -- Drugs and Cosmetics
82.1050 General.
82.1051 Lakes (D&C).
82.1104 D&C Blue No. 4.
82.1205 D&C Green No. 5.
82.1206 D&C Green No. 6.
82.1254 D&C Orange No. 4.
82.1255 D&C Orange No. 5.
82.1260 D&C Orange No. 10.
82.1261 D&C Orange No. 11.
82.1306 D&C Red No. 6.
82.1307 D&C Red No. 7.
82.1317 D&C Red No. 17.
82.1321 D&C Red No. 21.
82.1322 D&C Red No. 22.
82.1327 D&C Red No. 27.
82.1328 D&C Red No. 28.
82.1330 D&C Red No. 30.
82.1331 D&C Red No. 31.
82.1333 D&C Red No. 33.
82.1334 D&C Red No. 34.
82.1336 D&C Red No. 36.
82.1602 D&C Violet No. 2.
82.1707 D&C Yellow No. 7.
82.1708 D&C Yellow No. 8.
82.1710 D&C Yellow No. 10.
21 CFR 81.32 Subpart D -- Externally Applied Drugs and Cosmetics
82.2050 General.
82.2051 Lakes (Ext. D&C).
82.2707a Ext. D&C Yellow No. 7.
Authority: Secs. 701, 706 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 371, 376, 376 note).
Source: 42 FR 15669, Mar. 22, 1977, unless otherwise noted.
21 CFR 81.32 Subpart A -- General Provisions
21 CFR 82.3 Definitions.
For the purposes of this part:
(a) -- (f) (Reserved)
(g) The term alumina means a suspension in water of precipitated
aluminum hydroxide.
(h) The term blanc fixe means a suspension in water of precipitated
barium sulfate.
(i) The term gloss white means a suspension in water of
co-precipitated aluminum hydroxide and barium sulfate.
(j) The term mixed oxides means the sum of the quantities of
aluminum, iron, calcium, and magnesium (in whatever combination they may
exist in a coal-tar color) calculated as aluminum trioxide, ferric
oxide, calcium oxide, and magnesium oxide.
(k) -- (m) (Reserved)
(n) The term externally applied drugs and cosmetics means drugs and
cosmetics which are applied only to external parts of the body and not
to the lips or any body surface covered by mucous membrane.
(o) -- (p) (Reserved)
(q) The definitions and interpretations of terms contained in section
201 of the Federal Food, Drug, and Cosmetic Act shall be applicable also
to such terms when used in this part.
21 CFR 82.5 General specifications for straight colors.
No batch of a straight color listed in subpart B, C, or D shall be
certified under this part unless:
(a) It is free from all impurities (other than those named in
paragraph (b) of this section or in the specifications set forth in such
paragraph for such color) to the extent that such impurities can be
avoided by good manufacturing practice.
(b) It conforms to the following specifications:
(1) In the case of a straight color listed in subpart B:
(i) Lead (as Pb), not more than 0.001 percent.
(ii) Arsenic (as As2O3), not more than 0.00014 percent.
(iii) Heavy metals (except Pb and As) (by precipitation as sulfides),
not more than trace.
(2) In the case of a straight color listed in subpart C or D:
(i) Lead (as Pb), not more than 0.002 percent.
(ii) Arsenic (as As2O3), not more than 0.0002 percent.
(iii) Heavy metals (except Pb and As) (by precipitation as sulfides),
not more than 0.003 percent.
(3) In the case of a straight color which contains a barium salt
listed in subpart C or D -- soluble barium (in dilute HCl) (as BaCl2),
not more than 0.05 percent.
21 CFR 82.6 Certifiable mixtures.
(a) A batch of a mixture which contains no straight color listed in
subpart C or D may be certified for use in food, drugs and cosmetics,
if:
(1) Each coal-tar color used as an ingredient in mixing such batch is
from a previously certified batch and such color has not changed in
composition in any manner whatever since such previous certification,
except by mixing into such batch of mixture;
(2) Each diluent in such batch of mixture is harmless and suitable
for use therein; and
(3) No diluent (except resins, natural gum, pectin and, in the case
of mixtures which are aqueous solutions or aqueous pastes, sodium
benzoate in a quantity of not more than 1/10 of 1 percent) in such
mixture is a nonnutritive substance, unless such mixture is for external
application to shell eggs, or for use in coloring a food specified in
the requests for certification of such batch submitted in accordance
with 80.21 of this chapter, and such diluent, in the usual process of
manufacturing such food, is removed and does not become a component of
such food.
(b) A batch of a mixture which contains no straight color listed in
subpart D, or which contains a diluent not permitted by paragraph (a)(3)
of this section, may be certified in accordance with the provisions of
this part, for use only in drugs and cosmetics, if:
(1) Each coal-tar color used as an ingredient in mixing such batch is
from a previously certified batch and such color has not changed in
composition in any manner whatever since such previous certification,
except by mixing into such batch of mixture.
(2) Each diluent in such batch of mixture is harmless and suitable
for use therein.
(c) A batch of a mixture which contains a straight color listed in
subpart D may be certified in accordance with the provisions of this
part, for use only in externally applied drugs and cosmetics, if:
(1) Each coal-tar color used as an ingredient in mixing such batch is
from a previously certified batch and such color has not changed in
composition in any manner whatever since such previous certification,
except by mixing into such batch of mixture; and
(2) Each diluent in such batch of mixture is harmless and suitable
for use therein.
21 CFR 82.6 Subpart B -- Foods, Drugs, and Cosmetics
21 CFR 82.50 General.
A batch of a straight color listed in this subpart may be certified,
in accordance with the provisions of the regulations in this part, for
use in food, drugs, and cosmetics, if such batch conforms to the
requirements of 82.5 and to the specifications in this subpart set
forth for such color.
21 CFR 82.51 Lakes (FD&C).
(a)(1) General. Any lake made by extending on a substratum of
alumina, a salt prepared from one of the certified water-soluble
straight colors hereinbefore listed in this subpart by combining such
color with the basic radical aluminum or calcium.
(2) Specifications.
Prepared from previously certified colors listed in this subpart.
Soluble chlorides and sulfates (as sodium salts), not more than 2.0
percent.
Inorganic matter, insoluble HCl, not more than 0.5 percent.
(b) Each lake made as prescribed in paragraph (a) of this section
shall be considered to be a straight color and to be listed therein
under the name which is formed as follows:
(1) The listed name of the color from which the lake is prepared;
(2) The name of the basic radical combined in such color; and
(3) The word ''Lake''.
(For example, the name of a lake prepared by extending the aluminum
salt prepared from FD&C Blue No. 1 upon the substratum would be FD&C
Blue No. 1 -- Aluminum Lake.)
21 CFR 82.101 FD&C Blue No. 1.
The color additive FD&C Blue No. 1 shall conform in identity and
specifications to the requirements of 74.101(a)(1) and (b) of this
chapter.
21 CFR 82.102 FD&C Blue No. 2.
The color additive FD&C Blue No. 2 shall conform in identity and
specifications to the requirements of 74.102(a)(1) and (b) of this
chapter.
(48 FR 5261, Feb. 4, 1983)
21 CFR 82.203 FD&C Green No. 3.
The color additive FD&C Green No. 3 shall conform in identity and
specifications to the requirements of 74.203(a)(1) and (b) of this
chapter.
(47 FR 52144, Nov. 19, 1982)
21 CFR 82.304 FD&C Red No. 4.
The color additive FD&C Red No. 4 shall conform in identity and
specifications to the requirements of 74.1304(a)(1) and (b) of this
chapter. FD&C Red No. 4 is restricted to use in externally applied
drugs and cosmetics.
21 CFR 82.705 FD&C Yellow No. 5.
The color additive FD&C Yellow No. 5 shall conform in identity and
specifications to the requirements of 74.705 (a)(1) and (b) of this
chapter.
(51 FR 24519, July 7, 1986)
21 CFR 82.706 FD&C Yellow No. 6.
(a) The color additive FD&C Yellow No. 6 shall conform in identity
and specifications to the requirements of 74.706 (a)(1) and (b) of this
chapter.
(b) All lakes including current D&C external and D&C lakes of FD&C
Yellow No. 6 shall be manufactured from previously certified batches of
the straight color additive.
(52 FR 21509, June 8, 1987)
21 CFR 82.706 Subpart C -- Drugs and Cosmetics
21 CFR 82.1050 General.
A batch of a straight color listed in this subpart may be certified,
in accordance with the provisions of this part, for use only in drugs
and cosmetics, if such batch conforms to the requirements of 82.5 and
to the specifications set forth in this subpart for such color.
21 CFR 82.1051 Lakes (D&C).
(a)(1) General. Any lake, other than those listed in subpart B, made
by extending on a substratum of alumina, blanc fixe, gloss white, clay,
titanium dioxide, zinc oxide, talc, rosin, aluminum benzoate, calcium
carbonate, or any combination of two or more of these, (i) one of the
straight colors (except lakes) listed in subpart B or hereinbefore
listed in this subpart, which color is a salt in which is combined the
basic radical sodium, potassium, aluminum, barium, calcium, strontium,
or zirconium; or (ii) a salt prepared from one of the straight colors
(except lakes) listed in subpart B, or hereinbefore listed in this
subpart, by combining such color with the basic radical sodium,
potassium, aluminum, barium, calcium, strontium, or zirconium.
(2) Specifications.
Ether extracts, not more than 0.5 percent.
Soluble chlorides and sulfates (as sodium salts), not more than 3.0
percent.
Intermediates, not more than 0.2 percent.
(b) Each lake made as prescribed in paragraph (a) of this section
shall be considered to be a straight color and to be listed therein
under the name which is formed as follows:
(1) The listed name of the color from which the lake is prepared,
except that if such name contains the symbol ''FD&C'' such symbol shall
be changed to ''D&C'';
(2) The name of the basic radical combined in such color; and
(3) The word ''Lake.''
(For example, the name of a lake prepared by extending the color D&C
Red No. 9 upon a substratum is ''D&C Red No. 9 -- Barium Lake'', and a
lake prepared by extending the aluminum salt prepared from FD&C Green
No. 1 upon a substratum other than alumina is ''D&C Green No. 1 --
Aluminum Lake''.)
21 CFR 82.1104 D&C Blue No. 4.
The color additive D&C Blue No. 4 shall conform in identity and
specifications to the requirements of 74.1104(a)(1) and (b) of this
chapter. D&C Blue No. 4 is restricted to use in externally applied
drugs and cosmetics.
21 CFR 82.1205 D&C Green No. 5.
The color additive D&C Green No. 5 shall conform in identity and
specifications to the requirements of 74.1205(a)(1) and (b)(2) of this
chapter.
(47 FR 24285, June 4, 1982)
21 CFR 82.1206 D&C Green No. 6.
The color additive D&C Green No. 6 shall conform in identity and
specifications to the requirements of 74.1206 (a) and (b) of this
chapter. D&C Green No. 6 is restricted to use in externally applied
drugs and cosmetics.
(47 FR 14147, Apr. 2, 1982, as amended at 51 FR 9785, Mar. 21, 1986)
21 CFR 82.1254 D&C Orange No. 4.
The color additive D&C Orange No. 4 shall conform in identity and
specifications to the requirements of 74.1254(a)(1) and (b) of this
chapter. D&C Orange No. 4 is restricted to use in externally applied
drugs and cosmetics.
(42 FR 52396, Sept. 30, 1977)
21 CFR 82.1255 D&C Orange No. 5.
(a) The color additive D&C Orange No. 5 shall conform in identity
and specifications to the requirements of 74.1255(a)(1) and (b) of this
chapter. D&C Orange No. 5 is restricted to the uses described in this
section.
(b) The color additive D&C Orange No. 5. may be safely used for
coloring externally applied drugs in amounts not exceeding 5 milligrams
per daily dose of the drug. The color additive D&C Orange No. 5 may be
safely used for coloring lipsticks and other cosmetics intended to be
applied to the lips in amounts not exceeding 5.0 percent by weight of
the finished cosmetic products, and for coloring mouthwashes,
dentifrices, and externally applied cosmetics in amounts consistent with
current good manufacturing practice.
(49 FR 13343, Apr. 4, 1984)
21 CFR 82.1260 D&C Orange No. 10.
The color additive D&C Orange No. 10 shall conform in identity and
specifications to the requirements to 74.1260(a)(1) and (b) of this
chapter. D&C Orange No. 10 is restricted to use in externally applied
drugs and cosmetics.
(46 FR 18954, Mar. 27, 1981)
21 CFR 82.1261 D&C Orange No. 11.
The color additive D&C Orange No. 11 shall conform in identity and
specifications to the requirements of 74.1261(a)(1) and (b) of this
chapter. D&C Orange No. 11 is restricted to use in externally applied
drugs and cosmetics.
(46 FR 18954, Mar. 27, 1981)
21 CFR 82.1306 D&C Red No. 6.
(a) The color additive D&C Red No. 6 shall conform in identity and
specifications to the requirements of 74.1306 (a)(1) and (b) of this
chapter.
(b) The color additive D&C Red No. 6 may be safely used for coloring
drugs such that the combined total of D&C Red No. 6 and D&C Red No. 7
does not exceed 5 milligrams per daily dose of the drug.
(47 FR 57691, Dec. 28, 1982)
21 CFR 82.1307 D&C Red No. 7.
(a) The color additive D&C Red No. 7 shall conform in identity and
specifications to the requirements of 74.1307 (a)(1) and (b) of this
chapter.
(b) The color additive D&C Red No. 7 may be safely used for coloring
drugs such that the combined total of D&C Red No. 6 and D&C Red No. 7
does not exceed 5 milligrams per daily dose of the drug.
(47 FR 57691, Dec. 28, 1982)
21 CFR 82.1317 D&C Red No. 17.
The color additive D&C Red No. 17 shall conform in identity and
specifications to the requirements of 74.1317 (a)(1) and (b) of this
chapter. D&C Red No. 17 is restricted to use in externally applied
drugs and cosmetics.
21 CFR 82.1321 D&C Red No. 21.
The color additive D&C Red No. 21 shall conform in identity and
specifications to the requirements of 74.1321 (a)(1) and (b) of this
chapter.
(47 FR 53847, Nov. 30, 1982)
21 CFR 82.1322 D&C Red No. 22.
The color additive D&C Red No. 22 shall conform in identity and
specifications to the requirements of 74.1322 (a)(1) and (b) of this
chapter.
(47 FR 53847, Nov. 30, 1982)
21 CFR 82.1327 D&C Red No. 27.
The color additive D&C Red No. 27 shall conform in identity and
specifications to the requirements of 74.1327 (a)(1) and (b) of this
chapter.
(47 FR 42568, Sept. 28, 1982)
21 CFR 82.1328 D&C Red No. 28.
The color additive D&C Red No. 28 shall conform in identity and
specifications to the requirements of 74.1328 (a)(1) and (b) of this
chapter.
(47 FR 42568, Sept. 28, 1982)
21 CFR 82.1330 D&C Red No. 30.
The color additive D&C Red No. 30 shall conform in identity and
specifications to the requirements of 74.1330 (a)(1) and (b) of this
chapter.
(47 FR 22511, May 25, 1982)
21 CFR 82.1331 D&C Red No. 31.
The color additive D&C Red No. 31 shall conform in identity and
specifications to the requirements of 74.1331(a)(1) and (b) of this
chapter. D&C Red No. 31 is restricted to use in externally applied
drugs and cosmetics.
21 CFR 82.1333 D&C Red No. 33.
(a) The color additive D&C Red. No. 33 shall conform in identity and
specifications to the requirements of 74.1333(a) (1) and (b) of this
chapter.
(b) All lakes of D&C Red. No. 33 shall be manufactured from
previously certified batches of the straight color additive.
(53 FR 33121, Aug. 30, 1988)
21 CFR 82.1334 D&C Red No. 34.
Calcium salt of 3-hydroxy-4-((1-sulfo-2
-naphthalenyl)azol-2-naphthalenecarboxylic acid.
Sum of volatile matter (at 135 C) and chlorides and sulfates
(calculated as sodium salts), not more than 15 percent.
2-Amino-1-naphthalenesulfonic acid, calcium salt, not more than 0.2
percent.
3-Hydroxy-2-naphthoic acid, not more than 0.4 percent.
Subsidiary colors, not more than 4 percent.
Total color not less than 85 percent.
21 CFR 82.1336 D&C Red No. 36.
(a) The color additive D&C Red No. 36 shall conform in identity and
specifications to the requirements of 74.1336 (a)(1) and (b) of this
chapter.
(b) All lakes of D&C Red No. 36 shall be manufactured from
previously certified batches of the straight color additive.
(53 FR 29031, Aug. 2, 1988)
21 CFR 82.1602 D&C Violet No. 2.
The color additive D&C Violet No. 2 shall conform in identity and
specifications to the requirements of 74.1602(a)(1) and (b) of this
chapter.
21 CFR 82.1707 D&C Yellow No. 7.
The color additive D&C Yellow No. 7 shall conform in identity and
specifications to the requirements of 74.1707(a)(1) and (b) of this
chapter. D&C Yellow No. 7 is restricted to use in externally applied
drugs and cosmetics.
21 CFR 82.1708 D&C Yellow No. 8.
The color additive D&C Yellow No. 8 shall conform in identity and
specifications to the requirements of 74.1707(a)(1) and (b) of this
chapter. D&C Yellow No. 8 is restricted to use in externally applied
drugs and cosmetics.
21 CFR 82.1710 D&C Yellow No. 10.
The color additive D&C Yellow No. 10 shall conform in identity and
specifications to the requirements of 74.1710(a)(1) and (b) of this
chapter.
(48 FR 39220, Aug. 30, 1983)
21 CFR 82.1710 Subpart D -- Externally Applied Drugs and Cosmetics
21 CFR 82.2050 General.
A batch of a straight color listed in this subpart may be certified,
in accordance with the provisions of this part, for use in externally
applied drugs and cosmetics, if such batch conforms to the requirements
of 82.5 and to the specifications set forth in this subpart for such
color.
21 CFR 82.2051 Lakes (Ext. D&C).
(a)(1) General. Any lake made by extending on a substratum of
alumina, blanc fixe, gloss white, clay, titanium dioxide, zinc oxide,
talc, rosin, aluminum benzoate, calcium carbonate, or on any combination
of two or more of these (i) one of the straight colors hereinbefore
listed in this subpart, which color is a salt in which is combined the
basic radical sodium, potassium, barium, or calcium; or (ii) a salt
prepared from one of the straight colors hereinbefore listed in this
subpart by combining such color with the basic radical sodium,
potassium, aluminum, barium, calcium, strontium, or zirconium.
(2) Specifications.
Ether extracts, not more than 0.5 percent.
Soluble chlorides and sulfates (as sodium salts), not more than 3.0
percent.
Intermediates, not more than 0.2 percent.
(b) Each lake made as prescribed in paragraph (a) of this section
shall be considered to be a straight color and to be listed therein
under the name which is formed as follows:
(1) The listed name of the color from which the lake is prepared;
(2) The name of the basic radical combined in such color; and
(3) The word ''Lake.'' (For example, the name of a lake prepared by
extending the color Ext. D&C Yellow No. 2 upon a substratum is ''Ext.
D&C Yellow No. 2 -- Calcium Lake,'' and a lake prepared by extending the
barium salt prepared from Ext. D&C Red No. 2 upon the substratum is
''Ext. D&C Red No. 2 -- Barium Lake.'')
21 CFR 82.2707a Ext. D&C Yellow No. 7.
The color additive Ext. D&C Yellow No. 7 shall conform in identity
with specifications to the requirements of 74.1707a(a)(1) and (b) of
this chapter. Ext. D&C Yellow No. 7 is restricted to use in externally
applied drugs and cosmetics.
21 CFR 82.2707a PARTS 83-99 (RESERVED)
21 CFR 82.2707a FINDING AIDS
A list of CFR titles, subtitles, chapters, subchapters and parts and
an alphabetical list of agencies publishing in the CFR are included in
the CFR Index and Finding Aids volume to the Code of Federal Regulations
which is published separately and revised annually.
Material Approved for Incorporation by Reference
Table of CFR Titles and Chapters
Alphabetical List of Agencies Appearing in the CFR
List of CFR Sections Affected
Title 21 -- Food and Drug
Material Approved for Incorporation by Reference
Material Approved for Incorporation by Reference
The Director of the Federal Register has approved under 5 U.S.C.
552(a) and 1 CFR Part 51 the incorporation by reference of the following
publications. This list contains only those incorporations by reference
effective as of the revision date of this volume. Incorporations by
reference found within a regulation are effective upon the effective
date of that regulation. For more information on incorporation by
reference, see the preliminary pages of this volume.
21 CFR 82.2707a 21 CFR CHAPTER I (PARTS 1 TO 99)
FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR
Association of Official Analytical Chemists
2200 Wilson Blvd., Suite 400, Arlington, VA 22201-3301
Official Methods of Analysis, 13th Ed., 1980 2.19
NOTE: The following materials are available through the Food and
Drug Administration at the addresses indicated.
Center for Food Safety and Applied Nutrition (HFF-330), Food and Drug
Administration
200 C St. SW., Washington DC 20204
Measure Container Code of the National Bureau of Standards Handbook
44 ''Sec. 4.45 Measure-Containers'' 1.24(a)(6)(i), (ii) and (iii)
National Academy Press
2101 Constitution Ave., N.W., Washington, D.C. 20418
Food Chemicals Codex, 3d Ed (1981) 73.160 (a) and (b); 73.450 (a)
and (b)
Chap.
21 CFR 82.2707a Table of CFR Titles and Chapters
21 CFR 82.2707a Title 1 -- General Provisions
I Administrative Committee of the Federal Register (Parts 1 -- 49)
II Office of the Federal Register (Parts 50 -- 299)
III Administrative Conference of the United States (Parts 300 -- 399)
IV Miscellaneous Agencies (Parts 400 -- 500)
21 CFR 82.2707a Title 2 -- (Reserved)
21 CFR 82.2707a Title 3 -- The President
I Executive Office of the President (Parts 100 -- 199)
21 CFR 82.2707a Title 4 -- Accounts
I General Accounting Office (Parts 1 -- 99)
II Federal Claims Collection Standards (General Accounting Office --
Department of Justice) (Parts 100 -- 299)
III General Accounting Office (CASB) (Parts 300 -- 499)
21 CFR 82.2707a Title 5 -- Administrative Personnel
I Office of Personnel Management (Parts 1 -- 1199)
II Merit Systems Protection Board (Parts 1200 -- 1299)
III Office of Management and Budget (Parts 1300 -- 1399)
IV Advisory Committee on Federal Pay (Parts 1400 -- 1499)
V The International Organizations Employees Loyalty Board (Parts 1500
-- 1599)
VI Federal Retirement Thrift Investment Board (Parts 1600 -- 1699)
VII Advisory Commission on Intergovernmental Relations (Parts 1700 --
1799)
VIII Office of Special Council (Parts 1800 -- 1899)
IX Appalachian Regional Commission (Parts 1900 -- 1999)
XI United States Soldiers' and Airmen's Home (Parts 2100 -- 2199)
XIV Federal Labor Relations Authority, General Counsel of the Federal
Labor Relations Authority and Federal Service Impasses Panel (Parts 2400
-- 2499)
XV Office of Administration, Executive Office of the President (Parts
2500 -- 2599)
XVI Office of Government Ethics (Parts 2600 -- 2699)
21 CFR 82.2707a Title 6 -- Economic Stabilization (Reserved)
21 CFR 82.2707a Title 7 -- Agriculture
Subtitle A -- Office of the Secretary of Agriculture (Parts 0 -- 26)
Subtitle B -- Regulations of the Department of Agriculture
I Agricultural Marketing Service (Standards, Inspections, Marketing
Practices), Department of Agriculture (Parts 27 -- 209)
II Food and Nutrition Service, Department of Agriculture (Parts 210
-- 299)
III Animal and Plant Health Inspection Service, Department of
Agriculture (Parts 300 -- 399)
IV Federal Crop Insurance Corporation, Department of Agriculture
(Parts 400 -- 499)
V Agricultural Research Service, Department of Agriculture (Parts 500
-- 599)
VI Soil Conservation Service, Department of Agriculture (Parts 600 --
699)
VII Agricultural Stabilization and Conservation Service (Agricultural
Adjustment), Department of Agriculture (Parts 700 -- 799)
VIII Federal Grain Inspection Service, Department of Agriculture
(Parts 800 -- 899)
IX Agricultural Marketing Service (Marketing Agreements and Orders;
Fruits, Vegetables, Nuts), Department of Agriculture (Parts 900 -- 999)
X Agricultural Marketing Service (Marketing Agreements and Orders;
Milk), Department of Agriculture (Parts 1000 -- 1199)
XI Agricultural Marketing Service (Marketing Agreements and Orders;
Miscellaneous Commodities), Department of Agriculture (Parts 1200 --
1299)
XIV Commodity Credit Corporation, Department of Agriculture (Parts
1400 -- 1499)
XV Foreign Agricultural Service, Department of Agriculture (Parts
1500 -- 1599)
XVI Rural Telephone Bank, Department of Agriculture (Parts 1600 --
1699)
XVII Rural Electrification Administration, Department of Agriculture
(Parts 1700 -- 1799)
XVIII Farmers Home Administration, Department of Agriculture (Parts
1800 -- 2099)
XXI Foreign Economic Development Service, Department of Agriculture
(Parts 2100 -- 2199)
XXII Office of International Cooperation and Development, Department
of Agriculture (Parts 2200 -- 2299)
XXV Office of the General Sales Manager, Department of Agriculture
(Parts 2500 -- 2599)
XXVI Office of Inspector General, Department of Agriculture (Parts
2600 -- 2699)
XXVII Office of Information Resources Management, Department of
Agriculture (Parts 2700 -- 2799)
XXVIII Office of Operations, Department of Agriculture (Parts 2800 --
2899)
XXIX Office of Energy, Department of Agriculture (Parts 2900 -- 2999)
XXX Office of Finance and Management, Department of Agriculture
(Parts 3000 -- 3099)
XXXI Office of Environmental Quality, Department of Agriculture
(Parts 3100 -- 3199)
XXXII Office of Grants and Program Systems, Department of Agriculture
(Parts 3200 -- 3299)
XXXIII Office of Transportation, Department of Agriculture (Parts
3300 -- 3399)
XXXIV Cooperative State Research Service, Department of Agriculture
(Parts 3400 -- 3499)
XXXVI National Agricultural Statistics Service, Department of
Agriculture (Parts 3600 -- 3699)
XXXVII Economic Research Service, Department of Agriculture (Parts
3700 -- 3799)
XXXVIII World Agricultural Outlook Board, Department of Agriculture
(Parts 3800 -- 3899)
XXXIX Economic Analysis Staff, Department of Agriculture (Parts 3900
-- 3999)
XL Economics Management Staff, Department of Agriculture (Parts 4000
-- 4099)
XLI National Agricultural Library, Department of Agriculture (Part
4100)
21 CFR 82.2707a Title 8 -- Aliens and Nationality
I Immigration and Naturalization Service, Department of Justice
(Parts 1 -- 499)
21 CFR 82.2707a Title 9 -- Animals and Animal Products
I Animal and Plant Health Inspection Service, Department of
Agriculture (Parts 1 -- 199)
II Packers and Stockyards Administration, Department of Agriculture
(Parts 200 -- 299)
III Food Safety and Inspection Service, Meat and Poultry Inspection,
Department of Agriculture (Parts 300 -- 399)
21 CFR 82.2707a Title 10 -- Energy
I Nuclear Regulatory Commission (Parts 0 -- 199)
II Department of Energy (Parts 200 -- 699)
III Department of Energy (Parts 700 -- 999)
X Department of Energy (General Provisions) (Parts 1000 -- 1099)
XV Office of the Federal Inspector for the Alaska Natural Gas
Transportation System (Parts 1500 -- 1599)
XVII Defense Nuclear Facilities Safety Board (Parts 1700 -- 1799)
21 CFR 82.2707a Title 11 -- Federal Elections
I Federal Election Commission (Parts 1 -- 9099)
21 CFR 82.2707a Title 12 -- Banks and Banking
I Comptroller of the Currency, Department of the Treasury (Parts 1 --
199)
II Federal Reserve System (Parts 200 -- 299)
III Federal Deposit Insurance Corporation (Parts 300 -- 399)
IV Export-Import Bank of the United States (Parts 400 -- 499)
V Office of Thrift Supervision, Department of The Treasury (Parts 500
-- 599)
VI Farm Credit Administration (Parts 600 -- 699)
VII National Credit Union Administration (Parts 700 -- 799)
VIII Federal Financing Bank (Parts 800 -- 899)
IX Federal Housing Finance Board (Parts 900 -- 999)
XI Federal Financial Institutions Examination Council (Parts 1100 --
1199)
XIII Farm Credit System Assistance Board (Parts 1300 -- 1399)
XIV Farm Credit System Insurance Corporation (Parts 1400 -- 1499)
XV Thrift Depositor Protection Oversight Board (Parts 1500 -- 1599)
XVI Resolution Trust Corporation (Parts 1600 -- 1699)
21 CFR 82.2707a Title 13 -- Business Credit and Assistance
I Small Business Administration (Parts 1 -- 199)
III Economic Development Administration, Department of Commerce
(Parts 300 -- 399)
21 CFR 82.2707a Title 14 -- Aeronautics and Space
I Federal Aviation Administration, Department of Transportation
(Parts 1 -- 199)
II Office of the Secretary, Department of Transportation (Aviation
Proceedings) (Parts 200 -- 399)
III Office of Commercial Space Transportation, Department of
Transportation (Parts 400 -- 499)
V National Aeronautics and Space Administration (Parts 1200 -- 1299)
21 CFR 82.2707a Title 15 -- Commerce and Foreign Trade
Subtitle A -- Office of the Secretary of Commerce (Parts 0 -- 29)
Subtitle B -- Regulations Relating to Commerce and Foreign Trade
I Bureau of the Census, Department of Commerce (Parts 30 -- 199)
II National Institute of Standards and Technology, Department of
Commerce (Parts 200 -- 299)
III International Trade Administration, Department of Commerce (Parts
300 -- 399)
IV Foreign-Trade Zones Board (Parts 400 -- 499)
VII Bureau of Export Administration, Department of Commerce (Parts
700 -- 799)
VIII Bureau of Economic Analysis, Department of Commerce (Parts 800
-- 899)
IX National Oceanic and Atmospheric Administration, Department of
Commerce (Parts 900 -- 999)
XI Technology Administration, Department of Commerce (Parts 1100 --
1199)
XII United States Travel and Tourism Administration, Department of
Commerce (Parts 1200 -- 1299)
XIII East-West Foreign Trade Board (Parts 1300 -- 1399)
XIV Minority Business Development Agency (Parts 1400 -- 1499)
Subtitle C -- Regulations Relating to Foreign Trade Agreements
XX Office of the United States Trade Representative (Parts 2000 --
2099)
Subtitle D -- Regulations Relating to Telecommunications and
Information
XXIII National Telecommunications and Information Administration,
Department of Commerce (Parts 2300 -- 2399)
21 CFR 82.2707a Title 16 -- Commercial Practices
I Federal Trade Commission (Parts 0 -- 999)
II Consumer Product Safety Commission (Parts 1000 -- 1799)
21 CFR 82.2707a Title 17 -- Commodity and Securities Exchanges
I Commodity Futures Trading Commission (Parts 1 -- 199)
II Securities and Exchange Commission (Parts 200 -- 399)
IV Department of the Treasury (Parts 400 -- 499)
21 CFR 82.2707a Title 18 -- Conservation of Power and Water Resources
I Federal Energy Regulatory Commission, Department of Energy (Parts 1
-- 399)
III Delaware River Basin Commission (Parts 400 -- 499)
VI Water Resources Council (Parts 700 -- 799)
VIII Susquehanna River Basin Commission (Parts 800 -- 899)
XIII Tennessee Valley Authority (Parts 1300 -- 1399)
21 CFR 82.2707a Title 19 -- Customs Duties
I United States Customs Service, Department of the Treasury (Parts 1
-- 199)
II United States International Trade Commission (Parts 200 -- 299)
III International Trade Administration, Department of Commerce (Parts
300 -- 399)
21 CFR 82.2707a Title 20 -- Employees' Benefits
I Office of Workers' Compensation Programs, Department of Labor
(Parts 1 -- 199)
II Railroad Retirement Board (Parts 200 -- 399)
III Social Security Administration, Department of Health and Human
Services (Parts 400 -- 499)
IV Employees' Compensation Appeals Board, Department of Labor (Parts
500 -- 599)
V Employment and Training Administration, Department of Labor (Parts
600 -- 699)
VI Employment Standards Administration, Department of Labor (Parts
700 -- 799)
VII Benefits Review Board, Department of Labor (Parts 800 -- 899)
VIII Joint Board for the Enrollment of Actuaries (Parts 900 -- 999)
IX Office of the Assistant Secretary for Veterans' Employment and
Training, Department of Labor (Parts 1000 -- 1099)
21 CFR 82.2707a Title 21 -- Food and Drugs
I Food and Drug Administration, Department of Health and Human
Services (Parts 1 -- 1299)
II Drug Enforcement Administration, Department of Justice (Parts 1300
-- 1399)
21 CFR 82.2707a Title 22 -- Foreign Relations
I Department of State (Parts 1 -- 199)
II Agency for International Development, International Development
Cooperation Agency (Parts 200 -- 299)
III Peace Corps (Parts 300 -- 399)
IV International Joint Commission, United States and Canada (Parts
400 -- 499)
V United States Information Agency (Parts 500 -- 599)
VI United States Arms Control and Disarmament Agency (Parts 600 --
699)
VII Overseas Private Investment Corporation, International
Development Cooperation Agency (Parts 700 -- 799)
IX Foreign Service Grievance Board Regulations (Parts 900 -- 999)
X Inter-American Foundation (Parts 1000 -- 1099)
XI International Boundary and Water Commission, United States and
Mexico, United States Section (Parts 1100 -- 1199)
XII United States International Development Cooperation Agency (Parts
1200 -- 1299)
XIII Board for International Broadcasting (Parts 1300 -- 1399)
XIV Foreign Service Labor Relations Board; Federal Labor Relations
Authority; General Counsel of the Federal Labor Relations Authority;
and the Foreign Service Impasse Disputes Panel (Parts 1400 -- 1499)
XV African Development Foundation (Parts 1500 -- 1599)
XVI Japan-United States Friendship Commission (Parts 1600 -- 1699)
21 CFR 82.2707a Title 23 -- Highways
I Federal Highway Administration, Department of Transportation (Parts
1 -- 999)
II National Highway Traffic Safety Administration and Federal Highway
Administration, Department of Transportation (Parts 1200 -- 1299)
III National Highway Traffic Safety Administration, Department of
Transportation (Parts 1300 -- 1399)
21 CFR 82.2707a Title 24 -- Housing and Urban Development
Subtitle A -- Office of the Secretary, Department of Housing and
Urban Development (Parts 0 -- 99)
Subtitle B -- Regulations Relating to Housing and Urban Development
I Office of Assistant Secretary for Equal Opportunity, Department of
Housing and Urban Development (Parts 100 -- 199)
II Office of Assistant Secretary for Housing-Federal Housing
Commissioner, Department of Housing and Urban Development (Parts 200 --
299)
III Government National Mortgage Association, Department of Housing
and Urban Development (Parts 300 -- 399)
V Office of Assistant Secretary for Community Planning and
Development, Department of Housing and Urban Development (Parts 500 --
599)
VI Office of Assistant Secretary for Community Planning and
Development, Department of Housing and Urban Development (Parts 600 --
699)
VII Office of the Secretary, Department of Housing and Urban
Development (Section 8 Housing Assistance Programs and Public and Indian
Housing Programs) (Parts 700 -- 799)
VIII Office of the Assistant Secretary for Housing -- Federal Housing
Commissioner, Department of Housing and Urban Development (Section 8
Housing Assistance Programs and Section 202 Direct Loan Program) (Parts
800 -- 899)
IX Office of Assistant Secretary for Public and Indian Housing,
Department of Housing and Urban Development (Parts 900 -- 999)
X Office of Assistant Secretary for Housing -- Federal Housing
Commissioner, Department of Housing and Urban Development (Interstate
Land Sales Registration Program) (Parts 1700 -- 1799)
XI Solar Energy and Energy Conservation Bank, Department of Housing
and Urban Development (Parts 1800 -- 1899)
XII Office of Inspector General, Department of Housing and Urban
Development (Parts 2000 -- 2099)
XV Mortgage Insurance and Loan Programs under the Emergency
Homeowners' Relief Act, Department of Housing and Urban Development
(Parts 2700 -- 2799)
XX Office of Assistant Secretary for Housing -- Federal Housing
Commissioner, Department of Housing and Urban Development (Parts 3200 --
3699)
XXV Neighborhood Reinvestment Corporation (Parts 4100 -- 4199)
21 CFR 82.2707a Title 25 -- Indians
I Bureau of Indian Affairs, Department of the Interior (Parts 1 --
299)
II Indian Arts and Crafts Board, Department of the Interior (Parts
300 -- 399)
III National Indian Gaming Commission (Parts 500 -- 599)
IV Office of Navajo and Hopi Indian Relocation (Parts 700 -- 799)
21 CFR 82.2707a Title 26 -- Internal Revenue
I Internal Revenue Service, Department of the Treasury (Parts 1 --
799)
21 CFR 82.2707a Title 27 -- Alcohol, Tobacco Products and Firearms
I Bureau of Alcohol, Tobacco and Firearms, Department of the Treasury
(Parts 1 -- 299)
21 CFR 82.2707a Title 28 -- Judicial Administration
I Department of Justice (Parts 0 -- 199)
III Federal Prison Industries, Inc., Department of Justice (Parts 300
-- 399)
V Bureau of Prisons, Department of Justice (Parts 500 -- 599)
VI Offices of Independent Counsel, Department of Justice (Parts 600
-- 699)
VII Office of Independent Counsel (Parts 700 -- 799)
21 CFR 82.2707a Title 29 -- Labor
Subtitle A -- Office of the Secretary of Labor (Parts 0 -- 99)
Subtitle B -- Regulations Relating to Labor
I National Labor Relations Board (Parts 100 -- 199)
II Bureau of Labor-Management Relations and Cooperative Programs,
Department of Labor (Parts 200 -- 299)
III National Railroad Adjustment Board (Parts 300 -- 399)
IV Office of Labor-Management Standards, Department of Labor (Parts
400 -- 499)
V Wage and Hour Division, Department of Labor (Parts 500 -- 899)
IX Construction Industry Collective Bargaining Commission (Parts 900
-- 999)
X National Mediation Board (Parts 1200 -- 1299)
XII Federal Mediation and Conciliation Service (Parts 1400 -- 1499)
XIV Equal Employment Opportunity Commission (Parts 1600 -- 1699)
XVII Occupational Safety and Health Administration, Department of
Labor (Parts 1900 -- 1999)
XX Occupational Safety and Health Review Commission (Parts 2200 --
2499)
XXV Pension and Welfare Benefits Administration, Department of Labor
(Parts 2500 -- 2599)
XXVI Pension Benefit Guaranty Corporation (Parts 2600 -- 2699)
XXVII Federal Mine Safety and Health Review Commission (Parts 2700 --
2799)
21 CFR 82.2707a Title 30 -- Mineral Resources
I Mine Safety and Health Administration, Department of Labor (Parts 1
-- 199)
II Minerals Management Service, Department of the Interior (Parts 200
-- 299)
III Board of Surface Mining and Reclamation Appeals, Department of
the Interior (Parts 300 -- 399)
IV Geological Survey, Department of the Interior (Parts 400 -- 499)
VI Bureau of Mines, Department of the Interior (Parts 600 -- 699)
VII Office of Surface Mining Reclamation and Enforcement, Department
of the Interior (Parts 700 -- 999)
21 CFR 82.2707a Title 31 -- Money and Finance: Treasury
Subtitle A -- Office of the Secretary of the Treasury (Parts 0 -- 50)
Subtitle B -- Regulations Relating to Money and Finance
I Monetary Offices, Department of the Treasury (Parts 51 -- 199)
II Fiscal Service, Department of the Treasury (Parts 200 -- 399)
IV Secret Service, Department of the Treasury (Parts 400 -- 499)
V Office of Foreign Assets Control, Department of the Treasury (Parts
500 -- 599)
VI Bureau of Engraving and Printing, Department of the Treasury
(Parts 600 -- 699)
VII Federal Law Enforcement Training Center, Department of the
Treasury (Parts 700 -- 799)
VIII Office of International Investment, Department of the Treasury
(Parts 800 -- 899)
21 CFR 82.2707a Title 32 -- National Defense
Subtitle A -- Department of Defense
I Office of the Secretary of Defense (Parts 1 -- 399)
V Department of the Army (Parts 400 -- 699)
VI Department of the Navy (Parts 700 -- 799)
VII Department of the Air Force (Parts 800 -- 1099)
Subtitle B -- Other Regulations Relating to National Defense
XII Defense Logistics Agency (Parts 1200 -- 1299)
XVI Selective Service System (Parts 1600 -- 1699)
XIX Central Intelligence Agency (Parts 1900 -- 1999)
XX Information Security Oversight Office (Parts 2000 -- 2099)
XXI National Security Council (Parts 2100 -- 2199)
XXIV Office of Science and Technology Policy (Parts 2400 -- 2499)
XXVII Office for Micronesian Status Negotiations (Parts 2700 -- 2799)
XXVIII Office of the Vice President of the United States (Parts 2800
-- 2899)
21 CFR 82.2707a Title 33 -- Navigation and Navigable Waters
I Coast Guard, Department of Transportation (Parts 1 -- 199)
II Corps of Engineers, Department of the Army (Parts 200 -- 399)
IV Saint Lawrence Seaway Development Corporation, Department of
Transportation (Parts 400 -- 499)
21 CFR 82.2707a Title 34 -- Education
Subtitle A -- Office of the Secretary, Department of Education (Parts
1 -- 99)
Subtitle B -- Regulations of the Offices of the Department of
Education
I Office for Civil Rights, Department of Education (Parts 100 -- 199)
II Office of Elementary and Secondary Education, Department of
Education (Parts 200 -- 299)
III Office of Special Education and Rehabilitative Services,
Department of Education (Parts 300 -- 399)
IV Office of Vocational and Adult Education, Department of Education
(Parts 400 -- 499)
V Office of Bilingual Education and Minority Languages Affairs,
Department of Education (Parts 500 -- 599)
VI Office of Postsecondary Education, Department of Education (Parts
600 -- 699)
VII Office of Educational Research and Improvement, Department of
Education (Parts 700 -- 799)
21 CFR 82.2707a Title 35 -- Panama Canal
I Panama Canal Regulations (Parts 1 -- 299)
21 CFR 82.2707a Title 36 -- Parks, Forests, and Public Property
I National Park Service, Department of the Interior (Parts 1 -- 199)
II Forest Service, Department of Agriculture (Parts 200 -- 299)
III Corps of Engineers, Department of the Army (Parts 300 -- 399)
IV American Battle Monuments Commission (Parts 400 -- 499)
V Smithsonian Institution (Parts 500 -- 599)
VII Library of Congress (Parts 700 -- 799)
VIII Advisory Council on Historic Preservation (Parts 800 -- 899)
IX Pennsylvania Avenue Development Corporation (Parts 900 -- 999)
XI Architectural and Transportation Barriers Compliance Board (Parts
1100 -- 1199)
XII National Archives and Records Administration (Parts 1200 -- 1299)
21 CFR 82.2707a Title 37 -- Patents, Trademarks, and Copyrights
I Patent and Trademark Office, Department of Commerce (Parts 1 --
199)
II Copyright Office, Library of Congress (Parts 200 -- 299)
III Copyright Royalty Tribunal (Parts 300 -- 399)
IV Assistant Secretary for Technology Policy, Department of Commerce
(Parts 400 -- 499)
V Under Secretary for Technology, Department of Commerce (Parts 500
-- 599)
21 CFR 82.2707a Title 38 -- Pensions, Bonuses, and Veterans' Relief
I Department of Veterans Affairs (Parts 0 -- 99)
21 CFR 82.2707a Title 39 -- Postal Service
I United States Postal Service (Parts 1 -- 999)
III Postal Rate Commission (Parts 3000 -- 3099)
21 CFR 82.2707a Title 40 -- Protection of Environment
I Environmental Protection Agency (Parts 1 -- 799)
V Council on Environmental Quality (Parts 1500 -- 1599)
21 CFR 82.2707a Title 41 -- Public Contracts and Property Management
Subtitle B -- Other Provisions Relating to Public Contracts
50 Public Contracts, Department of Labor (Parts 50-1 -- 50-999)
51 Committee for Purchase from the Blind and Other Severely
Handicapped (Parts 51-1 -- 51-99)
60 Office of Federal Contract Compliance Programs, Equal Employment
Opportunity, Department of Labor (Parts 60-1 -- 60-999)
61 Office of the Assistant Secretary for Veterans Employment and
Training, Department of Labor (Parts 61-1 -- 61-999)
Subtitle C -- Federal Property Management Regulations System
101 Federal Property Management Regulations (Parts 101-1 -- 101-99)
105 General Services Administration (Parts 105-1 -- 105-999)
109 Department of Energy Property Management Regulations (Parts 109-1
-- 109-99)
114 Department of the Interior (Parts 114-1 -- 114-99)
115 Environmental Protection Agency (Parts 115-1 -- 115-99)
128 Department of Justice (Parts 128-1 -- 128-99)
132 Department of the Air Force (Parts 132-1 -- 132-99)
Subtitle D -- Other Provisions Relating to Property Management
(Reserved)
Subtitle E -- Federal Information Resources Management Regulations
System
201 Federal Information Resources Management Regulation (Parts 201-1
-- 201-99)
Subtitle F -- Federal Travel Regulation System
301 Travel Allowances (Parts 301-1 -- 301-99)
302 Relocation Allowances (Parts 302-1 -- 302-99)
303 Payment of Expenses Connected with the Death of Certain Employees
(Parts 303-1 -- 303-2)
304 Payment from a non-Federal source for travel expenses (Parts
304-1 -- 304-99)
21 CFR 82.2707a Title 42 -- Public Health
I Public Health Service, Department of Health and Human Services
(Parts 1 -- 199)
IV Health Care Financing Administration, Department of Health and
Human Services (Parts 400 -- 499)
V Office of Inspector General-Health Care, Department of Health and
Human Services (Parts 1000 -- 1999)
21 CFR 82.2707a Title 43 -- Public Lands: Interior
Subtitle A -- Office of the Secretary of the Interior (Parts 1 --
199)
Subtitle B -- Regulations Relating to Public Lands
I Bureau of Reclamation, Department of the Interior (Parts 200 --
499)
II Bureau of Land Management, Department of the Interior (Parts 1000
-- 9999)
21 CFR 82.2707a Title 44 -- Emergency Management and Assistance
I Federal Emergency Management Agency (Parts 0 -- 399)
IV Department of Commerce and Department of Transportation (Parts 400
-- 499)
21 CFR 82.2707a Title 45 -- Public Welfare
Subtitle A -- Department of Health and Human Services, General
Administration (Parts 1 -- 199)
Subtitle B -- Regulations Relating to Public Welfare
II Office of Family Assistance (Assistance Programs), Family Support
Administration, Department of Health and Human Services (Parts 200 --
299)
III Office of Child Support Enforcement (Child Support Enforcement
Program), Family Support Administration, Department of Health and Human
Services (Parts 300 -- 399)
IV Office of Refugee Resettlement, Administration for Children and
Families Department of Health and Human Services (Parts 400 -- 499)
V Foreign Claims Settlement Commission of the United States,
Department of Justice (Parts 500 -- 599)
VI National Science Foundation (Parts 600 -- 699)
VII Commission on Civil Rights (Parts 700 -- 799)
VIII Office of Personnel Management (Parts 800 -- 899)
X Office of Community Services, Family Support Administration,
Department of Health and Human Services (Parts 1000 -- 1099)
XI National Foundation on the Arts and the Humanities (Parts 1100 --
1199)
XII ACTION (Parts 1200 -- 1299)
XIII Office of Human Development Services, Department of Health and
Human Services (Parts 1300 -- 1399)
XVI Legal Services Corporation (Parts 1600 -- 1699)
XVII National Commission on Libraries and Information Science (Parts
1700 -- 1799)
XVIII Harry S. Truman Scholarship Foundation (Parts 1800 -- 1899)
XX Commission on the Bicentennial of the United States Constitution
(Parts 2000 -- 2099)
XXI Commission on Fine Arts (Parts 2100 -- 2199)
XXII Christopher Columbus Quincentenary Jubilee Commission (Parts
2200 -- 2299)
XXIV James Madison Memorial Fellowship Foundation (Parts 2400 --
2499)
21 CFR 82.2707a Title 46 -- Shipping
I Coast Guard, Department of Transportation (Parts 1 -- 199)
II Maritime Administration, Department of Transportation (Parts 200
-- 399)
III Coast Guard (Great Lakes Pilotage), Department of Transportation
(Parts 400 -- 499)
IV Federal Maritime Commission (Parts 500 -- 599)
21 CFR 82.2707a Title 47 -- Telecommunication
I Federal Communications Commission (Parts 0 -- 199)
II Office of Science and Technology Policy and National Security
Council (Parts 200 -- 299)
III National Telecommunications and Information Administration,
Department of Commerce (Parts 300 -- 399)
21 CFR 82.2707a Title 48 -- Federal Acquisition Regulations System
1 Federal Acquisition Regulation (Parts 1 -- 99)
2 Department of Defense (Parts 200 -- 299)
3 Department of Health and Human Services (Parts 300 -- 399)
4 Department of Agriculture (Parts 400 -- 499)
5 General Services Administration (Parts 500 -- 599)
6 Department of State (Parts 600 -- 699)
7 Agency for International Development (Parts 700 -- 799)
8 Department of Veterans Affairs (Parts 800 -- 899)
9 Department of Energy (Parts 900 -- 999)
10 Department of the Treasury (Parts 1000 -- 1099)
12 Department of Transportation (Parts 1200 -- 1299)
13 Department of Commerce (Parts 1300 -- 1399)
14 Department of the Interior (Parts 1400 -- 1499)
15 Environmental Protection Agency (Parts 1500 -- 1599)
16 Office of Personnel Management Federal Employees Health Benefits
Acquisition Regulation (Parts 1600 -- 1699)
17 Office of Personnel Management (Parts 1700 -- 1799)
18 National Aeronautics and Space Administration (Parts 1800 -- 1899)
19 United States Information Agency (Parts 1900 -- 1999)
22 Small Business Administration (Parts 2200 -- 2299)
24 Department of Housing and Urban Development (Parts 2400 -- 2499)
25 National Science Foundation (Parts 2500 -- 2599)
28 Department of Justice (Parts 2800 -- 2899)
29 Department of Labor (Parts 2900 -- 2999)
34 Department of Education Acquisition Regulation (Parts 3400 --
3499)
35 Panama Canal Commission (Parts 3500 -- 3599)
44 Federal Emergency Management Agency (Parts 4400 -- 4499)
51 Department of the Army Acquisition Regulations (Parts 5100 --
5199)
52 Department of the Navy Acquisition Regulations (Parts 5200 --
5299)
53 Department of the Air Force Federal Acquisition Regulation
Supplement (Parts 5300 -- 5399)
57 African Development Foundation (Parts 5700 -- 5799)
61 General Services Administration Board of Contract Appeals (Parts
6100 -- 6199)
63 Department of Transportation Board of Contract Appeals (Parts 6300
-- 6399)
99 Cost Accounting Standards Board, Office of Federal Procurement
Policy, Office of Management and Budget (Parts 9900 -- 9999)
21 CFR 82.2707a Title 49 -- Transportation
Subtitle A -- Office of the Secretary of Transportation (Parts 1 --
99)
Subtitle B -- Other Regulations Relating to Transportation
I Research and Special Programs Administration, Department of
Transportation (Parts 100 -- 199)
II Federal Railroad Administration, Department of Transportation
(Parts 200 -- 299)
III Federal Highway Administration, Department of Transportation
(Parts 300 -- 399)
IV Coast Guard, Department of Transportation (Parts 400 -- 499)
V National Highway Traffic Safety Administration, Department of
Transportation (Parts 500 -- 599)
VI Urban Mass Transportation Administration, Department of
Transportation (Parts 600 -- 699)
VII National Railroad Passenger Corporation (AMTRAK) (Parts 700 --
799)
VIII National Transportation Safety Board (Parts 800 -- 899)
X Interstate Commerce Commission (Parts 1000 -- 1399)
21 CFR 82.2707a Title 50 -- Wildlife and Fisheries
I United States Fish and Wildlife Service, Department of the Interior
(Parts 1 -- 199)
II National Marine Fisheries Service, National Oceanic and
Atmospheric Administration, Department of Commerce (Parts 200 -- 299)
III International Regulatory Agencies (Fishing and Whaling) (Parts
300 -- 399)
IV Joint Regulations (United States Fish and Wildlife Service,
Department of the Interior and National Marine Fisheries Service,
National Oceanic and Atmospheric Administration, Department of
Commerce); Endangered Species Committee Regulations (Parts 400 -- 499)
V Marine Mammal Commission (Parts 500 -- 599)
VI Fishery Conservation and Management, National Oceanic and
Atmospheric Administration, Department of Commerce (Parts 600 -- 699)
21 CFR 82.2707a CFR Index and Finding Aids Subject/Agency Index
List of Agency Prepared Indexes Parallel Table of Statutory Authorities
and Rules Acts Requiring Publication in the Federal Register List of CFR
Titles, Chapters, Subchapters, and Parts
21 CFR 82.2707a Alphabetical List of Agencies Appearing in the CFR
CFR Title, Subtitle or
Agency
Chapter
ACTION 45, XII
Administrative Committee of the Federal Register 1, I
Administrative Conference of the United States 1, III
Advisory Commission on Intergovernmental Relations 5, VII
Advisory Committee on Federal Pay 5, IV
Advisory Council on Historic Preservation 36, VIII
African Development Foundation 22, XV; 48, 57
Agency for International Development 22, II; 48, 7
Agricultural Marketing Service 7, I, IX, X, XI
Agricultural Research Service 7, V
Agricultural Stabilization and Conservation Service 7, VII
Agriculture Department
Agricultural Marketing Service 7, I, IX, X, XI
Agricultural Research Service 7, V
Agricultural Stabilization and Conservation Service 7, VII
Animal and Plant Health Inspection Service 7, III; 9, I
Commodity Credit Corporation 7, XIV
Cooperative State Research Service 7, XXXIV
Economic Analysis Staff 7, XXXIX
Economic Research Service 7, XXXVII
Economics Management Staff 7, XL
Energy, Office of 7, XXIX
Environmental Quality, Office of 7, XXXI
Farmers Home Administration 7, XVIII
Federal Acquisition Regulation 48, 4
Federal Crop Insurance Corporation 7, IV
Federal Grain Inspection Service 7, VIII
Finance and Management, Office of 7, XXX
Food and Nutrition Service 7, II
Food Safety and Inspection Service 9, III
Foreign Agricultural Service 7, XV
Foreign Economic Development Service 7, XXI
Forest Service 36, II
General Sales Manager, Office of 7, XXV
Grants and Program Systems, Office of 7, XXXII
Information Resources Management, Office of 7, XXVII
Inspector General, Office of 7, XXVI
International Cooperation and Development Office 7, XXII
National Agricultural Library 7, XLI
National Agricultural Statistics Service 7, XXXVI
Operations Office 7, XXVIII
Packers and Stockyards Administration 9, II
Rural Electrification Administration 7, XVII
Rural Telephone Bank 7, XVI
Secretary of Agriculture, Office of 7, Subtitle A
Soil Conservation Service 7, VI
Transportation, Office of 7, XXXIII
World Agriculture Outlook Board 7, XXXVIII
Air Force Department 32, VII; 41, Subtitle C, Ch. 132
Federal Acquisition Regulation Supplement 48, 53
Alaska Natural Gas Transportation System, Office of the Federal
Inspector 10, XV
Alcohol, Tobacco and Firearms, Bureau of 27, I
AMTRAK 49, VII
American Battle Monuments Commission 36, IV
Animal and Plant Health Inspection Service 7, III; 9, I
Appalachian Regional Commission 5, IX
Architectural and Transportation Barriers Compliance Board 36, XI
Arms Control and Disarmament Agency, U.S. 22, VI
Army Department 32, V
Engineers, Corps of 33, II; 36, III
Federal Acquisition Regulation 48, 51
Assistant Secretary for Technology Policy, Department of Commerce 37,
IV
Benefits Review Board 20, VII
Bicentennial of the United States Constitution, Commission on the 45,
XX
Bilingual Education and Minority Languages Affairs, Office of 34, V
Blind and Other Severely Handicapped, Committee for Purchase from 41,
51
Board for International Broadcasting 22, XIII
Budget, Office of Management and 5, III
Census Bureau 15, I
Central Intelligence Agency 32, XIX
Child Support Enforcement, Office of 45, III
Christopher Columbus Quincentenary Jubilee Commission 45, XXII
Civil Rights Commission 45, VII
Civil Rights, Office for (Education Department) 34, I
Claims Collection Standards, Federal 4, II
Coast Guard 33, I; 46, I, III; 49, IV
Commerce Department 44, IV
Census Bureau 15, I
Assistant Secretary for Technology Policy 37, IV
Economic Affairs, Under Secretary 37, V
Economic Analysis, Bureau of 15, VIII
Economic Development Administration 13, III
Endangered Species Committee 50, IV
Export Administration Bureau 15, VII
Federal Acquisition Regulation 48, 13
Fishery Conservation and Management 50, VI
International Trade Administration 15, III; 19, III
National Institute of Standards and Technology 15, II
National Marine Fisheries Service 50, II, IV
National Oceanic and Atmospheric Administration 15, IX; 50, II, III,
IV, VI
National Telecommunications and Information Administration 15, XXIII;
47, III
Patent and Trademark Office 37, I
Productivity, Technology and Innovation, Assistant Secretary for 37,
IV
Secretary of Commerce, Office of 15, Subtitle A
Technology Administration 15, XI
Under Secretary for Technology 37, V
United States Travel and Tourism Administration 15, XII
Commercial Space Transportation, Office of, Department of
Transportation 14, III
Commission on the Bicentennial of the United States Constitution 45,
XX
Committee for Purchase from the Blind and Other Severely Handicapped
41, 51
Commodity Credit Corporation 7, XIV
Commodity Futures Trading Commission 17, I
Community Planning and Development, Office of Assistant Secretary for
24, V, VI
Community Services, Office of 45, X
Comptroller of the Currency 12, I
Construction Industry Collective Bargaining Commission 29, IX
Consumer Product Safety Commission 16, II
Cooperative State Research Service 7, XXXIV
Copyright Office 37, II
Copyright Royalty Tribunal 37, III
Cost Accounting Standards Board, Office of Federal Procurement Policy
48, 99
Council on Environmental Quality 40, V
Customs Service, United States 19, I
Defense Department 32, Subtitle A
Air Force Department 32, VII; 41, Subtitle C, Ch. 132
Army Department 32, V; 33, II; 36, III, 48, 51
Engineers, Corps of 33, II; 36, III
Federal Acquisition Regulation 48, 2
Navy Department 32, VI; 48, 52
Secretary of Defense, Office of 32, I
Defense Logistics Agency 32, XII
Defense Nuclear Facilities Safety Board 10, XVII
Delaware River Basin Commission 18, III
Drug Enforcement Administration 21, II
East-West Foreign Trade Board 15, XIII
Economic Affairs, Under Secretary (Commerce) 37, V
Economic Analysis, Bureau of 15, VIII
Economic Analysis Staff, Department of Agriculture 7, XXXIX
Economic Development Administration 13, III
Economics Management Staff 7, XL
Economic Research Service 7, XXXVII
Education, Department of
Bilingual Education and Minority Languages Affairs, Office of 34, V
Civil Rights, Office for 34, I
Educational Research and Improvement, Office of 34, VII
Elementary and Secondary Education, Office of 34, II
Federal Acquisition Regulation 48, 34
Postsecondary Education, Office of 34, VI
Secretary of Education, Office of 34, Subtitle A
Special Education and Rehabilitative Services, Office of 34, III
Vocational and Adult Education, Office of 34, IV
Educational Research and Improvement, Office of 34, VII
Elementary and Secondary Education, Office of 34, II
Employees' Compensation Appeals Board 20, IV
Employees Loyalty Board, International Organizations 5, V
Employment and Training Administration 20, V
Employment Standards Administration 20, VI
Endangered Species Committee 50, IV
Energy, Department of 10, II, III, X; 41, 109
Federal Acquisition Regulation 48, 9
Federal Energy Regulatory Commission 18, I
Energy, Office of, Department of Agriculture 7, XXIX
Engineers, Corps of 33, II; 36, III
Engraving and Printing, Bureau of 31, VI
Environmental Protection Agency 40, I; 41, 115; 48, 15
Environmental Quality, Office of (Agriculture Department) 7, XXXI
Equal Employment Opportunity Commission 29, XIV
Equal Opportunity, Office of Assistant Secretary for 24, I
Executive Office of the President 3, I
Administration, Office of 5, XV
Export Administration Bureau 15, VII
Export-Import Bank of the United States 12, IV
Family Assistance, Office of 45, II
Family Support Administration 45, II, III, IV, X
Farm Credit Administration 12, VI
Farm Credit System Assistance Board 12, XIII
Farm Credit System Insurance Corporation 12, XIV
Farmers Home Administration 7, XVIII
Federal Acquisition Regulation 48, 1
Federal Aviation Administration 14, I
Federal Claims Collection Standards 4, II
Federal Communications Commission 47, I
Federal Contract Compliance Programs, Office of 41, 60
Federal Crop Insurance Corporation 7, IV
Federal Deposit Insurance Corporation 12, III
Federal Election Commission 11, I
Federal Emergency Management Agency 44, I; 48, 44
Federal Energy Regulatory Commission 18, I
Federal Financial Institutions Examination Council 12, XI
Federal Financing Bank 12, VIII
Federal Grain Inspection Service 7, VIII
Federal Highway Administration 23, I, II; 49, III
Federal Home Loan Mortgage Corporation 1, IV
Federal Housing Finance Board 12, IX
Federal Information Resources Management Regulations 41, Subtitle E,
Ch. 201
Federal Inspector for the Alaska Natural Gas Transportation System,
Office of 10, XV
Federal Labor Relations Authority, and General Counsel of the Federal
Labor Relations Authority 5, XIV; 22, XIV
Federal Law Enforcement Training Center 31, VII
Federal Maritime Commission 46, IV
Federal Mediation and Conciliation Service 29, XII
Federal Mine Safety and Health Review Commission 29, XXVII
Federal Pay, Advisory Committee on 5, IV
Federal Prison Industries, Inc. 28, III
Federal Procurement Policy Office 48, 99
Federal Property Management Regulations 41, 101
Federal Property Management Regulations System 41, Subtitle C
Federal Railroad Administration 49, II
Federal Register, Administrative Committee of 1, I
Federal Register, Office of 1, II
Federal Reserve System 12, II
Federal Retirement Thrift Investment Board 5, VI
Federal Service Impasses Panel 5, XIV
Federal Trade Commission 16, I
Federal Travel Regulation System 41, Subtitle F
Finance and Management, Department of Agriculture 7, XXX
Fine Arts Commission 45, XXI
Fiscal Service 31, II
Fish and Wildlife Service, United States 50, I, IV
Fishery Conservation and Management 50, VI
Fishing and Whaling, International Regulatory Agencies 50, III
Food and Drug Administration 21, I
Food and Nutrition Service 7, II
Food Safety and Inspection Service 9, III
Foreign Agricultural Service 7, XV
Foreign Assets Control, Office of 31, V
Foreign Claims Settlement Commission of United States 45, V
Foreign Economic Development Service 7, XXI
Foreign Service Grievance Board 22, IX
Foreign Service Impasse Disputes Panel 22, XIV
Foreign Service Labor Relations Board 22, XIV
Foreign-Trade Zones Board 15, IV
Forest Service 36, II
General Accounting Office 4, I, II, III
General Sales Manager, Office of 7, XXV
General Services Administration
Contract Appeals Board 48, 61
Federal Acquisition Regulation 48, 5
Federal Information Resources Management Regulations 41, Subtitle E,
Ch. 201
Federal Property Management Regulations System 41, 101, 105
Federal Travel Regulation System 41, Subtitle F
Payment of Expenses Connected With the Death of Certain Employees 41,
303
Reduction in Meeting and Training Allowance Payments 41, 304
Relocation Allowances 41, 302
Travel Allowances 41, 301
Geological Survey 30, IV
Government Ethics, Office of 5, XVI
Government National Mortgage Association 24, III
Grants and Program Systems, Office of 7, XXXII
Great Lakes Pilotage 46, III
Harry S. Truman Scholarship Foundation 45, XVIII
Health and Human Services, Department of 45, Subtitle A
Child Support Enforcement, Office of 45, III
Community Services, Office of 45, X
Family Assistance, Office of 45, II
Family Support Administration 45, II, III, IV, X
Federal Acquisition Regulation 48, 3
Food and Drug Administration 21, I
Health Care Financing Administration 42, IV
Human Development Services Office 45, XIII
Inspector General, Office of 42, V
Public Health Service 42, I
Refugee Resettlement, Office of 45, IV
Social Security Administration 20, III; 45, IV
Health Care Financing Administration 42, IV
Housing and Urban Development, Department of
Community Planning and Development, Office of Assistant Secretary for
24, V, VI
Equal Opportunity, Office of Assistant Secretary for 24, I
Federal Acquisition Regulation 48, 24
Government National Mortgage Association 24, III
Housing -- Federal Housing Commissioner, Office of Assistant
Secretary for 24, II, VIII, X, XX
Inspector General, Office of 24, XII
Mortgage Insurance and Loan Programs Under Emergency Homeowners'
Relief Act 24, XV
Public and Indian Housing, Office of Assistant Secretary for 24, IX
Secretary, Office of 24, Subtitle B, VII
Solar Energy and Energy Conservation Bank 24, XI
Housing -- Federal Housing Commissioner, Office of Assistant
Secretary for 24, II, VIII, X, XX
Human Development Services Office 45, XIII
Immigration and Naturalization Service 8, I
Indian Affairs, Bureau of 25, I
Indian Arts and Crafts Board 25, II
Information Agency, United States 22, V; 48, 19
Information Resources Management, Office of, Agriculture Department
7, XXVII
Information Security Oversight Office 32, XX
Inspector General, Office of, Agriculture Department 7, XXVI
Inspector General, Office of, Health and Human Services Department
42, V
Inspector General, Office of, Housing and Urban Development
Department 24, XII
Inter-American Foundation 22, X
Intergovernmental Relations, Advisory Commission on 5, VII
Interior Department
Endangered Species Committee 50, IV
Federal Acquisition Regulation 48, 14
Federal Property Management Regulations System 41, 114
Fish and Wildlife Service, United States 50, I, IV
Geological Survey 30, IV
Indian Affairs, Bureau of 25, I
Indian Arts and Crafts Board 25, II
Land Management Bureau 43, II
Minerals Management Service 30, II
Mines, Bureau of 30, VI
National Park Service 36, I
Reclamation Bureau 43, I
Secretary of the Interior, Office of 43, Subtitle A
Surface Mining and Reclamation Appeals, Board of 30, III
Surface Mining Reclamation and Enforcement, Office of 30, VII
United States Fish and Wildlife Service 50, I, IV
Internal Revenue Service 26, I
International Boundary and Water Commission, United States and Mexico
22, XI
International Cooperation and Development Office, Department of
Agriculture 7, XXII
International Development, Agency for 22, II
International Development Cooperation Agency 22, XII
International Development, Agency for 22, II
Overseas Private Investment Corporation 22, VII
International Joint Commission, United States and Canada 22, IV
International Organizations Employees Loyalty Board 5, V
International Regulatory Agencies (Fishing and Whaling) 50, III
International Trade Administration 15, III; 19, III
International Trade Commission, United States 19, II
Interstate Commerce Commission 49, X
Japan-United States Friendship Commission 22, XVI
Joint Board for the Enrollment of Actuaries 20, VIII
Justice Department 28, I; 41, 128
Drug Enforcement Administration 21, II
Federal Acquisition Regulation 48, 28
Federal Claims Collection Standards 4, II
Federal Prison Industries, Inc. 28, III
Foreign Claims Settlement Commission of the United States 45, V
Immigration and Naturalization Service 8, I
Offices of Independent Counsel 28, VI
Prisons, Bureau of 28, V
Labor Department
Benefits Review Board 20, VII
Employees' Compensation Appeals Board 20, IV
Employment and Training Administration 20, V
Employment Standards Administration 20, VI
Federal Acquisition Regulation 48, 29
Federal Contract Compliance Programs, Office of 41, 60
Federal Procurement Regulations System 41, 50
Labor-Management Relations and Cooperative Programs, Bureau of 29, II
Labor-Management Standards, Office of 29, IV
Mine Safety and Health Administration 30, I
Occupational Safety and Health Administration 29, XVII
Pension and Welfare Benefits Administration 29, XXV
Public Contracts 41, 50
Secretary of Labor, Office of 29, Subtitle A
Veterans' Employment and Training, Office of the Assistant Secretary
for 41, 61; 20, IX
Wage and Hour Division 29, V
Workers' Compensation Programs, Office of 20, I
Labor-Management Relations and Cooperative Programs, Bureau of 29, II
Labor-Management Standards, Office of 29, IV
Land Management, Bureau of 43, II
Legal Services Corporation 45, XVI
Library of Congress 36, VII
Copyright Office 37, II
Management and Budget, Office of 5, III; 48, 99
Marine Mammal Commission 50, V
Maritime Administration 46, II
Merit Systems Protection Board 5, II
Micronesian Status Negotiations, Office for 32, XXVII
Mine Safety and Health Administration 30, I
Minerals Management Service 30, II
Mines, Bureau of 30, VI
Minority Business Development Agency 15, XIV
Miscellaneous Agencies 1, IV
Monetary Offices 31, I
Mortgage Insurance and Loan Programs Under the Emergency Homeowners'
Relief Act, Department of Housing and Urban Development 24, XV
National Aeronautics and Space Administration 14, V; 48, 18
National Agricultural Library 7, XLI
National Agricultural Statistics Service 7, XXXVI
National Archives and Records Administration 36, XII
National Bureau of Standards 15, II
National Capital Planning Commission 1, IV
National Commission for Employment Policy 1, IV
National Commission on Libraries and Information Science 45, XVII
National Credit Union Administration 12, VII
National Foundation on the Arts and the Humanities 45, XI
National Highway Traffic Safety Administration 23, II, III; 49, V
National Indian Gaming Commission 25, III
National Institute of Standards and Technology 15, II
National Labor Relations Board 29, I
National Marine Fisheries Service 50, II, IV
National Mediation Board 29, X
National Oceanic and Atmospheric Administration 15, IX; 50, II, III,
IV, VI
National Park Service 36, I
National Railroad Adjustment Board 29, III
National Railroad Passenger Corporation (AMTRAK) 49, VII
National Science Foundation 45, VI; 48, 25
National Security Council 32, XXI
National Security Council and Office of Science and Technology Policy
47, II
National Telecommunications and Information Administration 15, XXIII;
47, III
National Transportation Safety Board 49, VIII
Navy Department 32, VI; 48, 52
Neighborhood Reinvestment Corporation 24, XXV
Nuclear Regulatory Commission 10, I
Occupational Safety and Health Administration 29, XVII
Occupational Safety and Health Review Commission 29, XX
Office of Independent Counsel 28, VII
Office of Navajo and Hopi Indian Relocation 25, IV
Offices of Independent Counsel, Department of Justice 28, VI
Operations Office, Department of Agriculture 7, XXVIII
Overseas Private Investment Corporation 22, VII
Oversight Board 12, XV
Packers and Stockyards Administration 9, II
Panama Canal Commission 48, 35
Panama Canal Regulations 35, I
Patent and Trademark Office 37, I
Payment of Expenses Connected With the Death of Certain Employees 41,
303
Peace Corps 22, III
Pennsylvania Avenue Development Corporation 36, IX
Pension and Welfare Benefits Administration, Department of Labor 29,
XXV
Pension Benefit Guaranty Corporation 29, XXVI
Personnel Management, Office of 5, I; 45, VIII; 48, 17
Federal Employees Health Benefits Acquisition Regulation 48, 16
Postal Rate Commission 39, III
Postal Service, United States 39, I
Postsecondary Education, Office of 34, VI
President's Commission on White House Fellowships 1, IV
Presidential Documents 3
Prisons, Bureau of 28, V
Productivity, Technology and Innovation, Assistant Secretary
(Commerce) 37, IV
Property Management Regulations System, Federal 41, Subtitle C
Public Contracts, Department of Labor 41, 50
Public Health Service 42, I
Railroad Retirement Board 20, II
Reclamation Bureau 43, I
Reduction in Meeting and Training Allowance Payments 41, 304
Refugee Resettlement, Office of 45, IV
Regional Action Planning Commissions 13, V
Relocation Allowances 41, 302
Research and Special Programs Administration 49, I
Resolution Trust Corporation 12, XVI
Rural Electrification Administration 7, XVII
Rural Telephone Bank 7, XVI
Saint Lawrence Seaway Development Corporation 33, IV
Science and Technology Policy, Office of 32, XXIV
Science and Technology Policy, Office of, and National Security
Council 47, II
Secret Service 31, IV
Securities and Exchange Commission 17, II
Selective Service System 32, XVI
Small Business Administration 13, I; 48, 22
Smithsonian Institution 36, V
Social Security Administration 20, III; 45, IV
Soil Conservation Service 7, VI
Solar Energy and Energy Conservation Bank, Department of Housing and
Urban Development 24, XI
Soldiers' and Airmen's Home, United States 5, XI
Special Counsel, Office of 5, VIII
Special Education and Rehabilitative Services, Office of 34, III
State Department 22, I
Federal Acquisition Regulation 48, 6
Surface Mining and Reclamation Appeals, Board of 30, III
Susquehanna River Basin Commission 18, VIII
Technology Administration 15, XI
Tennessee Valley Authority 18, XIII
Thrift Supervision Office, Department of the Treasury 12, V
Trade Representative, United States, Office of 15, XX
Transportation, Department of 44, IV
Coast Guard 33, I; 46, I, III; 49, IV
Commercial Space Transportation, Office of 14, III
Contract Appeals Board 48, 63
Federal Acquisition Regulation 48, 12
Federal Aviation Administration 14, I
Federal Highway Administration 23, I, II; 49, III
Federal Railroad Administration 49, II
Maritime Administration 46, II
National Highway Traffic Safety Administration 23, II, III; 49, V
Research and Special Programs Administration 49, I
Saint Lawrence Seaway Development Corporation 33, IV
Secretary of Transportation, Office of 14, II; 49, Subtitle A
Urban Mass Transportation Administration 49, VI
Transportation, Office of, Department of Agriculture 7, XXXIII
Travel Allowance 41, 301
Travel and Tourism Administration, United States 15, XII
Treasury Department 17, IV
Alcohol, Tobacco and Firearms, Bureau of 27, I
Comptroller of the Currency 12, I
Customs Service, United States 19, I
Engraving and Printing, Bureau of 31, VI
Federal Acquisition Regulation 48, 10
Federal Law Enforcement Training Center 31, VII
Fiscal Service 31, II
Foreign Assets Control, Office of 31, V
Internal Revenue Service 26, I
Monetary Offices 31, I
Secret Service 31, IV
Secretary of the Treasury, Office of 31, Subtitle A
Thrift Supervision Office 12, V
United States Customs Service 19, I
Truman, Harry S. Scholarship Foundation 45, XVIII
Under Secretary for Technology, Department of Commerce 37, V
United States and Canada, International Joint Commission 22, IV
United States Arms Control and Disarmament Agency 22, VI
United States Customs Service 19, I
United States Fish and Wildlife Service 50, I, IV
United States Information Agency 22, V; 48, 19
United States International Development Cooperation Agency 22, XII
United States International Trade Commission 19, II
United States Postal Service 39, I
United States Soldiers' and Airmen's Home 5, XI
United States Trade Representative, Office of 15, XX
United States Travel and Tourism Adminstration 15, XII
Urban Mass Transportation Administration 49, VI
Veterans Affairs Department 38, I; 48, 8
Veterans' Employment and Training, Office of the Assistant Secretary
for 41, 61; 20, IX
Vice President of the United States, Office of 32, XXVIII
Vocational and Adult Education, Office of 34, IV
Wage and Hour Division 29, V
Water Resources Council 18, VI
Workers' Compensation Programs, Office of 20, I
World Agriculture Outlook Board 7, XXXVIII
21 CFR 82.2707a 21 CFR (4-1-92 Edition)
21 CFR 82.2707a List of CFR Sections Affected
21 CFR 82.2707a List of CFR Sections Affected
All changes in this volume of the Code of Federal Regulations which
were made by documents published in the Federal Register since January
1, 1986, are enumerated in the following list. Entries indicate the
nature of the changes effected. Page numbers refer to Federal Register
pages. The user should consult the entries for chapters and parts as
well as sections for revisions.
For the period before January 1, 1986, see the ''List of CFR Sections
Affected, 1949-1963, 1964-1972, and 1973-1985'' published in seven
separate volumes.
21 CFR 82.2707a 1986
21 CFR
51 FR
Page
Chapter I
Chapter I Mandatory compliance date 1-1-89 34085
2.125 (Subpart G) Authority citation revised 4591
(e)(9) and (10) added 4591
5 Authority citation revised; section authority citations removed
19328
5.10 (a)(28) added 19328
5.22 (a)(12)(v) removed; (a)(12)(vi) and (vii) redesignated as
(a)(12)(v) and (vi); (a)(2), (6), and (12)(iii) revised 11428
(a)(12)(iii) revised 32452
(a)(4)(iii), (7)(iii), (iv), and (vi), and (8)(v) revised 41765
5.23 (a)(8) removed; (a)(9) and (10) redesignated as (a)(8) and (9);
(a)(2) revised 11428
5.28 Added 25883
5.30 (a)(7) and (c)(8) revised 11428, 32452
5.31 (f)(4) and (5) added 17011
5.36 Revised 11428, 32452
5.37 (a)(5)(iv) and (b)(4) introductory text revised 11428, 32452
5.45 (a) introductory text, (b) introductory text, (c)(5), (d), and
(e)(4) revised 11428, 32452
5.47 (d) revised 11428, 32452
5.63 Introductory text revised 11428, 32452
5.89 (a) introductory text revised 11428, 32452
5.100 Revised 11429
5.115 Amended 11430
14 Authority citation revised; section authority citations removed
32631
14.100 (d)(3) removed 32631
16 Authority citation revised 26364
16.1 (b)(2) amended 26364
(b)(2) Technical correction 34589
20.100 (c)(8) revised 22475
73.75 (c) revision effective date confirmed 5989
73.3111 Added 24816
Effective date confirmed 33032
Technical correction 40160
73.3121 (a)(7) through (9) addition effective date confirmed 2478
73.3122 Added 11432
Effective date confirmed 21911
73.3123 Added 11436
Effective date confirmed 19543
73.3124 Added 11433
Effective date corrected 12607
Effective date confirmed 21911
73.3125 Added 24816
Effective date confirmed 33032
Technical correction 40160
73.3126 Added 24816
Effective date confirmed 33032
Technical correction 40160
74 Authority citation revised 28346, 28363
74.705 (a)(1) and (b) revised 24519
Effective date confirmed 39654
74.706 Added 41782
74.1206 (b) and (c) revised (eff. 4-22-86) 9784
(b) and (c) revision effective date confirmed 18883
74.1267 Added 28346
Technical correction 35509
Effective date revised 35511
74.1308 Added 43898
74.1309 Added 43898
74.1319 Added 28363
Effective date revised 35511
74.1705 (a) and (b) revision effective date deferred 376, 7934
(a) and (b) revision effective date deferred 16675
(a) and (b) revision eff. 10-7-85 24519
(a) revised 24519
Effective date confirmed 39654
74.1706 Added 41782
74.2206 (a) revised (eff. 4-22-86) 9784
(a) revision effective date confirmed 18883
74.2267 Added 28346
Technical correction 35509
Effective date revised 35511
74.2308 Added 43898
74.2309 Added 43898
74.2319 Added 28363
Effective date revised 35511
74.2705 Revision effective date deferred 376, 7934
Revision effective date deferred 16675
Revision eff. 10-7-85 24519
(a) revised 24519, 24524
Effective date confirmed 39654
74.2706 Added 41782
74.3045 (b) amended 22929
(c)(1)(iii) removed 28930
(b) amendment confirmed 32453
(c)(2) revised 39371
(c)(1)(iii) removal confirmed 46852
74.3106 (c)(3) removal effective date confirmed 5990
74.3206 (a), (b) and (c) revised (eff. 4 -- 26 -- 86) 9784
(a), (b), and (c) revision effective date confirmed 18883
(b) revised; (c)(3) removed 37909
81.1 (a) table amended 376, 7934
(a) table amended 16675,
24524, 31324, 39857, 41783
(a) and (b) tables amended 20786, 28364, 35511, 43900
(b) table amended 20787,
28346, 28363, 43899
Technical correction 35509
Effective date confirmed 35510, 39654
81.10 (q) redesignated as (q)(1); (q)(2) added 20787
(t) added 43899
81.25 (a)(1) and (c)(1) amended; (b)(1)(ii) removed; (a)(2),
(b)(2), and (c)(2) revised 43899
81.27 (d) introductory text table amended 376,
7934, 16675, 20786, 20788, 24524, 28346, 28363, 28364, 31324, 35511,
39857, 41783, 43899, 43900
Technical correction 35509
Effective date confirmed 39654
81.30 (r)(2) revised; (r)(3) added 20788
(s) added 43899
82 Authority citation corrected 11014
Authority citation revised 28346, 28363
82.705 Revision effective date deferred 376, 7934, 16675
Revision eff. 10-7-85 24519
Revised 24519
Effective date confirmed 39654
82.706 Revised 41783
82.1206 (a) amended (eff. 4-22-86) 9785
Amendment effective date confirmed 18883
82.1267 Revised 28346
Technical correction 35509
82.1308 Revised 43899
82.1309 Revised 43899
82.1319 Revised 28363
82.1337 Removed 20788
21 CFR 82.2707a 1987
21 CFR
52 FR
Page
Chapter I
2.125 (e)(11) added 15717
5 Authority citation revised 5951
Corrected 7969
5.22 (a)(9)(v) and (vi) added 41986
5.31 (a) introductory text revised; (a)(3) added 2514
5.44 Added 7269
5.61 (b)(2) redesignated as (b)(3); (b)(1) and (d)(3) revised;
(b)(2) added 5951
5.71 (a)(1)(ii) redesignated as (a)(1)(iii); (a)(1)(ii) and (iv)
added 7829
5.80 (b)(1) and (c) introductory text revised; (d) added 37764
5.86 Revised 29664
5.87 Revised 29664
5.93 Added 10881
5.94 Added 2514
5.100 Revised 6970
5.115 Amended 6971
10.40 (h) revised 36401
10.95 (d)(8) revised 35064
58 Authority citation revised 33779
Technical correction 36863
58.1 Existing text designated as (a); (b) added 33779
58.3 Nomenclature change; (c), (d), and (e)(8) revised; (e)(12)
removed; (e)(17) and (18) amended; (o) and (p) added 33779
58.31 (b) revised 33780
58.35 (a) and (b) introductory text, (1), and (3) revised; (e)
removed; OMB number 33780
58.41 Revised 33780
58.43 (c) amended; (e) removed 33780
58.45 Amended 33780
58.49 Revised 33780
58.53 Removed 33780
58.61 Revised 33780
58.63 (b) revised; OMB number 33780
58.81 (c) amended 33780
58.90 (b) and (c) revised; OMB number 33780
58.105 (a) amended; (b) revised; OMB number 33781
58.113 (a)(2) revised 33781
58.120 (a) revised; OMB number 33781
58.130 (d) and (e) revised; OMB number 33781
58.185 (b) revised 33781
58.190 (a) and (e) revised; OMB number 33781
58.195 (c) revised; (g) redesignated as (h); new (g) added 33781
70 Authority citation revised 49586
70.50 (c) added 49586
73.1496 (a)(1), (b), and (c) revised 29665
Technical correction 32644
(a)(1), (b), and (c) revision effective date confirmed 42429
74.102 Eff. 7-31-87 28553
74.706 Addition effective date confirmed; (a)(1) revised 21508
(a)(1) revision effective date confirmed 31990
74.1102 Eff. 7-31-87 28553
74.1267 Preamble clarification 5081
74.1308 Effective date corrected 902
74.1309 Effective date corrected 902
(a)(1) revised 21305
Technical correction 24583
Effective date confirmed 28552
74.1319 Preamble clarification 5083
74.1706 Addition effective date confirmed; (c)(2) revised 21508
74.2267 Preamble clarification 5081
74.2308 Effective date corrected 902
74.2309 Effective date corrected 902
74.2319 Preamble clarification 5083
74.2706 Addition effective date confirmed 21506
74.3045 Technical correction 3224
(c)(2) revision effective date confirmed 7829
(c)(1) introductory text and (i) revised 15945
Effective date confirmed 27542
74.3206 (b) revision and (c)(3) removal effective date confirmed 1902
Technical correction 7261
74.3602 Added 19722
74.3710 Added 28690
Addition effective date confirmed 45938
81 Authority citation revised 42098
81.1 Effective date corrected 902
(a) and (b) tables amended 3224, 10882
Preamble clarification 5081, 5083
(b) table amended 6323, 15946
21305, 25209, 33574, 42098
(a) table amendment effective date confirmed; (a) table amended
21509
Technical correction 24583
(a) table amended 42097
81.10 Effective date and (t) corrected 902
81.25 Effective date corrected 902
81.27 Effective date corrected 902
(d) introductory text table amended 3224, 6323
10882, 15946, 21306, 21509, 25209, 33574, 42097, 42098
Preamble clarification 5081, 5083
(d) introductory text table amendment effective date confirmed 21509
Technical correction 24583
81.30 Effective date and (s)(1) and (2) corrected 902
82.102 Eff. 7-31-87 28553
82.706 Revised 21509
82.1267 Preamble clarification 5081
82.1308 Effective date corrected 902
82.1309 Effective date corrected 902
82.1319 Preamble clarification 5083
21 CFR 82.2707a 1988
21 CFR
53 FR
Page
Chapter I
Chapter I Uniform compliance date 1-1-91 44861
1 Authority citation revised; section authority citations removed
2828
1.4 Added 2828
5 Authority citation revised 26049
5.10 (a)(29) added 26049
5.24 Added 26049
5.35 (a)(1) revised 22293
5.83 (c) redesignated as (d); new (c) added 2225
(d)(1) and (2) revised; (d)(3) added 17186
(b)(1) and (c)(1) revised 40055
5.93 Revised 18274
5.100 Revised 8617
5.115 Revised 8618
12 Authority citation revised 29453
Authority citation corrected 34871
12.125 (a), (c), and (d) revised 29453
14.80 (a)(2) and (b)(1)(ii) revised 50949
14.95 (a) revised 50949
14.100 (c) added 49550
(d)(1)(iv) amended 50950
16 Authority citation revised 4615
16.26 Added 4615
60 Added 7305
73 Technical correction 49823
73.3107 Added 41324
73.3110a Added 41325
74.706 (d)(2) suspended 49138
74.1267 Removed 26770
Clarification 29655
74.1308 Removed 26768
Clarification 29655
74.1309 Removed 26768
Clarification 29655
74.1319 Removed 26770
Clarification 29655
74.1333 Added 33120
Technical correction 41649
Addition confirmed 43682
74.1336 Added 29031
(b) corrected 35255
(c) addition deferred in part 43683
(c) deferral at 53 FR 43683 removed; (c) amended 52130
74.1706 (c)(2) suspended 49138
74.2267 Removed 26770
Clarification 29655
74.2308 Removed 26768
Clarification 29655
74.2309 Removed 26768
Clarification 29655
74.2319 Removed 26770
Clarification 29655
74.2333 Added 33120
Technical correction 41649
74.2336 Added 29031
Addition confirmed 43683
81.1 (a) and (b) tables amended 15551, 25127
(b) table amended 20, 6984,
29031, 33121, 33122
Technical correction 41649
(b) table amendment at 53 FR 33121 confirmed 43682
(b) table amendment at 53 FR 29031 deferred; (b) table amended 43683
(a) table amended 43687, 52131
(b) deferral at 53 FR 43683 removed 52130
81.25 (a)(1) table, (b)(1)(i), and (c)(1) table amended 29031
Removed 33121
Technical correction 41649
Removal deferred in part 43682
(c)(1) table amendment deferred in part 43682, 43683
(c)(1) deferral at 53 FR 43683 removed 52130
81.27 (d) introductory text table amended 20, 6984,
15551, 25127, 29031, 33121, 33122, 43687, 52131
Technical correction 41649
(d) introductory text table amendment at 53 FR 33121 confirmed 43682
81.30 (s)(3) and (4) added 26768
(r)(4) and (5) and (t)(3) and (4) added 26770
Clarification 29655
82.1267 Removed 26770
Clarification 29655
82.1308 Removed 26768
Clarification 29655
82.1309 Removed 26768
Clarification 29655
82.1319 Removed 26770
Clarification 29655
82.1333 Revised 33121
Technical correction 41649
Revision confirmed 43682
82.1336 Revised 29031
Revision confirmed 43683
21 CFR 82.2707a 1989
21 CFR
54 FR
Page
Chapter I
1 Heading and authority citation revised 39630
1.4 Revised 39630
1.24 (a)(6)(i), (ii), and (iii) amended 9033
1.96 (a)(3) amended 9033
2 Authority citation revised; sectional authority citations removed
39631
2.19 Amended 9034
2.125 (d), (g), (h)(1) and (2) introductory text, and (i) amended
9034
5 Authority citation corrected 8053
5 Technical correction 22278
Authority citation revised 39631
5.10 (a)(7) amended 9034
(a)(30) added 20381
(a)(31) added 48592
5.22 (a)(7)(vi) removed; (a)(12) redesignated as (a)(13); new
(a)(12) added; (a)(7)(i) through (v), (9)(ii) and new (a)(13)(v) and
(vi) revised 8315
(a)(12)(iv) corrected 11866
(a)(7)(iv) and (v) revised 43961
5.23 (b) and (e) revised 8315
5.25 (a)(1) and (3) revised; (a)(6) added 8316
5.26 Heading, (b), (c), and (d) revised; (g) redesignated as (h);
new (g) added 8316
5.30 (a)(2) and (c)(3) revised; (a)(5) through (7) and (c)(6)
through (9) redesignated as (a)(6) through (8) and (c)(7) through (10);
new (a)(5) and (c)(6) added 8316
(c) introductory text amended 9034
5.31 (e)(2) amended; (f)(6) reserved; (f)(7) added 6884
(a), (b)(1), (2), and (3), (c)(1), (d)(1) and (2), (e)(3), and (f)(1)
through (5) revised; (e)(4) and (f)(6) added 8316
(e)(5) added 14797
5.37 (a)(1) revised; (a)(5) redesignated as (a)(6); new (a)(5)
added 8317
5.44 (a)(1)(i), (ii), (b)(1)(i) through (iv), (c)(1) and (2) revised;
(a)(1)(iii) and (iv) added; (c)(3) removed 8317
5.45 (e) introductory text revised; (f) added 6518
(e)(1)(iii) and (iv) revised 8317
(c) introductory text amended 9034
5.47 (a)(3) and (4) revised 8317
5.49 (b) revised 8317
5.50 (b) revised 8317
Heading corrected 11866
5.52 (b) revised 8317
5.53 (a)(2) and (b)(1)(ii) revised 8317
5.54 (b) revised 8318
5.55 (b) revised 8318
5.58 (c)(1) and (2) revised; (c)(3) removed 8318
5.59 (a)(2) revised 8318
5.63 (b) amended 9034
5.67 Introductory text revised 8318
5.68 Heading, (a), and (b) revised 8318
5.69 (a), (b), and (c) revised 8318
5.70 Revised 8318
5.71 (a) revised; (b) redesignated as (d); new (b) and (c) added
8318
5.73 (a) through (d) revised 8317
5.74 (a) and (b) revised 8319
5.75 (a), (b), and (c) revised 8319
5.76 (a) through (d) revised 8319
5.78 (a)(1) and (2) revised 8319
5.79 Removed 8319
5.80 Introductory text removed; (a), (b), (c)(1)(i), (ii), (2)(ii),
(d)(1), and (2) revised 8319
5.82 Revised 8319
5.94 (a) and (b) revised; (c) removed 8320
5.100 Revised 11696
5.110 (c) amended 9034
5.115 Revised 11697
7 Authority citation revised; sectional authority citations removed
39631
7.70 -- 7.75 (Subpart D) Removed 11519
7.73 Introductory text amended 9034
10 Authority citation revised 6885
Authority citation revised; sectional authority citations removed
39631
10.1 Amended 9034
(a) correctly designated 11607
10.3 (a) amended 6886
(a) and (b) amended 9034
10.20 (c)(1)(v) amended 9034
10.25 (a) amended 9034
10.30 (b) and (h)(4) amended 9034
10.35 (d) amended 9034
10.40 (b)(1)(ix) and (i)(1) amended 9034
10.45 (h) redesignated as (i); (i)(2)(i) amended; new (h) added
6886
(f) amended 9034
10.50 (a)(2) amended 9034
10.55 (c) amended 9035
10.80 (d)(2)(iii)(b) amended 9035
10.90 (b)(4) and (5) amended 9035
10.95 (d)(1) introductory text and (2) amended 9035
10.100 (b)(3)(v) removed 9035
10.203 (b) amended 9035
10.206 (a) amended 9035
12 Authority citation revised; sectional authority citations removed
39631
12.21 (a)(2) amended 9035
12.22 (a)(5)(i)(c) and (b) introductory text amended 9035
12.24 (b)(6) and (c) amended 9035
12.50 (a) amended 9035
12.85 (a) amended 9035
13 Authority citation revised 9035, 39631
13.5 Authority citation removed 39631
13.15 (a) amended 9035
13.25 (b) amended 9035
14 Authority citation revised 39631
14.1 (a)(2)(ix) amended 9035
14.20 (b)(9) amended 9035
14.22 (a)(1) amended 9035
14.75 (a)(6)(i) and (ii) amended 9035
14.80 (d) amended 9035
14.84 (c)(1) amended 9035
14.100 Revised 9036
(c)(3) added 11698
14.125 (d) amended 9037
14.171 (d), (e), and (f) amended 9037
15 Authority citation revised 39631
15.20 Authority citation removed 39631
16 Authority citation revised; sectional authority citations removed
39631
16.1 (b)(2) amended 9037
16.24 (c) amended 9037
16.40 Amended 9037
16.42 (c)(1) amended 9037
16.119 Amended 9037
19 Authority citation revised 39631
20 Authority citation revised 9037
Authority citation revised; sectional authority citations removed
39631
20.21 (b) amended 9037
20.42 (c) amended 9037
20.50 Amended 9038
20.81 (a)(3) amended 9038
20.100 (c)(13) amended; (c)(3), (14) through (17), and (21) revised
9038
20.103 (b) amended 9038
20.112 (a) amended 9038
20.117 (a)(3) and (b) amended 9038
21 Authority citation revised 39631
21.45 (c) amended 9038
21.71 (e)(4) amended 9038
25 Authority citation revised 39631
25.15 (c)(18) revised 9038
25.22 (a)(14) amended 9038
25.24 (c)(4) amended 9038
50 Authority citation revised 9038, 39632
50.3 (b)(6) revised; (b)(11) amended 9038
Authority citation removed 39632
50.20 -- 50.27 (Subpart B) Authority citation removed 39632
56 Authority citation revised 9038, 39632
56.102 (b)(6) revised; (b)(10) amended 9038
58 Authority citation revised 9038, 15924, 39632
58.3 (e)(5) revised; (e)(9) amended 9039
58.90 (d) amended 15924
58.195 (b)(1) amended 9039
60 Authority citation revised 39632
70 Authority citation revised 39632
70.19 (p) amended 24890
70.50 Authority citation removed 39632
71 Authority citation revised; sectional authority citations removed
39632
71.1 (c) amended 24890
73 Authority citation revised; sectional authority citations removed
39632
73.3107 Addition effective date confirmed 3775
73.3110a Addition effective date confirmed 3775
74 Authority citation revised; sectional authority citations removed
39632
74.1336 Regulation at 53 FR 52130 effective date confirmed 9200
80 Authority citation revised 39632
80.10 (d) amended 24890
Authority citation removed 39632
80.21 (j)(1) through (4) amended 24890
81 Authority citation revised; sectional authority citations removed
39632
81.1 (a) table amended 27640,
35861, 43962
(b) table amended 37307
81.27 (d) introductory text table amended 27641,
35861, 37307, 43962
82 Authority citation revised; sectional authority citation removed
39632
21 CFR 82.2707a 1990
21 CFR
55 FR
Page
Chapter I
Chapter I Uniform compliance date 1-1-93 276
2.125 (e)(12) added 39267
5 Authority citation revised 9078
Authority citation corrected 14916
5.22 (a)(12)(v) added 6247
(a)(9)(iii) and (iv) revised 47053
5.23 (c)(2) and (3) revised 47053
5.31 (f)(3) revised 6247
(a)(2)(iv) added 51688
5.37 (a)(2)(ii), (iii), (b)(2) and (3) revised; (b)(4) redesignated
as (b)(5); new (b)(4) added 47053
5.45 (b) introductory text, (4), (c)(2) and (e)(1)(ii) revised;
(e)(1)(iii) and (iv) redesignated as (e)(1)(iv) and (v); new
(e)(1)(iii) added 47053
5.46 Revised 47053
5.47 (a)(2) revised 47053
5.51 Added 6794
5.58 (c)(1)(iv) added 51688
5.59 (a)(1) and (b) revised 47053
5.71 (b)(2) and (c)(2) revised 51688
5.72 Added 5445
5.80 (c)(1)(i) and (ii) revised; (c)(1)(iii) added 6247
(a)(1)(iii) added 51688
5.86 (b) revised 47053
5.87 (b) revised 47053
5.88 Revised 47054
5.89 (a) introductory text and (b) introductory text revised 47054
5.91 Revised 47054
5.93 (b) revised 6247
5.94 (b)(4) added 51688
5.100 Revised 9418
5.115 Revised 9419
7 Authority citation revised 9079
10 Authority citation revised 9079
12 Authority citation revised 9079
13 Authority citation revised 9079
14 Authority citation revised 9079
14.7 (b) removed 1404
14.31 (e) amended 42703
14.40 (b) amended 42703
14.100 (c)(16) added 5838
(b)(2)(ii), (c)(11)(i) and (d)(2)(i) amended; (c)(2)(ii) and (e)(2)
revised 7316
(d)(1)(i)(B), (ii)(B), (iii)(B), (iv)(B), (v)(B), (vi)(B),
(vii)(B), (viii)(B), (ix)(B), (x)(B), (xi)(B), (xii)(B), (xiii)(B),
(xiv)(B), (xv)(B), and (xvi)(B) amended 42703
(d)(1) revised 51282
15 Authority citation revised 9079
16 Authority citation revised 9079
19.10 (a) amended 1404
20 Authority citation revised 9079
20.41 (b)(4) amended 1405
20.47 (c) amended 1405
25 Authority citation revised 9079
50.23 (d) added; interim 52817
73.3106 Added 30214
Technical correction 33816
Regulation at 55 FR 30214 effective date confirmed 46044
74.1602 (c) revised 18868
(c)(2)(i) amended 12172
Regulation at 55 FR 12172 eff. date confirmed 26430
74.3045 (c)(1) introductory text revised 19620
Effective date confirmed 31824
Effective date corrected 21674
74.3230 Added 22898
Regulation at 55 FR 22898 eff. date confirmed 37868
74.3602 (b)(2) revised; (b)(3) and (4) added 18868
Effective date confirmed 31823
81.1 (a) table amended 3519
81.10 (u) added 3519
81.27 Removed 3519
81.30 (u) added 3519
82.303 Removed 3519
21 CFR 82.2707a 1991
21 CFR
56 FR
Page
Chapter I
3 Added 58756
Regulation at 56 FR 58756 comment period extended to 2-21-92 66347
5 Authority citation revised 42527, 51170
Technical correction 64687
Authority citation corrected 65930
5.10 (a)(32) added 3034
(a)(33) added 42527
(b) amended 8709
5.20 (e) redesignated as (f); new (e) added 36001
5.32 Added 58758
5.33 Added 58759
5.35 (a)(1) amended; (b) redesignated as (c); new (b) and (c)(3)
added; new (c) introductory text revised 23788
5.56 Added 51170
5.57 Added 51170
5.67 (d) added 25025
5.80 (a)(1)(iv) added 55454
5.95 Added 6263
5.100 Revised 8276
5.105 Amended 8709
5.115 Amended 8277
10.40 (b) introductory text and (d) revised 13758
14 Authority citation revised 48103
14.100 Technical correction 559
(d)(1)(i) and (ii) revised 26613
(c)(17) added 48103
50.3 (l) revised 28028
56.102 (i) revised; (m) added 28028
56.104 (d) added 28028
56.107 (a), (b) and (c) revised 28028
(a) corrected 29756
56.108 (a) revised; (c) removed; (d) redesignated as (c); new (b)
added; OMB number 28028
Corrected 29756
56.110 (b) revised 28029
56.111 (a)(3) and (b) revised 28029
56.115 (a)(6) revised; OMB number 28029
58.90 (d) amended 32088
21 CFR 82.2707a 1992
21 CFR
57 FR
Page
Chapter I
5 Authority citation revised 10288
Footnote 1 redesignated as footnote 5; footnote 5 and footnote 6
revised 10287
Revised 10288
5.100 Amended 6475
Authority citation revised 8064
14.100 (g) added 8064
81.1 Introductory text amended 10616
21
Food and Drugs
PARTS 1 TO 99
Revised as of April 1, 1992
CONTAINING
A CODIFICATION OF DOCUMENTS
OF GENERAL APPLICABILITY
AND FUTURE EFFECT
AS OF APRIL 1, 1992
With Ancillaries
Published by
the Office of the Federal Register
National Archives and Records
Administration
as a Special Edition of
the Federal Register
Washington, DC 20402-9328
21 CFR 82.2707a Table of Contents
Page
Explanation v
Title 21:
Chapter I -- Food and Drug Administration, Department of Health and
Human Services
Finding Aids:
Material Approved for Incorporation by Reference
Table of CFR Titles and Chapters
Alphabetical List of Agencies Appearing in the CFR
List of CFR Sections Affected
21 CFR 82.2707a Explanation
The Code of Federal Regulations is a codification of the general and
permanent rules published in the Federal Register by the Executive
departments and agencies of the Federal Government. The Code is divided
into 50 titles which represent broad areas subject to Federal
regulation. Each title is divided into chapters which usually bear the
name of the issuing agency. Each chapter is further subdivided into
parts covering specific regulatory areas.
Each volume of the Code is revised at least once each calendar year
and issued on a quarterly basis approximately as follows:
Title 1 through Title 16 as of January 1
Title 17 through Title 27 as of April 1
Title 28 through Title 41 as of July 1
Title 42 through Title 50 as of October 1
The appropriate revision date is printed on the cover of each volume.
LEGAL STATUS
The contents of the Federal Register are required to be judicially
noticed (44 U.S.C. 1507). The Code of Federal Regulations is prima facie
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HOW TO USE THE CODE OF FEDERAL REGULATIONS
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Provisions that become obsolete before the revision date stated on
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21 CFR 82.2707a THIS TITLE
Title 21 -- Food and Drugs is composed of nine volumes. The parts in
these volumes are arranged in the following order: Parts 1-99, 100-169,
170-199, 200-299, 300-499, 500-599, 600-799, 800-1299 and 1300-End. The
first eight volumes, containing parts 1-1299, comprise Chapter I -- Food
and Drug Administration, Department of Health and Human Services. The
ninth volume, containing part 1300 to End, includes Chapter II -- Drug
Enforcement Administration, Department of Justice. The contents of
these volumes represent all current regulations codified under this
title of the CFR as of April 1, 1992.
The Table of Exempted Prescription Products to part 1308 appears in
the volume containing part 1300-End.
Redesignation tables for Chapter I -- Food and Drug Administration
appear in the Finding Aids section for the volumes containing parts
170-199 and 500-599.
For this volume, Ann Worley was Chief Editor. The Code of Federal
Regulations publication program is under the direction of Richard L.
Claypoole, assisted by Alomha S. Morris.
21 CFR 0.0 21 CFR Ch. I (4-1-92 Edition)
21 CFR 0.0 Food and Drug Administration, HHS
21 CFR 0.0 Title 21 -- Food and Drugs
21 CFR 0.0 (This book contains parts 100 to 169)
Part
chapter i -- Food and Drug Administration, Department of Health and
Human Services (Continued) 100
Cross References: Food Safety and Inspection Service, Department of
Agriculture: See Meat and Poultry Inspection, 9 CFR chapter III.
Federal Trade Commission: See Commercial Practices, 16 CFR chapter
I.
United States Customs Service, Department of the Treasury: See
Customs Duties, 19 CFR chapter I.
Internal Revenue Service, Department of the Treasury: See Internal
Revenue, 26 CFR chapter I.
Bureau of Alcohol, Tobacco, and Firearms, Department of the Treasury:
See Alcohol, Tobacco Products and Firearms, 27 CFR chapter I.
21 CFR 0.0 21 CFR Ch. I (4-1-92 Edition)
21 CFR 0.0 Food and Drug Administration, HHS
21 CFR 0.0 CHAPTER I -- FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES -- CONTINUED
21 CFR 0.0 (Parts 100 to 169)
Editorial Notes: 1. Nomenclature changes affecting this chapter
appear at 45 FR 40976, June 17, 1980, and 46 FR 8454, Jan. 27, 1981.
2. The Food and Drug Administration published a document at 49 FR
41019, Oct. 19, 1984, establishing July 1, 1987, as a new uniform
effective date for compliance for regulations affecting the labeling of
food products. At 51 FR 34085, Sept. 25, 1986, FDA established January
1, 1989, as a new uniform effectived date for compliance. The new
uniform effective date will apply only to final FDA food labeling
regulations published after July 1, 1986, and before January 1, 1988.
21 CFR 0.0 SUBCHAPTER B -- FOOD FOR HUMAN CONSUMPTION
Part
Page
100 General
101 Food labeling
102 Common or usual name for nonstandardized foods
103 Quality standards for foods with no identity standards
104 Nutritional quality guidelines for foods
105 Foods for special dietary use
106 Infant formula quality control procedures
107 Infant formula
108 Emergency permit control
109 Unavoidable contaminants in food for human consumption and
food-packaging material
110 Current good manufacturing practice in manufacturing, packing, or
holding human food
113 Thermally processed low-acid foods packaged in hermetically
sealed containers
114 Acidified foods
129 Processing and bottling of bottled drinking water
130 Food standards: General
131 Milk and cream
133 Cheeses and related cheese products
135 Frozen desserts
136 Bakery products
137 Cereal flours and related products
139 Macaroni and noodle products
145 Canned fruits
146 Canned fruit juices
150 Fruit butters, jellies, preserves, and related products
152 Fruit pies
155 Canned vegetables
156 Vegetable juices
158 Frozen vegetables
160 Eggs and egg products
161 Fish and shellfish
163 Cacao products
164 Tree nut and peanut products
165 (Reserved)
166 Margarine
168 Sweeteners and table sirups
169 Food dressings and flavorings
21 CFR 0.0
21 CFR 0.0 21 CFR Ch. I (4-1-92 Edition)
21 CFR 0.0 Food and Drug Administration, HHS
21 CFR 0.0 SUBCHAPTER B -- FOOD FOR HUMAN CONSUMPTION
21 CFR 0.0 Pt. 100
21 CFR 0.0 PART 100 -- GENERAL
21 CFR 0.0 Subparts A-F (Reserved)
21 CFR 0.0 Subpart G -- Specific Administrative Rulings and Decisions
Sec.
100.120 Artificially red-dyed yellow varieties of sweet potatoes.
100.130 Combinations of nutritive and nonnutritive sweeteners in
''diet beverages.''
100.135 Disposition of incubator reject eggs.
100.140 Label declaration of salt in frozen vegetables.
100.145 Notice to packers of comminuted tomato products.
100.150 Notice to packers and shippers of shelled peanuts.
100.155 Salt and iodized salt.
100.160 Tolerances for moldy and insect-infected cocoa beans.
Authority: Secs. 201, 301, 402, 403, 409, 701 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321, 331, 342, 343, 348, 371).
Source: 42 FR 14306, Mar. 15, 1977, unless otherwise noted.
21 CFR 0.0 Subparts A-F (Reserved)
21 CFR 0.0 Subpart G -- Specific Administrative Rulings and Decisions
21 CFR 100.120 Artificially red-dyed yellow varieties of sweet
potatoes.
(a) It has been the practice of some growers, packers, and
distributors of yellow varieties of sweet potatoes to artificially color
the skins of such potatoes with a red dye. Surveys made by the Food and
Drug Administration and letters received by the Administration from
consumers reveal that this practice can deceive those persons who prefer
the naturally red varieties of sweet potatoes. Also, representatives of
the red sweet potato industry have alleged that some consumers refuse to
purchase any red sweet potatoes since they cannot distinguish between
the naturally red ones and those artificially colored with red dye.
(b) The Food and Drug Administration concludes, therefore, that
yellow varieties of sweet potatoes artificially colored with a red dye
are adulterated within the meaning of section 402(b) of the Federal
Food, Drug, and Cosmetic Act.
(c) The Food and Drug Administration will consider appropriate
regulatory action regarding such adulterated sweet potatoes shipped in
interstate commerce if the act of adulterating the potatoes occurs after
90 days following the date of publication of this statement of policy in
the Federal Register.
21 CFR 100.130 Combinations of nutritive and nonnutritive sweeteners in
''diet beverages.''
As a result of the removal of cyclamic acid and its salts from the
list of substances generally recognized as safe (Part 182 of this
chapter) by an order published in the Federal Register of October 21,
1969 (34 FR 17063), the Commissioner of Food and Drugs has received
inquiries as to the proper composition and labeling, from the standpoint
of application of the Federal Food, Drug, and Cosmetic Act, of so-called
''diet beverages'' that will be made from mixtures of nutritive
sweeteners and saccharin or its salts. The Commissioner concludes that:
(a) Any ''diet beverage'' or diet beverage base made with
combinations of nutritive and nonnutritive sweeteners must be so
formulated that each ingredient is one which is generally recognized as
safe and is not a food additive as defined in section 201(s) or a color
additive as defined in section 201(t) of the act, or if it is a food
additive or a color additive as so defined, is used in accordance with a
regulation established pursuant to section 409 or 706 of the act.
(b) The product is to be so formulated that its caloric value is at
least 50 percent less than the caloric value of the comparable product
made without artificial sweeteners. In no case shall the beverage
provide more than 6 calories per fluid ounce.
(c) If it is to be marketed under a name heretofore used on a product
represented to have no, or only a few, calories per serving, the name
shall be modified by the word ''new'' for at least 1 year following the
time such product is introduced in a given market.
(d) (1) The label must bear a complete statement of ingredients
except that spices, flavorings, and colorings may be designated as such
without naming each.
(2) The label must bear a statement of the caloric content per fluid
ounce, the carbohydrate content per fluid ounce, a statement of the
percentage of saccharin or saccharin salt used, and the statement
''Contains ------ mg saccharin (or saccharin salt, as the case may be)
per ounce, a nonnutritive artificial sweetener.''
(3) To further avoid injury through inadvertent use by diabetics in
the belief that the product does not contain carbohydrates, the label of
a beverage containing sugar(s) must bear the statement ''Contains
sugar(s); not for use by diabetics without advice of a physician.''
(4) To avoid confusion by diabetics, the label of a beverage
containing sorbitol, mannitol, or other hexitol, must bear the statement
''Contains carbohydrates, not for use by diabetics without advice of a
physician''. To further avoid confusion of these beverages with those
sweetened solely with nonnutritive artificial sweeteners which have been
marketed in containers bearing prominent statements such as ''sugar
free'', ''sugarless'', or ''no sugar'', the labels of beverages
containing hexitols must not bear these or similar statements.
(e) Bottlers of diet drinks have on hand large stocks of returnable
lithographed bottles bearing statements indicating that the beverages
contain cyclamates and/or declarations such as ''sugar free'', ''less
than 1 calorie per bottle'', or ''less than 2 calories per bottle''
which bottles were formerly used for artificially sweetened beverages
containing cyclamates. The Food and Drug Administration will not object
to continued use of these bottles under the following conditions:
(1) The bottles when filled with beverages made with combinations of
nutritive and nonnutritive sweeteners may be marketed only:
(i) In multiunit cartons labeled prominently on each principal
display panel with the information set forth in paragraphs (c) and (d)
of this section and with a prominent, forthright notice that any
information on bottles which is contrary to that on the cartons should
be disregarded because it is incorrect. To assure adequate prominence
and conspicuousness, the following statements should stand out in marked
contrast with other labeling: The statement of caloric content and
carbohydrate content per fluid ounce, the statement required by
paragraph (d) (3) or (4) of this section as applicable, and the notice
to disregard any information on bottles which is contrary to that on the
cartons. These statements may be made to stand out by means such as
setting them forth in boxes, printing in bold capitals on lines
separated from other printed labeling, using colors that contrast with
those used for other label statements, or other similar means.
(ii) In vending machines bearing durable labeling which includes all
of the information required to appear on cartons set forth with the same
degree of prominence.
(2) In addition, the bottles must bear caps labeled prominently with
the words ''Contains Sugar'' or ''Contains Carbohydrates'', and accurate
statements of the caloric content and carbohydrate content per fluid
ounce.
21 CFR 100.135 Disposition of incubator reject eggs.
(a) Investigations by the Food and Drug Administration and a number
of State regulatory agencies have revealed that incubator reject eggs,
removed as infertile or otherwise unhatchable during hatching
operations, are being diverted for human food use. Such eggs are
regarded as adulterated within the meaning of section 402(a)(3) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(a)(3)) because they
are unfit for food.
(b) The introduction or delivery for introduction into interstate
commerce of adulterated eggs is prohibited under section 301(a) of the
aforesaid act (21 U.S.C. 331(a)) unless they have been broken, crushed,
or smashed and then denatured with kerosene, creolin, or other suitable
denaturant to preclude their diversion to human food channels.
21 CFR 100.140 Label declaration of salt in frozen vegetables.
(a) In a number of diseases or disease conditions it is important to
restrict the intake of sodium. Sodium occurs in all natural foods, but
added salt makes the most important contribution to the total sodium
intake in the diet. Most fresh vegetables are of low sodium content and
consumers generally regard frozen vegetables as being free of added salt
and suitable for use in low-sodium diets. While salt may not be added
directly as a seasoning ingredient during the processing of frozen
vegetables, the use of salt brine in quality separation of such
vegetables as peas and lima beans preparatory to freezing may contribute
substantial amounts of salt to the finished article. The failure of the
labels of frozen vegetables to declare the presence of salt has been the
basis of complaints to the Food and Drug Administration.
(b) Section 403(i)(2) of the Federal Food, Drug, and Cosmetic Act
requires the label of a fabricated food to bear the common or usual name
of each ingredient present. The Department of Health and Human Services
regards any frozen vegetable containing salt, added directly or
indirectly, as misbranded in violation of section 403(i)(2) of the
Federal Food, Drug, and Cosmetic Act unless its label names salt as an
ingredient.
21 CFR 100.145 Notice to packers of comminuted tomato products.
(a) It has long been known that tomato rot may be caused by one or
more of the following: Fungus diseases, bacterial diseases, virus
diseases, and certain nonparasitic diseases. Only the fungus rots are
characterized by the presence of mold filaments. Mold counts on
comminuted tomato products are not increased by incorporating within the
product tomato rot caused by bacteria, virus, or nonparasitic factors.
Although high mold counts on these products reveal that large amounts of
rotten material are present, low mold counts do not necessarily
demonstrate absence of the type of rot caused by the tomato diseases
that are not characterized by mold filaments.
(b) Inspections of canneries engaged in the packing of comminuted
tomato products show that most packers effectively trim, sort out, and
discard rotten tomatoes from the raw stock. Some packers, however, do
not properly eliminate rotten tomato material, and a few packers
deliberately use rotten tomatoes in these foods, provided the mold count
remains low. Some packers, on occasion, have mixed tomato products
having a high mold count with tomato products containing little or no
mold, so as to produce a blend with a low mold count.
(c) Packers of comminuted tomato products who rely upon the mold
count as the sole or primary control procedure, to the neglect of
adequate sorting and trimming, may produce products with low mold counts
which contain substantial amounts of rot.
(d) It is the purpose of this announcement to advise all canners of
tomato products that:
(1) Although high mold count is conclusive evidence of inclusion of
substantial amounts of rot, mold count is not the only way of
establishing that comminuted tomato products contain decomposed tomato
material.
(2) Where factory observations or other evidence reveals that
comminuted tomato products contain rot not caused by mold, such rot, as
well as that caused by mold, will be taken into account in applying the
provisions of the Federal Food, Drug, and Cosmetic Act against
adulteration.
(3) The blending of tomato products adulterated with tomato rot, of
whatever kind, with tomato products made from sound tomatoes, or with
other sound food, renders the blend adulterated.
21 CFR 100.150 Notice to packers and shippers of shelled peanuts.
(a) Investigations by the Food and Drug Administration have shown
that a number of interstate shipments of shelled peanuts in bags holding
from approximately 100 to 125 pounds each have failed to bear labeling
as required by the terms of the Federal Food, Drug, and Cosmetic Act.
(b) Shelled peanuts in sacks, whether or not shipped in carload lots,
should bear the following information required by the law on food in
package form:
(1) The name of the product.
(2) An accurate statement of net weight.
(3) The name and place of business of the packer or distributor.
(c) The information required by paragraph (b) of this section should
be conspicuously set forth. It may be printed or stenciled on each bag
or, if desired, placed on tags which are securely attached to each bag.
(d) The net weight marked on the bags must be the correct net weight
of the peanuts at the time they are delivered to the carrier for
interstate shipment. The tare weight of the bag should not be included
in the weight declaration.
21 CFR 100.155 Salt and iodized salt.
(a) For the purposes of this section, the term ''iodized salt'' or
''iodized table salt'' is designated as the name of salt for human food
use to which iodide has been added in the form of cuprous iodide or
potassium iodide permitted by 184.1265 and 184.1634 of this chapter.
In the labeling of such products, all words in the name shall be equal
in prominence and type size. The statement ''This salt supplies iodide,
a necessary nutrient'' shall appear on the label immediately following
the name and shall be in letters which are not less in height than those
required for the declaration of the net quantity of contents as
specified in 101.105 of this chapter.
(b) Salt or table salt for human food use to which iodide has not
been added shall bear the statement, ''This salt does not supply iodide,
a necessary nutrient.'' This statement shall appear immediately
following the name of the food and shall be in letters which are not
less in height than those required for the declaration of the net
quantity of contents as specified in 101.105 of this chapter.
(c) Salt, table salt, iodized salt, or iodized table salt to which
anticaking agents have been added may bear in addition to the ingredient
statement designating the anticaking agent(s), a label statement
describing the characteristics imparted by such agent(s) (for example,
''free flowing''), providing such statement does not appear with greater
prominence or in type size larger than the statements which immediately
follow the name of the food as required by paragraphs (a) and (b) of
this section.
(d) Individual serving-sized packages containing less than 1/2 ounce
and packages containing more than 2 1/2 pounds of a food described in
this section shall be exempt from declaration of the statements which
paragraphs (a) and (b) of this section require immediately following the
name of the food. Such exemption shall not apply to the outer container
or wrapper of a multiunit retail package.
(e) All salt, table salt, iodized salt, or iodized table salt in
packages intended for retail sale shipped in interstate commerce 18
months after the date of publication of this statement of policy in the
Federal Register, shall be labeled as prescribed by this section; and
if not so labeled, the Food and Drug Administration will regard them as
misbranded within the meaning of sections 403 (a) and (f) of the Federal
Food, Drug, and Cosmetic Act.
(42 FR 14306, Mar. 15, 1977, as amended at 48 FR 10811, Mar. 15,
1983; 49 FR 24119, June 12, 1984)
21 CFR 100.160 Tolerances for moldy and insect-infested cocoa beans.
On and after February 22, 1963, shipments of cocoa beans offered for
entry into the United States must meet a tolerance of 6 percent total
moldy and insect-infested, including insect-damaged, beans, but not more
than 4 percent of either moldy or insect-infested, including
insect-damaged, beans. This statement of policy supersedes the notice
issued August 27, 1931, addressed to shippers, importers, and dealers in
cocoa beans and manufacturers of chocolate and cocoa products and the
statement of policy issued June 22, 1961, in this section.
21 CFR 100.160 Pt. 101
21 CFR 100.160 PART 101 -- FOOD LABELING
21 CFR 100.160 Subpart A -- General Provisions
Sec.
101.1 Principal display panel of package form food.
101.2 Information panel of package form food.
101.3 Identity labeling of food in packaged form.
101.4 Food; designation of ingredients.
101.5 Food; name and place of business of manufacturer, packer, or
distributor.
101.6 Label designation of ingredients for standardized foods.
101.8 Labeling of food with number of servings.
101.9 Nutrition labeling of food.
101.10 Nutrition labeling of restaurant foods.
101.11 Saccharin and its salts; retail establishment notice.
101.13 Sodium labeling.
101.15 Food; prominence of required statements.
101.17 Food labeling warning and notice statements.
101.18 Misbranding of food.
21 CFR 100.160 Subpart B -- Specific Food Labeling Requirements
101.22 Foods; labeling of spices, flavorings, colorings and chemical
preservatives.
101.25 Labeling of foods in relation to fat and fatty acid and
cholesterol content.
101.29 Labeling of kosher and kosher-style foods.
101.33 Label declaration of D-erythroascorbic acid when it is an
ingredient of a fabricated food.
101.35 Notice to manufacturers and users of monosodium glutamate and
other hydrolyzed vegetable protein products.
21 CFR 100.160 Subpart C -- Specific Nutrition Labeling Requirements
and Guidelines
101.42 Nutrition labeling of raw fruit, vegetables, and fish.
101.43 Substantial compliance of food retailers with the guidelines
for the voluntary nutrition labeling of raw fruit, vegetables, and fish.
101.44 Identification of the 20 most frequently consumed raw fruit,
vegetables, and fish in the United States.
101.45 Guidelines for the voluntary nutrition labeling of raw fruit,
vegetables, and fish.
21 CFR 100.160 Subparts D-E (Reserved)
21 CFR 100.160 Subpart F -- Exemptions From Food Labeling Requirements
101.100 Food; exemptions from labeling.
101.103 Petitions requesting exemptions from or special requirements
for label declaration of ingredients.
101.105 Declaration of net quantity of contents when exempt.
101.108 Temporary exemptions for purposes of conducting authorized
food labeling experiments.
Appendix A to Part 101 -- Monier-Williams Procedure (With
Modifications) for Sulfites in Food, Center for Food Safety and Applied
Nutrition, Food and Drug Administration (November 1985)
Authority: Secs. 4, 5, 6 of the Fair Packaging and Labeling Act (15
U.S.C. 1453, 1454, 1455); secs. 201, 301, 402, 403, 409, 701 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 342, 343, 348,
371).
Source: 42 FR 14308, Mar. 15, 1977, unless otherwise noted.
21 CFR 100.160 Subpart A -- General Provisions
21 CFR 101.1 Principal display panel of package form food.
The term ''principal display panel'' as it applies to food in package
form and as used in this part, means the part of a label that is most
likely to be displayed, presented, shown, or examined under customary
conditions of display for retail sale. The principal display panel
shall be large enough to accommodate all the mandatory label information
required to be placed thereon by this part with clarity and
conspicuousness and without obscuring design, vignettes, or crowding.
Where packages bear alternate principal display panels, information
required to be placed on the principal display panel shall be duplicated
on each principal display panel. For the purpose of obtaining uniform
type size in declaring the quantity of contents for all packages of
substantially the same size, the term ''area of the principal display
panel'' means the area of the side or surface that bears the principal
display panel, which area shall be:
(a) In the case of a rectangular package where one entire side
properly can be considered to be the principal display panel side, the
product of the height times the width of that side;
(b) In the case of a cylindrical or nearly cylindrical container, 40
percent of the product of the height of the container times the
circumference;
(c) In the case of any otherwise shaped container, 40 percent of the
total surface of the container: Provided, however, That where such
container presents an obvious ''principal display panel'' such as the
top of a triangular or circular package of cheese, the area shall
consist of the entire top surface. In determining the area of the
principal display panel, exclude tops, bottoms, flanges at tops and
bottoms of cans, and shoulders and necks of bottles or jars. In the
case of cylindrical or nearly cylindrical containers, information
required by this part to appear on the principal display panel shall
appear within that 40 percent of the circumference which is most likely
to be displayed, presented, shown, or examined under customary
conditions of display for retail sale.
21 CFR 101.2 Information panel of package form food.
(a) The term ''information panel'' as it applies to packaged food
means that part of the label immediately contiguous and to the right of
the principal display panel as observed by an individual facing the
principal display panel with the following exceptions:
(1) If the part of the label immediately contiguous and to the right
of the principal display panel is too small to accommodate the necessary
information or is otherwise unusable label space, e.g., folded flaps or
can ends, the panel immediately contiguous and to the right of this part
of the label may be used.
(2) If the package has one or more alternate principal display
panels, the information panel is immediately contiguous and to the right
of any principal display panel.
(3) If the top of the container is the principal display panel and
the package has no alternate principal display panel, the information
panel is any panel adjacent to the principal display panel.
(b) All information required to appear on the label of any package of
food pursuant to 101.4, 101.5, 101.8, 101.9, 101.17, 101.25 and Part
105 of this chapter shall appear either on the principal display panel
or on the information panel, unless otherwise specified by regulations
in this chapter.
(c) All information appearing on the principal display panel or the
information panel pursuant to this section shall appear prominently and
conspicuously, but in no case may the letters and/or numbers be less
than one-sixteenth inch in height unless an exemption pursuant to
paragraph (f) of this section is established. The requirements for
conspicuousness and legibility shall include the specifications of
101.105(h) (1) and (2) and 101.15.
(1) Packaged foods are exempt from the type size requirements of this
paragraph: Provided, That:
(i) The package is designed such that it has a surface area that can
bear an information panel and/or an alternate principal display panel.
(ii) The area of surface available for labeling on the principal
display panel of the package as this term is defined in 101.1 is less
than 10 square inches.
(iii) The label information includes:
(a) Nutrition labeling in accordance with 101.9.
(b) A full list of ingredients in accordance with regulations in this
part and the policy expressed in 101.6.
(iv) The information required by paragraph (b) of this section
appears on the principal display panel or information panel label in
accordance with the provisions of this paragraph (c) except that the
type size is not less than three sixty-fourths inch in height.
(2) Packaged foods are exempt from the type size requirements of this
paragraph: Provided, That:
(i) The package is designed such that it has a single ''obvious
principal display panel'' as this term is defined in 101.1 and has no
other available surface area for an information panel or alternate
principal display panel.
(ii) The area of surface available for labeling on the principal
display panel of the package as this term is defined in 101.1 is less
than 12 square inches and bears all labeling appearing on the package.
(iii) The label information includes:
(a) Nutrition labeling in accordance with 101.9.
(b) A full list of ingredients in accordance with regulations in this
part and the policy expressed in 101.6.
(iv) The information required by paragraph (b) of this section
appears on the single, obvious principal display panel in accordance
with the provisions of this paragraph (c) except that the type size is
not less than one thirty-second inch in height.
(3) Packaged foods are exempt from the type size requirements of this
paragraph: Provided, That:
(i) The package is designed such that it has a total surface area
available to bear labeling of less than 12 square inches.
(ii) The label information includes:
(a) Nutrition labeling in accordance with 101.9.
(b) A full list of ingredients in accordance with regulations in this
part and the policy expressed in 101.6.
(iii) The information required by paragraph (b) of this section
appears on the principal display panel or information panel label in
accordance with the provisions of this paragraph (c) except that the
type size is not less than one thirty-second inch in height.
(4)(i) Soft drinks packaged in bottles manufactured before October
31, 1975 shall be exempt from the requirements prescribed by this
section to the extent that information which is blown, lithographed, or
formed onto the surface of the bottle is exempt from the size and
placement requirements of this section.
(ii) Soft drinks packaged in bottles shall be exempt from the size
and placement requirements prescribed by this section if all of the
following conditions are met:
(a) If the soft drink is packaged in a bottle bearing a paper,
plastic foam jacket, or foil label, or is packaged in a nonreusable
bottle bearing a label lithographed onto the surface of the bottle or is
packaged in metal cans, the product shall not be exempt from any
requirement of this section other than the exemptions created by
1.24(a)(5) (ii) and (v) of this chapter and the label shall bear all
required information in the specified minimum type size, except the
label will not be required to bear the information required by 101.5 if
this information appears on the bottle closure or on the lid of the can
in a type size not less than one-sixteenth inch in height, or if
embossed on the lid of the can in a type size not less than one-eighth
inch in height.
(b) If the soft drink is packaged in a bottle which does not bear a
paper, plastic foam jacket or foil label, or is packaged in a reusable
bottle bearing a label lithographed onto the surface of the bottle:
(1) Neither the bottle nor the closure is required to bear nutrition
labeling in compliance with 101.9, except that any multiunit retail
package in which it is contained shall bear nutrition labeling if
required by 101.9; and any vending machine in which it is contained
shall bear nutrition labeling if nutrition labeling is not present on
the bottle or closure, if required by 101.9.
(2) All other information pursuant to this section shall appear on
the top of the bottle closure prominently and conspicuously in letters
and/or numbers no less than one thirty-second inch in height, except
that if the information required by 101.5 is placed on the side of the
closure in accordance with 1.24(a)(5)(ii) of this chapter, such
information shall appear in letters and/or numbers no less than
one-sixteenth inch in height.
(3) Upon the petition of any interested person demonstrating that the
bottle closure is too small to accommodate this information, the
Commissioner may by regulation establish an alternative method of
disseminating such information. Information appearing on the closure
shall appear in the following priority:
(i) The warning required by 100.130 of this chapter.
(ii) The statement of ingredients.
(iii) The name and address of the manufacturer, packer, or
distributor.
(iv) The statement of identity.
(5) Individual serving-size packages of food served with meals in
restaurants, institutions, and on board passenger carriers, and not
intended for sale at retail, are exempt from type-size requirements of
this paragraph, provided:
(i) The package has a total area of 3 square inches or less available
to bear labeling;
(ii) There is insufficient area on the package available to print all
required information in a type size of 1/16 inch in height;
(iii) The label information includes a full list of ingredients in
accordance with regulations in this part and the policy expressed in
101.6 of this chapter; and
(iv) The information required by paragraph (b) of this section
appears on the label in accordance with the provisions of this
paragraph, except that the type size is not less than 1/32 inch in
height.
(d)(1) All information required to appear on the principal display
panel or on the information panel pursuant to this section shall appear
on the same panel unless there is insufficient space. In determining
the sufficiency of the available space, any vignettes, design, and other
nonmandatory label information shall not be considered. If there is
insufficient space for all of this information to appear on a single
panel, it may be divided between these two panels except that the
information required pursuant to any given section or part shall all
appear on the same panel. A food whose label is required to bear the
ingredient statement on the principal display panel may bear all other
information specified in paragraph (b) of this section on the
information panel.
(2) Any food, not otherwise exempted in this section, if packaged in
a container consisting of a separate lid and body, and bearing nutrition
labeling pursuant to 101.9, and if the lid qualifies for and is
designed to serve as a principal display panel, shall be exempt from the
placement requirements of this section in the following respects:
(i) The name and place of business information required by 101.5
shall not be required on the body of the container if this information
appears on the lid in accordance with this section.
(ii) The nutrition information required by 101.9 shall not be
required on the lid if this information appears on the container body in
accordance with this section.
(iii) The statement of ingredients required by 101.4 shall not be
required on the lid if this information appears on the container body in
accordance with this section. Further, the statement of ingredients is
not required on the container body if this information appears on the
lid in accordance with this section.
(e) All information appearing on the information panel pursuant to
this section shall appear in one place without other intervening
material.
(f) If the label of any package of food is too small to accommodate
all of the information required by 101.4, 101.5, 101.8, 101.9, 101.17,
and 101.25, and Part 105 of this chapter, the Commissioner may establish
by regulation an acceptable alternative method of disseminating such
information to the public, e.g., a type size smaller than one-sixteenth
inch in height, or labeling attached to or inserted in the package or
available at the point of purchase. A petition requesting such a
regulation, as an amendment to this paragraph shall be submitted
pursuant to Part 10 of this chapter.
(42 FR 14308, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22,
1977; 42 FR 45905, Sept. 13, 1977; 42 FR 47191, Sept. 20, 1977; 44 FR
16006, Mar. 16, 1979; 49 FR 13339, Apr. 4, 1984; 53 FR 16068, May 5,
1988)
21 CFR 101.3 Identity labeling of food in packaged form.
(a) The principal display panel of a food in package form shall bear
as one of its principal features a statement of the identity of the
commodity.
(b) Such statement of identity shall be in terms of:
(1) The name now or hereafter specified in or required by any
applicable Federal law or regulation; or, in the absence thereof,
(2) The common or usual name of the food; or, in the absence
thereof,
(3) An appropriately descriptive term, or when the nature of the food
is obvious, a fanciful name commonly used by the public for such food.
(c) Where a food is marketed in various optional forms (whole,
slices, diced, etc.), the particular form shall be considered to be a
necessary part of the statement of identity and shall be declared in
letters of a type size bearing a reasonable relation to the size of the
letters forming the other components of the statement of identity;
except that if the optional form is visible through the container or is
depicted by an appropriate vignette, the particular form need not be
included in the statement. This specification does not affect the
required declarations of identity under definitions and standards for
foods promulgated pursuant to section 401 of the act.
(d) This statement of identity shall be presented in bold type on the
principal display panel, shall be in a size reasonably related to the
most prominent printed matter on such panel, and shall be in lines
generally parallel to the base on which the package rests as it is
designed to be displayed.
(e) Under the provisions of section 403(c) of the Federal Food, Drug,
and Cosmetic Act, a food shall be deemed to be misbranded if it is an
imitation of another food unless its label bears, in type of uniform
size and prominence, the word ''imitation'' and, immediately thereafter,
the name of the food imitated.
(1) A food shall be deemed to be an imitation and thus subject to the
requirements of section 403(c) of the act if it is a substitute for and
resembles another food but is nutritionally inferior to that food.
(2) A food that is a substitute for and resembles another food shall
not be deemed to be an imitation provided it meets each of the following
requirements:
(i) It is not nutritionally inferior to the food for which it
substitutes and which it resembles.
(ii) Its label bears a common or usual name that complies with the
provisions of 102.5 of this chapter and that is not false or
misleading, or in the absence of an existing common or usual name, an
appropriately descriptive term that is not false or misleading. The
label may, in addition, bear a fanciful name which is not false or
misleading.
(3) A food for which a common or usual name is established by
regulation (e.g., in a standard of identity pursuant to section 401 of
the act, in a common or usual name regulation pursuant to Part 102 of
this chapter, or in a regulation establishing a nutritional quality
guideline pursuant to Part 104 of this chapter), and which complies with
all of the applicable requirements of such regulation(s), shall not be
deemed to be an imitation.
(4) Nutritional inferiority includes: (i) Any reduction in the
content of an essential nutrient that is present in a measurable amount,
but does not include a reduction in the caloric or fat content provided
the food is labeled pursuant to the provisions of 101.9, and provided
the labeling with respect to any reduction in caloric content complies
with the provisions applicable to caloric content in Part 105 of this
chapter.
(ii) For the purpose of this section, a measurable amount of an
essential nutrient in a food shall be considered to be 2 percent or more
of the U.S. RDA of protein or any vitamin or mineral listed under
101.9(c)(7)(iv) of this chapter per average or usual serving, or where
the food is customarily not consumed directly, per average or usual
portion, as established in 101.9.
(iii) If the Commissioner concludes that a food is a substitute for
and resembles another food but is inferior to the food imitated for
reasons other than those set forth in this paragraph, he may propose
appropriate revisions to this regulation or he may propose a separate
regulation governing the particular food.
(f) A label may be required to bear the percentage(s) of a
characterizing ingredient(s) or information concerning the presence or
absence of an ingredient(s) or the need to add an ingredient(s) as part
of the common or usual name of the food pursuant to Subpart B of Part
102 of this chapter.
(42 FR 14308, Mar. 15, 1977, as amended at 48 FR 10811, Mar. 15,
1983)
21 CFR 101.4 Food; designation of ingredients.
(a)(1) Ingredients required to be declared on the label of a food,
including foods that comply with standards of identity that require
labeling in compliance with this Part 101, except those exempted by
101.100, shall be listed by common or usual name in descending order of
predominance by weight on either the principal display panel or the
information panel in accordance with the provisions of 101.2.
(2) The descending order of predominance requirements of paragraph
(a)(1) of this section do not apply to ingredients present in amounts of
2 percent or less by weight when a listing of these ingredients is
placed at the end of the ingredient statement following an appropriate
quantifying statement, e.g., ''Contains XXX percent or less of XXX,'' or
''Less than XXX percent of XXX.'' The blank percentage within the
quantifying statement shall be filled in with a threshold level of 2
percent, or, if desired, 1.5 percent, 1.0 percent, or 0.5 percent, as
appropriate. No ingredient to which the quantifying phrase applies may
be present in an amount greater than the stated threshold.
(b) The name of an ingredient shall be a specific name and not a
collective (generic) name, except that:
(1) Spices, flavorings, colorings and chemical preservatives shall be
declared according to the provisions of 101.22.
(2) An ingredient which itself contains two or more ingredients and
which has an established common or usual name, conforms to a standard
established pursuant to the Meat Inspection or Poultry Products
Inspection Acts by the U.S. Department of Agriculture, or conforms to a
definition and standard of identity established pursuant to section 401
of the Federal Food, Drug, and Cosmetic Act, shall be designated in the
statement of ingredients on the label of such food by either of the
following alternatives:
(i) By declaring the established common or usual name of the
ingredient followed by a parenthetical listing of all ingredients
contained therein in descending order of predominance except that, if
the ingredient is a food subject to a definition and standard of
identity established in this Subchapter B, only the ingredients required
to be declared by the definition and standard of identity need be
listed; or
(ii) By incorporating into the statement of ingredients in descending
order of predominance in the finished food, the common or usual name of
every component of the ingredient without listing the ingredient itself.
(3) Skim milk, concentrated skim milk, reconstituted skim milk, and
nonfat dry milk may be declared as ''skim milk'' or ''nonfat milk''.
(4) Milk, concentrated milk, reconstituted milk, and dry whole milk
may be declared as ''milk''.
(5) Bacterial cultures may be declared by the word ''cultured''
followed by the name of the substrate, e.g., ''made from cultured skim
milk or cultured buttermilk''.
(6) Sweetcream buttermilk, concentrated sweetcream buttermilk,
reconstituted sweetcream buttermilk, and dried sweetcream buttermilk may
be declared as ''buttermilk''.
(7) Whey, concentrated whey, reconstituted whey, and dried whey may
be declared as ''whey''.
(8) Cream, reconstituted cream, dried cream, and plastic cream
(sometimes known as concentrated milk fat) may be declared as ''cream''.
(9) Butteroil and anhydrous butterfat may be declared as
''butterfat''.
(10) Dried whole eggs, frozen whole eggs, and liquid whole eggs may
be declared as ''eggs''.
(11) Dried egg whites, frozen egg whites, and liquid egg whites may
be declared as ''egg whites''.
(12) Dried egg yolks, frozen egg yolks, and liquid egg yolks may be
declared as ''egg yolks''.
(13) (Reserved)
(14) Each individual fat and/or oil ingredient of a food intended for
human consumption shall be declared by its specific common or usual name
(e.g., ''beef fat'', ''cottonseed oil'') in its order of predominance in
the food except that blends of fats and/or oils may be designated in
their order of predominance in the foods as '' ---- shortening'' or
''blend of ---- oils'', the blank to be filled in with the word
''vegetable'', ''animal'', ''marine'', with or without the terms ''fat''
or ''oils'', or combination of these, whichever is applicable if,
immediately following the term, the common or usual name of each
individual vegetable, animal, or marine fat or oil is given in
parentheses, e.g., ''vegetable oil shortening (soybean and cottonseed
oil)''. For products that are blends of fats and/or oils and for foods
in which fats and/or oils constitute the predominant ingredient, i.e.,
in which the combined weight of all fat and/or oil ingredients equals or
exceeds the weight of the most predominant ingredient that is not a fat
or oil, the listing of the common or usual names of such fats and/or
oils in parentheses shall be in descending order of predominance. In
all other foods in which a blend of fats and/or oils is used as an
ingredient, the listing of the common or usual names in parentheses need
not be in descending order of predominance if the manufacturer, because
of the use of varying mixtures, is unable to adhere to a constant
pattern of fats and/or oils in the product. If the fat or oil is
completely hydrogenated, the name shall include the term
''hydrogenated'', or if partially hydrogenated, the name shall include
the term ''partially hydrogenated''. If each fat and/or oil in a blend
or the blend is completely hydrogenated, the term ''hydrogenated'' may
precede the term(s) describing the blend, e.g., ''hydrogenated vegetable
oil (soybean, cottonseed, and palm oils)'', rather than preceding the
name of each individual fat and/or oil; if the blend of fats and/or
oils is partially hydrogenated, the term ''partially hydrogenated'' may
be used in the same manner. Fat and/or oil ingredients not present in
the product may be listed if they may sometimes be used in the product.
Such ingredients shall be identified by words indicating that they may
not be present, such as ''or'', ''and/or'', ''contains one or more of
the following:'', e.g., ''vegetable oil shortening (contains one or more
of the following: cottonseed oil, palm oil, soybean oil)''. No fat or
oil ingredient shall be listed unless actually present if the fats
and/or oils constitute the predominant ingredient of the product, as
defined in this paragraph (b)(14).
(15) When all the ingredients of a wheat flour are declared in an
ingredient statement, the principal ingredient of the flour shall be
declared by the name(s) specified in 137.105, 137.200, 137.220 and
137.225 of this chapter, i.e., the first ingredient designated in the
ingredient list of flour, or bromated flour, or enriched flour, or
self-rising flour is ''flour'', ''white flour'', ''wheat flour'', or
''plain flour''; the first ingredient designated in the ingredient list
of durum flour is ''durum flour''; the first ingredient designated in
the ingredient list of whole wheat flour, or bromated whole wheat flour
is ''whole wheat flour'', ''graham flour'', or ''entire wheat flour'';
and the first ingredient designated in the ingredient list of whole
durum wheat flour is ''whole durum wheat flour''.
(16) Ingredients that act as leavening agents in food may be declared
in the ingredient statement by stating the specific common or usual name
of each individual leavening agent in parentheses following the
collective name ''leavening'', e.g., ''leavening (baking soda,
monocalcium phosphate, and calcium carbonate)''. The listing of the
common or usual name of each individual leavening agent in parentheses
shall be in descending order of predominance: Except, That if the
manufacturer is unable to adhere to a constant pattern of leavening
agents in the product, the listing of individual leavening agents need
not be in descending order of predominance. Leavening agents not
present in the product may be listed if they are sometimes used in the
product. Such ingredients shall be identified by words indicating that
they may not be present, such as ''or'', ''and/or'', ''contains one or
more of the following:''.
(17) Ingredients that act as yeast nutrients in foods may be declared
in the ingredient statement by stating the specific common or usual name
of each individual yeast nutrient in parentheses following the
collective name ''yeast nutrients'', e.g., ''yeast nutrients (calcium
sulfate and ammonium phosphate)''. The listing of the common or usual
name of each individual yeast nutrient in parentheses shall be in
descending order of predominance: Except, That if the manufacturer is
unable to adhere to a constant pattern of yeast nutrients in the
product, the listing of the common or usual names of individual yeast
nutrients need not be in descending order of predominance. Yeast
nutrients not present in the product may be listed if they are sometimes
used in the product. Such ingredients shall be identified by words
indicating that they may not be present, such as ''or'', ''and/or'', or
''contains one or more of the following:''.
(18) Ingredients that act as dough conditioners may be declared in
the ingredient statement by stating the specific common or usual name of
each individual dough conditioner in parentheses following the
collective name ''dough conditioner'', e.g., ''dough conditioners
(L-cysteine, ammonium sulfate)''. The listing of the common or usual
name of each dough conditioner in parentheses shall be in descending
order of predominance: Except, That if the manufacturer is unable to
adhere to a constant pattern of dough conditioners in the product, the
listing of the common or usual names of individual dough conditioners
need not be in descending order of predominance. Dough conditioners not
present in the product may be listed if they are sometimes used in the
product. Such ingredients shall be identified by words indicating that
they may not be present, such as ''or'', ''and/or'', or ''contains one
or more of the following:''.
(19) Ingredients that act as firming agents in food (e.g., salts of
calcium and other safe and suitable salts in canned vegetables) may be
declared in the ingredient statement, in order of predominance
appropriate for the total of all firming agents in the food, by stating
the specific common or usual name of each individual firming agent in
descending order of predominance in parentheses following the collective
name ''firming agents''. If the manufacturer is unable to adhere to a
constant pattern of firming agents in the food, the listing of the
individual firming agents need not be in descending order of
predominance. Firming agents not present in the product may be listed
if they are sometimes used in the product. Such ingredients shall be
identified by words indicating that they may not be present, such as
''or'', ''and/or'', ''contains one or more of the following:''.
(c) When water is added to reconstitute, completely or partially, an
ingredient permitted by paragraph (b) of this section to be declared by
a class name, the position of the ingredient class name in the
ingredient statement shall be determined by the weight of the
unreconstituted ingredient plus the weight of the quantity of water
added to reconstitute that ingredient, up to the amount of water needed
to reconstitute the ingredient to single strength. Any water added in
excess of the amount of water needed to reconstitute the ingredient to
single strength shall be declared as ''water'' in the ingredient
statement.
(42 FR 14308, Mar. 15, 1977, as amended at 43 FR 12858, Mar. 28,
1978; 43 FR 24519, June 6, 1978; 48 FR 8054, Feb. 25, 1983; 55 FR
17433, Apr. 25, 1990)
21 CFR 101.5 Food; name and place of business of manufacturer, packer,
or distributor.
(a) The label of a food in packaged form shall specify conspicuously
the name and place of business of the manufacturer, packer, or
distributor.
(b) The requirement for declaration of the name of the manufacturer,
packer, or distributor shall be deemed to be satisfied, in the case of a
corporation, only by the actual corporate name, which may be preceded or
followed by the name of the particular division of the corporation. In
the case of an individual, partnership, or association, the name under
which the business is conducted shall be used.
(c) Where the food is not manufactured by the person whose name
appears on the label, the name shall be qualified by a phrase that
reveals the connection such person has with such food; such as
''Manufactured for -------------- '', ''Distributed by --------------
'', or any other wording that expresses the facts.
(d) The statement of the place of business shall include the street
address, city, State, and ZIP code; however, the street address may be
omitted if it is shown in a current city directory or telephone
directory. The requirement for inclusion of the ZIP code shall apply
only to consumer commodity labels developed or revised after the
effective date of this section. In the case of nonconsumer packages,
the ZIP code shall appear either on the label or the labeling (including
invoice).
(e) If a person manufactures, packs, or distributes a food at a place
other than his principal place of business, the label may state the
principal place of business in lieu of the actual place where such food
was manufactured or packed or is to be distributed, unless such
statement would be misleading.
21 CFR 101.6 Label designation of ingredients for standardized foods.
(a) There is significant consumer interest that the labels of
standardized foods bear complete information on the ingredients
contained in the food. In the absence of legal authority to require
that the label bear such information, the Food and Drug Administration
encourages all manufacturers, packers, and distributors to voluntarily
make such disclosure.
(b) The Food and Drug Administration intends to amend the definitions
and standards of identity of food by setting into motion as rapidly as
possible the provisions of section 401 of the act to require label
declaration of all optional ingredients with the exception of optional
spices, flavorings, and colorings which may continue to be designated as
such without specific ingredient declaration.
(c) Statutory authority does not exist to require the declaration of
mandatory ingredients on the label of standardized foods.
(d) The requirement (set forth in some of the definitions and
standards of identity for food) that designated optional ingredients
such as spices, flavorings, colorings, emulsifiers, flavor enhancers,
stabilizers, preservatives, and sweeteners be declared in a specified
manner on the label wherever the name of the standardized food appears
on the label so conspicuously as to be easily seen under customary
conditions of purchase shall not apply to any manufacturer, packer, or
distributor of a standardized food who voluntarily labels such food in
the manner indicated by section 403(i) of the act (21 U.S.C. 343(i)),
and the regulations promulgated thereunder, and who otherwise complies
with such definition and standard. Words and statements that
significantly differentiate between several foods complying with the
same standard by describing the optional forms or varieties, the packing
medium, and significant characterizing ingredients present in the food,
shall continue to be declared in the manner as required by the
particular standard.
21 CFR 101.8 Labeling of food with number of servings.
(a) The label of any package of a food which bears a representation
as to the number of servings contained in such package shall bear in
immediate conjunction with such statement, and in the same size type as
is used for such statement, a statement of the net quantity (in terms of
weight, measure, or numerical count) of each such serving; however,
such statement may be expressed in terms that differ from the terms used
in the required statement of net quantity of contents (for example,
cupfuls, tablespoonfuls, etc.) when such differing term is common to
cookery and describes a constant quantity. Such statement may not be
misleading in any particular. A statement of the number of units in a
package is not in itself a statement of the number of servings.
(b) If there exists a voluntary product standard promulgated pursuant
to the procedures found in 15 CFR Part 10 by the Department of Commerce,
quantitatively defining the meaning of the term ''serving'' with respect
to a particular food, then any label representation as to the number of
servings in such packaged food shall correspond with such quantitative
definition. (Copies of published standards are available upon request
from the National Bureau of Standards, Department of Commerce,
Washington, DC 20234.)
21 CFR 101.9 Nutrition labeling of food.
(a) Nutrition information relating to food may be included on the
label and in the labeling of a product: Provided, That it conforms to
the requirements of this section. Except as provided in paragraph (h)
of this section, inclusion of any added vitamin, mineral, or protein in
a product or of any nutrition claim or information, other than sodium
content, on a label or in advertising for a food subjects the label to
the requirements of this section, and in labeling for a food subjects
the label and that labeling to the requirements of this section.
(1) Solicitation of requests for nutrition information by a statement
''For nutrition information write to ---------------- '' on the label or
in the labeling or advertising for a food, or providing such information
in a direct written reply to a solicited or unsolicited request, does
not subject the label or the labeling to the requirements of this
section if no other nutrition claim is made on the label or in other
labeling or advertising, if the reply to the request conforms to the
requirements of this section, and if no vitamin, mineral, or protein is
added to the food.
(2) If any vitamin and/or mineral is added to a food so that a single
serving provides 50 percent or more of the U.S. Recommended Daily
Allowance (U.S. RDA) for adults and children 4 years or more of age, as
specified in paragraph (c)(7)(iv) of this section, of any one of the
added vitamins and/or minerals, unless such addition is permitted or
required in other regulations, e.g., a standard of identity or
nutritional quality guideline, or is otherwise exempted by the
Commissioner the food shall be considered a food for special dietary use
within the meaning of 105.3(a)(1)(iii) of this chapter.
(b) All nutrient quantities (including vitamins, minerals, calories,
protein, carbohydrate, and fat) shall be declared in relation to the
average or usual serving or, where the food is customarily not consumed
directly, in relation to the average or usual portion. Another column
of figures may be used to declare the nutrient quantities in relation to
the average or usual amount consumed on a daily basis, in the same
format required in paragraph (c) of this section for the serving
(portion), where reliable data have established that the food is
customarily consumed more than once during the day and the average or
usual amount so consumed.
(1) The term ''serving'' means that reasonable quantity of food
suited for or practicable of consumption as part of a meal by an adult
male engaged in light physical activity, or by an infant or child under
4 years of age when the article purports or is represented to be for
consumption by an infant or child under 4 years of age. The term
''portion'' means the amount of a food customarily used only as an
ingredient in the preparation of a meal component (e.g., 1/2 cup flour,
1/2 tablespoon cooking oil or 1/4 cup tomato paste). A label statement
regarding a serving (portion) shall be in terms of a convenient unit of
such food or a convenient unit of measure that can be easily identified
as an average or usual serving (portion) and can be readily understood
by purchasers of such food (e.g., a serving (portion) may be expressed
in slices, cookies, or wafers; or in terms of ounces, fluid ounces,
teaspoonfuls, tablespoonfuls, or cupfuls).
(2) A teaspoonful shall be considered to mean 5 milliliters
(approximately one-sixth fluid ounce) in volume; a tablespoon shall be
considered to mean 15 milliliters (approximately one-half fluid ounce)
in volume; and a cupful shall be considered to mean 240 milliliters
(approximately 8 fluid ounces) in volume. The weight of the serving
(portion) may also be expressed in grams.
(3) The declaration of nutrient quantities shall be on the basis of
the food as packaged. Another column of figures may be used to declare
the nutrient quantities on the basis of the food as consumed after
cooking or other preparation, in the same format required in paragraph
(c) of this section for the food alone: Provided, That the specific
method of cooking or other preparation shall be disclosed in a prominent
statement immediately following the information required by paragraph
(c) of this section.
(c) The declaration of nutrition information on the label and in
labeling shall contain the following information in the following order,
except for sodium and potassium which shall follow fat and cholesterol
information, using the headings specified, under the overall heading of
''Nutrition Information Per Serving (Portion).'' The terms ''Per Serving
(Portion)'' are optional and may follow or be placed directly below the
terms ''Nutrition Information.''
(1) ''Serving (portion) size'': A statement of the serving (portion)
size.
(2) ''Servings (portions) per container'': The number of servings
(portions) per container.
(3) ''Caloric content'' or ''Calories'': A statement of the caloric
content per serving (portion), expressed to the nearest 2-calorie
increment up to and including 20 calories, 5-calorie increment above 20
calories and up to and including 50 calories, and 10-calorie increment
above 50 calories. Caloric content will be determined by the Atwater
method as described in A.L. Merrill and B. K. Watt, ''Energy Value of
Foods -- Basis and Derivation,'' USDA Handbook 74 (1955), except that
the nondigestible dietary fiber may be subtracted from the total
carbohydrate content before calculation of the calories contributed by
the carbohydrate portion of the food. The nondigestible dietary fiber
will be determined by the method ''Total Dietary Fiber in Foods,
Enzymatic Gravimetric Method, First Action,'' in the Journal of the
Association of Official Analytical Chemists (JAOAC), 68:399, 1985, as
amended in JAOAC, 69:370, 1986. Both methods are incorporated by
reference. Copies of both methods are available from the Division of
Nutrition, Center for Food Safety and Applied Nutrition (HFF-260), Food
and Drug Administration, 200 C St. SW., Washington, DC 20204, or
available for inspection at the Office of the Federal Register, 1100 L
St. NW., Washington, DC 20408. Caloric content may be calculated on
the basis of 4, 4, and 9 calories per gram for protein, carbohydrate,
and fat respectively unless the use of these values gives a caloric
value more than 20 percent greater than the caloric value obtained when
using the more accurate values determined by use of the Atwater method
as found in USDA Handbook 74 (1955).
(4) ''Protein content'' or ''Protein'': A statement of the number of
grams of protein in a serving (portion), expressed to the nearest gram
except that if a serving (portion) contains less than one gram, the
statement ''Contains less than one gram'' or ''less than one gram'' may
be used as an alternative. Protein content may be calculated on the
basis of the factor of 6.25 times the nitrogen content of the food as
determined by the appropriate method of analysis of the ''Official
Methods of Analysis of the Association of Official Analytical
Chemists,'' 13th Ed. (1980), which is incorporated by reference, except
when the official procedure for a specific food requires another factor.
Copies may be obtained from the Association of Official Analytical
Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may
be examined at the Office of the Federal Register, 1100 L St. NW.,
Washington, DC 20408.
(5) ''Carbohydrate content'' or ''Carbohydrate'': A statement of the
number of grams of carbohydrate in a serving (portion) expressed to the
nearest gram except that if a serving (portion) contains less than one
gram, the statement ''Contains less than one gram'' or ''less than one
gram'' may be used as an alternative.
(6) ''Fat content'' or ''Fat'': A statement of the number of grams
of fat in a serving (portion) expressed to the nearest gram, except that
if a serving (portion) contains less than one gram, the statement
''Contains less than one gram'' or ''less than one gram'' may be used as
an alternative. Fatty acid composition and cholesterol content may also
be declared in compliance with 101.25.
(i) When fatty acid composition is declared, the information on fatty
acids required by 101.25(c) shall be placed on the label immediately
following the statement of fat content. The declaratory information
statement required by 101.25(d) shall be placed either immediately
following the statement on fat and fatty acids or shall be appropriately
referenced by symbol and placed immediately following the completed
nutrition information statement.
(ii) When cholesterol content is declared, the information on
cholesterol required by 101.25(b) shall immediately follow the
statement on fat content (and fatty acids, if stated). The declaratory
information statement required by 101.25(d) shall be placed either
immediately following the statement on cholesterol or shall be
appropriately referenced by symbol and placed immediately following the
completed nutrition information statement.
(iii) When both fatty acid and cholesterol information are provided,
the declaratory information statement may be combined as permitted by
101.25(d).
(7) ''Percentage of U.S. Recommended Daily Allowances (U.S. RDA)'':
A statement of the amount per serving (portion) of the protein,
vitamins, and minerals, as described in this paragraph (c)(7), expressed
in percentage of the U.S. Recommended Daily Allowance (U.S. RDA).
(i) The percentages shall be expressed in 2-percent increments up to
and including the 10-percent level, 5-percent increments above 10
percent and up to and including the 50-percent level, and 10-percent
increments above the 50-percent level. Nutrients present in amounts
less than 2 percent of the U.S. RDA may be indicated by a zero, or by an
asterisk referring to another asterisk placed at the bottom of the table
and followed by the statement ''contains less than 2 percent of the U.S.
RDA of this (these) nutrient (nutrients).'' However, when a product
contains less than 2 percent of the U.S. RDA for each of five or more of
the eight nutrients specified in paragraph (c)(7)(iii) of this section,
the manufacturer or distributor may choose to declare no more than three
of those nutrients and none of the remainder listed in paragraph
(c)(7)(iv) of this section. The statement ''contains less than 2
percent of the U.S. RDA of ------------ '', listing whichever of the
eight nutrients are present at less than 2 percent of the U.S. RDA and
have not been declared, shall directly follow the declared nutrient in
the same type size. Any nutrient declared shall always appear in the
order established in paragraph (c)(7)(iv) of this section.
(ii) The declaration of protein, which shall come first, shall be a
statement of the amount per serving (portion) of protein, expressed as a
percentage of the U.S. RDA.
(a) The U.S. RDA of the protein in a food product is 45 grams if the
protein efficiency ratio (PER) of the total protein in the product is
equal to or greater than that of casein, and 65 grams if the PER of the
total protein in the product is less than that of casein. The
percentage of the U.S. RDA shall be declared as described in paragraph
(c)(7)(i) of this section.
(b) Total protein with a PER less than 20 percent of the PER of
casein may not be stated on the label in terms of percentage U.S. RDA,
and the statement of protein content in grams per serving (portion)
under paragraph (c)(4) of this section shall be modified by the
statement ''not a significant source of protein'' immediately adjacent
to the protein content statement regardless of the actual amount of
protein present.
(iii) The declaration of vitamins and minerals as a percent of the
U.S. RDA which shall follow the protein declaration, shall include
vitamin A, vitamin C, thiamine, riboflavin, niacin, calcium, and iron,
in that order, and shall include any of the other vitamins and minerals
listed in paragraph (c)(7)(iv) of this section when they are added and
may list any of the other vitamins and minerals listed in paragraph
(c)(7)(iv) of this section when they are naturally occurring in the
order listed therein.
(iv) The following U.S. Recommended Daily Allowances (U.S. RDA) and
nomenclature are established for these vitamins and minerals, essential
in human nutrition:
Vitamin A, 5,000 International Units.
Vitamin C, 60 milligrams. 3 004
Thiamine, 1.5 milligrams.3
Riboflavin, 1.7 milligrams.3
Niacin, 20 milligrams.
Calcium, 1.0 gram.
Iron, 18 milligrams.
Vitamin D, 400 International Units.
Vitamin E, 30 International Units.
Vitamin B6, 2.0 milligrams.
Folic acid, 0.4 milligrams.
Vitamin B12, 6 micrograms.
Phosphorus, 1.0 gram.
Iodine, 150 micrograms.
Magnesium, 400 milligrams.
Zinc, 15 milligrams.
Copper, 2 milligrams.
Biotin, 0.3 milligram.
Pantothenic acid, 10 milligrams.
These nutrients and levels have been derived by the Food and Drug
Administration from the ''Recommended Dietary Allowances,'' published by
the Food and Nutrition Board, National Academy of Sciences-National
Research Council, and are subject to amendment from time to time as more
information on human nutrition becomes available.
(v) No claim may be made that a food is a significant source of a
nutrient unless that nutrient is present in the food at a level equal to
or in excess of 10 percent of the U.S. RDA in a serving (portion). No
claim may be made that a food is nutritionally superior to another food
unless it contains at least 10 percent more of the U.S. RDA of the
claimed nutrient per serving (portion).
(8)(i) Sodium content'' or ''Sodium'': A statement of the number of
milligrams of sodium in a specified serving (portion) of food shall be
placed on the nutrition label immediately following the statement on fat
content (and fatty acid and/or cholesterol, if stated). In the absence
of nutrition labeling, a statement of the number of milligrams of sodium
in a specified serving (portion), i.e., ''Contains ---- milligrams
sodium per ---- serving (portion)'' may be provided on the principal
display panel or information panel of the label. Sodium content shall
be expressed as zero when the serving (portion) contains less than 5
milligrams of sodium, to the nearest 5-milligram increment when the
serving (portion) contains 5 to 140 milligrams of sodium and to the
nearest 10-milligram increment when the serving (portion) contains
greater than 140 milligrams of sodium. Sodium content will be
determined by direct instrumental methods of analysis for sodium ions in
accordance with the applicable methods in the Official Methods of
Analysis of the Association of Official Analytical Chemists (AOAC), 13th
ed., 1980, pp. 146, 290, and 871-872, which is incorporated by
reference, or if no AOAC method is applicable, by an equivalent direct
instrumental analysis method for sodium ion. Copies of the
incorporation by reference are available from the Association of
Official Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington,
VA 22201-3301, or available for inspection at the Office of the Federal
Register, 1100 L St. NW., Washington, DC 20408.
(ii) Potassium may be declared voluntarily on the label. Information
on potassium shall be placed on the label immediately following the
sodium content and shall include a statement of the number of milligrams
of potassium in a specified serving (portion) of food. Potassium
content shall be expressed as zero when the serving (portion) contains
less than 5 milligrams of potassium to the nearest 5-milligram increment
when the serving (portion) contains less than or equal to 140 milligrams
of potassium and to the nearest 10-milligram increment when the serving
(portion) contains greater than 140 milligrams potassium. Potassium
content will be determined by direct instrumental methods for potassium
ions in accordance with the applicable methods in the Offical Methods of
Analysis of the Association of Official Analytical Chemists (AOAC), 13th
ed., 1980, pp. 18-19, 146, 186-187, 290, and 871-872, which is
incorporated by reference, or, if no AOAC method is applicable, by an
equivalent direct instrumental analysis method for potassium ion.
Copies of the incorporation by reference are available from the
Association of Official Analytical Chemists, 2200 Wilson Blvd., Suite
400, Arlington, VA 22201-3301, or available for inspection at the Office
of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(d) Products with separately packaged ingredients or to which other
ingredients are added by the user may be labeled as follows:
(1) If a product is comprised of two or more separately packaged
ingredients enclosed in an outer container, nutrition labeling of the
total product shall be located on the outer container to provide
information for the consumer at the point of purchase. However, when
two or more food products are simply combined together in such a manner
that no outer container is used, or no outer label is available, each
product shall have its own nutrition information, e.g., two boxes taped
together or two cans combined in a clear plastic overwrap.
(2) If a food is commonly combined with another ingredient(s) before
eating and directions for such combination are provided, another column
of figures may be used to provide a list of the nutrient contents for
the final combination in the same format required in paragraph (c) of
this section for the food alone (e.g., a dry ready-to-eat cereal may be
described with one set of percentage U.S. RDA values for the cereal as
sold (per ounce), and another set for the cereal and milk as suggested
in the label (per ounce of cereal and one-half cup of vitamin D
fortified whole milk); and a cake mix may be labeled with one set of
percentage U.S. RDA values for the dry mix (per serving), and another
set for a serving of the final cake when prepared). The type and
quantity of the other ingredient(s) to be added by the user to the
product shall be specified.
(e) Compliance with this section shall be determined as follows:
(1) A collection of primary containers or units of the same size,
type, and style produced under conditions as nearly uniform as possible,
designated by a common container code or marking, or in the absence of
any common container code or marking a day's production, constitutes a
''lot.''
(2) The sample for nutrient analysis shall consist of a composite of
12 subsamples (consumer units), taken one from each of 12 different
randomly chosen shipping cases, to be representative of a lot.
Composites shall be analyzed by Association of Official Analytical
Chemists (AOAC) methods where available or, if no AOAC method is
available, by reliable and appropriate analytical procedures.
Alternative methods of analysis may be submitted to the Food and Drug
Administration to determine their acceptability.
(3) Two classes of nutrients are defined for purposes of compliance:
Class I. Added nutrients in fortified or fabricated foods.
Class II. Naturally occurring (indigenous) nutrients.
If any ingredient which contains a naturally occurring (indigenous)
nutrient is added to a food, the total amount of such nutrient in the
final food product is subject to Class II requirements unless the same
nutrient is also added.
(4) A food with a label declaration of a vitamin, mineral, or protein
shall be deemed to be misbranded under section 403(a) of the act unless
it meets the following requirements:
(i) Class I vitamin, mineral, or protein. The nutrient content of
the composite is at least equal to the value for that nutrient declared
on the label.
(ii) Class II vitamin, mineral, or protein. The nutrient content of
the composite is at least equal to 80 percent of the value for that
nutrient declared on the label.
Provided, That no regulatory action will be based on a determination
of a nutrient value which falls below this level by a factor less than
the variability generally recognized for the analytical method used in
that food at the level involved.
(5) A food with a label declaration of calories, carbohydrates, fat,
or sodium shall be deemed to be misbranded under section 403(a) of the
act if the nutrient content of the composite is greater than 20 percent
in excess of the value for that nutrient declared on the label.
(6) Reasonable excesses of a vitamin, mineral, or protein over
labeled amounts are acceptable within current good manufacturing
practice. Reasonable deficiencies of calories, fat, or sodium under
labeled amounts are acceptable within current good manufacturing
practice.
(f) Nutrition information provided by a manufacturer or distributor
directly to professionals (e.g., physicians, dietitians, educators) may
vary from the requirements of this section but shall also contain or
have attached to it the nutrition information exactly as required by
this section.
(g) The location of nutrition information on a label shall be in
compliance with 101.2.
(h) The following foods are exempt from this section or are subject
to special labeling requirements:
(1)(i) Except where expressly covered by 105.65 of this chapter,
infant, baby, and junior-type food promoted for infants and children
under 4 years of age shall include nutrition information on the label
and in labeling in compliance with this section.
(ii) Both the U.S. RDA levels for infants from birth to 12 months of
age and the U.S. RDA values for children under 4 years of age may be
declared for foods represented or intended for use by both infants and
children under 4 years of age. If such dual declaration is used on any
label, it shall also be included in all labeling, and equal prominence
shall be given to both values in all promotional material.
(iii) For the purposes of labeling these foods with a percent of the
U.S. RDA for protein for infants, a value of 18 grams of protein shall
be the U.S. RDA value for protein with a protein efficiency ratio (PER)
equal to or greater than casein, and 25 grams if the PER of the protein
is less than the PER of casein but greater than 40 percent of casein.
For purposes of labeling foods for children under 4 years of age with a
percent of the U.S. RDA for protein, a value of 20 grams of protein
shall be the U.S. RDA value for protein with a PER equal to or greater
than casein, and 28 grams if the PER of the protein is less than the PER
of casein but greater than 20 percent of casein.
(iv) Total protein with a PER less than 40 percent of the PER of
casein may not be stated on the label in terms of percentage U.S. RDA
for infants, and the statement of protein content in grams per serving
under paragraph (c)(4) of this section shall be modified by the
statement ''not a significant source of protein for infants''
immediately adjacent to the protein content statement regardless of the
actual amount of protein present.
(2) Dietary supplements are exempted, except that the labeling of a
dietary supplement in food form, e.g., a breakfast cereal, shall conform
to the labeling established in paragraph (c) of this section, including
the order for listing vitamins and minerals established in paragraph
(c)(7)(iv) of this section.
(3) Any food represented for use as the sole item of the diet shall
be labeled in compliance with Part 105 of this chapter.
(4) Foods represented for use solely under medical supervision to
meet nutritional requirements in specific medical conditions shall be
labeled in compliance with Part 105 of this chapter.
(5) Iodized salt shall be labeled in compliance with 100.155 of this
chapter and when used in a food does not subject that food to labeling
under this section if it is declared in the ingredient statement by its
name (iodized salt) and neither iodine nor iodized salt is otherwise
referred to on the label or in labeling or advertising.
(6) A nutrient(s) included in food solely for technological purposes
may be declared solely in the ingredient statement, without complying
with this section, if the nutrient(s) is otherwise not referred to on
the label or in labeling or in advertising.
(7) A standardized food containing an added nutrient(s), e.g.,
enriched flour, and included in another food as a component may be
declared in the ingredient statement by its standardized name, without
compliance with this section, if neither the nutrient(s) nor the
component is otherwise referred to on the label or in labeling or in
advertising.
(8) Food products shipped in bulk form for use solely in the
manufacture of other foods and not for distribution to consumers in such
bulk form or container.
(9) Food products containing an added vitamin, mineral, or protein,
or for which a nutritional claim is made on the label or in labeling or
in advertising, which are supplied for institutional food service use
only: Provided, That the manufacturer or distributor provides the
nutrition information required by this section directly to those
institutions on a current basis.
(10) Fresh fruits and fresh vegetables, pending promulgation of
specific labeling requirements for these products.
(11) A percentage declaration of the fat (milkfat, butterfat) content
appearing only in the ingredient statement on the label of a food listed
in 1.24(a)(7)(i) of this chapter does not constitute a ''nutrition
claim or information'' within the meaning of paragraph (a) of this
section if:
(i) The declaration appears on the information panel (for
requirements for information panels, see 101.2) with no greater
prominence than any other printed matter appearing on the panel, and in
a type size no larger than the minimum type size required by 101.105(i)
for the declaration of net quantity of contents, and
(ii) The declaration is not required by other regulations in this
chapter.
(i) A food labeled under the provisions of this section shall be
deemed to be misbranded under sections 201(n) and 403(a) of the act if
its labeling represents, suggests, or implies:
(1) That the food because of the presence or absence of certain
dietary properties, is adequate or effective in the prevention, cure,
mitigation, or treatment of any disease or symptom.
(2) That a balanced diet of ordinary foods cannot supply adequate
amounts of nutrients.
(3) That the lack of optimum nutritive quality of a food, by reason
of the soil on which that food was grown, is or may be responsible for
an inadequacy or deficiency in the quality of the daily diet.
(4) That the storage, transportation, processing or cooking of a food
is or may be responsible for an inadequacy or deficiency in the quality
of the daily diet.
(5) That the food has dietary properties when such properties are of
no significant value or need in human nutrition. Ingredients or
products such as rutin, other bioflavonoids, para-amino-benzoic acid,
inositol, and similar substances which have in the past been represented
as having nutritional properties but which have not been shown to be
essential in human nutrition may not be combined with vitamins and/or
minerals, added to food labeled in accordance with this section, or
otherwise used or represented in any way which states or implies
nutritional benefit. Ingredients or products of this type may be
marketed as individual products or mixtures thereof: Provided, That the
possibility of nutritional, dietary, or therapeutic value is not stated
or implied, e.g., their labeling does not state that their usefulness in
human nutrition has not been established and does not otherwise disclaim
nutritional, dietary, or therapeutic value.
(6) That a natural vitamin in a food is superior to an added or
synthetic vitamin, or to differentiate in any way between vitamins
naturally present from those added.
(Information Collection requirements were approved by the Office of
Management and Budget under OMB control number 0910-0198)
(42 FR 14308, Mar. 15, 1977, as amended at 42 FR 27226, May 27, 1977;
44 FR 16006, Mar, 16, 1979; 45 FR 37422, June 3, 1980; 47 FR 11820,
Mar. 19, 1982; 49 FR 5609, Feb. 14, 1984; 49 FR 15533, Apr. 18, 1984;
49 FR 26572, June 28, 1984; 52 FR 28691, Aug. 3, 1987; 54 FR 24891,
June 12, 1989)
0043The following synonyms may be added in parentheses immediately
following the name of the vitamin:
Vitamin C Ascorbic acid
Folic acid Folacin
Riboflavin Vitamin B2
Thiamine Vitamin B1
21 CFR 101.10 Nutrition labeling of restaurant foods.
A nutrition claim or nutrition information concerning a combination
of restaurant foods, e.g., the total nutritional value of a meal
consisting of a hamburger, french fries, and milk shake, may be included
in advertising and/or in labeling (other than labels), without causing
nutrition information to be required on the label(s) of each article of
food: Provided, That complete nutrition information for the combination
of foods (the combination as an entity without the nutritional value of
each article being specified) in the format established by 101.9(c) is
effectively displayed to the customer both when he orders the food and
when he consumes the food. This statement of policy does not apply to
food dispensed in automatic vending machines.
21 CFR 101.11 Saccharin and its salts; retail establishment notice.
Each retail establishment (except restaurants) that sells food that
contains saccharin shall display the following notice in the locations
set forth in paragraph (b) of this section:
Insert illus. 10a
Each notice shall be displayed prominently, in a manner highly
visible to consumers (e.g., not shielded by other store signs or
merchandise displays) and set up to reduce the likelihood that a notice
will be torn, defaced, or removed.
(a) The notice shall be printed in a combination of red and black ink
on white card stock and be at least 11 by 14 inches. The background of
the bold heading, ''Saccharin Notice,'' and the boxed warning statement
shall be bright red and the lettering, white. The remaining background
shall be white with black ink. All lettering shall be in gothic
typeface.
(b) Except as provided in paragraph (c) of this section, each retail
establishment that sells food that contains saccharin shall display a
notice in each of the following three locations:
(1) Near the entrance to the retail establishment and arranged so
that consumers are likely to see the notice upon entering.
(2) Centrally located in the area of the retail establishment in
which soft drinks containing saccharin are displayed. If there is more
than one such place, then in the area where the greatest quantity of
diet soft drinks are displayed.
(3) In the area in the establishment in which the largest quantity of
saccharin-containing foods (including saccharin sold in package form as
a sugar substitute) are displayed, other than the area where diet soft
drinks are displayed.
(c) The following are exceptions to the requirements set forth in
paragraph (b) of this section:
(1) A retail establishment with 3,200 square feet or less of floor
space shall display at least one notice. The notice shall be located
near the entrance to the retail establishment and arranged so that
consumers are likely to see the notice upon entering.
(2) A retail establishment with more than 3,200 but less than 10,000
square feet of floor space shall display at least two notices. The
first notice shall be located near the entrance to the retail
establishment and arranged so that consumers are likely to see the
notice upon entering. The second notice shall be centrally located in
the area of the retail establishment in which soft drinks containing
saccharin are displayed. If there is more than one such place, then in
the area where the greatest quantity of diet soft drinks are displayed.
If diet soft drinks are not sold, then in the area of the establishment
in which the largest quantity of saccharin-containing foods (including
saccharin sold in package form as a sugar substitute) are displayed.
(3) A large retail establishment, e.g., department store, whose
primary business consists of selling nonfood items (i.e., the proportion
of food sold is extremely small compared to other items) shall display
at least one notice. The notice shall be located in the area of the
establishment in which foods containing saccharin are displayed. If
there is more than one such area, then a notice shall be displayed in
each area.
(d) Each manufacturer of saccharin-containing food who customarily
delivers his products directly to retail establishments shall make
available at least three notices to each retail establishment in which
his products are sold. Each manufacturer shall also arrange to supply
additional notices to a retail establishment that asks for them.
(e) Manufacturers who do not customarily deliver their
saccharin-containing food products directly to retail establishments may
fulfill their obligation to provide notices either in the manner set
forth in paragraph (d) of this section or by participating in, and
performing the actions required by, a trade association coordinated
program that meets the following requirements:
(1) The coordinating association shall have filed notice of the
program with the Food and Drug Administration, including the
association's name, mailing address, telephone number, and contact
person.
(2) Each manufacturer participating in the program shall file notice
of its participation with the coordinating association, including its
name, mailing address, telephone number, and contact person.
(3) The association shall ensure that retail establishment notices,
in the form specified in this section, are readily available to
participating manufacturers.
(4) The association shall take affirmative steps to coordinate with
retail establishments, their trade associations, and the trade press to
disseminate information about the applicable requirements of the
Saccharin Study and Labeling Act and these regulations, the existence of
the association coordinated program, and the availability of notices
through the program.
(5) Each manufacturer shall, in consultation with the association,
communicate with its contacts in the distributional chain to inform them
of the applicable requirements of the Saccharin Study and Labeling Act
and these regulations, and the continued availability of notices.
(6) Each manufacturer shall ensure that notices are promptly provided
on request to any retail establishment carrying its products.
(7) The association shall consult with participating manufacturers
concerning the implementation and progress of the program and shall
disseminate information to facilitate the conduct of the program based
on such consultations or consultation with the Food and Drug
Administration.
(8) The association shall, on request, permit the Food and Drug
Administration to have access to the participation notices filed by
manufacturers, samples showing the form of retail establishment notices
made available, and typical communication materials used by the
association in the course of the program.
(43 FR 8795, Mar. 3, 1978)
21 CFR 101.13 Sodium labeling.
(a) Certain descriptive terms about the quantitative sodium content
of foods may be used on the label and in labeling provided such
statements comply with the following rules:
(1) The term ''sodium free'' may be used on the label and in labeling
of foods that contain less than 5 milligrams of sodium per serving.
(2) The term ''very low sodium'' may be used on the label and
labeling of foods that contain 35 milligrams or less of sodium per
serving.
(3) The term ''low sodium'' may be used on the label and in the
labeling of foods that contain 140 milligrams or less of sodium per
serving.
(4) The term ''reduced sodium'' may be used on the label and in the
labeling of foods that have been formulated to serve as and are
represented as direct replacements for foods containing at least four
times the sodium content (75 percent reduction). The label of such a
food shall provide information comparing the sodium content per serving
with that of the food it replaces.
(5) When any of the definitions set forth in paragraph (a) (1), (2),
(3), or (4) of this section are used in labeling or when any other
truthful statement about sodium content is used in labeling,
quantitative information shall be provided on the label in conformity
with 105.69 or 101.9 of this chapter.
(b) The term ''salt'' is not synonymous with ''sodium.'' Salt refers
to sodium chloride. References to salt content such as ''unsalted,''
''no salt added,'' or ''without added salt'' or an equivalent term may
be used on the label and in labeling of food only if:
(1) No salt is added during processing;
(2) The food that it resembles and for which it substitutes is
normally processed with salt; and
(3) Sodium content information is provided in conformity with 105.69
or 101.9 of this chapter.
(49 FR 15534, Apr. 18, 1984)
21 CFR 101.15 Food; prominence of required statements.
(a) A word, statement, or other information required by or under
authority of the act to appear on the label may lack that prominence and
conspicuousness required by section 403(f) of the act by reason (among
other reasons) of:
(1) The failure of such word, statement, or information to appear on
the part or panel of the label which is presented or displayed under
customary conditions of purchase;
(2) The failure of such word, statement, or information to appear on
two or more parts or panels of the label, each of which has sufficient
space therefor, and each of which is so designed as to render it likely
to be, under customary conditions of purchase, the part or panel
displayed;
(3) The failure of the label to extend over the area of the container
or package available for such extension, so as to provide sufficient
label space for the prominent placing of such word, statement, or
information;
(4) Insufficiency of label space (for the prominent placing of such
word, statement, or information) resulting from the use of label space
for any word, statement, design, or device which is not required by or
under authority of the act to appear on the label;
(5) Insufficiency of label space (for the prominent placing of such
word, statement, or information) resulting from the use of label space
to give materially greater conspicuousness to any other word, statement,
or information, or to any design or device; or
(6) Smallness or style of type in which such word, statement, or
information appears, insufficient background contrast, obscuring designs
or vignettes, or crowding with other written, printed, or graphic
matter.
(b) No exemption depending on insufficiency of label space, as
prescribed in regulations promulgated under section 403 (e) or (i) of
the act, shall apply if such insufficiency is caused by:
(1) The use of label space for any word, statement, design, or device
which is not required by or under authority of the act to appear on the
label;
(2) The use of label space to give greater conspicuousness to any
word, statement, or other information than is required by section 403(f)
of the act; or
(3) The use of label space for any representation in a foreign
language.
(c)(1) All words, statements, and other information required by or
under authority of the act to appear on the label or labeling shall
appear thereon in the English language: Provided, however, That in the
case of articles distributed solely in the Commonwealth of Puerto Rico
or in a Territory where the predominant language is one other than
English, the predominant language may be substituted for English.
(2) If the label contains any representation in a foreign language,
all words, statements, and other information required by or under
authority of the act to appear on the label shall appear thereon in the
foreign language: Provided, however, That individual serving-size
packages of foods containing no more than 1 1/2 avoirdupois ounces or no
more than 1 1/2 fluid ounces served with meals in restaurants,
institutions, and passenger carriers and not intended for sale at retail
are exempt from the requirements of this paragraph (c)(2), if the only
representation in the foreign language(s) is the name of the food.
(3) If any article of labeling (other than a label) contains any
representation in a foreign language, all words, statements, and other
information required by or under authority of the act to appear on the
label or labeling shall appear on such article of labeling.
21 CFR 101.17 Food labeling warning and notice statements.
(a) Self-pressurized containers. (1) The label of a food packaged in
a self-pressurized container and intended to be expelled from the
package under pressure shall bear the following warning:
Warning -- Avoid spraying in eyes. Contents under pressure. Do not
puncture or incinerate. Do not store at temperature above 120 F. Keep
out of reach of children.
(2) In the case of products intended for use by children, the phrase
''except under adult supervision'' may be added at the end of the last
sentence in the warning required by paragraph (a)(1) of this section.
(3) In the case of products packaged in glass containers, the word
''break'' may be substituted for the word ''puncture'' in the warning
required by paragraph (a)(1) of this section.
(4) The words ''Avoid spraying in eyes'' may be deleted from the
warning required by paragraph (a)(1) of this section in the case of a
product not expelled as a spray.
(b) Self-pressurized containers with halocarbon or hydrocarbon
propellants. (1) In addition to the warning required by paragraph (a)
of this section, the label of a food packaged in a self-pressurized
container in which the propellant consists in whole or in part of a
halocarbon or a hydrocarbon shall bear the following warning:
Warning -- Use only as directed. Intentional misuse by deliberately
concentrating and inhaling the contents can be harmful or fatal.
(2) The warning required by paragraph (b)(1) of this section is not
required for the following products:
(i) Products expelled in the form of a foam or cream, which contain
less than 10 percent propellant in the container.
(ii) Products in a container with a physical barrier that prevents
escape of the propellant at the time of use.
(iii) Products of a net quantity of contents of less than 2 ounces
that are designed to release a measured amount of product with each
valve actuation.
(iv) Products of a net quantity of contents of less than one-half
ounce.
(c) Self-pressurized containers with a chlorofluorocarbon propellant.
(1) In addition to the warning required by paragraphs (a) and (b) of
this section, the label on each package of a food in a self-pressurized
container in which the propellant consists in whole or in part of a
fully halogenated chlorofluoroalkane (chlorofluorocarbon) shall bear the
following warning:
Warning -- Contains a chlorofluorocarbon that may harm the public
health and environment by reducing ozone in the upper atmosphere.
(2) The warning required by paragraph (c)(1) of this section shall
appear on an appropriate panel with such prominence and conspicuousness
as to render it likely to be read and understood by ordinary individuals
under normal conditions of purchase. The warning may appear on a firmly
affixed tag, tape, card, or sticker or similar overlabeling attached to
the package. The warning shall comply in all other respects with
101.2, e.g., type-size requirements.
(3) The warning required by paragraph (c)(1) of this section is
applicable only to self-pressurized containers that use
chlorofluorocarbons in whole or in part as a propellant to expel from
the container liquid or solid material different from the propellant,
but the warning is not applicable to the use of chlorofluorocarbon as a
stabilizer in food toppings and spreads.
(d) Protein products. (1) The label and labeling of any food product
in liquid, powdered, tablet, capsule, or similar forms that derives more
than 50 percent of its total caloric value from either whole protein,
protein hydrolysates, amino acid mixtures, or a combination of these,
and that is represented for use in reducing weight shall bear the
following warning:
Warning: Very low calorie protein diets (below 400 Calories per day)
may cause serious illness or death. Do Not Use for Weight Reduction in
Such Diets Without Medical Supervision. Not for use by infants,
children, or pregnant or nursing women.
(2) Products described in paragraph (d)(1) of this section are exempt
from the labeling requirements of that paragraph if the protein products
are represented as part of a nutritionally balanced diet plan providing
400 or more Calories (kilocalories) per day and the label or labeling of
the product specifies the diet plan in detail or provides a brief
description of that diet plan and adequate information describing where
the detailed diet plan may be obtained and the label and labeling bear
the following statement:
Notice: For weight reduction, use only as directed in the
accompanying diet plan (the name and specific location in labeling of
the diet plan may be included in this statement in place of
''accompanying diet plan''). Do not use in diets supplying less than
400 Calories per day without medical supervision.
(3) The label and labeling of food products represented or intended
for dietery (food) supplementation that derive more than 50 percent of
their total caloric value from either whole protein, protein
hydrolysates, amino acid mixtures, or a combination of these, that are
represented specifically for purposes other than weight reduction; and
that are not covered by the requirements of paragraph (d) (1) and (2) of
this section; shall bear the following statement:
Notice: Use this product as a food supplement only. Do not use for
weight reduction.
(4) The provisions of this paragraph are separate from and in
addition to any labeling requirements promulgated by the Federal Trade
Commission for protein supplements.
(5) Protein products shipped in bulk form for use solely in the
manufacture of other foods and not for distribution to consumers in such
container are exempt from the labeling requirements of this paragraph.
(6) The warning and notice statements required by paragraphs (d) (1),
(2), and (3) of this section shall appear prominently and conspicuously
on the principal display panel of the package label and any other
labeling.
(42 FR 14308, Mar. 15, 1977, as amended at 42 FR 22033, Apr. 29,
1977; 49 FR 13690, Apr. 6, 1984; 49 FR 28548, July 13, 1984)
21 CFR 101.18 Misbranding of food.
(a) Among representations in the labeling of a food which render such
food misbranded is a false or misleading representation with respect to
another food or a drug, device, or cosmetic.
(b) The labeling of a food which contains two or more ingredients may
be misleading by reason (among other reasons) of the designation of such
food in such labeling by a name which includes or suggests the name of
one or more but not all such ingredients, even though the names of all
such ingredients are stated elsewhere in the labeling.
(c) Among representations in the labeling of a food which render such
food misbranded is any representation that expresses or implies a
geographical origin of the food or any ingredient of the food except
when such representation is either:
(1) A truthful representation of geographical origin.
(2) A trademark or trade name provided that as applied to the article
in question its use is not deceptively misdescriptive. A trademark or
trade name composed in whole or in part of geographical words shall not
be considered deceptively misdescriptive if it:
(i) Has been so long and exclusively used by a manufacturer or
distributor that it is generally understood by the consumer to mean the
product of a particular manufacturer or distributor; or
(ii) Is so arbitrary or fanciful that it is not generally understood
by the consumer to suggest geographic origin.
(3) A part of the name required by applicable Federal law or
regulation.
(4) A name whose market significance is generally understood by the
consumer to connote a particular class, kind, type, or style of food
rather than to indicate geographical origin.
21 CFR 101.18 Subpart B -- Specific Food Labeling Requirements
21 CFR 101.22 Foods; labeling of spices, flavorings, colorings and
chemical preservatives.
(a)(1) The term ''artificial flavor'' or ''artificial flavoring''
means any substance, the function of which is to impart flavor, which is
not derived from a spice, fruit or fruit juice, vegetable or vegetable
juice, edible yeast, herb, bark, bud, root, leaf or similar plant
material, meat, fish, poultry, eggs, dairy products, or fermentation
products thereof. Artificial flavor includes the substances listed in
172.515(b) and 182.60 of this chapter except where these are derived
from natural sources.
(2) The term ''spice'' means any aromatic vegetable substance in the
whole, broken, or ground form, except for those substances which have
been traditionally regarded as foods, such as onions, garlic and celery;
whose significant function in food is seasoning rather than
nutritional; that is true to name; and from which no portion of any
volatile oil or other flavoring principle has been removed. Spices
include the spices listed in 182.10 and Part 184 of this chapter, such
as the following:
Allspice, Anise, Basil, Bay leaves, Caraway seed, Cardamon, Celery
seed, Chervil, Cinnamon, Cloves, Coriander, Cumin seed, Dill seed,
Fennel seed, Fenugreek, Ginger, Horseradish, Mace, Marjoram, Mustard
flour, Nutmeg, Oregano, Paprika, Parsley, Pepper, black; Pepper, white;
Pepper, red; Rosemary, Saffron, Sage, Savory, Star aniseed, Tarragon,
Thyme, Turmeric.
Paprika, turmeric, and saffron or other spices which are also colors,
shall be declared as ''spice and coloring'' unless declared by their
common or usual name.
(3) The term ''natural flavor'' or ''natural flavoring'' means the
essential oil, oleoresin, essence or extractive, protein hydrolysate,
distillate, or any product of roasting, heating or enzymolysis, which
contains the flavoring constituents derived from a spice, fruit or fruit
juice, vegetable or vegetable juice, edible yeast, herb, bark, bud,
root, leaf or similar plant material, meat, seafood, poultry, eggs,
dairy products, or fermentation products thereof, whose significant
function in food is flavoring rather than nutritional. Natural flavors
include the natural essence or extractives obtained from plants listed
in 182.10, 182.20, 182.40, and 182.50 and Part 184 of this chapter,
and the substances listed in 172.510 of this chapter.
(4) The term ''artificial color'' or ''artificial coloring'' means
any ''color additive'' as defined in 70.3(f) of this chapter.
(5) The term ''chemical preservative'' means any chemical that, when
added to food, tends to prevent or retard deterioration thereof, but
does not include common salt, sugars, vinegars, spices, or oils
extracted from spices, substances added to food by direct exposure
thereof to wood smoke, or chemicals applied for their insecticidal or
herbicidal properties.
(b) A food which is subject to the requirements of section 403(k) of
the act shall bear labeling, even though such food is not in package
form.
(c) A statement of artificial flavoring, artificial coloring, or
chemical preservative shall be placed on the food or on its container or
wrapper, or on any two or all three of these, as may be necessary to
render such statement likely to be read by the ordinary person under
customary conditions of purchase and use of such food. The specific
artificial color used in a food shall be identified on the labeling when
so required by regulation in Part 74 of this chapter to assure safe
conditions of use for the color additive.
(d) A food shall be exempt from compliance with the requirements of
section 403(k) of the act if it is not in package form and the units
thereof are so small that a statement of artificial flavoring,
artificial coloring, or chemical preservative, as the case may be,
cannot be placed on such units with such conspicuousness as to render it
likely to be read by the ordinary individual under customary conditions
of purchase and use.
(e) A food shall be exempt while held for sale from the requirements
of section 403(k) of the act (requiring label statement of any
artificial flavoring, artificial coloring, or chemical preservatives) if
said food, having been received in bulk containers at a retail
establishment, is displayed to the purchaser with either (1) the
labeling of the bulk container plainly in view or (2) a counter card,
sign, or other appropriate device bearing prominently and conspicuously
the information required to be stated on the label pursuant to section
403(k).
(f) A fruit or vegetable shall be exempt from compliance with the
requirements of section 403(k) of the act with respect to a chemical
preservative applied to the fruit or vegetable as a pesticide chemical
prior to harvest.
(g) A flavor shall be labeled in the following way when shipped to a
food manufacturer or processor (but not a consumer) for use in the
manufacture of a fabricated food, unless it is a flavor for which a
standard of identity has been promulgated, in which case it shall be
labeled as provided in the standard:
(1) If the flavor consists of one ingredient, it shall be declared by
its common or usual name.
(2) If the flavor consists of two or more ingredients, the label
either may declare each ingredient by its common or usual name or may
state ''All flavor ingredients contained in this product are approved
for use in a regulation of the Food and Drug Administration.'' Any
flavor ingredient not contained in one of these regulations, and any
nonflavor ingredient, shall be separately listed on the label.
(3) In cases where the flavor contains a solely natural flavor(s),
the flavor shall be so labeled, e.g., ''strawberry flavor'', ''banana
flavor'', or ''natural strawberry flavor''. In cases where the flavor
contains both a natural flavor and an artificial flavor, the flavor
shall be so labeled, e.g., ''natural and artificial strawberry flavor''.
In cases where the flavor contains a solely artificial flavor(s), the
flavor shall be so labeled, e.g., ''artificial strawberry flavor''.
(h) The label of a food to which flavor is added shall declare the
flavor in the statement of ingredients in the following way:
(1) Spice, natural flavor, and artificial flavor may be declared as
''spice'', ''natural flavor'', or ''artificial flavor'', or any
combination thereof, as the case may be.
(2) An incidental additive in a food, originating in a spice or
flavor used in the manufacture of the food, need not be declared in the
statement of ingredients if it meets the requirements of 101.100(a)(3).
(3) Substances obtained by cutting, grinding, drying, pulping, or
similar processing of tissues derived from fruit, vegetable, meat, fish,
or poultry, e.g., powdered or granulated onions, garlic powder, and
celery powder, are commonly understood by consumers to be food rather
than flavor and shall be declared by their common or usual name.
(4) Any salt (sodium chloride) used as an ingredient in food shall be
declared by its common or usual name ''salt.''
(5) Any monosodium glutamate used as an ingredient in food shall be
declared by its common or usual name ''monosodium glutamate.''
(6) Any pyroligneous acid or other artificial smoke flavors used as
an ingredient in a food may be declared as artificial flavor or
artificial smoke flavor. No representation may be made, either directly
or implied, that a food flavored with pyroligneous acid or other
artificial smoke flavor has been smoked or has a true smoked flavor, or
that a seasoning sauce or similar product containing pyroligneous acid
or other artificial smoke flavor and used to season or flavor other
foods will result in a smoked product or one having a true smoked
flavor.
(i) If the label, labeling, or advertising of a food makes any direct
or indirect representations with respect to the primary recognizable
flavor(s), by word, vignette, e.g., depiction of a fruit, or other
means, or if for any other reason the manufacturer or distributor of a
food wishes to designate the type of flavor in the food other than
through the statement of ingredients, such flavor shall be considered
the characterizing flavor and shall be declared in the following way:
(1) If the food contains no artificial flavor which simulates,
resembles or reinforces the characterizing flavor, the name of the food
on the principal display panel or panels of the label shall be
accompanied by the common or usual name of the characterizing flavor,
e.g., ''vanilla'', in letters not less than one-half the height of the
letters used in the name of the food, except that:
(i) If the food is one that is commonly expected to contain a
characterizing food ingredient, e.g., strawberries in ''strawberry
shortcake'', and the food contains natural flavor derived from such
ingredient and an amount of characterizing ingredient insufficient to
independently characterize the food, or the food contains no such
ingredient, the name of the characterizing flavor may be immediately
preceded by the word ''natural'' and shall be immediately followed by
the word ''flavored'' in letters not less than one-half the height of
the letters in the name of the characterizing flavor, e.g., ''natural
strawberry flavored shortcake,'' or ''strawberry flavored shortcake''.
(ii) If none of the natural flavor used in the food is derived from
the product whose flavor is simulated, the food in which the flavor is
used shall be labeled either with the flavor of the product from which
the flavor is derived or as ''artificially flavored.''
(iii) If the food contains both a characterizing flavor from the
product whose flavor is simulated and other natural flavor which
simulates, resembles or reinforces the characterizing flavor, the food
shall be labeled in accordance with the introductory text and paragraph
(i)(1)(i) of this section and the name of the food shall be immediately
followed by the words ''with other natural flavor'' in letters not less
than one-half the height of the letters used in the name of the
characterizing flavor.
(2) If the food contains any artificial flavor which simulates,
resembles or reinforces the characterizing flavor, the name of the food
on the principal display panel or panels of the label shall be
accompanied by the common or usual name(s) of the characterizing flavor,
in letters not less than one-half the height of the letters used in the
name of the food and the name of the characterizing flavor shall be
accompanied by the word(s) ''artificial'' or ''artificially flavored'',
in letters not less than one-half the height of the letters in the name
of the characterizing flavor, e.g., ''artificial vanilla'',
''artificially flavored strawberry'', or ''grape artificially
flavored''.
(3) Wherever the name of the characterizing flavor appears on the
label (other than in the statement of ingredients) so conspicuously as
to be easily seen under customary conditions of purchase, the words
prescribed by this paragraph shall immediately and conspicuously precede
or follow such name, without any intervening written, printed, or
graphic matter, except:
(i) Where the characterizing flavor and a trademark or brand are
presented together, other written, printed, or graphic matter that is a
part of or is associated with the trademark or brand may intervene if
the required words are in such relationship with the trademark or brand
as to be clearly related to the characterizing flavor; and
(ii) If the finished product contains more than one flavor subject to
the requirements of this paragraph, the statements required by this
paragraph need appear only once in each statement of characterizing
flavors present in such food, e.g., ''artificially flavored vanilla and
strawberry''.
(iii) If the finished product contains three or more distinguishable
characterizing flavors, or a blend of flavors with no primary
recognizable flavor, the flavor may be declared by an appropriately
descriptive generic term in lieu of naming each flavor, e.g.,
''artificially flavored fruit punch''.
(4) A flavor supplier shall certify, in writing, that any flavor he
supplies which is designated as containing no artificial flavor does
not, to the best of his knowledge and belief, contain any artificial
flavor, and that he has added no artificial flavor to it. The
requirement for such certification may be satisfied by a guarantee under
section 303(c)(2) of the act which contains such a specific statement.
A flavor used shall be required to make such a written certification
only where he adds to or combines another flavor with a flavor which has
been certified by a flavor supplier as containing no artificial flavor,
but otherwise such user may rely upon the supplier's certification and
need make no separate certification. All such certifications shall be
retained by the certifying party throughout the period in which the
flavor is supplied and for a minimum of three years thereafter, and
shall be subject to the following conditions:
(i) The certifying party shall make such certifications available
upon request at all reasonable hours to any duly authorized office or
employee of the Food and Drug Administration or any other employee
acting on behalf of the Secretary of Health and Human Services. Such
certifications are regarded by the Food and Drug Administration as
reports to the government and as guarantees or other undertakings within
the meaning of section 301(h) of the act and subject the certifying
party to the penalties for making any false report to the government
under 18 U.S.C. 1001 and any false guarantee or undertaking under
section 303(a) of the act. The defenses provided under section
303(c)(2) of the act shall be applicable to the certifications provided
for in this section.
(ii) Wherever possible, the Food and Drug Administration shall verify
the accuracy of a reasonable number of certifications made pursuant to
this section, constituting a representative sample of such
certifications, and shall not request all such certifications.
(iii) Where no person authorized to provide such information is
reasonably available at the time of inspection, the certifying party
shall arrange to have such person and the relevant materials and records
ready for verification as soon as practicable: Provided, That, whenever
the Food and Drug Administration has reason to believe that the supplier
or user may utilize this period to alter inventories or records, such
additional time shall not be permitted. Where such additional time is
provided, the Food and Drug Administration may require the certifying
party to certify that relevant inventories have not been materially
disturbed and relevant records have not been altered or concealed during
such period.
(iv) The certifying party shall provide, to an officer or
representative duly designated by the Secretary, such qualitative
statement of the composition of the flavor or product covered by the
certification as may be reasonably expected to enable the Secretary's
representatives to determine which relevant raw and finished materials
and flavor ingredient records are reasonably necessary to verify the
certifications. The examination conducted by the Secretary's
representative shall be limited to inspection and review of inventories
and ingredient records for those certifications which are to be
verified.
(v) Review of flavor ingredient records shall be limited to the
qualitative formula and shall not include the quantitative formula. The
person verifying the certifications may make only such notes as are
necessary to enable him to verify such certification. Only such notes
or such flavor ingredient records as are necessary to verify such
certification or to show a potential or actual violation may be removed
or transmitted from the certifying party's place of business: Provided,
That, where such removal or transmittal is necessary for such purposes
the relevant records and notes shall be retained as separate documents
in Food and Drug Administration files, shall not be copied in other
reports, and shall not be disclosed publicly other than in a judicial
proceeding brought pursuant to the act or 18 U.S.C. 1001.
(j) A food to which a chemical preservative(s) is added shall, except
when exempt pursuant to 101.100 bear a label declaration stating both
the common or usual name of the ingredient(s) and a separate description
of its function, e.g., ''preservative'', ''to retard spoilage'', ''a
mold inhibitor'', ''to help protect flavor'' or ''to promote color
retention''.
(42 FR 14308, Mar. 15, 1977, as amended at 44 FR 3963, Jan. 19, 1979;
44 FR 37220, June 26, 1979; 54 FR 24891, June 12, 1989)
21 CFR 101.25 Labeling of foods in relation to fat and fatty acid and
cholesterol content.
(a) Implicit or explicit claims for the value of food in preventing
or treating heart or artery disease can be misleading to consumers.
However, a significant segment of the medical community is recommending
that individuals modify their total diet by eliminating certain foods or
by replacing certain foods with others in order to effect changes in the
levels of blood components. Although there have been no definitive
studies which have demonstrated beyond doubt that extensive changes in
the consumption of fat and cholesterol by the general public are
desirable, it is nevertheless appropriate to provide for informative
labeling which will help individuals to identify foods for inclusion in
fat-modified diets recommended by physicians. It is also appropriate to
prohibit label statements which misrepresent specific foods as being, of
themselves, of value in the control of the levels of these blood
components or in the control of heart or artery disease.
(b) A food label or labeling may include a statement of the
cholesterol content of the food: Provided, That it meets the following
conditions:
(1) The food is labeled in compliance with the provisions of 101.9.
(2) The following information is included in the following order, in
accordance with the provisions of 101.9(c)(6)(ii):
(i) The cholesterol content, stated to the nearest 5-milligram
increment per serving.
(ii) The cholesterol content, stated to the nearest 5-milligram
increment per 100 grams of the food.
(iii) The statement required by paragraph (d) of this section.
(c) A food label or labeling may include information on the fatty
acid content of the food: Provided, That it meets the following
conditions:
(1) The food contains 10 percent or more fat on a dry weight basis
and not less than 2 grams of fat in an average serving. Any food
containing less than 10 percent total fat on a dry weight basis and/or
containing less than 2 grams of fat in a serving is not suitable for use
by man as a means of regulating the intake of fatty acids.
(2) The food is labeled in compliance with 101.9 and the following
information is included in the following order in accordance with
101.9(c)(6)(ii):
(i) The total fat content in terms of the percentage of the total
calories in the food provided by fat with the heading ''Percent of
calories from fat''.
(ii) The amount of fatty acids, calculated as the triglycerides,
shall be stated in grams per serving to the nearest gram in the
following two categories, stated with the following headings, in the
following order, and displayed in equal prominence:
(a) Cis,cis-methylene-interrupted polyunsaturated fatty acids, stated
as ''Polyunsaturated'';
(b) The sum of lauric, myristic, palmitic, and stearic acids, stated
as ''Saturated''; and
(iii) The statement required by paragraph (d) of this section.
(d) A food labeled in accordance with paragraph (b) or (c) of this
section shall display the following statement on the label:
''Information (or ''this information'') on fat (and/or cholesterol,
where appropriate) content is provided for individuals who, on the
advice of a physician, are modifying their dietary intake of fat (and/or
cholesterol, where appropriate).''
(e) Compliance with this section shall be determined as follows:
(1) A collection of primary containers or units of the same size,
type, and style produced under conditions as nearly uniform as possible,
designated by a common container code or marking or, in the absence of
any common container code or marking, a day's production, constitutes a
''lot.''
(2) The sample for analysis shall consist of a composite of 12
subsamples (consumer units), taken one from each of 12 different
randomly chosen shipping cases, to be representative of a lot.
(3) Composites shall be analyzed for fat and saturated fatty acids by
the methods of the Association of Official Analytical Chemists (AOAC),
13th Ed. (1980), which is incoporated by reference. Copies are
available from the Association of Official Analytical Chemists, 2200
Wilson Blvd., Suite 400, Arlington, VA 22201-3301. The methods for fat,
fatty acids, and cholesterol will be those of the Association of
Official Analytical Chemists (AOAC), or other reliable and appropriate
methods. Alternative methods of analysis may be submitted to the Food
and Drug Administration to determine their acceptability. The
determination of cis, cis-methylene-interrupted polyunsaturated fatty
acids will be by the method prescribed in the ''Official Methods of
Analysis of the Association of Official Analytical Chemists,'' 13th Ed.
(1980), 28.071-28.074, which is incorporated by reference. Copies may
be obtained from the Association of Official Analytical Chemists, 2200
Wilson Blvd., Suite 400, Arlington, VA 22201-3301. Both incorporations
by reference are available for inspection at the Office of the Federal
Register, 1100 L St. NW., Washington, DC 20408.
(4) A food with a label declaration of cholesterol content shall be
deemed to be misbranded under section 403(a) of the act if the content
of the composite is greater than 20 percent in excess of the value for
the cholesterol content declared on the label.
(5) A food with a label declaration of fat content shall be deemed to
be misbranded under section 403(a) of the act if the content of the
composite is greater than 20 percent in excess of the value for the fat
content declared on the label or less than required by good
manufacturing practices.
(6) A food with a label declaration of fatty acid content shall be
deemed to be misbranded under section 403(a) of the act if the content
of the composite is greater than 20 percent in excess of the value, or
less than 80 percent of the value, for the fatty acid content declared
on the label.
(f) Label statements made in accordance with paragraph (b), (c), or
(d) of this section shall comply with the requirements of 101.2, but in
no case may they be printed in larger than the minimum size type
required by the provisions of 101.105 for the declaration of net
quantity of contents.
(g) No label or labeling may contain a claim indicating, suggesting,
or implying that the product will prevent, mitigate, or cure heart or
artery disease or any attendant condition. The principal display panel
of the label may state ''cholesterol (fat) information appears --------
,'' the blank to be filled in with a phrase stating where the
information is contained. The statement shall appear in
one-sixteenth-inch type size or in the alternative in a type size no
larger than one-half the minimum type size required for the declaration
of net quantity of contents by the provisions of 101.105 of this
chapter.
(h) No statements relating to cholesterol, fat or fatty acids, other
than those expressly permitted by this section may be made. Any label
or labeling containing any statement concerning cholesterol, fat or
fatty acids which is not in conformity with this section shall be deemed
to be misbranded under sections 201(n) and 403(a) of the act.
(42 FR 14308, Mar. 15, 1977, as amended at 47 FR 11820, Mar. 19,
1982; 49 FR 5609, Feb. 14, 1984; 54 FR 24891, June 12, 1989)
21 CFR 101.29 Labeling of kosher and kosher-style foods.
The term ''kosher'' should be used only on food products that meet
certain religious dietary requirements. The precise significance of the
phrase ''kosher style'' as applied to any particular product by the
public has not been determined. There is a likelihood that the use of
the term may cause the prospective purchaser to think that the product
is ''kosher.'' Accordingly, the Food and Drug Administration believes
that use of the phrase should be discouraged on products that do not
meet the religious dietary requirements.
21 CFR 101.33 Label declaration of D-erythroascorbic acid when it is an
ingredient of a fabricated food.
(a) The article d-erythroascorbic acid (d-araboascorbic acid,
d-erythro-3-keto-hexonic acid lactone) has sometimes been designated as
d-isoascorbic acid. However, this designation is capable of misleading
purchasers of food in which it is used as an ingredient because of the
similarity of such designation to the chemical name and the common name
of vitamin C, which is ascorbic acid. Ascorbic acid (vitamin C) is
capable of preventing the deficiency disease scurvy, but d-isoascorbc
acid is ineffective for this purpose.
(b) The Joint Committee on Nomenclature of the American Institute of
Nutrition and the Society of Biological Chemists has considered this
matter, and pursuant to the Committee's recommendation the respective
scientific organizations approved a resolution to drop the use of the
designation d-isoascorbic acid and to adopt as a common name the name
erythorbic acid for d-erythroascorbic acid.
(c) The compound d-erythroascorbic acid is not specified as an
ingredient of any food for which a standard has been established. For
foods other than those for which standards have been established,
section 403(i)(2) of the Federal Food, Drug, and Cosmetic Act requires
that ingredients be listed on labels by their common or usual names. If
the label on a food that contains d-erythroascorbic acid designates that
ingredient by the name erythorbic acid, the requirement that the label
bear the common or usual name of the ingredient will be regarded as
having been met.
21 CFR 101.35 Notice to manufacturers and users of monosodium glutamate
and other hydrolyzed vegetable protein products.
Following a review of various statements submitted by manufacturers
and distributors of monosodium glutamate and various hydrolyzed plant
protein products, the following conclusions have been reached:
(a) The facts submitted established that there are three classes of
products to be considered:
(1) Purified monosodium glutamate.
(2) Hydrolyzed proteins (amino acid salts) from which none of the
monosodium glutamate has been removed.
(3) Hydrolyzed proteins (amino acid salts), a byproduct in the
manufacture of purified monosodium glutamate but from which a
substantial proportion of the monosodium glutamate has been removed.
(b) (Reserved)
(c)(1) The substance described in paragraph (a)(2) of this section
has long been designated as ''hydrolyzed vegetable protein.''
(2) The substance covered by paragraph (a)(3) of this section should
have a distinctive name, since one of its original constituents has been
partially removed. Manufacturers have suggested that this substance be
described as ''hydrolyzed vegetable protein with reduced monosodium
glutamate content.'' This designation appears acceptable.
(d) While the substances referred to in paragraphs (a) (2) and (3) of
this section contain a number of amino acid salts as well as sodium
chloride, monosodium glutamate is the ingredient which has been quite
generally emphasized, and is best known to consumers under that name.
No objection is offered under the Federal Food, Drug, and Cosmetic Act
to the addition of a quantitative declaration on the labels of
containers of such hydrolyzed vegetable protein or hydrolyzed vegetable
protein with reduced monosodium glutamate content showing the percentage
amounts of monosodium glutamate, the total of other amino acid salts,
salt, and water, if in liquid form, all to be declared in the order of
their decreasing percentages. If monosodium glutamate represents a
smaller proportion of the substance than the other amino acid salts and
salt (sodium chloride), it should be declared last in the list of
ingredients.
(e) When the substances described in paragraphs (a) (2) and (3) of
this section are used as ingredients in a fabricated food, either may be
declared as ''salt and hydrolyzed vegetable protein'' (or ''salt and
hydrolyzed plant protein'') on the label of the fabricated food product:
Provided, That where salt is declared as a separate ingredient of the
fabricated food, in compliance with section 403(i)(2) of the act, the
word ''salt'' need not be repeated in connection with the ''hydrolyzed
vegetable protein'' (or ''hydrolyzed plant protein'') declaration.
21 CFR 101.35 Subpart C -- Specific Nutrition Labeling Requirements and
Guidelines
Source: 55 FR 60890, Nov. 27, 1991, unless otherwise noted.
21 CFR 101.42 Nutrition labeling of raw fruit, vegetables, and fish.
(a) The Food and Drug Administration (FDA) urges food retailers to
provide nutrition information, as provided in 101.9(c), for raw fruit,
vegetables, and fish at the point-of-purchase. If retailers choose to
provide such information, they should do so in a manner that conforms to
the guidelines in 101.45.
(b) In 101.44, FDA has listed the 20 varieties of raw fruit,
vegetables, and fish that are most frequently consumed during a year and
to which the guidelines apply.
(c) FDA has also defined in 101.43, the circumstances that
constitute substantial compliance by food retailers with the guidelines.
(d) By May 8, 1993, FDA will issue a report on actions taken by food
retailers to provide consumers with nutrition information for raw fruit,
vegetables, and fish under the guidelines established in 101.45.
(1) The report will include a determination of whether there is
substantial compliance, as defined in 101.43, with the guidelines.
(2) In evaluating substantial compliance, FDA will consider only the
20 varieties of raw fruit, vegetables, and fish most frequently consumed
as identified in 101.44.
(e) If FDA finds that there is substantial compliance with the
guidelines for the nutrition labeling of raw fruit and vegetables or of
fish, the agency will so state in the report, and the guidelines will
remain in effect. FDA will reevaluate the market place for substantial
compliance every 2 years.
(f) If FDA determines that there is not substantial compliance with
the guidelines for raw fruit and vegetables or for raw fish, the agency
will at that time issue proposed regulations requiring that any person
who offers raw fruit and vegetables or fish to consumers provide, in a
manner prescribed by regulations, the nutrition information required by
101.9. Final regulations would have to be issued 6 months after issuance
of proposed regulations, and they would become effective 6 months after
the date of their promulgation.
21 CFR 101.43 Substantial compliance of food retailers with the
guidelines for the voluntary nutrition labeling of raw fruit,
vegetables, and fish.
(a) The Food and Drug Administration (FDA) will judge a food retailer
who sells raw agricultural commodities or raw fish to be in compliance
with the guidelines in 101.45 with respect to raw agricultural
commodities if the retailer displays or provides nutrition labeling for
at least 90 percent of the raw agricultural commodities listed in
101.44 that it sells, and with respect to raw fish if the retailer
displays or provides nutrition labeling for at least 90 percent of the
types of raw fish listed in 101.44 that it sells. To be in compliance,
the nutrition labeling shall:
(1) Be presented in the store or other type of establishment in a
manner that is consistent with 101.45(a);
(2) Be presented in content and format that are consistent with
101.45(b); and
(3) Include data that have been provided by FDA (see 101.45(i)),
that have been accepted by FDA (see 101.45 (c), (f), and (g)), or that
are consistent with 101.45 (d) and (e) and have not been found to be
out of compliance after a review under 101.9(e) (see 101.45(h)).
(b) To determine whether there is substantial compliance by food
retailers with the guidelines in 101.45 for the voluntary nutrition
labeling of raw fruit and vegetables and of raw fish, FDA will select a
representative sample of 2,000 stores, allocated by store type and size,
for raw fruit and vegetables and for raw fish.
(c) FDA will find that there is substantial compliance with the
guidelines in 101.45 if it finds based on paragraph (a) of this section
that at least 60 percent of all stores that are evaluated are in
compliance.
(d) FDA will evaluate substantial compliance separately for raw
agricultural commodities and for raw fish.
21 CFR 101.44 Identification of the 20 most frequently consumed raw
fruit, vegetables, and fish in the United States.
(a) The 20 most frequently consumed raw fruit are: Banana, apple,
watermelon, orange, cantaloupe, grape, grapefruit, strawberry, peach,
pear, nectarine, honeydew melon, plum, avocado, lemon, pineapple,
tangerine, sweet cherry, kiwifruit, and lime.
(b) The 20 most frequently consumed raw vegetables are: Potato,
iceberg lettuce, tomato, onion, carrot, celery, sweet corn, broccoli,
green cabbage, cucumber, bell pepper, cauliflower, leaf lettuce, sweet
potato, mushroom, green onion, green (snap) bean, radish, summer squash,
and asparagus.
(c) The 20 most frequently consumed raw fish are: Shrimp, cod,
pollack, catfish, scallop, Atlantic/coho salmon, flounder, sole, oyster,
orange roughy, Atlantic/Pacific and jack mackerel, ocean perch,
rockfish, whiting, clam, haddock, blue crab, rainbow trout, halibut, and
lobster.
21 CFR 101.45 Guidelines for the voluntary nutrition labeling of raw
fruit, vegetables, and fish.
Nutrition labeling for raw fruit, vegetables, and fish listed in
101.44 should be presented to the public in the following manner:
(a) Nutrition labeling information should be displayed at the point
of purchase by an appropriate means, including by affixing it to the
food, by posting a sign, or by making the information readily available
in brochure, notebook, or leaflet form in close proximity to the foods.
The nutrition labeling information may also be supplemented by a video,
live demonstration, or other media.
(b) Nutrition information should be provided on the label or in
labeling in accordance with 101.9, as modified by the following
guidelines:
(1) The percent U.S. RDA for protein, thiamin, riboflavin, and niacin
may be declared in the nutrition labeling. Declaration of complex
carbohydrates, sugars, dietary fiber, saturated fat, and cholesterol is
also voluntary.
(2) Nutrition labeling information may be presented on individual
labels or in charts in vertical columns or in lines. When lines are
used, any subcomponents declared should be listed parenthetically after
principal components (e.g., saturated fat should be parenthetically
listed after fat).
(3) Declaration of the number of servings per container need not be
included in nutrition labeling of raw fruit, vegetables, and fish.
(4) The nutrition label data should be based on raw edible portion
for fruit and vegetables and on a cooked edible portion for fish. The
methods used to cook fish should be those that do not add fat, breading,
or seasoning (e.g., salt or spices).
(c) Nutrient data and proposed nutrient values for nutrition labeling
for raw fruit, vegetables, and fish may be submitted to the Division of
Nutrition (HFF-260), Center for Food Safety and Applied Nutrition, Food
and Drug Administration, 200 C St. SW., Washington, DC 20204, for
review and evaluation. The data and nutrient values for nutrition
labeling are appropriate for use if they are accepted by the Food and
Drug Administration (FDA). The submission to FDA should include
information on the source of the data (names of investigators, name of
organization, place of analysis, dates of analyses), number of samples,
sampling scheme, analytical methods, statistical treatment of the data,
and proposed quantitative label declarations. The nutrient values for
the nutrition labeling should be determined in accordance with FDA
guidance.
(d) Composite data that reflect representative nutrient levels for
various varieties, species, cultivars; seasons; and geographic regions
may be used to label raw fruit, vegetables, and fish. Alternatively,
data that reflect a specific variety, species, cultivar; season; or
geographic region may be used to label raw fruit, vegetables, and fish;
the nutrition labeling information for such variety, etc., should
provide food names and descriptions for the fruit, vegetables, and fish
that appropriately reflect the samples analyzed for nutrient values.
(e) The FDA manual ''Compliance Procedures for Nutrition Labeling''
(or subsequent revisions of this manual) should be used to develop
nutrition label values from data base values. The manual is available
from the Division of Nutrition.
(f) If the agency's Center for Food Safety and Applied Nutrition
agrees to all aspects of a submitted data base, FDA will notify a
submitter in writing of its acceptance of the nutrient data and nutrient
values for nutrition labeling. FDA's acceptance will be for a period of
10 years or until other data for the same food are submitted to FDA and
found to be superior. Those obtaining data base and nutrient value
acceptance from FDA are responsible for continued maintenance of the
data base. FDA will renew its acceptance of a data base upon request
after 10 years unless the data have been superseded by other data on the
same food or there have been demonstrated changes in agricultural or
industry practices. When agricultural or industry practices change
(e.g., a change occurs in a predominant variety produced), or when FDA
monitoring suggests that the data base or nutrient values are no longer
representative of the item sold in this country, FDA will take steps to
revoke its acceptance of the data base and nutrient values. A revised
data base and proposed nutrient values may be submitted to FDA for
acceptance.
(g) If the nutrition information is in accordance with an
FDA-accepted data base, the nutrient values have been computed following
FDA guidelines, and the food has been handled in accordance with current
good manufacturing practices to prevent nutrient loss, a nutrition label
will not be subject to the agency compliance review under 101.9(e).
(h) Organizations may use data bases that they believe validly
reflect the nutrient content of raw fruit, vegetables, and fish;
however, labeling computed from data bases not reviewed, evaluated, and
accepted by the agency is subject to the compliance procedures of
101.9(e).
(i) FDA will publish, and provide an opportunity for comment on,
updates of the nutrition labeling data for the 20 most frequently
consumed raw fruit, vegetables, and fish (or a notice that the data sets
have not changed from the previous publication) at least every 2 years
in the Federal Register. FDA accepted data for other raw fruit,
vegetables, and fish, or for other nutrients, are available from the
Division of Nutrition, Center for Food Safety and Applied Nutrition, 200
C St. SW., Washington, DC 20204.
21 CFR 101.45 Subparts D-E (Reserved)
21 CFR 101.45 Subpart F -- Exemptions From Food Labeling Requirements
21 CFR 101.100 Food; exemptions from labeling.
(a) The following foods are exempt from compliance with the
requirements of section 403(i)(2) of the act (requiring a declaration on
the label of the common or usual name of each ingredient when the food
is fabricated from two or more ingredients).
(1) An assortment of different items of food, when variations in the
items that make up different packages packed from such assortment
normally occur in good packing practice and when such variations result
in variations in the ingredients in different packages, with respect to
any ingredient that is not common to all packages. Such exemption,
however, shall be on the condition that the label shall bear, in
conjunction with the names of such ingredients as are common to all
packages, a statement (in terms that are as informative as practicable
and that are not misleading) indicating by name other ingredients which
may be present.
(2) A food having been received in bulk containers at a retail
establishment, if displayed to the purchaser with either (i) the
labeling of the bulk container plainly in view or (ii) a counter card,
sign, or other appropriate device bearing prominently and conspicuously
the information required to be stated on the label pursuant to section
403(i)(2) of the act.
(3) Incidental additives that are present in a food at insignificant
levels and do not have any technical or functional effect in that food.
For the purposes of this paragraph (a)(3), incidental additives are:
(i) Substances that have no technical or functional effect but are
present in a food by reason of having been incorporated into the food as
an ingredient of another food, in which the substance did have a
functional or technical effect.
(ii) Processing aids, which are as follows:
(a) Substances that are added to a food during the processing of such
food but are removed in some manner from the food before it is packaged
in its finished form.
(b) Substances that are added to a food during processing, are
converted into constituents normally present in the food, and do not
significantly increase the amount of the constitutents naturally found
in the food.
(c) Substances that are added to a food for their technical or
functional effect in the processing but are present in the finished food
at insignificant levels and do not have any technical or functional
effect in that food.
(iii) Substances migrating to food from equipment or packaging or
otherwise affecting food that are not food additives as defined in
section 201(s) of the act; or if they are food additives as so defined,
they are used in conformity with regulations established pursuant to
section 409 of the act.
(4) For the purposes of paragraph (a)(3) of this section, any
sulfiting agent (sulfur dioxide, sodium sulfite, sodium bisulfite,
potasssium bisulfite, sodium metabisulfite, and potassium metabisulfite)
that has been added to any food or to any ingredient in any food and
that has no technical effect in that food will be considered to be
present in an insignificant amount only if no detectable amount of the
agent is present in the finished food. A detectable amount of sulfiting
agent is 10 parts per million or more of the sulfite in the finished
food. Compliance with this paragraph will be determined using sections
20.123-20.125, ''Total Sulfurous Acid,'' in ''Official Methods of
Analysis of the Association of Official Analytical Chemists,'' 14th Ed.
(1984), which is incorporated by reference and the refinements of the
''Total Sulfurous Acid'' procedure in the ''Monier-Williams Procedure
(with Modifications) for Sulfites in Foods,'' which is Appendix A to
Part 101. A copy of sections 20.123-20-125 of the Official Methods of
Analysis of the Association of Official Analytical Chemists'' is
available from the Association of Official Analytical Chemists, P.O.
Box 540, Benjamin Franklin Station, Washington, DC 20044, or available
for inspection at the Office of the Federal Register, 1100 L Street NW.,
Washington, DC 20408.
(b) A food repackaged in a retail establishment is exempt from the
following provisions of the act if the conditions specified are met.
(1) Section 403(e)(1) of the act (requiring a statement on the label
of the name and place of business of the manufacturer, packer, or
distributor).
(2) Section 403(g)(2) of the act (requiring the label of a food which
purports to be or is represented as one for which a definition and
standard of identity has been prescribed to bear the name of the food
specified in the definition and standard and, insofar as may be required
by the regulation establishing the standard the common names of the
optional ingredients present in the food), if the food is displayed to
the purchaser with its interstate labeling clearly in view, or with a
counter card, sign, or other appropriate device bearing prominently and
conspicuously the information required by these provisions.
(3) Section 403(i)(1) of the act (requiring the label to bear the
common or usual name of the food), if the food is displayed to the
purchaser with its interstate labeling clearly in view, or with a
counter card, sign, or other appropriate device bearing prominently and
conspicuously the common or usual name of the food, or if the common or
usual name of the food is clearly revealed by its appearance.
(c) An open container (a container of rigid or semirigid
construction, which is not closed by lid, wrapper, or otherwise other
than by an uncolored transparent wrapper which does not obscure the
contents) of a fresh fruit or fresh vegetable, the quantity of contents
of which is not more than 1 dry quart, shall be exempt from the labeling
requirements of sections 403(e), (g)(2) (with respect to the name of the
food specified in the definition and standard), and (i)(1) of the act;
but such exemption shall be on the condition that if two or more such
containers are enclosed in a crate or other shipping package, such crate
or package shall bear labeling showing the number of such containers
enclosed therein and the quantity of the contents of each.
(d) Except as provided by paragraphs (e) and (f) of this section, a
shipment or other delivery of a food which is, in accordance with the
practice of the trade, to be processed, labeled, or repacked in
substantial quantity at an establishment other than that where
originally processed or packed, shall be exempt, during the time of
introduction into and movement in interstate commerce and the time of
holding in such establishment, from compliance with the labeling
requirements of section 403 (c), (e), (g), (h), (i), (j), and (k) of the
act if:
(1) The person who introduced such shipment or delivery into
interstate commerce is the operator of the establishment where such food
is to be processed, labeled, or repacked; or
(2) In case such person is not such operator, such shipment or
delivery is made to such establishment under a written agreement, signed
by and containing the post office addresses of such person and such
operator, and containing such specifications for the processing,
labeling, or repacking, as the case may be, of such food in such
establishment as will ensure, if such specifications are followed, that
such food will not be adulterated or misbranded within the meaning of
the act upon completion of such processing, labeling, or repacking.
Such person and such operator shall each keep a copy of such agreement
until 2 years after the final shipment or delivery of such food from
such establishment, and shall make such copies available for inspection
at any reasonable hour to any officer or employee of the Department who
requests them.
(3) The article is an egg product subject to a standard of identity
promulgated in Part 160 of this chapter, is to be shipped under the
conditions specified in paragraph (d) (1) or (2) of this section and for
the purpose of pasteurization or other treatment as required in such
standard, and each container of such egg product bears a conspicuous tag
or label reading ''Caution -- This egg product has not been pasteurized
or otherwise treated to destroy viable Salmonella microorganisms''. In
addition to safe and suitable bactericidal processes designed
specifically for Salmonella destruction in egg products, the term
''other treatment'' in the first sentence of this paragraph shall
include use in acidic dressings in the processing of which the pH is not
above 4.1 and the acidity of the aqueous phase, expressed as acetic
acid, is not less than 1.4 percent, subject also to the conditions that:
(i) The agreement required in paragraph (d) (2) of this section shall
also state that the operator agrees to utilize such unpasteurized egg
products in the processing of acidic dressings according to the
specifications for pH and acidity set forth in this paragraph, agrees
not to deliver the acidic dressing to a user until at least 72 hours
after such egg product is incorporated in such acidic dressing, and
agrees to maintain for inspection adequate records covering such
processing for 2 years after such processing.
(ii) In addition to the caution statement referred to above, the
container of such egg product shall also bear the statement
''Unpasteurized ------ for use in acidic dressings only'', the blank
being filled in with the applicable name of the eggs or egg product.
(e) Conditions affecting expiration of exemptions: (1) An exemption
of a shipment or other delivery of a food under paragraph (d) (1) or (3)
of this section shall, at the beginning of the act of removing such
shipment or delivery, or any part thereof, from such establishment
become void ab initio if the food comprising such shipment, delivery, or
part is adulterated or misbranded within the meaning of the act when so
removed.
(2) An exemption of a shipment or other delivery of a food under
paragraph (d) (2) or (3) of this section shall become void ab initio
with respect to the person who introduced such shipment or delivery into
interstate commerce upon refusal by such person to make available for
inspection a copy of the agreement, as required by paragraph (d) (2) or
(3) of this section.
(3) An exemption of a shipment or other delivery of a food under
paragraph (d) (2) or (3) of this section shall expire:
(i) At the beginning of the act of removing such shipment or
delivery, or any part thereof, from such establishment if the food
constituting such shipment, delivery, or part is adulterated or
misbranded within the meaning of the act when so removed; or
(ii) Upon refusal by the operator of the establishment where such
food is to be processed, labeled, or repacked, to make available for
inspection a copy of the agreement, as required by such paragraph.
(f) The word ''processed'' as used in this paragraph shall include
the holding of cheese in a suitable warehouse at a temperature of not
less than 35 F for the purpose of aging or curing to bring the cheese
into compliance with requirements of an applicable definition and
standard of identity. The exemptions provided for in paragraph (d) of
this section shall apply to cheese which is, in accordance with the
practice of the trade, shipped to a warehouse for aging or curing, on
condition that the cheese is identified in the manner set forth in one
of the applicable following paragraphs, and in such case the provisions
of paragraph (e) of this section shall also apply:
(1) In the case of varieties of cheese for which definitions and
standards of identity require a period of aging whether or not they are
made from pasteurized milk, each such cheese shall bear on the cheese a
legible mark showing the date at which the preliminary manufacturing
process has been completed and at which date curing commences, and to
each cheese, on its wrapper or immediate container, shall be affixed a
removable tag bearing the statement ''Uncured ------ cheese for
completion of curing and proper labeling'', the blank being filled in
with the applicable name of the variety of cheese. In the case of swiss
cheese, the date at which the preliminary manufacturing process had been
completed and at which date curing commences is the date on which the
shaped curd is removed from immersion in saturated salt solution as
provided in the definition and standard of identity for swiss cheese,
and such cheese shall bear a removable tag reading, ''To be cured and
labeled as 'swiss cheese,' but if eyes do not form, to be labeled as
'swiss cheese for manufacturing'''.
(2) In the case of varieties of cheeses which when made from
unpasteurized milk are required to be aged for not less than 60 days,
each such cheese shall bear a legible mark on the cheese showing the
date at which the preliminary manufacturing process has been completed
and at which date curing commences, and to each such cheese or its
wrapper or immediate container shall be affixed a removable tag reading,
'' ------ cheese made from unpasteurized milk. For completion of curing
and proper labeling'', the blank being filled in with the applicable
name of the variety of cheese.
(3) In the case of cheddar cheese, washed curd cheese, colby cheese,
granular cheese, and brick cheese made from unpasteurized milk, each
such cheese shall bear a legible mark on the cheese showing the date at
which the preliminary manufacturing process has been completed and at
which date curing commences, and to each such cheese or its wrapper or
immediate container shall be affixed a removable tag reading '' ------
cheese made from unpasteurized milk. For completion of curing and
proper labeling, or for labeling as ------ cheese for manufacturing'',
the blank being filled in with the applicable name of the variety of
cheese.
(g) The label declaration of a harmless marker used to identify a
particular manufacturer's product may result in unfair competition
through revealing a trade secret. Exemption from the label declaration
of such a marker is granted, therefore, provided that the following
conditions are met:
(1) The person desiring to use the marker without label declaration
of its presence has submitted to the Commissioner of Food and Drugs full
information concerning the proposed usage and the reasons why he
believes label declaration of the marker should be subject to this
exemption; and
(2) The person requesting the exemption has received from the
Commissioner of Food and Drugs a finding that the marker is harmless and
that the exemption has been granted.
(h) Wrapped fish fillets of nonuniform weight intended to be unpacked
and marked with the correct weight at or before the point of retail sale
in an establishment other than that where originally packed shall be
exempt from the requirement of section 403(e)(2) of the act during
introduction and movement in interstate commerce and while held for sale
prior to weighing and marking:
(1) Provided, That (i) The outside container bears a label
declaration of the total net weight; and
(ii) The individual packages bear a conspicuous statement ''To be
weighed at or before time of sale'' and a correct statement setting
forth the weight of the wrapper;
(2) Provided further, That it is the practice of the retail
establishment to weigh and mark the individual packages with a correct
net-weight statement prior to or at the point of retail sale. A
statement of the weight of the wrapper shall be set forth so as to be
readily read and understood, using such term as ''wrapper tare --
ounce'', the blank being filled in with the correct average weight of
the wrapper used.
(3) The act of delivering the wrapped fish fillets during the retail
sale without the correct net-weight statement shall be deemed an act
which results in the product's being misbranded while held for sale.
Nothing in this paragraph shall be construed as requiring net-weight
statements for wrapped fish fillets delivered into institutional trade
provided the outside container bears the required information.
(i) Wrapped clusters (consumer units) of bananas of nonuniform weight
intended to be unpacked from a master carton or container and weighed at
or before the point of retail sale in an establishment other than that
where originally packed shall be exempt from the requirements of section
403(e)(2) of the act during introduction and movement in interstate
commerce and while held for sale prior to weighing:
(1) Provided, That (i) The master carton or container bears a label
declaration of the total net weight; and
(ii) The individual packages bear a conspicuous statement ''To be
weighed at or before the time of sale'' and a correct statement setting
forth the weight of the wrapper; using such term as ''wrapper tare
------ ounce'', the blank being filled in with the correct average
weight of the wrapper used;
(2) Provided further, That it is the practice of the retail
establishment to weigh the individual packages either prior to or at the
time of retail sale.
(3) The act of delivering the wrapped clusters (consumer units)
during the retail sale without an accurate net weight statement or
alternatively without weighing at the time of sale shall be deemed an
act which results in the product's being misbranded while held for sale.
Nothing in this paragraph shall be construed as requiring net-weight
statements for clusters (consumer units) delivered into institutional
trade, provided that the master container or carton bears the required
information.
(42 FR 14308, Mar. 15, 1977, as amended at 51 FR 25017, July 9, 1986)
21 CFR 101.103 Petitions requesting exemptions from or special
requirements for label declaration of ingredients.
The Commissioner of Food and Drugs, either on his own initiative or
on behalf of any interested person who has submitted a petition pursuant
to Part 10 of this chapter may issue a proposal to amend 101.4 to
specify the manner in which an ingredient(s) shall be declared, i.e., by
specific or class name, or 101.100 to exempt an ingredient(s) from the
requirements for label declaration.
(42 FR 14308, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22,
1977)
21 CFR 101.105 Declaration of net quantity of contents when exempt.
(a) The principal display panel of a food in package form shall bear
a declaration of the net quantity of contents. This shall be expressed
in the terms of weight, measure, numerical count, or a combination of
numerical count and weight or measure. The statement shall be in terms
of fluid measure if the food is liquid, or in terms of weight if the
food is solid, semisolid, or viscous, or a mixture of solid and liquid;
except that such statement may be in terms of dry measure if the food is
a fresh fruit, fresh vegetable, or other dry commodity that is
customarily sold by dry measure. If there is a firmly established
general consumer usage and trade custom of declaring the contents of a
liquid by weight, or a solid, semisolid, or viscous product by fluid
measure, it may be used. Whenever the Commissioner determines that an
existing practice of declaring net quantity of contents by weight,
measure, numerical count, or a combination in the case of a specific
packaged food does not facilitate value comparisons by consumers and
offers opportunity for consumer confusion, he will by regulation
designate the appropriate term or terms to be used for such commodity.
(b)(1) Statements of weight shall be in terms of avoirdupois pound
and ounce.
(2) Statements of fluid measure shall be in terms of the U.S. gallon
of 231 cubic inches and quart, pint, and fluid ounce subdivisions
thereof, and shall:
(i) In the case of frozen food that is sold and consumed in a frozen
state, express the volume at the frozen temperature.
(ii) In the case of refrigerated food that is sold in the
refrigerated state, express the volume at 40 F (4 C).
(iii) In the case of other foods, express the volume at 68 F (20
C).
(3) Statements of dry measure shall be in terms of the U.S. bushel of
2,150.42 cubic inches and peck, dry quart, and dry pint subdivisions
thereof.
(c) When the declaration of quantity of contents by numerical count
does not give adequate information as to the quantity of food in the
package, it shall be combined with such statement of weight, measure, or
size of the individual units of the foods as will provide such
information.
(d) The declaration may contain common or decimal fractions. A
common fraction shall be in terms of halves, quarters, eighths,
sixteenths, or thirty-seconds; except that if there exists a firmly
established general consumer usage and trade custom of employing
different common fractions in the net quantity declaration of a
particular commodity, they may be employed. A common fraction shall be
reduced to its lowest terms; a decimal fraction shall not be carried
out to more than two places. A statement that includes small fractions
of an ounce shall be deemed to permit smaller variations than one which
does not include such fractions.
(e) The declaration shall be located on the principal display panel
of the label, and with respect to packages bearing alternate principal
panels it shall be duplicated on each principal display panel.
(f) The declaration shall appear as a distinct item on the principal
display panel, shall be separated (by at least a space equal to the
height of the lettering used in the declaration) from other printed
label information appearing above or below the declaration and (by at
least a space equal to twice the width of the letter ''N'' of the style
of type used in the quantity of contents statement) from other printed
label information appearing to the left or right of the declaration. It
shall not include any term qualifying a unit of weight, measure, or
count (such as ''jumbo quart'' and ''full gallon'') that tends to
exaggerate the amount of the food in the container. It shall be placed
on the principal display panel within the bottom 30 percent of the area
of the label panel in lines generally parallel to the base on which the
package rests as it is designed to be displayed: Provided, That on
packages having a principal display panel of 5 square inches or less,
the requirement for placement within the bottom 30 percent of the area
of the label panel shall not apply when the declaration of net quantity
of contents meets the other requirements of this part.
(g) The declaration shall accurately reveal the quantity of food in
the package exclusive of wrappers and other material packed therewith:
Provided, That in the case of foods packed in containers designed to
deliver the food under pressure, the declaration shall state the net
quantity of the contents that will be expelled when the instructions for
use as shown on the container are followed. The propellant is included
in the net quantity declaration.
(h) The declaration shall appear in conspicuous and easily legible
boldface print or type in distinct contrast (by typography, layout,
color, embossing, or molding) to other matter on the package; except
that a declaration of net quantity blown, embossed, or molded on a glass
or plastic surface is permissible when all label information is so
formed on the surface. Requirements of conspicuousness and legibility
shall include the specifications that:
(1) The ratio of height to width (of the letter) shall not exceed a
differential of 3 units to 1 unit (no more than 3 times as high as it is
wide).
(2) Letter heights pertain to upper case or capital letters. When
upper and lower case or all lower case letters are used, it is the lower
case letter ''o'' or its equivalent that shall meet the minimum
standards.
(3) When fractions are used, each component numeral shall meet
one-half the minimum height standards.
(i) The declaration shall be in letters and numerals in a type size
established in relationship to the area of the principal display panel
of the package and shall be uniform for all packages of substantially
the same size by complying with the following type specifications:
(1) Not less than one-sixteenth inch in height on packages the
principal display panel of which has an area of 5 square inches or less.
(2) Not less than one-eighth inch in height on packages the principal
display panel of which has an area of more than 5 but not more than 25
square inches.
(3) Not less than three-sixteenths inch in height on packages the
principal display panel of which has an area of more than 25 but not
more than 100 square inches.
(4) Not less than one-fourth inch in height on packages the principal
display panel of which has an area of more than 100 square inches,
except not less than 1/2 inch in height if the area is more than 400
square inches.
Where the declaration is blown, embossed, or molded on a glass or
plastic surface rather than by printing, typing, or coloring, the
lettering sizes specified in paragraphs (h)(1) through (4) of this
section shall be increased by one-sixteenth of an inch.
(j) On packages containing less than 4 pounds or 1 gallon and labeled
in terms of weight or fluid measure:
(1) The declaration shall be expressed both in ounces, with
identification by weight or by liquid measure and, if applicable (1
pound or 1 pint or more) followed in parentheses by a declaration in
pounds for weight units, with any remainder in terms of ounces or common
or decimal fractions of the pound (see examples set forth in paragraphs
(m) (1) and (2) of this section), or in the case of liquid measure, in
the largest whole units (quarts, quarts and pints, or pints, as
appropriate) with any remainder in terms of fluid ounces or common or
decimal fractions of the pint or quart (see examples in paragraphs (m)
(3) and (4) of this section).
(2) If the net quantity of contents declaration appears on a random
package, that is a package which is one of a lot, shipment, or delivery
of packages of the same consumer commodity with varying weights and with
no fixed weight pattern, it may, when the net weight exceeds 1 pound, be
expressed in terms of pounds and decimal fractions of the pound carried
out to not more than two decimal places. When the net weight does not
exceed 1 pound, the declaration on the random package may be in decimal
fractions of the pound in lieu of ounces (see example in paragraph
(m)(5) of this section).
(3) The declaration may appear in more than one line. The term ''net
weight'' shall be used when stating the net quantity of contents in
terms of weight. Use of the terms ''net'' or ''net contents'' in terms
of fluid measure or numerical count is optional. It is sufficient to
distinguish avoirdupois ounce from fluid ounce through association of
terms; for example, ''Net wt. 6 oz'' or ''6 oz Net wt.'' and ''6 fl
oz'' or ''Net contents 6 fl oz''.
(k) On packages containing 4 pounds or 1 gallon or more and labeled
in terms of weight or fluid measure, the declaration shall be expressed
in pounds for weight units with any remainder in terms of ounces or
common or decimal fraction of the pound, or in the case of fluid
measure, it shall be expressed in the largest whole unit (gallons
followed by common or decimal fraction of a gallon or by the next
smaller whole unit or units (quarts, or quarts and pints)) with any
remainder in terms of fluid ounces or common or decimal fractions of the
pint or quart (see paragraph (m)(6) of this section).
(l) (Reserved)
(m) Examples:
(1) A declaration of 1 1/2 pounds weight shall be expressed as ''Net
Wt. 24 oz (1 lb 8 oz),'' ''Net Wt. 24 oz (1 1/2 lb),'' or ''Net Wt.
24 oz (1.5 lb)''.
(2) A declaration of three-fourths pound avoirdupois weight shall be
expressed as ''Net Wt. 12 oz''.
(3) A declaration of 1 quart liquid measure shall be expressed as
''Net 32 fl oz (1 qt)''.
(4) A declaration of 1 3/4 quarts liquid measure shall be expressed
as ''Net contents 56 fluid ounces (1 quart 1 1/2 pints)'' or as ''Net 56
fluid oz (1 qt 1 pt 8 oz)'', but not in terms of quart and ounce such as
''Net 56 fluid oz (1 quart 24 ounces)''.
(5) On a random package, declaration of three-fourths pound
avoirdupois may be expressed as ''Net Wt. .75 lb''.
(6) A declaration of 2 1/2 gallons liquid measure shall be expressed
as ''Net contents 2 1/2 gallons,'' ''Net contents 2.5 gallons,'' or
''Net contents 2 gallons 2 quarts'' and not as ''2 gallons 4 pints''.
(n) For quantities, the following abbreviations and none other may be
employed (periods and plural forms are optional):
(o) Nothing in this section shall prohibit supplemental statements at
locations other than the principal display panel(s) describing in
nondeceptive terms the net quantity of contents; Provided, that such
supplemental statements of net quantity of contents shall not include
any term qualifying a unit of weight, measure, or count that tends to
exaggerate the amount of the food contained in the package; for
example, ''jumbo quart'' and ''full gallon''. Dual or combination
declarations of net quantity of contents as provided for in paragraphs
(a), (c), and (j) of this section (for example, a combination of net
weight plus numerical count, net contents plus dilution directions of a
concentrate, etc.) are not regarded as supplemental net quantity
statements and may be located on the principal display panel.
(p) A separate statement of the net quantity of contents in terms of
the metric system is not regarded as a supplemental statement and an
accurate statement of the net quantity of contents in terms of the
metric system of weight or measure may also appear on the principal
display panel or on other panels.
(q) The declaration of net quantity of contents shall express an
accurate statement of the quantity of contents of the package.
Reasonable variations caused by loss or gain of moisture during the
course of good distribution practice or by unavoidable deviations in
good manufacturing practice will be recognized. Variations from stated
quantity of contents shall not be unreasonably large.
(r) The declaration of net quantity of contents on pickles and pickle
products, including relishes but excluding one or two whole pickles in
clear plastic bags which may be declared by count, shall be expressed in
terms of the U.S. gallon of 231 cubic inches and quart, pint, and fluid
ounce subdivisions thereof.
(s) On a multiunit retail package, a statement of the quantity of
contents shall appear on the outside of the package and shall include
the number of individual units, the quantity of each individual unit,
and, in parentheses, the total quantity of contents of the multiunit
package in terms of avoirdupois or fluid ounces, except that such
declaration of total quantity need not be followed by an additional
parenthetical declaration in terms of the largest whole units and
subdivisions thereof, as required by paragraph (j)(1) of this section.
A multiunit retail package may thus be properly labeled: ''6-16 oz
bottles -- (96 fl oz)'' or ''3-16 oz cans -- (net wt. 48 oz)''. For the
purposes of this section, ''multiunit retail package'' means a package
containing two or more individually packaged units of the identical
commodity and in the same quantity, intended to be sold as part of the
multiunit retail package but capable of being individually sold in full
compliance with all requirements of the regulations in this part. Open
multiunit retail packages that do not obscure the number of units or
prevent examination of the labeling on each of the individual units are
not subject to this paragraph if the labeling of each individual unit
complies with the requirements of paragraphs (f) and (i) of this
section. The provisions of this section do not apply to that butter or
margarine covered by the exemptions in 1.24(a) (10) and (11) of this
chapter.
(t) Where the declaration of net quantity of contents is in terms of
net weight and/or drained weight or volume and does not accurately
reflect the actual quantity of the contents or the product falls below
the applicable standard of fill of container because of equipment
malfunction or otherwise unintentional product variation, and the label
conforms in all other respects to the requirements of this chapter
(except the requirement that food falling below the applicable standard
of fill of container shall bear the general statement of substandard
fill specified in 130.14(b) of this chapter), the mislabeled food
product, including any food product that fails to bear the general
statement of substandard fill specified in 130.14(b) of this chapter,
may be sold by the manufacturer or processor directly to institutions
operated by Federal, State or local governments (schools, prisons,
hospitals, etc.): Provided, That:
(1) The purchaser shall sign a statement at the time of sale stating
that he is aware that the product is mislabeled to include
acknowledgment of the nature and extent of the mislabeling, (e.g.,
''Actual net weight may be as low as ---- % below labeled quantity'')
and that any subsequent distribution by him of said product except for
his own institutional use is unlawful. This statement shall be kept on
file at the principal place of business of the manufacturer or processor
for 2 years subsequent to the date of shipment of the product and shall
be available to the Food and Drug Administration upon request.
(2) The product shall be labeled on the outside of its shipping
container with the statement(s):
(i) When the variation concerns net weight and/or drained weight or
volume, ''Product Mislabeled. Actual net weight (drained weight or
volume where appropriate) may be as low as ---- % below labeled
quantity. This Product Not for Retail Distribution'', the blank to be
filled in with the maximum percentage variance between the labeled and
actual weight or volume of contents of the individual packages in the
shipping container, and
(ii) When the variation is in regard to a fill of container standard,
''Product Mislabeled. Actual fill may be as low as -- % below standard
of fill. This Product Not for Retail Distribution''.
(3) The statements required by paragraphs (t)(2) (i) and (ii) of this
section, which may be consolidated where appropriate, shall appear
prominently and conspicuously as compared to other printed matter on the
shipping container and in boldface print or type on a clear, contrasting
background in order to render them likely to be read and understood by
the purchaser under ordinary conditions of purchase.
(42 FR 14308, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22,
1977)
21 CFR 101.108 Temporary exemptions for purposes of conducting
authorized food labeling experiments.
(a) The food industry is encouraged to experiment voluntarily, under
controlled conditions and in collaboration with the Food and Drug
Administration, with graphics and other formats for presenting nutrition
and other related food labeling information that is consistent with the
current quantitative system in 101.9 and 101.25 and with 105.66,
105.67, and 105.69 of this chapter.
(b) Any firm that intends to undertake a labeling experiment that
requires exemptions from certain requirements of 101.9 and 101.25 and
105.66, 105.67, and 105.69 of this chapter should submit a written
proposal containing a thorough discussion of each of the following
information items that apply to the particular experiment:
(1) A description of the labeling format to be tested;
(2) A statement of the criteria to be used in the experiment for
assigning foods to categories, e.g., nutrient or other values defining
''low'' and ''reduced'';
(3) A draft of the material to be used in the store, e.g., shelf
tags, booklets, posters, etc.;
(4) The dates on which the experiment will begin and end and on which
a written report of analysis of the experimental data will be submitted
to FDA, together with a commitment not to continue the experiment beyond
the proposed ending date without FDA approval;
(5) The geographic area or areas in which the experiment is to be
conducted;
(6) The mechanism to measure the effectiveness of the experiment;
(7) The method for conveying to consumers the required nutrition and
other labeling information that is exempted from the label during the
experiment;
(8) The method that will be or has been used to determine the actual
nutritional characteristics of foods for which a claim is made; and
(9) A statement of the sections of the regulations for which an
exemption is sought.
(c) The written proposal should be sent to the Dockets Management
Branch (HFA-305), Food and Drug Administration, Rm. 4-62, 5600 Fishers
Lane, Rockville, MD 20857. The proposal should be clearly identified as
a request for a temporary exemption for purposes of conducting
authorized food labeling experiments and submitted as a citizen petition
under 10.30 of this chapter.
(d) Approval for food labeling experiments will be given by FDA in
writing. Foods labeled in violation of existing regulations will be
subject to regulatory action unless an FDA-approved exemption to the
specific regulation has been granted for that specific product.
(e) Reporting requirements contained in 101.108(b) have been
approved by this Office of Management and Budget and assigned number
0910-0151.
(48 FR 15240, Apr. 8, 1983)
21 CFR 101.108 Pt. 101, App. A
The AOAC official method for sulfites (Official Methods of Analysis,
14th Edition, 20.123-20.125, Association of Official Analytical
Chemists) has been modified, in FDA laboratories, to facilitate the
determination of sulfites at or near 10 ppm in food. Method
instructions, including modifications, are described below.
Apparatus -- The apparatus shown diagrammatically (Figure 1) is
designed to accomplish the selective transfer of sulfur dioxide from the
sample in boiling aqueous hydrochloric acid to a solution of 3% hydrogen
peroxide. This apparatus is easier to assemble than the official
apparatus and the back pressure inside the apparatus is limited to the
unavoidable pressure due to the height of the 3% H2O2 solution above the
tip of the bubbler (F). Keeping the backpressure as low as possible
reduces the likelihood that sulfur dioxide will be lost through leaks.
The apparatus should be assembled as shown in Fig. 1 with a thin
film of stopcock grease on the sealing surfaces of all the joints except
the joint between the separatory funnel and the flask. Each joint
should be clamped together to ensure a complete seal throughout the
analysis. The separatory funnel, B, should have a capacity of 100 ml or
greater. An inlet adapter, A, with a hose connector (Kontes K-183000 or
equivalent) is required to provide a means of applying a head of
pressure above the solution. (A pressure equalizing dropping funnel is
not recommended because condensate, perhaps with sulfur dioxide, is
deposited in the funnel and the side arm.) The round bottom flask, C, is
a 1000 ml flask with three 24/40 tapered joints. The gas inlet tube, D,
(Kontes K-179000 or equivalent) should be of sufficient length to permit
introduction of the nitrogen within 2.5 cm of the bottom of the flask.
The Allihn condenser, E, (Kontes K-431000-2430 or equivalent) has a
jacket length of 300 mm. The bubbler, F, was fabricated from glass
according to the dimensions given in Fig. 2. The 3% hydrogen peroxide
solution can be contained in a vessel, G, with an i.d. of ca. 2.5 cm
and a depth of 18 cm.
Buret -- A 10 ml buret (Fisher Cat. No. 03-848-2A or equivalent) with
overflow tube and hose connections for an Ascarite tube or equivalent
air scrubbing apparatus. This will permit the maintenance of a carbon
dioxide-free atmosphere over the standardized 0.01N sodium hydroxide.
Chilled Water Circulator -- The condensor must be chilled with a
coolant, such as 20% methanol-water, maintained at 5 C. A circulating
pump equivalent to the Neslab Coolflow 33 is suitable.
(a) Aqueous hydrochloric acid, 4N. -- For each analysis prepare 90 ml
of hydrochloric acid by adding 30 ml of concentrated hydrochloric acid
(12N) to 60 ml of distilled water.
(b) Methyl red indicator. -- Dissolve 250 mg of methyl red in 100 ml
ethanol.
(c) Hydrogen peroxide solution, 3%. -- Dilute ACS reagent grade 30%
hydrogen peroxide to 3% with distilled water. Just prior to use, add
three drops of methyl red indicator and titrate to a yellow end-point
using 0.01N sodium hydroxide. If the end-point is exceeded discard the
solution and prepare another 3% H2O2 solution.
(d) Standardized titrant, 0.01N NaOH. -- Certified reagent may be
used (Fisher SO-5-284). It should be standardized with reference
standard potassium hydrogen phthalate.
(e) Nitrogen. -- A source of high purity nitrogen is required with a
flow regulator that will maintain a flow of 200 cc per minute. To guard
against the presence of oxygen in the nitrogen, an oxygen scrubbing
solution such as an alkaline pyrogallol trap may be used. Prepare
pyrogallol trap as follows:
1. Add 4.5 g pyrogallol to the trap.
2. Purge trap with nitrogen for 2 to 3 minutes.
3. Prepare a KOH solution prepared by adding 65g KOH to 85 ml
distilled water (caution: heat).
4. Add the KOH solution to the trap while maintaining an atmosphere
of nitrogen in the trap.
Assemble the apparatus as shown in Fig. 1. The flask C must be
positioned in a heating mantle that is controlled by a power regulating
device such as Variac or equivalent. Add 400 ml of distilled water to
flask C. Close the stopcock of separatory funnel, B, and add 90 ml of
4N hydrochloric acid to the separatory funnel. Begin the flow of
nitrogen at a rate of 200 10 cc/min. The condenser coolant flow must be
initiated at this time. Add 30 ml of 3% hydrogen peroxide, which has
been titrated to a yellow end-point with 0.01N NaOH, to container G.
After fifteen minutes the apparatus and the distilled water will be
thoroughly de-oxygenated and the apparatus is ready for sample
introduction.
Sample preparation (solids) -- Transfer 50 g of food, or a quantity
of food with a convenient quantity of SO2 (500 to 1500 mcg SO2), to a
food processor or blender. Add 100 ml of 5% ethanol in water and
briefly grind the mixture. Grinding or blending should be continued
only until the food is chopped into pieces small enough to pass through
the 24/40 point of flask C.
Sample preparation (liquids) -- Mix 50 g of the sample, or a quantity
with a convenient quantity of SO2 (500 to 1500 mcg SO2), with 100 ml of
5% ethanol in water.
Sample introduction and distillation -- Remove the separatory funnel
B, and quantitatively transfer the food sample in aqueous ethanol to
flask C. Wipe the tapered joint clean with a laboratory tissue, apply
stopcock grease to the outer joint of the separatory funnel, and return
the separatory funnel, B, to tapered joint flask C. The nitrogen flow
through the 3% hydrogen peroxide solution should resume as soon as the
funnel, B, is re-inserted into the appropriate joint in flask C.
Examine each joint to ensure that it is sealed.
Apply a head pressure above the hydrochloric acid solution in B with
a rubber bulb equipped with a valve. Open the stopcock in B and permit
the hydrochloric acid solution to flow into flask C. Continue to
maintain sufficient pressure above the acid solution to force the
solution into the flask C. The stopcock may be closed, if necessary, to
pump up the pressure above the acid and then opened again. Close the
stopcock before the last few milliliters drain out of the separatory
funnel, B, to guard against the escape of sulfur dioxide into the
separatory funnel.
Apply the power to the heating mantle. Use a power setting which
will cause 80 to 90 drops per minute of condensate to return to the
flask from condenser, E. After 1.75 hours of boiling the contents of
the 1000 ml flask and remove trap G.
Titration. -- Titrate the contents with 0.01N sodium hydroxide.
Titrate with 0.01N NaOH to a yellow end-point that persists for at least
twenty seconds. Compute the sulfite content, expressed as micrograms
sulfur dioxide per gram of food (ppm) as follows:
ppm=(32.03xVBxNx1000) Wt
where 32.03=milliequivalent weight of sulfur dioxide; VB=volume of
sodium hydroxide titrant of normality, N, required to reach endpoint;
the factor, 1000, converts milliequivalents to microequivalents and
Wt=weight (g) of food sample introduced into the 1000 ml flask.
Insert illus. 762
Figure 1. The optimized Monier-Williams apparatus. Component
identification is given in text.
Insert illus. 763
Figure 2. Diagram of bubbler (F in Figure 1). Lengths are given in
mm.
(42 FR 14308, Mar. 15, 1977, as amended at 51 FR 25017, July 9, 1986)
21 CFR 101.108 PART 102 -- COMMON OR USUAL NAME FOR NONSTANDARDIZED FOODS
21 CFR 101.108 Subpart A -- General Provisions
Sec.
102.5 General principles.
102.19 Petitions.
21 CFR 101.108 Subpart B -- Requirements for Specific Nonstandardized
Foods
102.23 Peanut spreads.
102.26 Frozen ''heat and serve'' dinners.
102.28 Foods packaged for use in the preparation of ''main dishes''
or ''dinners.''
102.30 Noncarbonated beverage products containing no fruit or
vegetable juice.
102.32 Diluted orange juice beverages.
102.33 Diluted fruit or vegetable juice beverages other than diluted
orange juice beverages.
102.37 Mixtures of edible fat or oil and olive oil.
102.39 Onion rings made from diced onion.
102.41 Potato chips made from dried potatoes.
102.45 Fish sticks or portions made from minced fish.
102.46 Pacific whiting.
102.47 Bonito.
102.49 Fried clams made from minced clams.
102.50 Crabmeat.
102.54 Seafood cocktails.
102.55 Nonstandardized breaded composite shrimp units.
102.57 Greenland turbot (Reinhardtius hippoglossoides).
Authority: Secs. 201, 403, 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321, 343, 371).
Source: 42 FR 14322, Mar. 15, 1977, unless otherwise noted.
21 CFR 101.108 Subpart A -- General Provisions
21 CFR 102.5 General principles.
(a) The common or usual name of a food, which may be a coined term,
shall accurately identify or describe, in as simple and direct terms as
possible, the basic nature of the food or its characterizing properties
or ingredients. The name shall be uniform among all identical or
similar products and may not be confusingly similar to the name of any
other food that is not reasonably encompassed within the same name.
Each class or subclass of food shall be given its own common or usual
name that states, in clear terms, what it is in a way that distinguishes
it from different foods.
(b) The common or usual name of a food shall include the
percentage(s) of any characterizing ingredient(s) or component(s) when
the proportion of such ingredient(s) or component(s) in the food has a
material bearing on price or consumer acceptance or when the labeling or
the appearance of the food may otherwise create an erroneous impression
that such ingredient(s) or component(s) is present in an amount greater
than is actually the case. The following requirements shall apply
unless modified by a specific regulation in Subpart B of this part.
(1) The percentage of a characterizing ingredient or component shall
be declared on the basis of its quantity in the finished product (i.e.,
weight/weight in the case of solids, or volume/volume in the case of
liquids).
(2) The percentage of a characterizing ingredient or component shall
be declared by the words ''containing (or contains) ---- percent (or %)
---- '' or '' ---- percent (or %) ---- '' with the first blank filled in
with the percentage expressed as a whole number not greater than the
actual percentage of the ingredient or component named and the second
blank filled in with the common or usual name of the ingredient or
component. The word ''containing'' (or ''contains''), when used, shall
appear on a line immediately below the part of the common or usual name
of the food required by paragraph (a) of this section. For each
characterizing ingredient or component, the words '' ---- percent or %)
---- '' shall appear following or directly below the word ''containing''
(or contains), or directly below the part of the common or usual name of
the food required by paragraph (a) of this section when the word
''containing'' (or contains) is not used, in easily legible boldface
print or type in distinct contrast to other printed or graphic matter,
and in a height not less than the larger of the following alternatives:
(i) Not less than one-sixteenth inch in height on packages having a
principal display panel with an area of 5 square inches or less and not
less than one-eighth inch in height if the area of the principal display
panel is greater than 5 square inches; or
(ii) Not less than one-half the height of the largest type appearing
in the part of the common or usual name of the food required by
paragraph (a) of this section.
(c) The common or usual name of a food shall include a statement of
the presence or absence of any characterizing ingredient(s) or
component(s) and/or the need for the user to add any characterizing
ingredient(s) or component(s) when the presence or absence of such
ingredient(s) or component(s) in the food has a material bearing on
price or consumer acceptance or when the labeling or the appearance of
the food may otherwise create an erroneous impression that such
ingredient(s) or component(s) is present when it is not, and consumers
may otherwise be misled about the presence or absence of the
ingredient(s) or component(s) in the food. The following requirements
shall apply unless modified by a specific regulation in Subpart B of
this part.
(1) The presence or absence of a characterizing ingredient or
component shall be declared by the words ''containing (or contains)
---------- '' or ''containing (or contains) no ---------- '' or ''no
---------- '' or ''does not contain ---------- '', with the blank being
filled in with the common or usual name of the ingredient or component.
(2) The need for the user of a food to add any characterizing
ingredient(s) or component(s) shall be declared by an appropriate
informative statement.
(3) The statement(s) required under paragraph (c)(1) and/or (2) of
this section shall appear following or directly below the part of the
common or usual name of the food required by paragraphs (a) and (b) of
this section, in easily legible boldface print or type in distinct
contrast to other printed or graphic matter, and in a height not less
than the larger of the alternatives established under paragraphs (b)(2)
(i) and (ii) of this section.
(d) A common or usual name of a food may be established by common
usage or by establishment of a regulation in Subpart B of this part, in
Part 104 of this chapter, in a standard of identity, or in other
regulations in this chapter.
21 CFR 102.19 Petitions.
(a) The Commissioner of Food and Drugs, either on his own initiative
or on behalf of any interested person who has submitted a petition, may
publish a proposal to issue, amend, or revoke, under this part, a
regulation prescribing a common or usual name for a food, pursuant to
Part 10 of this chapter.
(b) If the principal display panel of a food for which a common or
usual name regulation is established is too small to accommodate all
mandatory requirements, the Commissioner may establish by regulation an
acceptable alternative, e.g., a smaller type size. A petition
requesting such a regulation, which would amend the applicable
regulation, shall be submitted pursuant to Part 10 of this chapter.
(42 FR 14322, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22,
1977)
21 CFR 102.19 Subpart B -- Requirements for Specific Nonstandardized Foods
21 CFR 102.23 Peanut spreads.
(a) The common or usual name of a spreadable peanut product that does
not conform to 164.150 of this chapter, and more than 10 percent of
which consists of nonpeanut ingredients, shall consist of the term
''peanut spread'' and a statement of the percentage by weight of peanuts
in the product in the manner set forth in 102.5(b), except that peanut
percentages shall be based on the amount of peanuts used to make the
finished food and shall be declared in 5-percent increments expressed as
a multiple of 5, not to exceed the actual percentage of peanuts in the
products.
(b) A spreadable peanut product that is nutritionally inferior to
peanut butter shall be labeled as an imitation of peanut butter under
101.3(e)(2) of this chapter; a spreadable peanut product shall be
considered nutritionally equivalent to peanut butter if it meets all of
the following conditions:
(1) Protein. (i) The protein content of the product is at least 24
percent by weight of the finished product, and the overall biological
quality of the protein contained in the product is at least 68 percent
that of casein; or
(ii) The protein content of the product is at least 16.6 percent by
weight of the finished product, and the overall biological quality of
the protein contained in the product is equal to or greater than that of
casein.
(2) Other nutrients. The product contains the following levels of
nutrients per 100 grams of product:
(c) Compliance with the requirements of paragraph (b) of this section
shall be determined by methods described in the following references
except that in determining protein quantity in products with mixed
protein sources a nitrogen conversion factor of 6.25 may be used.
(1) Protein quantity: ''Official Methods of Analysis of the
Association of Official Analytical Chemists'' (AOAC), 13th Ed. (1980),
using the method described in section 27.007, which is incorporated by
reference. Copies may be obtained from the Association of Official
Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA
22201-3301, or may be examined at the Office of the Federal Register,
1100 L St. NW., Washington, DC 20408.
(2) Biological quality of protein: AOAC, 13th Ed. (1980), using the
method described in sections 43.212-43.216, which is incorporated by
reference. The availability of this incorporation by reference is given
in paragraph (c)(1) of this section.
(3) Niacin: AOAC, 13th Ed. (1980), using the method described in
sections 43.044-43.046, which is incorporated by reference. The
availability of this incorporation by reference is given in paragraph
(c)(1) of this section.
(4) Vitamin B6: AOAC, 13th Ed. (1980), using the method described
in sections 43.188-43.193, which is incorporated by reference. The
availability of this incorporation by reference is given in paragraph
(c)(1) of this section.
(5) Folic acid: Using the method described in U.S. Department of
Agriculture Handbook No. 29, modified by use of ascorbate buffer as
described by Ford and Scott, Journal of Dairy Research, 35:85-90 (1968),
which is incorporated by reference. Copies are available from the
Division of Nutrition, Center for Food Safety and Applied Nutrition
(HFF-260), Food and Drug Administration, 200 C St. SW., Washington, DC
20204, or available for inspection at the Office of the Federal
Register, 1100 L St. NW., Washington, DC 20408
(6) Iron: AOAC, 13th Ed. (1980), using the method described in
sections 43.217-43.219, which is incorporated by reference. The
availability of this incorporation by reference is given in paragraph
(c)(1) of this section.
(7) Zinc: AOAC, 13th Ed. (1980), using the method described in
sections 25.150-25.153, which is incorporated by reference. The
availability of this incorporation by reference is given in paragraph
(c)(1) of this section.
(8) Copper: AOAC, 13th Ed. (1980), using the method described in
sections 25.038-25.043, which is incorporated by reference. The
availability of this incorporation by reference is given in paragraph
(c)(1) of this section.
(9) Magnesium: AOAC, 13th Ed. (1980), using the method described in
sections 2.109-2.113, which is incorporated by reference. The
availability of this incorporation by reference is given in paragraph
(c)(1) of this section.
(42 FR 36455, July 15, 1977, as amended at 47 FR 11821, Mar. 19,
1982; 49 FR 5609, Feb. 14, 1984; 54 FR 24891, June 12, 1989)
21 CFR 102.26 Frozen ''heat and serve'' dinners.
(a) A frozen ''heat and serve'' dinner:
(1) Shall contain at least three components, one of which shall be a
significant source of protein and each of which shall consist of one or
more of the following: meat, poultry, fish, cheese, eggs, vegetables,
fruit, potatoes, rice, or other cereal based products (other than bread
or rolls).
(2) May also contain other servings of food (e.g., soup, bread or
rolls, beverage, dessert).
(b) The common or usual name of the food consists of all of the
following:
(1) The phrase ''frozen 'heat and serve' dinner,'' except that the
name of the predominant characterizing ingredient or other appropriately
descriptive term may immediately precede the word ''dinner'' (e.g.,
''frozen chicken dinner'' or ''frozen heat and serve beef dinner'').
The words ''heat and serve'' are optional. The word ''frozen'' is also
optional, provided that the words ''Keep Frozen'' or the equivalent are
prominently and conspicuously placed on the principal display panel in
type size not less than that specified in 102.5(b)(2)(i).
(2) The phrase ''containing (or contains) ------ '' the blank to be
filled in with an accurate description of each of the three or more dish
components listed in paragraph (a)(1) of this section in their order of
descending predominance by weight (e.g., ham, mashed potatoes, and
peas), followed by any of the other servings specified in paragraph
(a)(2) of this section contained in the package (e.g., onion soup,
enriched white bread, and artificially flavored vanilla pudding) in
their order of descending predominance by weight. This part of the name
shall be placed immediately following or directly below the part
specified in paragraph (b)(1) of this section in the manner set forth in
102.5(c)(3). The words ''contains'' or ''containing'' are optional.
(3) If the labeling implies that the package contains other foods and
these foods are not present in the package, e.g., if a vignette on the
package depicts a ''serving suggestion'' which includes any foods not
present in the package, the principal display panel shall bear a
statement that such foods are not present, in type size not less than
that specified in 102.5(b)(2)(i).
21 CFR 102.28 Foods packaged for use in the preparation of ''main
dishes'' or ''dinners.''
(a) The common or usual name of a packaged food which is represented
on the principal display panel by word or vignette to be used in the
preparation of a ''main dish'', ''dinner'', or other such food serving,
and to which some other important characterizing ingredient(s) or
component(s) not present in the package must be added, consists of all
the following:
(1) The common or usual name of each important ingredient or
component in the package, in descending order of predominance by weight
(e.g., ''noodles and tomato sauce'').
(2) An appropriate informative statement identifying the food to be
prepared by use of the package contents (e.g., ''for preparation of
chicken casserole'').
(3) An appropriate informative statement that additional
characterizing ingredient(s) or component(s) must be added and which
names the additional characterizing ingredient(s) or component(s) (e.g.,
''you must add ------ to complete the recipe,'' the blank to be filled
in with the name(s) of the important characterizing ingredient(s) or
component(s) that must be added).
(b) The labeling required by paragraph (a) of this section shall
appear on the principal display panel.
(1) No word in the statement required by paragraph (a)(2) of this
section may appear on the principal display panel more conspicuously or
in larger type than the smallest and least conspicuous type employed on
the panel for any word, phrase or statement within the scope of
paragraph (a)(1) of this section.
(2) Every word in the statement required by paragraph (a)(3) of this
section shall appear on the principal display panel in easily legible
bold face print or type in distinct contrast to other printed or graphic
matter, and in a height not less than the larger of the following
alternatives:
(i) Not less than one-sixteenth inch in height on packages having a
principal display panel with an area of 5 square inches or less and not
less than one-eighth inch in height if the area of the principal display
panel is greater than 5 square inches; or
(ii) Not less than one-half the height of the largest type appearing
in the part of the common or usual name of the food required by
paragraphs (a) (1) and (2) of this section.
(c) Any vignette which shows any food or characterizing ingredient(s)
or component(s) not included in the package shall be accompanied either
by the statement required by paragraph (a)(3) of this section or by a
separate statement specifying the food or characterizing ingredient(s)
or component(s) shown in the vignette but not included in the package.
(d) If the statement specified in paragraph (a)(2) of this section is
used on any panel in addition to the principal display panel as a
product identification statement, the complete common or usual name
shall appear on such panel in the manner specified in paragraph (b) of
this section.
(e) When a brand name or other prominent product designation contains
a word or words that includes or suggests an important characterizing
ingredient(s) or component(s) that must be added, or otherwise states or
implies that the package contains a complete main dish, dinner, or other
food serving, the part of the common or usual name of the food required
by paragraph (a)(3) of this section shall appear in direct conjunction
with such brand name or other designation and in type size not less than
one-half the height of the largest type appearing in such brand name or
other designation.
21 CFR 102.30 Noncarbonated beverage products containing no fruit or
vegetable juice.
The common or usual name of noncarbonated beverage products
(including a concentrated, dehydrated, powdered, or other counterpart)
containing no fruit or vegetable juice shall include the following:
(a) A descriptive name for the product meeting the requirements of
102.5(a); and
(b) When the labeling or the color and flavor of the beverage
represents, suggests, or implies that any fruit or vegetable juice may
be present (e.g., the product label bears the name or a variation of the
name or any pictorial representation of any fruit or vegetable, or the
product contains color and flavor which give the beverage the appearance
and taste of containing a fruit or vegetable juice) the statement
''Containing (or contains) no -------------------- juice'', or ''no
-------------- juice'', or ''does not contain -------------- juice'',
the blank to be filled in with the name of the fruit(s) or vegetable(s)
represented, suggested, or implied, in the manner set forth in
102.5(c). If a nonspecific fruit or vegetable juice content is
represented, suggested, or implied, the blank shall be filled in with
the word ''fruit'' or ''vegetable'' as applicable.
21 CFR 102.32 Diluted orange juice beverages.
(a) The common or usual name of a noncarbonated beverage containing
less than 100 percent and more than 0 percent orange juice shall be as
follows:
(1) A descriptive name for the product meeting the requirements of
102.5(a) (e.g., diluted orange juice beverage or another descriptive
phrase), and
(2) A statement of the percent of orange juice contained in the
product in the manner set forth in 102.5(b)(2). The percent of orange
juice shall be declared in 5-percent increments, expressed as a multiple
of five not greater than the actual percentage of orange juice in the
product, except that the percent of orange juice in products containing
more than 0 percent but less than 5-percent orange juice shall be
declared in the statement as ''less than 5'' percent.
(b) The percent of orange juice in the product shall be determined on
the basis of the orange juice having an equivalent single strength of
11.8 percent orange juice soluble solids.
21 CFR 102.33 Diluted fruit or vegetable juice beverages other than
diluted orange juice beverages.
(a) The common or usual name of a noncarbonated beverage containing
less than 100 percent and more than zero percent fruit or vegetable
juice(s), other than only orange juice, shall be as follows:
(1) A descriptive name meeting the requirements of 102.5(a) (e.g.,
''diluted grape juice beverage'', ''grape juice drink'', or another
descriptive phrase) and
(2) A statement of the percent of each juice contained in the
beverage in the manner set forth in 102.5(b)(2). The percent of juice
shall be declared in 5-percent increments, expressed as a multiple of
five not greater than the actual percentage of juice in the beverage
except that the percent of any juice in beverages containing more than
zero percent but less than 5 percent of that juice shall be declared in
the statement as ''less than 5'' percent. The following special
requirements apply:
(i) Beverages containing multiple juices with a label or labeling
which does not make direct or indirect representations with respect to
the individual characterizing juices by word, vignette (i.e., depiction
of fruit or vegetable), or other means other than in the statement of
ingredients shall declare the percent of the total juice content (e.g.,
Mixed Fruit Punch contains ---- % fruit juice).
(ii) Beverages containing multiple juices with a label or labeling
which makes any direct or indirect representations with respect to the
characterizing juices by word, vignette (i.e., depiction of a fruit or
vegetable), or other means other than in the statement of ingredients
shall declare the percent of the total juice content followed by a
statement in parentheses of the percent of each juice represented (e.g.,
Pineapple-Grapefruit Drink contains ---- % fruit juice ( ---- %
pineapple, ---- % grapefruit)).
(b) The percent of fruit or vegetable juice(s) in a diluted juice
beverage shall be calculated on the basis of the soluble solids content
of the single-strength (undiluted) juice(s) used to prepare the diluted
beverage and shall be declared on a volume/volume basis. If the
finished beverage is prepared from concentrated juice(s), the percent of
fruit or vegetable juice(s) shall be calculated on the basis of the
soluble solids content of the single-strength (unconcentrated) juice(s)
used to produce such concentrated juice(s). The soluble solids content
of single-strength high-acid juice (lemon, lime, or cranberry juice)
shall be the weight of soluble solids obtained from refractometer
readings corrected for acidity as set forth in section 22.025, Official
Methods of Analysis of the Association of Official Analytical Chemists,
13th Ed. (1980), which is incorporated by reference. Copies are
available from the Association of Official Analytical Chemists, P.O. Box
540, Benjamin Franklin Station, Washington, DC 20044, or available for
inspection at the Office of the Federal Register, 1100 L Street, NW.,
Washington, DC 20408.
(45 FR 39250, June 10, 1980, as amended at 47 FR 11821, Mar. 19,
1982)
Effective Date Note: Section 102.33, was added at 45 FR 39250, June
10, 1980, effective July 1, 1981. The compliance date was extended to
July 1, 1982, at 45 FR 80497, Dec. 5, 1980, and further extended to
July 1, 1984, at 48 FR 2736, Jan. 21, 1983. At 49 FR 26541, June 27,
1984, the effective date for compliance was extended indefinitely.
21 CFR 102.37 Mixtures of edible fat or oil and olive oil.
The common or usual name of a mixture of edible fats and oils
containing less than 100 percent and more than 0 percent olive oil shall
be as follows:
(a) A descriptive name for the product meeting the requirements of
102.5(a), e.g., ''cottonseed oil and olive oil'' or another descriptive
phrase, and
(b) When the label bears any representation, other than in the
ingredient listing, of the presence of olive oil in the mixture, the
descriptive name shall be followed by a statement of the percentage of
olive oil contained in the product in the manner set forth in
102.5(b)(2).
21 CFR 102.39 Onion rings made from diced onion.
(a) The common or usual name of the food product that resembles and
is of the same composition as onion rings, except that it is composed of
comminuted onions, shall be as follows:
(1) When the product is composed of dehydrated onions, the name shall
be ''onion rings made from dried diced onions.''
(2) When the product is composed of any form of onion other than
dehydrated, the name shall be ''onion rings made from diced onions.''
(b) The words ''made from dried diced onions'' or ''made from diced
onions'' shall immediately follow or appear on a line(s) immediately
below the words ''onion rings'' in easily legible boldface print or type
in distinct contrast to other printed or graphic matter, and in a height
not less than the larger of the following alternatives:
(1) Not less than one-sixteenth inch in height on packages having a
principal display panel with an area of 5 square inches or less and not
less than one-eighth inch in height if the area of the principal display
panel is greater than 5 square inches; or
(2) Not less than one-half the height of the largest type used in the
words ''onion rings.''
21 CFR 102.41 Potato chips made from dried potatoes.
(a) The common or usual name of the food product that resembles and
is of the same composition as potato chips, except that it is composed
of dehydrated potatoes (buds, flakes, granules, or other form), shall be
''potato chips made from dried potatoes.''
(b) The words ''made from dried potatoes'' shall immediately follow
or appear on a line(s) immediately below the words ''potato chips'' in
easily legible boldface print or type in distinct contrast to other
printed or graphic matter, and in a height not less than the larger of
the following alternatives:
(1) Not less than one-sixteenth inch in height on packages having a
principal display panel with an area of 5 square inches or less and not
less than one-eighth inch in height if the area of the principal display
panel is greater than 5 square inches; or
(2) Not less than one-half the height of the largest type used in the
words ''potato chips.''
21 CFR 102.45 Fish sticks or portions made from minced fish.
(a) The common or usual name of the food product that resembles and
is of the same composition as fish sticks or fish portions, except that
it is composed of comminuted fish flesh, shall be ''fish ------------
made from minced fish,'' the blank to be filled in with the word
''sticks'' or ''portions'' as the case may be.
(b) The words ''made from minced fish'' shall immediately follow or
appear on a line(s) immediately below the words ''fish ------------ ''
in easily legible boldface print or type in distinct contrast to other
printed or graphic matter, and in a height not less than the larger of
the following alternatives:
(1) Not less than one-sixteenth inch in height on packages having a
principal display panel with an area of 5 square inches or less and not
less than one-eighth inch in height if the area of the principal display
panel is greater than 5 square inches; or
(2) Not less than one-half the height of the largest type used in the
words ''fish ------------ .''
21 CFR 102.46 Pacific whiting.
''Pacific whiting'' or ''North Pacific whiting'' is the common or
usual name of the food fish Merluccius productus.
(44 FR 45617, Aug. 3, 1979)
21 CFR 102.47 Bonito.
''Bonito'' or ''bonito fish'' is the common or usual name of the
following food fishes:
Cybiosarda elegans (Whitely, 1935) -- Leaping bonito
Gymnosarda unicolor (Ruppell, 1838) -- Dogtooth tuna
Orcynopsis unicolor (Geoffroy St. Hilaire, 1817) -- Plain bonito
Sarda australis (Macleay, 1880) -- Australian bonito
Sarda chiliensis (Cuvier, 1831) -- Eastern Pacific bonito
Sarda orientalis (Temminck and Schlegel, 1844) -- Striped bonito
Sarda sarda (Bloch, 1793) -- Atlantic bonito
(55 FR 45797, Oct. 31, 1990)
21 CFR 102.49 Fried clams made from minced clams.
(a) The common or usual name of the food product that resembles and
is of the same composition as fried clams, except that it is composed of
comminuted clams, shall be ''fried clams made from minced clams.''
(b) The words ''made from minced clams'' shall immediately follow or
appear on a line(s) immediately below the words ''fried clams'' and in
easily legible boldface print or type in distinct contrast to other
printed or graphic matter, and in a height not less than the larger of
the following alternatives:
(1) Not less than one-sixteenth inch in height on packages having a
principal display panel with an area of 5 square inches or less and not
less than one-eighth inch in height if the area of the principal display
panel is greater than 5 square inches; or
(2) Not less than one-half the height of the largest type used in the
words ''fried clams.''
21 CFR 102.50 Crabmeat.
The common or usual name of crabmeat derived from each of the
following designated species of crabs shall be as follows:
21 CFR 102.54 Seafood cocktails.
The common or usual name of a seafood cocktail in package form
fabricated with one or more seafood ingredients shall be:
(a) When the cocktail contains only one seafood ingredient, the name
of the seafood ingredient followed by the word ''cocktail'' (e.g.,
shrimp cocktail, crabmeat cocktail) and a statement of the percentage by
weight of that seafood ingredient in the product in the manner set forth
in 102.5(b).
(b) When the cocktail contains more than one seafood ingredient, the
term ''seafood cocktail'' and a statement of the percentage by weight of
each seafood ingredient in the product in the manner set forth in
102.5(b).
21 CFR 102.55 Nonstandardized breaded composite shrimp units.
(a) The common on usual name of the food product that conforms to the
definition and standard of identity described by 161.175(c)(6) of this
chapter, except that the food is made from comminuted shrimp and is not
in raw frozen form, shall be '' ------------ made from minced shrimp,''
the blank to be filled in with the words ''breaded shrimp sticks'' or
''breaded shrimp cutlets'' depending upon the shape of the product, or
if prepared in a shape other than that of sticks or cutlets ''breaded
shrimp ------------ made from minced shrimp,'' the blank to be filled by
a word or phrase that accurately describes the shape and that is not
misleading.
(b) The words ''made from minced shrimp'' shall immediately follow or
appear on a line(s) immediately below the other words required by this
section in easily legible boldface print or type in distinct contrast to
other printed or graphic matter, and in a height not less than the
larger of the following alternatives:
(1) Not less than one-sixteenth inch in height on packages having a
principal display panel with an area of 5 square inches or less and no
less than one-eighth inch in height if the area of the principal display
panel is greater than 5 square inches; or
(2) Not less than one-half the height of the largest type used in the
words ''breaded shrimp sticks'' or the other comparable words required
by this section.
21 CFR 102.57 Greenland turbot (Reinhardtius hippoglossoides).
''Greenland turbot'' is the common or usual name of the food fish
Reinhardtius hippoglossoides, a species of Pleuronectidae right-eye
flounders. The term ''halibut'' may be associated only with Atlantic
halibut (Hippoglossus hippoglossus) or Pacific halibut (Hippoglossus
stenolepis).
21 CFR 102.57 Pt. 103
21 CFR 102.57 PART 103 -- QUALITY STANDARDS FOR FOODS WITH NO IDENTITY STANDARDS
21 CFR 102.57 Subpart A -- General Provisions
Sec.
103.3 Definitions.
103.5 General principles.
21 CFR 102.57 Subpart B -- Standards of Quality
103.35 Bottled water.
Authority: Secs. 201, 401, 403, 409, 410, 701, 706 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 343, 348, 349, 371,
376).
21 CFR 102.57 Subpart A -- General Provisions
21 CFR 103.3 Definitions.
(a) A ''lot'' is:
(1) For purposes of determining quality factors related to
manufacture, processing, or packing, a collection of primary containers
or units of the same size, type, and style produced under conditions as
nearly uniform as possible and usually designated by a common container
code or marking, or in the absence of any common container code or
marking, a day's production.
(2) For purposes of determining quality factors related to
distribution and storage, a collection of primary containers or units
transported, stored, or held under conditions as nearly uniform as
possible.
(b) A ''sample'' consists of 10 subsamples (consumer units), taken
one from each of 10 different randomly chosen shipping cases to be
representative of a given lot, unless otherwise specified in a specific
quality standard in this part.
(c) An ''analytical unit'' is the portion(s) of food taken from a
subsample of a sample for the purpose of analysis.
(42 FR 14325, Mar. 15, 1977)
21 CFR 103.5 General principles.
(a) The quality of a food depends upon numerous characteristics
including but not limited to the levels of microorganisms and such
physical factors as turbidity, color, flavor, and odor. Such
characteristics are indicative of the quality of the raw materials and
ingredients, the degree of quality control used in manufacture,
processing, and packing, and the conditions of distribution and storage.
The diversity of raw materials, food processing, and distribution
practices, as well as the variation in quality factors important to
consumers, requires that individual standards of quality be established
for different types of food.
(b)(1) The label of a food that fails to meet the requirements of an
applicable standard of quality promulgated pursuant to this part shall
bear the general statement of substandard quality specified in
130.14(a) of this chapter in the manner and form therein specified; but
in lieu of such general statement of substandard quality, the label may
bear the alternative statement, ''Below Standard in Quality ----------
'', the blank to be filled in with whichever of the following are
applicable:
(i) ''Contains Excessive Bacteria''.
(ii) ''Excessively Turbid''.
(iii) ''Abnormal Color''.
(iv) The phrase specified in the applicable standard of quality to
describe any other quality deviation.
(2) The statement of substandard quality shall appear on the
principal display panel or panels and shall immediately and
conspicuously precede or follow, without intervening written, printed or
graphic matter, the name of the food.
(c) Product descriptions included in a standard of quality
promulgated pursuant to this part are intended only to designate the
class of foods to which the standards apply, and are not standards of
identity for the products involved. Should a standard of identity later
be established for any of these foods, the standard of quality will be
recodified to appear in the same part of the regulations.
(d) The food characteristics included in a standard of quality
published in this part relate only to the quality of the food and not to
compliance with any of the adulteration provision of section 402 of the
act. Compliance with a standard of quality promulgated pursuant to this
part does not excuse failure to observe either the requirement of
section 402(a)(4) of the act that food may not be prepared, packed, or
held under insanitary conditions, or the provisions of Parts 110 and 129
of this chapter requiring that food manufacturers must observe current
food manufacturing practices. For example, evidence obtained through
factory inspection indicating such a violation renders the food
unlawful, even though the food contains levels of microorganisms lower
than those prescribed by an applicable standard.
(e) The Commissioner of Food and Drugs, either on his own initiative
or on behalf of any interested person who has submitted a petition, may
establish, amend, or repeal, under Subpart B of this part, a regulation
prescribing a standard of quality for a food pursuant to Part 10 of this
chapter.
(42 FR 14325, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22,
1977; 44 FR 12172, Mar. 6, 1979)
21 CFR 103.5 Subpart B -- Standards of Quality
21 CFR 103.35 Bottled water.
(a) Definitions. (1) ''Bottled water'' is defined as water that is
sealed in bottles or other containers and intended for human
consumption. Bottled water does not include mineral water or any type
of soft drink commonly known as soda water, which is made by absorbing
carbon dioxide in potable water.
(2) ''Trihalomethane'' (THM) means one of the family of organic
compounds, named as derivatives of methane, wherein three of the four
hydrogen atoms in methane are each substituted by a halogen atom in the
molecular structure.
(3) ''Total Trihalomethanes'' (TTHM) means the sum of the
concentration in milligrams per liter of the trihalomethane compounds
(trichloromethane (chloroform), dibromochloromethane,
bromodichloromethane and tribromomethane (bromoform)), rounded to two
significant figures.
(b) Microbiological quality. Bottled water shall, when a sample
consisting of analytical units of equal volume is examined by the
methods described in applicable sections of ''Standard Methods for the
Examination of Water and Wastewater,'' 15th Ed. (1980), American Public
Health Association, which is incorporated by reference (copies may be
obtained from the Division of Food Chemistry and Technology, Center for
Food Safety and Applied Nutrition (HFF-410), 200 C St., SW., Washington,
DC 20204, or may be examined at the Office of the Federal Register, 1100
L St., NW., Washington, DC 20408), meet the following standards of
microbiological quality:
(1) Multiple-tube fermentation method. Not more than one of the
analytical units in the sample shall have a most probable number (MPN)
of 2.2 or more coliform organisms per 100 milliliters and no analytical
unit shall have an MPN of 9.2 or more coliform organisms per 100
milliliters; or
(2) Membrane filter method. Not more than one of the analytical
units in the sample shall have 4.0 or more coliform organisms per 100
milliliters and the arithmetic mean of the coliform density of the
sample shall not exceed one coliform organism per 100 milliliters.
(c) Physical quality. Bottled water shall, when a composite of
analytical units of equal volume from a sample is examined by the method
described in applicable sections of ''Standard Methods for the
Examination of Water and Wastewater,'' 15th Ed. (1980), which is
incorporated by reference (the availability of this incorporation by
reference is given in paragraph (b) of this section), meet the following
standards of physical quality:
(1) The turbidity shall not exceed 5 units.
(2) The color shall not exceed 15 units.
(3) The odor shall not exceed threshold odor No. 3.
(d) Chemical quality. (1)(i) Bottled water shall, when a composite
of analytical units of equal volume from a sample is examined by the
methods described in paragraph (d)(1)(ii) of this section, meet
standards of chemical quality and shall not contain chemical substances
in excess of the following concentrations:
(ii) Analyses conducted to determine compliance with paragraph
(d)(1)(i) of this section shall be made in accordance with the methods
described in the applicable sections of ''Standard Methods for the
Examination of Water and Wastewater,'' 15th Ed. (1980), or ''Methods
for Chemical Analysis of Water and Wastes,'' Environmental Monitoring
and Support Laboratory, EPA-600/4-82-055, March 1983, U.S.
Environmental Protection Agency, both of which are incorporated by
reference. Analyses for organic substances shall be determined by
appropriate methods described in ''Methods for Organochlorine Pesticides
in Industrial Effluents'' and ''Methods for Chlorinated Phenoxy Acid
Herbicides in Industrial Effluents,'' November 28, 1973, which are
incorporated by reference, and ''Part I: The Analysis of
Trihalomethanes in Finished Waters by the Purge and Trap Method,''
Method 501.1 and ''Part II: The Analysis of Trihalomethanes in Drinking
Water by Liquid/Liquid Extraction,'' Method 501.2 in 40 CFR Part 141,
Appendix C (45 FR 68672; November 29, 1979). The availability of these
incorporations by reference are given in paragraph (b) of this section.
(2)(i) Bottled water packaged in the United States to which no
fluoride is added shall not contain fluoride in excess of the levels in
Table 1 and these levels shall be based on the annual average of maximum
daily air temperatures at the location where the bottled water is sold
at retail.
(ii) Imported bottled water to which no fluoride is added shall not
contain fluoride in excess of 1.4 milligrams per liter.
(iii) Bottled water packaged in the United States to which fluoride
is added shall not contain fluoride in excess of levels in Table 2 and
these levels shall be based on the annual average of maximum daily air
temperatures at the location where the bottled water is sold at retail.
(iv) Imported bottled water to which fluoride is added shall not
contain fluoride in excess of 0.8 milligram per liter.
(e) Radiological quality. (1) Bottled water shall, when a composite
of analytical units of equal volume from a sample is examined by the
methods described in paragraph (e)(2) of this section, meet standards of
radiological quality as follows:
(i) The bottled water shall not contain a combined radium-226 and
radium-228 activity in excess of 5 picocuries per liter of water.
(ii) The bottled water shall not contain a gross alpha particle
activity (including radium-226, but excluding radon and uranium) in
excess of 15 picocuries per liter of water.
(iii) The bottled water shall not contain beta particle and photon
radioactivity from manmade radionuclides in excess of that which would
produce an annual dose equivalent to the total body or any internal
organ of 4 millirems per year calculated on the basis of an intake of 2
liters of the water per day. If two or more beta or photon-emitting
radionuclides are present, the sum of their annual dose equivalent to
the total body or to any internal organ shall not exceed 4 millirems per
year.
(2) Analyses conducted to determine compliance with paragraph (e)(1)
of this section shall be made in accordance with the methods described
in the applicable sections of ''Standard Methods for the Examination of
Water and Wastewater,'' 15th Ed. (1980), and ''Interim Radiochemical
Methodology for Drinking Water,'' Environmental Monitoring and Support
Laboratory, EPA-600/4-75-008 (Revised), March 1976, U.S. Environmental
Protection Agency, both of which are incorporated by reference. The
availability of these incorporations by reference is given in paragraph
(b) of this section.
(f) Label statements. Bottled water, the quality of which is below
that prescribed by this section, shall be labeled with a statement of
substandard quality as follows:
(1) When the microbiological quality of bottled water is below that
prescribed by paragraph (b) of this section, the label shall bear the
statement of substandard quality specified in 103.5(b).
(2) When the physical, chemical, and/or radiological quality of
bottled water is below that prescribed by paragraphs (c) through (e)
respectively of this section, the label shall bear the statement of
substandard quality specified in 103.5(b) except that, as appropriate,
instead of or in addition to the words ''Contains Excessive Bacteria''
the following statement(s) shall be used:
(i) ''Excessively Turbid'', ''Abnormal Color'', and/or ''Abnormal
Odor'' if the bottled water fails to meet the requirements of paragraph
(c) (1), (2), and/or (3), respectively, of this section.
(ii) ''Contains Excessive Chemical Substances'', if the bottled water
fails to meet any of the requirements of paragraph (d) of this section.
The specific chemical(s) may be declared in lieu of the words ''Chemical
Substances'' in the statement ''Contains Excessive Chemical
Substances''. When a specific chemical is declared, that name by which
the chemical(s) is designated in paragraph (d) of this section shall be
used. Example: ''Contains Excessive Copper''.
(iii) ''Excessively Radioactive'' if the bottled water fails to meet
the requirements of paragraph (e) of this section.
(g) Adulteration. Bottled water containing a substance at a level
considered injurious to health under section 402(a)(1) of the act is
deemed to be adulterated, regardless of whether or not the bottled water
bears a label statement of substandard quality prescribed by paragraph
(f) of this section.
(42 FR 14325, Mar. 15, 1977, as amended at 44 FR 12172, Mar. 6, 1979;
46 FR 41037, Aug. 14, 1981; 47 FR 11821, Mar. 19, 1982; 49 FR 10090,
Mar. 19, 1984; 54 FR 400, Jan. 6, 1989; 54 FR 24891, June 12, 1989)
21 CFR 103.35 -- Pt. 104
21 CFR 103.35 -- PART 104 -- NUTRITIONAL QUALITY GUIDELINES FOR FOODS
21 CFR 103.35 -- Subpart A -- General Provisions
Sec.
104.5 General principles.
104.19 Petitions.
21 CFR 103.35 -- Subpart B -- Fortification Policy
104.20 Statement of purpose.
21 CFR 103.35 -- Subpart C -- Specific Nutritional Quality Guidelines
104.47 Frozen ''heat and serve'' dinner.
Authority: Secs. 201, 403, 701(a) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321, 343, 371(a)).
Source: 42 FR 14327, Mar. 15, 1977, unless otherwise noted.
21 CFR 103.35 -- Subpart A -- General Provisions
21 CFR 104.5 General principles.
(a) A nutritional quality guideline prescribes the minimum level or
range of nutrient composition (nutritional quality) appropriate for a
given class of food.
(b) Labeling for a product which complies with all of the
requirements of the nutritional quality guideline established for its
class of food may state ''This product provides nutrients in amounts
appropriate for this class of food as determined by the U.S.
Government,'' except that the words ''this product'' are optional. This
statement, if used, shall be printed on the principal display panel, and
may also be printed on the information panel, in letters not larger than
twice the size of the minimum type required for the declaration of net
quantity of contents by 101.105 of this chapter. Labeling of
noncomplying products may not include any such statement or otherwise
represent, suggest, or imply the product as being, in whole or in part,
in compliance with a guideline.
(c) A product bearing the statement provided for in paragraph (b) of
this section, in addition to meeting the requirements of the applicable
nutritional quality guideline, shall comply with the following
requirements:
(1) The label of the product shall bear the common or usual name of
the food in accordance with the provisions of the guideline and 101.3
and 102.5(a) of this chapter.
(2) The label of the product shall bear nutrition labeling in
accordance with 101.2 and 101.9 of this chapter and all other labeling
required by applicable sections of Part 101 of this chapter.
(d) No claim or statement may be made on the label or in labeling
representing, suggesting, or implying any nutritional or other
differences between a product to which nutrient addition has or has not
been made in order to meet the guideline, except that a nutrient
addition shall be declared in the ingredient statement.
(e) Compliance with a nutrient level specified in a nutritional
quality guideline shall be determined by the procedures and requirements
established in 101.9(e) of this chapter.
(f) A product within a class of food for which a nutritional quality
guideline has been established and to which has been added a discrete
nutrient either for which no minimum nutrient level or nutrient range or
other allowance has been established as appropriate in the nutritional
quality guideline, or at a level that exceeds any maximum established as
appropriate in the guideline, shall be ineligible to bear the guideline
statement provided for in paragraph (b) of this section, and such a
product shall also be deemed to be misbranded under the act unless the
label and all labeling bear the following prominent and conspicuous
statement: ''The addition of ---- to (or ''The addition of ---- at the
level contained in) this product has been determined by the U.S.
Government to be unnecessary and inappropriate and does not increase the
dietary value of the food,'' the blank to be filled in with the common
or usual name of the nutrient(s) involved.
(42 FR 14327, Mar. 5, 1977)
21 CFR 104.19 Petitions.
The Commissioner of Food and Drugs, on his own initiative, on the
advice of the National Academy of Sciences or other experts, or on
behalf of any interested person who has submitted a petition, may issue
a proposal to issue, amend, or revoke a regulation prescribing a
nutritional quality guideline for a class of foods, pursuant to Part 10
of this chapter.
(42 FR 14327, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22,
1977)
21 CFR 104.19 Subpart B -- Fortification Policy
21 CFR 104.20 Statement of purpose.
(a) The fundamental objective of this subpart is to establish a
uniform set of principles that will serve as a model for the rational
addition of nutrients to foods. The achievement and maintenance of a
desirable level of nutritional quality in the nation's food supply is an
important public health objective. The addition of nutrients to
specific foods can be an effective way of maintaining and improving the
overall nutritional quality of the food supply. However, random
fortification of foods could result in over- or underfortification in
consumer diets and create nutrient imbalances in the food supply. It
could also result in deceptive or misleading claims for certain foods.
The Food and Drug Administration does not encourage indiscriminate
addition of nutrients to foods, nor does it consider it appropriate to
fortify fresh produce; meat, poultry, or fish products; sugars; or
snack foods such as candies and carbonated beverages. To preserve a
balance of nutrients in the diet, manufacturers who elect to fortify
foods are urged to utilize these principles when adding nutrients to
food. It is reasonable to anticipate that the U.S. RDA's as delineated
in 101.9 of this chapter and in paragraph (d) of this section will be
amended from time to time to list additional nutrients and/or to change
the levels of specific U.S. RDA's as improved knowledge about human
nutrient requirements and allowances develops. The policy set forth in
this section is based on U.S. dietary practices and nutritional needs
and may not be applicable in other countries.
(b) A nutrient(s) listed in paragraph (d)(3) of this section may
appropriately be added to a food to correct a dietary insufficiency
recognized by the scientific community to exist and known to result in
nutritional deficiency disease if:
(1) Sufficient information is available to identify the nutritional
problem and the affected population groups, and the food is suitable to
act as a vehicle for the added nutrients. Manufacturers contemplating
using this principle are urged to contact the Food and Drug
Administration before implementing a fortification plan based on this
principle.
(2) The food is not the subject of any other Federal regulation for a
food or class of food that requires, permits, or prohibits nutrient
additions. (Other Federal regulations include, but are not limited to,
standards of identity promulgated under section 401 of the Federal Food,
Drug, and Cosmetic Act, nutritional quality guidelines established in
Subpart C of this part, and common or usual name regulations established
in Part 102 of this chapter.)
(c) A nutrient(s) listed in paragraph (d)(3) of this section may
appropriately be added to a food to restore such nutrient(s) to a
level(s) representative of the food prior to storage, handling, and
processing, when:
(1) The nutrient(s) is shown by adequate scientific documentation to
have been lost in storage, handling, or processing in a measurable
amount equal to at least 2 percent of the U.S. RDA (and 2 percent of 2.5
grams of potassium and 4.0 milligrams of manganese, when appropriate) in
a normal serving of the food;
(2) Good manufacturing practices and normal storage and handling
procedures cannot prevent the loss of such nutrient(s),
(3) All nutrients, including protein, iodine and vitamin D, that are
lost in a measurable amount are restored and all ingredients of the food
product that contribute nutrients are considered in determining
restoration levels; and
(4) The food is not the subject of any other Federal regulation that
requires or prohibits nutrient addition(s), or the food has not been
fortified in accordance with any other Federal regulation that permits
voluntary nutrient additions.
(d) A nutrient(s) listed in paragraph (d)(3) of this section may be
added to a food in proportion to the total caloric content of the food,
to balance the vitamin, mineral, and protein content if:
(1) A normal serving of the food contains at least 40 kilocalories
(that is, 2 percent of a daily intake of 2,000 kilocalories);
(2) The food is not the subject of any other Federal regulation for a
food or class of food that requires, permits, or prohibits nutrient
additions; and
(3) The food contains all of the following nutrients per 100
kilocalories based on a 2,000-kilocalorie total intake as a daily
standard:
(e) A nutrient(s) may appropriately be added to a food that replaces
traditional food in the diet to avoid nutritional inferiority in
accordance with 101.3(e)(2) of this chapter.
(f) Nutrient(s) may be added to foods as permitted or required by
applicable regulations established elsewhere in this chapter.
(g) A nutrient added to a food is appropriate only when the nutrient:
(1) Is stable in the food under customary conditions of storage,
distribution, and use;
(2) Is physiologically available from the food;
(3) Is present at a level at which there is a reasonable assurance
that consumption of the food containing the added nutrient will not
result in an excessive intake of the nutrient, considering cumulative
amounts from other sources in the diet; and
(4) Is suitable for its intended purpose and is in compliance with
applicable provisions of the act and regulations governing the safety of
substances in food.
(h) Any claims or statements in the labeling of food about the
addition of a vitamin, mineral, or protein to a food shall be made only
if the claim or statement is not false or misleading and otherwise
complies with the act and any applicable regulations. The following
label claims are acceptable:
(1) The labeling claim ''fully restored with vitamins and minerals''
or ''fully restored with vitamins and minerals to the level of
unprocessed ---- '' (the blank to be filled in with the common or usual
name of the food) may be used to describe foods fortified in accordance
with the principles established in paragraph (c) of the section.
(2) The labeling claim, ''vitamins and minerals (and ''protein'' when
appropriate) added are in proportion to caloric content'' may be used to
describe food fortified in accordance with the principles established in
paragraph (d) of this section.
(3) When labeling claims are permitted, the term ''enriched,''
''fortified,'' ''added,'' or similar terms may be used interchangeably
to indicate the addition of one or more vitamins or minerals or protein
to a food, unless an applicable Federal regulation requires the use of
specific words or statements.
(i) It is inappropriate to make any claim or statement on a label or
in labeling, other than in a listing of the nutrient ingredients as part
of the ingredient statement, that any vitamin, mineral, or protein has
been added to a food to which nutrients have been added pursuant to
paragraph (e) of this section.
(45 FR 6323, Jan. 25, 1980)
21 CFR 104.20 Subpart C -- Specific Nutritional Quality Guidelines
21 CFR 104.47 Frozen ''heat and serve'' dinner.
(a) A product, for which a common or usual name is established in
102.26 of this chapter, in order to be eligible to bear the guideline
statement set forth at 104.5(b), shall contain at least the following
three components:
(1) One or more sources of protein derived from meat, poultry, fish,
cheese, or eggs.
(2) One or more vegetables or vegetable mixtures other than potatoes,
rice, or cereal-based product.
(3) Potatoes, rice, or cereal-based product (other than bread or
rolls) or another vegetable or vegetable mixture.
(b) The three or more components named in paragraph (a) of this
section, including their sauces, gravies, breading, etc.:
(1) Shall contribute not less than the minimum levels of nutrients
prescribed in paragraph (d) of this section.
(2) Shall be selected so that one or more of the listed protein
sources of paragraph (a)(1) of this section, excluding their sauces,
gravies, breading, etc., shall provide not less than 70 percent of the
total protein supplied by the components named in paragraph (a) of this
section.
(c) If it is necessary to add any nutrient(s) in order to meet the
minimum nutrient levels prescribed in paragraph (d) of this section, the
addition of each such nutrient may not result in a total nutrient level
exceeding 150 percent of the minimum level prescribed. Nutrients used
for such addition shall be biologically available in the final product.
(d) Minimum levels of nutrients for a frozen ''heat and serve''
dinner are as follows:
(1) A frozen ''heat and serve'' dinner prepared from conventional
food ingredients listed in paragraph (a) of this section will also
contain folic acid, magnesium, iodine, calcium, and zinc. Minimum
levels for these nutrients cannot be established at the present time but
may be specified as additional data are obtained.
(2) The minimum levels for pantothenic acid, vitamin B-6, and vitamin
B-12 are tentative. Final levels will be established when sufficient
data are available. Until final levels are established, a product
containing less than the tentative levels will not be deemed to be
misbranded when labeled in accordance with 104.5(b).
(3) When technologically practicable, iodized salt shall be used or
iodine shall be present at a level equivalent to that which would be
present if iodized salt were used in the manufacture of the product.
(4) When technologically practicable, product components and
ingredients shall be selected to obtain the desirable calcium to
phosphorous ratio of 1:1. Technological addition of phosphates shall be
minimized and shall not exceed the amount necessary for the intended
effect.
(e) If the product includes servings of food which are not prescribed
by paragraph (a) of this section (e.g., soup, bread or rolls, beverage,
or dessert), their contribution shall not be considered in determining
compliance with the nutrient levels established in paragraph (d) of this
section but shall be included in any nutrition labeling.
(f) For the purposes of labeling, an ''average serving'' shall be one
entire frozen ''heat and serve'' dinner.
(42 FR 14327, Mar. 5, 1977)
21 CFR 104.47 PART 105 -- FOODS FOR SPECIAL DIETARY USE
21 CFR 104.47 Pt. 105
21 CFR 104.47 Subpart A -- General Provisions
Sec.
105.3 Definitions and interpretations.
21 CFR 104.47 Subpart B -- Label Statements
105.62 Hypoallergenic foods.
105.65 Infant foods.
105.66 Label statements relating to usefulness in reducing or
maintaining caloric intake or body weight.
105.67 Certain label statements relating to food for use in the diet
of diabetics.
105.69 Foods used to regulate sodium intake.
21 CFR 104.47 Subpart C (Reserved)
21 CFR 104.47 Subpart D -- Standards of Identity (Reserved)
Authority: Secs. 201, 401, 403, 409, 411, 701, 706 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 343, 348, 350, 371,
376).
Source: 42 FR 14328, Mar. 15, 1977, unless otherwise noted.
21 CFR 104.47 Subpart A -- General Provisions
21 CFR 105.3 Definitions and interpretations.
The definitions and interpretations of terms contained in section 201
of the Federal Food, Drug, and Cosmetic Act (hereafter ''the act'')
shall be applicable with the following additions:
(a)(1) The term ''special dietary uses'', as applied to food for man,
means particular (as distinguised from general) uses of food, as
follows:
(i) Uses for supplying particular dietary needs which exist by reason
of a physical, physiological, pathological or other condition, including
but not limited to the conditions of diseases, convalescence, pregnancy,
lactation, allergic hypersensitivity to food, underweight, and
overweight;
(ii) Uses for supplying particular dietary needs which exist by
reason of age, including but not limited to the ages of infancy and
childhood;
(iii) Uses for supplementing or fortifying the ordinary or usual diet
with any vitamin, mineral, or other dietary property. Any such
particular use of a food is a special dietary use, regardless of whether
such food also purports to be or is represented for general use.
(2) The use of an artificial sweetener in a food, except when
specifically and solely used for achieving a physical characteristic in
the food which cannot be achieved with sugar or other nutritive
sweetener, shall be considered a use for regulation of the intake of
calories and available carbohydrate, or for use in the diets of
diabetics and is therefore a special dietary use.
(b) -- (d) (Reserved)
(e) For the purposes of the regulations in this part, the terms
''infant,'' ''child,'' and ''adult'' mean persons not more than 12
months old, more than 12 months but less than 12 years old, and 12 years
or more old, respectively.
(42 FR 14328, Mar. 15, 1977, as amended at 44 FR 16006, Mar. 16,
1979; 44 FR 49665, Aug. 24, 1979)
21 CFR 105.3 Subpart B -- Label Statements
21 CFR 105.62 Hypoallergenic foods.
If a food purports to be or is represented for special dietary use by
reason of the decrease or absence of any allergenic property or by
reason of being offered as food suitable as a substitute for another
food having an allergenic property, the label shall bear:
(a) The common or usual name and the quantity or proportion of each
ingredient (including spices, flavoring, and coloring) in case the food
is fabricated from two or more ingredients.
(b) A qualification of the name of the food, or the name of each
ingredient thereof in case the food is fabricated from two or more
ingredients, to reveal clearly the specific plant or animal that is the
source of such food or of such ingredient, if such food or such
ingredient consists in whole or in part of plant or animal matter and
such name does not reveal clearly the specific plant or animal that is
such a source.
(c) An informative statement of the nature and effect of any
treatment or processing of the food or any ingredient thereof, if the
changed allergenic property results from such treatment or processing.
21 CFR 105.65 Infant foods.
(a) If a food (other than a dietary supplement of vitamins and/or
minerals alone) purports to be or is represented for special dietary use
for infants, the label shall bear, if such food is fabricated from two
or more ingredients, the common or usual name of each ingredient,
including spices, flavoring, and coloring.
(b) If such food, or any ingredient thereof, consists in whole or in
part of plant or animal matter and the name of such food or ingredient
does not clearly reveal the specific plant or animal which is its
source, such name shall be so qualified as to reveal clearly the
specific plant or animal that is such source.
(42 FR 14328, Mar. 15, 1977, as amended at 47 FR 947, Jan. 8, 1982;
49 FR 10090, Mar. 19, 1984; 50 FR 1840, Jan. 14, 1985)
21 CFR 105.66 Label statements relating to usefulness in reducing or
maintaining caloric intake or body weight.
(a) General requirements. Any food that purports to be or is
represented for special dietary use because of usefulness in maintaining
or reducing caloric intake or body weight, including, but not limited
to, any food that bears representations that it is low or reduced in
calories, shall bear:
(1) Nutrition labeling in conformity with 101.9 of this chapter,
unless exempt under that section; and
(2) The labeling provided for in paragraph (c) or (d) of this
section, or a conspicuous statement of the basis upon which the food
claims to be of special dietary usefulness.
(b) Nonnutritive ingredients. (1) Any food subject to paragraph (a)
of this section that achieves its special dietary usefulness by use of a
nonnutritive ingredient (i.e., one not utilized in normal metabolism)
shall bear on its label a statement that it contains a nonnutritive
ingredient and the percentage by weight of the nonnutritive ingredient.
(2) A special dietary food may contain a nonnutritive sweetener or
other ingredient only if the ingredient is safe for use in the food
under the applicable law and regulations of this chapter. Any food that
achieves its special dietary usefulness in reducing or maintaining
caloric intake or body weight through the use of a nonnutritive
sweetener shall bear on its label the statement required by paragraph
(b)(1) of this section, but need not state the percentage by weight of
the nonnutritive sweetener. If a nutritive sweetener(s) as well as
nonnutritive sweetener(s) is added, the statement shall indicate the
presence of both type of sweeteners, e.g., ''Sweetened with nutritive
sweetener(s) and nonnutritive sweetener(s).''
(c) ''Low calorie'' foods. (1) A food may purport to be or be
represented as ''low calorie'' only if:
(i) A serving of the food supplies no more than 40 calories, and
(ii) The food does not provide more than 0.4 calorie per gram, as
consumed, or is a sugar substitute, and
(iii) The food bears on its principal display panel the term ''low
calorie,'' ''low in calories,'' or ''a low calorie food''.
(2) Foods that are low calorie within the meaning of paragraph (c)(1)
of this section, as naturally occurring, without having any fabrication
or alteration, may be labeled as a low calorie food, e.g., ''celery, a
low calorie food.'' They may not be labeled with the term ''low
calorie'' immediately preceding the name of the food because such
terminology would imply that the food has been altered to lower its
calories with respect to other foods of the same type.
(d) ''Reduced calorie'' foods, and other comparative claims. (1) A
food may be labeled as ''reduced calorie,'' or with other terms
representing or suggesting special dietary usefulness on the basis of a
fabrication or alteration that makes the food lower in calories than a
food it can substitute for in the diet only if:
(i) A comparison of the calorie content of a specified serving of the
food with the calorie content of an equivalent serving of the same food
without the fabrication or alteration of special dietary significance
reveals a calorie reduction of at least one-third;
(ii) The food bears on its label a statement that clearly and
concisely describes the comparison upon which the claim of special
dietary usefulness is made. The statement shall either identify a
specific food having at least one and a half times as many calories per
serving for which the food can substitute, or indicate that the claim of
special dietary usefulness is based on a comparison with the same food
without the fabrication or alteration of special dietary significance.
The statement shall also include a comparison between the calorie
content of a specified serving of the food and an equivalent serving of
the food it substitutes for, or the same food without the fabrication or
alteration of special dietary significance, and
(iii) The food is not nutritionally inferior, under the criteria set
forth in 101.3(e) of this chapter, to the food for which it substitutes
or the same food without the fabrication or alteration of special
dietary significance.
(2)(i) Any food subject to this paragraph (d) that is similar in all
its organoleptic properties to the food it is represented as
substituting for, or to the food without the fabrication or alteration
of special dietary significance, shall be labeled as ''reduced
calorie,'' ''reduced in calories,'' or ''a reduced calorie food.''
(ii) Any food subject to this paragraph (d) that does not resemble in
all its organoleptic properties the specific food for which it
substitutes, e.g., canned pears packed in unsweetened water, in
comparison with pears in heavy syrup, may be labeled with appropriate
terms to indicate its dietary usefulness, but in immediate proximity
such labeling shall indicate material differences in organoleptic
properties between it and the food to which it is compared. The food
shall not bear terms in juxtaposition with its name or in the labeling
that represent or suggest that the food is essentially the same as the
other food in all its organoleptic properties except for a reduction in
calories.
(3) It may not be technologically feasible to manufacture a ''reduced
calorie'' food under the criteria set forth in this paragraph for all
foods that are significant dietary sources of calories and for which it
would be useful to those on calorie-restricted diets to have a reduced
calorie substitute. Accordingly, the Commissioner may establish by
regulation acceptable alternative criteria for a ''reduced calorie''
food, in a regulation issued pursuant to section 401 of the act
establishing a standard of identity for the food, in a regulation in
part 102 of this chapter establishing a common or usual name for the
food, in an amendment to this section, or in a regulation issued
pursuant to sections 201(n) and 403(a) of the act. A petition
requesting such a regulation shall be submitted to the Dockets
Management Branch in the form established by Part 10 of this chapter.
Under no circumstances will a food be permitted to be labeled as
''reduced calorie'' unless (i) the petition demonstrates that it is not
feasible to attain a greater caloric reduction than that for which
approval is sought and (ii) the petition demonstrates that the use of
the food, with the caloric reduction attained, will result in a
significant reduction in calories in the diet and be useful to those on
weight control programs.
(e) Label terms suggesting usefulness as low calorie or reduced
calorie foods. (1) Except as provided in paragraphs (e) (2) and (3) of
this section, a food may be labeled with terms such as ''diet,''
''dietetic,'' ''artificially sweetened,'' ''sweetened with nonnutritive
sweetener,'' or other such terms representing or suggesting that the
food is low calorie or reduced calorie or that the food may make a
comparative claim of special dietary usefulness, only if: The food is
labeled ''low calorie'' or ''reduced calorie'' or bears a comparative
claim of special dietary usefulness in compliance with paragraph (c) or
(d) of this section.
(2) Paragraph (e)(1) of this section shall not apply to any use of
such terms that is specifically authorized by a regulation governing a
particular food, or, unless otherwise restricted by regulation, to any
use of the term ''diet,'' which clearly shows that the food is offered
solely for dietary use(s) other than regulating caloric intake or body
weight, e.g., ''for low-sodium diets.''
(3) Paragraph (e)(1) of this section shall not apply to any use of
such terms on a formulated meal replacement, low calorie meal, or other
food that is represented to be of special dietary use as a whole meal,
pending the issuance of a regulation governing the use of such terms on
such foods.
(f) Use of terms such as ''sugar free,'' ''sugarless,'' ''no sugar,''
etc. (1) Consumers may reasonably be expected to regard terms that
represent that the food contains no sugars or sweeteners, e.g., ''sugar
free,'' ''sugarless,'' ''no sugar,'' as indicating a product which is
low in calories or significantly reduced in calories. Consequently,
except as provided in paragraph (f)(2) of this section, a food may not
be labeled with such terms unless:
(i) It is labeled ''low calorie'' or ''reduced calorie'' or bears a
comparative claim of special dietary usefulness labeled in compliance
with paragraph (c) or (d) of this section, or
(ii) Such term is immediately accompanied, each time it is used, by
the statement ''Not a reduced calorie food,'' ''Not a low calorie
food,''''Not for weight control,'' ''Useful Only In Not Promoting Tooth
Decay,'' or other term indicating that the sole special usefulness of
the food is for a specified purpose other than weight control.
(2) Paragraph (f)(1) of this section shall not apply to a factual
statement that a food is unsweetened or contains no added sweeteners in
the case of a food that contains apparent substantial inherent sugar
content, e.g., juices.
(43 FR 43259, Sept. 22, 1978; 43 FR 52700, Nov. 14, 1978)
21 CFR 105.67 Label statement relating to food for use in the diet of
diabetics.
(a) A food that purports to be represented for special dietary use
because of usefulness in the diet of diabetics shall bear nutrition
labeling in compliance with 101.9 of this chapter, unless exempt under
that section, and the statement ''Diabetics: This product may be useful
in your diet on the advice of a physician. This food is not a reduced
calorie food.'' If the food is useful in maintaining or reducing calorie
intake or body weight and labeled in conformity with 105.66, the last
sentence may be eliminated.
(b) A food shall not be represented to be useful in the diets of
diabetics if such representation is false or misleading.
(c) The term ''diabetic,'' ''for diabetics,'' ''diabetes,'' or the
like, shall not be included as part of the name of any food, or
otherwise be included on the labeling more prominently than the
statement required by paragraph (a) of this section.
(d) The term ''dietetic,'' ''diet,'' or the like, shall not be
included in the labeling of a food solely because of its possible
usefulness in the diet of diabetics.
(e) A food shall not purport to be or be represented for special
dietary use because of usefulness in the diet of diabetics solely by
virtue of its being a food useful in reducing or maintaining caloric
intake or body weight.
(43 FR 43259, Sept. 22, 1978)
21 CFR 105.69 Foods used to regulate sodium intake.
If a food purports to be or is represented for special dietary use by
man by reason of its use as a means of regulating the intake of sodium
or salt (sodium chloride), the label shall bear either nutrition
labeling or a statement of the number of milligrams of sodium in a
specified serving (portion) of such food, in conformance with the
applicable provisions of 101.9 of this chapter.
(49 FR 15534, Apr. 18, 1984)
21 CFR 105.69 Subpart C (Reserved)
21 CFR 105.69 Subpart D -- Standards of Identity (Reserved)
21 CFR 105.69 PART 106 -- INFANT FORMULA QUALITY CONTROL PROCEDURES
21 CFR 105.69 Pt. 106
21 CFR 105.69 Subpart A -- General Provisions
Sec.
106.1 Status and applicability of the quality control procedures
regulation.
106.3 Definitions.
21 CFR 105.69 Subpart B -- Quality Control Procedures for Assuring
Nutrient Content of Infant Formulas
106.20 Ingredient control.
106.25 In-process control.
106.30 Finished product evaluation.
106.90 Coding.
21 CFR 105.69 Subpart C -- Records and Reports
106.100 Records.
21 CFR 105.69 Subpart D -- Notification Requirements
106.120 New formulations and reformulations.
Authority: Secs. 201, 412, 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321, 350a, 371).
Source: 47 FR 17025, Apr. 20, 1982, unless otherwise noted.
21 CFR 105.69 Subpart A -- General Provisions
21 CFR 106.1 Status and applicability of the quality control procedures
regulation.
(a) The criteria set forth in 106.20, 106.25, 106.30, 106.90, and
106.100 shall apply in determining whether an infant formula meets the
safety, quality, and nutrient requirements of section 412 of the act and
the requirements of regulations promulgated under section 412(a)(2) of
the act.
(b) The failure to comply with any regulation set forth in 106.20,
106.25, 106.30, 106.90, and 106.100 applicable to the manufacturing,
processing, and packaging of an infant formula shall render such formula
adulterated under section 412(a)(1)(C) of the act.
(c) References in this part to regulatory sections of the Code of
Federal Regulations are to Chapter I of Title 21 unless otherwise noted.
21 CFR 106.3 Definitions.
The definitions and interpretations contained in section 201 of the
act are applicable to such terms when used in this part. The following
definitions shall also apply:
(a) Indicator nutrient. An indicator nutrient is a nutrient whose
concentration is measured during the manufacture of an infant formula to
confirm complete addition and/or uniform distribution of a premix or
other substance of which the indicator nutrient is a part.
(b) In-process batch. An in-process batch is a combination of
ingredients at any point in the manufacturing process before packaging.
(c) Manufacturer. A manufacturer is a person who prepares,
reconstitutes, or otherwise changes the physical or chemical
characteristics of an infant formula and/or packages the product in a
container for distribution.
(d) Nutrient. A nutrient is any vitamin, mineral, or other substance
required in accordance with the table set out in section 412(g) of the
act or by regulations promulgated under section 412(a)(2)(A) of the act.
(e) Nutrient premix. A nutrient premix is a combination of
ingredients containing two or more nutrients. A nutrient premix either
may be received from a supplier or be prepared by an infant formula
manufacturer.
21 CFR 106.3 Subpart B -- Quality Control Procedures for Assuring Nutrient Content of Infant Formulas
21 CFR 106.20 Ingredient control.
(a) Except as provided in 106.20(b), no analysis before use in
manufacturing is needed for ingredients that are generally stable in
shipping and storage, and that either are received under a supplier's
guarantee or certification that the mixture has been analyzed as to
nutrient composition or are labeled as having nutrient compositions
complying with specifications in the U.S. Pharmacopeia, the National
Formulary, the Food Chemicals Codex, or other similar recognized
standards.
(b) Unless each batch of finished product is analyzed as specified in
106.30(b)(1) before release of product for commercial or charitable
distribution, the following shall apply:
(1) When an ingredient is relied upon as a source of a nutrient(s)
and when evidence indicates that such nutrient(s) in that ingredient is
likely to be affected adversely by shipping or storage conditions, the
manufacturer shall analyze that ingredient for each relied-upon nutrient
that may be affected, using validated analytical methods.
(2) Ingredients, including nutrient premixes, that are either without
a supplier's guarantee or certification, or not labeled as complying
with prescribed standards, shall be sampled and analyzed for each
relied-upon nutrient by the manufacturer, except that ingredients used
as a major source of protein or fat need not be analyzed for each
relied-upon nutrient if the manufacturer has records to show that each
relied-upon nutrient is present at a reasonably constant level.
Nutrient premixes prepared by the infant formula manufacturer shall be
sampled and analyzed for each relied-upon nutrient. Nutrient premixes
which are received from suppliers shall be sampled and analyzed for each
relied-upon nutrient unless the supplier has sampled and analyzed each
batch of premix for each relied-upon nutrient and has so certified in
writing.
21 CFR 106.25 In-process control.
(a) For each infant formula, a master manufacturing order shall be
prepared and approved by a responsible official of the manufacturer.
The manufacturer shall establish a quality control system that assures
and verifies the addition of each ingredient specified in the
manufacturing order.
(b) Unless each batch of finished product is analyzed as specified in
106.30(b)(1), the manufacturer shall analyze each in-process batch for:
(1) Solids;
(2) Protein, fat, and carbohydrates (carbohydrates either by analysis
or by mathematical difference);
(3) The indicator nutrient(s) in each nutrient premix;
(4) Each nutrient added independently of nutrient premixes during
formulation of the product, except for linoleic acid, vitamin D, vitamin
K, choline, inositol, and biotin; and
(5) Solids or an appropriate nutrient to confirm proper dilution when
final dilution is made after performance of the analyses in paragraph
(b) (1) through (4) of this section.
21 CFR 106.30 Finished product evaluation.
(a) The manufacturer shall establish criteria for sampling and
testing to ensure that each batch of infant formula meets the nutrient
requirements of section 412(g) of the act or of regulations promulgated
under section 412(a)(2) of the act before release of product for
commercial or charitable distribution.
(b)(1) Immediate analysis. Before release of product for commercial
or charitable distribution, the manufacturer shall analyze
representative samples of each batch of finished product for:
(i) Specific nutrient(s) to assess process degradation; and
(ii) All nutrients not previously analyzed for by the manufacturers,
unless each in-process batch is analyzed for nutrients as specified in
106.25(b) and the ingredients are analyzed as specified in 106.20(b).
No analyses are needed for linoleic acid, vitamin D, vitamin K, choline,
inositol, and biotin; and for nutrients that are added as a part of a
nutrient premix analyzed by the manufacturer or having a supplier's
guarantee or certification and for which an indicator nutrient(s) was
analyzed by the manufacturer.
(2) Periodic analysis. The manufacturer shall sample at least one
newly processed finished product batch every 3 months and shall analyze
representative samples for all nutrients except those that the
manufacturers measured in the immediate analysis of that product batch.
(3) Stability analysis. Using representative samples collected from
finished product batches, the manufacturer shall conduct stability
analysis for selected nutrients with sufficient frequency to
substantiate the maintenance of nutrient content throughout the shelf
life of the product.
(c) The manufacturer shall evaluate new formulations and the effect
of changes in ingredients or processing conditions that could affect the
level of nutrients by means of a testing program designed to confirm
uniformity of batches and to determine the effects of such changes. The
following shall apply:
(1) A minor change is a minor reduction in nutrient levels, a minor
increase in levels of nutrients that are subject to maximum limits
established under section 412(g) of the act or in regulations
established under section 412(a)(2) of the act, or any other change
where experience or theory would not predict a possible significant
adverse impact on nutrient levels or nutrient availability. After a
minor change the manufacturer shall analyze representative samples for
all nutrients so changed and those possibly affected by the change.
(2) A major change is any new formulation, or any change of
ingredients or processes where experience or theory would predict a
possible significant adverse impact on levels of nutrients or
availability of nutrients. After a major change the manufacturer shall
analyze representative samples for osmolality, all nutrients, and the
biological quality of the protein. A protein biological quality
analysis is not necessary for a formulation change that is not expected
to have an adverse effect on the biological quality of the protein.
Vitamin D shall be determined by the rat bioassay method as prescribed
in ''Official Methods of Analysis of the Association of Official
Analytical Chemists'' (AOAC), 13th Ed. (1980), sections 43.195-43.208,
''Vitamin D (30) -- Official Final Action,'' which is incorporated by
reference. Copies are available from the Association of Official
Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA
22201-3301, or available for inspection at the Office of the Federal
Register, 1100 L St. NW., Washington, DC 20408. Before release of the
product for commercial or charitable distribution, the manufacturer
shall have completed all appropriate analyses except that shipment of
the product need not be delayed until results of the vitamin D bioassay
and, if required, a protein biological quality bioassay are complete,
provided such bioassays have been initiated, and if another analysis for
the vitamin D has been run and the protein content has been determined
by a suitable method. The biological quality of the protein shall be
determined by an appropriate modification of the AOAC bioassay method of
analysis. The manufacturer shall analyze additional samples from the
same batch for vitamin D, by any suitable method, and for the biological
quality of the protein. The manufacturer shall perform such analyses at
least annually for a period not to exceed the expected shelf life of the
product.
(d) A simple adjustment in the level of an ingredient to accommodate
inconsistencies in processing is considered to be neither a minor nor a
major change.
(47 FR 17025, Apr. 20, 1982, as amended at 54 FR 24891, June 12,
1989)
21 CFR 106.90 Coding.
The manufacturer shall code all infant formulas in conformity with
the coding requirements that are applicable to thermally processed
low-acid foods packaged in hermetically sealed containers as prescribed
in 113.60(c).
21 CFR 106.90 Subart C -- Records and Reports
21 CFR 106.100 Records.
(a) Every manufacturer of infant formula shall maintain the records
specified in this regulation in order to permit the Food and Drug
Administration to determine whether each manufacturer is in compliance
with section 412 of the Federal Food, Drug, and Cosmetic Act (the act).
(b) The manufacturer shall maintain all records that pertain to
food-packaging materials subject to 174.5 of this chapter and that bear
on whether such materials would cause an infant formula to be
adulterated within the meaning of section 402(a)(2)(C) of the act.
(c) The manufacturer shall maintain all records that pertain to
nutrient premix testing that it generates or receives. Such records
shall include, but are not limited to:
(1) Any results of testing conducted to ensure that each nutrient
premix is in compliance with the premix certificate and guarantee and
specifications that have been provided to the manufacturer by the premix
supplier, including tests conducted when nutrients exceed their
expiration date or shelf life (retest date).
(2) All certificates and guarantees given by premix suppliers
concerning the nutrients required by section 412(i) of the act and
107.100 of this chapter.
(d) The premix supplier shall maintain the results of all testing
conducted to provide all certificates and guarantees concerning nutrient
premixes for infant formulas. Such records shall include but are not
limited to:
(1) The results of tests conducted to determine the purity of each
nutrient required by section 412(i) of the act or 107.100 of this
chapter and any other nutrient listed in the certificate and guarantee;
(2) The weight of each nutrient added;
(3) The results of any quantitative tests conducted to determine the
amount of each nutrient certified or guaranteed; and
(4) The results of any quantitative tests conducted to identify the
nutrient levels present when nutrient premixes exceed their expiration
date or shelf life (retest date).
(e) The manufacturer shall maintain all records necessary to ensure
proper nutrient quality control in the manufacture of infant formula
products. Such records shall include the results of any testing
conducted to verify that each nutrient required by section 412(i) of the
act or 107.100 of this chapter is present in each batch of infant
formula at the appropriate concentration. This requirement pertains to
ingredients, in process batch and finished product from the time of
manufacture through its expiration date.
(f) The manufacturer shall maintain all records necessary to ensure
required nutrient content at the final product stage. Such records
shall include, but are not limited to, testing results for vitamins A,
B1 (thiamine), C, and E for each batch of infant formula. ''Final
product stage'' means the point in the manufacturing process prior to
distribution at which the infant formula is homogenous and not subject
to further degradation from the manufacturing process.
(g) The manufacturer shall maintain all records pertaining to
distribution of the infant formula. Such records shall include, but not
be limited to, all information and data necessary to effect and monitor
recalls of the manufacturer's infant formula products in accordance with
subpart E of part 107 of this chapter.
(h) The manufacturer shall maintain all records pertaining to the
microbiological quality and purity of raw materials and finished
powdered infant formula.
(i) (Reserved)
(j) The manufacturer shall maintain all records pertaining to
regularly scheduled audits, including audit plans and procedures. Audit
plans identify the specific manufacturing and quality control procedures
to be reviewed. Audit procedures are the methods used to review the
manufacturing and quality control procedures. Records of audits shall
include the information and data necessary for a determination as to
whether the manufacturer complies with the current good manufacturing
practices and quality procedures identified in parts 106, 107, 109, 110,
and 113 of this chapter. The records shall include written assurances
from the manufacturer that regularly scheduled audits are being
conducted by appropriately trained individuals who do not have any
direct responsibility for the manufacture or production of infant
formula, and that the complete audit plans and procedures for the firm
have been followed. The actual written reports of the audits need not
be made available.
(k) The manufacturer shall maintain procedures describing how all
written and oral complaints regarding infant formula will be handled.
The manufacturer shall follow these procedures and shall include in them
provisions for the review of any complaint involving an infant formula
and for determining the need for an investigation of the possible
existence of a hazard to health.
(1) For purposes of this section, every manufacturer shall interpret
a ''complaint'' as any communication that contains any allegation,
written or oral, expressing dissatisfaction with a product for any
reason, including concerns about the possible existence of a hazard to
health and about appearance, taste, odor, and quality. Correspondence
about prices, package size or shape, or other matters that could not
possibly reveal the existence of a hazard to health shall not, for
compliance purposes, be considered a complaint and therefore need not be
made available to an FDA investigator.
(2) When a complaint shows that a hazard to health possibly exists,
the manufacturer shall conduct an investigation into the validity of the
complaint. Where such an investigation is conducted, the manufacturer
shall include in its file on the complaint the determination as to
whether a hazard to health exists and the basis for that determination.
No investigation is necessary when the manufacturer determines that
there is no possibility of a hazard to health. When no investigation is
necessary, the manufacturer shall include in the record the reason that
an investigation was found to be unnecessary and the name of the
responsible person making that determination.
(3) When there is a reasonable possibility of a causal relationship
between the consumption of an infant formula and an infant's death, the
manufacturer shall, within 15 days of receiving such information,
conduct an investigation and notify the agency as required in
106.120(b).
(4) The manufacturer shall maintain in designated files all records
pertaining to the complaints it receives. The manufacturer shall
separate the files into two classes:
(i) Those complaints that allege that the infant became ill from
consuming the product or required treatment by a physician or
health-care provider.
(ii) Those complaints that may involve a possible existence of a
hazard to health but do not refer to an infant becoming ill or the need
for treatment by physician or a health care provider.
(5) The manufacturer shall include in a complaint file the following
information concerning the complaint:
(i) The name of the infant formula;
(ii) The batch number;
(iii) The name of complainant;
(iv) A copy of the complaint or a memo of the telephone conversation
or meeting and all correspondence with the complainant;
(v) By reference or copy, all the associated manufacturing records
and complaint investigation records needed to evaluate the complaint.
When copies of such records are not maintained in the complaint file,
they must be available within 24 hours when requested by an FDA
official.
(vi) All actions taken to follow up on the complaint; and
(vii) All findings and evaluations of the complaint.
(6) The manufacturer should maintain the files regarding infant
formula complaints at the establishment where the infant formula was
manufactured, processed, or packed. When the manufacturer wishes to
maintain all consumer complaints for the entire firm at one location
other than at the facility where an infant formula was manufactured,
processed, or packed, the manufacturer may do so as long as all records
required by this section are available within 24 hours of request for
inspection at that facility. However, all records of consumer
complaints, including summaries, any reports, and any files, maintained
at the manufacturing facility or at any other facility shall be made
available to investigators for review and copying upon request.
(l) The manufacturer shall make readily available for authorized
inspection all records required under this part or copies of such
records. Records shall be available at any reasonable time at the
establishment where the activities described in such records occurred.
(Infant formula complaint files may be maintained at one facility, as
provided in 106.100(k)(6), if all required records are readily
available at that facility.) These records or copies thereof shall be
subject to photocopying or other means of reproduction as part of such
inspection. Records that can be immediately retrieved from another
location by electronic means shall be considered as meeting the
requirements of this paragraph.
(m) Records required under this part may be retained either as
original records or as true copies such as photocopies, microfilm,
microfiche, or other accurate reproductions of the original records.
Where reduction techniques, such as microfilming are used, suitable
reader and photocopying equipment shall be readily available.
(n) Production control, product testing, testing results, complaints,
and distribution records necessary to verify compliance with parts 106,
107, 109, 110, and 113 of this chapter, or with other appropriate
regulations, shall be retained for 1 year after the expiration of the
shelf life of the infant formula or 3 years from the date of
manufacture, whichever is greater.
(o) The manufacturer shall maintain quality control records that
contain sufficient information to permit a public health evaluation of
any batch of infant formula.
(56 FR 66571, Dec. 24, 1991; 57 FR 7435, Mar. 2, 1992)
Effective Date Note: At 56 FR 66571, Dec. 24, 1991 106.100 was
revised, effective April 22, 1992. For the convenience of the reader,
the superseded text is set forth as follows:
106.100 Records.
(a) The manufacturer shall maintain quality control records that
contain sufficient information to permit a public health evaluation of
any batch of infant formula.
(b) Copies of records required by paragraph (a) of this section shall
be retained at the processing plant for a period of time that exceeds
the shelf life of the infant formula by 1 year. These records shall be
made available to Food and Drug Administration investigators for review
and copying upon request.
(c) The recordkeeping and reporting requirements contained in Subpart
C of this Part will affect fewer than 10 firms. Therefore, they are not
subject to clearance by the Office of Management and Budget under the
Paperwork Reduction Act of 1980 (Pub. L. 96-511).
21 CFR 106.100 Subpart D -- Notification Requirements
21 CFR 106.120 New formulations and reformulations.
(a) Information required by section 412(b)(2) and (3) of the act
shall be submitted to Chief, Regulatory Affairs Staff (HFF-204), Center
for Food Safety and Applied Nutrition, Food and Drug Administration, 200
C St. SW., Washington, DC 20204.
(b) The manufacturer shall promptly notify the Food and Drug
Administration when the manufacturer has knowledge (as defined in
section 412(c)(2) of the act) that reasonably supports the conclusion
that an infant formula that has been processed by the manufacturer and
that has left an establishment subject to the control of the
manufacturer may not provide the nutrients required by section 412(g) of
the act and by regulations promulgated under section 412(a)(2) of the
act, or when there is an infant formula that is otherwise adulterated or
misbranded and that may present risk to human health. This notification
shall be made, by telephone, to the Director of the appropriate Food and
Drug Administration district office specified in 5.115. After normal
business hours (8 a.m. to 4:30 p.m.) the FDA emergency number,
202-737-0448, shall be used. The manufacturer shall send a followup
written confirmation to the Division of Regulatory Guidance (HFF-310),
Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 200 C St. SW., Washington, DC 20204, and to the
appropriate Food and Drug Administration district office specified in
5.115.
(47 FR 17025, Apr. 20, 1982, as amended at 54 FR 24891, June 12,
1989)
21 CFR 106.120 Pt. 107
21 CFR 106.120 PART 107 -- INFANT FORMULA
21 CFR 106.120 Subpart A -- General Provisions
Sec.
107.3 Definitions.
21 CFR 106.120 Subpart B -- Labeling
107.10 Nutrient information.
107.20 Directions for use.
107.30 Exemptions.
21 CFR 106.120 Subpart C -- Exempt Infant Formulas
107.50 Terms and conditions.
21 CFR 106.120 Subpart D -- Nutrient Requirements
107.100 Nutrient specifications.
21 CFR 106.120 Subpart E -- Infant Formula Recalls
107.200 Food and Drug Administration-required recall.
107.210 Firm-initiated product removals.
107.220 Scope and effect of infant formula recalls.
107.230 Elements of an infant formula recall.
107.240 Notification requirements.
107.250 Termination of an infant formula recall.
107.260 Revision of an infant formula recall.
107.270 Compliance with this subpart.
107.280 Records retention.
Authority: Secs. 201, 403, 412, 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321, 343, 350a, 371).
Source: 50 FR 1840, Jan. 14, 1985, unless otherwise noted.
21 CFR 106.120 Subpart A -- General Provisions
21 CFR 107.3 Definitions.
The following definitions shall apply, in addition to the definitions
contained in section 201 of the Federal Food, Drug, and Cosmetic Act
(the act):
Exempt formula. An exempt infant formula is an infant formula
intended for commercial or charitable distribution that is represented
and labeled for use by infants who have inborn errors of metabolism or
low birth weight, or who otherwise have unusual medical or dietary
problems.
Manufacturer. A manufacturer is a person who prepares, reconstitutes,
or otherwise changes the physical or chemical characteristics of an
infant formula or packages the infant formula in containers for
distribution.
References. References in this part to regulatory sections of the
Code of Federal Regulations are to Chapter I of Title 21, unless
otherwise noted.
(50 FR 48186, Nov. 22, 1985)
21 CFR 107.3 Subpart B -- Labeling
21 CFR 107.10 Nutrient information.
(a) The labeling of infant formulas, as defined in section 201(aa) of
the Federal Food, Drug, and Cosmetic Act, shall bear in the order given,
in the units specified, and in tabular format, the following information
regarding the product as prepared in accordance with label directions
for infant consumption:
(1) A statement of the number of fluid ounces supplying 100
kilocalories (in case of food label statements, a kilocalorie is
represented by the word ''Calorie''); and
(2) A statement of the amount of each of the following nutrients
supplied by 100 kilocalories:
(b) In addition the following apply:
(1) Vitamin A content may also be declared on the label in units of
microgram retinol equivalents, vitamin D content in units of micrograms
cholecalciferol, vitamin E content in units of milligram
alpha-tocopherol equivalents, and sodium, potassium, and chloride
content in units of millimoles, micromoles, or milliequivalents. When
these declarations are made they shall appear in parentheses immediately
following the declarations in International Units for vitamins A, D, and
E, and immediately following the declarations in milligrams for sodium,
potassium, and chloride.
(2) Biotin, choline, and inositol content shall be declared except
when they are not added to milk-based infant formulas.
(3) Each of the listed nutrients, and the caloric density, may also
be declared on the label on other bases, such as per 100 milliliters or
per liter, as prepared for infant consumption.
(4) One of the following statements shall appear on the principal
display panel, as appropriate:
(i) The statement ''Infant Formula With Iron'', or a similar
statement, if the product contains 1 milligram or more of iron in a
quantity of product that supplies 100 kilocalories when prepared in
accordance with label directions for infant consumption.
(ii) The statement ''Additional Iron May Be Necessary'', or a similar
statement, if the product contains less than 1 milligram of iron in a
quantity of product that supplies 100 kilocalories when prepared in
accordance with label directions for infant consumption.
(5) Any additional vitamin may be declared at the bottom of the
vitamin list and any additional minerals may be declared between iodine
and sodium, provided that any additionally declared nutrient (i) has
been identified as essential by the National Academy of Sciences through
its development of a recommended dietary allowance or an estimated safe
and adequate daily dietary intake range, or has been identified as
essential by the Food and Drug Administration through a Federal Register
publication or establishment of a U.S. Recommended Daily Allowance, and
(ii) is provided at a level considered in these publications as having
biological significance, when these levels are known.
(Information Collection requirements were approved by the Office of
Management and Budget under control number 0910-0159)
21 CFR 107.20 Directions for use.
In addition to the applicable labeling requirements in Parts 101 and
105 of this chapter, the product label shall bear:
(a) Under the heading ''Directions For Preparation and Use'',
directions for:
(1) Storage of infant formula before and after the container has been
opened, including a statement indicating that prolonged storage at
excessive temperatures should be avoided;
(2) Agitating liquid infant formula before opening the container,
such as ''Shake Well Before Opening'';
(3) ''Sterilization'' of water, bottle, and nipples when necessary
for preparing infant formula for use;
(4) Dilution of infant formula, when appropriate. Directions for
powdered infant formula shall contain the weight and volume of powdered
formula to be reconstituted.
(b) In close proximity to the ''Directions for Preparation and Use''
a pictogram depicting the major steps for preparation of that infant
formula, such as (for a concentrated formula):
(c) A ''Use by ------------ '' date, the blank to be filled in with
the month and year selected by the manufacturer, packer, or distributor
of the infant formula on the basis of tests or other information showing
that the infant formula, until that date, under the conditions of
handling, storage, preparation, and use prescribed by label directions,
will: (1) when consumed, contain not less than the quantity of each
nutrient, as set forth on its label; and (2) otherwise be of an
acceptable quality (e.g., pass through an ordinary bottle nipple).
(d) The statement ''Add Water'' or ''Do Not Add Water'', as
appropriate, to appear on the principal display panel of concentrated or
ready-to-feed infant formulas. In close proximity to the statement
''Add Water'', a symbol such as
if the addition of water is necessary. The symbol shall be placed on
a white background encircled by a dark border.
(e) A warning statement beneath or in close proximity to the
''Directions For Preparation and Use'' that cautions against improper
preparation or use of an infant formula, such as ''THE HEALTH OF YOUR
INFANT DEPENDS ON CAREFULLY FOLLOWING THE DIRECTIONS FOR PREPARATION AND
USE''.
(f) A statement indicating that parents should consult their
physicians about the use of infant formulas, such as ''USE AS DIRECTED
BY A PHYSICIAN''.
(Collection of information requirements were approved by the Office
of Management and Budget (OMB) and assigned OMB control number
0910-0159)
21 CFR 107.30 Exemptions.
When containers of ready-to-feed infant formula, to be sold at the
retail level, are contained within a multiunit package, the labels of
the individual containers shall contain all of the label information
required by section 403 of the Federal Food, Drug, and Cosmetic Act (the
act), 107.10 and 107.20, and all appropriate sections of Part 101 of
this chapter, except that the labels of the individual containers
contained within the outer package shall be exempt from compliance with
the requirements of section 403 (e)(1) and (i)(2) of the act; and
107.10 (a) and (b)(2) and 107.20 (b), (e), and (f), provided that (a)
the multiunit package meets all the requirements of this part; (b)
individual containers are securely enclosed within and are not intended
to be separated from the retail package under conditions of retail sale;
and (c) the label on each individual container includes the statement
''This Unit Not Intended For Individual Sale'' in type size not less
than one-sixteenth inch in height. The word ''Retail'' may be used in
lieu of or immediately following the word ''Individual'' in the
statement.
21 CFR 107.30 Subpart C -- Exempt Infant Formulas
21 CFR 107.50 Terms and conditions.
(a) Terms and conditions. Section 412(f)(1) of the act exempts from
the requirements of section 412(a), (b), and (c)(1)(A) of the act infant
formulas that are represented and labeled for use by an infant who has
an inborn error of metabolism or low brith weight or who otherwise has
an unusual medical or dietary problem, if such formulas comply with
regulations prescribed by the Secretary. The regulations in this
subpart establish the terms and conditions that a manufacturer must meet
with respect to such infant formulas.
(b) Infant formulas generally available at the retail level. (1)
These exempt infant formulas can generally be purchased from retail
store shelves that are readily available to the public. Such formulas
are also typically represented and labeled for use to provide dietary
management for diseases or conditions that are not clinically serious or
life-threatening, even though such formulas may also be represented and
labeled for use in clinically serious or life-threatening disorders.
(2) Except as provided in paragraphs (b)(4) and (5) of this section,
an infant formula manufacturer shall, with respect to each formula
covered by this paragraph, comply with the nutrient requirements of
section 412(g) of the act or of regulations promulgated under section
412(a)(2) of the act, the quality control procedure requirements of Part
106, and the labeling requirements of Subpart B of this part.
(3) To retain the exempt status of an infant formula covered by this
paragraph, the manufacturer shall submit to the Food and Drug
Administration (FDA), at the address specified in paragraph (e)(1) of
this section, on or before May 21, 1986, or on or before the 90th day
before the first processing of the infant formula for commercial or
charitable distribution, whichever occurs later, the label and other
labeling of the infant formula, a complete quantitative formulation for
the infant formula, and a detailed description of the medical conditions
for which the infant formula is represented. FDA will review the
information under paragraph (d) of this section.
(4) To retain the exempt status of an infant formula covered by this
paragraph, when any change in ingredients or processes that may result
in an adverse impact on levels of nutrients or availability of nutrients
is instituted, the manufacturer shall submit to FDA at the address
specified in paragraph (e)(1) of this section, before the first
processing of the infant formula, the label and other labeling of the
infant formula, a complete quantitative formulation for the infant
formula, a detailed description of the reformulation and the rationale
for the reformulation, a complete description of the change in
processing, and a detailed description of the medical conditions for
which the infant formula is represented. FDA will review that
information under paragraph (d) of this section.
(5) A manufacturer may deviate from the requirements of paragraph
(b)(2) of this section only with respect to those specific requirements
for which it submits to FDA, at the address specified in paragraph
(e)(1) of this section, the medical, nutritional, scientific, or
technological rationale (including any appropriate animal or human
clinical studies). FDA will review that information under paragraph (d)
of this section.
(c) Infant formulas not generally available at the retail level. (1)
These exempt infant formulas are not generally found on retail shelves
for general consumer purchase. Such formulas typically are prescribed
by a physician, and must be requested from a pharmacist or are
distributed directly to institutions such as hospitals, clinics, and
State or Federal agencies. Such formulas are also generally represented
and labeled solely to provide dietary management for specific diseases
or conditions that are clinically serious or life-threatening and
generally are required for prolonged periods of time. Exempt infant
formulas distributed directly to institutions such as hospitals,
clinics, and State or Federal agencies that are of the same formulation
as those generally available at the retail level are subject to the
requirements of paragraph (b) of this section rather than to the
requirements of this paragraph.
(2) Except as provided for in paragraph (c)(5) of this section, an
infant formula manufacturer shall, with respect to each formula covered
by this paragraph, comply with the nutrient requirements of section
412(g) of the act or of regulations promulgated under section 412(a)(2)
of the act, and the labeling requirements of Subpart B of this part.
(3) Each manufacturer of an infant formula covered by this paragraph
shall establish quality control procedures designed to ensure that the
infant formula meets applicable nutrient requirements of this section,
including any special nutritional characteristics for the specific
disorders or conditions for which the formula is represented for use.
Each manufacturer shall maintain records of such quality control
procedures sufficient to permit a public health evaluation of each
manufactured batch of infant formula and shall permit any authorized FDA
employee at all reasonable times to have access to and to copy and
verify the records referred to in this paragraph.
(4) To retain the exempt status of an infant formula covered by this
paragraph, the manufacturer shall submit the information required by
paragraphs (b)(3) and (4) of this section.
(5) A manufacturer may deviate from the requirements of paragraph
(c)(2) of this section only with respect to those specific requirements
for which it submits to FDA, at the address specified in paragraph
(e)(1) of this section, the medical, nutritional, scientific, or
technological rationale (including any appropriate animal or human
clinical studies). FDA will review that information under paragaraph
(d) of this section.
(6) The requirements of this section do not apply to an infant
formula specially and individually prepared for one or more specific
infants on a physician's request.
(d) FDA review of exempt status. (1) FDA's Center for Food Safety
and Applied Nutrition will review information submitted by infant
formula manufacturers under paragraph (b) (3), (b) (4), or (c) (4) of
this section. On the basis of such review and other information
available to the agency, the Center for Food Safety and Applied
Nutrition may impose additional conditions on, or modify requirements
for, the quality control procedures, nutrient specifications, or
labeling of an infant formula, or withdraw a product's exempt status.
Such determinations will be made by the Director of the Center for Food
Safety and Applied Nutrition.
(2)(i) If after completing its review of all information submitted,
the Center for Food Safety and Applied Nutrition concludes that
additional or modified quality control, nutrient, or labeling
requirements are needed, or that a product's exempt status is withdrawn,
the Center for Food Safety and Applied Nutrition will so notify the
manufacturer and this notification will specify the reasons therefor.
Upon receipt of this notification, the manufacturer has 10 working days
to have the decision reviewed under 10.75 by the office of the
Commissioner of Food and Drugs. A determination by the Director of the
Center for Food Safety and Applied Nutrition that is not appealed
becomes a final agency decision.
(ii) After a final decision by the Director or by the office of the
Commissioner that a product's exempt status is withdrawn, the
manufacturer shall comply with the nutrient requirements of section
412(g) of the act or of regulations promulgated under section 412(a)(2)
of the act, the quality control requirements of Part 106, and the
labeling requirements of Subpart B of this part.
(iii) The compliance date for the withdrawal of a product's exempt
status or the imposition of additional or modified quality control,
nutrient, or labeling requirements is 60 calendar days after issuance of
the final decision except as otherwise provided for reasons stated in
the decision. If the agency determines that a health hazard may exist
and so notifies the manufacturer, withdrawal of a product's exempt
status shall be effective on the date of receipt of notification from
the Director of the Center for Food Safety and Applied Nutrition.
Additional or modified requirements, or the withdrawal of an exemption,
apply only to those formulas that are manufactured after the compliance
date. A postponement of the compliance date may be granted for good
cause.
(3) FDA may decide that withdrawal of an exemption is necessary when,
on the basis of its review under paragraph (d)(1) of this section, it
concludes that quality control procedures are not adequate to ensure
that the formula contains all required nutrients, that deviations in
nutrient levels are not supported by generally accepted scientific,
nutritional, or medical rationale, or that deviations from Subpart B of
this part are not necessary to provide appropriate directions for
preparation and use of the infant formula, or that additional labeling
information is necessary.
(4) FDA will use the following criteria in determining whether
deviations from the requirements of this subpart are necessary and will
adequately protect the public health:
(i) A deviation from the nutrient requirements of section 412(g) of
the act or of regulations promulgated under section 412(a)(2) of the act
is necessary to provide an infant formula that is appropriate for the
dietary management of a specific disease, disorder, or medical
condition;
(ii) For exempt infant formulas subject to paragraph (b) of this
section, a deviation from the quality control procedures requirements of
Part 106 is necessary because of unusal or difficult technological
problems in manufacturing the infant formula; and
(iii) A deviation from the labeling requirements of Subpart B of this
part is necessary because label information, including pictograms and
symbols required by those regulations, could lead to inappropriate use
of the product.
(e) Notification requirements. (1) Information required by
paragraphs (b) and (c) of this section shall be submitted to Chief,
Regulatory Affairs Staff (HFF-204), Center for Food Safety and Applied
Nutrition, Food and Drug Administration, 200 C St. SW., Washington, DC
20204.
(2) The manufacturer shall promptly notify FDA when the manufacturer
has knowledge (as defined in section 412(c)(2) of the act) that
reasonably supports the conclusion that an exempt infant formula that
has been processed by the manufacturer and that has left an
establishment subject to the control of the manufacturer may not provide
the nutrients required by paragraph (b) or (c) of this section, or when
there is an exempt infant formula that may be otherwise adulterated or
misbranded and if so adulterated or misbranded presents a risk of human
health. This notification shall be made, by telephone, to the Director
of the appropriate FDA district office specified in 5.115. After normal
business hours (8 a.m. to 4:30 p.m.), the FDA emergency number,
202-737-0448, shall be used. The manufacturer shall send a followup
written confirmation to the Division of Regulatory Guidance (HFF-310),
Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 200 C St. SW., Washington, DC 20204, and to the
appropriate FDA district office specified in 5.115.
(Information Collection requirements were approved by the Office of
Management and Budget under control number 0910-0158)
(50 FR 48187, Nov. 22, 1985)
21 CFR 107.50 Subpart D -- Nutrient Requirements
21 CFR 107.100 Nutrient specifications.
(a) An infant formula shall contain the following nutrients at a
level not less than the minimum level specified and not more than the
maximum level specified for each 100 kilocalories of the infant formula
in the form prepared for consumption as directed on the container:
In addition to the specifications established in the table in this
paragraph for vitamins and minerals, the following also apply:
(b) Vitamin E shall be present at a level of at least 0.7
International Unit of vitamin E per gram of linoleic acid.
(c) Any vitamin K added shall be in the form of phylloquinone.
(d) Vitamin B6 shall be present at a level of at least 15 micrograms
of vitamin B6 for each gram of protein in excess of 1.8 grams of protein
per 100 kilocalories of infant formula in the form prepared for
consumption as directed on the container.
(e) The ratio of calcium to phosphorus in infant formula in the form
prepared for consumption as directed on the container shall be no less
than 1.1 and not more than 2.0.
(f) Protein shall be present in an amount not to exceed 4.5 grams per
100 kilocalories regardless of quality, and not less than 1.8 grams per
100 kilocalories of infant formula in the form prepared for consumption
as directed on the container when its biological quality is equivalent
to or better than that of casein. If the biological quality of the
protein is less than that of casein, the minimum amount of protein shall
be increased proportionately to compensate for its lower biological
quality. For example, an infant formula containing protein with a
biological quality of 75 percent of casein shall contain at least 2.4
grams of protein (1.8/0.75). No protein with a biological quality less
than 70 percent of casein shall be used.
(50 FR 45108, Oct. 30, 1985)
21 CFR 107.100 Subpart E -- Infant Formula Recalls
Source: 54 FR 4008, Jan. 27, 1989, unless otherwise noted.
21 CFR 107.200 Food and Drug Administration-required recall.
When the Food and Drug Administration determines that an adulterated
or misbranded infant formula presents a risk to human health, a
manufacturer shall immediately take all actions necessary to recall that
formula, extending to and including the retail level, consistent with
the requirements of this subpart.
21 CFR 107.210 Firm-initiated product removals.
(a) If a manufacturer has determined to recall voluntarily from the
market an infant formula that is not subject to 107.200 but that
otherwise violates the laws and regulations administered by the Food and
Drug Administration (FDA) and that would be subject to legal action, the
manufacturer, upon prompt notification to FDA, shall administer such
voluntary recall consistent with the requirements of this subpart.
(b) If a manufacturer has determined to withdraw voluntarily from the
market an infant formula that is adulterated or misbranded in only a
minor way and that would not be subject to legal action, such removal
from the market is deemed to be a market withdrawal, as defined in
7.3(j) of this chapter. As required by 107.240(a), the manufacturer
shall promptly notify FDA of such violative formula and may, but is not
required to, conduct such market withdrawal consistent with the
requirements of this subpart pertaining to product recalls.
21 CFR 107.220 Scope and effect of infant formula recalls.
(a) The requirements of this subpart apply:
(1) When the Food and Drug Administration has determined that it is
necessary to remove from the market a distributed infant formula that is
in violation of the laws and regulations administered by the Food and
Drug Administration and that poses a risk to human health; or
(2) When a manufacturer has determined that it is necessary to remove
from the market a distributed infant formula that:
(i) Is no longer subject to the manufacturer's control;
(ii) Is in violation of the laws and regulations administered by the
Food and Drug Administration and against which the agency could initiate
legal or regulatory action; and
(iii) Does not present a human risk.
(b) The Food and Drug Administration will monitor continually the
recall action and will take appropriate actions to ensure that the
violative infant formula is removed from the market.
21 CFR 107.230 Elements of an infant formula recall.
A recalling firm shall conduct an infant formula recall with the
following elements:
(a) The recalling firm shall evaluate in writing the hazard to human
health associated with the use of the infant formula. This health
hazard evaluation shall include consideration of any disease, injury, or
other adverse physiological effect that has been or that could be caused
by the infant formula and of the seriousness, likelihood, and
consequences of the diseases, injury, or other adverse physiological
effect. The Food and Drug Administration will conduct its own health
hazard evaluation and promptly notify the recalling firm of the results
of that evaluation if the criteria for recall under 107.200 have been
met.
(b) The recalling firm shall devise a written recall strategy suited
to the individual circumstances of the particular recall. The recall
strategy shall take into account the health hazard evaluation and
specify the following: The extent of the recall; if necessary, the
public warning to be given about any hazard presented by the infant
formula; the disposition of the recalled infant formula; and the
effectiveness checks that will be made to determine that the recall is
carried out.
(c) The recalling firm shall promptly notify each of its affected
direct accounts about the recall. The format of a recall communication
shall be distinctive, and the content and extent of a recall
communication shall be commensurate with the hazard of the infant
formula being recalled and the strategy developed for the recall. The
recall communication shall instruct consignees to report back quickly to
the recalling firm about whether they are in possession of the recalled
infant formula and shall include a means of doing so. The recalled
communication shall also advise consignees how to return the recall
infant formula to the manufacturer or otherwise dispose of it. The
recalling firm shall send a followup recall communication to any
consignee that does not respond to the initial recall communication.
(d) If the infant formula presents a risk to human health, the
recalling firm shall request that each establishment, at which such
infant formula is sold or available for sale, post at the point of
purchase of such formula a notice of such recall at such establishment.
The notice shall be provided by the recalling firm after approval of the
notice by the Food and Drug Administration. The recalling firm shall
also request that each retail establishment maintain such notice on
display until such time as the Food and Drug Administration notifies the
recalling firm that the agency considers the recall completed.
(e) The recalling firm shall furnish promptly to the appropriate Food
and Drug Administration district office listed in 5.115 of this
chapter, as they are available, copies of the health hazard evaluation,
the recall strategy, and all recall communications (including, for a
recall under 107.200, the notice to be displayed at retail
establishments) directed to consignees, distributors, retailers, and
members of the public.
21 CFR 107.240 Notification requirements.
(a) Notification of a violative infant formula. A manufacturer shall
promptly notify the Food and Drug Administration when the manufacturer
has knowledge (as defined in section 412(e)(2) of the Federal Food,
Drug, and Cosmetic Act (the act)) that reasonably supports the
conclusion that an infant formula that has been processed by the
manufacturer and that has left an establishment subject to the control
of the manufacturer:
(1) May not provide the nutrients required by section 412(i) of the
act and by regulations promulgated under section 412(i)(2) of the act;
or
(2) May be otherwise adulterated or misbranded.
(b) Method of notification. The notification made pursuant to
107.240(a) shall be made, by telephone, to the Director of the
appropriate Food and Drug Administration district office specified in
5.115 of this chapter. After normal business hours (8 a.m. to 4:30
p.m.), FDA's emergency number, 202-857-8400, shall be used. The
manufacturer shall send written confirmation of the notification to the
Division of Regulatory Guidance (HFF-310), Center for Food Safety and
Applied Nutrition, Food and Drug Administration, 200 C St. SW.,
Washington, DC 20204, and to the appropriate Food and Drug
Administration district office specified in 5.115 of this chapter.
(c) Reports about an infant formula recall -- (1) Telephone report.
When a determination is made that an infant formula is to be recalled,
the recalling firm shall telephone within 24 hours the appropriate Food
and Drug Administration district office listed in 5.115 of this chapter
and shall provide relevant information about the infant formula that is
to be recalled.
(2) Initial written report. Within 14 days after the recall has
begun, the recalling firm shall provide a written report to the
appropriate Food and Drug Administration district office. The report
shall contain relevant information, including the following cumulative
information concerning the infant formula that is being recalled:
(i) Number of consignees notified of the recall, and date and method
of notification, including, for a recall pursuant to 107.200
information about the notice provided for retail display and the request
for its display.
(ii) Number of consignees responding to the recall communication and
quantity of recalled infant formula on hand at the time it was received.
(iii) Quantity of recalled infant formula returned or corrected by
each consignee contacted and the quantity of recalled infant formula
accounted for.
(iv) Number and results of effectiveness checks that were made.
(v) Estimated timeframes for completion of the recall.
(3) Status reports. The recalling firm shall submit to the
appropriate Food and Drug Administration district office a written
status report on the recall at least every 14 days until the recall is
terminated. The status report shall describe the steps taken by the
recalling firm to carry out the recall since the last report and the
results of these steps.
21 CFR 107.250 Termination of an infant formula recall.
The recalling firm may submit a recommendation for termination of the
recall to the appropriate Food and Drug Administration district office
listed in 5.115 of this chapter for transmittal to the Division of
Regulatory Guidance, Center for Food Safety and Applied Nutrition, for
action. Any such recommendation shall contain information supporting a
conclusion that the recall strategy has been effective. The agency will
respond within 15 days of receipt by the Division of Regulatory
Guidance, Center for Food Safety and Applied Nutrition, of the request
for termination. The recalling firm shall continue to implement the
recall strategy until it receives final written notification from the
agency that the recall has been terminated. The agency will send such a
notification unless it has information, from FDA's own audits or from
other sources, demonstrating that the recall has not been effective.
The agency may conclude that a recall has not been effective if:
(a) The recalling firm's distributors have failed to retrieve the
recalled infant formula; or
(b) Stocks of the recalled infant formula remain in distribution
channels that are not in direct control of the recalling firm.
21 CFR 107.260 Revision of an infant formula recall.
If after a review of the recalling firm's recall strategy or periodic
reports or other monitoring of the recall, the Food and Drug
Administration concludes that the actions of the recalling firm are
deficient, the agency shall notify the recalling firm of any serious
deficiency. The agency may require the firm to:
(a) Change the extent of the recall, if the agency concludes on the
basis of available data that the depth of the recall is not adequate in
light of the risk to human health presented by the infant formula.
(b) Carry out additional effectiveness checks, if the agency's
audits, or other information, demonstrate that the recall has not been
effective.
(c) Issue additional notifications to the firm's direct accounts, if
the agency's audits, or other information demonstrate that the original
notifications were not received, or were disregarded in a significant
number of cases.
21 CFR 107.270 Compliance with this subpart.
A recalling firm may satisfy the requirements of this subpart by any
means reasonable calculated to meet the obligations set forth in this
Subpart E. The recall guidelines in Subpart C of Part 7 of this chapter
specify procedures that may be useful to a recalling firm in determining
how to comply with these regulations.
21 CFR 107.280 Records retention.
Each manufacturer of an infant formula shall make and retain such
records respecting the distribution of the infant formula through any
establishment owned or operated by such manufacturer as may be necessary
to effect and monitor recalls of the formula. Such records shall be
retained for at least 1 year after the expiration of the shelf life of
the infant formula.
(Collection of information requirements in this section were approved
by the Office of Management and Budget under OMB control number
0910-0188.)
21 CFR 107.280 PART 108 -- EMERGENCY PERMIT CONTROL
21 CFR 107.280 Pt. 108
21 CFR 107.280 Subpart A -- General Provisions
Sec.
108.3 Definitions.
108.5 Determination of the need for a permit.
108.6 Revocation of determination of need for permit.
108.7 Issuance or denial of permit.
108.10 Suspension and reinstatement of permit.
108.12 Manufacturing, processing, or packing without a permit, or in
violation of a permit.
108.19 Establishment of requirements for exemption from section 404
of the act.
21 CFR 107.280 Subpart B -- Specific Requirements and Conditions for
Exemption From or Compliance With an Emergency Permit
108.25 Acidified foods.
108.35 Thermal processing of low-acid foods packaged in hermetically
sealed containers.
Authority: Secs. 402, 404, 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 342, 344, 371).
Source: 42 FR 14334, Mar. 15, 1977, unless otherwise noted.
21 CFR 107.280 Subpart A -- General Provisions
21 CFR 108.3 Definitions.
(a) The definitions contained in section 201 of the Federal Food,
Drug, and Cosmetic Act are applicable to such terms when used in this
part.
(b) ''Commissioner'' means the Commissioner of Food and Drugs.
(c) ''Act'' means the Federal Food, Drug, and Cosmetic Act, as
amended.
(d) ''Permit'' means an emergency permit issued by the Commissioner
pursuant to section 404 of the act for such temporary period of time as
may be necessary to protect the public health.
(e) ''Manufacture, processing, or packing of food in any locality''
means activities conducted in a single plant or establishment, a series
of plants under a single management, or all plants in an industry or
region, by a manufacturer, processor, or packer.
21 CFR 108.5 Determination of the need for a permit.
(a) Whenever the Commissioner determines after investigation that a
manufacturer, processor, or packer of a food for which a regulation has
been promulgated in Subpart B of this part does not meet the mandatory
conditions and requirements established in such regulation, he shall
issue to such manufacturer, processor, or packer an order determining
that a permit shall be required before the food may be introduced or
delivered for introduction into interstate commerce by that person. The
order shall specify the mandatory conditions and requirements with which
there is a lack of compliance.
(1) The manufacturer, processor, or packer shall have 3 working days
after receipt of such order within which to file objections. Such
objections may be filed by telegram, telex, or any other mode of written
communication addressed to the Food and Drug Administration, Center for
Food Safety and Applied Nutrition (HFF-310), 200 C St. SW., Washington,
DC 20204. If such objections are filed, the determination is stayed
pending a hearing to be held within 5 working days after the filing of
objections on the issues involved unless the Commissioner determines
that the objections raise no genuine and substantial issue of fact to
justify a hearing.
(2) If the Commissioner finds that there is an imminent hazard to
health, the order shall contain this finding and the reasons therefor,
and shall state that the determination of the need for a permit is
effective immediately pending an expedited hearing.
(b) A hearing under this section shall be conducted by the
Commissioner or his designee at a location agreed upon by the objector
and the Commissioner or, if such agreement cannot be reached, at a
location designated by the Commissioner. The manufacturer, processor,
or packer shall have the right to cross-examine the Food and Drug
Administration's witnesses and to present witnesses on his own behalf.
(c) Within 5 working days after the hearing, and based on the
evidence presented at the hearing, the Commissioner shall determine
whether a permit is required and shall so inform the manufacturer,
processor, or packer in writing, with the reasons for his decision.
(d) The Commissioner's determination of the need for a permit
constitutes final agency action from which appeal lies to the courts.
The Commissioner will not stay a determination of the need for a permit
pending court appeal except in unusual circumstances, but will
participate in expediting any such appeal.
(42 FR 14334, Mar. 15, 1977, as amended at 54 FR 24891, June 12,
1989)
21 CFR 108.6 Revocation of determination of need for permit.
(a) A permit shall be required only during such temporary period as
is necessary to protect the public health.
(b) Whenever the Commissioner has reason to believe that a permit
holder is in compliance with the mandatory requirements and conditions
established in Subpart B of this part and is likely to remain in
compliance, he shall, on his own initiative or on the application of the
permit holder, revoke both the determination of need for a permit and
the permit that had been issued. If denied, the applicant shall, upon
request, be afforded a hearing conducted in accordance with 108.5 (b)
and (c) as soon as practicable. Such revocation is without prejudice to
the initiation of further permit proceedings with respect to the same
manufacturer, processor, or packer should later information again show
the need for a permit.
21 CFR 108.7 Issuance or denial of permit.
(a) After a determination and notification by the Commissioner in
accordance with the provisions of 108.5 that a manufacturer, processor,
or packer requires a permit, such manufacturer, processor, or packer may
not thereafter introduce or deliver for introduction into interstate
commerce any such food manufactured, processed, or packed by him unless
he holds a permit issued by the Commissioner or obtains advance written
approval of the Food and Drug Administration pursuant to 108.12(a).
(b) Any manufacturer, processor, or packer for whom the Commissioner
has made a determination that a permit is necessary may apply to the
Commissioner for the issuance of such a permit. The application shall
contain such data and information as is necessary to show that all
mandatory requirements and conditions for the manufacturer, processing
or packing of a food for which regulations are established in Subpart B
of this part are met and, in particular, shall show that the deviations
specified in the Commissioner's determination of the need for a permit
have been corrected or suitable interim measures established. Within 10
working days after receipt of such application, (except that the
Commissioner may extend such time an additional 10 working days where
necessary), the Commissioner shall issue a permit, deny the permit, or
offer the applicant a hearing conducted in accordance with 108.5 (b)
and (c) as to whether the permit should be issued. The Commissioner
shall issue such a permit to which shall be attached, in addition to the
mandatory requirements and conditions of Subpart B of this part, any
additional requirements or conditions which may be necessary to protect
the public health if he finds that all mandatory requirements and
conditions of Subpart B of this part are met or suitable interim
measures are established.
(c) Denial of a permit constitutes final agency action from which
appeal lies to the courts. The Commissioner will not stay such denial
pending court appeal except in unusual circumstances, but will
participate in expediting any such appeal.
21 CFR 108.10 Suspension and reinstatement of permit.
(a) Whenever the Commissioner finds that a permit holder is not in
compliance with the mandatory requirements and conditions established by
the permit, he shall immediately suspend the permit and so inform the
permit holder, with the reasons for the suspension.
(b) Upon application for reinstatement of a permit, the Commissioner
shall, within 10 working days, reinstate the permit if he finds that the
person is in compliance with the mandatory requirements and conditions
established by the permit or deny the application.
(c) Any person whose permit has been suspended or whose application
for reinstatement has been denied may request a hearing. The hearing
shall be conducted by the Commissioner or his designee within 5 working
days of receipt of the request at a location agreed upon by the objector
and the Commissioner or, if an agreement cannot be reached, at a
location designated by the Commissioner. The permit holder shall have
the right to present witnesses on his own behalf and to cross-examine
the Food and Drug Administration's witnesses.
(d) Within 5 working days after the hearing, and based on the
evidence presented at the hearing, the Commissioner shall determine
whether the permit shall be reinstated and shall so inform the permit
holder, with the reasons for his decision.
(e) Denial of an application for reinstatement of a permit
constitutes final agency action from which appeal lies to the courts.
The Commisioner will not stay such denial pending court appeal except in
unusual circumstances, but will participate in expediting any such
appeal.
21 CFR 108.12 Manufacturing, processing, or packing without a permit,
or in violation of a permit.
(a) A manufacturer, processor, or packer may continue at his own risk
to manufacture, process, or pack without a permit a food for which the
Commissioner has determined that a permit is required. All food so
manufactured, processed, or packed during such period without a permit
shall be retained by the manufacturer, processor, or packer and may not
be introduced or delivered for introduction into interstate commerce
without the advance written approval of the Food and Drug
Administration. Such approval may be granted only upon an adequate
showing that such food is free from microorganisms of public health
significance. The manufacturer, processor, or packer may provide to the
Commissioner, for his consideration in making any such determination, an
evaluation of the potential public health significance of such food by a
competent authority in accordance with procedures recognized as being
adequate to detect any potential hazard to public health. Within 20
working days after receipt of a written request for such written
approval the Food and Drug Administration shall either issue such
written approval or deny the request. If the request is denied, the
applicant shall, upon request, be afforded a prompt hearing conducted in
accordance with 108.5 (b) and (c).
(b) Except as provided in paragraph (a) of this section, no
manufacturer, processor, or packer may introduce or deliver for
introduction into interstate commerce without a permit or in violation
of a permit a food for which the Commissioner has determined that a
permit is required. Where a manufacturer, processor, or packer utilizes
a consolidation warehouse or other storage facility under his control,
interstate shipment of any such food from the point of production to
that warehouse or storage facility shall not violate this paragraph,
provided that no further introduction or delivery for introduction into
interstate commerce is made from that consolidated warehouse or storage
facility except as provided in paragraph (a) of this section.
21 CFR 108.19 Establishment of requirements for exemption from section
404 of the act.
(a) Whenever the Commissioner finds after investigation that the
distribution in interstate commerce of any class of food may, by reason
of contamination with microorganisms during the manufacture, processing,
or packing thereof in any locality, be injurious to health, and that
such injurious nature cannot be adequately determined after such
articles have entered interstate commerce, he shall promulgate
regulations in Subpart B of this part establishing requirements and
conditions governing the manufacture, processing, or packing of the food
necessary to protect the public health. Such regulations may be
proposed by the Commissioner on his own initiative or in response to a
petition from any interested person pursuant to Part 10 of this chapter.
(b) A manufacturer, processor, or packer of a food for which a
regulation has been promulgated in Subpart B of this part shall be
exempt from the requirement for a permit only if he meets all of the
mandatory requirements and conditions established in that regulation.
(42 FR 14334, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22,
1977)
21 CFR 108.19 Subpart B -- Specific Requirements and Conditions for Exemption From or Compliance With an Emergency Permit
21 CFR 108.25 Acidified foods.
(a) Inadequate or improper manufacture, processing, or packing of
acidified foods may result in the distribution in interstate commerce of
processed foods that may be injurious to health. The harmful nature of
such foods cannot be adequately determined after these foods have
entered into interstate commerce. The Commissioner of Food and Drugs
therefore finds that, to protect the public health, it may be necessary
to require any commericial processor, in any establishment engaged in
the manufacture, processing, or packing of acidified foods, to obtain
and hold a temporary emergency permit provided for under section 404 of
the Federal Food, Drug, and Cosmetic Act. Such a permit may be required
whenever the Commissioner finds, after investigation, that the
commercial processor has failed to fulfill all the requirements of this
section, including registration and filing of process information, and
the mandatory portions of 114.10, 114.80(a) (1) and (2), and (b),
114.83, 114.89, and 114.100 (b), (c), and (d) of this chapter as they
relate to acidified foods. These requirements are intended to ensure
safe manufacturing, processing, and packing processes and to permit the
Food and Drug Administration to verify that these processes are being
followed. Failure to meet these requirements shall constitute a prima
facie basis for the immediate application of the emergency permit
control provisions of section 404 of the act to that establishment,
under the procedures established in Subpart A of this part.
(b) The definitions in 114.3 of this chapter are applicable when
those terms are used in this section.
(c) (1) Registration. A commercial processor, when first engaging in
the manufacture, processing, or packing of acidified foods in any State,
as defined in section 201(a)(1) of the act, shall, not later than 10
days after first so engaging, register and file with the Food and Drug
Administration on Form FDA 2541 (food canning establishment
registration) information including, but not limited to, the name of the
establishment, principal place of business, the location of each
establishment in which that processing is carried on, the processing
method in terms of acidity and pH control, and a list of foods so
processed in each establishment. These forms are available from the
Food and Drug Administration, Center for Food Safety and Applied
Nutrition, LACF Registration Coordinator (HFF-233), 200 C St. SW.,
Washington, DC 20204, or at any Food and Drug Administration district
office. The completed form shall be submitted to the Food and Drug
Administration, Bureau of Foods, Industry Guidance Branch (HFF-342), 200
C St. SW., Washington, DC 20204. Commercial processors presently so
engaged shall register within 120 days after the effective date of this
regulation. Foreign processors shall register within 120 days after the
effective date of this regulation or before any offering of foods for
import into the United States, whichever is later. Commercial
processors duly registered under this section shall notify the Food and
Drug Administration not later than 90 days after the commercial
processor ceases or discontinues the manufacture, processing, or packing
of the foods in any establishment, except that this notification shall
not be required for temporary cessations due to the seasonal character
of an establishment's production or by temporary conditions including,
but not limited to, labor disputes, fire, or acts of God.
(2) Process filing. A commercial processor engaged in the processing
of acidified foods shall, not later than 60 days after registration, and
before packing any new product, provide the Food and Drug Administration
information on the scheduled processes including, as necessary,
conditions for heat processing and control of pH, salt, sugar, and
preservative levels and source and date of the establishment of the
process, for each acidified food in each container size. Filing of this
information does not constitute approval of the information by the Food
and Drug Administration, and information concerning processes and other
data so filed shall be regarded as trade secrets within the meaning of
21 U.S.C. 331(j) and 18 U.S.C. 1905. This information shall be submitted
on form FDA 2541a (food canning establishment process filing form for
all methods except aseptic). Forms are available from the Food and Drug
Administration, Center for Food Safety and Applied Nutrition, LACF
Registration Coordinator (HFF-233), 200 C St. SW., Washington, DC
20204, or at Food and Drug Administration district office. The
completed form shall be submitted to the Food and Drug Administration,
Center for Food Safety and Applied Nutrition, LACF Registration
Coordinator (HFF-233), 200 C St. SW., Washington, DC 20204.
(3) Process adherence and information -- (i) Scheduling. A
commercial processor engaged in processing acidified foods in any
registered establishment shall process each food in conformity with at
least the scheduled processes filed under paragraph (c)(2) of this
section.
(ii) Process and pH information availability. When requested by the
Food and Drug Administration in writing, a commercial processor engaged
in the processing of acidified foods shall provide the Food and Drug
Administration with any process and procedure information that the Food
and Drug Administration deems necessary to determine the adequacy of the
process. Furnishing of this information does not constitute approval by
the Food and Drug Administration of the content of the information
filed, and the information concerning processes and other data so
furnished shall be considered trade secrets within the meaning of 21
U.S.C. 331(j) and 18 U.S.C. 1905 (to the extent that they qualify under
those provisions).
(d) A commercial processor engaged in the processing of acidified
foods shall promptly report to the Food and Drug Administration any
instance of spoilage, process deviation, or contamination with
microorganisms, the nature of which has potential health-endangering
significance, where any lot of such food has in whole or in part entered
distribution in commerce.
(e) A commercial processor engaged in the processing of acidified
foods shall prepare and maintain files on a current procedure for use
for products under the processor's control, which that processor will
ask the distributor to follow, including plans for recalling products
that may be injurious to health; for identifying, collecting,
warehousing, and controlling products; for determining the
effectiveness of recalls; for notifying the Food and Drug
Administration of any recalls; and for implementing recall programs.
(f) All plant personnel involved in acidification, pH control, heat
treatment, or other critical factors of the operation shall be under the
operating supervision of a person who has attended a school approved by
the Commissioner for giving instruction in food-handling techniques,
food protection principles, personal hygiene, plant sanitation
practices, pH controls, and critical factors in acidification, and who
has satisfactorily completed the prescribed course of instruction. The
Commissioner will consider students who have satisfactorily completed
the required portions of the courses presented under 108.35 and Part
113 of this chapter before March 16, 1979, as having satisfactorily
completed the prescribed course of instruction under this section and
Part 114 of this chapter. The Commissioner will not withhold approval
of any school qualified to give such instruction.
(g) A commercial processor engaged in the processing of acidified
foods shall prepare, review, and retain at the processing plant or other
reasonably accessible location for a period of 3 years from the date of
manufacture, all records of processing, deviations in processing, pH,
and other records specified in Part 114 of this chapter. Upon written
demand during the course of a factory inspection under section 704 of
the act by a duly authorized employee of the Food and Drug
Administration, a commercial processor shall permit the inspection and
copying by that employee of these records to verify the pH and the
adequacy of processing.
(h) This section shall not apply to the commercial processing of any
food processed under the continuous inspection of the meat and poultry
inspection program of the Food Safety and Inspection Service of the
Department of Agriculture under the Federal Meat Inspection Act (34
Stat. 1256, as amended by 81 Stat. 584 (21 U.S.C. 601 et seq.)) and the
Poultry Products Inspection Act (71 Stat. 441, as amended by 82 Stat.
791 (21 U.S.C. 451 et seq.)).
(i) Wherever the Commissioner finds that any State regulates the
commercial processing of acidified foods under effective regulations
specifying at least the requirements of Part 114 of this chapter, the
Commissioner shall issue a notice stating that compliance with such
State regulations shall constitute compliance with this section, if the
State through its regulatory agency or each processor of acidified foods
in the State files with the Food and Drug Administration the
registration information and the processing information prescribed in
paragraph (c) of this section.
(j) Imports: (1) This section applies to any foreign commercial
processor engaged in the processing of acidified foods and offering
those foods for import into the United States except that, in lieu of
providing for the issuance of an emergency permit under paragraph (a) of
this section, the Commissioner will request the Secretary of the
Treasury to refuse admission into the United States, under section 801
of the act, to any acidified foods which the Commissioner determines,
after investigation, may result in the distribution in interstate
commerce of processed foods that may be injurious to health as set forth
in paragraph (a) of this section.
(2) Any acidified food so refused admission shall not be admitted
until the Commissioner determines that the commercial processor offering
the food for import has complied with the requirements of this section
and that the food is not injurious to health. To assist the
Commissioner in making this determination, a duly authorized employee of
the Food and Drug Administration shall be permitted to inspect the
commercial processor's manufacturing, processing, and packing
facilities.
(k) The following information submitted to the Food and Drug
Administration under this section is not available for public disclosure
unless it has been previously disclosed to the public as defined in
20.81 of this chapter or it relates to a product or ingredient that has
been abandoned and no longer represents a trade secret or confidential
commercial or financial information as defined in 20.61 of this
chapter:
(1) Manufacturing methods or processes, including quality control
information.
(2) Production, sales, distribution, and similar information, except
that any compilation of the information aggregated and prepared in a way
that does not reveal information which is not available for public
disclosure under this provision is available for public disclosure.
(3) Quantitative or semiquantitative formulas.
(44 FR 16207, Mar. 16, 1979, as amended at 54 FR 24891, June 12,
1989)
21 CFR 108.35 Thermal processing of low-acid foods packaged in
hermetically sealed containers.
(a) Inadequate or improper manufacture, processing, or packing of
thermally processed low-acid foods in hermetically sealed containers may
result in the distribution in interstate commerce of processed foods
that may be injurious to health. The harmful nature of such foods
cannot be adequately determined after these foods have entered into
interstate commerce. The Commissioner of Food and Drugs therefore finds
that, in order to protect the public health, it may be necessary to
require any commercial processor, in any establishment engaged in the
manufacture, processing, or packing of thermally processed low-acid
foods in hermetically sealed containers, to obtain and hold a temporary
emergency permit provided for under section 404 of the Federal Food,
Drug, and Cosmetic Act. Such a permit may be required whenever the
Commissioner finds, after investigation, that the commercial processor
has failed to fulfill all the requirements of this section, including
registration and the filing of process information, and the mandatory
portions of Part 113 of this chapter. These requirements are intended
to ensure safe manufacture, processing, and packing procedures and to
permit the Food and Drug Administration to verify that these procedures
are being followed. Such failure shall constitute a prima facie basis
for the immediate application of the emergency permit control provisions
of section 404 of the act to that establishment, pursuant to the
procedures established in Subpart A of this part.
(b) The definitions in 113.3 of this chapter are applicable when
such terms are used in this section.
(c) Registration and process filing. (1) Registration. A commercial
processor when first engaging in the manufacture, processing, or packing
of thermally processed low-acid foods in hermetically sealed containers
in any state, as defined in section 201(a)(1) of the act, shall, not
later than 10 days after first so engaging, register with the Food and
Drug Administration on Form FDA 2541 (food canning establishment
registration) information including (but not limited to) his name,
principal place of business, the location of each establishment in which
such processing is carried on, the processing method in terms of the
type of processing equipment employed, and a list of the low-acid foods
so processed in each such establishment. These forms are available from
the Food and Drug Administration, Center for Food Safety and Applied
Nutrition, LACF Registration Coordinator HFF-233, 200 C St. SW.,
Washington, DC 20204, or at any Food and Drug Administration district
office. The completed form shall be submitted to the Food and Drug
Administration, Center for Food Safety and Applied Nutrition, LACF
Registration Coordinator HFF-233, 200 C St. SW., Washington, DC 20204.
Commercial processors presently so engaged shall register not later than
July 13, 1973. Commercial processors duly registered in accordance with
this section shall notify the Food and Drug Administration not later
than 90 days after such commercial processor ceases or discontinues the
manufacture, processing, or packing of thermally processed foods in any
establishment: Provided, That such notification shall not be required
as to the temporary cessation necessitated by the seasonal character of
the particular establishment's production or caused by temporary
conditions including but not limited to strikes, lockouts, fire, or acts
of God.
(2) Process filing. A commercial processor engaged in the thermal
processing of low-acid foods packaged in hermetically sealed containers
shall, not later than 60 days after registration and prior to the
packing of a new product, provide the Food and Drug Administration
information as to the scheduled processes including but not limited to
the processing method, type of retort or other thermal processing
equipment employed, minimum initial temperatures, times and temperatures
of processing, sterilizing value (Fo), or other equivalent scientific
evidence of process adequacy, critical control factors affecting heat
penetration, and source and date of the establishment of the process,
for each such low-acid food in each container size: Provided, That the
filing of such information does not constitute approval of the
information by the Food and Drug Administration, and that information
concerning processes and other data so filed shall be regarded as trade
secrets within the meaning of 21 U.S.C. 331(j) and 18 U.S.C. 1905. This
information shall be submitted on the following forms as appropriate:
Form FDA 2541a (food canning establishment process filing for all
methods except aseptic), or Form FDA 2541c (food canning establishment
process filing for aseptic systems). These forms are available from the
Food and Drug Administration, Center for Food Safety and Applied
Nutrition, LACF Registration Coordinator, HFF-233, 200 C St. SW.,
Washington, DC 20204, or at any Food and Drug Administration district
office. The completed form(s) shall be submitted to the Food and Drug
Administration, Center for Food Safety and Applied Nutrition, LACF
Registration Coordinator, HFF-233, 200 C St. SW., Washington, DC 20204.
(i) If all the necessary information is not available for existing
products, the processor shall, at the time the existing information is
provided to the Food and Drug Administration request in writing an
extension of time for submission of such information, specifying what
additional information is to be supplied and the date by which it is to
be submitted. Within 30 working days after receipt of such request the
Food and Drug Administration shall either grant or deny such request in
writing.
(ii) If a packer intentionally makes a change in a previously filed
scheduled process by reducing the initial temperature or retort
temperature, reducing the time of processing, or changing the product
formulation, the container, or any other condition basic to the adequacy
of scheduled process, he shall prior to using such changed process
obtain substantiation by qualified scientific authority as to its
adequacy. Such substantiation may be obtained by telephone, telegram,
or other media, but must be promptly recorded, verified in writing by
the authority, and contained in the packer's files for review by the
Food and Drug Administration. Within 30 days after first use, the
packer shall submit to the Food and Drug Administration, Center for Food
Safety and Applied Nutrition, DFCT, HFF-414, 200 C St. SW., Washington,
DC 20204 a complete description of the modifications made and utilized,
together with a copy of his file record showing prior substantiation by
a qualified scientific authority as to the safety of the changed
process. Any intentional change of a previously filed scheduled process
or modification thereof in which the change consists solely of a higher
initial temperature, a higher retort temperature, or a longer processing
time, shall not be considered a change subject to this paragraph, but if
that modification is thereafter to be regularly scheduled, the modified
process shall be promptly filed as a scheduled process, accompanied by
full information on the specified forms as provided in this paragraph.
(iii) Many packers employ an ''operating'' process in which retort
operators are instructed to use retort temperatures and/or processing
times slightly in excess of those specified in the scheduled process as
a safety factor to compensate for minor fluctuations in temperature or
time to assure that the minimum times and temperatures in the scheduled
process are always met. This would not constitute a modification of the
scheduled process.
(3) Process adherence and information. (i) A commercial processor
engaged in the thermal processing of low-acid foods packaged in
hermetically sealed containers in any registered establishment shall
process each low-acid food in each container size in conformity with at
least the scheduled processes and modifications filed pursuant to
paragraph (c)(2) of this section.
(ii) Process information availability: When requested by the Food
and Drug Administration in writing, a commercial processor engaged in
thermal processing of low-acid foods packaged in hermetically sealed
containers shall provide the Food and Drug Administration with any
information concerning processes and procedures which is deemed
necessary by the Food and Drug Administration to determine the adequacy
of the process: Provided, That the furnishing of such information does
not constitute approval of the information by the Food and Drug
Administration, and that the information concerning processes and other
data so furnished shall be regarded as trade secrets within the meaning
of 21 U.S.C. 331(j) and 18 U.S.C. 1905.
(d) A commercial processor engaged in the thermal processing of
low-acid foods packaged in hermetically sealed containers shall promptly
report to the Food and Drug Administration any instance of spoilage or
process deviation the nature of which indicates potential health
significance where any lot of such food has in whole or in part entered
distribution.
(e) A commercial processor engaged in thermal processing of low-acid
foods packaged in hermetically sealed containers shall promptly report
to the Food and Drug Administration any instance wherein any lot of such
food, which may be injurious to health by reason of contamination with
microorganisms, has in whole or in part entered distribution.
(f) A commercial processor engaged in the thermal processing of
low-acid foods packaged in hermetically sealed containers shall have
prepared and in his files a current procedure which he will use for
products under his control and which he will ask his distributor to
follow, including plans for effecting recalls of any product that may be
injurious to health; for identifying, collecting, warehousing, and
controlling the product; for determining the effectiveness of such
recall; for notifying the Food and Drug Administration of any such
recall; and for implementing such recall program.
(g) All operators of retorts, thermal processing systems, aseptic
processing and packaging systems, or other thermal processing systems,
and container closure inspectors shall be under the operating
supervision of a person who has attended a school approved by the
Commissioner for giving instruction in retort operations, aseptic
processing and packaging systems operations or other thermal processing
systems operations, and container closure inspections, and has
satisfactorily completed the prescribed course of instruction:
Provided, That this requirement shall not apply in the State of
California as listed in paragraph (j) of this section and shall not
apply until March 25, 1975 in any other State. The Commissioner will
not withhold approval of any school qualified to give such instruction.
(h) A commercial processor engaged in the thermal processing of
low-acid foods packaged in hermetically sealed containers shall prepare,
review, and retain at the processing plant for a period of not less than
one year, and at the processing plant or other reasonably accessible
location for an additional two years, all records of processing,
deviations in processing, container closure inspections, and other
records specified in Part 113 of this chapter. If during the first year
of the three-year record retention period the processing plant is closed
for a prolonged period between seasonal packs, the records may be
transferred to some other reasonably accessible location at the end of
the seasonal pack. Upon written demand during the course of a factory
inspection pursuant to section 704 of the act by a duly authorized
employee of the Food and Drug Administration, a commercial processor
shall permit the inspection and copying by such employee of these
records to verify the adequacy of processing, the integrity of container
closures, and the coding of the products.
(i) This section shall not apply to the commercial processing of any
food processed under the continuous inspection of the meat and poultry
inspection program of the Animal and Plant Health Inspection Service of
the Department of Agriculture under the Federal Meat Inspection Act (34
Stat. 1256, as amended by 81 Stat. 584 (21 U.S.C. 601 et seq.)) and the
Poultry Products Inspection Act (71 Stat. 441, as amended by 82 Stat.
791 (21 U.S.C. 451 et seq.)).
(j) Compliance with State regulations: (1) Wherever the Commissioner
finds that any State regulates the commercial thermal processing of
low-acid foods in accordance with effective regulations specifying at
least the requirements of Part 113 of this chapter, he shall issue a
notice stating that compliance with such State regulations shall
constitute compliance with Part 113 of this chapter. However, the
provisions of this section shall remain applicable to the commercial
processing of low-acid foods in any such State, except that, either the
State through its regulatory agency or each processor of low-acid foods
in such State shall file with the Center for Food Safety and Applied
Nutrition the registration information and the processing information
prescribed in paragraph (c) of this section.
(2) The Commissioner finds that the regulations adopted by the State
of California under the laws relating to cannery inspections governing
thermal processing of low-acid foods packaged in hermetically sealed
containers satisfy the requirements of Part 113 of this chapter.
Accordingly, processors, who under the laws relating to cannery
inspections are licensed by the State of California and who comply with
such state regulations, shall be deemed to comply with the requirements
of Part 113 of this chapter.
(k) Imports: (1) This section shall apply to any foreign commercial
processor engaged in the thermal processing of low-acid foods packaged
in hermetically sealed containers and offering such foods for import
into the United States except that, in lieu of providing for the
issuance of an emergency permit under paragraph (a) of this section, the
Commissioner will request the Secretary of the Treasury to refuse
admission into the United States, pursuant to section 801 of the act, of
any such low-acid foods which the Commissioner determines, after
investigation, may result in the distribution in interstate commerce of
processed foods that may be injurious to health as set forth in
paragraph (a) of this section.
(2) Any such food refused admission shall not be admitted until such
time as the Commissioner may determine that the commercial processor
offering the food for import is in compliance with the requirements and
conditions of this section and that such food is not injurious to
health. For the purpose of making such determination, the Commissioner
reserves the right for a duly authorized employee of the Food and Drug
Administration to inspect the commercial processor's manufacturing,
processing, and packing facilities.
(l) The following data and information submitted to the Food and Drug
Administration pursuant to this section are not available for public
disclosure unless they have been previously disclosed to the public as
defined in 20.81 of this chapter or they relate to a product or
ingredient that has been abandoned and they no longer represent a trade
secret or confidential commercial or financial information as defined in
20.81 of this chapter:
(1) Manufacturing methods or processes, including quality control
information.
(2) Production, sales, distribution, and similar data and
information, except that any compilation of such data and information
aggregated and prepared in a way that does not reveal data or
information which is not available for public disclosure under this
provision is available for public disclosure.
(3) Quantitative or semiquantitative formulas.
(42 FR 14334, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22,
1977; 54 FR 24891, June 12, 1989)
21 CFR 108.35 PART 109 -- UNAVOIDABLE CONTAMINANTS IN FOOD FOR HUMAN CONSUMPTION AND FOOD-PACKAGING MATERIAL
21 CFR 108.35 Pt. 109
21 CFR 108.35 Subpart A -- General Provisions
Sec.
109.3 Definitions and interpretations.
109.4 Establishment of tolerances, regulatory limits, and action
levels.
109.5 Petitions.
109.6 Added poisonous or deleterious substances.
109.7 Unavoidability.
109.15 Use of polychlorinated biphenyls (PCB's) in establishments
manufacturing food-packaging materials.
21 CFR 108.35 Subpart B -- Tolerances for Unavoidable Poisonous or
Deleterious Substances
109.30 Tolerances for polychlorinated biphenyls (PCB's).
21 CFR 108.35 Subpart C -- Regulatory Limits for Added Poisonous or Deleterious Substances (Reserved)
21 CFR 108.35 Subpart D -- Naturally Occurring Poisonous or Deleterious
Substances (Reserved)
Authority: Secs. 306, 402, 406, 408, 409, 701 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 336, 342, 346, 346a, 348, 371).
Source: 42 FR 52819, Sept. 30, 1977, unless otherwise noted.
21 CFR 108.35 Subpart A -- General Provisions
21 CFR 109.3 Definitions and interpretations.
(a) Act means the Federal Food, Drug, and Cosmetic Act.
(b) The definitions of terms contained in section 201 of the act are
applicable to such terms when used in this part unless modified in this
section.
(c) A naturally occurring poisonous or deleterious substance is a
poisonous or deleterious substance that is an inherent natural
constituent of a food and is not the result of environmental,
agricultural, industrial, or other contamination.
(d) An added poisonous or deleterious substance is a poisonous or
deleterious substance that is not a naturally occurring poisonous or
deleterious substance. When a naturally occurring poisonous or
deleterious substance is increased to abnormal levels through
mishandling or other intervening acts, it is an added poisonous or
deleterious substance to the extent of such increase.
(e) Food includes human food and substances migrating to food from
food-contact articles.
21 CFR 109.4 Establishment of tolerances, regulatory limits, and action
levels.
(a) When appropriate under the criteria of 109.6, a tolerance for an
added poisonous or deleterious substance, which may be a food additive,
may be established by regulation in Subpart B of this part under the
provisions of section 406 of the act. A tolerance may prohibit any
detectable amount of the substance in food.
(b) When appropriate under the criteria of 109.6, and under section
402(a)(1) of the act, a regulatory limit for an added poisonous or
deleterious substance, which may be a food additive, may be established
by regulation in subpart C of this part under the provisions of sections
402(a)(1) and 701(a) of the act. A regulatory limit may prohibit any
detectable amount of the substance in food. The regulatory limit
established represents the level at which food is adulterated within the
meaning of section 402(a)(1) of the act.
(c) (1) When appropriate under the criteria of 109.6, an action
level for an added poisonous or deleterious substance, which may be a
food additive, may be established to define a level of contamination at
which a food may be regarded as adulterated.
(2) Whenever an action level is established or changed, a notice
shall be published in the Federal Register as soon as practicable
thereafter. The notice shall call attention to the material supporting
the action level which shall be on file with the Dockets Management
Branch before the notice is published. The notice shall invite public
comment on the action level.
(d) A regulation may be established in subpart D of this part to
identify a food containing a naturally occurring poisonous or
deleterious substance which will be deemed to be adulterated under
section 402(a)(1) of the act. These regulations do not constitute a
complete list of such foods.
(42 FR 52819, Sept. 30, 1977, as amended at 55 FR 20785, May 21,
1990)
21 CFR 109.5 Petitions.
The Commissioner of Food and Drugs, either on his own initiative or
on behalf of any interested person who has submitted a petition, may
issue a proposal to establish, revoke, or amend a regulation under this
part. Any such petition shall include an adequate factual basis to
support the petition, shall be in the form set forth in 10.65 of this
chapter, and will be published in the Federal Register for comment if it
contains reasonable grounds for the proposed regulation.
21 CFR 109.6 Added poisonous or deleterious substances.
(a) Use of an added poisonous or deleterious substance, other than a
pesticide chemical, that is also a food additive, will be controlled by
a regulation issued under section 409 of the act when possible. When
such a use cannot be approved under the criteria of section 409 of the
act, or when the added poisonous or deleterious substance is not a food
additive, a tolerance, regulatory limit, or action level may be
established pursuant to the criteria in paragraphs (b), (c), or (d) of
this section. Residues resulting from the use of an added poisonous or
deleterious substance that is also a pesticide chemical will ordinarily
be controlled by a tolerance established in a regulation issued under
sections 406, 408, or 409 of the act by the U.S. Environmental
Protection Agency (EPA). When such a regulation has not been issued, an
action level for an added poisonous or deleterious substance that is
also a pesticide chemical may be established by the Food and Drug
Administration. The Food and Drug Administration will request EPA to
recommend such an action level pursuant to the criteria established in
paragraph (d) of this section.
(b) A tolerance for an added poisonous or deleterious substance in
any food may be established when the following criteria are met:
(1) The substance cannot be avoided by good manufacturing practice.
(2) The tolerance established is sufficient for the protection of the
public health, taking into account the extent to which the presence of
the substance cannot be avoided and the other ways in which the consumer
may be affected by the same or related poisonous or deleterious
substances.
(3) No technological or other changes are foreseeable in the near
future that might affect the appropriateness of the tolerance
established. Examples of changes that might affect the appropriateness
of the tolerance include anticipated improvements in good manufacturing
practice that would change the extent to which use of the substance is
unavoidable and anticipated studies expected to provide significant new
toxicological or use data.
(c) A regulatory limit for an added poisonous or deleterious
substance in any food may be established when each of the following
criteria is met:
(1) The substance cannot be avoided by current good manufacturing
practices.
(2) There is no tolerance established for the substance in the
particular food under sections 406, 408, or 409 of the act.
(3) There is insufficient information by which a tolerance may be
established for the substance under section 406 of the act or
technological changes appear reasonably possible that may affect the
appropriateness of a tolerance. The regulatory limit established
represents the level at which food is adulterated within the meaning of
section 402(a)(1) of the act.
(d) An action level for an added poisonous or deleterious substance
in any food may be established when the criteria in paragraph (b) of
this section are met, except that technological or other changes that
might affect the appropriateness of the tolerance are foreseeable in the
near future. An action level for an added poisonous or deleterious
substance in any food may be established at a level at which the Food
and Drug Administration may regard the food as adulterated within the
meaning of section 402(a)(1) of the act, without regard to the criteria
in paragraph (b) of this section or in section 406 of the act. An
action level will be withdrawn when a tolerance or regulatory limit for
the same substance and use has been established.
(e) Tolerances will be established under authority appropriate for
action levels (sections 306, 402(a), and 701(a) of the act, together
with section 408 or 409 of the act, if appropriate) as well as under
authority appropriate for tolerances (sections 406 and 701 of the act).
In the event the effectiveness of a tolerance is stayed pursuant to
section 701(e)(2) of the act by the filing of an objection, the order
establishing the tolerance shall be deemed to be an order establishing
an action level until final action is taken upon such objection.
(42 FR 52819, Sept. 30, 1977, as amended at 55 FR 20785, May 21,
1990)
21 CFR 109.7 Unavoidability.
(a) Tolerances and action levels in this part are established at
levels based on the unavoidability of the poisonous or deleterious
substance concerned and do not establish a permissible level of
contamination where it is avoidable.
(b) Compliance with tolerances, regulatory limits, and action levels
does not excuse failure to observe either the requirement in section
402(a)(4) of the act that food may not be prepared, packed, or held
under insanitary conditions or the other requirements in this chapter
that food manufacturers must observe current good manufacturing
practices. Evidence obtained through factory inspection or otherwise
indicating such a violation renders the food unlawful, even though the
amounts of poisonous or deleterious substances are lower than the
currently established tolerances, regulatory limits, or action levels.
The manufacturer of food must at all times utilize quality control
procedures which will reduce contamination to the lowest level currently
feasible.
(42 FR 52819, Sept. 30, 1977, as amended at 55 FR 20785, May 21,
1990)
21 CFR 109.15 Use of polychlorinated biphenyls (PCB's) in
establishments manufacturing food-packaging materials.
(a) Polychlorinated biphenyls (PCB's) represent a class of toxic
industrial chemicals manufactured and sold under a variety of trade
names, including: Aroclor (United States); Phenoclor (France);
Colphen (Germany); and Kanaclor (Japan). PCB's are highly stable, heat
resistant, and nonflammable chemicals. Industrial uses of PCB's
include, or did include in the past, their use as electrical transformer
and capacitor fluids, heat transfer fluids, hydraulic fluids, and
plasticizers, and in formulations of lubricants, coatings, and inks.
Their unique physical and chemical properties and widespread,
uncontrolled industrial applications have caused PCB's to be a
persistent and ubiquitous contaminant in the environment, causing the
contamination of certain foods. In addition, incidents have occurred in
which PCB's have directly contaminated animal feeds as a result of
industrial accidents (leakage or spillage of PCB fluids from plant
equipment). These accidents in turn caused the contamination of food
products intended for human consumption (meat, milk and eggs).
Investigations by the Food and Drug Administration have revealed that a
significant percentage of paper food-packaging material contains PCB's
which can migrate to the packaged food. The origin of PCB's in such
material is not fully understood. Reclaimed fibers containing
carbonless copy paper (contains 3 to 5 percent PCB's) have been
identified as a primary source of PCB's in paper products. Some virgin
paper products have also been found to contain PCB's, the source of
which is generally attributed to direct contamination from industrial
accidents from the use of PCB-containing equipment and machinery in food
packaging manufacturing establishments. Since PCB's are toxic
chemicals, the PCB contamination of food-packaging materials as a result
of industrial accidents, which can cause the PCB contamination of food,
represents a hazard to public health. It is therefore necessary to
place certain restrictions on the industrial uses of PCB's in
establishments manufacturing food-packaging materials.
(b) The following special provisions are necessary to preclude the
accidental PCB contamination of food-packaging materials:
(1) New equipment or machinery for manufacturing food-packaging
materials shall not contain or use PCB's.
(2) On or before September 4, 1973, the management of establishments
manufacturing food-packaging materials shall:
(i) Have the heat exchange fluid used in existing equipment for
manufacturing food-packaging materials sampled and tested to determine
whether it contains PCB's or verify the absence of PCB's in such
formulations by other appropriate means. On or before Sept. 4, 1973,
any such fluid formulated with PCB's must to the fullest extent possible
commensurate with current good manufacturing practices be replaced with
a heat exchange fluid that does not contain PCB's.
(ii) Eliminate to the fullest extent possible commensurate with
current good manufacturing practices from the establishment any other
PCB-containing equipment, machinery and materials wherever there is a
reasonable expectation that such articles could cause food-packaging
materials to become contaminated with PCB's either as a result of normal
use or as a result of accident, breakage, or other mishap.
(iii) The toxicity and other characteristics of fluids selected as
PCB replacements must be adequately determined so that the least
potentially hazardous replacement is used. In making this determination
with respect to a given fluid, consideration should be given to (a) its
toxicity; (b) the maximum quantity that could be spilled onto a given
quantity of food before it would be noticed, taking into account its
color and odor; (c) possible signaling devices in the equipment to
indicate a loss of fluid, etc.; and (d) its environmental stability and
tendency to survive and be concentrated through the food chain. The
judgment as to whether a replacement fluid is sufficiently non-hazardous
is to be made on an individual installation and operation basis.
(c) The provisions of this section do not apply to electrical
transformers and condensers containing PCB's in sealed containers.
21 CFR 109.15 Subpart B -- Tolerances for Unavoidable Poisonous or Deleterious Substances
21 CFR 109.30 Tolerances for polychlorinated biphenyls (PCB's).
(a) Polychlorinated biphenyls (PCB's) are toxic, industrial
chemicals. Because of their widespread, uncontrolled industrial
applications, PCB's have become a persistent and ubiquitous contaminant
in the environment. As a result, certain foods and animal feeds,
principally those of animal and marine origin, contain PCB's as
unavoidable, environmental contaminants. PCB's are transmitted to the
food portion (meat, milk, and eggs) of food-producing animals ingesting
PCB-contaminated animal feed. In addition, a significant percentage of
paper food-packaging materials contain PCB's which may migrate to the
packaged food. The source of PCB's in paper food-packaging materials is
primarily of certain types of carbonless copy paper (containing 3 to 5
percent PCB's) in waste paper stocks used for manufacturing recycled
paper. Therefore, temporary tolerances for residues of PCB's as
unavoidable environmental or industrial contaminants are established for
a sufficient period of time following the effective date of this
paragraph to permit the elimination of such contaminants at the earliest
practicable time. For the purposes of this paragraph, the term
''polychlorinated biphenyls (PCB's)'' is applicable to mixtures of
chlorinated biphenyl compounds, irrespective of which mixture of PCB's
is present as the residue. The temporary tolerances for residues of
PCB's are as follows:
(1) 1.5 parts per million in milk (fat basis).
(2) 1.5 parts per million in manufactured dairy products (fat basis).
(3) 3 parts per million in poultry (fat basis).
(4) 0.3 parts per million in eggs.
(5) 0.2 parts per million in finished animal feed for food-producing
animals (except the following finished animal feeds: feed concentrates,
feed supplements, and feed premixes).
(6) 2 parts per million in animal feed components of animal origin,
including fishmeal and other by-products of marine origin and in
finished animal feed concentrates, supplements, and premixes intended
for food producing animals.
(7) 2 parts per million in fish and shellfish (edible portion). The
edible portion of fish excludes head, scales, viscera, and inedible
bones.
(8) 0.2 parts per million in infant and junior foods.
(9) 10 parts per million in paper food-packaging material intended
for or used with human food, finished animal feed and any components
intended for animal feeds. The tolerance shall not apply to paper
food-packaging material separated from the food therein by a functional
barrier which is impermeable to migration of PCB's.
(b) A compilation entitled ''Analytical Methodology for
Polychlorinated Biphenyls, June 1979'' for determining compliance with
the tolerances established in this section is available from the Dockets
Management Branch, Department of Health and Human Services, Room 4-62,
Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857.
(c) A barrier is functional for purposes of paragraph (a)(9) of this
section if the barrier limits migration of PCB's from the packaging
material to food to a level not exceeding the migration which occurs
under the same test conditions from packaging material containing 10
parts per million PCB without the use of a barrier. A class of barrier
material is functional for purposes of paragraph (a)(9) of this section
if a representative barrier of the class limits migration of PCB's from
the packaging material to food to a level not exceeding the migration
which occurs under the same test conditions from packaging material
containing 10 parts per million PCB without the use of a barrier.
Migration levels shall be determined for purpose of this paragraph
solely by use of testing conditions described in ''Test Procedures for
Determination of PCB Permeability of Food Packaging, Inner-Wraps,
September 1976, revised May 1983'', which is incorporated by reference.
Copies are available from the Dockets Management Branch (HFA-305), Food
and Drug Administration, Rm. 4-62, 5600 Fishers Lane, Rockville, MD
20857, or available for inspection at the Office of the Federal
Register, 1100 L St. NW., Washington, DC 20204. A class of barrier
material shall be deemed functional only if the definition of the class
and the designation of one or more representative barriers has been
approved by the Director, Center for Food Safety and Applied Nutrition,
Food and Drug Administration. In the event that the Director, Center
for Food Safety and Applied Nutrition, does not approve a proposal made
to the Center regarding the definition of a class of barrier material or
the designation of representative barriers, the Director shall advise
the person making the proposal of the reasons for the Center's
disapproval within 90 days of receipt of the proposal. All proposals
for definition of classes and determinations of the Food and Drug
Administration regarding such proposals shall be on file with the
Dockets Management Branch (HFA-305), Food and Drug Administration, Rm.
4-62, 5600 Fishers Lane, Rockville, MD 20857.
(d) Any person who asserts that a barrier or class of barriers is
functional shall submit the results of tests conducted to determine the
functionality of the barrier or class of barriers to Contaminants
Program Unit (HFF-421, or its successor), Food and Drug Administration,
200 C St. SW., Washington, DC 20204. All barriers or classes of
barriers shall be tested with the four solid food receptors specified in
''Test Procedures for Determination of PCB Permeability of Food
Packaging, Inner-Wraps, September 1976, revised May 1983'', which is
incorporated by reference. The availability of this reference is given
in paragraph (c) of this section. The test results as to each barrier
shall be accompanied by (1) a description of the barrier's composition
adequate to enable identification; and (2) a specific definition of the
barrier by relevant technical characteristics. The Center for Food
Safety and Applied Nutrition shall review submitted test results
promptly. Within 60 days of the receipt of test results, the Director,
Center for Food Safety and Applied Nutrition, shall notify the person
submitting the test results whether the tests were conducted in
accordance with the ''Analytical Methodology for Polychlorinated
Biphenyls; June 1979'', which is incorporated by reference, or the
''Test Procedures for Determination of PCB Permeability of Food
Packaging, Inner-Wraps, September 1976, revised May 1983'' and whether,
therefore, the barrier or class of barriers is deemed functional within
the meaning of paragraph (c) of this section. The test results and any
response of the Food and Drug Administration shall be placed on file
with the Dockets Management Branch, Food and Drug Administration, Rm.
4-62, 5600 Fishers Lane, Rockville, MD 20857.
(42 FR 52819, Sept. 30, 1977, as amended at 44 FR 38340, June 29,
1979; 46 FR 8459, Jan. 27, 1981; 48 FR 10811, Mar. 15, 1983; 48 FR
37021, Aug. 16, 1983; 54 FR 24892, June 12, 1989)
Editorial Note: At 38 FR 22794, Aug. 24, 1973, the following
appeared concerning 109.30(a)(9) (formerly 122.10(a)(9)):
* * * 109.30(a)(9) is hereby stayed pending full review of the
objections and requests for hearing. * * *
In the interim, as stated in the final order (38 FR 18098) the Food
and Drug Administration will enforce the temporary tolerance level
established by 109.30(a)(9) by seizing any paper food-packaging
material shipped in interstate commerce after September 4, 1973
containing higher than the specified level of PCB's as adulterated in
violation of sec. 402 of the act.
21 CFR 109.30 Subpart C -- Regulatory Limits for Added Poisonous or Deleterious Substances (Reserved)
21 CFR 109.30 Subpart D -- Naturally Occurring Posionous or Deleterious Substances (Reserved)
21 CFR 109.30 PART 110 -- CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD
21 CFR 109.30 Pt. 110
21 CFR 109.30 Subpart A -- General Provisions
Sec.
110.3 Definitions.
110.5 Current good manufacturing practice.
110.10 Personnel.
110.19 Exclusions.
21 CFR 109.30 Subpart B -- Buildings and Facilities
110.20 Plant and grounds.
110.35 Sanitary operations.
110.37 Sanitary facilities and controls.
21 CFR 109.30 Subpart C -- Equipment
110.40 Equipment and utensils.
21 CFR 109.30 Subpart D (Reserved)
21 CFR 109.30 Subpart E -- Production and Process Controls
110.80 Processes and controls.
110.93 Warehousing and distribution.
21 CFR 109.30 Subpart F (Reserved)
21 CFR 109.30 Subpart G -- Defect Action Levels
110.110 Natural or unavoidable defects in food for human use that
present no health hazard.
Authority: Secs. 402, 701, 704 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 342, 371, 374); sec. 361 of the Public Health
Service Act (42 U.S.C. 264).
Source: 51 FR 24475, June 19, 1986, unless otherwise noted.
21 CFR 109.30 Subpart A -- General Provisions
21 CFR 110.3 Definitions.
The definitions and interpretations of terms in section 201 of the
Federal Food, Drug, and Cosmetic Act (the act) are applicable to such
terms when used in this part. The following definitions shall also
apply:
(a) ''Acid foods or acidified foods'' means foods that have an
equilibrium pH of 4.6 or below.
(b) ''Adequate'' means that which is needed to accomplish the
intended purpose in keeping with good public health practice.
(c) ''Batter'' means a semifluid substance, usually composed of flour
and other ingredients, into which principal components of food are
dipped or with which they are coated, or which may be used directly to
form bakery foods.
(d) ''Blanching,'' except for tree nuts and peanuts, means a
prepackaging heat treatment of foodstuffs for a sufficient time and at a
sufficient temperature to partially or completely inactivate the
naturally occurring enzymes and to effect other physical or biochemical
changes in the food.
(e) ''Critical control point'' means a point in a food process where
there is a high probability that improper control may cause, allow, or
contribute to a hazard or to filth in the final food or decomposition of
the final food.
(f) ''Food'' means food as defined in section 201(f) of the act and
includes raw materials and ingredients.
(g) ''Food-contact surfaces'' are those surfaces that contact human
food and those surfaces from which drainage onto the food or onto
surfaces that contact the food ordinarily occurs during the normal
course of operations. ''Food-contact surfaces'' includes utensils and
food-contact surfaces of equipment.
(h) ''Lot'' means the food produced during a period of time indicated
by a specific code.
(i) ''Microorganisms'' means yeasts, molds, bacteria, and viruses and
includes, but is not limited to, species having public health
significance. The term ''undesirable microorganisms'' includes those
microorganisms that are of public health significance, that subject food
to decomposition, that indicate that food is contaminated with filth, or
that otherwise may cause food to be adulterated within the meaning of
the act. Occasionally in these regulations, FDA used the adjective
''microbial'' instead of using an adjectival phrase containing the word
microorganism.
(j) ''Pest'' refers to any objectionable animals or insects
including, but not limited to, birds, rodents, flies, and larvae.
(k) ''Plant'' means the building or facility or parts thereof, used
for or in connection with the manufacturing, packaging, labeling, or
holding of human food.
(l) ''Quality control operation'' means a planned and systematic
procedure for taking all actions necessary to prevent food from being
adulterated within the meaning of the act.
(m) ''Rework'' means clean, unadulterated food that has been removed
from processing for reasons other than insanitary conditions or that has
been successfully reconditioned by reprocessing and that is suitable for
use as food.
(n) ''Safe-moisture level'' is a level of moisture low enough to
prevent the growth of undesirable microorganisms in the finished product
under the intended conditions of manufacturing, storage, and
distribution. The maximum safe moisture level for a food is based on
its water activity (aw). An aw will be considered safe for a food if
adequate data are available that demonstrate that the food at or below
the given aw will not support the growth of undesirable microorganisms.
(o) ''Sanitize'' means to adequately treat food-contact surfaces by a
process that is effective in destroying vegetative cells of
microorganisms of public health significance, and in substantially
reducing numbers of other undesirable microorganisms, but without
adversely affecting the product or its safety for the consumer.
(p) ''Shall'' is used to state mandatory requirements.
(q) ''Should'' is used to state recommended or advisory procedures or
identify recommended equipment.
(r) ''Water activity'' (aw) is a measure of the free moisture in a
food and is the quotient of the water vapor pressure of the substance
divided by the vapor pressure of pure water at the same temperature.
21 CFR 110.5 Current good manufacturing practice.
(a) The criteria and definitions in this part shall apply in
determining whether a food is adulterated (1) within the meaning of
section 402(a)(3) of the act in that the food has been manufactured
under such conditions that it is unfit for food; or (2) within the
meaning of section 402(a)(4) of the act in that the food has been
prepared, packed, or held under insanitary conditions whereby it may
have become contaminated with filth, or whereby it may have been
rendered injurious to health. The criteria and definitions in this part
also apply in determining whether a food is in violation of section 361
of the Public Health Service Act (42 U.S.C. 264).
(b) Food covered by specific current good manufacturing practice
regulations also is subject to the requirements of those regulations.
21 CFR 110.10 Personnel.
The plant management shall take all reasonable measures and
precautions to ensure the following:
(a) Disease control. Any person who, by medical examination or
supervisory observation, is shown to have, or appears to have, an
illness, open lesion, including boils, sores, or infected wounds, or any
other abnormal source of microbial contamination by which there is a
reasonable possibility of food, food-contact surfaces, or food-packaging
materials becoming contaminated, shall be excluded from any operations
which may be expected to result in such contamination until the
condition is corrected. Personnel shall be instructed to report such
health conditions to their supervisors.
(b) Cleanliness. All persons working in direct contact with food,
food-contact surfaces, and food-packaging materials shall conform to
hygienic practices while on duty to the extent necessary to protect
against contamination of food. The methods for maintaining cleanliness
include, but are not limited to:
(1) Wearing outer garments suitable to the operation in a manner that
protects against the contamination of food, food-contact surfaces, or
food-packaging materials.
(2) Maintaining adequate personal cleanliness.
(3) Washing hands thoroughly (and sanitizing if necessary to protect
against contamination with undesirable microorganisms) in an adequate
hand-washing facility before starting work, after each absence from the
work station, and at any other time when the hands may have become
soiled or contaminated.
(4) Removing all unsecured jewelry and other objects that might fall
into food, equipment, or containers, and removing hand jewelry that
cannot be adequately sanitized during periods in which food is
manipulated by hand. If such hand jewelry cannot be removed, it may be
covered by material which can be maintained in an intact, clean, and
sanitary condition and which effectively protects against the
contamination by these objects of the food, food-contact surfaces, or
food-packaging materials.
(5) Maintaining gloves, if they are used in food handling, in an
intact, clean, and sanitary condition. The gloves should be of an
impermeable material.
(6) Wearing, where appropriate, in an effective manner, hair nets,
headbands, caps, beard covers, or other effective hair restraints.
(7) Storing clothing or other personal belongings in areas other than
where food is exposed or where equipment or utensils are washed.
(8) Confining the following to areas other than where food may be
exposed or where equipment or utensils are washed: eating food, chewing
gum, drinking beverages, or using tobacco.
(9) Taking any other necessary precautions to protect against
contamination of food, food-contact surfaces, or food-packaging
materials with microorganisms or foreign substances including, but not
limited to, perspiration, hair, cosmetics, tobacco, chemicals, and
medicines applied to the skin.
(c) Education and training. Personnel responsible for identifying
sanitation failures or food contamination should have a background of
education or experience, or a combination thereof, to provide a level of
competency necessary for production of clean and safe food. Food
handlers and supervisors should receive appropriate training in proper
food handling techniques and food-protection principles and should be
informed of the danger of poor personal hygiene and insanitary
practices.
(d) Supervision. Responsibility for assuring compliance by all
personnel with all requirements of this part shall be clearly assigned
to competent supervisory personnel.
(51 FR 24475, June 19, 1986, as amended at 54 FR 24892, June 12,
1989)
21 CFR 110.19 Exclusions.
(a) The following operations are not subject to this part:
Establishments engaged solely in the harvesting, storage, or
distribution of one or more ''raw agricultural commodities,'' as defined
in section 201(r) of the act, which are ordinarily cleaned, prepared,
treated, or otherwise processed before being marketed to the consuming
public.
(b) FDA, however, will issue special regulations if it is necessary
to cover these excluded operations.
21 CFR 110.19 Subpart B -- Buildings and Facilities
21 CFR 110.20 Plant and grounds.
(a) Grounds. The grounds about a food plant under the control of the
operator shall be kept in a condition that will protect against the
contamination of food. The methods for adequate maintenance of grounds
include, but are not limited to:
(1) Properly storing equipment, removing litter and waste, and
cutting weeds or grass within the immediate vicinity of the plant
buildings or structures that may constitute an attractant, breeding
place, or harborage for pests.
(2) Maintaining roads, yards, and parking lots so that they do not
constitute a source of contamination in areas where food is exposed.
(3) Adequately draining areas that may contribute contamination to
food by seepage, foot-borne filth, or providing a breeding place for
pests.
(4) Operating systems for waste treatment and disposal in an adequate
manner so that they do not constitute a source of contamination in areas
where food is exposed.
If the plant grounds are bordered by grounds not under the operator's
control and not maintained in the manner described in paragraph (a) (1)
through (3) of this section, care shall be exercised in the plant by
inspection, extermination, or other means to exclude pests, dirt, and
filth that may be a source of food contamination.
(b) Plant construction and design. Plant buildings and structures
shall be suitable in size, construction, and design to facilitate
maintenance and sanitary operations for food-manufacturing purposes.
The plant and facilities shall:
(1) Provide sufficient space for such placement of equip- ment and
storage of materials as is necessary for the maintenance of sanitary
operations and the production of safe food.
(2) Permit the taking of proper precautions to reduce the potential
for contamination of food, food-contact surfaces, or food-packaging
materials with microorganisms, chemicals, filth, or other extraneous
material. The potential for contamination may be reduced by adequate
food safety controls and operating practices or effective design,
including the separation of operations in which contamination is likely
to occur, by one or more of the following means: location, time,
partition, air flow, enclosed systems, or other effective means.
(3) Permit the taking of proper precautions to protect food in
outdoor bulk fermentation vessels by any effective means, including:
(i) Using protective coverings.
(ii) Controlling areas over and around the vessels to eliminate
harborages for pests.
(iii) Checking on a regular basis for pests and pest infestation.
(iv) Skimming the fermentation vessels, as necessary.
(4) Be constructed in such a manner that floors, walls, and ceilings
may be adequately cleaned and kept clean and kept in good repair; that
drip or condensate from fixtures, ducts and pipes does not contaminate
food, food-contact surfaces, or food-packaging materials; and that
aisles or working spaces are provided between equipment and walls and
are adequately unobstructed and of adequate width to permit employees to
perform their duties and to protect against contaminating food or
food-contact surfaces with clothing or personal contact.
(5) Provide adequate lighting in hand-washing areas, dressing and
locker rooms, and toilet rooms and in all areas where food is examined,
processed, or stored and where equipment or utensils are cleaned; and
provide safety-type light bulbs, fixtures, skylights, or other glass
suspended over exposed food in any step of preparation or otherwise
protect against food contamination in case of glass breakage.
(6) Provide adequate ventilation or control equipment to minimize
odors and vapors (including steam and noxious fumes) in areas where they
may contaminate food; and locate and operate fans and other air-blowing
equipment in a manner that minimizes the potential for contaminating
food, food-packaging materials, and food-contact surfaces.
(7) Provide, where necessary, adequate screening or other protection
against pests.
21 CFR 110.35 Sanitary operations.
(a) General maintenance. Buildings, fixtures, and other physical
facilities of the plant shall be maintained in a sanitary condition and
shall be kept in repair sufficient to prevent food from becoming
adulterated within the meaning of the act. Cleaning and sanitizing of
utensils and equipment shall be conducted in a manner that protects
against contamination of food, food-contact surfaces, or food-packaging
materials.
(b) Substances used in cleaning and sanitizing; storage of toxic
materials. (1) Cleaning compounds and sanitizing agents used in
cleaning and sanitizing procedures shall be free from undesirable
microorganisms and shall be safe and adequate under the conditions of
use. Compliance with this requirement may be verified by any effective
means including purchase of these substances under a supplier's
guarantee or certification, or examination of these substances for
contamination. Only the following toxic materials may be used or stored
in a plant where food is processed or exposed:
(i) Those required to maintain clean and sanitary conditions;
(ii) Those necessary for use in laboratory testing procedures;
(iii) Those necessary for plant and equipment maintenance and
operation; and
(iv) Those necessary for use in the plant's operations.
(2) Toxic cleaning compounds, sanitizing agents, and pesticide
chemicals shall be identified, held, and stored in a manner that
protects against contamination of food, food-contact surfaces, or
food-packaging materials. All relevant regulations promulgated by other
Federal, State, and local government agencies for the application, use,
or holding of these products should be followed.
(c) Pest control. No pests shall be allowed in any area of a food
plant. Guard or guide dogs may be allowed in some areas of a plant if
the presence of the dogs is unlikely to result in contamination of food,
food-contact surfaces, or food-packaging materials. Effective measures
shall be taken to exclude pests from the processing areas and to protect
against the contamination of food on the premises by pests. The use of
insecticides or rodenticides is permitted only under precautions and
restrictions that will protect against the contamination of food,
food-contact surfaces, and food-packaging materials.
(d) Sanitation of food-contact surfaces. All food-contact surfaces,
including utensils and food-contact surfaces of equipment, shall be
cleaned as frequently as necessary to protect against contamination of
food.
(1) Food-contact surfaces used for manufacturing or holding
low-moisture food shall be in a dry, sanitary condition at the time of
use. When the surfaces are wet-cleaned, they shall, when necessary, be
sanitized and thoroughly dried before subsequent use.
(2) In wet processing, when cleaning is necessary to protect against
the introduction of microorganisms into food, all food-contact surfaces
shall be cleaned and sanitized before use and after any interruption
during which the food-contact surfaces may have become contaminated.
Where equipment and utensils are used in a continuous production
operation, the utensils and food-contact surfaces of the equipment shall
be cleaned and sanitized as necessary.
(3) Non-food-contact surfaces of equipment used in the operation of
food plants should be cleaned as frequently as necessary to protect
against contamination of food.
(4) Single-service articles (such as utensils intended for one-time
use, paper cups, and paper towels) should be stored in appropriate
containers and shall be handled, dispensed, used, and disposed of in a
manner that protects against contamination of food or food-contact
surfaces.
(5) Sanitizing agents shall be adequate and safe under conditions of
use. Any facility, procedure, or machine is acceptable for cleaning and
sanitizing equipment and utensils if it is established that the
facility, procedure, or machine will routinely render equipment and
utensils clean and provide adequate cleaning and sanitizing treatment.
(e) Storage and handling of cleaned portable equipment and utensils.
Cleaned and sanitized portable equipment with food-contact surfaces and
utensils should be stored in a location and manner that protects
food-contact surfaces from contamination.
(51 FR 24475, June 19, 1986, as amended at 54 FR 24892, June 12,
1989)
21 CFR 110.37 Sanitary facilities and controls.
Each plant shall be equipped with adequate sanitary facilities and
accommodations including, but not limited to:
(a) Water supply. The water supply shall be sufficient for the
operations intended and shall be derived from an adequate source. Any
water that contacts food or food-contact surfaces shall be safe and of
adequate sanitary quality. Running water at a suitable temperature, and
under pressure as needed, shall be provided in all areas where required
for the processing of food, for the cleaning of equipment, utensils, and
food-packaging materials, or for employee sanitary facilities.
(b) Plumbing. Plumbing shall be of adequate size and design and
adequately installed and maintained to:
(1) Carry sufficient quantities of water to required locations
throughout the plant.
(2) Properly convey sewage and liquid disposable waste from the
plant.
(3) Avoid constituting a source of contamination to food, water
supplies, equipment, or utensils or creating an unsanitary condition.
(4) Provide adequate floor drainage in all areas where floors are
subject to flooding-type cleaning or where normal operations release or
discharge water or other liquid waste on the floor.
(5) Provide that there is not backflow from, or cross-connection
between, piping systems that discharge waste water or sewage and piping
systems that carry water for food or food manufacturing.
(c) Sewage disposal. Sewage disposal shall be made into an adequate
sewerage system or disposed of through other adequate means.
(d) Toilet facilities. Each plant shall provide its employees with
adequate, readily accessible toilet facilities. Compliance with this
requirement may be accomplished by:
(1) Maintaining the facilities in a sanitary condition.
(2) Keeping the facilities in good repair at all times.
(3) Providing self-closing doors.
(4) Providing doors that do not open into areas where food is exposed
to airborne contamination, except where alternate means have been taken
to protect against such contamination (such as double doors or positive
air-flow systems).
(e) Hand-washing facilities. Hand-washing facilities shall be
adequate and convenient and be furnished with running water at a
suitable temperature. Compliance with this requirement may be
accomplished by providing:
(1) Hand-washing and, where appropriate, hand-sanitizing facilities
at each location in the plant where good sanitary practices require
employees to wash and/or sanitize their hands.
(2) Effective hand-cleaning and sanitizing preparations.
(3) Sanitary towel service or suitable drying devices.
(4) Devices or fixtures, such as water control valves, so designed
and constructed to protect against recontamination of clean, sanitized
hands.
(5) Readily understandable signs directing employees handling
unproteced food, unprotected food-packaging materials, of food-contact
surfaces to wash and, where appropriate, sanitize their hands before
they start work, after each absence from post of duty, and when their
hands may have become soiled or contaminated. These signs may be posted
in the processing room(s) and in all other areas where employees may
handle such food, materials, or surfaces.
(6) Refuse receptacles that are constructed and maintained in a
manner that protects against contamination of food.
(f) Rubbish and offal disposal. Rubbish and any offal shall be so
conveyed, stored, and disposed of as to minimize the development of
odor, minimize the potential for the waste becoming an attractant and
harborage or breeding place for pests, and protect against contamination
of food, food-contact surfaces, water supplies, and ground surfaces.
21 CFR 110.37 Subpart C -- Equipment
21 CFR 110.40 Equipment and utensils.
(a) All plant equipment and utensils shall be so designed and of such
material and workmanship as to be adequately cleanable, and shall be
properly maintained. The design, construction, and use of equipment and
utensils shall preclude the adulteration of food with lubricants, fuel,
metal fragments, contaminated water, or any other contaminants. All
equipment should be so installed and maintained as to facilitate the
cleaning of the equipment and of all adjacent spaces. Food-contact
surfaces shall be corrosion-resistant when in contact with food. They
shall be made of nontoxic materials and designed to withstand the
environment of their intended use and the action of food, and, if
applicable, cleaning compounds and sanitizing agents. Food-contact
surfaces shall be maintained to protect food from being contaminated by
any source, including unlawful indirect food additives.
(b) Seams on food-contact surfaces shall be smoothly bonded or
maintained so as to minimize accumulation of food particles, dirt, and
organic matter and thus minimize the opportunity for growth of
microorganisms.
(c) Equipment that is in the manufacturing or food-handling area and
that does not come into contact with food shall be so constructed that
it can be kept in a clean condition.
(d) Holding, conveying, and manufacturing systems, including
gravimetric, pneumatic, closed, and automated systems, shall be of a
design and construction that enables them to be maintained in an
appropriate sanitary condition.
(e) Each freezer and cold storage compartment used to store and hold
food capable of supporting growth of microorganisms shall be fitted with
an indicating thermometer, temperature-measuring device, or
temperature-recording device so installed as to show the temperature
accurately within the compartment, and should be fitted with an
automatic control for regulating temperature or with an automatic alarm
system to indicate a significant temperature change in a manual
operation.
(f) Instruments and controls used for measuring, regulating, or
recording temperatures, pH, acidity, water activity, or other conditions
that control or prevent the growth of undesirable microorganisms in food
shall be accurate and adequately maintained, and adequate in number for
their designated uses.
(g) Compressed air or other gases mechanically introduced into food
or used to clean food-contact surfaces or equipment shall be treated in
such a way that food is not contaminated with unlawful indirect food
additives.
21 CFR 110.40 Subpart D (Reserved)
21 CFR 110.40 Subpart E -- Production and Process Controls
21 CFR 110.80 Processes and controls.
All operations in the receiving, inspecting, transporting,
segregating, preparing, manufacturing, packaging, and storing of food
shall be conducted in accordance with adequate sanitation principles.
Appropriate quality control operations shall be employed to ensure that
food is suitable for human consumption and that food-packaging materials
are safe and suitable. Overall sanitation of the plant shall be under
the supervision of one or more competent individuals assigned
responsibility for this function. All reasonable precautions shall be
taken to ensure that production procedures do not contribute
contamination from any source. Chemical, microbial, or
extraneous-material testing procedures shall be used where necessary to
identify sanitation failures or possible food contamination. All food
that has become contaminated to the extent that it is adulterated within
the meaning of the act shall be rejected, or if permissible, treated or
processed to eliminate the contamination.
(a) Raw materials and other ingredients. (1) Raw materials and other
ingredients shall be inspected and segregated or otherwise handled as
necessary to ascertain that they are clean and suitable for processing
into food and shall be stored under conditions that will protect against
contamination and minimize deterioration. Raw materials shall be washed
or cleaned as necessary to remove soil or other contamination. Water
used for washing, rinsing, or conveying food shall be safe and of
adequate sanitary quality. Water may be reused for washing, rinsing, or
conveying food if it does not increase the level of contamination of the
food. Containers and carriers of raw materials should be inspected on
receipt to ensure that their condition has not contributed to the
contamination or deterioration of food.
(2) Raw materials and other ingredients shall either not contain
levels of microorganisms that may produce food poisoning or other
disease in humans, or they shall be pasteurized or otherwise treated
during manufacturing operations so that they no longer contain levels
that would cause the product to be adulterated within the meaning of the
act. Compliance with this requirement may be verified by any effective
means, including purchasing raw materials and other ingredients under a
supplier's guarantee or certification.
(3) Raw materials and other ingredients susceptible to contamination
with aflatoxin or other natural toxins shall comply with current Food
and Drug Administration regulations, guidelines, and action levels for
poisonous or deleterious substances before these materials or
ingredients are incorporated into finished food. Compliance with this
requirement may be accomplished by purchasing raw materials and other
ingredients under a supplier's guarantee or certification, or may be
verified by analyzing these materials and ingredients for aflatoxins and
other natural toxins.
(4) Raw materials, other ingredients, and rework susceptible to
contamination with pests, undesirable microorganisms, or extraneous
material shall comply with applicable Food and Drug Administration
regulations, guidelines, and defect action levels for natural or
unavoidable defects if a manufacturer wishes to use the materials in
manufacturing food. Compliance with this requirement may be verified by
any effective means, including purchasing the materials under a
supplier's guarantee or certification, or examination of these materials
for contamination.
(5) Raw materials, other ingredients, and rework shall be held in
bulk, or in containers designed and constructed so as to protect against
contamination and shall be held at such temperature and relative
humidity and in such a manner as to prevent the food from becoming
adulterated within the meaning of the act. Material scheduled for
rework shall be identified as such.
(6) Frozen raw materials and other ingredients shall be kept frozen.
If thawing is required prior to use, it shall be done in a manner that
prevents the raw materials and other ingredients from becoming
adulterated within the meaning of the act.
(7) Liquid or dry raw materials and other ingredients received and
stored in bulk form shall be held in a manner that protects against
contamination.
(b) Manufacturing operations. (1) Equipment and utensils and
finished food containers shall be maintained in an acceptable condition
through appropriate cleaning and sanitizing, as necessary. Insofar as
necessary, equipment shall be taken apart for thorough cleaning.
(2) All food manufacturing, including packaging and storage, shall be
conducted under such conditions and controls as are necessary to
minimize the potential for the growth of microorganisms, or for the
contamination of food. One way to comply with this requirement is
careful monitoring of physical factors such as time, temperature,
humidity, aw, pH, pressure, flow rate, and manufacturing operations such
as freezing, dehydration, heat processing, acidification, and
refrigeration to ensure that mechanical breakdowns, time delays,
temperature fluctuations, and other factors do not contribute to the
decomposition or contamination of food.
(3) Food that can support the rapid growth of undesirable
microorganisms, particularly those of public health significance, shall
be held in a manner that prevents the food from becoming adulterated
within the meaning of the act. Compliance with this requirement may be
accomplished by any effective means, including:
(i) Maintaining refrigerated foods at 45 F (7.2 C) or below as
appropriate for the particular food involved.
(ii) Maintaining frozen foods in a frozen state.
(iii) Maintaining hot foods at 140 F (60 C) or above.
(iv) Heat treating acid or acidified foods to destroy mesophilic
microorganisms when those foods are to be held in hermetically sealed
containers at ambient temperatures.
(4) Measures such as sterilizing, irradiating, pasteurizing,
freezing, refrigerating, controlling pH or controlling aw that are taken
to destroy or prevent the growth of undesirable microorganisms,
particularly those of public health significance, shall be adequate
under the conditions of manufacture, handling, and distribution to
prevent food from being adulterated within the meaning of the act.
(5) Work-in-process shall be handled in a manner that protects
against contamination.
(6) Effective measures shall be taken to protect finished food from
contamination by raw materials, other ingredients, or refuse. When raw
materials, other ingredients, or refuse are unprotected, they shall not
be handled simultaneously in a receiving, loading, or shipping area if
that handling could result in contaminated food. Food transported by
conveyor shall be protected against contamination as necessary.
(7) Equipment, containers, and utensils used to convey, hold, or
store raw materials, work-in-process, rework, or food shall be
constructed, handled, and maintained during manufacturing or storage in
a manner that protects against contamination.
(8) Effective measures shall be taken to protect against the
inclusion of metal or other extraneous material in food. Compliance
with this requirement may be accomplished by using sieves, traps,
magnets, electronic metal detectors, or other suitable effective means.
(9) Food, raw materials, and other ingredients that are adulterated
within the meaning of the act shall be disposed of in a manner that
protects against the contamination of other food. If the adulterated
food is capable of being reconditioned, it shall be reconditioned using
a method that has been proven to be effective or it shall be reexamined
and found not to be adulterated within the meaning of the act before
being incorporated into other food.
(10) Mechanical manufacturing steps such as washing, peeling,
trimming, cutting, sorting and inspecting, mashing, dewatering, cooling,
shredding, extruding, drying, whipping, defatting, and forming shall be
performed so as to protect food against contamination. Compliance with
this requirement may be accomplished by providing adequate physical
protection of food from contaminants that may drip, drain, or be drawn
into the food. Protection may be provided by adequate cleaning and
sanitizing of all food-contact surfaces, and by using time and
temperature controls at and between each manufacturing step.
(11) Heat blanching, when required in the preparation of food, should
be effected by heating the food to the required temperature, holding it
at this temperature for the required time, and then either rapidly
cooling the food or passing it to subsequent manufacturing without
delay. Thermophilic growth and contamination in blanchers should be
minimized by the use of adequate operating temperatures and by periodic
cleaning. Where the blanched food is washed prior to filling, water
used shall be safe and of adequate sanitary quality.
(12) Batters, breading, sauces, gravies, dressings, and other similar
preparations shall be treated or maintained in such a manner that they
are protected against contamination. Compliance with this requirement
may be accomplished by any effective means, including one or more of the
following:
(i) Using ingredients free of contamination.
(ii) Employing adequate heat processes where applicable.
(iii) Using adequate time and temperature controls.
(iv) Providing adequate physical protection of components from
contaminants that may drip, drain, or be drawn into them.
(v) Cooling to an adequate temperature during manufacturing.
(vi) Disposing of batters at appropriate intervals to protect against
the growth of microorganisms.
(13) Filling, assembling, packaging, and other operations shall be
performed in such a way that the food is protected against
contamination. Compliance with this requirement may be accomplished by
any effective means, including:
(i) Use of a quality control operation in which the critical control
points are identified and controlled during manufacturing.
(ii) Adequate cleaning and sanitizing of all food-contact surfaces
and food containers.
(iii) Using materials for food containers and food- packaging
materials that are safe and suitable, as defined in 130.3(d) of this
chapter.
(iv) Providing physical protection from contamination, particularly
airborne contamination.
(v) Using sanitary handling procedures.
(14) Food such as, but not limited to, dry mixes, nuts, intermediate
moisture food, and dehydrated food, that relies on the control of aw for
preventing the growth of undesirable microorganisms shall be processed
to and maintained at a safe moisture level. Compliance with this
requirement may be accomplished by any effective means, including
employment of one or more of the following practices:
(i) Monitoring the aw of food.
(ii) Controlling the soluble solids-water ratio in finished food.
(iii) Protecting finished food from moisture pickup, by use of a
moisture barrier or by other means, so that the aw of the food does not
increase to an unsafe level.
(15) Food such as, but not limited to, acid and acidified food, that
relies principally on the control of pH for preventing the growth of
undesirable microorganisms shall be monitored and maintained at a pH of
4.6 or below. Compliance with this requirement may be accomplished by
any effective means, including employment of one or more of the
following practices:
(i) Monitoring the pH of raw materials, food in process, and finished
food.
(ii) Controlling the amount of acid or acidified food added to
low-acid food.
(16) When ice is used in contact with food, it shall be made from
water that is safe and of adequate sanitary quality, and shall be used
only if it has been manufactured in accordance with current good
manufacturing practice as outlined in this part.
(17) Food-manufacturing areas and equipment used for manufacturing
human food should not be used to manufacture nonhuman food-grade animal
feed or inedible products, unless there is no reasonable possibility for
the contamination of the human food.
21 CFR 110.93 Warehousing and distribution.
Storage and transportation of finished food shall be under conditions
that will protect food against physical, chemical, and microbial
contamination as well as against deterioration of the food and the
container.
21 CFR 110.93 Subpart F (Reserved)
21 CFR 110.93 Subpart G -- Defect Action Levels
21 CFR 110.110 Natural or unavoidable defects in food for human use
that present no health hazard.
(a) Some foods, even when produced under current good manufacturing
practice, contain natural or unavoidable defects that at low levels are
not hazardous to health. The Food and Drug Administration establishes
maximum levels for these defects in foods produced under current good
manufacturing practice and uses these levels in deciding whether to
recommend regulatory action.
(b) Defect action levels are established for foods whenever it is
necessary and feasible to do so. These levels are subject to change
upon the development of new technology or the availability of new
information.
(c) Compliance with defect action levels does not excuse violation of
the requirement in section 402(a)(4) of the act that food not be
prepared, packed, or held under unsanitary conditions or the
requirements in this part that food manufacturers, distributors, and
holders shall observe current good manufacturing practice. Evidence
indicating that such a violation exists causes the food to be
adulterated within the meaning of the act, even though the amounts of
natural or unavoidable defects are lower than the currently established
defect action levels. The manufacturer, distributor, and holder of food
shall at all times utilize quality control operations that reduce
natural or unavoidable defects to the lowest level currently feasible.
(d) The mixing of a food containing defects above the current defect
action level with another lot of food is not permitted and renders the
final food adulterated within the meaning of the act, regardless of the
defect level of the final food.
(e) A compilation of the current defect action levels for natural or
unavoidable defects in food for human use that present no health hazard
may be obtained upon request from the Industry Programs Branch
(HFF-326), Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 200 C St. SW., Washington, DC 20204.
21 CFR 110.110 PART 113 -- THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS
21 CFR 110.110 Pt. 113
21 CFR 110.110 Subpart A -- General Provisions
Sec.
113.3 Definitions.
113.5 Current good manufacturing practice.
113.10 Personnel.
21 CFR 110.110 Subpart B (Reserved)
21 CFR 110.110 Subpart C -- Equipment
113.40 Equipment and procedures.
21 CFR 110.110 Subpart D -- Control of Components, Food Product
Containers, Closures, and In-Process Material
113.60 Containers.
21 CFR 110.110 Subpart E -- Production and Process Controls
113.81 Product preparation.
113.83 Establishing scheduled processes.
113.87 Operations in the thermal processing room.
113.89 Deviations in processing, venting, or control of critical
factors.
21 CFR 110.110 Subpart F -- Records and Reports
113.100 Processing and production records.
Authority: Secs. 402, 701, 704 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 342, 371, 374); sec. 361 of the Public Health
Service Act (42 U.S.C. 264).
Source: 44 FR 16215, Mar. 16, 1979, unless otherwise noted.
21 CFR 110.110 Subpart A -- General Provisions
21 CFR 113.3 Definitions.
For the purposes of this part, the following definitions apply:
(a) ''Aseptic processing and packaging'' means the filling of a
commercially sterilized cooled product into presterilized containers,
followed by aseptic hermetical sealing, with a presterilized closure, in
an atmosphere free of microorganisms.
(b) ''Bleeders'' means openings used to remove air that enters with
steam from retorts and steam chambers and to promote circulation of
steam in such retorts and steam chambers. Bleeders may serve as a means
of removing condensate.
(c) ''Come-up-time'' means the time which elapses between the
introduction of steam into the closed retort and the time when the
retort reaches the required processing temperature.
(d) ''Commercial processor'' includes any person engaged in
commercial, custom, or institutional (church, school, penal, or other
organization) processing of food, including pet food. Persons engaged
in the production of foods that are to be used in market or consumer
tests are also included.
(e) ''Commercial sterility'': (1) ''Commercial sterility'' of
thermally processed food means the condition achieved --
(i) By the application of heat which renders the food free of --
(a) Microorganisms capable of reproducing in the food under normal
nonrefrigerated conditions of storage and distribution; and
(b) Viable microorganisms (including spores) of public health
significance; or
(ii) By the control of water activity and the application of heat,
which renders the food free of microorganisms capable of reproducing in
the food under normal nonrefrigerated conditions of storage and
distribution.
(2) ''Commercial sterility'' of equipment and containers used for
aseptic processing and packaging of food means the condition achieved by
application of heat, chemical sterilant(s), or other appropriate
treatment that renders the equipment and containers free of viable
microorganisms having public health significance, as well as
microorganisms of nonhealth significance, capable of reproducing in the
food under normal nonrefrigerated conditions of storage and
distribution.
(f) ''Critical factor'' means any property, characteristic,
condition, aspect, or other parameter, variation of which may affect the
scheduled process and the attainment of commercial sterility.
(g) ''Flame sterilizer'' means an apparatus in which hermetically
sealed containers are agitated at atmospheric pressure, by either
continuous, discontinuous, or reciprocating movement, with impinging gas
flames to achieve sterilization temperatures. A holding period in a
heated section may follow the initial heating period.
(h) ''Headspace, gross'' is the vertical distance between the level
of the product (generally the liquid surface) in an upright rigid
container and the top edge of the container (the top of the double seam
of a can or the top edge of a glass jar).
(i) ''Headspace, net'' of a container is the vertical distance
between the level of the product (generally the liquid surface) in the
upright rigid container and the inside surface of the lid.
(j) ''Hermetically sealed container'' means a container that is
designed and intended to be secure against the entry of microorganisms
and thereby to maintain the commercial sterility of its contents after
processing.
(k) ''Incubation'' means the holding of a sample(s) at a specified
temperature for a specified period of time for the purpose of permitting
or stimulating the growth of microorganisms.
(l) ''Initial temperature'' means the average temperature of the
contents of the coldest container to be processed at the time the
thermal processing cycle begins, as determined after thorough stirring
or shaking of the filled and sealed container.
(m) ''Lot'' means that amount of a product produced during a period
of time indicated by a specific code.
(n) ''Low-acid foods'' means any foods, other than alcoholic
beverages, with a finished equilibrium pH greater than 4.6 and a water
activity (aw) greater than 0.85. Tomatoes and tomato products having a
finished equilibrium pH less than 4.7 are not classed as low-acid foods.
(o) ''Minimum thermal process'' means the application of heat to
food, either before or after sealing in a hermetically sealed container,
for a period of time and at a temperature scientifically determined to
be adequate to ensure destruction of microorganisms of public health
significance.
(p) ''Operating process'' means the process selected by the processor
that equals or exceeds the minimum requirements set forth in the
scheduled process.
(q) ''Retort'' means any closed vessel or other equipment used for
the thermal processing of foods.
(r) ''Scheduled process'' means the process selected by the processor
as adequate under the conditions of manufacture for a given product to
achieve commercial sterility. This process may be in excess of that
necessary to ensure destruction of microorganisms of public health
significance, and shall be at least equivalent to the process
established by a competent processing authority to achieve commercial
sterility.
(s) ''Shall'' is used to state mandatory requirements.
(t) ''Should'' is used to state recommended or advisory procedures or
to identify recommended equipment.
(u) ''Vacuum-packed products'' means those products that are sealed
in a container under the vacuum specified in the scheduled process, the
maintenance of which vacuum is critical to the adequacy of the scheduled
process.
(v) ''Vents'' means openings through the retort shell, controlled by
gate, plug cock, or other adequate valves used for the elimination of
air during the venting period.
(w) ''Water activity'' (aw) is a measure of the free moisture in a
product and is the quotient of the water vapor pressure of the substance
divided by the vapor pressure of pure water at the same temperature.
21 CFR 113.5 Current good manufacturing practice.
The criteria in 113.10, 113.40, 113.60, 113.81, 113.83, 113.87,
113.89, and 113.100 shall apply in determining whether the facilities,
methods, practices, and controls used by the commercial processor in the
manufacture, processing, or packing of low-acid foods in hermetically
sealed containers are operated or administered in a manner adequate to
protect the public health.
21 CFR 113.10 Personnel.
The operators of processing systems, retorts, aseptic processing and
packaging systems and product formulating systems (including systems
wherein water activity is used in conjunction with thermal processing)
and container closure inspectors shall be under the operating
supervision of a person who has attended a school approved by the
Commissioner for giving instruction appropriate to the preservation
technology involved and who has been identified by that school as having
satisfactorily completed the prescribed course of instruction. This
person shall supervise only in those areas for which a school approved
by the Commissioner identifies the person as having satisfactorily
completed training.
21 CFR 113.10 Subpart B (Reserved)
21 CFR 113.10 Subpart C -- Equipment
21 CFR 113.40 Equipment and procedures.
(a) Equipment and procedures for pressure processing in steam in
still retorts -- (1) Indicating mercury-in-glass thermometer. Each
retort shall be equipped with at least one mercury-in-glass thermometer
whose divisions are easily readable to 1 F and whose temperature range
does not exceed 17 F per inch of graduated scale. Thermometers shall
be tested for accuracy against a known accurate standard thermometer
upon installation and at least once a year thereafter, or more
frequently if necessary, to ensure their accuracy. Records of
thermometer accuracy checks that specify date, standard used, method
used, and person performing the test should be maintained. Each
thermometer should have a tag, seal, or other means of identity that
includes the date on which it was last tested for accuracy. A
thermometer that has a divided mercury column or that cannot be adjusted
to the standard shall be repaired or replaced before further use of the
retort. Thermometers shall be installed where they can be accurately
and easily read. Bulbs of indicating thermometers shall be installed
either within the retort shell or in external wells attached to the
retort. External wells or pipes shall be connected to the retort
through at least a 3/4-inch diameter opening and equipped with a
1/16-inch or larger bleeder opening so located as to provide a full flow
of steam past the length of the thermometer bulb. The bleeders for
external wells shall emit steam continuously during the entire
processing period. The mercury thermometer -- not the recorder chart --
shall be the reference instrument for indicating the processing
temperature.
(2) Temperature-recording device. Each still retort shall have an
accurate temperature-recording device. Graduations on the
temperature-recording devices shall not exceed 2 F within a range of 10
F of the processing temperature. Each chart shall have a working scale
of not more than 55 F per inch within a range of 20 F of the
processing temperature. The temperature chart shall be adjusted to
agree as nearly as possible with, but to be in no event higher than, the
known accurate mercury-in-glass thermometer during the process time. A
means of preventing unauthorized changes in adjustment shall be
provided. A lock, or a notice from management posted at or near the
recording device which provides a warning that only authorized persons
are permitted to make adjustments, is a satisfactory means for
preventing unauthorized changes. The recorder may be combined with the
steam controller and may be a recording-controlling instrument. The
temperature-recorder bulb shall be installed either within the retort
shell or in a well attached to the shell. Each temperature-recorder
bulb well shall have a 1/16-inch or larger bleeder which emits steam
continuously during the processing period. Air-operated temperature
controllers should have adequate filter systems to ensure a supply of
clean, dry air.
(3) Pressure gages. Each retort should be equipped with a pressure
gage that should be graduated in divisions of 2 pounds or less.
(4) Steam controller. Each retort shall be equipped with an
automatic steam controller to maintain the retort temperature. This may
be a recording-controlling instrument when combined with a recording
thermometer. The steam controller may be air-operated and actuated by a
temperature sensor positioned near the mercury-in-glass thermometer in
the retort; a steam controller activated by the steam pressure of the
retort is acceptable if it is carefully maintained mechanically so that
it operates satisfactorily.
(5) Steam inlet. The steam inlet to each still retort shall be large
enough to provide sufficient steam for proper operation of the retort.
Steam may enter either the top portion or the bottom portion of the
retort but, in any case, shall enter the portion of the retort opposite
the vent; for example, steam inlet in bottom portion and vent in top
portion.
(6) Crate supports. A bottom crate support shall be used in vertical
still retorts. Baffle plates shall not be used in the bottom of still
retorts.
(7) Steam spreaders. Steam spreaders are continuations of the steam
inlet line inside the retort. Horizontal still retorts shall be
equipped with steam spreaders that extend the length of the retort. For
steam spreaders along the bottom of the retort, the perforations should
be along the top 90 of this pipe, that is, within 45 on either side of
the top center. Horizontal still retorts over 30 feet long should have
two steam inlets connected to the spreader. In vertical still retorts,
the steam spreaders, if used, should be perforated along the center line
of the pipe facing the interior of the retort or along the sides of the
pipe. The number of perforations should be such that the total
cross-sectional area of the perforations is equal to 1 1/2 to 2 times
the cross-sectional area of the smallest restriction in the steam inlet
line.
(8) Bleeders. Bleeders, except those for thermometer wells, shall be
one-eighth inch or larger and shall be wide open during the entire
process, including the come-up-time. For horizontal still retorts,
bleeders shall be located within approximately 1 foot of the outermost
locations of containers at each end along the top of the retort;
additional bleeders shall be located not more than 8 feet apart along
the top. Bleeders may be installed at positions other than those
specified above, as long as there is evidence in the form of heat
distribution data that they accomplish adequate removal of air and
circulation of steam within the retort. Vertical retorts shall have at
least one bleeder opening located in that portion of the retort opposite
the steam inlet. In retorts having top steam inlet and bottom venting,
a bleeder shall be installed in the bottom of the retort to remove
condensate. All bleeders shall be arranged so that the operator can
observe that they are functioning properly.
(9) Stacking equipment and position of containers. Crates, trays,
gondolas, etc., for holding containers shall be made of strap iron,
adequately perforated sheet metal, or other suitable material. When
perforated sheet metal is used for the bottoms, the perforations should
be approximately the equivalent of 1-inch holes on 2-inch centers. If
dividers are used between the layers of containers, they should be
perforated as above. The positioning of containers in the retort, when
specified in the scheduled process, shall be in accordance with that
process.
(10) Air valves. Retorts using air for pressure cooling shall be
equipped with a suitable valve to prevent air leakage into the retort
during processing.
(11) Water valves. Retorts using water for cooling shall be equipped
with a suitable valve to prevent leakage of water into the retort during
processing.
(12) Vents. Vents shall be installed in such a way that air is
removed from the retort before timing of the process is started. Vents
shall be controlled by gate, plug cock, or other adequate type valves
which shall be fully open to permit rapid discharge of air from the
retort during the venting period. Vents shall not be connected directly
to a closed drain system. If the overflow is used as a vent, there
shall be an atmospheric break in the line before it connects to a closed
drain. The vent shall be located in that portion of the retort opposite
the steam inlet; for example, steam inlet in bottom portion and vent in
top portion. Where a retort manifold connects several vent pipes from a
single still retort, it shall be controlled by a gate, plug cock, or
other adequate type valve. The retort manifold shall be of a size that
the cross-sectional area of the pipe is larger than the total
cross-sectional area of all connecting vents. The discharge shall not
be directly connected to a closed drain without an atmospheric break in
the line. A manifold header connecting vents or manifolds from several
still retorts shall lead to the atmosphere. The manifold header shall
not be controlled by a valve and shall be of a size that the
cross-sectional area is at least equal to the total cross-sectional area
of all connecting retort manifold pipes from all retorts venting
simultaneously. Timing of the process shall not begin until the retort
has been properly vented and the processing temperature has been
reached. Some typical installations and operating procedures reflecting
the requirements of this section for venting still retorts are given in
paragraph (a)(12)(i)(a) through (d) and (ii)(a) and (b) of this section.
(i) Venting horizontal retorts. (a) Venting through multiple 1-inch
vents discharging directly to atmosphere.
INSERT ILLUS. 059
Specifications. One 1-inch vent for every 5 feet of retort length,
equipped with a gate or plug cock valve and discharging to atmosphere;
end vents not more than 2 1/2 feet from ends of retort.
Venting method. Vent valves should be wide open for at least 5
minutes and to at least 225 F, or at least 7 minutes and to at least
220 F.
(b) Venting through multiple 1-inch vents discharging through a
manifold to atmosphere.
INSERT ILLUS. 063
Specifications. One 1-inch vent for every 5 feet of retort length;
and vents not over 2 1/2 feet from ends of retort: Size of manifold --
for retorts less than 15 feet in length, 2 1/2 inches; for retorts 15
feet and over in length, 3 inches.
Venting method. Manifold vent gate or plug cock valve should be wide
open for at least 6 minutes and to at least 225 F, or for at least 8
minutes and to at least 220 F.
(c) Venting through water spreaders.
INSERT ILLUS. 0066
Size of vent and vent valve. For retorts less than 15 feet in
length, 2 inches; for retorts 15 feet and over in length, 2 1/2 inches.
Size of water spreader. For retorts less than 15 feet in length, 1
1/2 inches; for retorts 15 feet and over in length, 2 inches. The
number of holes should be such that their total cross-sectional area is
approximately equal to the cross-sectional area of the vent pipe inlet.
Venting method. Water spreader vent gate or plug cock valve should
be wide open for at least 5 minutes and to at least 225 F, or for at
least 7 minutes and to at least 220 F.
(d) Venting through a single 2 1/2-inch top vent (for retorts not
exceeding 15 feet in length).
INSERT ILLUS. 069
Specifications: A 2 1/2-inch vent equipped with a 2 1/2-inch gate or
plug cock valve and located within 2 feet of the center of the retort.
Venting method: Vent gate or plug cock valve should be wide open for
at least 4 minutes and to at least 220 F.
(ii) Venting vertical retorts. (a) Venting through a 1 1/2-inch
overflow.
INSERT ILLUS. 072
Specifications. A 1 1/2-inch overflow pipe equipped with a 1 1/2-inch
gate or plug cock valve and with not more than 6 feet of 1 1/2-inch pipe
beyond the valve before break to the atmosphere or to a manifold header.
Venting method. Vent gate or plug cock valve should be wide open for
at least 4 minutes and to at least 218 F, or for at least 5 minutes and
to at least 215 F.
(b) Venting through a single 1-inch side or top vent.
INSERT ILLUS. 075
Specifications. A 1-inch vent in lid or top side, equipped with a
1-inch gate or plug cock valve and discharging directly into the
atmosphere or to a manifold header.
Venting method. Vent gate or plug cock valve should be wide open for
at least 5 minutes and to at least 230 F, or for at least 7 minutes and
to at least 220 F.
(iii) Other installations and operating procedures that deviate from
the above specifications may be used if there is evidence in the form of
heat distribution data, which shall be kept on file, that they
accomplish adequate venting of air.
(13) Critical factors. Critical factors specified in the scheduled
process shall be measured and recorded on the processing record at
intervals of sufficient frequency to ensure that the factors are within
the limits specified in the scheduled process.
(i) When maximum fill-in or drained weight is specified in the
scheduled process, it shall be measured and recorded at intervals of
sufficient frequency to ensure that the weight of the product does not
exceed the maximum for the given container size specified in the
scheduled process.
(ii) Closing machine vacuum in vacuum-packed products shall be
observed and recorded at intervals of sufficient frequency to ensure
that the vacuum is as specified in the scheduled process.
(iii) Such measurements and recordings should be made at intervals
not to exceed 15 minutes.
(iv) When the product style results in stratification or layering of
the primary product in the containers, the positioning of containers in
the retort shall be according to the scheduled process.
(b) Equipment and procedures for pressure processing in water in
still retorts -- (1) Indicating mercury-in-glass thermometer. Each
retort shall be equipped with at least one mercury-in-glass thermometer
whose divisions are easily readable to 1 F and whose temperature range
does not exceed 17 F per inch of graduated scale. Thermometers shall
be tested for accuracy against a known accurate standard thermometer
upon installation and at least once a year thereafter, or more
frequently if necessary, to ensure their accuracy. Records of
thermometer accuracy checks which specify date, standard used, method
used, and person performing the test should be maintained. Each
thermometer should have a tag, seal, or other means of identity that
includes the date when it was last tested for accuracy. A thermometer
that has a divided mercury column or that cannot be adjusted to the
standard shall be repaired or replaced before further use of the retort.
Thermometers shall be installed where they can be accurately and easily
read. Bulbs of indicating thermometers shall be located in such a
position that they are beneath the surface of the water throughout the
process. On horizontal retorts, this entry should be made in the side
at the center, and the thermometer bulbs shall be inserted directly into
the retort shell. In both vertical and horizontal retorts, the
thermometer bulbs shall extend directly into the water a minimum of at
least 2 inches without a separable well or sleeve. The mercury
thermometer -- not the recorder chart -- shall be the reference
instrument for indicating the processing temperature.
(2) Temperature-recording device. Each still retort shall have an
accurate temperature-recording device. Graduations on the
temperature-recording devices shall not exceed 2 F within a range of 10
F of the processing temperature. Each chart shall have a working scale
of not more than 55 F per inch within a range of 20 F of the
processing temperature. The temperature chart shall be adjusted to
agree as nearly as possible with, but to be in no event higher than, the
known accurate mercury-in-glass thermometer during the process time. A
means of preventing unauthorized changes in adjustment shall be
provided. A lock, or a notice from management posted at or near the
recording device which provides a warning that only authorized persons
are permitted to make adjustments, is a satisfactory means for
preventing unauthorized changes. The recorder may be combined with the
steam controller and may be a recording-controlling instrument. The
recording-thermometer bulb should be located adjacent to the bulb of the
mercury-in-glass thermometer, except in the case of a vertical retort
equipped with a combination recorder-controller. In such vertical
retorts, the temperature recorder-control bulb shall be located at the
bottom of the retort below the lowest crate rest in such a position that
the steam does not strike it directly. In horizontal retorts, the
temperature recorder-control bulb shall be located between the water
surface and the horizontal plane passing through the center of the
retort so that there is no opportunity for direct steam impingement on
the control bulb. Air-operated temperature controllers should have
adequate filter systems to ensure a supply of clean, dry air.
(3) Pressure gages. (i) Each retort should be equipped with a
pressure gage, which should be graduated in divisions of 2 pounds or
less.
(ii) Each retort should have an adjustable pressure relief or control
valve of a capacity sufficient to prevent an undesired increase in
retort pressure when the water valve is wide open and should be
installed in the overflow line.
(4) Steam controller. Each retort shall be equipped with an
automatic steam controller to maintain the retort temperature. This may
be a recording-controlling instrument when combined with a recording
thermometer.
(5) Steam introduction. Steam shall be distributed in the bottom of
the retort in a manner adequate to provide uniform heat distribution
throughout the retort. In vertical retorts, uniform steam distribution
can be achieved by any of several methods. In horizontal retorts, the
steam distributor shall run the length of the bottom of the retort with
perforations distributed uniformly along the upper part of the pipe.
(6) Crate supports. A bottom crate support shall be used in vertical
still retorts. Baffle plates shall not be used in the bottom of the
retort. Centering guides should be installed so as to ensure that there
is about a 1 1/2-inch clearance between the side wall of the crate and
the retort wall.
(7) Stacking equipment and position of containers. Crates, trays,
gondolas, etc., for holding containers shall be made of strap iron,
adequately perforated sheet metal, or other suitable material. When
perforated sheet metal is used for the bottoms, the perforations should
be approximately the equivalent of 1-inch holes on 2-inch centers. If
divider plates are used between the layers of containers, they should be
perforated as above. The positioning of containers in the retort, when
specified in the scheduled process, shall be in accordance with that
process. Dividers, racks, trays, or other means of positioning of
flexible containers shall be designed and employed to ensure even
circulation of heating medium around all containers in the retort.
(8) Drain valve. A nonclogging, water-tight valve shall be used.
Screens should be installed over all drain openings.
(9) Water level indicator. There shall be a means of determining the
water level in the retort during operation, e.g., by using a gage, water
glass, or petcock(s). Water shall cover the top layer of containers
during the entire come-up-time and processing periods and should cover
the top layer of containers during the cooling periods. The operator
shall check and record the water level at intervals sufficient to ensure
its adequacy.
(10)(i) Air supply and controls. In both horizontal and vertical
still retorts for pressure processing in water, a means shall be
provided for introducing compressed air at the proper pressure and rate.
The proper pressure shall be controlled by an automatic pressure
control unit. A check valve shall be provided in the air supply line to
prevent water from entering the system. Air or water circulation shall
be maintained continuously during the come-up-time and during processing
and cooling periods; the adequacy of the air or water circulation for
uniform heat distribution within the retort shall be established in
accordance with procedures recognized by a competent processing
authority and records shall be kept on file; if air is used to promote
circulation, it shall be introduced into the steam line at a point
between the retort and the steam control valve at the bottom of the
retort.
(ii) Water circulation. When a water circulating system is used for
heat distribution, is shall be installed in such a manner that water
will be drawn from the bottom of the retort through a suction manifold
and discharged through a spreader which extends the length of the top of
the retort. The holes in the water spreader shall be uniformly
distributed and should have an aggregate area not greater than the
cross-section area of the outlet line from the pump. The suction
outlets should be protected with nonclogging screens to keep debris from
entering the circulating system. The pump shall be equipped with a
pilot light or other signaling device to warm the operator when it is
not running, and with a bleeder to remove air when starting operations.
Alternative methods for circulation of water in the retort may be used
when established by a competent authority as adequate for even heat
distribution.
(11) Cooling water supply. In vertical retorts the cooling water
should be introduced at the top of the retort between the water and
container levels; in horizontal retorts the cooling water should be
introduced into the suction side of the pump. A check valve should be
included in the cooling water line.
(12) Retort headspace. The headspace necessary to control the air
pressure should be maintained between the water level and the top of the
retort shell.
(13) Vertical and horizontal still retorts. Vertical and horizontal
still retorts should follow the arrangements in the diagrams below in
this paragraph. Other installation and operating procedures that
deviate from these arrangements may be used, as long as there is
evidence in the form of heat distribution data or other suitable
information, which shall be kept on file, that demonstrates that the
heat distribution is adequate.
INSERT ILLUS. 086
A -- Water line.
B -- Steam line.
C -- Temperature control.
D -- Overflow line.
E1 -- Drain line.
E2 -- Screens.
F -- Check valves.
G -- Line from hot water storage.
H -- Suction line and manifold.
I -- Circulating pump.
J -- Petcocks.
K -- Recirculating line.
L -- Steam distributor.
M -- Temperature-controller bulb.
N -- Thermometer.
O -- Water spreader.
P -- Safety valve.
Q -- Vent valve for steam processing.
R -- Pressure gage.
S -- Inlet air control.
T -- Pressure control.
U -- Air line.
V -- To pressure control instrument.
W -- To temperature control instrument.
X -- Wing nuts.
Y1 -- Crate support.
Y2 -- Crate guides.
Z -- Constant flow orifice valve.
Z1 -- Constant flow orifice valve used during come-up.
Z2 -- Constant flow orifice valve used during cook.
(14) Critical factors. Critical factors specified in the scheduled
process shall be measured and recorded on the processing record at
intervals of sufficient frequency to ensure that the factors are within
the limits specified in the scheduled process.
(i) When maximum fill-in or drained weight is specified in the
scheduled process, it shall be measured and recorded at intervals of
sufficient frequency to ensure that the weight of the product does not
exceed the maximum for the given container size specified in the
scheduled process.
(ii) Closing machine vacuum in vacuum-packed products shall be
observed and recorded at intervals of sufficient frequency to ensure
that the vacuum is as specified in the scheduled process.
(iii) Such measurements and recordings should be made at intervals
not to exceed 15 minutes.
(iv) When the product style results in stratification or layering of
the primary product in the containers, the positioning of containers in
the retort shall be according to the scheduled process.
(c) Equipment and procedures for pressure processing in steam in
continuous agitating retorts -- (1) Indicating mercury-in-glass
thermometer. Each retort shall be equipped with at least one
mercury-in-glass thermometer whose divisions are easily readable to 1 F
and whose temperature range does not exceed 17 F per inch of graduated
scale. Thermometers shall be tested for accuracy against a known
accurate standard thermometer upon installation and at least once a year
thereafter, or more frequently if necessary, to ensure their accuracy.
Records of thermometer accuracy checks which specify date, standard
used, method used, and person performing the test should be maintained.
Each thermometer should have a tag, seal, or other means of identity
that includes the date on which it was last tested for accuracy. A
thermometer that has a divided mercury column or that cannot be adjusted
to the standard shall be repaired or replaced before further use of the
retort. Thermometers shall be installed where they can be accurately
and easily read. Bulbs in indicating thermometers shall be installed
either within the retort shell or in external wells attached to the
retort. External wells or pipes shall be connected to the retort
through at least a 3/4-inch diameter opening, and equipped with a
1/16-inch or larger bleeder opening so located as to provide a full flow
of steam past the length of the thermometer bulb. The bleeders for
external wells shall emit steam continuously during the entire
processing period. The mercury thermometer -- not the recorder chart --
shall be the reference instrument for indicating the processing
temperature.
(2) Temperature-recording device. Each retort shall have an accurate
temperature-recording device. Graduations on the temperature-recording
devices shall not exceed 2 F within a range of 10 F of the processing
temperature. Each chart shall have a working scale of not more than 55
F per inch within a range of 20 F of the processing temperature. The
temperature chart shall be adjusted to agree as nearly as possible with,
but to be in no event higher than, the known accurate mercury-in-glass
thermometer during the process time. A means of preventing unauthorized
changes in adjustment shall be provided. A lock, or a notice from
management posted at or near the recording device that provides a
warning that only authorized persons are permitted to make adjustments,
is a satisfactory means of preventing unauthorized changes. The
recorder may be combined with the steam controller and may be a
recording-controlling instrument. The temperature-recorder bulb shall
be installed either within the retort shell or in a well attached to the
shell. Each temperature-recorder bulb well shall have a 1/16-inch or
larger bleeder opening emitting steam continuously during the processing
period. Air-operated temperature controllers should have adequate
filter systems to ensure a supply of clean, dry air.
(3) Pressure gages. Each retort should be equipped with a pressure
gage that should be graduated in divisions of 2 pounds or less.
(4) Steam controller. Each retort shall be equipped with an
automatic steam controller to maintain the retort temperature. This may
be a recording-controlling instrument when combined with a recording
thermometer. A steam controller activated by the steam pressure of the
retort is acceptable if it is carefully maintained mechanically so that
it operates satisfactorily.
(5) Bleeders. Bleeders, except those for thermometer wells, shall be
one-eight inch or larger and shall be wide open during the entire
process, including the come-up-time. Bleeders shall be located within
approximately 1 foot of the outermost location of containers at each end
along the top of the retort; additional bleeders shall be located not
more than 8 feet apart along the top of the retort. All bleeders shall
be arranged so that the operator can observe that they are functioning
properly. The condensate bleeder shall be checked with sufficient
frequency to ensure adequate removal of condensate or shall be equipped
with an automatic alarm system(s) that would serve as a continuous
monitor of condensate-bleeder functioning. Visual checks should be done
at intervals of not more than 15 minutes. A record of such checks
should be kept to show that the bleeder is functioning properly.
(6) Venting and condensate removal. Vents shall be located in that
portion of the retort opposite the steam inlet. Air shall be removed
before processing is started. Heat distribution data or documentary
proof from the manufacturer or from a competent processing authority,
demonstrating that adequate venting is achieved, shall be kept on file.
At the time steam is turned on, the drain should be opened for a time
sufficient to remove steam condensate from the retort, and provision
shall be made for continuing drainage of condensate during the retort
operation. The condensate bleeder in the bottom of the shell serves as
an indicator of continuous condensate removal.
(7) Retort speed timing. The rotational speed of the retort shall be
specified in the scheduled process. The speed shall be adjusted and
recorded when the retort is started, at any time a speed change is made,
and at intervals of sufficient frequency to ensure that the retort speed
is maintained as specified in the scheduled process. These adjustments
and recordings should be made every 4 hours or less. Alternatively, a
recording tachometer may be used to provide a continuous record of the
speed. A means of preventing unauthorized speed changes on retorts
shall be provided. A lock, or a notice from management posted at or
near the speed adjustment device that provides a warning that only
authorized persons are permitted to make adjustments, is a satisfactory
means of preventing unauthorized changes.
(8) Emergency stops. If a retort jams or breaks down during
processing operations, necessitating cooling the retort for repairs, the
retort shall be operated in such a way that ensures that the product is
commercially sterile, or the retort is to be cooled promptly and all
containers either reprocessed, repacked and reprocessed, or discarded.
When operated as a still retort, all containers shall be given a full
still retort process before the retort is cooled. If, in such an
emergency, a scheduled still process or another process established to
ensure commercial sterility is to be used, it shall be made readily
available to the retort operator.
(i) Any containers in the retort intake valve or in transfer valves
between cooker shells of a continuous retort at the time of breakdown
shall either be reprocessed, repacked and reprocessed, or discarded.
(ii) Both the time at which the reel stopped and the time the retort
was used for a still retort process, if so used, shall be marked on the
recording chart and entered on the other production records required in
this chapter. If the alternative procedure of prompt cooling is
followed, the subsequent handling methods used for the containers in the
retort at the time of stopping and cooling shall be entered on the
production records.
(9) Temperature drop. If the temperature of the continuous retort
drops below the temperature specified in the scheduled process while
containers are in the retort, the retort reel shall be stopped promptly.
An automatic device should be used to stop the reel when the
temperature drops below the specified process temperature. Before the
reel is restarted, all containers in the retort shall be given a
complete scheduled still retort process if the temperature drop was 10
F or more below the specified temperature, or alternatively, container
entry to the retort shall be stopped and the reel restarted to empty the
retort. The discharged containers shall be either reprocessed, repacked
and reprocessed, or discarded. Both the time at which the reel stopped
and the time the retort was used for a still retort process, if so used,
shall be marked on the recording chart and entered on the other
production records required in this chapter. If the alternative
procedure of emptying the retort is followed, the subsequent handing
methods used for the containers in the retort at the time of the
temperature drop shall be entered on the production records. If the
temperature drop was less than 10 F, a scheduled authorized emergency
still process approved by a qualified person(s) having expert knowledge
of thermal processing requirements may be used before restarting the
retort reel. Alternatively, container entry to the retort shall be
stopped and an authorized emergency agitating process may be used before
container entry to the retort is restarted. When emergency procedures
are used, no containers may enter the retort and the process and
procedures used shall be noted on the production records.
(10) Critical factors. Critical factors specified in the scheduled
process shall be measured and recorded on the processing record at
intervals of sufficient frequency to ensure that the factors are within
the limits specified in the scheduled process. The minimum headspace of
containers, if specified in the scheduled process, shall be measured and
recorded at intervals of sufficient frequency to ensure that the
headspace is as specified in the scheduled process. The headspace of
solder-tipped, lapseam (vent hole) cans may be measured by net weight
determinations. The headspace of double seamed cans may also be
measured by net weight determinations for homogenous liquids, taking
into account the specific can end profile and other factors which affect
the headspace, if proof of the accuracy of such measurements is
maintained and the procedure and resultant headspace is in accordance
with the scheduled process. When the product consistency is specified
in the scheduled process, the consistency of the product shall be
determined by objective measurements on the product taken from the
filler before processing and recorded at intervals of sufficient
frequency to ensure that the consistency is as specified in the
scheduled process. Minimum closing machine vacuum in vacuum-packed
products, maximum fill-in or drained weight, minimum net weight, and
percent solids shall be as specified in the scheduled process for all
products when deviations from such specifications may affect the
scheduled process. All measurements and recordings of critical factors
should be made at intervals not to exceed 15 minutes.
(d) Equipment and procedures for pressure processing in steam in
discontinuous agitating retorts -- (1) Indicating mercury-in-glass
thermometer. Each retort shall be equipped with at least one
mercury-in-glass thermometer whose divisions are easily readable to 1 F
and whose temperature range does not exceed 17 F per inch of graduated
scale. Thermometers shall be tested for accuracy against a known
accurate standard thermometer upon installation and at least once a year
thereafter, or more frequently if necessary, to ensure their accuracy.
Records of thermometer accuracy checks which specify date, standard
used, method used, and person performing the test should be maintained.
Each thermometer should have a tag, seal, or other means of identity
that includes the date on which it was last tested for accuracy. A
thermometer that has a divided mercury column or that cannot be adjusted
to the standard shall be repaired or replaced before further use of the
retort. Thermometers shall be installed where they can be accurately
and easily read. Bulbs of indicating thermometers shall be installed
either within the retort shell or in external wells attached to the
retort. External wells or pipes shall be connected to the retort
through at least a 3/4-inch-diameter opening, and equipped with a
1/16-inch or larger bleeder opening so located as to provide a full flow
of steam past the length of the thermometer bulb. The bleeder for
external wells shall emit steam continuously during the entire
processing period. The mercury thermometer -- not the recorder chart --
shall be the reference instrument for indicating the processing
temperature.
(2) Temperature-recording device. Each retort shall have an accurate
temperature-recording device. Graduations on the temperature-recording
devices shall not exceed 2 F within a range of 10 F of the processing
temperature. Each chart shall have a working scale of not more than 55
F per inch within a range of 20 F of the processing temperature. The
temperature chart shall be adjusted to agree as nearly as possible with,
but to be in no event higher than, the known accurate mercury-in-glass
thermometer during the process time. A means of preventing unauthorized
changes in adjustment shall be provided. A lock, or a notice from
management posted at or near the recording device that provides a
warning that only authorized persons are permitted to make adjustments,
is a satisfactory means for preventing unauthorized changes. The
recorder may be combined with the steam controller and may be a
recording-controlling instrument. The temperature-recorder bulb shall
be installed either within the retort shell or in a well attached to the
shell. Each temperature-recorder bulb well shall have a 1/16-inch or
larger bleeder opening emitting steam continuously during the processing
period. Air-operated temperature controllers should have adequate
filter systems to ensure a supply of clean, dry air.
(3) Pressure gages. Each retort should be equipped with a pressure
gage, which should be graduated in divisions of 2 pounds or less.
(4) Steam controller. Each retort shall be equipped with an
automatic steam controller to maintain the retort temperature. This may
be a recording-controlling instrument when combined with a recording
thermometer. A steam controller activated by the steam pressure of the
retort is acceptable if it is mechanically maintained so that it
operates satisfactorily.
(5) Bleeders. Bleeders, except those for thermometer wells, shall be
one-eighth inch or larger and shall be wide open during the entire
process, including the come-up-time. Bleeders shall be located within
approximately 1 foot of the outermost location of containers, at each
end along the top of the retort; additional bleeders shall be located
not more than 8 feet apart along the top. Bleeders may be installed at
positions other than those specified above, as long as there is evidence
in the form of heat distribution data that they accomplish adequate
removal of air and circulation of heat within the retort. In retorts
having top steam inlet and bottom venting, a bleeder shall be installed
in the bottom of the retort to remove condensate. All bleeders shall be
arranged in a way that enables the operator to observe that they are
functioning properly.
(6) Venting and condensate removal. The air in each retort shall be
removed before processing is started. Heat distribution data or
documentary proof from the manufacturer or from a competent processing
authority, demonstrating that adequate venting is achieved, shall be
kept on file. At the time steam is turned on, the drain should be
opened for a time sufficient to remove steam condensate from the retort
and provision should be made for containing drainage of condensate
during the retort operation.
(7) Retort speed timing. The rotational speed of the retort shall be
specified in the schedules process. The speed shall be adjusted, as
necessary, to ensure that the speed is as specified in the scheduled
process. The rotational speed as well as the process time shall be
recorded for each retort load processed. Alternatively, a recording
tachometer may be used to provide a continuous record of the speed. A
means of preventing unauthorized speed changes on retorts shall be
provided. A lock, or a notice from management posted at or near the
speed-adjustment device that provides a warning that only authorized
persons are permitted to make adjustments, is a satisfactory means of
preventing unauthorized changes.
(8) Critical factors. Critical factors specified in the schedules
process shall be measured and recorded on the processing record at
intervals of sufficient frequency to ensure that the factors are within
the limits specified in the scheduled process. The minimum headspace of
containers in each retort load to be processed, if specified in the
scheduled process, shall be measured and recorded at intervals of
sufficient frequency to ensure that the headspace is as specified in the
scheduled process. The headspace of solder-tipped, lap seam (vent hole)
cans may be measured by net weight determinations. When the product
consistency is specified in the scheduled process, the consistency of
the product shall be determined by objective measurements on the product
taken from the filler before processing and recorded at intervals of
sufficient frequency to ensure that the consistency is as specified in
the scheduled process. Minimum closing machine vacuum in vacuum-packed
products, maximum fill-in or drained weight, minimum net weight, and
percent solids shall be as specified in the scheduled process for all
products for which deviations from such specifications may affect the
scheduled process. All measurements and recordings of critical factors
should be made at intervals not to exceed 15 minutes.
(e) Equipment and procedures for pressure processing in water in
discontinuous agitating retorts -- (1) Indicating mercury-in-glass
thermometer. Each retort shall be equipped with at least one
mercury-in-glass thermometer whose divisions are easily readable to 1 F
and whose temperature range does not exceed 17 F per inch of graduated
scale. Thermometers shall be tested for accuracy against a known
accurate standard thermometer upon installation and at least once a year
thereafter, or more frequently if necessary, to ensure their accuracy.
Records of thermometer accuracy checks which specify date, standard use,
method used, and person performing the test should be maintained. Each
thermometer should have a tag, seal, or other means of identity that
includes the date on which it was last tested for accuracy. A
thermometer that has a divided mercury column or that cannot be adjusted
to the standard shall be repaired or replaced before further use of the
retort. Thermometers shall be installed where they can be accurately
and easily read. Bulbs of indicating thermometers shall be installed
either within the retort shell or in external wells attached to the
retort. The mercury thermometer -- not the recorder chart -- shall be
the reference instrument for indicating the processing temperature.
(2) Temperature-recording device. Each retort shall have an accurate
temperature-recording device. Graduations on the temperature-recording
devices shall not exceed 2 F within a range of 10 F of the processing
temperature. Each chart shall have a working scale of not more than 55
F per inch within a range of 20 F of the processing temperature. The
temperature chart shall be adjusted to agree as nearly as possible with,
but to be in no event higher than, the known accurate mercury-in-glass
thermometer during the process time. A means of preventing unauthorized
changes in adjustment shall be provided. A lock, or a notice from
management posted at or near the recording device that provides a
warning that only authorized persons are permitted to make adjustment,
is a satisfactory means for preventing unauthorized changes. This
recorder may be combined with the steam controller and may be a
recording-controlling instrument. The temperature-recorder bulb shall
be installed either within the retort shell or in a well attached to the
shell. Air-operated temperature controllers should have adequate filter
systems to ensure a supply of clean dry air.
(3) Pressure gages. Each retort should be equipped with a pressure
gage which should be graduated in divisions of 2 pounds or less.
(4) Steam controller. Each retort shall be equipped with an
automatic steam controller to maintain the retort temperature. This may
be a recording-controlling instrument when combined with a recording
thermometer.
(5) Retort speed timing. The rotational speed of the retort shall be
specified in the scheduled process. The speed shall be adjusted, as
necessary, to ensure that the speed is as specified in the scheduled
process. The rotational speed as well as the process time shall be
recorded for each retort load processed. Alternatively, a recording
tachometer may be used to provide a continuous record of the speed. A
means of preventing unauthorized speed changes shall be provided. A
lock, or a notice from management posted at or near the speed adjustment
device that provides a warning that only authorized persons are
permitted to make adjustment, is a satisfactory means of preventing
unauthorized changes.
(6) Air supply and controls. Means shall be provided for introducing
compressed air at the proper pressure and rate, which shall be
controlled by an automatic pressure control unit. A check valve shall
be provided in the air supply line to prevent water from entering the
system.
(7) Critical factors. Critical factors specified in the scheduled
process shall be measured and recorded on the processing record at
intervals of sufficient frequency to ensure that the factors are within
the limits specified in the scheduled process. The minimum headspace of
containers, if specified in the scheduled process, shall be measured and
recorded at intervals of sufficient frequency to ensure that the
headspace is as specified in the scheduled process. The headspace of
solder-tipped, lap seam (vent hole) cans may be measured by net weight
determinations. When the product consistency is specified in the
scheduled process, the consistency of the product shall be determined by
objective measurements on the product taken from the filler before
processing and recorded at intervals of sufficient frequency to ensure
that the consistency is as specified in the scheduled process. Minimum
closing machine vaccum in vacuum-packed products, maximum fill-in or
drained weight, minimum net weight, and percent solids shall be as
specified in the scheduled process for all products when deviations from
such specifications may affect the scheduled process. All measurements
and recordings of critical factors should be made at intervals not to
exceed 15 minutes.
(f) Equipment and procedures for pressure processing in steam in
hydrostatic retorts -- (1) Indicating mercury-in-glass thermometer.
Each retort shall be equipped with at least one mercury-in-glass
thermometer whose divisions are easily readable to 1 F and whose
temperature range does not exceed 17 F per inch of graduated scale.
Thermometer shall be tested for accuracy against a known accurate
standard thermometer upon installation and at least once a year
thereafter, or more frequently if necessary, to ensure their accuracy.
Records of thermometer accuracy checks which specify date, standard
used, method used, and person performing the test should be maintained.
Each thermometer should have a tag, seal, or other means of identity
that includes the date on which it was last tested for accuracy. A
thermometer that has a divided mercury column or that cannot be adjusted
to the standard shall be repaired or replaced before further use of the
retort. Thermometers shall be installed where they can be accurately
and easily read. The thermometer shall be located in the steam dome
near the steam-water interface. When the scheduled process specifies
maintenance of particular temperatures in the hydrostatic water legs, a
mercury-in-glass thermometer shall be located in each hydrostatic water
leg in a position near the bottom automatic recorder. The mercury
thermometer -- not the recorder chart -- shall be the references
instrument for indicating the processing temperature.
(2) Temperature-recording device. Each retort shall have an accurate
temperature-recording device. Graduations on the temperature-recording
devices shall not exceed 2 F within a range of 10 F of the processing
temperature. Each chart shall have a working scale of not more than 55
F per inch within a range of 20 F of the processing temperature. The
temperature chart shall be adjusted to agree as nearly as possible with,
but to be in no event higher than, the known accurate mercury-in-glass
thermometer during the process time. A means of preventing unauthorized
changes in adjustment shall be provided. A lock, or a notice from
management posted at or near the recording device that provides a
warning that only authorized persons are permitted to make adjustments,
is a satisfactory means for preventing unauthorized changes. The
recorder may be combined with the steam controller and may be a
recording-controlling instrument. The temperature-recorder bulb shall
be installed either within the steam dome or in a well attached to the
dome. Each temperature-recorder bulb well shall have a 1/16-inch or
larger bleeder opening which emits steam continuously during the
processing period. Additional temperature-recorder bulbs shall be
installed in the hydrostatic water legs if the scheduled process
specified maintenance of particular temperatures in the hydrostatic
water legs. Air-operated temperature controllers should have adequate
filter systems to ensure a supply of clean dry air.
(3) Pressure gages. Each retort should be equipped with a pressure
gage which should be graduated in divisions of 2 pounds or less.
(4) Recording of temperatures. Temperatures indicated by the
mercury-in-glass thermometer or thermometers shall be entered on a
suitable form during processing operations. Temperatures shall be
recorded by an accurate automatic recorder or recorders at the following
points:
(i) In the steam chamber between the steam-water interface and the
lowest container position.
(ii) Near the top and the bottom of each hydrostatic water leg if the
scheduled process specifies maintenance of particular temperatures in
the legs.
(5) Steam controller. Each retort shall be equipped with an
automatic steam controller to maintain the retort temperature. This may
be a recording-controlling instrument when combined with a recording
thermometer. A steam controller activated by the steam pressure of the
retort is acceptable if it is carefully mechanically maintained so that
it operates satisfactorily.
(6) Venting. Before the start of processing operations, the retort
steam chamber or chambers shall be vented to ensure removal of air.
(7) Bleeders. Bleeder openings 1/4-inch or larger shall be located
at the top of the steam chamber or chambers opposite the point of steam
entry. Bleeders shall be wide open and shall emit steam continuously
during the entire process, including the come-up-time. All bleeders
shall be arranged in such a way that the operator can observe that they
are functioning properly.
(8) Retort speed. The speed of the container-conveyor chain shall be
specified in the scheduled process and shall be determined and recorded
at the start of processing and at intervals of sufficient frequency to
ensure that the retort speed is maintained as specified. The speed
should be determined and recorded every 4 hours. An automatic device
should be used to stop the chain when the temperature drops below that
specified in the scheduled process. A means of preventing unauthorized
speed changes shall be provided. A lock, or a notice from management
posted at or near the speed-adjusting device that provides a warning
that only authorized persons are permitted to make adjustments, is a
satisfactory means of preventing unauthorized changes.
(9) Critical factors. Critical factors specified in the scheduled
process shall be measured and recorded on the processing record at
intervals of sufficient frequency to ensure that the factors are within
the limits specified in the scheduled process.
(i) When maximum fill-in or drained weight is specified in the
scheduled process, it shall be measured and recorded at intervals of
sufficient frequency to ensure that the weight of the product does not
exceed the maximum for the given container size specified in the
scheduled process.
(ii) Closing machine vacuum in vacuum-packed products shall be
observed and recorded at intervals of sufficient frequency to ensure
that the vacuum is as specified in the scheduled process.
(iii) Such measurements and recordings should be made at intervals
not to exceed 15 minutes.
(g) Aseptic processing and packaging systems -- (1) Product
sterilizer -- (i) Equipment -- (a) Temperature-indicating device. Each
product sterilizer shall be equipped with at least one mercury-in-glass
thermometer or an equivalent temperature-indicating device, such as a
thermocouple-recorder. Mercury-in-glass thermometers shall have
divisions that are easily readable to 1 F and whose temperature range
does not exceed 17 F per inch of graduated scale. Thermometers and
temperature-indicating devices shall be tested for accuracy against a
known accurate standard thermometer upon installation and at least once
a year thereafter, or more frequently if necessary, to ensure their
accuracy. Records of accuracy checks which specify date, standard used,
method used, and person performing the test should be maintained. Each
thermometer and temperature-indicating device should have a tag, seal,
or other means of identity that includes the date on which it was last
tested for accuracy. A thermometer that has a divided mercury column or
that cannot be adjusted to essential agreement with the standard shall
be repaired or replaced. Thermometers and temperature-indicating
devices shall be installed where they can be accurately and easily read.
The temperature-indicating device shall be the reference instrument for
indicating the processing temperature.
(b) Temperature-recording device. There shall be an accurate
temperature recording device on each product sterilizer. The device
shall be installed in the product at the holding-tube outlet between the
holding tube and the inlet to the cooler. Temperature-recording devices
shall have graduations that do not exceed 2 F within a range of 10 F
of the processing temperature. Each chart shall have a working scale of
not more than 55 F per inch within a range of 20 F of the desired
product-sterilization temperature.
The temperature chart shall be adjusted to agree as nearly as
possible with, but to be in no event higher than, a known accurate
mercury-in-glass thermometer. A means of preventing unauthorized
changes in adjustment shall be provided. A lock; or a notice from
management posted at or near the recording device that provides a
warning that only authorized persons are permitted to make adjustments,
is a satisfactory means for preventing unauthorized changes.
(c) Temperature recorder-controller. An accurate temperature
recorder-controller shall be located in the product sterilizer at the
final heater outlet. It shall be capable of ensuring that the desired
product sterilization temperature is maintained. The chart graduations
shall not exceed 2 F within a range of 10 F of the desired product
sterilization temperature. Air-operated temperature controllers should
have adequate filter systems to ensure a supply of clean, dry air.
(d) Product-to-product regenerators. When a product-to-product
regenerator is used to heat the cold unsterilized product entering the
sterilizer by means of a heat exchange system, it shall be designed,
operated, and controlled so that the pressure of the sterilized product
in the regenerator is greater than the pressure of any unsterilized
product in the regenerator to ensure that any leakage in the regenerator
is from the sterilized product into the unsterilized product.
(e) Differential pressure recorder-controller. When a
product-to-product regenerator is used, there shall be an accurate
differential pressure recorder-controller installed on the regenerator.
The scale divisions shall not exceed 2 pounds per square inch on the
working scale of not more than 20 pounds per square inch per inch. The
controller shall be tested for accuracy against a known accurate
standard pressure indicator upon installation and at least once every 3
months of operation thereafter, or more frequently if necessary, to
ensure its accuracy. One pressure sensor shall be installed at the
sterilized product regenerator outlet and the other pressure sensor
shall be installed at the unsterilized product regenerator inlet.
(f) Metering pump. A metering pump shall be located upstream from
the holding tube and shall be operated to maintain the required rate of
product flow. A means of preventing unauthorized speed changes shall be
provided. A lock, or a notice from management posted at or near the
speed-adjusting device that provides a warning that only authorized
persons are permitted to make adjustments, is a satisfactory means of
preventing unauthorized changes.
(g) Product holding tube. The product-sterilizing holding tube shall
be designed to give continous holding of every particle of food for at
least the minimum holding time specified in the scheduled process. The
holding tube shall be designed so that no portion of the tube between
the product inlet and the product outlet can be heated, and it must be
sloped upward at least 0.25 inch per foot.
(h) Flow-diversion systems. If a processor elects to install a
flow-diversion system, it should be installed in the product piping
located between the product cooler and the product filler or aseptic
surge tank and should be designed to divert flow away from the filler or
aseptic surge tank automatically. Controls and/or warning systems
should be designed and installed with necessary sensors and actuators to
operate whenever the sterilizing temperature in the holding tube or
pressure differential in the product regenerator drops below specified
limits. Flow-diversion systems should be designed and operated in
accordance with recommendations of an aseptic processing and packaging
authority.
(i) Equipment downstream from the holding tube. Product coolers,
aseptic surge tanks, or any other equipment downstream from the holding
tube, with rotating or reciprocating shafts, valve stems, instrument
connections, or other such points, are subject to potential entry of
microorganisms into the product. Such locations in the system should be
equipped with steam seals or other effective barriers at the potential
access points. Appropriate means should be provided to permit the
operator to monitor the performance of the seals or barriers during
operations.
(ii) Operation -- (a) Startup. Before the start of aseptic
processing operations the product sterilizer and all product-contact
surfaces downstream shall be brought to a condition of commercial
sterility.
(b) Temperature drop in product-sterilizing holding tube. When
product temperature in the holding tube drops below the temperature
specified in the scheduled process, product flow should be diverted away
from the filler or aseptic surge tank by means of a flow-diversion
system. If for any reason product subjected to a temperature drop below
the scheduled process is filled into containers, the product shall be
segregated from product that received the scheduled process. The
processing deviation shall be handled in accordance with 113.89. The
product holding tube and any further system portions affected shall be
returned to a condition of commercial sterility before product flow is
resumed to the filler or to the aseptic surge tank.
(c) Loss of proper pressures in the regenerator. When a regenerator
is used, the product may lose sterility whenever the pressure of
sterilized product in the regenerator is less than 1 pound per square
inch greater than the pressure of unsterilized product in the
regenerator. In this case, product flow should be diverted away from
the filler or aseptic surge tank by means of the flow-diversion system.
If for any reason the product is filled into containers, the product
shall be segregated from product that received the scheduled process and
shall be reprocessed or destroyed. Product flow to the filler or to the
aseptic surge tank shall not be resumed until the cause of the improper
pressure relationships in the regenerator has been corrected and the
affected system(s) has been returned to a condition of commercial
sterility.
(d) Loss of sterile air pressure or other protection level in the
aseptic surge tank. When an aseptic surge tank is used, conditions of
commercial sterility may be lost when the sterile air overpressure or
other means of protection drops below the scheduled process value.
Product flow to and/or from the aseptic surge tank shall not be resumed
until the potentially contaminated product in the tank is removed, and
the aseptic surge tank has been returned to a condition of commercial
sterility.
(e) Records. Readings at the following points shall be observed and
recorded at the start of aseptic packaging operations and at intervals
of sufficient frequency to ensure that these values are as specified in
the scheduled process: Temperature-indicating device in holding tube
outlet; temperature recorder in holding tube outlet; temperature
recorder-controller at final heater outlet; differential pressure
recorder-controller, if a product-to-product regenerator is used;
product flow rate as established by the metering pump or as determined
by filling and closing rates and, if an aseptic surge tank is used,
sterile air pressure or other protection means; and proper performance
of seam seals or other similar devices. The measurements and recordings
should be made at intervals not to exceed 1 hour.
(2) Container sterilizing, filling, and closing operation -- (i)
Equipment -- (a) Recording device. The container and closure
sterilization system and product filling and closing system shall be
instrumented to demonstrate that the required sterilization is being
accomplished continuously. Automatic recording devices shall be used to
record, when applicable, the sterilization media flow rates,
temperature, concentration, or other factors. When a batch system is
used for container sterilization, the sterilization conditions shall be
recorded.
(b) Timing method(s). A method(s) shall be used either to give the
retention time of containers, and closures if applicable, in the
sterilizing environment specified in the scheduled process, or to
control the sterilization cycle at the rate specified in the scheduled
process. A means of preventing unauthorized speed changes must be
provided. A lock, or a notice from management posted at or near the
speed adjusting device that provides a warning that only authorized
persons are permitted to make adjustments, is a satisfactory means of
preventing unauthorized changes.
(ii) Operation -- (a) Startup. Before the start of packaging
operations, both the container and closure sterilizing system and the
product filling and closing system shall be brought to a condition of
commercial sterility.
(b) Loss of sterility. A system shall be provided to stop packaging
operations, or alternatively to ensure segregation of any product
packaged when the packaging conditions fall below scheduled processes.
Compliance with this requirement may be accomplished by diverting
product away from the filler, by preventing containers from entering the
filler, or by other suitable means. In the event product is packaged
under conditions below those specified in the scheduled process, all
such product shall be segregated and handled in accordance with 113.89.
In the event of loss of sterility, the system(s) shall be returned to a
condition of commercial sterility before resuming packaging operations.
(c) Records. Observations and measurements of operating conditions
shall be made and recorded at intervals of sufficient frequency to
ensure that commercial sterility of the food product is being achieved;
such measurements shall include the sterilization media flow rates,
temperatures, the container and closure rates (if applicable) through
the sterilizing system, and the sterilization conditions if a batch
system is used for container sterilization. The measurements and
recordings should be made at intervals not to exceed 1 hour.
(3) Incubation. Incubation tests should be conducted on a
representative sample of containers of product from each code; records
of the test results should be maintained.
(4) Critical factors. Critical factors specified in the scheduled
process shall be measured and recorded on the processing record at
intervals of sufficient frequency to ensure that the factors are within
the limits specified in the scheduled process. Such measurements and
recordings should be done at intervals not to exceed 15 minutes.
(h) Equipment and procedures for flame sterilizers. The container
conveyor speed shall be specified in the scheduled process. The
container conveyor speed shall be measured and recorded at the start of
operations and at intervals of sufficient frequency to ensure that the
conveyor speed is as specified in the scheduled process. Such
measurements and recordings should be done at 1-hour intervals.
Alternatively, recording tachometer may be used to provide a continuous
record of the speed. A means of preventing changes in flame intensity
and unauthorized speed changes on the conveyor shall be provided. A
lock, or a notice from management posted at or near the speed adjusting
device that provides a warning that only authorized persons are
permitted to make adjustments, is a satisfactory means of preventing
unauthorized changes. The surface temperature of at least one container
from each conveyor channel shall be measured and recorded at the entry
and at the end of the holding period at intervals of sufficient
frequency to ensure that the temperatures specified in the scheduled
process are maintained. Such measurements and recordings should be done
at intervals not to exceed 15 minutes.
(1) Process interruption. In the event of process interruption
wherein the temperature of the product may have dropped, an authorized,
scheduled emergency plan approved by a qualified person having expert
knowledge of the process requirements may be used.
(2) Critical factors. Critical factors specified in the scheduled
process shall be measured and recorded on the processing record at
intervals of sufficient frequency to ensure that the factors are within
the limits specified in the scheduled process.
(i) Equipment and procedures for thermal processing of foods wherein
critical factors such as water activity are used in conjunction with
thermal processing. The methods and controls used for the manufacture,
processing, and packing of such foods shall be as established in the
scheduled process and shall be operated or administered in a manner
adequate to ensure that the product is safe. The time and temperature
of processing and other critical factors specified in the scheduled
process shall be measured with instruments having the accuracy and
dependability adequate to ensure that the requirements of the scheduled
process are met. All measurements shall be made and recorded at
intervals of sufficient frequency to ensure that the critical factors
are within the limits specified in the scheduled process.
(j) Other systems. All systems, whether or not specifically
mentioned in this part, for the thermal processing of low-acid foods in
hermetically sealed containers shall conform to the applicable
requirements of this part and the methods and controls used for the
manufacture, processing, and packing of these foods shall be as
established in the scheduled process. These systems shall be operated
or administered in a manner adequate to ensure that commercial sterility
is achieved. Critical factors specified in the scheduled process shall
be measured and recorded at intervals of sufficient frequency to ensure
that the critical factors are within the limits specified in the
scheduled process.
21 CFR 113.40 Subpart D -- Control of Components, Food Product Containers, Closures, and In-Process Materials
21 CFR 113.60 Containers.
(a) Closures. Regular observations shall be maintained during
production runs for gross closure defects. Any such defects shall be
recorded and corrective action taken and recorded. At intervals of
sufficient frequency to ensure proper closure, the operator, closure
supervisor, or other qualified container closure inspection person shall
visually examine either the top seam of a can randomly selected from
each seaming head or the closure of any other type of container being
used and shall record the observations made. For double-seam cans, each
can should be examined for cutover or sharpness, skidding or
deadheading, false seam, droop at the crossover or lap, and condition of
inside of countersink wall for evidence of broken chuck. Such
measurements and recordings should be made at intervals not to exceed 30
minutes. Additional visual closure inspections shall be made
immediately following a jam in a closing machine, after closing machine
adjustment, or after startup of a machine following a prolonged
shutdown. All pertinent observations shall be recorded. When
irregularities are found, the corrective action shall be recorded.
(1) Teardown examinations for double-seam cans shall be performed by
a qualified individual and the results therefrom shall be recorded at
intervals of sufficient frequency on enough containers from each seaming
station to ensure maintenance of seam integrity. Such examinations and
recordings should be made at intervals not to exceed 4 hours. The
results of the teardown examinations shall be recorded and the
corrective action taken, if any, shall be noted.
(i) Required and optional can seam measurements:
(a) Micrometer measurement system:
(b) Seam scope or projector:
(c) Can double seam terminology:
INSERT ILLUS 087
(1) ''Crossover'': The portion of a double seam at the lap.
(2) ''Cutover'': A fracture, sharp bend, or break in the metal at
the top of the inside portion of the double seam.
(3) ''Deadhead'': A seam which is incomplete due to chuck spinning
in the countersink.
(4) ''Droop'': Smooth projection of double seam below bottom of
normal seam.
(5) ''False seam'': A small seam breakdown where the cover hook and
the body hook are not overlapped.
(6) ''Lap'': Two thicknesses of material bonded together.
(ii) Two measurements at different locations, excluding the side
seam, shall be made for each double seam characteristic if a seam scope
or seam projector is used. When a micrometer is used, three
measurements shall be made at points approximately 120 apart, excluding
the side seam.
(iii) Overlap length can be calculated by the following formula:
The theoretical overlap length=
CH+BH+T^W, where
CH=cover hook
BH=body hook
T=cover thickness, and
W=seam width (height, length)
(2) For glass containers with vacuum closures, capper efficiency must
be checked by a measurement of the cold water vacuum. This shall be
done before actual filling operations, and the results shall be
recorded.
(3) For closures other than double seams and glass containers,
appropriate detailed inspections and tests shall be conducted by
qualified personnel at intervals of sufficient frequency to ensure
proper closing machine performance and consistently reliable hermetic
seal production. Records of such tests shall be maintained.
(b) Cooling water. Container cooling water shall be chlorinated or
otherwise sanitized as necessary for cooling canals and for recirculated
water supplies. There should be a measurable residual of the sanitizer
employed at the water discharge point of the container cooler.
(c) Coding. Each hermetically sealed container of low-acid processed
food shall be marked with an identifying code that shall be permanently
visible to the naked eye. When the container does not permit the code
to be embossed or inked, the label may be legibly perforated or
otherwise marked, if the label is securely affixed to the product
container. The required identification shall identify in code the
establishment where packed, the product contained therein, the year
packed, the day packed, and the period during which packed. The packing
period code shall be changed with sufficient frequency to enable ready
identification of lots during their sale and distribution. Codes may be
changed on the basis of one of the following: intervals of 4 to 5
hours; personnel shift changes; or batches, as long as the containers
that constitute the batch do not extend over a period of more than one
personnel shift.
(d) Postprocess handling. When cans are handled on belt conveyors,
the conveyors should be so constructed as to minimize contact by the
belt with the double seam, i.e., cans should not be rolled on the double
seam. All worn and frayed belting, can retarders, cushions, etc.
should be replaced with new nonporous material. All tracks and belts
that come into contact with the can seams should be thoroughly scrubbed
and sanitized at intervals of sufficient frequency to avoid product
contamination. Automatic equipment used in handling filled containers
should be so designed and operated as to preserve the can seam or other
container closure integrity.
21 CFR 113.60 Subpart E -- Production and Process Controls
21 CFR 113.81 Product preparation.
(a) Before using raw materials and ingredients susceptible to
microbiological contamination, the processor shall ensure that those
materials and ingredients are suitable for use in processing low-acid
food. Compliance with this requirement may be accomplished by receiving
the raw materials and ingredients under a supplier's guarantee that they
are suitable for use, by examining them for their microbiological
condition, or by other acceptable means.
(b) Blanching by heat, when required in the preparation of food for
canning, should be effected by heating the food to the required
temperature, holding it at this temperature for the required time, and
then either rapidly cooling the food or passing it to subsequent
processing without delay. Thermophilic growth and contamination in
blanchers should be minimized by the use of adequate operating
temperatures and by cleaning. If the blanched food product is washed
before filling, potable water should be used.
(c) The filling of containers, either mechanically or by hand, shall
be controlled so as to ensure that the filling requirements specified in
the scheduled process are met.
(d) The exhausting of containers for the removal of air shall be
controlled so as to meet the conditions for which the process was
designed. Compliance with the requirement may be accomplished by heat
exhausting, mechanical exhausting, hot brining, or steam injection.
(e) When the maintenance of pH (above 4.6) of a normally low-acid
food is a basis for a scheduled process, there shall be careful
supervision to ensure that the equilibrium pH of the finished product
meets that of the scheduled process. The methodology described in
114.90 of this chapter should be used.
(f) When the scheduled process sets forth critical factors to prevent
the growth of microorganisms not destroyed by the thermal process, the
factors shall be carefully controlled to ensure that the limits
established in the scheduled process are not exceeded. When normally
low-acid foods require sufficient solute to permit safe processing at
low temperatures, such as in boiling water, there shall be careful
supervision to ensure that the equilibrium water activity (aw) of the
finished product meets that of the scheduled process. The scheduled
thermal processes for foods having an aw greater than 0.85 and less than
the aw that would allow the growth of spores of microorganisms of public
health significance shall be sufficient to render the food free of
microorganisms capable of reproducing in the food under normal
nonrefrigerated conditions of storage and distribution.
21 CFR 113.83 Establishing scheduled processes.
Scheduled processes for low-acid foods shall be established by
qualified persons having expert knowledge of thermal processing
requirements for low-acid foods in hermetically sealed containers and
having adequate facilities for making such determinations. The type,
range, and combination of variations encountered in commercial
production shall be adequately provided for in establishing the
scheduled process. Critical factors, e.g., minimum headspace,
consistency, maximum fill-in or drained weight, aw, etc., that may
affect the scheduled process, shall be specified in the scheduled
process. Acceptable scientific methods of establishing heat
sterilization processes shall include, when necessary, but shall not be
limited to, microbial thermal death time data, process calculations
based on product heat penetration data, and inoculated packs.
Calculation shall be performed according to procedures recognized by
competent processing authorities. If incubation tests are necessary for
process confirmation, they shall include containers from test trials and
from actual commercial production runs during the period of instituting
the process. The incubation tests for confirmation of the scheduled
processes should include the containers from the test trials and a
number of containers from each of four or more actual commercial
production runs. The number of containers from actual commercial
production runs should be determined on the basis of recognized
scientific methods to be of a size sufficient to ensure the adequacy of
the process. Complete records covering all aspects of the establishment
of the process and associated incubation tests shall be prepared and
shall be permanently retained by the person or organization making the
determination.
21 CFR 113.87 Operations in the thermal processing room.
(a) Operating processes and retort venting procedures to be used for
each product and container size being packed shall either be posted in a
conspicuous place near the processing equipment or be made readily
available to the retort or processing system operator and any duly
authorized employee of the Food and Drug Administration. Scheduled
processes must be made readily available to the supervisor and any duly
authorized employee of the Food and Drug Administration.
(b) A system for product traffic control in the retort room shall be
established to prevent unretorted product from bypassing the retort
process. Each retort basket, truck, car, or crate used to hold
containers in a retort, or one or more containers therein, shall, if it
contains any retorted food product, be plainly and conspicuously marked
with a heat-sensitive indicator, or by other effective means that will
indicate visually, to thermal processing personnel, those units that
have been retorted. A visual check shall be performed to determine
whether or not the appropriate change has occurred in the heat-sensitive
indicator as a result of retorting for all retort baskets, trucks, cars,
or crates, to ensure that each unit of product has been retorted. A
written record of these checks should be made.
(c) The initial temperature of the contents of the containers to be
processed shall be determined and recorded with sufficient frequency to
ensure that the temperature of the product is no lower than the minimum
initial temperature specified in the scheduled process. For those
operations that use water during the filling of the retort or during
processing, provision shall be made to ensure that the water will not,
before the start of each thermal process, lower the initial temperature
of the product below that specified in the scheduled process.
(d) Timing devices used in recording thermal process time information
shall be accurate to the extent needed to ensure that the processing
time and venting time specified in the scheduled process are achieved.
Pocket or wrist watches are not considered satisfactory for timing
purposes. Digital clocks may be used if the operating process and the
venting schedule have a 1-minute or greater safety factor over the
scheduled process.
(e) Clock times on recording-temperature charts should reasonably
correspond to the time of day on the written processing records to
provide correlation of these records.
(f) The steam supply to the thermal processing system shall be
adequate to the extent needed to ensure that sufficient steam pressure
is maintained during thermal processing, regardless of other demands of
steam by the plant.
(g) If mufflers are used on bleeders or vent systems, evidence that
the bleeders or vents are operated in a manner that does not
significantly impede the removal of air shall be kept on file. This
evidence may be in the form of heat distribution data or other
satisfactory evidence such as a letter from the manufacturer, the
designer, or a competent processing authority.
21 CFR 113.89 Deviations in processing, venting, or control of critical
factors.
Whenever any process is less than the scheduled process or when
critical factors are out of control for any low-acid food or container
system as disclosed from records by processor check or otherwise, the
commerical processor of that low-acid food shall either fully reprocess
that portion of the production involved, keeping full records of the
reprocessing conditions or, alternatively, must set aside that portion
of the product involved for further evaluation as to any potential
public health significance. Such evaluation shall be made by a
competent processing authority and shall be in accordance with
procedures recognized by competent processing authorities as being
adequate to detect any potential hazard to public health. Unless this
evaluation demonstrates that the product had been given a thermal
process that rendered it free of microorganisms of potential public
health significance, the product set aside shall be either fully
reprocessed to render it commercially sterile or destroyed. A record
shall be made of the evaluation procedures used and the results. Either
upon completion of full reprocessing and the attainment of commerical
sterility or after the determination that no significant potential for
public health hazard exists, that portion of the product involved may be
shipped in normal distribution. Otherwise, the portion of the product
involved shall be destroyed. All process deviations involving a failure
to satisfy the minimum requirements of the scheduled process, including
emergencies arising from a jam or breakdown of a continuous agitating
retort necessitating cooling the retort for repairs, shall be recorded
and made the subject of a separate file (or a log identifying the
appropriate data) detailing those deviations and the actions taken.
21 CFR 113.89 Subpart F -- Records and Reports
21 CFR 113.100 Processing and production records.
(a) Processing and production information shall be entered at the
time it is observed by the retort or processing system operator, or
other designated person, on forms that include the product, the code
number, the date, the retort or processing system number, the size of
container, the approximate number of containers per coding interval, the
initial temperature, the actual processing time, the mercury-in-glass
and recording thermometer readings, and other appropriate processing
data. Closing machine vacuum in vacuum-packed products, maximum fill-in
or drained weight, or other critical factors specified in the scheduled
process shall also be recorded. In addition, the following records
shall be maintained:
(1) Still retorts. Time steam on; time temperature up to processing
temperature; time steam off; venting time and temperature to which
vented.
(2) Agitating retorts. Functioning of condensate bleeder; retort
speed; and, when specified in the scheduled process, headspace,
consistency, maximum drained weight, minimum net weight, and percent
solids.
(3) Hydrostatic retorts. The temperature in the steam chamber
between the steam-water interface and the lowest container position;
speed of the container conveyor chain; and, when the scheduled process
specifies maintenance of particular temperatures in the hydrostatic
water legs, the temperatures near the top and the bottom of each
hydrostatic water leg.
(4) Aseptic processing and packaging systems. Product temperature in
the holding tube outlet as indicated by the temperature-indicating
device and the temperature recorder; product temperature in the final
heater outlet as indicated by the temperature recorder-controller;
differential pressure as indicated by the differential pressure
recorder-controller, if a product-to-product regenerator is used;
product flow rate, as determined by the metering pump or by filling and
closing rates; sterilization media flow rate or temperature or both;
retention time of containers, and closures when applicable, in the
sterilizing environment; and, when a batch system is used for container
and/or closure sterilization, sterilization cycle times and
temperatures.
(5) Flame sterilizers. Container conveyor speed; surface
temperature at the beginning and at the end of the holding period;
nature of container.
(6) Food preservation methods wherein critical factors such as water
activity are used in conjunction with thermal processing. Product
formulation and scheduled processes used, including the thermal process,
its associated critical factors, as well as other critical factors, and
results of aw determinations.
(7) Other systems. Critical factors specified in the formulation of
the product or in the scheduled process.
(b) Recording thermometer charts shall be identified by date, retort
number, and other data as necessary, so they can be correlated with the
written record of lots processed. Each entry on the processing and
production records shall be made by the retort or processing system
operator, or other designated person, at the time the specific retort or
processing system condition or operation occurs, and this retort or
processing system operator or other designated person shall sign or
initial each record form. Not later that 1 working day after the actual
process, and before shipment or release for distribution, a
representative of plant management who is qualified by suitable training
or experience shall review all processing and production records for
completeness and to ensure that the product received the scheduled
process. The records, including the recording thermometer chart(s),
shall be signed or initialed and dated by the reviewer.
(c) Written records of all container closure examinations shall
specify the product code, the date and time of container closure
inspections, the measurements obtained, and all corrective actions
taken. Records shall be signed or initialed by the container closure
inspector and reviewed by management with sufficient frequency to ensure
that the containers are hermetically sealed.
(d) Records shall be maintained to identify the initial distribution
of the finished product to facilitate, when necessary, the segregation
of specific food lots that may have become contaminated or otherwise
rendered unfit for their intended use.
(e) Copies of all records provided for in this part, except those
required under 113.83 establishing scheduled processes, shall be
retained at the processing plant for a period of not less than 1 year
from the date of manufacture, and at the processing plant or other
reasonably accessible location for an additional 2 years. If, during
the first year of the 3-year record-retention period, the processing
plant is closed for a prolonged period between seasonal packs, the
records may be transferred to some other reasonably accessible location
at the end of the seasonal pack.
21 CFR 113.100 PART 114 -- ACIDIFIED FOODS
21 CFR 113.100 Pt. 114
21 CFR 113.100 Subpart A -- General Provisions
Sec.
114.3 Definitions.
114.5 Current good manufacturing practices.
114.10 Personnel.
21 CFR 113.100 Subparts B-D (Reserved)
21 CFR 113.100 Subpart E -- Production and Process Controls
114.80 Processes and controls.
114.83 Establishing scheduled processes.
114.89 Deviations from scheduled procedures.
114.90 Methodology.
21 CFR 113.100 Subpart F -- Records and Reports
114.100 Records.
Authority: Secs. 402, 701, 704 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 342, 371, 374); sec. 361 of the Public Health
Service Act (42 U.S.C. 264).
Source: 44 FR 16235, Mar. 16, 1979, unless otherwise noted.
21 CFR 113.100 Subpart A -- General Provisions
21 CFR 114.3 Definitions.
For the purposes of this part, the following definitions apply.
(a) ''Acid foods'' means foods that have a natural pH of 4.6 or
below.
(b) ''Acidified foods'' means low-acid foods to which acid(s) or acid
food(s) are added; these foods include, but are not limited to, beans,
cucumbers, cabbage, artichokes, cauliflower, puddings, peppers, tropical
fruits, and fish, singly or in any combination. They have a water
activity (aw) greater than 0.85 and have a finished equilibrium pH of
4.6 or below. These foods may be called, or may purport to be,
''pickles'' or ''pickled ---------- .'' Carbonated beverages, jams,
jellies, preserves, acid foods (including such foods as standardized and
nonstandardized food dressings and condiment sauces) that contain small
amounts of low-acid food(s) and have a resultant finished equilibrium pH
that does not significantly differ from that of the predominant acid or
acid food, and foods that are stored, distributed, and retailed under
refrigeration are excluded from the coverage fo this part.
(c) ''Lot'' means the product produced during a period indicated by a
specific code.
(d) ''Low-acid foods'' means any foods, other than alcoholic
beverages, with a finished equilibrium pH greater than 4.6 and a water
activity (aw) greater than 0.85. Tomatoes and tomato products having a
finished equilibrium pH less than 4.7 are not classed as low-acid foods.
(e) ''Scheduled process'' means the process selected by a processor
as adequate for use under the conditions of manufacture for a food in
achieving and maintaining a food that will not permit the growth of
microorganisms having public health significance. It includes control
of pH and other critical factors equivalent to the process established
by a competent processing authority.
(f) ''Shall'' is used to state mandatory requirements.
(g) ''Should'' is used to state recommended or advisory procedures or
to identify recommended equipment.
(h) ''Water activity'' (aw) is a measure of the free moisture in a
product and is the quotient of the water vapor pressure of the substance
divided by the vapor pressure of pure water at the same temperature.
21 CFR 114.5 Current good manufacturing practice.
The criteria in 114.10, 114.80, 114.83, 114.89, and 114.100, as
well as the criteria in Part 110 of this chapter, apply in determining
whether an article of acidified food is adulterated (1) within the
meaning of section 402(a)(3) of the act (21 U.S.C. 342(a)(3)) in that it
has been manufactured under such conditions that it is unfit for food,
or (2) within the meaning of section 402(a)(4) of the act (21 U.S.C.
342(a)(4)) in that it has been prepared, packed, or held under
insanitary conditions whereby it may have become contaminated with
filth, or whereby it may have been rendered injurious to health.
21 CFR 114.10 Personnel.
All operators of processing and packaging systems shall be under the
operating supervisions of a person who has attended a school approved by
the Commissioner for giving instruction in food-handling techniques,
food-protection principles, personal hygiene and plant sanitation
practices, pH controls and critical factors in acidification, and who
has been identified by that school as having satisfactorily completed
the prescribed course of instruction. The Commissioner will consider
students who have satisfactorily completed the required portions of the
courses presented under 108.35 and Part 113 of this chapter before
March 16, 1979, to be in compliance with the requirement of this
section.
21 CFR 114.10 Subparts B-D (Reserved)
21 CFR 114.10 Subpart E -- Production and Process Controls
21 CFR 114.80 Processes and controls.
(a) Processing operations. The manufacturer shall employ appropriate
quality control procedures to ensure that finished foods do not present
a health hazard.
(1) Acidified foods shall be so manufactured, processed, and packaged
that a finished equilibrium pH value of 4.6 or lower is achieved within
the time designated in the scheduled process and maintained in all
finished foods. Manufacturing shall be in accordance with the scheduled
process. Acidified foods shall be thermally processed to an extent that
is sufficient to destroy the vegetative cells of microorganisms of
public health significance and those of nonhealth significance capable
of reproducing in the food under the conditions in which the food is
stored, distributed, retailed and held by the user. Permitted
preservatives may be used to inhibit reproduction of microorganisms of
nonhealth significance (in lieu of thermal processing).
(2) Sufficient control, including frequent testing and recording of
results, shall be exercised so that the finished equilibrium pH values
for acidified foods are not higher than 4.6. Measurement of acidity of
foods in-process may be made by potentiometric methods, titratable
acidity, or colorimetric methods. If the finished equilibrium pH of the
food is above 4.0, the measurement of the finished equilibrium pH shall
be by a potentiometric method, and the in-process measurements by
titration or colorimetry shall be related to the finished equilibrium
pH. If the finished equilibrium pH is 4.0 or below, then the
measurement of acidity of the final product may be made by any suitable
method. Special care should be taken when food ingredients have been
subjected to lye, lime, or similar high pH materials.
(3) Procedures for acidification to attain acceptable equilibrium pH
levels in the final food include, but are not limited to, the following:
(i) Blanching of the food ingredients in acidified aqueous solutions.
(ii) Immersion of the blanched food in acid solutions. Although
immersion of food in an acid solution is a satisfactory method for
acidification, care must be taken to ensure that the acid concentration
is properly maintained.
(iii) Direct batch acidification, which can be achieved by adding a
known amount of an acid solution to a specified amount of food during
acidification.
(iv) Direct addition of a predetermined amount of acid to individual
containers during production. Liquid acids are generally more effective
than solid or pelleted acids. Care must be taken to ensure that the
proper amount of acid is added to each container.
(v) Addition of acid foods to low-acid foods in controlled
proportions to conform to specific formulations.
(4) Testing and examinations of containers shall occur often enough
to ensure that the container suitably protects the food from leakage or
contamination.
(b) Coding. Each container or product shall be marked with an
identifying code permanently visible to the naked eye. If the container
does not permit the code to be embossed or inked, the label may be
legibly perforated or otherwise marked, as long as the label is securely
affixed to the product container. The required identification shall
specify in code the establishment where the product was packed, the
product contained therein, and the year, day, and period during which it
was packed. The packing period code shall be changed often enough to
enable ready identification of lots during their sale and distribution.
Codes may be changed periodically on one of the following bases:
intervals of 4 to 5 hours; personnel shift changes; or batches, as
long as the containers constituting the batch do not represent those
processed during more than one personnel shift.
21 CFR 114.83 Establishing scheduled processes.
The scheduled process shall be established by a qualified person who
has expert knowledge acquired through appropriate training and
experience in the acidification and processing of acidified foods.
21 CFR 114.89 Deviations from scheduled processes.
Whenever any process operation deviates from the scheduled process
for any acidified food and/or the equilibrium pH of the finished product
is higher than 4.6, the commercial processor of the acidified food shall
either: (a) Fully reprocess that portion of the food by a process
established by a competent processing authority as adequate to ensure a
safe product; (b) thermally process it as a low-acid food under Part
113 of this chapter; or (c) set aside that portion of the food involved
for further evaluation as to any potential public health significance.
The evaluation shall be made by a competent processing authority and
shall be in accordance with procedures recognized by competent
processing authorities as being adequate to detect any potential hazard
to public health. Unless the evaluation demonstrates that the food has
undergone a process that has rendered it safe, the food set aside shall
either be fully reprocessed to render it safe, or be destroyed. A
record shall be made of the procedures used in the evaluation and the
results. Either upon completion of full reprocessing and the attainment
of a safe food, or after the determination that no significant potential
for public health hazard exists, that portion of the food involved may
be shipped in normal distribution. Otherwise, the portion of the food
involved shall be destroyed.
21 CFR 114.90 Methodology.
Methods that may be used to determine pH or acidity for acidified
foods include, but are not limited to, the following:
(a) Potentiometric method for the determination of pH -- (1)
Principles. The term ''pH'' is used to designate the intensity or
degree of acidity. The value of pH, the logarithm of the reciprocal of
the hydrogen ion concentration in solution, is determined by measuring
the difference in potential between two electrodes immersed in a sample
solution. A suitable system consists of a potentiometer, a glass
electrode, and a reference electrode. A precise pH determination can be
made by making an electromotive force (emf) measurement of a standard
buffer solution whose pH is known, and then comparing that measurement
to an emf measurement of a sample of the solution to be tested.
(2) Instruments. The primary instrument for use in pH determination
is the pH meter or potentiometer. For most work, an instrument with a
direct-reading pH scale is necessary. Battery and line-operated
instruments are available commercially. If the line voltage is
unstable, line-operated instruments should be fitted with voltage
regulators to eliminate drifting of meter-scale readings. Batteries
should be checked frequently to ensure proper operation of battery
operated instruments. An instrument using an expanded unit scale or a
digital readout system is preferred since it allows more precise
measurements.
(3) Electrodes. The typical pH meter is equipped with a glass
membrane electrode and a reference electrode or a single probe
combination electrode. Various types of electrodes designed for
specific uses are available. The most commonly used reference electrode
is the calomel electrode, which incorporates a salt bridge filled with
saturated potassium chloride solution.
(i) Care and use of electrodes. Calomel electrodes should be kept
filled with saturated potassium chloride solution or other solution
specified by the manufacturer because they may become damaged if they
are allowed to dry out. For best results, electrodes should be soaked
in buffer solution, distilled or deionized water, or other liquid
specified by the manufacturer for several hours before using and kept
ready by storing with tips immersed in distilled water or in buffer
solution used for standardization. Electrodes should be rinsed with
water before immersing in the standard buffers and rinsed with water or
the solution to be measured next between sample determinations. A lag
in meter response may indicate aging effects or fouling of the
electrodes, and cleaning and rejuvenation of the electrodes may be
necessary and may be accomplished by placing the electrodes in 0.1 molar
sodium hydroxide solution for 1 minute and then transferring them to 0.1
molar hydrochloric acid solution for 1 minute. The cycle should be
repeated two times, ending with the electrodes in the acid solution.
The electrodes should then be thoroughly rinsed with water and blotted
with soft tissue before proceeding with the standardization.
(ii) Temperature. To obtain accurate results, a uniform temperature
should be maintained for the electrodes, the standard buffer solutions,
and the samples. Tests should be made at a temperature between 20 and
30 C, the optimum being 25 C. Any temperature determinations made
without meter compensation may affect pH values. An automatic
temperature compensator may be used.
(iii) Accuracy. The accuracy of most pH meters is stated to be
approximately 0.1 pH unit, and reproducibility is usually 0.05 pH unit
or less. Some meters permit the expansion of any pH unit range to cover
the entire scale and have an accuracy of approximately 0.01 pH unit and
a reproducibility of 0.005 pH units.
(4) General procedure for determining pH. When operating an
instrument, the operator should use the manufacturer's instructions and
should observe the following techniques for pH determinations:
(i) Switch the instrument on and allow the electronic components to
warm up and stabilize before proceeding.
(ii) Standardize the instrument and electrodes with commercially
prepared standard 4.0 pH buffer or with freshly prepared 0.05 molar
potassium acid phthalate buffer solution prepared as outlined in
''Official Methods of Analysis of the Association of Official Analytical
Chemists'' (AOAC), 13th Ed. (1980), section 50.007(c), under ''Buffer
Solutions for Calibration of pH Equipment -- Official Final Action,''
which is incorporated by reference. Copies may be obtained from the
Association of Official Analytical Chemists, 2200 Wilson Blvd., Suite
400, Arlington, VA 22201-3301, or may be examined at the Office of the
Federal Register, 1100 L St. NW., Washington, DC 20408. Note the
temperature of the buffer solution and set the temperature compensator
control at the observed temperature (room temperature is near 25 C).
(iii) Rinse the electrodes with water and blot, but do not wipe, with
soft tissue.
(iv) Immerse the tips in the buffer solution and take the pH reading,
allowing about 1 minute for the meter to stabilize. Adjust the
standardization control so that the meter reading corresponds to the pH
of the known buffer (for example, 4.0) for the temperature observed.
Rinse the electrodes with water and blot with soft tissue. Repeat
procedure with fresh portions of buffer solution until the instrument
remains in balance on two successive trials. To check the operation of
the pH meter, check the pH reading using another standard buffer such as
one having a pH of 7.0, or check it with freshly prepared 0.025 molar
phosphate solution prepared as outlined in the AOAC, 13th Ed. (1980),
section 50.007(e), which is incorporated by reference. The availability
of this incorporation by reference is given in paragraph (a)(4)(ii) of
this section. Expanded scale pH meters may be checked with pH 3.0 or pH
5.0 standard buffers. Buffers and instruments can be further checked by
comparison with values obtained with a second properly standardized
instrument.
(v) Indicating electrodes may be checked for proper operation by
first using an acid buffer and then a base buffer. First standardize
the electrodes using a pH 4.0 buffer at or near 25 C. Standardization
control should be adjusted so that the meter reads exactly 4.0.
Electrodes should be rinsed with water, then blotted and immersed in a
pH 9.18 borax buffer prepared as outlined in the AOAC, 13th Ed. (1980),
section 50.007(f), which is incorporated by reference. The availability
of this incorporation by reference is given in paragraph (a)(4)(ii) of
this section. The pH reading should be within 0.3 units of the 9.18
value.
(vi) The pH meter can be tested for proper operation by shorting the
glass and reference electrode inputs, thereby reducing the voltage to
zero. In some meters this shorting is done by switching the instrument
to standby, and in other instruments by use of a shorting strap. With
the instrument shorted out, standardization control should be turned
from one extreme to another. This operation should produce a deflection
greater than 1.5 pH unit from center scale.
(5) Determining pH on samples. (i) Adjust the temperature of the
sample to room temperature (25 C), and set the temperature compensator
control to the observed temperature. With some expanded scale
instruments, the sample temperature must be the same as the temperature
of the buffer solution used for the standardization.
(ii) Rinse and blot the electrodes. Immerse the electrodes in the
sample and take the pH reading, allowing 1 minute for the meter to
stabilize. Rinse and blot the electrodes and repeat on a fresh portion
of sample. Oil and grease from the samples may coat the electrodes;
therefore, it is advisable to clean and standardize the instrument
frequently. When oily samples cause fouling problems, it may become
necessary to rinse the electrodes with ethyl ether.
(iii) Determine two pH values on the well-mixed sample. These
readings should agree with one another to indicate that the sample is
homogeneous. Report values to the nearest 0.05 pH unit.
(6) Preparation of samples. Some food products may consist of a
mixture of liquid and solid components that differ in acidity. Other
food products may be semisolid in character. The following are examples
of preparation procedures for pH testing for each of these categories:
(i) Liquid and solid component mixtures. Drain the contents of the
container for 2 minutes on a U.S. standard No. 8 sieve (preferably
stainless steel) inclined at a 17- to 20-degree angle. Record weight of
the liquid and solid portions and retain each portion separately.
(a) If the liquid contains sufficient oil to cause electrode fouling,
separate the layers with a separatory funnel and retain the aqueous
layer. The oil layer may be discarded. Adjust the temperature of the
aqueous layer to 25 C and determine its pH.
(b) Remove the drained solids from the sieve, blend to a uniform
paste, adjust the temperature of the paste to 25 C and determine its
pH.
(c) Mix aliquots of solid and liquid fractions in the same ratio as
found in the original container and blend to a uniform consistency.
Adjust the temperature of the blend to 25 C and determine the
equilibriated pH. Alternatively, blend the entire contents of the
container to a uniform paste, adjust the temperature of the paste to 25
C, and determine the equilibriated pH.
(ii) Marinated oil products. Separate the oil from the solid
product. Blend the solid in a blender to a paste consistency; it may
become necessary to add a small amount of distilled water to some
samples to facilitate the blending. A small amount of added water will
not alter the pH of most food products, but caution must be exercised
concerning poorly buffered foods. No more than 20 milliliters of
distilled water should be added to each 100 grams of product. Determine
the pH by immersing electrodes in the prepared paste after adjusting the
temperature to 25 C.
(iii) Semisolid products. Food products of a semisolid consistency,
such as puddings, potato salad, etc., may be blended to a paste
consistency, and the pH may be determined on the prepared paste. If
more fluidity is required, 10 to 20 milliliters of distilled water may
be added to 100 grams of product. Adjust the temperature of the
prepared paste to 25 C and determine its pH.
(iv) Special product mixtures. For special product mixtures such as
antipasto, pour off the oil, blend the remaining product to a paste, and
determine the pH of the blended paste. If more fluidity is required,
add 10 to 20 milliliters of distilled water to each 100 grams of product
and blend. Adjust the temperature of the prepared paste to 25 C and
determine its pH.
(7) Process pH determination. Obtain sample portions of material for
pH determination.
(i) For process liquids, adjust the temperature of the liquid to 25
C and determine the pH by immersing the electrodes in the liquid.
(ii) Drain solid materials on a sieve and blend to a workable paste.
Adjust the temperature of the prepared paste to 25 C and determine its
pH.
(iii) If enough solid materials are available to make a paste, blend
representative aliquots of liquid and solid materials to a workable
paste. Adjust the temperature of the prepared paste to 25 C and
determine the equilibrated pH. Alternatively, blend the entire contents
of the container to a uniform paste, adjust the temperature of the paste
to 25 C, and determine the equilibrated pH.
(b) Colorimetric methods for the determination of pH. This method
may be used in lieu of the potentiometric method if the pH is 4.0 or
lower.
(1) Principle. The colorimetric method for pH involves the use of
indicator dyes in solutions that gradually change color over limited pH
ranges. An indicator that has the greatest color change at
approximately the pH of the sample being tested is selected. The pH is
determined by the color of the indicator when exposed to the sample
under test.
(2) Indicator solutions. Most indicator solutions are prepared as a
0.04 percent solution of the indicator dye in alcohol. In testing, a
few drops of indicator solution are added to 10-milliliter portions of
the sample solution. Colors should be compared using a bright
background. Approximate determinations can be made on white porcelain
spot plates, the test colors being compared thereon with a set of color
standards. More accurate colorimetric tests can be made using a
comparator block fitted with sets of tubes of standard indicator
solutions of known pH.
(3) Indicator paper. A paper tape treated with indicator dye is
dipped into the sample solution. Depending upon the pH of the solution,
the tape will change color and an approximate pH can be determined by
comparison with a standard color chart.
(c) Titratable acidity. Acceptable methods for determining
titratable acidity are described in the AOAC, 13th Ed. (1980), section
22.060, under ''Titratable Acidity -- Official Final Action,'' for
''Indicator Method,'' and section 22.061 for ''Glass Electrode Method --
Official Final Action,'' which is incorporated by reference. The
availability of this incorporation by reference is given in paragraph
(a)(4)(ii) of this section. The procedure for preparing and
standardizing the sodium hydroxide solution is described in the AOAC,
13th Ed. (1980), sections 50.032-50.035, under ''Sodium Hydroxide --
Official Final Action'' by the ''Standard Potassium Hydroxide Phthalate
Method,'' which is also incorporated by reference and available as set
forth in paragraph (a)(4)(ii) of this section.
(44 FR 16235, Mar. 16, 1979, as amended at 47 FR 11822, Mar. 19,
1982; 49 FR 5609, Feb. 14, 1984; 54 FR 24892, June 12, 1989)
21 CFR 114.90 Subpart F -- Records and Reports
21 CFR 114.100 Records.
(a) Records shall be maintained of examinations of raw materials,
packaging materials, and finished products, and of suppliers' guarantees
or certifications that verify compliance with Food and Drug
Administration regulations and guidelines or action levels.
(b) Processing and production records showing adherence to scheduled
processes, including records of pH measurements and other critical
factors intended to ensure a safe product, shall be maintained and shall
contain sufficient additional information such as product code, date,
container size, and product, to permit a public health hazard evaluation
of the processes applied to each lot, batch, or other portion of
production.
(c) All departures from scheduled processes having a possible bearing
on public health or the safety of the food shall be noted and the
affected portion of the product identified; these departures shall be
recorded and made the subject of a separate file (or log identifying the
appropriate data) delineating them, the action taken to rectify them,
and the disposition of the portion of the product involved.
(d) Records shall be maintained identifying initial distribution of
the finished product to facilitate, when necessary, the segregation of
specific food lots that may have become contaminated or otherwise unfit
for their intended use.
(e) Copies of all records provided for in paragraphs (b), (c), and
(d) of this section shall be retained at the processing plant or other
reasonably accessible location for a period of 3 years from the date of
manufacture.
21 CFR 114.100 Pt. 129
21 CFR 114.100 PART 129 -- PROCESSING AND BOTTLING OF BOTTLED DRINKING WATER
21 CFR 114.100 Subpart A -- General Provisions
Sec.
129.1 Current good manufacturing practice.
129.3 Definitions.
21 CFR 114.100 Subpart B -- Buildings and Facilities
129.20 Plant construction and design.
129.35 Sanitary facilities.
129.37 Sanitary operations.
21 CFR 114.100 Subpart C -- Equipment
129.40 Equipment and procedures.
21 CFR 114.100 Subpart D (Reserved)
21 CFR 114.100 Subpart E -- Production and Process Controls
129.80 Processes and controls.
Authority: Secs. 402, 409, 701, 704 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 342, 348, 371, 374); sec. 361 of the Public
Health Service Act (42 U.S.C. 264).
Source: 42 FR 14355, Mar. 15, 1977, unless otherwise noted.
21 CFR 114.100 Subpart A -- General Provisions
21 CFR 129.1 Current good manufacturing practice.
The applicable criteria in Part 110 of this chapter, as well as the
criteria in 129.20, 129.35, 129.37, 129.40, and 129.80 shall apply in
determining whether the facilities, methods, practices, and controls
used in the processing, bottling, holding, and shipping of bottled
drinking water are in conformance with or are operated or administered
in conformity with good manufacturing practice to assure that bottled
drinking water is safe and that it has been processed, bottled, held,
and transported under sanitary conditions.
21 CFR 129.3 Definitions.
For the purposes of this part, the following definitions apply:
(a) ''Approved source'' when used in reference to a plant's product
water or operations water means a source of water and the water
therefrom, whether it be from a spring, artesian well, drilled well,
municipal water supply, or any other source, that has been inspected and
the water sampled, analyzed, and found to be of a safe and sanitary
quality according to applicable laws and regulations of State and local
government agencies having jurisdiction. The presence in the plant of
current certificates or notifications of approval from the government
agency or agencies having jurisdiction constitutes approval of the
source and the water supply.
(b) ''Bottled drinking water'' means all water which is sealed in
bottles, packages, or other containers and offered for sale for human
consumption, including bottled mineral water.
(c) ''Lot'' means a collection of primary containers or unit packages
of the same size, type, and style produced under conditions as nearly
uniform as possible and designated by a common container code or
marking.
(d) ''Multiservice containers'' means containers intended for use
more than one time.
(e) ''Nontoxic materials'' means materials for product water contact
surfaces utilized in the transporting, processing, storing, and
packaging of bottled drinking water, which are free of substances which
may render the water injurious to health or which may adversely affect
the flavor, color, odor, or bacteriological quality of the water.
(f) ''Operations water'' means water which is delivered under
pressure to a plant for container washing, hand washing, plant and
equipment cleanup and for other sanitary purposes.
(g) ''Primary container'' means the immediate container in which the
product water is packaged.
(h) ''Product water'' means processed water used by a plant for
bottled drinking water.
(i) ''Shall and should.'' ''Shall'' refers to mandatory requirements
and ''should'' refers to recommended or advisory procedures or
equipment.
(j) ''Shipping case'' means a container in which one or more primary
containers of the product are held.
(k) ''Single-service container'' means a container intended for one
time usage only.
(l) ''Unit package'' means a standard commercial package of bottled
drinking water, which may consist of one or more containers.
(42 FR 14355, Mar. 6, 1977, as amended at 44 FR 12175, Mar. 6, 1979)
21 CFR 129.3 Subpart B -- Buildings and Facilities
21 CFR 129.20 Plant construction and design.
(a) The bottling room shall be separated from other plant operations
or storage areas by tight walls, ceilings, and self-closing doors to
protect against contamination. Conveyor openings shall not exceed the
size required to permit passage of containers.
(b) If processing operations are conducted in other than a sealed
system under pressure, adequate protection shall be provided to preclude
contamination of the water and the system.
(c) Adequate ventilation shall be provided to minimize condensation
in processing rooms, bottling rooms, and in container washing and
sanitizing areas.
(d) The washing and sanitizing of containers for bottled drinking
water shall be performed in an enclosed room. The washing and
sanitizing operation shall be positioned within the room so as to
minimize any possible post-sanitizing contamination of the containers
before they enter the bottling room.
(e) Rooms in which product water is handled, processed, or held or in
which containers, utensils, or equipment are washed or held shall not
open directly into any room used for domestic household purposes.
21 CFR 129.35 Sanitary facilities.
Each plant shall provide adequate sanitary facilities including, but
not limited to, the following:
(a) Product water and operations water -- (1) Product water. The
product water supply for each plant shall be from an approved source
properly located, protected, and operated and shall be easily
accessible, adequate, and of a safe, sanitary quality which shall be in
conformance at all times with the applicable laws and regulations of the
government agency or agencies having jurisdiction.
(2) Operations water. If different from the product water supply,
the operations water supply shall be obtained from an approved source
properly located, protected, and operated and shall be easily
accessible, adequate, and of a safe, sanitary quality which shall be in
conformance at all times with the applicable laws and regulations of the
government agency or agencies having jurisdiction.
(3) Product water and operations water from approved sources. (i)
Samples of source water are to be taken and analyzed by the plant as
often as necessary, but at a minimum frequency of once each year for
chemical contaminants and once every 4 years for radiological
contaminants. Additionally, source water obtained from other than a
public water system is to be sampled and analyzed for microbiological
contaminants at least once each week. This sampling is in addition to
any performed by govermnnt agencies having jusisdiction. Records of
approval of the source water by government agencies having jusisdiction
and of sampling and analyses for which the plant is responsible are to
be maintained on file at the plant.
(ii) Test and sample methods shall be those recognized and approved
by the government agency or agencies having jurisdiction over the
approval of the water source, and shall be consistent with the minimum
requirements set forth in 103.35 of this chapter.
(iii) Analysis of the samples may be performed for the plant by
competent commercial laboratories.
(b) Air under pressure. Whenever air under pressure is directed at
product water or a product water-contact surface, it shall be free of
oil, dust, rust, excessive moisture, and extraneous materials; shall
not affect the bacteriological quality of the water; and should not
adversely affect the flavor, color, or odor of the water.
(c) Locker and lunchrooms. When employee locker and lunchrooms are
provided, they shall be separate from plant operations and storage areas
and shall be equipped with self-closing doors. The rooms shall be
maintained in a clean and sanitary condition and refuse containers
should be provided. Packaging or wrapping material or other processing
supplies shall not be stored in locker or lunchrooms.
(42 FR 14355, Mar. 15, 1977, as amended at 44 FR 12175, Mar. 6, 1979)
21 CFR 129.37 Sanitary operations.
(a) The product water-contact surfaces of all multiservice
containers, utensils, pipes, and equipment used in the transportation,
processing, handling, and storage of product water shall be clean and
adequately sanitized. All product water-contact surfaces shall be
inspected by plant personnel as often as necessary to maintain the
sanitary condition of such surfaces and to assure they are kept free of
scale, evidence of oxidation, and other residue. The presence of any
unsanitary condition, scale, residue, or oxidation shall be immediately
remedied by adequate cleaning and sanitizing of that product
water-contact surface prior to use.
(b) After cleaning, all multiservice containers, utensils, and
disassembled piping and equipment shall be transported and stored in
such a manner as to assure drainage and shall be protected from
contamination.
(c) Single-service containers and caps or seals shall be purchased
and stored in sanitary closures and kept clean therein in a clean, dry
place until used. Prior to use they shall be examined, and as
necessary, washed, rinsed, and sanitized and shall be handled in a
sanitary manner.
(d) Filling, capping, closing, sealing, and packaging of containers
shall be done in a sanitary manner so as to preclude contamination of
the bottled drinking water.
21 CFR 129.37 Subpart C -- Equipment
21 CFR 129.40 Equipment and procedures.
(a) Suitability. (1) All plant equipment and utensils shall be
suitable for their intended use. This includes all collection and
storage tanks, piping, fittings, connections, bottle washers, fillers,
cappers, and other equipment which may be used to store, handle,
process, package, or transport product water.
(2) All product water contact surfaces shall be constructed of
nontoxic and nonabsorbant material which can be adequately cleaned and
sanitized and is in compliance with section 409 of the act.
(b) Design. Storage tanks shall be of the type that can be closed to
exclude all foreign matter and shall be adequately vented.
21 CFR 129.40 Subpart D (Reserved)
21 CFR 129.40 Subpart E -- Production and Process Controls
21 CFR 129.80 Processes and controls.
(a) Treatment of product water. All treatment of product water by
distillation, ion-exchanging, filtration, ultraviolet treatment, reverse
osmosis, carbonation, mineral addition, or any other process shall be
done in a manner so as to be effective in accomplishing its intended
purpose and in accordance with section 409 of the Federal Food, Drug,
and Cosmetic Act. All such processes shall be performed in and by
equipment and with substances which will not adulterate the bottled
product. A record of the type and date of physical inspections of such
equipment, conditions found, and the performance and effectiveness of
such equipment shall be maintained by the plant. Product water samples
shall be taken after processing and prior to bottling by the plant and
analyzed as often as is necessary to assure uniformity and effectiveness
of the processes performed by the plant. The methods of analysis shall
be those approved by the government agency or agencies having
jurisdiction.
(b) Containers. (1) Multiservice primary containers shall be
adequately cleaned, sanitized, and inspected just prior to being filled,
capped, and sealed. Containers found to be unsanitary or defective by
the inspection shall be reprocessed or discarded. All multiservice
primary containers shall be washed, rinsed, and sanitized by mechanical
washers or by any other method giving adequate sanitary results.
Mechanical washers shall be inspected as often as is necessary to assure
adequate performance. Records of physical maintenance, inspections and
conditions found, and performance of the mechanical washer shall be
maintained by the plant.
(2) Multiservice shipping cases shall be maintained in such condition
as to assure they will not contaminate the primary container or the
product water. Adequate dry or wet cleaning procedures shall be
performed as often as necessary to maintain the cases in satisfactory
condition.
(c) Cleaning and sanitizing solutions. Cleaning and sanitizing
solutions utilized by the plant shall be sampled and tested by the plant
as often as is necessary to assure adequate performance in the cleaning
and sanitizing operations. Records of these tests shall be maintained
by the plant.
(d) Sanitizing operations. Sanitizing operations, including those
performed by chemical means or by any other means such as circulation of
live steam or hot water, shall be adequate to effect sanitization of the
intended product water-contact surfaces and any other critical area.
The plant should maintain a record of the intensity of the sanitizing
agent and the time duration that the agent was in contact with the
surface being sanitized. The following times and intensities shall be
considered a minimum:
(1) Steam in enclosed system: At least 170 F for at least 15
minutes or at least 200 F for at least 5 minutes.
(2) Hot water in enclosed system: At least 170 F for at least 15
minutes or at least 200 F for at least 5 minutes.
(3) Chemical sanitizers shall be equivalent in bactericidal action to
a 2-minute exposure of 50 parts per million of available chlorine at 57
F when used as an immersion or circulating solution. Chemical
sanitizers applied as a spray or fog shall have as a minimum 100 parts
per million of available chlorine at 57 F or its equivalent in
bactericidal action.
(4) 0.1 part per million ozone water solution in an enclosed system
for at least 5 minutes.
(5) When containers are sanitized using a substance other than one
provided for in 178.1010 of this chapter, such substance shall be
removed from the surface of the container by a rinsing procedure. The
final rinse, prior to filling the container with product water, shall be
performed with a disinfected water rinse free of pathogenic bacteria or
by an additional sanitizing procedure equivalent in bactericidal action
to that required in paragraph (d)(3) of this section.
(e) Unit package production code. Each unit package from a batch or
segment of a continuous production run of bottled drinking water shall
be identified by a production code. The production code shall identify
a particular batch or segment of a continuous production run and the day
produced. The plant shall record and maintain information as to the
kind of product, volume produced, date produced, lot code used, and the
distribution of the finished product to wholesale and retail outlets.
(f) Filling, capping, or sealing. During the process of filling,
capping or sealing either single-service or multiservice containers, the
performance of the filler, capper or sealer shall be monitored and the
filled containers visually or electronically inspected to assure they
are sound, properly capped or sealed, and coded and labeled. Containers
which are not satisfactory shall be reprocessed or rejected. Only
nontoxic containers and closures shall be used. All containers and
closures shall be sampled and inspected to ascertain that they are free
from contamination. At least once each 3 months, a bacteriological swab
and/or rinse count should be made from at least four containers and
closures selected just prior to filling and sealing. No more than one
of the four samples may exceed more than one bacteria per milliliter of
capacity or one colony per square centimeter of surface area. All
samples shall be free of coliform organisms. The procedure and
apparatus for these bacteriological tests shall be in conformance with
those recognized by the government agency or agencies having
jurisdiction. Tests shall be performed either by qualified plant
personnel or a competent commercial laboratory.
(g) Compliance procedures. A quality standard for bottled drinking
water, excluding mineral water, is established in 103.35 of this
chapter. To assure that the plant'a production of bottled drinking
water complies with the applicable standards, laws, and regulations of
the govenrment agency or agencies having jusisdiction, the plant will
analyze product samples as follows:
(1) For bacteriological purposes, take and analyze at least once a
week a representative sample from a batch or segment of a continuous
production run for each type of bottled drinking water produced during a
day's production. The representative sample shall consist of primary
containers of product or unit packages of product.
(2) For chemical, physical, and radiological purposes, take and
analyze at least annually a representative sample from a batch or
segment of a continuous production run for each type of bottled drinking
water produced during a day's production. The representtive sample(s)
consists of primary containers of product of unit packages of product.
(3) Analyze such samples by methods approved by the government agency
or agencies having jurisdiction. The plant shall maintain records of
date of sampling, type of product sampled, production code, and results
of the analysis.
(h) Record retention. All records required by 129.1, 129.20,
129.35, 129.37, 129.40, and 129.80 shall be maintained at the plant for
not less than 2 years. Plants shall also retain, on file at the plant,
current certificates or notifications of approval issued by the
government agency or agencies approving the plant's source and supply of
product water and operations water. All required documents shall be
available for official review at reasonable times.
(42 FR 14355, Mar. 15, 1977, as amended at 44 FR 12175, Mar, 6, 1979)
21 CFR 129.80 Pt. 130
21 CFR 129.80 PART 130 -- FOOD STANDARDS: GENERAL
21 CFR 129.80 Subpart A -- General Provisions
Sec.
130.3 Definitions and interpretations.
130.5 Procedure for establishing a food standard.
130.6 Review of Codex Alimentarius food standards.
130.8 Conformity to definitions and standards of identity.
130.12 General methods for water capacity and fill of containers.
130.14 General statements of substandard quality and substandard fill
of container.
130.17 Temporary permits for interstate shipment of experimental
packs of food varying from the requirements of definitions and standards
of identity.
21 CFR 129.80 Subpart B -- Food Additives in Standardized Foods
130.20 Food additives proposed for use in foods for which definitions
and standards of identity are established.
Authority: Secs. 201, 306, 401, 403, 701 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321, 336, 341, 343, 371).
Source: 42 FR 14357, Mar. 15, 1977, unless otherwise noted.
21 CFR 129.80 Subpart A -- General Provisions
21 CFR 130.3 Definitions and interpretations.
(a) The definitions and interpretations of terms contained in section
201 of the act shall be applicable also to such terms when used in
regulations promulgated under the act.
(b) If a regulation prescribing a definition and standard of identity
for a food has been promulgated under section 401 of the act and the
name therein specified for the food is used in any other regulation
under section 401 or any other provision of the act, such name means the
food which conforms to such definition and standard, except as otherwise
specifically provided in such other regulation.
(c) No provision of any regulation prescribing a definition and
standard of identity or standard of quality or fill of container under
section 401 of the act shall be construed as in any way affecting the
concurrent applicability of the general provisions of the act and the
regulations thereunder relating to adulteration and misbranding. For
example, all regulations under section 401 contemplate that the food and
all articles used as components or ingredients thereof shall not be
poisonous or deleterious and shall be clean, sound, and fit for food. A
provision in such regulations for the use of coloring or flavoring does
not authorize such use under circumstances or in a manner whereby damage
or inferiority is concealed or whereby the food is made to appear better
or of greater value than it is.
(d) ''Safe and suitable'' means that the ingredient:
(1) Performs an appropriate function in the food in which it is used.
(2) Is used at a level no higher than necessary to achieve its
intended purpose in that food.
(3) Is not a food additive or color additive as defined in section
201 (s) or (t) of the Federal Food, Drug, and Cosmetic Act as used in
that food, or is a food additive or color additive as so defined and is
used in conformity with regulations established pursuant to section 409
or 706 of the act.
21 CFR 130.5 Procedure for establishing a food standard.
(a) The procedure for establishing a food standard under section 401
of the act shall be governed by Part 10 of this chapter.
(b) Any petition for a food standard shall show that the proposal, if
adopted, would promote honesty and fair dealing in the interest of
consumers.
(c) Any petition for a food standard shall assert that the petitioner
commits himself to substantiate the information in the petition by
evidence in a public hearing, if such a hearing becomes necessary.
(d) If a petitioner fails to appear, or to substantiate the
information in his petition, at a public hearing on the matter, the
Commissioner may either (1) withdraw the regulation and terminate the
proceeding or (2) if he concludes that it is in accordance with the
requirements of section 401 of the act, continue the proceeding and
introduce evidence to substantiate such information.
(42 FR 14357, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22,
1977)
21 CFR 130.6 Review of Codex Alimentarius food standards.
(a) All food standards adopted by the Codex Alimentarius Commission
will be reviewed by the Food and Drug Administration and will be
accepted without change, accepted with change, or not accepted.
(b) Review of Codex standards will be accomplished in one of the
following three ways:
(1) Any interested person may petition the Commissioner to adopt a
Codex standard, with or without change, by proposing a new standard or
an appropriate amendment of an existing standard, pursuant to section
401 of the act. Any such petition shall specify any deviations from the
Codex standard, and the reasons for any such deviations. The
Commissioner shall publish such a petition in the Federal Register as a
proposal, with an opportunity for comment, if reasonable grounds are
provided in the petition. Any published proposal shall state any
deviations from the Codex standard and the stated reasons therefor.
(2) The Commissioner may on his own initiative propose by publication
in the Federal Register the adoption of a Codex standard, with or
without change, through a new standard or an appropriate amendment to an
existing standard, pursuant to section 401 of the act. Any such
proposal shall specify any deviations from the Codex standard, and the
reasons for any such deviations.
(3) Any Codex standard not handled under paragraph (b) (1) or (2) of
this section may be published in the Federal Register for review and
informal comment. Interested persons shall be requested to comment on
the desirability and need for the standard, on the specific provisions
of the standard, on additional or different provisions that should be
included in the standard, and on any other pertinent points. After
reviewing all such comments, the Commissioner either shall publish a
proposal to establish a food standard pursuant to section 401 of the act
covering the food involved, or shall publish a notice terminating
consideration of such a standard.
(c) All interested persons are encouraged to confer with different
interest groups (consumers, industry, the academic community,
professional organizations, and others) in formulating petitions or
comments pursuant to paragraph (b) of this section. All such petitions
or comments are requested to include a statement of any meetings and
discussions that have been held with other interest groups. Appropriate
weight will be given by the Commissioner to petitions or comments that
reflect a consensus of different interest groups.
21 CFR 130.8 Conformity to definitions and standards of identity.
In the following conditions, among others, a food does not conform to
the definition and standard of identity therefor:
(a) If it contains an ingredient for which no provision is made in
such definition and standard, unless such ingredient is an incidental
additive introduced at a nonfunctional and insignificant level as a
result of its deliberate and purposeful addition to another ingredient
permitted by the terms of the applicable standard and the presence of
such incidental additive in unstandardized foods has been exempted from
label declaration as provided in 101.100 of this chapter.
(b) If it fails to contain any one or more ingredients required by
such definition and standard;
(c) If the quantity of any ingredient or component fails to conform
to the limitation, if any, prescribed therefor by such definition and
standard.
21 CFR 130.12 General methods for water capacity and fill of
containers.
For the purposes of regulations promulgated under section 401 of the
act:
(a) The term ''general method for water capacity of containers''
means the following method:
(1) In the case of a container with lid attached by double seam, cut
out the lid without removing or altering the height of the double seam.
(2) Wash, dry, and weigh the empty container.
(3) Fill the container with distilled water at 68 F to 3/16 inch
vertical distance below the top level of the container, and weigh the
container thus filled.
(4) Subtract the weight found in paragraph (a)(2) of this section
from the weight found in paragraph (a)(3) of this section. The
difference shall be considered to be the weight of water required to
fill the container.
In the case of a container with lid attached otherwise than by double
seam, remove the lid and proceed as directed in paragraphs (a) (2) to
(4) of this section, except that under paragraph (a)(3) of this section,
fill the container to the level of the top thereof.
(b) The term ''general method for fill of containers'' means the
following method:
(1) In the case of a container with lid attached by double seam, cut
out the lid without removing or altering the height of the double seam.
(2) Measure the vertical distance from the top level of the container
to the top level of the food.
(3) Remove the food from the container; wash, dry, and weigh the
container.
(4) Fill the container with water to 3/16 inch vertical distance
below the top level of the container. Record the temperature of the
water, weigh the container thus filled, and determine the weight of the
water by subtracting the weight of the container found in paragraph
(b)(3) of this section.
(5) Maintaining the water at the temperature recorded in paragraph
(b)(4) of this section, draw off water from the container as filled in
paragraph (b)(4) of this section to the level of the food found in
paragraph (b)(2) of this section, weigh the container with remaining
water, and determine the weight of the remaining water by subtracting
the weight of the container found in paragraph (b)(3) of this section.
(6) Divide the weight of water found in paragraph (b)(5) of this
section by the weight of water found in paragraph (b)(4) of this
section, and multiply by 100. The result shall be considered to be the
percent of the total capacity of the container occupied by the food.
In the case of a container with lid attached otherwise than by double
seam, remove the lid and proceed as directed in paragraphs (b) (2) to
(6) of this section, except that under paragraph (b)(4) of this section,
fill the container to the level of the top thereof.
21 CFR 130.14 General statements of substandard quality and substandard
fill of container.
For the purposes of regulations promulgated under section 401 of the
act:
(a) The term ''general statement of substandard quality'' means the
statement ''Below Standard in Quality Good Food -- Not High Grade''
printed in two lines of Cheltenham bold condensed caps. The words
''Below Standard in Quality'' constitute the first line, and the second
immediately follows. If the quantity of the contents of the container
is less than 1 pound, the type of the first line is 12-point, and of the
second, 8-point. If such quantity is 1 pound or more, the type of the
first line is 14-point, and of the second, 10-point. Such statement is
enclosed within lines, not less than 6 points in width, forming a
rectangle. Such statement, with enclosing lines, is on a strongly
contrasting, uniform background, and is so placed as to be easily seen
when the name of the food or any pictorial representation thereof is
viewed, wherever such name or representation appears so conspicuously as
to be easily seen under customary conditions of purchase.
(b) The term ''general statement of substandard fill'' means the
statement ''Below Standard in Fill'' printed in Cheltenham bold
condensed caps. If the quantity of the contents of the container is
less than 1 pound, the statement is in 12-point type; if such quantity
is 1 pound or more, the statement is in 14-point type. Such statement
is enclosed within lines, not less than 6 points in width, forming a
rectangle; but if the statement specified in paragraph (a) of this
section is also used, both statements (one following the other) may be
enclosed within the same rectangle. Such statement or statements, with
enclosing lines, are on a strongly contrasting, uniform background, and
are so placed as to be easily seen when the name of the food or any
pictorial representation thereof is viewed, wherever such name or
representation appears so conspicuously as to be easily seen under
customary conditions of purchase.
21 CFR 130.17 Temporary permits for interstate shipment of experimental
packs of food varying from the requirements of definitions and standards
of identity.
(a) The Food and Drug Administration recognizes that before petitions
to amend food standards can be submitted, appropriate investigations of
potential advances in food technology sometimes require tests in
interstate markets of the advantages to and acceptance by consumers of
experimental packs of food varying from applicable definitions and
standards of identity prescribed under section 401 of the act.
(b) It is the purpose of the Food and Drug Administration to permit
such tests when it can be ascertained that the sole purpose of the tests
is to obtain data necessary for reasonable grounds in support of a
petition to amend food standards, that the tests are necessary to the
completion or conclusiveness of an otherwise adequate investigation, and
that the interests of consumers are adequately safeguarded; permits for
such tests shall normally be for a period not to exceed 15 months. The
Food and Drug Administration, or good cause shown by the applicant, may
provide for a longer test market period. The Food and Drug
Administration will therefore refrain from recommending regulatory
proceedings under the act on the charge that a food does not conform to
an applicable standard, if the person who introduces or causes the
introduction of the food into interstate commerce holds an effective
permit from the Food and Drug Administration providing specifically for
those variations in respect to which the food fails to conform to the
applicable definition and standard of identity. The test period will
begin on the date the person holding an effective permit from the Food
and Drug Administration introduces or causes the introduction of the
food covered by the permit into interstate commerce but not later than 3
months after notice of the issuance of the permit is published in the
Federal Register. The Food and Drug Administration shall be notified in
writing of the date on which the test period begins as soon as it is
determined.
(c) Any person desiring a permit may file with the Deputy Director,
Division of Food Chemistry and Technology, Center for Food Safety and
Applied Nutrition (HFF-410), Food and Drug Administration, 200 C St.
SW., Washington, DC 20204, a written application in triplicate
containing as part thereof the following:
(1) Name and address of the applicant.
(2) A statement of whether or not the applicant is regularly engaged
in producing the food involved.
(3) A reference to the applicable definition and standard of identity
(citing applicable section of regulations).
(4) A full description of the proposed variation from the standard.
(5) The basis upon which the food so varying is believed to be
wholesome and nondeleterious.
(6) The amount of any new ingredient to be added; the amount of any
ingredient, required by the standard, to be eliminated; any change of
concentration not contemplated by the standard; or any change in name
that would more appropriately describe the new product under test. If
such new ingredient is not a commonly known food ingredient, a
description of its properties and basis for concluding that it is not a
deleterious substance.
(7) The purpose of effecting the variation.
(8) A statement of how the variation is of potential advantage to
consumers. The statement shall include the reasons why the applicant
does not consider the data obtained in any prior investigations which
may have been conducted sufficient to support a petition to amend the
standard.
(9) The proposed label (or an accurate draft) to be used on the food
to be market tested. The label shall conform in all respects to the
general requirements of the act and shall provide a means whereby the
consumer can distinguish between the food being tested and such food
complying with the standard.
(10) The period during which the applicant desires to introduce such
food into interstate commerce, with a statement of the reasons
supporting the need for such period. If a period longer than 15 months
is requested, a detailed explanation of why a 15-month period is
inadequate shall be provided.
(11) The probable amount of such food that will be distributed. The
amount distributed should be limited to the smallest number of units
reasonably required for a bona fide market test. Justification for the
amount requested shall be included.
(12) The areas of distribution.
(13) The address at which such food will be manufactured.
(14) A statement of whether or not such food has been or is to be
distributed in the State in which it was manufactured.
(15) If it has not been or is not to be so distributed, a statement
showing why.
(16) If it has been or is to be so distributed, a statement of why it
is deemed necessary to distribute such food in other States.
(d) The Food and Drug Administration may require the applicant to
furnish samples of the food varying from the standard and to furnish
such additional information as may be deemed necessary for action on the
application.
(e) If the Food and Drug Administration concludes that the variation
may be advantageous to consumers and will not result in failure of the
food to conform to any provision of the act except section 403(g), a
permit shall be issued to the applicant for interstate shipment of such
food. The terms and conditions of the permit shall be those set forth
in the application with such modifications, restrictions, or
qualifications as the Food and Drug Administration may deem necessary
and state in the permit.
(f) The terms and conditions of the permit may be modified at the
discretion of the Food and Drug Administration or upon application of
the permittee during the effective period of the permit.
(g) The Food and Drug Administration may revoke a permit for cause,
which shall include but not be limited to the following:
(1) That the permittee has introduced a food into interstate commerce
contrary to the terms and conditions of the permit.
(2) That the application for a permit contains an untrue statement of
a material fact.
(3) That the need therefor no longer exists.
(h) During the period within which any permit is effective, it shall
be deemed to be included within the terms of any guaranty or undertaking
otherwise effective pursuant to the provisions of section 303(c) of the
act.
(i) If an application is made for an extension of the permit, it
shall be accompanied by a description of experiments conducted under the
permit, tentative conclusions reached, and reasons why further
experimental shipments are considered necessary. The application for an
extension shall be filed not later than 3 months prior to the expiration
date of the permit and shall be accompanied by a petition to amend the
affected food standard. If the Food and Drug Administration concludes
that it will be in the interest of consumers to issue an extension of
the time period for the market test, a notice will be published in the
Federal Register stating that fact. The notice will include an
invitation to all interested persons to participate in the market test
under the same conditions that applied to the initial permit holder,
including labeling and the amount to be distributed, except that the
designated area of distribution shall not apply. The extended market
test period shall not begin prior to the publication of a notice in the
Federal Register granting the extension and shall terminate either on
the effective date of an affirmative order ruling on the proposal or 30
days after a negative order ruling on the proposal, whichever the case
may be. Any interested person who accepts the invitation to participate
in the extended market test shall notify the Food and Drug
Administration in writing of that fact, the amount to be distributed,
and the area of distribution; and along with such notification, he
shall submit the labeling under which the food is to be distributed.
(j) Notice of the granting or revocation of any permit shall be
published in the Federal Register.
(k) All applications for a temporary permit, applications for an
extension of a temporary permit, and related records are available for
public disclosure when the notice of a permit or extension thereof is
published in the Federal Register. Such disclosure shall be in
accordance with the rules established in Part 20 of this chapter.
(l) Any person who contests denial, modification, or revocation of a
temporary permit shall have an opportunity for a regulatory hearing
before the Food and Drug Administration pursuant to Part 16 of this
chapter.
(42 FR 14357, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22,
1977; 46 FR 37500, July 21, 1981; 54 FR 24892, June 12, 1989)
21 CFR 130.17 Subpart B -- Food Additives in Standardized Foods
21 CFR 130.20 Food additives proposed for use in foods for which
definitions and standards of identity are established.
(a) Where a petition is received for the issuance or amendment of a
regulation establishing a definition and standard of identity for a food
under section 401 of the act, which proposes the inclusion of a food
additive in such definition and standard of identity, the provisions of
the regulations in Part 171 of this chapter shall apply with respect to
the information that must be submitted with respect to the food
additive. Since section 409(b)(5) of the act requires that the
Commissioner publish notice of a petition for the establishment of a
food additive regulation within 30 days after filing, notice of a
petition relating to a definition and standard of identity shall also be
published within that time limitation if it includes a request, so
designated, for the establishment of a regulation pertaining to a food
additive.
(b) If a petition for a definition and standard of identity contains
a proposal for a food additive regulation, and the petitioner fails to
designate it as such, the Commissioner, upon determining that the
petition includes a proposal for a food additive regulation, shall so
notify the petitioner and shall thereafter proceed in accordance with
the regulations in Part 171 of this chapter.
21 CFR 130.20 PART 131 -- MILK AND CREAM
21 CFR 130.20 Subpart A -- General Provisions
Sec.
131.3 Definitions.
131.25 Whipped cream products containing flavoring or sweetening.
21 CFR 130.20 Subpart B -- Requirements for Specific Standardized Milk
and Cream
131.110 Milk.
131.111 Acidified milk.
131.112 Cultured milk.
131.115 Concentrated milk.
131.120 Sweetened condensed milk.
131.122 Sweetened condensed skimmed milk.
131.123 Lowfat dry milk.
131.125 Nonfat dry milk.
131.127 Nonfat dry milk fortified with vitamins A and D.
131.130 Evaporated milk.
131.132 Evaporated skimmed milk.
131.135 Lowfat milk.
131.136 Acidified lowfat milk.
131.138 Cultured lowfat milk.
131.143 Skim milk.
131.144 Acidified skim milk.
131.146 Cultured skim milk.
131.147 Dry whole milk.
131.149 Dry Cream.
131.150 Heavy cream.
131.155 Light cream.
131.157 Light whipping cream.
131.160 Sour cream.
131.162 Acidified sour cream.
131.170 Eggnog.
131.180 Half-and-half.
131.185 Sour half-and-half.
131.187 Acidified sour half-and-half.
131.200 Yogurt.
131.203 Lowfat yogurt.
131.206 Nonfat yogurt.
Authority: Secs. 201, 401, 403, 409, 701, 706 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321, 341, 343, 348, 371, 376).
Source: 42 FR 14360, Mar. 15, 1977, unless otherwise noted.
21 CFR 130.20 Subpart A -- General Provisions
21 CFR 131.3 Definitions.
(a) ''Cream'' means the liquid milk product high in fat separated
from milk, which may have been adjusted by adding thereto: Milk,
concentrated milk, dry whole milk, skim milk, concentrated skim milk, or
nonfat dry milk. Cream contains not less than 18 percent milkfat.
(b) ''Pasteurized'' when used to describe a dairy product means that
every particle of such product shall have been heated in properly
operated equipment to one of the temperatures specified in the table of
this paragraph and held continuously at or above that temperature for
the specified time (or other time/temperature relationship which has
been demonstrated to be equivalent thereto in microbial destruction):
(c) ''Ultra-pasteurized'' when used to describe a dairy product means
that such product shall have been thermally processed at or above 280 F
for at least 2 seconds, either before or after packaging, so as to
produce a product which has an extended shelf life under refrigerated
conditions.
21 CFR 131.25 Whipped cream products containing flavoring or
sweetening.
The unqualified name ''whipped cream'' should not be applied to any
product other than one made by whipping the cream that complies with the
standards of identity for whipping cream ( 131.150 and 131.157 of this
chapter). If flavoring and/or sweetening is added, the resulting
product is a flavored and/or sweetened whipped cream, and should be so
identified.
21 CFR 131.25 Subpart B -- Requirements for Specific Standardized Milk and Cream
21 CFR 131.110 Milk.
(a) Description. Milk is the lacteal secretion, practically free
from colostrum, obtained by the complete milking of one or more healthy
cows. Milk that is in final package form for beverage use shall have
been pasteurized or ultrapasteurized, and shall contain not less than 8
1/4 percent milk solids not fat and not less than 3 1/4 percent milkfat.
Milk may have been adjusted by separating part of the milkfat
therefrom, or by adding thereto cream, concentrated milk, dry whole
milk, skim milk, concentrated skim milk, or nonfat dry milk. Milk may
be homogenized.
(b) Vitamin addition (Optional). (1) If added, vitamin A shall be
present in such quantity that each quart of the food contains not less
than 2000 International Units thereof within limits of good
manufacturing practice.
(2) If added, vitamin D shall be present in such quantity that each
quart of the food contains 400 International Units thereof within limits
of good manufacturing practice.
(c) Optional ingredients. The following safe and suitable
ingredients may be used:
(1) Carriers for vitamins A and D.
(2) Characterizing flavoring ingredients (with or without coloring,
nutritive sweetener, emulsifiers, and stabilizers) as follows:
(i) Fruit and fruit juice (including concentrated fruit and fruit
juice).
(ii) Natural and artificial food flavorings.
(d) Methods of analysis. Referenced methods are from ''Official
Methods of Analysis of the Association of Official Analytical
Chemists,'' 13th Ed. (1980), which is incorporated by reference.
Copies may be obtained from the Association of Official Analytical
Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may
be examined at the Office of the Federal Register, 1100 L St. NW.,
Washington, DC 20408.
(1) Milkfat content -- ''Fat, Roese-Gottlieb Method -- Official Final
Action,'' section 16.059.
(2) Milk solids not fat content -- Calculated by subtracting the milk
fat content from the total solids content as determined by the method
''Total Solids, Method I -- Official Final Action,'' section 16.032.
(3) Vitamin D content -- ''Vitamin D -- Official Final Action,''
sections 43.195-43.208.
(e) Nomenclature. The name of the food is ''milk''. The name of the
food shall be accompanied on the label by a declaration indicating the
presence of any characterizing flavoring, as specified in 101.22 of
this chapter.
(1) The following terms shall accompany the name of the food wherever
it appears on the principal display panel or panels of the label in
letters not less than one-half the height of the letters used in such
name:
(i) If vitamins are added, the phrase ''vitamin A'' or ''vitamin A
added'', or ''vitamin D'' or ''vitamin D added'', or ''vitamin A and D''
or ''vitamins A and D added'', as is appropriate. The word ''vitamin''
may be abbreviated ''vit.''.
(ii) The word ''ultra-pasteurized'' if the food has been
ultra-pasteurized.
(2) The following terms may appear on the label:
(i) The word ''pasteurized'' if the food has been pasteurized.
(ii) The word ''homogenized'' if the food has been homogenized.
(f) Label declaration. When used in the food, each of the
ingredients specified in paragraphs (b) and (c)(2) of this section shall
be declared on the label as required by the applicable sections of Part
101 of this chapter.
(42 FR 14360, Mar. 15, 1977, as amended at 47 FR 11822, Mar. 19,
1982; 49 FR 10090, Mar. 19, 1984; 54 FR 24892, June 12, 1989)
21 CFR 131.111 Acidified milk.
(a) Description. Acidified milk is the food produced by souring one
or more of the optional dairy ingredients specified in pargaph (c) of
this section with one or more of the acidifying ingredients specified in
paragraph (d) of this section, with or without the addition of
characterizing microbial organisms. One or more of the other optional
ingredients specified in paragraphs (b) and (e) of this section may also
be added. When one or more of the ingredients specified in paragraph
(e)(1) of this section are used, they shall be included in the souring
process. All ingredients used are safe and suitable. Acidified milk
contains not less than 3.25 percent milkfat and not less than 8.25
percent milk solids not fat and has a titratable acidity of not less
than 0.5 percent, expressed as lactic acid. The food may be homogenized
and shall be pasteurized or ultra-pasteurized prior to the addition of
the microbial culture and, when applicable, the addition of flakes or
granules of butterfat or milkfat.
(b) Vitamin addition (optional). (1) If added, vitamin A shall be
present in such quantity that each 946 milliliters (quart) of the food
contains not less than 2,000 International Units thereof, within limits
of good manufacturing practice.
(2) If added, vitamin D shall be present in such quantity that each
946 milliliters (quart) of the food contains 400 International Units
thereof, within limits of good manufacturing practice.
(c) Optional dairy ingredients. Cream, milk, partially skimmed milk,
or skim milk, used alone or in combination.
(d) Optional acidifying ingredients. Acetic acid, adipic acid,
citric acid, fumaric acid, glucono-delta-lactone, hydrochloric acid,
lactic acid, malic acid, phosphoric acid, succinic acid, and tartaric
acid.
(e) Other optional ingredients. (1) Concentrated skim milk, nonfat
dry milk, buttermilk, whey, lactose, lactalbumins, lactoglobulins, or
whey modified by partial or complete removal of lactose and/or minerals,
to increase the nonfat solids content of the food: Provided, That the
ratio of protein to total nonfat solids of the food, and the protein
efficiency ratio of all protein present, shall not be decreased as a
result of adding such ingredients.
(2) Nutritive carbohydrate sweeteners. Sugar (sucrose), beet or
cane; invert sugar (in paste or sirup form); brown sugar; refiner's
sirup; molasses (other than blackstrap); high fructose corn sirup;
fructose; fructose sirup; maltose; maltose sirup, dried maltose
sirup; malt extract, dried malt extract; malt sirup, dried malt sirup;
honey; maple sugar; or any of the sweeteners listed in Part 168 of
this chapter, except table sirup.
(3) Flavoring ingredients.
(4) Color additives that do not impart a color simulalting that of
milkfat or butterfat.
(5) Stabilizers.
(6) Butterfat or milkfat, which may or may not contain color
additives, in the form of flakes or granules.
(7) Aroma- and flavor-producing microbial culture.
(8) Salt.
(9) Citric acid, in a maximum amount of 0.15 percent by weight of the
milk used, or an equivalent amount of sodium citrate, as a flavor
precursor.
(f) Methods of analysis. The following referenced methods of
analysis are from ''Official Methods of Analysis of the Association of
Official Analytical Chemists,'' 13th Ed. (1980), which is incorporated
by reference. Copies are available from the Association of Official
Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA
22201-3301, or available for inspection at the Office of the Federal
Register, 1100 L St. NW., Washington, DC 20408.
(1) Milkfat content -- As determined by the method prescribed in
section 16.059, ''Roese-Gottlieb Method (Reference Method) (11) --
Official Final Action,'' under the heading ''Fat.''
(2) Milk solids not fat content -- Calculated by subtracting the
milkfat content from the total solids content as determined by the
method prescribed in section 16.032, ''Method I -- Official Final
Action,'' under the heading ''Total Solids.''
(3) Titratable acidity -- As determined by the method prescribed in
section 16.023, ''Acidity (2) -- Official Final Action,'' or by an
equivalent potentiometric method.
(g) Nomenclature. The name of the food is ''acidified milk''. The
full name of the food shall appear on the principal display panel of the
label in type of uniform size, style, and color. The name of the food
shall be accompanied by a declaration indicating the presence of any
characterizing flavoring as specified in 101.22 of this chapter, and
may be accompanied by a declaration such as a traditional name of the
food or the generic name of the organisms used, thereby indicating the
presence of the characterizing microbial organisms or ingredients when
used, e.g., ''acidified kefir milk'', ''acidified acidophilus milk'', or
when characterizing ingredients such as those in paragraphs (e) (6),
(7), (8), and (9) of this section are used, the food may be named
''acidified buttermilk''.
(1) The following terms shall accompany the name of the food wherever
it appears on the principal display panel or panels of the label in
letters not less than one-half of the height of the letters used in such
name:
(i) The phrase ''vitamin A'' or ''vitamin A added'', or ''vitamin D''
or ''vitamin D added'', or ''vitamins A and D added'', as appropriate.
The word ''vitamin'' may be abbreviated ''vit.''.
(ii) The word ''sweetened'' if nutritive carbohydrate sweetener is
added without the addition of characterizing flavoring.
(2) The term ''homogenized'' may appear on the label if the dairy
ingredients used are homogenized.
(h) Label declaration. Each of the ingredients used in the food
shall be declared on the label as required by the applicable sections of
Part 101 of this chapter.
(46 FR 9934, Jan. 30, 1981, as amended at 47 FR 11822, Mar. 19, 1982;
47 FR 41523, Sept. 21, 1982; 48 FR 24869, June 3, 1983; 54 FR 24892,
June 12, 1989)
21 CFR 131.112 Cultured milk.
(a) Description. Cultured milk is the food produced by culturing one
or more of the optional dairy ingredients specified in paragraph (c) of
this section with characterizing microbial organisms. One or more of
the other optional ingredients specified in paragraphs (b) and (d) of
this section may also be added. When one or more of the ingredients
specified in paragraph (d)(1) of this section are used, they shall be
included in the culturing process. All ingredients used are safe and
suitable. Cultured milk contains not less than 3.25 percent milkfat and
not less than 8.25 percent milk solids not fat and has a titratable
acidity of not less than 0.5 percent, expressed as lactic acid. The
food may be homogenized and shall be pasteurized or ultra-pasteurized
prior to the addition to the microbial culture, and when applicable, the
addition of flakes or granules of butterfat or milkfat.
(b) Vitamin addition (optional). (1) If added, vitamin A shall be
present in such quantity that each 946 milliliters (quart) of the food
contains not less than 2,000 International Units thereof, within limits
of good manufacturing practice.
(2) If added, vitamin D shall be present in such quantity that each
946 milliliters (quart) of the food contains 400 International Units
thereof, within limits of good manufacturing practice.
(c) Optional dairy ingredients. Cream, milk, partially skimmed milk,
or skim milk, used alone or in combination.
(d) Other optional ingredients. (1) Concentrated skim milk, nonfat
dry milk, buttermilk, whey, lactose, lactalbumins, lactoglobulins, or
whey modified by partial or complete removal of lactose and/or minerals,
to increase the nonfat solids content of the food: Provided, That the
ratio of protein to total nonfat solids of the food, and the protein
efficiency ratio of all protein present, shall not be decreased as a
result of adding such ingredients.
(2) Nutritive carbohydrate sweeteners. Sugar (sucrose), beet or
cane; invert sugar (in paste or sirup form); brown sugar; refiner's
sirup; molasses (other than blackstrap); high fructose corn sirup;
fructose; fructose sirup; maltose; maltose sirup, dried maltose
sirup; malt extract, dried malt extract; malt sirup, dried malt sirup;
honey; maple sugar; or any of the sweeteners listed in Part 168 of
this chapter, except table sirup.
(3) Flavoring ingredients.
(4) Color additives that do not impart a color simulating that of
milkfat or butterfat.
(5) Stabilizers.
(6) Butterfat or milkfat, which may or may not contain color
additives, in the form of flakes or granules.
(7) Aroma- and flavor-producing microbial culture.
(8) Salt.
(9) Citric acid, in a maximum amount of 0.15 percent by weight of the
milk used, or an equivalent amount of sodium citrate, as a flavor
precursor.
(e) Methods of analysis. The following referenced methods of
analysis are from ''Official Methods of Analysis of the Association of
Official Analytical Chemists,'' 13th Ed. (1980), which is incorporated
by reference. Copies may be obtained from the Association of Official
Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA
22201-3301, or available for inspection at the Office of the Federal
Register, 1100 L St. NW., Washington, DC 20408.
(1) Milkfat content -- section 16.059, ''Roese-Gottlieb Method
(Reference Method) (11) -- Official Final Action,'' under the heading
''Fat.''
(2) Milk solids not fat content -- Calculated by subtracting the
milkfat content from the total solids content as determined by the
method prescribed in section 16.032, ''Method I -- Official Final
Action,'' under the heading ''Total Solids.''
(3) Titratable acidity -- As determined by the methods prescribed in
section 16.023 ''Acidity (2) -- Official Final Action,'' or by an
equivalent potentiometric method.
(f) Nomenclature. The name of the food is ''cultured milk''. The
full name of the food shall appear on the principal display panel in
type of uniform size, style, and color. The name of the food shall be
accompanied by a declaration indicating the presence of any
characterizing flavoring as specified in 101.22 of this chapter, and
may be accompanied by a declaration such as a traditional name of the
food or the generic name of the organisms used, thereby indicating the
presence of the characterizing microbial organisms or ingredients, e.g.,
''kefir cultured milk'', ''acidophilus cultured milk'', or when
characterizing ingredients such as those in paragraphs (d) (6), (7),
(8), and (9) of this section, and lactic acid-producing organisms are
used the food may be named ''cultured buttermilk''.
(1) The following terms shall accompany the name of the food wherever
it appears on the principal display panel or panels of the label in
letters not less than one-half of the height of the letters used in such
name:
(i) The phrase ''vitamin A'' or ''vitamin A added'', or ''vitamin D''
or ''vitamin D added'', or ''vitamin A and D added'', as appropriate.
The word ''vitamin'' may be abbreviated ''vit.''.
(ii) The word ''sweetened'' if nutritive carbohydrate sweetener is
added without the addition of characterizing flavoring.
(2) The term ''homogenized'' may appear on the label if the dairy
ingredients used are homogenized.
(g) Label declaration. Each of the ingredients used in the food
shall be declared on the label as required by the applicable sections of
Part 101 of this chapter.
(46 FR 9934, Jan. 30, 1981, as amended at 47 FR 11822, Mar. 19, 1982;
47 FR 41523, Sept. 21, 1982; 48 FR 24869, June 3, 1983; 54 FR 24892,
June 12, 1989)
21 CFR 131.115 Concentrated milk.
(a) Description. Concentrated milk is the liquid food obtained by
partial removal of water from milk. The milkfat and total milk solids
contents of the food are not less than 7.5 and 25.5 percent,
respectively. It is pasteurized, but is not processed by heat so as to
prevent spoilage. It may be homogenized.
(b) Vitamin addition (Optional). If added, vitamin D shall be
present in such quantity that each fluid ounce of the food contains 25
International Units thereof, within limits of good manufacturing
practice.
(c) Optional ingredients. The following safe and suitable optional
ingredients may be used:
(1) Carrier for vitamin D.
(2) Characterizing flavoring ingredients, with or without coloring,
as follows:
(i) Fruit and fruit juice, including concentrated fruit and fruit
juice.
(ii) Natural and artificial food flavoring.
(d) Methods of analysis. Referenced methods are from ''Official
Methods of Analysis of the Association of Official Analytical
Chemists,'' 13th Ed. (1980), which is incorporated by reference.
Copies may be obtained from the Association of Official Analytical
Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may
be examined at the Office of the Federal Register, 1100 L St. NW.,
Washington, DC 20408.
(1) Milkfat content -- ''Fat -- Official Final Action,'' section
16.172.
(2) Total milk solids -- ''Total Solids -- Official Final Action,''
section 16.169.
(3) Vitamin D content -- ''Vitamin D in Milk -- Official Final
Action,'' sections 43.195-43.208.
(e) Nomenclature. The name of the food is ''Concentrated milk'' or
alternatively ''Condensed milk''. If the food contains added vitamin D,
the phrase ''vitamin D'' or ''vitamin D added'' shall accompany the name
of the food wherever it appears on the principal display panel or panels
of the label in letters not less than one-half the height of the letters
used in such name. The word ''homogenized'' may appear on the label if
the food has been homogenized. The name of the food shall include a
declaration of the presence of any characterizing flavoring, as
specified in 101.22 of this chapter.
(f) Label declaration. When used in the food, the optional
ingredients specified in paragraph (b) of this section shall be declared
on the label as required by the applicable sections of Part 101 of this
chapter.
(42 FR 14360, Mar. 15, 1977, as amended at 47 FR 11822, Mar. 19,
1982; 48 FR 13024, Mar. 29, 1983; 49 FR 10090, Mar. 19, 1984; 54 FR
24892, June 12, 1989)
21 CFR 131.120 Sweetened condensed milk.
(a) Description. Sweetened condensed milk is the food obtained by
partial removal of water only from a mixture of milk and safe and
suitable nutritive carbohydrate sweeteners. The finished food contains
not less than 8 percent by weight of milkfat, and not less than 28
percent by weight of total milk solids. The quantity of nutritive
carbohydrate sweetener used is sufficient to prevent spoilage. The food
is pasteurized and may be homogenized.
(b) Optional ingredients. The following safe and suitable
characterizing flavoring ingredients, with or without coloring and
nutritive carbohydrate sweeteners, may be used:
(1) Fruit and fruit juice, including concentrated fruit and fruit
juice.
(2) Natural and artificial food flavoring.
(c) Methods of analysis. The milkfat content is determined by the
method prescribed in ''Official Methods of Analysis of the Association
of Official Analytical Chemists,'' 13th Ed. (1980), section 16.185,
under ''Fat -- Official Final Action,'' which is incorporated by
reference. Copies may be obtained from the Association of Official
Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA
22201-3301, or may be examined at the Office of the Federal Register,
1100 L St. NW., Washington, DC 20408.
(d) Nomenclature. The name of the food is ''Sweetened condensed
milk.'' The word ''homogenized'' may appear on the label if the food has
been homogenized. The name of the food shall include a declaration of
the presence of any characterizing flavoring, as specified in 101.22 of
this chapter.
(e) Label declaration. The nutritive carbohydrate sweetener(s)
required in paragraph (a) of this section and each of the optional
ingredients specified in paragraph (b) of this section, when used in the
food, shall be declared on the label as required by the applicable
sections of Part 101 of this chapter.
(43 FR 21670, May 19, 1978, as amended at 47 FR 11823, Mar. 19, 1982;
49 FR 10091, Mar. 19, 1984; 54 FR 24892, June 12, 1989)
21 CFR 131.122 Sweetened condensed skimmed milk.
(a) Description. Sweetened condensed skimmed milk is the food
obtained by the partial removal of water only from a mixture of skim
milk and safe and suitable nutritive carbohydrate sweeteners. The
finished food contains not more than 0.5 percent by weight of milkfat
unless otherwise indicated and not less than 24 percent by weight of
total milk solids. The quantity of nutritive carbohydrate sweeteners
used is sufficient to prevent spoilage. The food is pasteurized and may
be homogenized.
(b) Optional ingredients. The following safe and suitable
characterizing flavoring ingredients, with or without coloring, and
nutritive carbohydrate sweeteners may be used:
(1) Fruit and fruit juice, including concentrated fruit and fruit
juice.
(2) Natural and artificial food flavoring.
(c) Methods of analysis. The milkfat content is determined by the
method prescribed in ''Official Methods of Analysis of the Association
of Official Analytical Chemists,'' 13th Ed. (1980), section 16.185,
under ''Fat -- Official Final Action,'' which is incorporated by
reference. Copies may be obtained from the Association of Official
Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA
22201-3301, or may be examined at the Office of the Federal Register,
1100 L St. NW., Washington, DC 20408.
(d) Nomenclature. The name of the food is ''Sweetened condensed
skimmed milk.'' The word ''homogenized'' may appear on the label if the
food has been homogenized. If the milkfat content is over 0.5 percent
by weight, the name of the food shall be accompanied by the statement
''Contains ------------ % milkfat'', the blank to be filled in with the
fraction '' 1/2'', or multiple thereof, closest to the actual milkfat
content of the product. The name of the food shall be accompanied by a
declaration of the presence of any characterizing flavoring, as
specified in 101.22 of ths chapter.
(e) Label declaration. The nutritive carbohydrate sweetener required
in paragraph (a) of this section and each of the optional ingredients
specified in paragraph (b) of this section when used in the food, shall
be declared on the label as required by the applicable sections of Part
101 of this chapter.
(43 FR 21670, May 19, 1978, as amended at 47 FR 11823, Mar. 19, 1982;
49 FR 10091, Mar. 19, 1984; 54 FR 24892, June 12, 1989)
21 CFR 131.123 Lowfat dry milk.
(a) Description. Lowfat dry milk is the product obtained by removal
of water only from pasteurized lowfat milk, as defined in 131.135(a),
which may have been homogenized. Alternatively, lowfat dry milk may be
obtained by blending fluid, condensed, or dried nonfat milk with liquid
or dried cream or with fluid, condensed, or dried milk, as appropriate,
Provided, The resulting lowfat dry milk is equivalent in composition to
that obtained by the method described in the first sentence of this
paragraph. It contains not less than 5 percent but less than 20 percent
by weight of milkfat on an as is basis. It contains not more than 5
percent by weight of moisture on a milk solids not fat basis. Lowfat
dry milk contains added vitamin A as prescribed by paragraph (b) of this
section.
(b) Vitamin addition. (1) Vitamin A shall be present in such
quantity that, when prepared according to label directions, each quart
of the reconstituted product contains not less than 2,000 International
Units thereof.
(2) Addition of vitamin D is optional. If added, vitamin D shall be
present in such quantity that, when prepared according to label
directions, each quart of the reconstituted product contains 400
International Units thereof.
(3) The requirements of this paragraph will be met if reasonable
overages, within limits of good manufacturing practice, are present to
ensure that the required levels of vitamins are maintained throughout
the expected shelf life of the food under customary conditions of
distribution.
(c) Optional ingredients. The following safe and suitable optional
ingredients may be used:
(1) Carriers for vitamins A and D.
(2) Emulsifiers.
(3) Stabilizers.
(4) Anticaking agents.
(5) Antioxidants.
(6) Characterizing flavoring ingredients, with or without coloring
and nutritive carbohydrate sweeteners, as follows:
(i) Fruit and fruit juice, including concentrated fruit and fruit
juice.
(ii) Natural and artificial food flavoring.
(d) Methods of analysis. The following referenced methods of
analysis are from ''Official Methods of Analysis of the Association of
Official Analytical Chemists,'' 13th Ed. (1980), which is incorporated
by reference. Copies may be obtained from the Association of Official
Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA
22201-3301, or may be examined at the Office of the Federal Register,
1100 L St. NW., Washington, DC 20408.
(1) Milkfat content -- ''Fat in Dried Milk -- Official Final
Action,'' sections 16.199-16.200.
(2) Moisture content -- ''Moisture -- Official Final Action,''
section 16.192.
(3) Vitamin D content -- ''Vitamin D -- Official Final Action,''
sections 43.195-43.208.
(e) Nomenclature. The name of the food is ''Lowfat dry milk.'' The
name of the food shall appear on the principal display panel of the
label in type of uniform size, style, and color. The name of the food
shall be accompanied by a declaration indicating the presence of any
characterizing flavoring, as specified in 101.22 of this chapter. The
following phrases in type size not less than one-half the height of the
type size used in such name shall accompany the name of the food
wherever it appears on the principal display panel or panels:
(1) The phrase ''Contains -- % milkfat'', the blank to be filled in
with the whole number closest to the actual fat content of the food.
(2) The phrase ''vitamin A'' or ''vitamin A added'', and if vitamin D
is added, the phrase ''vitamins A and D'' or ''vitamins A and D added'',
as appropriate. The word ''vitamin'' may be abbreviated ''vit.''
(f) Label declaration. Each of the optional ingredients used shall
be declared on the label as required by the applicable sections of Part
101 of this chapter.
(43 FR 19835, May 9, 1978, as amended at 47 FR 11823, Mar. 19, 1982;
48 FR 13024, Mar. 29, 1983; 49 FR 10091, Mar. 19, 1984; 54 FR 24892,
June 12, 1989)
21 CFR 131.125 Nonfat dry milk.
(a) Description. Nonfat dry milk is the product obtained by removal
of water only from pasteurized skim milk. It contains not more than 5
percent by weight of moisture, and not more than 1 1/2 percent by weight
of milkfat unless otherwise indicated.
(b) Optional ingredients. Safe and suitable characterizing flavoring
ingredients (with or without coloring and nutritive carbohydrate
sweetener) as follows:
(1) Fruit and fruit juice, including concentrated fruit and fruit
juice.
(2) Natural and artificial food flavorings.
(c) Methods of analysis. The following referenced methods of
analysis are from ''Official Methods of Analysis of the Association of
Official Analytical Chemists,'' 13th Ed. (1980), which is incorporated
by reference. Copies may be obtained from the Association of Official
Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA
22201-3301, or may be examined at the Office of the Federal Register,
1100 L St. NW., Washington, DC 20408.
(1) Milkfat content -- ''Fat in Dried Milk -- Official Final
Action,'' sections 16.199-16.200.
(2) Moisture content -- ''Moisture -- Official Final Action,''
section 16.192.
(d) Nomenclature. The name of the food is ''Nonfat dry milk''. If
the fat content is over 1 1/2 percent by weight, the name of the food on
the principal display panel or panels shall be accompanied by the
statement ''Contains ---- % milkfat'', the blank to be filled in with
the percentage to the nearest one-tenth of 1 percent of fat contained,
within limits of good manufacturing practice. The name of the food
shall include a declaration of the presence of any characterizing
flavoring, as specified in 101.22 of this chapter.
(e) Label declaration. Each of the optional ingredients used shall
be declared on the label as required by the applicable sections of Part
101 of this chapter.
(42 FR 14360, Mar. 15, 1977, as amended at 43 FR 19836, May 9, 1978;
47 FR 11823, Mar. 19, 1982; 49 FR 10091, Mar. 19, 1984; 54 FR 24892,
June 12, 1989)
21 CFR 131.127 Nonfat dry milk fortified with vitamins A and D.
(a) Description. Nonfat dry milk fortified with vitamins A and D
conforms to the standard of identity for nonfat dry milk, except that
vitamins A and D are added as prescribed by paragraph (b) of this
section.
(b) Vitamin addition. (1) Vitamin A is added in such quantity that,
when prepared according to label directions, each quart of the
reconstituted product contains 2000 International Units thereof.
(2) Vitamin D is added in such quantity that, when prepared according
to label directions, each quart of the reconstituted product contains
400 International Units thereof.
(3) The requirements of this paragraph will be deemed to have been
met if reasonable overages, within limits of good manufacturing
practice, are present to ensure that the required levels of vitamins are
maintained throughout the expected shelf life of the food under
customary conditions of distribution.
(c) Optional ingredients. The following safe and suitable optional
ingredients may be used:
(1) Carriers for vitamins A and D.
(2) Characterizing flavoring ingredients, with or without coloring
and nutritive carbohydrate sweetener, as follows:
(i) Fruit and fruit juice, including concentrated fruit and fruit
juice.
(ii) Natural and artificial food flavorings.
(d) Methods of analysis. The following referenced methods of
analysis are from ''Official Methods of Analysis of the Association of
Official Analytical Chemists,'' 13th Ed. (1980), which is incorporated
by reference. Copies may be obtained from the Association of Official
Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA
22201-3301, or may be examined at the Office of the Federal Register,
1100 L St. NW., Washington, DC 20408.
(1) Milkfat content -- ''Fat in Dried Milk -- Official Final
Action,'' sections 16.199-16.200.
(2) Moisture content -- ''Moisture -- Official Final Action,''
section 16.192.
(3) Vitamin D content -- ''Vitamin D -- Official Final Action,''
sections 43.195-43.208.
(e) Nomenclature. The name of the food is ''Nonfat dry milk
fortified with vitamins A and D''. If the fat content is over 1 1/2
percent by weight, the name of the food on the principal display panel
or panels shall be accompanied by the statement ''Contains -- %
milkfat'', the blank to be filled in to the nearest one-tenth of 1
percent with the percentage of fat contained within limits of good
manufacturing practice. The name of the food shall include a
declaration of the presence of any characterizing flavoring, as
specified in 101.22 of this chapter.
(f) Label declaration. Each of the optional ingredients used shall
be declared on the label as required by the applicable sections of Part
101 of this chapter.
(42 FR 14360, Mar. 15, 1977, as amended at 43 FR 19836, May 9, 1978;
43 FR 29769, July 11, 1978; 43 FR 36622, Aug. 18, 1978; 47 FR 11823,
Mar. 19, 1982; 49 FR 10091, Mar. 19, 1984; 54 FR 24892, June 12, 1989)
21 CFR 131.130 Evaporated milk.
(a) Description. Evaporated milk is the liquid food obtained by
partial removal of water only from milk. It contains not less than 7.5
percent by weight of milkfat and not less than 25 percent by weight of
total milk solids. Evaporated milk contains added vitamin D as
prescribed by paragraph (b) of this section. It is homogenized. It is
sealed in a container and so processed by heat, either before or after
sealing, as to prevent spoilage.
(b) Vitamin addition. (1) Vitamin D shall be present in such
quantity that each fluid ounce of the food contains 25 International
Units thereof within limits of good manufacturing practice.
(2) Addition of vitamin A is optional, If added, vitamin A shall be
present in such quantity that each fluid ounce of the food contains not
less than 125 International Units thereof within limits of good
maufacturing practice.
(c) Optional ingredients. The following safe and suitable
ingredients may be used:
(1) Carriers for vitamins A and D.
(2) Emulsifiers.
(3) Stabilizers, with or without dioctyl sodium sulfosuccinate (when
permitted by and complying with the provisions of 172.810 of this
chapter) as a solubilizing agent.
(4) Characterizing flavoring ingredients, with or without coloring
and nutritive carbohydrate sweeteners, as follows:
(i) Fruit and fruit juice, including concentrated fruit and fruit
juice.
(ii) Natural and artificial food flavoring.
(d) Methods of analysis. The following referenced methods of
analysis are from ''Official Methods of Analysis of the Association of
Official Analytical Chemists,'' 13th Ed. (1980), which is incorporated
by reference. Copies may be obtained from the Association of Official
Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA
22201-3301, or may be examined at the Office of the Federal Register,
1100 L St. NW., Washington, DC 20408.
(1) Milkfat content -- ''Fat -- Official Final Action,'' section
16.172.
(2) Total milk solids -- ''Total Solids -- Official Final Action,''
section 16.169.
(3) Vitamin D content -- ''Vitamin D in Milk -- Official Final
Action,'' sections 43.195-43.208.
(e) Nomenclature. The name of the food is ''Evaporated milk.'' The
phrase ''vitamin D'' or ''vitamin D added'', or ''vitamins A and D'' or
''vitamins A and D added'', as is appropriate, shall immediately precede
or follow the name of the food wherever it appears on the principal
display panel or panels of the label in letters not less than one-half
the height of the letters used in such name. The name of the food shall
include a declaration of a the presence of any characterizing flavoring,
as specified in 101.22 of this chapter.
(f) Label declaration. Each of the optional ingredients used shall
be declared on the label as required by the applicable sections of Part
101 of this chapter.
(43 FR 21670, May 19, 1978, as amended at 47 FR 11823, Mar. 19, 1982;
49 FR 10091, Mar. 19, 1984; 54 FR 24892, June 12, 1989)
21 CFR 131.132 Evaporated skimmed milk.
(a) Description. Evaporated skimmed milk is the liquid food obtained
by the partial removal of water only from skim milk. It contains not
less than 20 percent by weight of total milk solids, and not more than
0.5 percent by weight of milkfat unless otherwise indicated. Evaporated
skimmed milk contains added vitamins A and D as prescribed by paragraph
(b) of this section. It may be homogenized. It is sealed in a
container and so processed by heat, either before or after sealing, as
to prevent spoilage,
(b) Vitamin addition. (1) Vitamin D shall be present in such
quantity that each fluid ounce of the food contains 25 International
Units thereof within limits of good manufacturing practice.
(2) Vitamin A shall be present in such quantity that each fluid ounce
of the food contains not less than 125 International Units thereof
within limits of good manufacturing practice.
(c) Optional ingredients. The following safe and suitable
ingredients may be used:
(1) Carriers for vitamin A and D.
(2) Emulsifiers.
(3) Stabilizers, with or without dioctyl sodium sulfosuccinate (when
permitted by, and complying with provisions of 172.810 of this chapter)
as a solubilizing agent.
(4) Characterizing flavoring ingredients, with or without coloring
and nutritive carbohydrate sweeteners, as follows:
(i) Fruit and fruit juice, including concentrated fruit and fruit
juice.
(ii) Natural and artificial food flavoring.
(d) Methods of analysis. The following referenced methods of
analysis are from ''Official Methods of Analysis of the Association of
Official Analytical Chemists,'' 13th Ed. (1980), which is incorporated
by reference. Copies may be obtained from the Association of Official
Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA
22201-3301, or may be examined at the Office of the Federal Register,
1100 L St. NW., Washington, DC 20408.
(1) Milkfat content -- ''Fat -- Official Final Action,'' section
16.172.
(2) Total milk solids -- ''Total Solids -- Official Final Action,''
section 16.169.
(3) Vitamin D content -- ''Vitamin D in Milk -- Official Final
Action,'' sections 43.195-43.208.
(e) Nomenclature. The name of the food is ''Evaporated skimmed
milk.'' The phrase ''vitamins A and D'' or ''vitamins A and D added'',
shall immediately precede or follow the name of the food wherever it
appears on the principal display panel or panels of the label in letters
not less than one-half of the height of the letters used in such name.
If the milkfat content is over 0.5 percent by weight, the name of the
food shall be accompanied by the statement, ''Contains ------------ %
milkfat'', the blank to be filled in with the fraction '' 1/2'', or
multiple thereof, closest to the actual milkfat content of the product.
The name of the food shall be accompanied by a declaration indicating
the presence of any characterizing flavoring, as specified in 101.22 of
this chapter.
(f) Label declaration. Each of the optional ingredients used shall
be declared on the label as required by the applicable sections of Part
101 of this chapter.
(43 FR 21671, May 19, 1978, as amended at 47 FR 11823, Mar. 19, 1982;
49 FR 10091, Mar. 19, 1984; 54 FR 24892, June 12, 1989)
21 CFR 131.135 Lowfat milk.
(a) Description. Lowfat milk is milk from which sufficient milkfat
has been removed to produce a food having, within limits of good
manufacturing practice, one of the following milkfat contents: 1/2, 1,
1 1/2, or 2 percent. Lowfat milk is pasteurized or ultra-pasteurized,
contains added vitamin A as prescribed by paragraph (b) of this section,
and contains not less than 8 1/4 percent milk solids not fat. Lowfat
milk may be homogenized.
(b) Vitamin addition. (1) Vitamin A shall be present in such
quantity that each quart of the food contains not less than 2000
International Units thereof within limits of good manufacturing
practice.
(2) Addition of vitamin D is optional. If added, vitamin D shall be
present in such quantity that each quart of the food contains 400
International Units thereof within limits of good manufacturing
practice.
(c) Optional ingredients. The following safe and suitable
ingredients may be used:
(1) Carriers for vitamins A and D.
(2) Concentrated skim milk, nonfat dry milk, or other milk derived
ingredients to increase the nonfat solids content of the food:
Provided, That the ratio of protein to total nonfat solids of the food,
and the protein efficiency ratio of all protein present, shall not be
decreased as a result of adding such ingredients.
(3) When one or more of the optional milk derived ingredients in
paragraph (c)(2) of this section are used, emulsifiers, stabilizers, or
both, in an amount not more than 2 percent by weight of the solids in
such ingredients.
(4) Characterizing flavoring ingredients (with or without coloring,
nutritive sweetener, emulsifiers, and stabilizers) as follows:
(i) Fruit and fruit juice (including concentrated fruit and fruit
juice).
(ii) Natural and artificial food flavorings.
(d) Methods of analysis. Referenced methods are from ''Official
Methods of Analysis of the Association of Official Analytical
Chemists,'' 13th Ed. (1980), which is incorporated by reference.
Copies may be obtained from the Association of Official Analytical
Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may
be examined at the Office of the Federal Register, 1100 L St. NW.,
Washington, DC 20408.
(1) Milkfat content -- ''Fat, Roese-Gottlieb Method -- Official Final
Action,'' section 16.059.
(2) Milk solids not fat content (or total nonfat solids content) --
Calculated by subtracting the milkfat content from the total solids
content as determined by the method ''Total Solids, Method I -- Official
Final Action,'' section 16.032.
(3) Vitamin D content -- ''Vitamin D -- Official Final Action,''
sections 43.195-43.208.
(e) Nomenclature. The name of the food is ''Lowfat milk''. The name
of the food shall appear on the label in type of uniform size, style,
and color. The name of the food shall be accompanied on the label by a
declaration indicating the presence of any characterizing flavoring, as
specified in 101.22 of this chapter.
(1) The following terms shall accompany the name of the food wherever
it appears on the principal display panel or panels of the label in
letters not less than one-half of the height of the letters used in such
name:
(i) The phrase '' ---- % milkfat'', the blank to be filled in with
the fraction 1/2, or multiple thereof, to indicate the actual fat
content of the food.
(ii) The phrase ''vitamin A'' or ''vitamin A added'', or, if vitamin
D is added, the phrase ''vitamins A and D added''. The word ''vitamin''
may be abbreviated ''vit.''.
(iii) The word ''ultra-pasteurized'' if the food has been
ultra-pasteurized.
(iv) The phrase ''with added milk solids not fat'' if the food
contains not less than 10 percent milk-derived nonfat solids.
(2) The following terms may appear on the label:
(i) The word ''pasteurized'' if the food has been pasteurized.
(ii) The word ''homogenized'' if the food has been homogenized.
(f) Label declaration. When ingredients are used in the food as
specified in paragraphs (b)(2) and (c) (2), (3), and (4) of this
section, such ingredients shall be declared on the label as required by
the applicable sections of Part 101 of this chapter except that
concentrated skim milk and nonfat dry milk may be declared as ''nonfat
milk solids''.
(42 FR 14360, Mar. 15, 1977, as amended at 45 FR 81737, Dec. 12,
1980; 47 FR 11823, Mar. 19, 1982; 49 FR 10091, Mar. 19, 1984; 54 FR
24893, June 12, 1989)
Effective Date Note: Paragraph (e)(1)(iv) of 131.135 was revised at
45 FR 81737, Dec. 12, 1980, effective date for compliance July 1, 1983.
The effective date for compliance was stayed until further notice at 47
FR 11271, Mar. 16, 1982. Paragraph (e)(1)(iv) published at 42 FR
14360, Mar. 15, 1977, and set forth below is currently effective.
131.135 Lowfat milk.
(e) * * *
(1) * * *
(iv) The phrase ''protein fortified'' or ''fortified with protein''
if the food contains not less than 10 percent milk derived nonfat
solids.
21 CFR 131.136 Acidified lowfat milk.
(a) Description. Acidified lowfat milk is the food produced by
souring one or more of the optional dairy ingredients specified in
paragraph (c) of this section with one or more of the acidifying
ingredients specified in paragraph (d) of this section, with or without
the addition of characterizing microbial organisms. One or more of the
other optional ingredients specified in paragraphs (b) and (e) of this
section may also be added. When one or more of the ingredients
specified in paragraph (e)(1) of this section are used, they shall be
included in the souring process. All ingredients used are safe and
suitable. Acidified lowfat milk contains not less than 0.5 percent nor
more than 2.0 percent milkfat and not less than 8.25 percent milk solids
not fat and has a titratable acidity of not less than 0.5 percent,
expressed as lactic acid. The food may be homogenized and shall be
pasteurized or ultra-pasteurized prior to the addition of the microbial
culture and, when applicable, the addition of flakes or granules of
butterfat or milkfat.
(b) Vitamin addition (optional). (1) If added, vitamin A shall be
present in such quantity that each 946 milliliters (quart) of the food
contains not less than 2,000 International Units thereof, within limits
of good manufacturing practice.
(2) If added, vitamin D shall be present in such quantity that each
946 milliliters (quart) of the food contains 400 International Units
thereof, within limits of good manufacturing practice.
(c) Optional dairy ingredients. Cream, milk, partially skimmed milk,
or skim milk, used alone or in combination.
(d) Optional acidifying ingredients. Acetic acid, adipic acid,
citric acid, fumaric acid, glucono-delta-lactone, hydrochloric acid,
lactic acid, malic acid, phosphoric acid, succinic acid, and tartaric
acid.
(e) Other optional ingredients. (1) Concentrated skim milk, nonfat
dry milk, buttermilk, whey, lactose, lactalbumins, lactoglobulins, or
whey modified by partial or complete removal of lactose and/or minerals,
to increase the nonfat solids content of the food: Provided, That the
ratio of protein to total nonfat solids of the food, and the protein
efficiency ratio of all protein present, shall not be decreased as a
result of adding such ingredients.
(2) Nutritive carbohydrate sweeteners. Sugar (sucrose), beet or
cane; invert sugar (in paste or sirup form); brown sugar; refiner's
sirup; molasses (other than blackstrap); high fructose corn sirup;
fructose; fructose sirup; maltose; maltose sirup, dried maltose
sirup; malt extract, dried malt extract; malt sirup, dried malt sirup;
honey; maple sugar; or any of the sweeteners listed in Part 168 of
this chapter, except table sirup.
(3) Flavoring ingredients.
(4) Color additives that do not impart a color simulating that of
milkfat or butterfat.
(5) Stabilizers.
(6) Butterfat or milkfat, which may or may not contain color
additives, in the form of flakes or granules.
(7) Aroma- and flavor-producing microbial culture.
(8) Salt.
(9) Citric acid, in a maximum amount of 0.15 percent by weight of the
dairy ingredients used, or an equivalent amount of sodium citrate, as a
flavor precursor.
(f) Methods of analysis. The following referenced methods of
analysis are from ''Official Methods of Analysis of the Association of
Official Analytical Chemists,'' 13th Ed. (1980), which is incorporated
by reference. Copies are available from the Association of Official
Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA
22201-3301, or available for inspection at the Office of the Federal
Register, 1100 L St. NW., Washington, DC 20408.
(1) Milkfat content -- As determined by the method prescribed in
section 16.059, ''Roese-Gottlieb Method (Reference Method) (11) --
Official Final Action,'' under the heading ''Fat.''
(2) Milk solids not fat content -- Calculated by subtracting the
milkfat content from the total solids content as determined by the
method prescribed in section 16.032, ''Method I -- Official Final
Action,'' under the heading ''Total Solids.''
(3) Titratable acidity -- As determined by the method prescribed in
section 16.023, ''Acidity (2) -- Official Final Action,'' or by an
equivalent potentiometric method.
(g) Nomenclature. The name of the food is ''acidified lowfat milk''.
The full name of the food shall appear on the principal display panel
of the label in type of uniform size, style, and color. The name of the
food shall be accompanied by a declaration indicating the presence of
any characterizing flavoring as specified in 101.22 of this chapter,
and may be accompanied by a declaration such as a traditional name of
the food or the generic name of the organisms used, thereby indicating
the presence of the characterizing microbial organisms or ingredients
when used, e.g., ''acidified kefir lowfat milk'', ''acidified
acidophilus lowfat milk'', or when characterizing ingredients such as
those in paragraphs (e) (6), (7), (8), and (9) of this section are used,
the food may be named ''acidified lowfat buttermilk''.
(1) The following terms shall accompany the name of the food wherever
it appears on the principal display panel or panels of the label in
letters not less than one-half of the height of the letters used in such
name:
(i) The phrase '' ---- % milkfat'', the blank to be filled in with
the fraction 1/2 or multiple thereof closest to the actual fat content
of the food.
(ii) The word ''sweetened'' if nutritive carbohydrate sweetener is
added without the addition of characterizing flavoring.
(iii) The phrase ''vitamin A'' or ''vitamin A added'', or ''vitamin
D'' or ''vitamin D added'', or ''vitamins A and D added'', as
appropriate. The word ''vitamin'' may be abbreviated ''vit.''.
(2) The term ''homogenized'' may appear on the label if the dairy
ingredients used are homogenized.
(h) Label declaration. Each of the ingredients used in the food
shall be declared on the label as required by the applicable sections of
Part 101 of this chapter.
(46 FR 9936, Jan. 30, 1981, as amended at 47 FR 11823, Mar. 19, 1982;
47 FR 41523, Sept. 21, 1982; 48 FR 24869, June 3, 1983; 54 FR 24893,
June 12, 1989)
21 CFR 131.138 Cultured lowfat milk.
(a) Description. Cultured lowfat milk is the food produced by
culturing one or more of the optional dairy ingredients specified in
paragraph (c) of this section with characterizing microbial organisms.
One or more of the other optional ingredients specified in paragraphs
(b) and (d) of this section may also be added. When one or more of the
ingredients specified in paragraph (d)(1) of this section are used, they
shall be included in the culturing process. All ingredients used are
safe and suitable. Cultured lowfat milk contains not less than 0.5
percent nor more than 2 percent milkfat and not less than 8.25 percent
milk solids not fat and has a titratable acidity of not less than 0.5
percent, expressed as lactic acid. The food may be homogenized and
shall be pasteurized or ultra-pasteurized prior to the addition of the
microbial culture and, when applicable, the addition of flakes or
granules of butterfat or milkfat.
(b) Vitamin addition (optional). (1) If added, vitamin A shall be
present in such quantity that each 946 milliliters (quart) of the food
contains not less than 2,000 International Units thereof, within limits
of good manufacturing practice.
(2) If added, vitamin D shall be present in such quantity that each
946 milliliters (quart) of the food contains 400 International Units
thereof, within limits of good manufacturing practice.
(c) Optional dairy ingredients. Cream, milk, partially skimmed milk,
or skim milk, used alone or in combination.
(d) Other optional ingredients. (1) Concentrated skim milk, nonfat
dry milk, buttermilk, whey, lactose, lactalbumins, lactoglobulins, or
whey modified by partial or complete removal of lactose and/or minerals,
to increase the nonfat solids content of the food: Provided, That the
ratio of protein to total nonfat solids of the food, and the protein
efficiency ratio of all protein present shall not be decreased as a
result of adding such ingredients.
(2) Nutritive carbohydrate sweeteners. Sugar (sucrose), beet or
cane; invert sugar (in paste or sirup form); brown sugar; refiner's
sirup; molasses (other than blackstrap); high fructose corn sirup;
fructose; fructose sirup; maltose; maltose sirup, dried maltose
sirup; malt extract, dried malt extract; malt sirup, dried malt sirup;
honey; maple sugar; or any of the sweeteners listed in Part 168 of
this chapter, except table sirup.
(3) Flavoring ingredients.
(4) Color additives that do not impart a color simulating that of
milkfat or butterfat.
(5) Stabilizers.
(6) Butterfat or milkfat, which may or may not contain color
additives, in the form of flakes or granules.
(7) Aroma- and flavor-producing microbial culture.
(8) Salt.
(9) Citric acid, in a maximum amount of 0.15 percent by weight of the
milk used, or an equivalent amount of sodium citrate, as a flavor
precursor.
(e) Methods of analysis. The following referenced methods of
analysis are from ''Official Methods of Analysis of the Association of
Official Analytical Chemists,'' 13th Ed. (1980), which is incorporated
by reference. Copies may be obtained from the Association of Official
Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA
22201-3301, or available for inspection at the Office of the Federal
Register, 1100 L St. NW., Washington, DC 20408.
(1) Milkfat content -- As determined by the method prescribed in
section 16.059, ''Roese-Gottlieb Method (Reference Method) (11) --
Official Final Action,'' under the heading ''Fat.''
(2) Milk solids not fat content -- Calculated by subtracting the
milkfat content from the total solids content as determined by the
method prescribed in section 16.032, ''Method I -- Official Final
Action,'' under the heading ''Total Solids.''
(3) Titratable acidity -- As determined by the method prescribed in
section 16.023, ''Acidity (2) -- Official Final Action,'' or by an
equivalent potentiometric method.
(f) Nomenclature. The name of the food is ''cultured lowfat milk.''
The full name of the food shall appear on the principal display panel of
the label in type of uniform size, style, and color. The name of the
food shall be accompanied by a declaration indicating the presence of
any characterizing flavoring as specified in 101.22 of this chapter,
and may be accompanied by a declaration such as a traditional name of
the food or the generic name of the organisms used, thereby indicating
the presence of the characterizing microbial organisms or ingredients,
e.g., ''kefir cultured lowfat milk'', ''acidophilus cultured lowfat
milk,'' or when characterizing ingredients such as those in paragraphs
(d) (6), (7), (8), and (9) of this section, and lactic acid-producing
organisms are used the food may be named ''cultured lowfat buttermilk''.
(1) The following terms shall accompany the name of the food wherever
it appears on the principal display panel or panels of the label in
letters not less than one-half of the height of the letters used in such
name:
(i) The phrase ''vitamin A'' or ''vitamin A added,'' or ''vitamin D''
or ''vitamin D added'', or ''vitamins A and D added'', as appropriate.
The word ''vitamin'' may be abbreviated ''vit.''.
(ii) The phrase '' -- % milkfat'', the blank to be filled in with the
fraction 1/2 or multiple thereof closest to the actual fat content of
the food.
(iii) The word ''sweetened'' if nutritive carbohydrate sweetner is
added without the addition of characterizing flavoring.
(2) The term ''homogenized'' may appear on the label if the dairy
ingredients used are homogenized.
(g) Label declaration. Each of the ingredients used in the food
shall be declared on the label as required by the applicable sections of
Part 101 of this chapter.
(46 FR 9936, Jan. 30, 1981, as amended at 47 FR 11824, Mar. 19, 1982;
47 FR 41523, Sept. 21, 1982; 48 FR 24869, June 3, 1983; 54 FR 24893,
June 12, 1989)
21 CFR 131.143 Skim milk.
(a) Description. Skim milk is milk from which sufficient milkfat has
been removed to reduce its milkfat content to less than 0.5 percent.
Skim milk that is in final package form for beverage use shall have been
pasteurized or ultra-pasteurized, shall contain added vitamin A as
prescribed by paragraph (b) of this section, and shall contain not less
than 8 1/4 percent milk solids not fat. Skim milk may be homogenized.
(b) Vitamin addition. (1) Vitamin A shall be present in such
quantity that each quart of the food contains not less than 2000
International Units thereof within limits of good manufacturing
practice.
(2) Addition of vitamin D is optional. If added, vitamin D shall be
present in such quantity that each quart of the food contains 400
International Units thereof within limits of good manufacturing
practice.
(c) Optional ingredients. The following safe and suitable
ingredients may be used:
(1) Carriers for vitamins A and D.
(2) Concentrated skim milk, nonfat dry milk, or other milk derived
ingredients to increase the nonfat solids content of the food:
Provided, That the ratio of protein to total nonfat solids of the food,
and the protein efficiency ratio of all protein present, shall not be
decreased as a result of adding such ingredients.
(3) When one or more of the optional milk derived ingredients in
paragraph (c)(2) of this section are used, emulsifiers, stabilizers, or
a combination of both, in an amount not more than 2 percent by weight of
the solids in such ingredients.
(4) Characterizing flavoring ingredients (with or without coloring,
nutritive sweetener, emulsifiers, and stabilizers) as follows:
(i) Fruit and fruit juice (including concentrated fruit and fruit
juice).
(ii) Natural and artificial food flavoring.
(d) Methods of analysis. Referenced methods are from ''Official
Methods of Analysis of the Association of Official Analytical
Chemists,'' 13th Ed. (1980), which is incorporated by reference.
Copies may be obtained from the Association of Official Analytical
Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may
be examined at the Office of the Federal Register, 1100 L St. NW.,
Washington, DC 20408.
(1) Milkfat content -- ''Fat, Roese-Gottlieb Method -- Official Final
Action,'' section 16.059.
(2) Milk solids not fat content (or total nonfat solids content) --
Calculated by subtracting the milkfat content from the total solids
content as determined by the method ''Total Solids, Method I -- Official
Final Action,'' section 16.032.
(3) Vitamin D content -- ''Vitamin D -- Official Final Action,''
sections 43.195-43.208.
(e) Nomenclature. The name of the food is ''Skim milk'' or
alternatively ''Nonfat milk''. The name of the food shall appear on the
label in type of uniform size, style, and color. The name of the food
shall be accompanied on the label by a declaration indicating the
presence of any characterizing flavoring, as specified in 101.22 of
this chapter.
(1) The following terms shall accompany the name of the food wherever
it appears on the principal display panel or panels of the label in
letters not less than one-half of the height of the letters used in such
name:
(i) The phrase ''vitamin A'' or ''vitamin A added'', or, if vitamin D
is added, the phrase ''vitamins A and D'' or ''vitamins A and D added''.
The word ''vitamin'' may be abbreviated ''vit.''.
(ii) The word ''ultra-pasteurized'' if the food has been
ultra-pasteurized.
(iii) The phrase ''with added milk solids not fat'' if the food
contains not less than 10 percent milk-derived nonfat solids.
(2) The following terms may appear on the label:
(i) The word ''pasteurized'' if the food has been pasteurized.
(ii) The word ''homogenized'' if the food has been homogenized.
(f) Label declaration. When used in the food, each of the
ingredients specified in paragraphs (b)(2) and (c)(2), (3), and (4) of
this section shall be declared on the label as required by the
applicable sections of Part 101 of this chapter.
(42 FR 14360, Mar. 15, 1977, as amended at 45 FR 81737, Dec. 12,
1980. Redesignated at 46 FR 9934, Jan. 30, 1981, and amended at 47 FR
11824, Mar. 19, 1982; 49 FR 10091, Mar. 19, 1984; 54 FR 24893, June
12, 1989)
Effective Date Note: Paragraph (e)(1)(iii) of 131.143 was revised
at 45 FR 81737, Dec. 12, 1980, effective date for compliance July 1,
1983. The effective date for compliance was stayed until further notice
at 47 FR 11271, Mar. 16, 1982. Paragraph (e)(1)(iii) published at 42
FR 14360, Mar. 15, 1977, and set forth below is currently effective.
131.143 Skim milk.
(e) * * *
(1) * * *
(iii) The phrase ''protein fortified'' or ''fortified with protein''
if the food contains not less than 10 percent milk derived nonfat
solids.
21 CFR 131.144 Acidified skim milk.
(a) Description. Acidified skim milk is the food produced by souring
one or more of the optional dairy ingredients specified in paragraph (c)
of this section with one or more of the acidifying ingredients specified
in paragraph (d) of this section, with or without the addition of
characterizing microbial organisms. One or more of the other opitonal
ingredients specified in paragraphs (b) and (e) of this section may also
be added. When one or more of the ingredients specified in paragraph
(e)(1) of this section are used, they shall be included in the souring
process. All ingredients used are safe and suitable. Acidified skim
milk contains less than 0.5 percent milkfat and not less than 8.25
percent milk solids not fat and has a titratable acidity of not less
than 0.5 percent, expressed as lactic acid. The food may be homogenized
and shall be pasteurized or ultra-pasteurized prior to the addition of
the microbial culture and when applicable, the addition of flakes or
granules of butterfat or milkfat.
(b) Vitamin addition (optional). (1) If added, vitamin A shall be
present in such quantity that each 946 milliliters (quart) of the food
contains not less than 2,000 International Units thereof, within limits
of good manufacturing practice.
(2) If added, vitamin D shall be present in such quantity that each
946 milliliters (quart) of the food contains 400 International Units
thereof, within limits of good manufacturing practice.
(c) Optional dairy ingredients. Cream, milk, partially skimmed milk,
or skim milk, used alone or in combination.
(d) Optional acidifying ingredients. Acetic acid, adipic acid,
citric acid, fumaric acid, glucono-delta-lactone, hydrochloric acid,
lactic acid, malic acid, phosphoric acid, succinic acid, and tartaric
acid.
(e) Other optional ingredients. (1) Concentrated skim milk, nonfat
dry milk, buttermilk, whey, lactose, lactalbumins, lactoglobulins, or
whey modified by partial or complete removal of lactose and/or minerals,
to increase the nonfat solids content of the food: Provided, That the
ratio of protein to total nonfat solids of the food, and the protein
efficiency ratio of all protein present, shall not be decreased as a
result of adding such ingredients.
(2) Nutritive carbohydrate sweeteners. Sugar (sucrose), beet or
cane; invert sugar (in paste or sirup form); brown sugar; refiner's
sirup; molasses (other than blackstrap); high fructose corn sirup;
fructose; fructose sirup; maltose; maltose sirup, dried maltose
sirup; malt extract, dried malt extract; malt sirup, dried malt sirup;
honey; maple sugar; or any of the sweetners listed in Part 168 of
this chapter, except table sirup.
(3) Flavoring ingredients.
(4) Color additives that do not impart a color simulating that of
milkfat or butterfat.
(5) Stabilizers.
(6) Butterfat or milkfat, which may or may not contain color
additives, in the form of flakes or granules.
(7) Aroma- and flavor-producing microbial culture.
(8) Salt.
(9) Citric acid, in a maximum amount of 0.15 percent by weight of the
dairy ingredients used, or an equivalent amount of sodium citrate, as a
flavor precursor.
(f) Methods of analysis. The following referenced methods of
analysis are from ''Official Methods of Analysis of the Association of
Official Analytical Chemists,'' 13th Ed. (1980), which is incorporated
by reference. Copies are available from the Association of Official
Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA
22201-3301, or available for inspection at the Office of the Federal
Register, 1100 L St. NW., Washington, DC 20408.
(1) Milkfat content -- As determined by the method prescribed in
section 16.059, ''Roese-Gottlieb Method (Reference Method) (11) --
Official Final Action,'' under the heading ''Fat.''
(2) Milk solids not fat content -- Calculated by subtracting the
milkfat content from the total solids conttent as determined by the
method prescribed in section 16.032, ''Method I -- Official Final
Action,'' under the heading ''Total Solids.''
(3) Titratable acidity -- As determined by the method prescribed in
section 16.023, ''Acidity (2) -- Official Final Action,'' or by an
equivalent potentiometric method.
(g) Nomenclature. The name of the food is ''acidified skim milk'' or
alternatively, ''acidified nonfat milk''. The full name of the food
shall appear on the principal display panel of the food in type of
uniform size, style and color. The name of the food shall be
accompanied by a declaration indicating the presence of any
characterizing flavoring as specified in 101.22 of this chapter, and
may be accompanied by a declaration such as a traditional name of the
food or the generic name of the organisms used, thereby indicating the
presence of the characterizing microbial organisms or ingredients when
used, e.g., ''acidified kefir skim milk'', ''acidified acidophilus skim
milk'', or when characterizing ingredients such as those in paragraph
(e)(6), (7), (8), and (9) of this section are used, the food may be
named ''acidified skim milk buttermilk'' or alternatively ''acidified
nonfat buttermilk''.
(1) The following terms shall accompany the name of the food wherever
it appears on the principal display panel or panels of the label in
letters not less than one-half of the height of the letters used in such
name:
(i) The phrase ''vitamin A'' or ''vitamin A added'', or ''vitamin D''
or ''vitamin D added'', or ''vitamins A and D added'', as appropriate.
The word ''vitamin'' may be abbreviated ''vit.''.
(ii) The word ''sweetened'' if nutritive carbohydrate sweetener is
added without the addition of characterizing flavoring.
(2) The term ''homogenized'' may appear on the label if the dairy
ingredients used are homogenized.
(h) Label declaration. Each of the ingredients used in the food
shall be declared on the label as required by the applicable sections of
Part 101 of this chapter.
(46 FR 9937, Jan. 30, 1981, as amended at 47 FR 11824, Mar. 19, 1982;
47 FR 41523, Sept. 21, 1982; 48 FR 24869, June 3, 1983; 54 FR 24893,
June 12, 1989)
21 CFR 131.146 Cultured skim milk.
(a) Description. Cultured skim milk is the food produced by
culturing one or more of the optional dairy ingredients specified in
paragraph (c) of this section with characterizing microbial organisms.
One or more of the other optional ingredients specified in paragraphs
(b) and (d) of this section may also be added. When one or more of the
ingredients specified in paragraph (d)(1) of this section are used, they
shall be included in the culturing process. All ingredients used are
safe and suitable. Cultured skim milk contains less than 0.5 percent
milkfat and not less than 8.25 percent milk solids not fat and has a
titratable acidity of not less than 0.5 percent, expressed as lactic
acid. The food may be homogenized and shall be pasterurized or
ultra-pasterurized prior to the addition of the microbial culture and,
when applicable, the addition of flakes or granules of butterfat or
milkfat.
(b) Vitamin addition (optional). (1) If added, vitamin A shall be
present in such quantity that each 946 milliliters (quart) of the food
contains not less than 2,000 International Units thereof, within limits
of good manufacturing practice.
(2) If added, vitamin D shall be present in such quantity that each
946 milliliters (quart) of the food contains 400 International Units
thereof, within limits of good manufacturing practice.
(c) Optional dairy ingredients. Cream, milk, partially skimmed milk,
or skim milk, used alone or in combination.
(d) Other optional ingredients. (1) Concentrated skim milk, nonfat
dry milk, buttermilk, whey, lactose, lactalbumins, lactoglobulins, or
whey modified by partial or complete removal of lactose and/or minerals,
to increase the nonfat solids content of the food: Provided, That the
ratio of protein to total nonfat solids of the food, and the protein
efficiency ratio of all protein present shall not be decreased as a
result of adding such ingredients.
(2) Nutritive carbohydrate sweeteners. Sugar (sucrose), beet or
cane; invert sugar (in paste or sirup form); brown sugar; refiner's
sirup; molasses (other than blackstrap); high fructose corn sirup;
fructose; fructose sirup; maltose; maltose sirup, dried maltose
sirup; malt extract, dried malt extract; malt sirup, dried malt sirup;
honey; maple sugar; or any of the sweeteners listed in Part 168 of
this chapter, except table sirup.
(3) Flavoring ingredients.
(4) Color additives that do not impart a color simulating that of
milkfat or butterfat.
(5) Stabilizers.
(6) Butterfat or milkfat, which may or may not contain color
additives, in the form of flakes or granules.
(7) Aroma- and flavor-producing microbial culture.
(8) Salt.
(9) Citric acid, in a maximum amount of 0.15 percent by weight of the
milk used, or an equivalent amount of sodium citrate, as a flavor
precursor.
(e) Methods of analysis. The following referenced methods of
analysis are from ''Official Methods of Analysis of the Association of
Official Analytical Chemists,'' 13th Ed. (1980), which is incorporated
by reference. Copies are available from the Association of Official
Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA
22201-3301, or available for inspection at the Office of the Federal
Register, 1100 L St. NW., Washington, DC 20408.
(1) Milkfat content -- As determined by the method prescribed in
section 16.059, ''Roese-Gottlieb Method (Reference Method) (11) --
Official Final Action,'' under the heading ''Fat.''
(2) Milk solids not fat content -- Calculated by subtracting the
milkfat content from the total solids content as determined by the
method prescribed in section 16.032, ''Method I -- Official Final
Action,'' under the heading ''Total Solids.''
(3) Titratable acidity -- As determined by the method prescribed in
section 16.023, ''Acidity (2) -- Official Final Action,'' or by an
equivalent potentiometric method.
(f) Nomenclature. The name of the food is ''cultured skim milk'' or
alternatively, ''cultured nonfat milk''. The full name of the food
shall appear on the principal display panel of the label in type of
uniform size, style and color. The name of the food shall be
accompanied by a declaration indicating the presence of any
characterizing flavoring as specified in 101.22 of this chapter, and
may be accompanied by a declaration such as a traditional name of the
food or the generic name of the organisms used, thereby indicating the
presence of the characterizing microbial organisms or ingredients, e.g.,
''kefir cultured nonfat milk'', ''acidophilus cultured nonfat milk'', or
when characterizing ingredients such as those in paragraph (d) (6), (7),
(8), and (9) of this section, and lactic acid-producing organisms are
used the food may be named ''cultured skim milk buttermilk'' or
alternatively ''cultured nonfat buttermilk''.
(1) The following terms shall accompany the name of the food wherever
it appears on the principal display panel or panels of the label in
letters not less than one-half of the height of the letters used in such
name.
(i) The phrase ''vitamin A'' or ''vitamin A added'' or ''vitamin D''
or ''vitamin D added'', or ''vitamins A and D added'', as appropriate.
The word ''vitamin'' may be abbreviated ''vit.''.
(ii) The word ''sweetened'' if nutritive carbohydrate sweetener is
added without the addition of characterizing flavoring.
(2) The term ''homogenized'' may appear on the label if the dairy
ingredients used are homogenized.
(g) Label declaration. Each of the ingredients used in the food
shall be declared on the label as required by the applicable sections of
Part 101 of this chapter.
(46 FR 9937, Jan. 30, 1981, as amended at 47 FR 11824, Mar. 19, 1982;
47 FR 41524, Sept. 21, 1982; 48 FR 24869, June 3, 1983; 54 FR 24893,
June 12, 1989)
21 CFR 131.147 Dry whole milk.
(a) Description. Dry whole milk is the product obtained by removal
of water only from pasteurized milk, as defined in 131.110(a), which
may have been homogenized. Alternatively, dry whole milk may be
obtained by blending fluid, condensed, or dried nonfat milk with liquid
or dried cream or with fluid, condensed, or dried milk, as appropriate,
provided the resulting dry whole milk is equivalent in composition to
that obtained by the method described in the first sentence of this
paragraph. It contains the lactose, milk proteins, milkfat, and milk
minerals in the same relative proportions as the milk from which it was
made. It contains not less than 26 percent but less than 40 percent by
weight of milkfat on an as is basis. It contains not more than 5
percent by weight of moisture on a milk solids not fat basis.
(b) Vitamin addition. (1) Addition of vitamin A is optional. If
added, vitamin A shall be present in such quantity that, when prepared
according to label directions, each quart of the reconstituted product
shall contain not less than 2,000 International Units thereof.
(2) Addition of vitamin D is optional. If added, vitamin D shall be
present in such quantity that, when prepared according to label
directions, each quart of the reconstituted product shall contain 400
International Units thereof.
(3) The requirements of this paragraph will be met if reasonable
overages, within limits of good manufacturing practice, are present to
ensure that the required levels of vitamins are maintained throughout
the expected shelf life of the food under customary conditions of
distribution.
(c) Optional ingredients. The following safe and suitable optional
ingredients may be used:
(1) Carriers for vitamins A and D.
(2) Emulsifiers.
(3) Stabilizers.
(4) Anticaking agents.
(5) Antioxidants.
(6) Characterizing flavoring ingredients (with or without coloring
and nutritive carbohydrate sweetener) as follows:
(i) Fruit and fruit juice, including concentrated fruit and fruit
juice.
(ii) Natural and artificial food flavoring.
(d) Methods of analysis. The following referenced methods of
analysis are from ''Official Methods of Analysis of the Association of
Official Analytical Chemists,'' 13th Ed. (1980), which is incorporated
by reference. Copies may be obtained from the Association of Official
Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA
22201-3301, or may be examined at the Office of the Federal Register,
1100 L St. NW., Washington, DC 20408.
(1) Milkfat content -- ''Fat in Dried Milk -- Official Final
Action,'' sections 16.199-16.200.
(2) Moisture content -- ''Moisture -- Official Final Action,''
section 16.192.
(3) Vitamin D content -- ''Vitamin D -- Official Final Action,''
sections 43.195-43.208.
(e) Nomenclature. The name of the food is ''Dry whole milk.'' The
name of the food shall appear on the principal display panel of the
label in type of uniform size, style, and color. The name of the food
shall be accompanied by a declaration indicating the presence of any
characterizing flavoring as specified in 101.22 of this chapter. The
following phrases in type size not less than one-half the height of the
type size used in such name shall accompany the name of the food
wherever it appears on the principal display panel or panels.
(1) The phrase ''Contains -- % milkfat'', the blank to be filled in
with the whole number closest to the actual fat content of the food.
(2) If vitamins are '' added'', the phrase ''vitamin A'', or
''vitamin A added'', or ''vitamin D'', or ''vitamin D added'', or
''vitamins A and D'', or ''vitamins A and D added'', as appropriate.
The word ''vitamin'' may be abbreviated ''vit.''
(f) Label declaration. Each of the optional ingredients used shall
be declared on the label as required by the applicable sections of Part
101 of this chapter.
(43 FR 19836, May 9, 1978, as amended at 47 FR 11824, Mar. 19, 1982;
49 FR 10092, Mar. 19, 1984; 54 FR 24893, June 12, 1989)
21 CFR 131.149 Dry cream.
(a) Description. Dry cream is the product obtained by removal of
water only from pasteurized milk or cream or a mixture thereof, which
may have been homogenized. Alternatively, dry cream may be obtained by
blending dry milks as defined in 131.123(a), 131.125(a), and
131.147(a) with dry cream as appropriate: Provided, That the resulting
product is equivalent in composition to that obtained by the method
described in the first sentence of this paragraph. It contains not less
than 40 percent but less than 75 percent by weight of milkfat on an as
is basis. It contains not more than 5 percent by weight of moisture on
a milk solids not fat basis.
(b) Optional ingredients. The following safe and suitable optional
ingredients may be used:
(1) Emulsifiers.
(2) Stabilizers.
(3) Anticaking agents.
(4) Antioxidants.
(5) Nutritive carbohydrate sweeteners.
(6) Characterizing flavoring ingredients, with or without coloring,
as follows:
(i) Fruit and fruit juice, including concentrated fruit and fruit
juice.
(ii) Natural and artificial food flavoring.
(c) Methods of analysis. The following referenced methods of
analysis are from ''Official Methods of Analysis of the Association of
Official Analytical Chemists,'' 13th Ed. (1980), which is incorporated
by reference. Copies may be obtained from the Association of Official
Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA
22201-3301, or may be examined at the Office of the Federal Register,
1100 L St. NW., Washington, DC 20408.
(1) Milkfat content -- ''Fat in Dried Milk -- Official Final
Action,'' sections 16.199-16.200.
(2) Moisture content -- ''Moisture -- Official Final Action,''
section 16.192.
(d) Nomenclature. The name of the food is ''Dry cream.'' The name of
the food shall appear on the principal display panel of the label in
type of uniform size, style, and color. The name of the food shall be
accompanied by a declaration indicating the presence of any
characterizing flavoring as specified in 101.22 of this chapter. The
following terms shall accompany the name of the food wherever it appears
on the principal display panel or panels of the label, in letters not
less than one-half of the height of the letters used in such name:
(1) The phrase ''Contains -- % milkfat'', the blank to be filled in
with the whole number closest to the actual fat content of the food.
(2) The word ''sweetened'' if no characterizing flavoring ingredients
are used but nutritive carbohydrate sweetener is added.
(e) Label declaration. Each of the optional ingredients used shall
be declared on the label as required by the applicable sections of Part
101 of this chapter.
(43 FR 19836, May 9, 1978, as amended at 44 FR 3965, Jan. 19, 1979;
47 FR 11824, Mar. 19, 1982; 48 FR 13024, Mar. 29, 1983; 49 FR 10092,
Mar. 19, 1984; 54 FR 24893, June 12, 1989)
21 CFR 131.150 Heavy cream.
(a) Description. Heavy cream is cream which contains not less than
36 percent milkfat. It is pasteurized or ultra-pasteurized, and may be
homogenized.
(b) Optional ingredients. The following safe and suitable optional
ingredients may be used:
(1) Emulsifiers.
(2) Stabilizers.
(3) Nutritive sweeteners.
(4) Characterizing flavoring ingredients (with or without coloring)
as follows:
(i) Fruit and fruit juice (including concentrated fruit and fruit
juice).
(ii) Natural and artificial food flavoring.
(c) Methods of analysis. The milkfat content is determined by the
method prescribed in ''Official Methods of Analysis of the Association
of Official Analytical Chemists,'' 13th Ed. (1980), sections 16.156 and
16.059, under ''Fat, Roese-Gottlieb Method -- Official Final Action,''
which is incorporated by reference. Copies may be obtained from the
Association of Official Analytical Chemists, 2200 Wilson Blvd., Suite
400, Arlington, VA 22201-3301, or may be examined at the Office of the
Federal Register, 1100 L St. NW., Washington, DC 20408.
(d) Nomenclature. (1) The name of the food is ''Heavy cream'' or
alternatively ''Heavy whipping cream''. The name of the food shall be
accompanied on the label by a declaration indicating the presence of any
characterizing flavoring, as specified in 101.22 of this chapter. The
following terms shall accompany the name of the food wherever it appears
on the principal display panel or panels of the label in letters not
less than one-half the height of the letters used in such name:
(i) The word ''ultra-pasteurized'' if the food has been
ultra-pasteurized.
(ii) The word ''sweetened'' if no characterizing flavoring
ingredients are used, but nutritive sweetener is added.
(2) The following terms may appear on the label:
(i) The word ''pasteurized'' if the food has been pasteurized.
(ii) The word ''homogenized'' if the food has been homogenized.
(e) Label declaration. When used in the food, each of the
ingredients specified in paragraph (b) of this section shall be declared
on the label as required by the applicable sections of Part 101 of this
chapter.
(42 FR 14360, Mar. 15, 1977, as amended at 47 FR 11824, Mar. 19,
1982; 49 FR 10092, Mar. 19, 1984; 54 FR 24893, June 12, 1989)
21 CFR 131.155 Light cream.
(a) Description. Light cream is cream which contains not less than
18 percent but less than 30 percent milkfat. It is pasteurized or
ultra-pasteurized, and may be homogenized.
(b) Optional ingredients. The following safe and suitable
ingredients may be used:
(1) Stabilizers.
(2) Emulsifiers.
(3) Nutritive sweeteners.
(4) Characterizing flavoring ingredients (with or without coloring)
as follows:
(i) Fruit and fruit juice (including concentrated fruit and fruit
juice).
(ii) Natural and artificial food flavoring.
(c) Methods of analysis. The milkfat content is determined by the
method prescribed in ''Official Methods of Analysis of the Association
of Official Analytical Chemists,'' 13th Ed. (1980), sections 16.156 and
16.059, under ''Fat, Roese-Gottlieb Method -- Official Final Action,''
which is incorporated by reference. Copies may be obtained from the
Association of Official Analytical Chemists, 2200 Wilson Blvd., Suite
400, Arlington, VA 22201-3301, or may be examined at the Office of the
Federal Register, 1100 L St. NW., Washington, DC 20408.
(d) Nomenclature. The name of the food is ''Light cream'', or
alternatively ''Coffee cream'' or ''Table cream''. The name of the food
shall be accompanied on the label by a declaration indicating the
presence of any characterizing flavoring, as specified in 101.22 of
this chapter.
(1) The following terms shall accompany the name of the food wherever
it appears on the principal display panel or panels of the label in
letters not less than one-half the height of the letters used in such
name:
(i) The word ''ultra-pasteurized'' if the food has been
ultra-pasteurized.
(ii) The word ''sweetened'' if no characterizing flavoring
ingredients are used, but nutritive sweetener is added.
(2) The following terms may appear on the label:
(i) The word ''pasteurized'' if the food has been pasteurized.
(ii) The word ''homogenized'' if the food has been homogenized.
(e) Label declaration. When used in the food, each of the
ingredients specified in paragraph (b) of this section shall be declared
on the label as required by the applicable sections of Part 101 of this
chapter.
(42 FR 14360, Mar. 15, 1977, as amended at 47 FR 11824, Mar. 19,
1982; 49 FR 10092, Mar. 1, 1984; 54 FR 24893, June 12, 1989)
21 CFR 131.157 Light whipping cream.
(a) Description. Light whipping cream is cream which contains not
less than 30 percent but less than 36 percent milkfat. It is
pasteurized or ultra-pasteurized, and may be homogenized.
(b) Optional ingredients. The following safe and suitable optional
ingredients may be used:
(1) Emulsifiers.
(2) Stabilizers.
(3) Nutritive sweeteners.
(4) Characterizing flavoring ingredients (with or without coloring)
as follows:
(i) Fruit and fruit juice (including concentrated fruit and fruit
juice).
(ii) Natural and artificial food flavoring.
(c) Methods of analysis. The milkfat content is determined by the
method prescribed in ''Official Methods of Analysis of the Association
of Official Analytical Chemists,'' 13th Ed. (1980), sections 16.156 and
16.059, under ''Fat, Roese-Gottlieb Method -- Official Final Action,''
which is incorporated by reference. Copies may be obtained from the
Association of Official Analytical Chemists, 2200 Wilson Blvd., Suite
400, Arlington, VA 22201-3301, or may be examined at the Office of the
Federal Register, 1100 L St. NW., Washington, DC 20408.
(d) Nomenclature. The name of the food is ''Light whipping cream''
or alternatively ''Whipping cream''. The name of the food shall be
accompanied on the label by a declaration indicating the presence of any
characterizing flavoring, as specified in 101.22 of this chapter.
(1) The following terms shall accompany the name of the food wherever
it appears on the principal display panel or panels of the label in
letters not less than one-half the height of the letters used in such
name:
(i) The word ''ultra-pasteurized'' if the food has been
ultra-pasteurized.
(ii) The word ''sweetened'' if no characterizing flavoring
ingredients are used, but nutritive sweetener is added.
(2) The following terms may appear on the label:
(i) The word ''pasteurized'' if the food has been pasteurized.
(ii) The word ''homogenized'' if the food has been homogenized.
(e) Label declaration. When used in the food, each of the
ingredients specified in paragraph (b) of this section shall be declared
on the label as required by the applicable sections of Part 101 of this
chapter.
(42 FR 14360, Mar. 15, 1977, as amended at 47 FR 11824, Mar. 19,
1982; 49 FR 10092, Mar. 19, 1984; 54 FR 24893, June 12, 1989)
21 CFR 131.160 Sour cream.
(a) Description. Sour cream results from the souring, by lactic acid
producing bacteria, of pasteurized cream. Sour cream contains not less
than 18 percent milkfat; except that when the food is characterized by
the addition of nutritive sweeteners or bulky flavoring ingredients, the
weight of the milkfat is not less than 18 percent of the remainder
obtained by subtracting the weight of such optional ingredients from the
weight of the food; but in no case does the food contain less than 14.4
percent milkfat. Sour cream has a titratable acidity of not less than
0.5 percent, calculated as lactic acid.
(b) Optional ingredients. (1) Safe and suitable ingredients that
improve texture, prevent syneresis, or extend the shelf life of the
product.
(2) Sodium citrate in an amount not more than 0.1 percent may be
added prior to culturing as a flavor precursor.
(3) Rennet.
(4) Safe and suitable nutritive sweeteners.
(5) Salt.
(6) Flavoring ingredients, with or without safe and suitable
coloring, as follows:
(i) Fruit and fruit juice (including concentrated fruit and fruit
juice).
(ii) Safe and suitable natural and artificial food flavoring.
(c) Methods of analysis. Referenced methods in paragraph (c) (1) and
(2) of this section are from ''Official Methods of Analysis of the
Association of Official Analytical Chemists,'' 13th Ed. (1980), which
is incorporated by reference. Copies may be obtained from the
Association of Official Analytical Chemists, 2200 Wilson Blvd., Suite
400, Arlington, VA 22201-3301, or may be examined at the Office of the
Federal Register, 1100 L St. NW., Washington, DC 20408.
(1) Milkfat content -- ''Fat -- Official Final Action,'' section
16.172.
(2) Titratable acidity -- ''Acidity -- Official Final Action,''
section 16.023.
(d) Nomenclature. The name of the food is ''Sour cream'' or
alternatively ''Cultured sour cream''. The full name of the food shall
appear on the principal display panel of the label in type of uniform
size, style, and color. The name of the food shall be accompanied by a
declaration indicating the presence of any flavoring that characterizes
the product, as specified in 101.22 of this chapter. If nutritive
sweetener in an amount sufficient to characterize the food is added
without addition of characterizing flavoring, the name of the food shall
be preceded by the word ''sweetened''.
(e) Label declaration. Each of the ingredients used in the food
shall be declared on the label as required by the applicable sections of
Part 101 of this chapter, except that bacterial cultures may be declared
by the word ''cultured'' followed by the name of the substrate, e.g.,
''cultured cream''.
(42 FR 14360, Mar. 15, 1977, as amended at 47 FR 11824, Mar. 19,
1982; 49 FR 10092, Mar. 19, 1984; 54 FR 24893, June 12, 1989)
21 CFR 131.162 Acidified sour cream.
(a) Description. Acidified sour cream results from the souring of
pasteurized cream with safe and suitable acidifiers, with or without
addition of lactic acid producing bacteria. Acidified sour cream
contains not less than 18 percent milkfat; except that when the food is
characterized by the addition of nutritive sweeteners or bulky flavoring
ingredients, the weight of milkfat is not less than 18 percent of the
remainder obtained by subtracting the weight of such optional
ingredients from the weight of the food; but in no case does the food
contain less than 14.4 percent milkfat. Acidified sour cream has a
titratable acidity of not less than 0.5 percent, calculated as lactic
acid.
(b) Optional ingredients. (1) Safe and suitable ingredients that
improve texture, prevent syneresis, or extend the shelf life of the
product.
(2) Rennet.
(3) Safe and suitable nutritive sweeteners.
(4) Salt.
(5) Flavoring ingredients, with or without safe and suitable
coloring, as follows:
(i) Fruit and fruit juice, including concentrated fruit and fruit
juice.
(ii) Safe and suitable natural and artificial food flavoring.
(c) Methods of analysis. Referenced methods in paragraphs (c) (1)
and (2) of this section are from ''Official Methods of Analysis of the
Association of Official Analytical Chemists,'' 13th Ed. (1980), which
is incorporated by reference. Copies may be obtained from the
Association of Official Analytical Chemists, 2200 Wilson Blvd., Suite
400, Arlington, VA 22201-3301, or may be examined at the Office of the
Federal Register, 1100 L St. NW., Washington, DC 20408.
(1) Milkfat content -- ''Fat -- Official Final Action,'' section
16.172.
(2) Titratable acidity -- ''Acidity -- Official Final Action,''
section 16.023.
(d) Nomenclature. The name of the food is ''Acidified sour cream''.
The full name of the food shall appear on the principal display panel of
the label in type of uniform size, style, and color. The name of the
food shall be accompanied by a declaration indicating the presence of
any flavoring that characterizes the product, as specified in 101.22 of
this chapter. If nutritive sweetener in an amount sufficient to
characterize the food is added without addition of characterizing
flavoring, the name of the food shall be preceded by the word
''sweetened''.
(e) Label declaration. Each of the ingredients used in the food
shall be declared on the label as required by the applicable sections of
Part 101 of this chapter, except that bacterial cultures may be declared
by the word ''cultured'' followed by the name of the substrate, e.g.,
''cultured cream''.
(42 FR 14360, Mar. 15, 1977, as amended at 47 FR 11825, Mar. 19,
1982; 49 FR 10092, Mar. 19, 1984; 54 FR 24893, June 12, 1989)
21 CFR 131.170 Eggnog.
(a) Description. Eggnog is the food containing one or more of the
optional dairy ingredients specified in paragraph (b), one or more of
the optional egg yolk-containing ingredients specified in paragraph (c)
of this section, and one or more of the optional nutritive carbohydrate
sweeteners specified in paragraph (d) of this section. One or more of
the optional ingredients specified in paragraph (e) of this section may
also be added. All ingredients used are safe and suitable. Eggnog
contains not less than 6 percent milkfat and not less than 8.25 percent
milk solids not fat. The egg yolk solids content is not less than 1
percent by weight of the finished food. The food shall be pasteurized
or ultra-pasteurized and may be homogenized. Flavoring ingredients and
color additives may be added after the food is pasteurized or
ultra-pasteurized.
(b) Optional dairy ingredients. Cream, milk, partially skimmed milk,
or skim milk, used alone or in combination.
(c) Egg yolk-containing ingredients. Liquid egg yolk, frozen egg
yolk, dried egg yolk, liquid whole eggs, frozen whole eggs, dried whole
eggs, or any one or more of the foregoing ingredients with liquid egg
white or frozen egg white.
(d) Nutritive carbohydrate sweeteners. Sugar (sucrose), beet or
cane; invert sugar (in paste or sirup form); brown sugar; refiner's
sirup; molasses (other than blackstrap); high fructose corn sirup;
fructose; fructose sirup; maltose; maltose sirup, dried maltose
sirup; malt extract, dried malt extract; malt sirup, dried malt sirup;
honey; maple sugar; or any of the sweeteners listed in Part 168 of
this chapter, except table sirup.
(e) Other optional ingredients. (1) Concentrated skim milk, nonfat
dry milk, buttermilk, whey, lactose, lactalbumins, lactoglobulins, or
whey modified by partial or complete removal of lactose and/or minerals,
to increase the nonfat solids content of the food: Provided, That the
ratio of protein to total nonfat solids of the food, and the protein
efficiency ratio of all protein present shall not be decreased as a
result of adding such ingredients.
(2) Salt.
(3) Flavoring ingredients.
(4) Color additives that do not impart a color simulating that of egg
yolk, milkfat, or butterfat.
(5) Stabilizers.
(f) Methods of analysis. The following referenced methods of
analysis are from ''Official Methods of Analysis of the Association of
Official Analytical Chemists,'' 13th Ed. (1980), which is incorporated
by reference. Copies are available from the Association of Official
Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA
22201-3301, or available for inspection at the Office of the Federal
Register, 1100 L St. NW., Washington, DC 20408.
(1) Milkfat content -- As determined by the method prescribed in
section 16.059, ''Roese-Gottlieb Method (Reference Method) (11) --
Official Final Action,'' under the heading ''Fat.''
(2) Milk solids not fat content -- Calculated by subtracting the
milkfat content from the total solids content as determined by the
method prescribed in section 16.032, ''Method I -- Official Final
Action,'' under the heading ''Total Solids.''
(g) Nomenclature. The name of the food is ''eggnog''. The name of
the food shall be accompanied by a declaration indicating the presence
of any characterizing flavoring as specified in 101.22 of this chapter.
If the food is ultra-pasteurized, the phrase ''ultra-pasteurized''
shall accompany the name of the food wherever it appears on the label in
letters not less than one-half of the height of the letters used in the
name. The following terms may accompany the name of the food on the
label:
(1) The word ''pasteurized'' if the food has been pasteurized.
(2) The word ''homogenized'' if the food has been homogenized.
(h) Label declaration. Each of the ingredients used in the food
shall be declared on the label as required by the applicable sections of
Part 101 of this chapter.
(46 FR 9938, Jan. 30, 1981, as amended at 47 FR 11825, Mar. 19, 1982;
47 FR 41524, Sept. 21, 1982; 47 FR 49638, Nov. 2, 1982; 48 FR 24869,
June 3, 1983; 54 FR 24893, June 12, 1989)
21 CFR 131.180 Half-and-half.
(a) Description. Half-and-half is the food consisting of a mixture
of milk and cream which contains not less than 10.5 percent but less
than 18 percent milkfat. It is pasteurized or ultra-pasteurized, and
may be homogenized.
(b) Optional ingredients. The following safe and suitable optional
ingredients may be used:
(1) Emulsifiers.
(2) Stabilizers.
(3) Nutritive sweeteners.
(4) Characterizing flavoring ingredients (with or without coloring)
as follows:
(i) Fruit and fruit juice (including concentrated fruit and fruit
juice).
(ii) Natural and artificial food flavoring.
(c) Methods of analysis. The milkfat content is determined by the
method prescribed in ''Official Methods of Analysis of the Association
of Official Analytical Chemists,'' 13th Ed. (1980), in sections 16.156
and 16.059, under ''Fat, Roese-Gottlieb Method -- Official Final
Action,'' which is incorporated by reference. Copies may be obtained
from the Association of Official Analytical Chemists, 2200 Wilson Blvd.,
Suite 400, Arlington, VA 22201-3301, or may be examined at the Office of
the Federal Register, 1100 L St. NW., Washington, DC 20408.
(d) Nomenclature. The name of the food is ''Half-and-half''. The
name of the food shall be accompanied on the label by a declaration
indicating the presence of any characterizing flavoring, as specified in
101.22 of this chapter.
(1) The following terms shall accompany the name of the food wherever
it appears on the principal display panel or panels of the label in
letters not less than one-half the height of the letters used in such
name:
(i) The word ''ultra-pasteurized'' if the food has been
ultra-pasteurized.
(ii) The word ''sweetened'' if no characterizing flavor ingredients
are used, but nutritive sweetener is added.
(2) The following terms may appear on the label:
(i) The word ''pasteurized'' if the food has been pasteurized.
(ii) The word ''homogenized'' if the food has been homogenized.
(e) Label declaration. When used in the food, each of the
ingredients specified in paragraph (b) of this section shall be declared
on the label as required by the applicable sections of Part 101 of this
chapter.
(42 FR 14360, Mar. 15, 1977, as amended at 47 FR 11825, Mar. 19,
1982; 49 FR 10092, Mar. 19, 1984; 54 FR 24893, June 12, 1989)
21 CFR 131.185 Sour half-and-half.
(a) Description. Sour half-and-half results from the souring, by
lactic acid producing bacteria, of pasteurized half-and-half. Sour
half-and-half contains not less than 10.5 percent but less than 18
percent milkfat; except that when the food is characterized by the
addition of nutritive sweeteners or bulky flavoring ingredients, the
weight of milkfat is not less than 10.5 percent of the remainder
obtained by subtracting the weight of such optional ingredients from the
weight of the food; but in no case does the food contain less than 8.4
percent milkfat. Sour half-and-half has a titratable acidity of not
less than 0.5 percent, calculated as lactic acid.
(b) Optional ingredients. (1) Safe and suitable ingredients that
improve texture, prevent syneresis, or extend the shelf life of the
product.
(2) Sodium citrate in an amount not more than 0.1 percent may be
added prior to culturing as a flavor precursor.
(3) Rennet.
(4) Safe and suitable nutritive sweeteners.
(5) Salt.
(6) Flavoring ingredients, with or without safe and suitable
coloring, as follows:
(i) Fruit and fruit juice, including concentrated fruit and fruit
juice.
(ii) Safe and suitable natural and artificial food flavoring.
(c) Methods of analysis. Referenced methods in paragraph (c) (1) and
(2) of this section are from ''Official Methods of Analysis of the
Association of Official Analytical Chemists,'' 13th Ed. (1980), which
is incorporated by reference. Copies may be obtained from the
Association of Official Analytical Chemists, 2200 Wilson Blvd., Suite
400, Arlington, VA 22201-3301, or may be examined at the Office of the
Federal Register, 1100 L St. NW., Washington, DC 20408.
(1) Milkfat content -- ''Fat -- Official Final Action,'' section
16.172.
(2) Titratable acidity -- ''Acidity -- Official Final Action,''
section 16.023.
(d) Nomenclature. The name of the food is ''Sour half-and-half'' or
alternatively ''Cultured sour half-and-half''. The full name of the
food shall appear on the principal display panel of the label in type of
uniform size, style, and color. The name of the food shall be
accompanied by a declaration indicating the presence of any flavoring
that characterizes the product, as specified in 101.22 of this chapter.
If nutritive sweetener in an amount sufficient to characterize the food
is added without addition of characterizing flavoring, the name of the
food shall be preceded by the word ''sweetened''.
(e) Label declaration. Each of the ingredients used in the food
shall be declared on the label as required by the applicable sections of
Part 101 of this chapter, except that bacterial cultures may be declared
by the word ''cultured'' followed by the name of the substrate, e.g.,
''cultured cream''.
(42 FR 14360, Mar. 15, 1977, as amended at 47 FR 11825, Mar. 19,
1982; 49 FR 10092, Mar. 19, 1984; 54 FR 24893, June 12, 1989)
21 CFR 131.187 Acidified sour half-and-half.
(a) Description. Acidified sour half-and-half results from the
souring of pasteurized half-and-half with safe and suitable acidifiers,
and with or without addition of lactic acid producing bacteria.
Acidified sour half-and-half contains not less than 10.5 percent but
less than 18 percent milkfat; except that when the food is
characterized by the addition of nutritive sweeteners or bulky flavoring
ingredients, the weight of milkfat is not less than 10.5 percent of the
remainder obtained by subtracting the weight of such optional
ingredients from the weight of the food; but in no case does the food
contain less than 8.4 percent milkfat. Acidified sour half-and-half has
a titratable acidity of not less than 0.5 percent, calculated as lactic
acid.
(b) Optional ingredients. (1) Safe and suitable ingredients to
improve texture, prevent syneresis, or extend the shelf life of the
product.
(2) Rennet.
(3) Safe and suitable nutritive sweeteners.
(4) Salt.
(5) Flavoring ingredients, with or without safe and suitable
coloring, as follows:
(i) Fruit and fruit juice, including concentrated fruit and fruit
juice.
(ii) Safe and suitable natural and artificial food flavoring.
(c) Methods of analysis. Referenced methods in paragraph (c) (1) and
(2) of this section are from ''Official Methods of Analysis of the
Association of Official Analytical Chemists,'' 13th Ed. (1980), which
is incorporated by reference. Copies may be obtained from the
Association of Official Analytical Chemists, 2200 Wilson Blvd., Suite
400, Arlington, VA 22201-3301, Washington, DC 20044, or may be examined
at the Office of the Federal Register, 1100 L St. NW., Washington, DC
20408.
(1) Milkfat content -- ''Fat -- Official Final Action,'' section
16.172.
(2) Titratable acidity -- ''Acidity -- Official Final Action,''
section 16.023.
(d) Nomenclature. The name of the food is ''Acidified sour
half-and-half''. The full name of the food shall appear on the
principal display panel of the label in type of uniform size, style, and
color. The name of the food shall be accompanied by a declaration
indicating the presence of any flavoring that characterizes the product,
as specified in 101.22 of this chapter. If nutritive sweetener in an
amount sufficient to characterize the food is added without addition of
characterizing flavoring, the name of the food shall be preceded by the
word ''sweetened''.
(e) Label declaration. Each of the ingredients used in the food
shall be declared on the label as required by the applicable sections of
Part 101 of this chapter, except that bacterial cultures may be declared
by the word ''cultured'' followed by the name of the substrate, e.g.,
''cultured cream''.
(42 FR 14360, Mar. 15, 1977, as amended at 47 FR 11825, Mar. 19,
1982; 49 FR 10093, Mar. 19, 1984; 54 FR 24893, June 12, 1989)
21 CFR 131.200 Yogurt.
(a) Description. Yogurt is the food produced by culturing one or
more of the optional dairy ingredients specified in paragraph (c) of
this section with a characterizing bacterial culture that contains the
lactic acid-producing bacteria, Lactobacillus bulgaricus and
Streptococcus thermophilus. One or more of the other optional
ingredients specified in paragraphs (b) and (d) of this section may also
be added. When one or more of the ingredients specified in paragraph
(d)(1) of this section are used, they shall be included in the culturing
process. All ingredients used are safe and suitable. Yogurt, before
the addition of bulky flavors, contains not less than 3.25 percent
milkfat and not less than 8.25 percent milk solids not fat, and has a
titratable acidity of not less than 0.9 percent, expressed as lactic
acid. The food may be homogenized and shall be pasteurized or
ultra-pasteurized prior to the addition of the bacterial culture.
Flavoring ingredients may be added after pasteurization or
ultra-pasteurization. To extend the shelf life of the food, yogurt may
be heat treated after culturing is completed, to destroy viable
microorganisms.
(b) Vitamin addition (optional). (1) If added, vitamin A shall be
present in such quantity that each 946 milliliters (quart) of the food
contains not less than 2,000 International Units thereof, within limits
of current good manufacturing practice.
(2) If added, vitamin D shall be present in such quantity that each
946 milliliters (quart) of the food contains 400 International Units
thereof, within limits of current good manufacturing practice.
(c) Optional dairy ingredients. Cream, milk, partially skimmed milk,
or skim milk, used alone or in combination.
(d) Other optional ingredients. (1) Concentrated skim milk, nonfat
dry milk, buttermilk, whey, lactose, lactalbumins, lactoglobulins, or
whey modified by partial or complete removal of lactose and/or minerals,
to increase the nonfat solids content of the food: Provided, That the
ratio of protein to total nonfat solids of the food, and the protein
efficiency ratio of all protein present shall not be decreased as a
result of adding such ingredients.
(2) Nutritive carbohydrate sweeteners. Sugar (sucrose), beet or
cane; invert sugar (in paste or sirup form); brown sugar; refiner's
sirup; molasses (other than blackstrap); high fructose corn sirup;
fructose; fructose sirup; maltose; maltose sirup, dried maltose
sirup; malt extract, dried malt extract; malt sirup, dried malt sirup;
honey; maple sugar; or any of the sweeteners listed in Part 168 of
this chapter, except table sirup.
(3) Flavoring ingredients.
(4) Color additives.
(5) Stabilizers.
(e) Methods of analysis. The following referenced methods of
analysis are from ''Official Methods of Analysis of the Association of
Official Analytical Chemists,'' 13th Ed. (1980), which is incorporated
by reference. Copies are available from the Association of Official
Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA
22201-3301, or available for inspection at the Office of the Federal
Register, 1100 L St. NW., Washington, DC 20408.
(1) Milkfat content -- As determined by the method prescribed in
section 16.059 ''Roese-Gottlieb Method (Reference Method) (11) --
Official Final Action,'' under the heading ''Fat.''
(2) Milk solids not fat content -- Calculated by subtracting the
milkfat content from the total solids content as determined by the
method prescribed in section 16.032, ''Method I -- Official Final
Action,'' under the heading ''Total Solids.''
(3) Titratable acidity -- As determined by the method prescribed in
section 16.023, ''Acidity (2) -- Official Final Action,'' or by an
equivalent potentiometric method.
(f) Nomenclature. The name of the food is ''yogurt''. The name of
the food shall be accompanied by a declaration indicating the presence
of any characterizing flavoring as specified in 101.22 of this chapter.
(1) The following terms shall accompany the name of the food wherever
it appears on the principal display panel or panels of the label in
letters not less than one-half of the height of the letters used in such
name:
(i) The word ''sweetened'' if nutritive carbohydrate sweetener is
added without the addition of characterizing flavor.
(ii) The parenthetical phrase ''(heat-treated after culturing)''
shall follow the name of the food if the dairy ingredients have been
heat-treated after culturing.
(iii) The phrase ''vitamin A'' or ''vitamin A added'', or ''vitamin
D'' or ''vitamin D added'', or ''vitamins A and D added'', as
appropriate. The word ''vitamin'' may be abbreviated ''vit''.
(2) The term ''homogenized'' may appear on the label if the dairy
ingredients used are homogenized.
(g) Label declaration. Each of the ingredients used in the food
shall be declared on the label as required by the applicable sections of
Part 101 of this chapter.
(46 FR 9939, Jan. 30, 1981, as amended at 47 FR 11825, Mar. 19, 1982;
47 FR 41524, Sept. 21, 1982; 48 FR 24869, June 3, 1983; 54 FR 24893,
June 12, 1989)
21 CFR 131.203 Lowfat yogurt.
(a) Description. Lowfat yogurt is the food produced by culturing one
or more of the optional dairy ingredients specified in paragraph (c) of
this section with a characterizing bacterial culture that contains the
lactic acid-producing bacteria, Lactobacillus bulgaricus and
Streptococcus thermophilus. One or more of the other optional
ingredients specified in paragraphs (b) and (d) of this section may also
be added. When one or more of the ingredients specified in paragraph
(d)(1) of this section are used, they shall be included in the culturing
process. All ingredients used are safe and suitable. Lowfat yogurt,
before the addition of bulky flavors, contains not less than 0.5 percent
nor more than 2 percent milkfat and not less than 8.25 percent milk
solids not fat, and has a titratable acidity of not less than 0.9
percent, expressed as lactic acid. The food may be homogenized and
shall be pasteurized or ultra-pasteurized prior to the addition of the
bacterial culture. Flavoring ingredients may be added after
pasteurization or ultra-pasteurization. To extend the shelf life of the
food, lowfat yogurt may be heat treated after culturing is completed, to
destroy viable microorganisms.
(b) Vitamin addition (optional). (1) If added, vitamin A shall be
present in such quantity that each 946 milliliters (quart) of the food
contains not less than 2,000 International Units thereof, within limits
of current good manufacturing practice.
(2) If added, vitamin D shall be present in such quantity that each
946 milliliters (quart) of the food contains 400 International Units
thereof, within limits of current good manufacturing practice.
(c) Optional dairy ingredients. Cream, milk, partially skimmed milk,
or skim milk, used alone or in combination.
(d) Other optional ingredients. (1) Concentrated skim milk, nonfat
dry milk, buttermilk, whey, lactose, lactalbumins, lactoglobulins, or
whey modified by partial or complete removal of lactose and/or minerals,
to increase the nonfat solids content of the food: Provided, That the
ratio of protein to total nonfat solids of the food, and the protein
efficiency ratio of all protein present shall not be decreased as a
result of adding such ingredients.
(2) Nutritive carbohydrate sweeteners. Sugar (sucrose), beet or
cane; invert sugar (in paste or sirup form); brown sugar; refiner's
sirup; molasses (other than blackstrap); high fructose corn sirup;
fructose; fructose sirup; maltose, maltose sirup, dried maltose sirup;
malt extract, dried malt extract; malt sirup, dried malt sirup;
honey; maple sugar; or any of the sweeteners listed in Part 168 of
this chapter, except table sirup.
(3) Flavoring ingredients.
(4) Color additives.
(5) Stabilizers.
(e) Methods of analysis. The following referenced methods of
analysis are from ''Official Methods of Analysis of the Association of
Official Analytical Chemists,'' 13th Ed. (1980), which is incorporated
by reference. Copies are available from the Association of Official
Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA
22201-3301, or available for inspection at the Office of the Federal
Register, 1100 L St. NW., Washington, DC 20408.
(1) Milkfat content -- As determined by the method prescribed in
section 16.059 ''Roese-Gottlieb Method (Reference Method) (11) --
Official Final Action,'' under the heading ''Fat.''
(2) Milk solids not fat content -- Calculated by subtracting the
milkfat content from the total solids content as determined by the
method prescribed in section 16.032, ''Method I -- Official Final
Action,'' under the heading ''Total Solids.''
(3) Titratable acidity -- As determined by the method prescribed in
section 16.023, ''Acidity (2) -- Official Final Action,'' or by an
equivalent potentiometric method.
(f) Nomenclature. The name of the food is ''lowfat yogurt''. The
full name of the food shall appear on the principal display panel of the
label in type of uniform size, style, and color. The name of the food
shall be accompanied by a declaration indicating the presence of any
characterizing flavoring as specified in 101.22 of this chapter.
(1) The following terms shall accompany the name of the food wherever
it appears on the principal display panel or panels of the label in
letters not less than one-half of the height of the letters used in such
name.
(i) The phrase '' -- % milkfat'', the blank to be filled in with the
fraction 1/2 or multiple thereof closest to the actual fat content of
the food.
(ii) The word ''sweetened'' if nutritive carbohydrate sweetener is
added without the addition of characterizing flavoring.
(iii) The parenthetical phrase ''(heat-treated after culturing)''
shall follow the name of the food if the dairy ingredients have been
heat-treated after culturing.
(iv) The phrase ''vitamin A'' or ''vitamin A added'', or ''vitamin
D'' or ''vitamin D added'', or ''vitamins A and D added'', as
appropriate. The word ''vitamin'' may be abbreviated ''vit''.
(2) The term ''homogenized'' may appear on the label if the dairy
ingredients used are homogenized.
(g) Label declaration. Each of the ingredients used in the food
shall be declared on the label as required by the applicable sections of
Part 101 of this chapter.
(46 FR 9939, Jan. 30, 1981, as amended at 47 FR 11825, Mar. 19, 1982;
47 FR 41524, Sept. 21, 1982; 48 FR 24869, June 3, 1983; 54 FR 24893,
June 12, 1989)
21 CFR 131.206 Nonfat yogurt.
(a) Description. Nonfat yogurt is the food produced by culturing one
or more of the optional dairy ingredients specified in paragraph (c) of
this section with a characterizing bacterial culture that contains the
lactic acid-producing bacteria, Lactobacillus bulgaricus and
Streptococcus thermophilus. One or more of the other optional
ingredients specified in paragraphs (b) and (d) of this section may also
be added. When one or more of the ingredients specified in paragraph
(d)(1) of this section are used, they shall be included in the culturing
process. All ingredients used are safe and suitable. Nonfat yogurt,
before the addition of bulky flavors, contains less than 0.5 percent
milkfat and not less than 8.25 percent milk solids not fat, and has a
titratable acidity of not less than 0.9 percent, expressed as lactic
acid. The food may be homogenized and shall be pasteurized or
ultra-pasteurized prior to the addition of the bacterial culture.
Flavoring ingredients may be added after pasteurization or
ultra-pasteurization. To extend the shelf life of the food, nonfat
yogurt may be heat treated after culturing is completed, to destroy
viable microorganisms.
(b) Vitamin addition (optional). (1) If added, vitamin A shall be
present in such quantity that each 946 milliliters (quart) of the food
contains not less than 2,000 International Units thereof, within limits
of good manufacturing practice.
(2) If added, vitamin D shall be present in such quantity that each
946 milliliters (quart) of the food contains 400 International Units
thereof, within limits of good manufacturing practice.
(c) Optional dairy ingredients. Cream, milk, partially skimmed milk,
or skim milk, used alone or in combination.
(d) Other optional ingredients. (1) Concentrated skim milk, nonfat
dry milk, buttermilk, whey, lactose, lactalbumins, lactoglobulins, or
whey modified by partial or complete removal of lactose and/or minerals,
to increase the nonfat solids content of the food: Provided, That the
ratio of protein to total nonfat solids of the food, and the protein
efficiency ratio of all protein present shall not be decreased as a
result of adding such ingredients.
(2) Nutritive carbohydrate sweeteners. Sugar (sucrose), beet or
cane; invert sugar (in paste or sirup form); brown sugar; refiner's
sirup; molasses (other than blackstrap); high fructose corn sirup;
fructose; fructose sirup; maltose; maltose sirup, dried maltose
sirup; malt extract, dired malt extract; malt sirup, dried malt sirup;
honey; maple sugar; or any of the sweeteners listed in Part 168 of
this chapter, except table sirup.
(3) Flavoring ingredients.
(4) Color additives.
(5) Stabilizers.
(e) Methods of analysis. The following referenced methods of
analysis are from ''Official Methods of Analysis of the Association of
Official Analytical Chemists,'' 13th Ed. (1980), which is incorporated
by reference. Copies are available from the Association of Official
Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA
22201-3301, or available for inspection at the Office of the Federal
Register, 1100 L St. NW., Washington, DC 20408.
(1) Milkfat content -- As determined by the method prescribed in
section 16.059, ''Roese-Gottlieb Method (Reference Method) (11) --
Official Final Action,'' under the heading ''Fat.''
(2) Milk solids not fat content -- Calculated by subtracting the
milkfat content from the total solids content as determined by the
method prescribed in section 16.032, ''Method I -- Official Final
Action,'' under the heading ''Total Solids.''
(3) Titratable acidity -- As determined by the method prescribed in
section 16.023, ''Acidity (2) -- Official Final Action,'' or by an
equivalent potentiometric method.
(f) Nomenclature. The name of the food is ''nonfat yogurt''. The
full name of the food shall appear on the principal display panel of the
label in type of uniform size, style, and color. The name of the food
shall be accompanied by a declaration indicating the presence of any
characterizing flavoring as specified in 101.22 of this chapter.
(1) The following terms shall accompany the name of the food wherever
it appears on the principal display panel or panels of the label in
letters not less than one-half of the height of the letters used in such
name:
(i) The word ''sweetened'' if nutritive carbohydrate sweetener is
added without the addition of characterizing flavoring.
(ii) The parenthetical phrase ''(heat-treated after culturing)''
shall follow the name of the food if the dairy ingredients have been
heat-treated after culturing.
(iii) The phrase ''vitamin A'' or ''vitamin A added'', or ''vitamin
D'' or ''vitamin D added'', or ''vitamins A and D added'', as
appropriate. The word ''vitamin'' may be abbreviated ''vit''.
(2) The term ''homogenized'' may appear on the label if the dairy
ingredients used are homogenized.
(g) Label declaration. Each of the ingredients used in the food
shall be declared on the label as required by the applicable sections of
Part 101 of this chapter.
(46 FR 9940, Jan. 30, 1981, as amended at 47 FR 11825, Mar. 19, 1982;
47 FR 41524, Sept. 21, 1982; 48 FR 24869, June 3, 1983; 54 FR 24893,
June 12, 1989)
21 CFR 131.206 PART 133 -- CHEESES AND RELATED CHEESE PRODUCTS
21 CFR 131.206 Pt. 133
21 CFR 131.206 Subpart A -- General Provisions
Sec.
133.3 Definitions.
133.5 Methods of analysis.
133.10 Notice to manufacturers, packers, and distributors of
pasteurized blended cheese, pasteurized process cheese, cheese food,
cheese spread, and related foods.
21 CFR 131.206 Subpart B -- Requirements for Specific Standardized
Cheese and Related Products
133.102 Asiago fresh and asiago soft cheese.
133.103 Asiago medium cheese.
133.104 Asiago old cheese.
133.106 Blue cheese.
133.108 Brick cheese.
133.109 Brick cheese for manufacturing.
133.111 Caciocavallo siciliano cheese.
133.113 Cheddar cheese.
133.114 Cheddar cheese for manufacturing.
133.116 Low sodium cheddar cheese.
133.118 Colby cheese.
133.119 Colby cheese for manufacturing.
133.121 Low sodium colby cheese.
133.123 Cold-pack and club cheese.
133.124 Cold-pack cheese food.
133.125 Cold-pack cheese food with fruits, vegetables, or meats.
133.127 Cook cheese, koch kaese.
133.128 Cottage cheese.
133.129 Dry curd cottage cheese.
133.131 Lowfat cottage cheese.
133.133 Cream cheese.
133.134 Cream cheese with other foods.
133.136 Washed curd and soaked curd cheese.
133.137 Washed curd cheese for manufacturing.
133.138 Edam cheese.
133.140 Gammelost cheese.
133.141 Gorgonzola cheese.
133.142 Gouda cheese.
133.144 Granular and stirred curd cheese.
133.145 Granular cheese for manufacturing.
133.146 Grated cheeses.
133.147 Grated American cheese food.
133.148 Hard grating cheeses.
133.149 Gruyere cheese.
133.150 Hard cheeses.
133.152 Limburger cheese.
133.153 Monterey cheese and monterey jack cheese.
133.154 High-moisture jack cheese.
133.155 Mozzarella cheese and scamorza cheese.
133.156 Low-moisture mozzarella and scamorza cheese.
133.157 Part-skim mozzarella and scamorza cheese.
133.158 Low-moisture part-skim mozzarella and scamorza cheese.
133.160 Muenster and munster cheese.
133.161 Muenster and munster cheese for manufacturing.
133.162 Neufchatel cheese.
133.164 Nuworld cheese.
133.165 Parmesan and reggiano cheese.
133.167 Pasteurized blended cheese.
133.168 Pasteurized blended cheese with fruits, vegetables, or meats.
133.169 Pasteurized process cheese.
133.170 Pasteurized process cheese with fruits, vegetables, or meats.
133.171 Pasteurized process pimento cheese.
133.173 Pasteurized process cheese food.
133.174 Pasteurized process cheese food with fruits, vegetables, or
meats.
133.175 Pasteurized cheese spread.
133.176 Pasteurized cheese spread with fruits, vegetables, or meats.
133.178 Pasteurized neufchatel cheese spread with other foods.
133.179 Pasteurized process cheese spread.
133.180 Pasteurized process cheese spread with fruits, vegetables, or
meats.
133.181 Provolone cheese.
133.182 Soft ripened cheeses.
133.183 Romano cheese.
133.184 Roquefort cheese, sheep's milk blue-mold, and blue-mold
cheese from sheep's milk.
133.185 Samsoe cheese.
133.186 Sap sago cheese.
133.187 Semisoft cheeses.
133.188 Semisoft part-skim cheeses.
133.189 Skim milk cheese for manufacturing.
133.190 Spiced cheeses.
133.191 Part-skim spiced cheeses.
133.193 Spiced, flavored standardized cheeses.
133.195 Swiss and emmentaler cheese.
133.196 Swiss cheese for manufacturing.
Authority: Secs. 201, 401, 403, 409, 701, 706 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321, 341, 343, 348, 371, 376).
Source: 42 FR 14366, Mar. 15, 1977, unless otherwise noted.
21 CFR 131.206 Subpart A -- General Provisions
21 CFR 133.3 Definitions.
(a) ''Milk'' means the lacteal secretion, practically free from
colostrum, obtained by the complete milking of one or more healthy cows,
which may be clarified and may be adjusted by separating part of the fat
therefrom; concentrated milk, reconstituted milk, and dry whole milk.
Water, in a sufficient quantity to reconstitute concentrated and dry
forms, may be added.
(b) ''Nonfat milk'' means skim milk, concentrated skim milk,
reconstituted skim milk, and nonfat dry milk. Water, in a sufficient
quantity to reconstitute concentrated and dry forms, may be added.
(c) ''Cream'' means cream, reconstituted cream, dry cream, and
plastic cream. Water, in a sufficient quantity to reconstitute
concentrated and dry forms, may be added.
(d) ''Pasteurized'' when used to describe a dairy ingredient means
that every particle of such ingredient shall have been heated in
properly operated equipment to one of the temperatures specified in the
table of this paragraph and held continuously at or above that
temperature for the specified time (or other time/temperature
relationship which has been demonstrated to be equivalent thereto in
microbial destruction):
(e) ''Ultrapasteurized'' when used to describe a dairy ingredient
means that such ingredient shall have been thermally processed at or
above 280 F for at least 2 seconds.
(48 FR 2742, Jan. 21, 1983; 48 FR 11426, Mar. 18, 1983)
21 CFR 133.5 Methods of analysis.
Moisture, milkfat, and phosphatase levels in cheeses will be
determined by the following methods of analysis from ''Official Methods
of Analysis of the Association of Official Analytical Chemists,'' 13th
ed., 1980, which is incorporated by reference (copies are available from
the Association of Official Analytical Chemists, 2200 Wilson Blvd.,
Suite 400, Arlington, VA 22201-3301, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408):
(a) Moisture content -- section 16.233 ''Method I (52) -- Official
Final Action'', under the heading ''Moisture''.
(b) Milkfat content -- section 16.255 ''Fat (60) -- Official Final
Action''.
(c) Phenol equivalent value -- section 16.275 ''Reagents'', section
16.276 ''Sampling'', and section 16.277 ''Determination'', under the
heading ''Residual Phosphatase (27) Official Final Action''.
(d) Milkfat in solids (fat on a dry basis) -- Subtract the percent of
moisture found from 100; divide the remainder into the percent milkfat
found. The quotient, multiplied by 100, shall be considered to be the
percent of milkfat contained in the solids.
(48 FR 2742, Jan. 21, 1983; 48 FR 11426, Mar, 18, 1983, as amended
at 54 FR 24893, June 12, 1989)
21 CFR 133.10 Notice to manufacturers, packers, and distributors of
pasteurized blended cheese, pasteurized process cheese, cheese food,
cheese spread, and related foods.
(a) Definitions and standards of identity have recently been
promulgated under the authority of the Federal Food, Drug, and Cosmetic
Act for a number of foods made in part from cheese, including
pasteurized process cheese; pasteurized process cheese with fruits,
vegetables, or meats; pasteurized blended cheese; pasteurized process
cheese food; pasteurized process cheese spread, and related foods.
These standards prescribe the name for each such food. The act requires
that this name appear on the label. Many of these names consist of
several words. In the past it has been the practice of some
manufacturers to subordinate the words ''pasteurized,'' ''blended,''
''process,'' ''food,'' and ''spread'' to give undue prominence to the
word ''cheese'' and to words naming the variety of cheese involved.
(b) When placing the names of these foods on labels so as to comply
with the requirements of section 403 (a), (f), and (g) of the act, all
the words forming the name specified by a definition and standard of
identity should be given equal prominence. This can readily be
accomplished by printing the specified name of the food in letters of
the same size, color, and style of type, and with the same background.
(c) Where the names of optional ingredients are required to appear on
the label, the designations of all such ingredients should be given
equal prominence. The names of the optional ingredients should appear
prominently and conspicuously but should not be displayed with greater
prominence than the name of the food. The word ''contains'' may precede
the names of the optional ingredients, and when so used will not be
considered as intervening printed matter between name of food and name
of optional ingredients required to be placed on the label.
(d) Where a manufacturer elects to include a label statement of fat
and moisture content, the declaration should be on the basis of the food
as marketed. A fat declaration on a moisture-free basis is likely to be
misleading, and should not be used in labeling.
21 CFR 133.10 Subpart B -- Requirements for Specific Standardized Cheese and Related Products
21 CFR 133.102 Asiago fresh and asiago soft cheese.
(a) Asiago fresh cheese, asiago soft cheese, is the food prepared
from milk and other ingredients specified in this section, by the
procedure set forth in paragraph (b) of this section, or by another
procedure which produces a finished cheese having the same physical and
chemical properties as the cheese produced when the procedure set forth
in paragraph (b) of this section is used. It contains not more than 45
percent of moisture, and its solids contain not less than 50 percent of
milkfat, as determined by the methods prescribed in 133.5 (a), (b), and
(d). It is cured for not less than 60 days.
(b) Milk which may be pasteurized or clarified or both, and which may
be warmed, is subjected to the action of harmless lactic-acid producing
bacteria, present in such milk or added thereto. Harmless artificial
blue or green coloring in a quantity which neutralizes any natural
yellow coloring in the curd may be added. Sufficient rennet, or other
safe and suitable milk-clotting enzyme that produces equivalent curd
formation, or both, with or without purified calcium chloride in a
quantity not more than 0.02 percent (calculated as anhydrous calcium
chloride) of the weight of the milk, is added to set the milk to a
semisolid mass. The mass is cut, stirred, and heated to promote and
regulate separation of the whey from the curd. The whey is drained off.
When the curd is sufficiently firm it is removed from the kettle or
vat, further drained for a short time, packed into hoops, and pressed.
The pressed curd is salted in brine and cured in a well-ventilated room.
During curing the surface of the cheese is occasionally rubbed with a
vegetable oil. A harmless preparation of enzymes of animal or plant
origin capable of aiding in the curing or development of flavor of
asiago fresh cheese may be added during the procedure in such quantity
that the weight of the solids of such preparation is not more than 0.1
percent of the weight of the milk used.
(c) (1) For the purposes of this section, the word ''milk'' means
cow's milk, which may be adjusted by separating part of the fat
therefrom or by adding thereto one or more of the following: Cream,
skim milk, concentrated skim milk, nonfat dry milk, water in a quantity
sufficient to reconstitute any concentrated skim milk or nonfat dry milk
used.
(2) Such milk may be bleached by the use of benzoyl peroxide or a
mixture of benzoyl peroxide with potassium alum, calcium sulfate, and
magnesium carbonate; but the weight of the benzoyl peroxide is not more
than 0.002 percent of the weight of the milk bleached, and the weight of
the potassium alum, calcium sulfate, and magnesium carbonate, singly or
combined, is not more than six times the weight of the benzoyl peroxide
used. If milk is bleached in this manner, sufficient vitamin A is added
to the curd to compensate for the vitamin A or its precursors destroyed
in the bleaching process, and artificial coloring is not used.
(d) Safe and suitable antimycotic agent(s), the cumulative levels of
which shall not exceed current good manufacturing practice, may be added
to the surface of the cheese.
(e) Label declaration: The common or usual name of each of the
ingredients used in the food shall be declared on the label as required
by the applicable sections of Part 101 of this chapter, except that
enzymes of animal, plant, or microbial origin may be declared as
''enzymes''.
(42 FR 14366, Mar. 15, 1977, as amended at 48 FR 49013, Oct. 24,
1983; 49 FR 10093, Mar. 19, 1984)
21 CFR 133.103 Asiago medium cheese.
Asiago medium cheese conforms to the definition and standard of
identity and is subject to the requirements for label statement of
optional ingredients prescribed by 133.102 for asiago fresh cheese,
except that it contains not more than 35 percent moisture, its solids
contain not less than 45 percent of milk fat, and it is cured for not
less than 6 months.
21 CFR 133.104 Asiago old cheese.
Asiago old cheese conforms to the definition and standard of identity
and is subject to the requirements for label statement of optional
ingredients prescribed by 133.102 for asiago fresh cheese, except that
it contains not more than 32 percent moisture, its solids contain not
less than 42 percent of milk fat, and it is cured for not less than 1
year.
21 CFR 133.106 Blue cheese.
(a) Description. (1) Blue cheese is the food prepared by the
procedure set forth in paragraph (a)(2), of this section, or by any
other procedure which produces a finished cheese having the same
physical and chemical properties. It is characterized by the presence
of bluish-green mold, Penicillium roquefortii, throughout the cheese.
The minimum milkfat content is 50 percent by weight of the solids and
the maximum moisture content is 46 percent by weight, as determined by
the methods described in 133.5. The dairy ingredients used may be
pasteurized. Blue cheese is at least 60 days old.
(2) One or more of the dairy ingredients specified in paragraph
(b)(1) of this section may be homogenized, bleached, warmed, and is
subjected to the action of a lactic acid-producing bacterial culture.
One or more of the clotting enzymes specified in paragraph (b)(2) of
this section is added to set the dairy ingredients to a semisolid mass.
The mass is cut into smaller portions and allowed to stand for a time.
The mixed curd and whey is placed in forms permitting further drainage.
While the curd is being placed in forms, spores of the mold Penicillium
roquefortii are added. The forms are turned several times during
drainage. When sufficiently drained, the shaped curd is removed from
the forms and salted with dry salt or brine. Perforations are then made
in the shaped curd, and it is held at a temperature of approximately 50
F. at 90 to 95 percent relative humidity, until the characteristic mold
growth has developed. During storage the surface of the cheese may be
scraped to remove surface growth of undesirable microorganisms.
Antimycotics may be applied to the surface of the whole cheese. One or
more of the other optional ingredients specified in paragraph (b)(3) of
this section may be added during the procedure.
(b) Optional ingredients. The following safe and suitable
ingredients may be used:
(1) Dairy ingredients. Milk, nonfat milk, or cream, as defined in
133.3, used alone or in combination.
(2) Clotting enzymes. Rennet and/or other clotting enzymes of
animal, plant, or microbial origin.
(3) Other optional ingredients. (i) Blue or green color in an amount
to neutralize the natural yellow color of the curd.
(ii) Calcium chloride in an amount not more than 0.02 percent
(calculated as anhydrous calcium chloride) of the weight of the dairy
ingredients, used as a coagulation aid.
(iii) Enzymes of animal, plant, or microbial origin, used in curing
or flavor development.
(iv) Antimycotic agents, applied to the surface of slices or cuts in
consumer-sized packages or to the surface of the bulk cheese during
curing.
(v) Benzoyl peroxide or a mixture of benzoyl peroxide with potassium
alum, calcium sulfate, and magnesium carbonate used to bleach the dairy
ingredients. The weight of the benzoyl peroxide is not more than 0.002
percent of the weight of the milk being bleached, and the weight of the
potassium alum, calcium sulfate, and magnesium carbonate, singly or
combined, is not more than six times the weight of the benzoyl peroxide
used. If milk is bleached in this manner, vitamin A is added to the
curd in such quantity as to compensate for the vitamin A or its
precursors destroyed in the bleaching process, and artificial coloring
is not used.
(vi) Vegetable fats or oils, which may be hydrogenated, used as a
coating for the rind.
(c) Nomenclature. The name of the food is ''blue cheese.''
(d) Label declaration. The common or usual name of each of the
ingredients used in the food shall be declared on the label as required
by the applicable sections of Part 101 of this chapter, except that:
(1) Enzymes of animal, plant, or microbial origin may be declared as
''enzymes''; and
(2) The dairy ingredients may be declared, in descending order of
predominance, by the use of the terms ''milkfat and nonfat milk'' or
''nonfat milk and milkfat'', as appropriate.
(48 FR 2742, Jan. 21, 1983, as amended at 54 FR 32052, Aug. 4, 1989)
21 CFR 133.108 Brick cheese.
(a) Description. (1) Brick cheese is the food prepared from dairy
ingredients and other ingredients specified in this section by the
procedure set forth in paragraph (a)(3) of this section, or by any other
procedure which produces a finished cheese having the same physical and
chemical properties. The minimum milkfat content is 50 percent by
weight of the solids and the maximum moisture content is 44 percent by
weight, as determined by the methods described in 133.5. If the dairy
ingredients used are not pasteurized, the cheese is cured at a
temperature of not less than 35 F for at least 60 days.
(2) If pasteurized dairy ingredients are used, the phenol equivalent
value of 0.25 gram of brick cheese is not more than 5 micrograms as
determined by the method described in 133.5.
(3) One or more of the dairy ingredients specified in paragraph
(b)(1) of this section is brought to a temperature of about 88 F and
subjected to the action of a lactic acid-producing bacterial culutre.
One or more of the clotting enzymes specified in paragraph (b)(2) of
this section is added to set the dairy ingredients to a semisolid mass.
The mass is cut into cubes with sides approximately 3/8 inch long, and
stirred and heated so that the temperature rises slowly to about 96 F.
The stirring is continued until the curd is sufficiently firm. Part of
the whey is then removed, and the mixture diluted with water or salt
brine to control the acidity. The curd is transferred to forms, and
drained. During drainage it is pressed and turned. After drainage the
curd is salted, and the biological curing agents characteristic of brick
cheese are applied to the surface. The cheese is then cured to develop
the characteristics of brick cheese. One or more of the other optional
ingredients specified in paragraph (b)(3) of this section may be added
during the procedure.
(b) Optional ingredients. The following safe and suitable
ingredients may be used:
(1) Dairy ingredients. Milk, nonfat milk, or cream, as defined in
133.3, used alone or in combination.
(2) Clotting enzymes. Rennet and/or other clotting enzymes of
animal, plant, or microbial origin.
(3) Other optional ingredients. (i) Coloring.
(ii) Calcium chloride in an amount not more than 0.02 percent
(calculated as anhydrous calcium chloride) of the weight of the dairy
ingredients, used as a coagulation aid.
(iii) Enzymes of animal, plant, or microbial origin, used in curing
or flavor development.
(iv) Antimycotic agents, the cumulative level of which shall not
exceed current good manufacturing practice, may be added to the surface
of the cheese.
(c) Nomenclature. The name of the food is ''brick cheese''.
(d) Label declaration. The common or usual name of each of the
ingredients used in the food shall be declared on the label as required
by the applicable sections of part 101 of this chapter, except that:
(1) Enzymes of animal, plant, or microbial origin may be declared as
''enzymes''; and
(2) The dairy ingredients may be declared, in descending order of
predominance, by the use of the terms ''milkfat and nonfat milk'' or
''nonfat milk and milkfat'', as appropriate.
(54 FR 32052, Aug. 4, 1989; 54 FR 35756, Aug. 29, 1989)
21 CFR 133.109 Brick cheese for manufacturing.
Brick cheese for manufacturing conforms to the definition and
standard of identity for brick cheese prescribed by 133.108, except
that the dairy ingredients are not pasteurized and curing is not
required.
(54 FR 32053, Aug. 4, 1989)
21 CFR 133.111 Caciocavallo siciliano cheese.
(a) Caciocavallo siciliano cheese is the food prepared from cow's
milk or sheep's milk or goat's milk or mixtures of two or all of these
and other ingredients specified in this section, by the procedure set
forth in paragraph (b) of this section, or by another procedure which
produces a finished cheese having the same physical and chemical
properties as the cheese produced when the procedure set forth in
paragraph (b) of this section is used. It has a stringy texture, and is
made in oblong shapes. It contains not more than 40 percent of
moisture, and its solids contain not less than 42 percent milkfat as
determined by the methods prescribed in 133.5 (a), (b), and (d). It is
cured for not less than 90 days at a temperature of not less than 35 F.
(b) Milk, which may be pasteurized or clarified or both, and which
may be warmed, is subjected to the action of harmless
lactic-acid-producing bacteria, present in such milk or added thereto.
Harmless artificial blue or green coloring in a quantity which
neutralizes any natural yellow coloring in the curd may be added.
Sufficient rennet, rennet paste, extract of rennet paste, or other safe
and suitable milk-clotting enzyme that produces equivalent curd
formation, singly or in any combination (with or without purified
calcium chloride in a quantity not more than 0.02 percent, calculated as
anhydrous calcium chloride, of the weight of the milk) is added to set
the milk to a semisolid mass. The mass is cut, stirred, and heated so
as to promote and regulate the separation of whey from curd. The whey
is drained off, and the curd is removed to another vat containing hot
whey, in which it is soaked for several hours. This whey is withdrawn,
the curd is allowed to mat, and is cut into blocks. These are washed in
hot whey until the desired elasticity is obtained. The curd is removed
from the vat, drained, pressed into oblong forms, dried, and salted in
brine, and cured. It may be paraffined. A harmless preparation of
enzymes of animal or plant origin capable of aiding in the curing or
development of flavor of caciocavallo siciliano cheese may be added
during the procedure, in such quantity that the weight of the solids of
such preparation is not more than 0.1 percent of the weight of the milk
used.
(c)(1) For the purposes of this section, the word ''milk'' means
cow's milk or goat's milk or sheep's milk or mixtures of two or all of
these. Such milk may be adjusted by separating part of the fat
therefrom or (in the case of cow's milk) by adding one or more of the
following: Cream, skim milk, concentrated skim milk, nonfat dry milk;
(in the case of goat's milk) the corresponding products from goat's
milk; (in the case of sheep's milk) the corresponding products from
sheep's milk; water in a quantity sufficient to reconstitute any such
concentrated or dried products used.
(2) Such milk may be bleached by the use of benzoyl peroxide or a
mixture of benzoyl peroxide with potassium alum, calcium sulfate, and
magnesium carbonate; but the weight of the benzoyl peroxide is not more
than 0.002 percent of the weight of the milk bleached, and the weight of
the potassium alum, calcium sulfate, and magnesium carbonate, singly or
combined, is not more than six times the weight of the benzoyl peroxide
used. If milk is bleached in this manner, sufficient vitamin A is added
to the curd to compensate for the vitamin A or its precursors destroyed
in the bleaching process, and artificial coloring is not used.
(d) Safe and suitable antimycotic agent(s), the cumulative levels of
which shall not exceed current good manufacturing practice, may be added
to the cheese during the kneading and stretching process and/or applied
to the surface of the cheese.
(e) When caciocavallo siciliano cheese is made solely from cow's
milk, the name of such cheese is ''Caciocavallo siciliano cheese''.
When made from sheep's milk or goat's milk or mixtures of these, or one
or both of these with cow's milk, the name is followed by the words
''made from ------ '', the blank being filled in with the name or names
of the milks used, in order of predominance by weight.
(f) Label declaration: The common or usual name of each of the
ingredients used in the food shall be declared on the label as required
by the applicable sections of Part 101 of this chapter, except that
enzymes of animal, plant, or microbial origin may be declared as
''enzymes''.
(42 FR 14366, Mar. 15, 1977, as amended at 42 FR 39102, Aug. 2, 1977;
48 FR 49013, Oct. 24, 1983; 49 FR 10093, Mar. 19, 1984)
21 CFR 133.113 Cheddar cheese.
(a) Description. (1) Cheddar cheese is the food prepared by the
procedure set forth in paragraph (a)(3) of this section, or by any other
procedure which produces a finished cheese having the same physical and
chemical properties. The minimum milkfat content is 50 percent by
weight of the solids, and the maximum moisture content is 39 percent by
weight, as determined by the methods described in 133.5. If the dairy
ingredients used are not pasteurized, the cheese is cured at a
temperature of not less than 35 F for at least 60 days.
(2) If pasteurized dairy ingredients are used, the phenol equivalent
value of 0.25 gram of cheddar cheese is not more than 3 micrograms as
determined by the method described in 133.5.
(3) One or more of the dairy ingredients specified in paragraph
(b)(1) of this section may be warmed, treated with hydrogen
peroxide/catalase, and is subjected to the action of a lactic
acid-producing bacterial culture. One or more of the clotting enzymes
specified in paragraph (b)(2) of this section is added to set the dairy
ingredients to a semisolid mass. The mass is so cut, stirred, and
heated with continued stirring, as to promote and regulate the
separation of whey and curd. The whey is drained off, and the curd is
matted into a cohesive mass. The mass is cut into slabs, which are so
piled and handled as to promote the drainage of whey and the development
of acidity. The slabs are then cut into pieces, which may be rinsed by
sprinkling or pouring water over them, with free and continuous
drainage; but the duration of such rinsing is so limited that only the
whey on the surface of such pieces is removed. The curd is salted,
stirred, further drained, and pressed into forms. One or more of the
other optional ingredients specified in paragraph (b)(3) of this section
may be added during the procedure.
(b) Optional ingredients. The following safe and suitable
ingredients may be used:
(1) Dairy ingredients. Milk, nonfat milk, or cream, as defined in
133.3, used alone or in combination.
(2) Clotting enzymes. Rennet and/or other clotting enzymes of
animal, plant, or microbial origin.
(3) Other optional ingredients. (i) Coloring.
(ii) Calcium chloride in an amount not more than 0.02 percent
(calculated as anhydrous calcium chloride) of the weight of the dairy
ingredients, used as a coagulation aid.
(iii) Enzymes of animal, plant, or microbial orgin, used in curing or
flavor development.
(iv) Antimycotic agents, applied to the surface of slices or cuts in
consumer-sized packages.
(v) Hydrogen peroxide, followed by a sufficient quantity of catalase
preparation to eliminate the hydrogen peroxide. The weight of the
hydrogen peroxide shall not exceed 0.05 percent of the weight of the
milk and the weight of the catalase shall not exceed 20 parts per
million of the weight of the milk treated.
(c) Nomenclature. The name of the food is ''cheddar cheese''.
(d) Label declaration. The common or usual name of each of the
ingredients used in the food shall be declared on the label as required
by the applicable sections of Part 101 of this chapter, except that:
(1) Enzymes of animal, plant, or microbial origin may be declared as
''enzymes''; and
(2) The dairy ingredients may be declared, in descending order or
predominance, by the use of the terms ''milkfat and nonfat milk'' or
''nonfat milk and milkfat'', as appropriate.
(48 FR 2743, Jan. 21, 1983; 48 FR 11426, Mar. 18, 1983)
21 CFR 133.114 Cheddar cheese for manufacturing.
Cheddar cheese for manufacturing conforms to the definition and
standard of identity prescribed for cheddar cheese by 133.113, except
that the milk is not pasteurized, curing is not required, and the
provisions of paragraph (b)(3)(iv) of that section do not apply.
(48 FR 2743, Jan. 21, 1983)
21 CFR 133.116 Low sodium cheddar cheese.
Low sodium cheddar cheese is the food prepared from the same
ingredients and in the same manner prescribed in 133.113 for cheddar
cheese and complies with all the provisions of 133.113, including the
requirements for label statement of ingredients, except that:
(a) It contains not more than 96 milligrams of sodium per pound of
finished food.
(b) The name of the food is ''low sodium cheddar cheese''. The
letters in the words ''low sodium'' shall be of the same size and style
of type as the letters in the words ''cheddar cheese'', wherever such
words appear on the label.
(c) If a salt substitute is used, the label shall bear the statement
'' ---------- added as a salt substitute'', the blank being filled in
with the common name or names of the ingredient or ingredients used as a
salt substitute.
(d) Low sodium cheddar cheese is subject to 105.69 of this chapter.
(48 FR 2743, Jan. 21, 1983)
21 CFR 133.118 Colby cheese.
(a) Colby cheese is the food prepared from milk and other ingredients
specified in this section, by the procedure set forth in paragraph (b)
of this section, or by another procedure which produces a finished
cheese having the same physical and chemical properties as the cheese
produced when the procedure set forth in paragraph (b) of this section
is used. It contains not more than 40 percent of moisture, and its
solids contain not less than 50 percent of milkfat, as determined by the
methods prescribed in 133.5 (a), (b), and (d). If the milk used is not
pasteurized, the cheese so made is cured at a temperature of not less
than 35 F for not less than 60 days.
(b) Milk, which may be pasteurized or clarified or both, and which
may be warmed, is subjected to the action of harmless
lactic-acid-producing bacteria, present in such milk or added thereto.
Harmless artificial coloring may be added. Sufficient rennet, or other
safe and suitable milk-clotting enzyme that produces equivalent curd
formation, or both, with or without purified calcium chloride in a
quantity not more than 0.02 percent (calculated as anhydrous calcium
chloride) of the weight of the milk, is added to set the milk to a
semisolid mass. The mass is so cut, stirred, and heated with continued
stirring, as to promote and regulate the separation of whey and curd. A
part of the whey is drained off, and the curd is cooled by adding water,
the stirring being continued so as to prevent the pieces of curd from
matting. The curd is drained, salted, stirred, further drained, and
pressed into forms. A harmless preparation of enzymes of animal or
plant origin capable of aiding in the curing or development of flavor of
colby cheese may be added during the procedure, in such quantity that
the weight of the solids of such preparation is not more than 0.1
percent of the weight of the milk used.
(c) For the purposes of this section:
(1) The word ''milk'' means cow's milk, which may be adjusted by
separating part of the fat therefrom or by adding thereto one or more of
the following: Cream, skim milk, concentrated skim milk, nonfat dry
milk, water, in a quantity sufficient to reconstitute any concentrated
skim milk or nonfat dry milk used.
(2) Milk shall be deemed to have been pasteurized if it has been held
at a temperature of not less than 143 F for a period of not less than
30 minutes, or for a time and at a temperature equivalent thereto in
phosphatase destruction. Colby cheese shall be deemed not to have been
made from pasteurized milk if 0.25 gram shows a phenol equivalent of
more than 3 micrograms when tested by the method prescribed in
133.5(c).
(3) During the cheesemaking process the milk may be treated with
hydrogen peroxide/catalase as provided in 133.113(a)(3).
(d)(1) Colby cheese in the form of slices or cuts may have added to
it a clear aqueous solution prepared by condensing or precipitating wood
smoke in water.
(2) Colby cheese in the form of slices or cuts in consumer-sized
packages may contain an optional mold-inhibiting ingredient consisting
of sorbic acid, potassium sorbate, sodium sorbate, or any combination of
two or more of these, in an amount not to exceed 0.3 percent by weight
calculated as sorbic acid.
(e)(1) If colby cheese has added to it a clear aqueous solution
prepared by condensing or precipitating wood smoke in water as provided
in paragraph (d)(1) of this section, the name of the food is immediately
followed by the words ''with added smoke flavoring'' with all words in
this phrase of the same type size, style, and color without intervening
written, printed, or graphic matter.
(2) If colby cheese in sliced or cut form contains an optional
mold-inhibiting ingredient as specified in paragraph (d)(2) of this
section, the label shall bear the statement '' ------------ added to
retard mold growth'' or '' ------------ added as a preservative'', the
blank being filled in with the common name or names of the
mold-inhibiting ingredient or ingredients used.
(3) Wherever the name of the food appears on the label so
conspicuously as to be easily seen under customary conditions of
purchase, the statement specified in paragraph (e)(2) of this section,
showing the optional ingredient used, shall immediately and
conspicuously precede or follow such name, without intervening written,
printed, or graphic matter except for the statement ''with added smoke
flavoring,'' as set forth in paragraph (e)(1) of this section.
(42 FR 14366, Mar. 15, 1977, as amended at 49 FR 10093, Mar. 19,
1984)
21 CFR 133.119 Colby cheese for manufacturing.
Colby cheese for manufacturing conforms to the definition and
standard of identity prescribed for colby cheese by 133.118, except
that the milk is not pasteurized, curing is not required, and the
provisions of paragraph (d) of that section do not apply.
21 CFR 133.121 Low sodium colby cheese.
Low sodium colby cheese is the food prepared from the same
ingredients and in the same manner prescribed in 133.118 for colby
cheese and complies with all the provisions of 133.118, including the
requirements for label statement of optional ingredients, except that:
(a) Salt is not used. Any safe and suitable ingredient or
combination of ingredients that contains no sodium and that is
recognized as a salt substitute may be used.
(b) Sodium sorbate is not used.
(c) It contains not more than 96 milligrams of sodium per pound of
finished food.
(d) The name of the food is ''low sodium colby cheese''. The letters
in the words ''low sodium'' shall be of the same size and style of type
as the letters in the words ''colby cheese'', wherever such words appear
on the label.
(e) If a salt substitute as provided for in paragraph (a) of this
section is used, the label shall bear the statement '' --------------
added as a salt substitute'', the blank being filled in with the common
name or names of the ingredient or ingredients used as a salt
substitute.
(f) Low sodium colby cheese is subject to 105.69 of this chapter.
21 CFR 133.123 Cold-pack and club cheese.
(a)(1) Cold-pack cheese, club cheese, is the food prepared by
comminuting, without the aid of heat, one or more cheeses of the same or
two or more varieties, except cream cheese, neufchatel cheese, cottage
cheese, lowfat cottage cheese, cottage cheese dry curd, hard grating
cheese, semisoft part-skim cheese, part-skim spiced cheese and skim milk
cheese for manufacturing, into a homogeneous plastic mass. One or more
of the optional ingredients designated in paragraph (c) of this section
may be used.
(2) All cheeses used in a cold-pack cheese are made from pasteurized
milk or are held for not less than 60 days at a temperature of not less
than 35 F before being comminuted.
(3)(i) The moisture content of a cold-pack cheese made from a single
variety of cheese is not more than the maximum moisture content
prescribed by the definition and standard of identity, if any there be,
for the variety of cheese used. If there is no applicable definition
and standard of identity, or if such standard contains no provision as
to maximum moisture content, no water is used in the preparation of the
cold-pack cheese.
(ii) The fat content of the solids of a cold-pack cheese made from a
single variety of cheese is not less than the minimum prescribed by the
definition and standard of identity, if any there be, for the variety of
cheese used, but in no case is less than 47 percent, except that the fat
content of the solids of cold-pack swiss cheese is not less than 43
percent, and the fat content of the solids of cold-pack gruyere cheese
is not less than 45 percent.
(4)(i) The moisture content of a cold-pack cheese made from two or
more varieties of cheese is not more than the arithmetical average of
the maximum moisture contents prescribed by the definitions and
standards of identity, if any there be, for the varieties of cheese
used, but in no case is the moisture content more than 42 percent,
except that the moisture content of a cold-pack cheese made from two or
more of the varieties cheddar cheese, washed curd cheese, colby cheese,
and granular cheese is not more than 39 percent.
(ii) The fat content of the solids of a cold-pack cheese made from
two or more varieties of cheese is not less than the arithmetical
average of the minimum percent of fat prescribed by the definitions and
standards of identity, if any there be, for the varieties of cheese
used, but in no case is less than 47 percent, except that the fat
content of the solids of a cold-pack cheese made from swiss cheese and
gruyere cheese is not less than 45 percent.
(5) Moisture and fat are determined by the methods prescribed in
133.5(a), (b), and (d).
(6) The weight of each variety of cheese in a cold-pack cheese made
from two varieties of cheese is not less than 25 percent of the total
weight of both, except that the weight of blue cheese, nuworld cheese,
roquefort cheese, or gorgonzola cheese is not less than 10 percent of
the total weight of both, and the weight of limburger cheese is not less
than 5 percent of the total weight of both. The weight of each variety
of cheese in a cold-pack cheese made from three or more varieties of
cheese is not less than 15 percent of the total weight of all, except
that the weight of blue cheese, nuworld cheese, roquefort cheese, or
gorgonzola cheese is not less than 5 percent of the total weight of all,
and the weight of limburger cheese is not less than 3 percent of the
total weight of all. These limits do not apply to the quantity of
cheddar cheese, washed curd cheese, colby cheese, and granular cheese in
mixtures which are designated as ''American cheese'' as prescribed in
paragraph (d)(2) of this section. Such mixtures are considered as one
variety of cheese for the purpose of this paragraph (a)(6).
(b) Cold-pack cheese may be smoked, or the cheese or cheeses from
which it is made may be smoked, before comminuting and mixing, or it may
contain substances prepared by condensing or precipitating wood smoke.
(c) The optional ingredients referred to in paragraph (a) of this
section are:
(1) An acidifying agent consisting of one or any mixture of two or
more of the following: A vinegar, lactic acid, citric acid, acetic
acid, and phosphoric acid, in such quantity that the pH of the finished
cold-pack cheese is not below 4.5. For the purposes of this section
vinegar is considered to be acetic acid.
(2) Water.
(3) Salt.
(4) Harmless artificial coloring.
(5) Spices or flavorings, other than any which singly or in
combination with other ingredients simulate the flavor of a cheese of
any age or variety.
(6) Cold-pack cheese in consumer-sized packages may contain an
optional mold-inhibiting ingredient consisting of sorbic acid, potassium
sorbate, sodium sorbate, or any combination of two or more of these, in
an amount not to exceed 0.3 percent by weight, calculated as sorbic acid
or consisting of not more than 0.3 percent by weight of sodium
propionate, calcium propionate, or a combination of sodium propionate
and calcium propionate.
(d)(1) The name of a cold-pack cheese for which a definition and
standard of identity is prescribed by this section is ''Cold-pack ------
cheese'', '' ------ cold-pack cheese'' or '' ------ club cheese'', the
blanks being filled in with the name or names of the varieties of cheese
used, in order of predominance by weight.
(2) If the cold-pack cheese is made of cheddar cheese, washed curd
cheese, colby cheese, or granular cheese or any mixture of two or more
of these, it may be designated ''Cold-pack American cheese''; or when
cheddar cheese, washed curd cheese, colby cheese, granular cheese, or
any mixture of two or more of these is combined with other varieties of
cheese in the cheese ingredient any of such cheeses or such mixture may
be designated as ''American cheese''.
(3) The full name of the food shall appear on the principal display
panel of the label in type of uniform size, style, and color. Wherever
any word or statement emphasizing the name of any ingredient appears on
the label (other than in an ingredient statement as specified in
paragraph (f) of this section) so conspicuously as to be easily seen
under customary conditions of purchase, the full name of the food shall
immediately and conspicuously precede or follow such word or statement
in type of at least the same size as the type used in such word or
statement.
(e) The name of the food shall include a declaration of any
flavoring, including smoke and substances prepared by condensing or
precipitating wood smoke, that characterizes the product as specified in
101.22 of this chapter and a declaration of any spice that
characterizes the product.
(f) The common name of each of the ingredients used shall be declared
on the labels as required by the applicable sections of Part 101 of this
chapter, except that:
(1) Artificial coloring need not be declared.
(2) If the cheese ingredient contains cheddar cheese, washed curd
cheese, colby cheese, granular cheese, or any mixture of two or more of
these, such cheese or such mixture may be designated as ''American
cheese''.
(42 FR 14366, Mar. 15, 1977, as amended at 49 FR 10093, Mar. 19,
1984)
21 CFR 133.124 Cold-pack cheese food.
(a) (1) Cold-pack cheese food is the food prepared by comminuting and
mixing, without the aid of heat, one or more of the optional cheese
ingredients prescribed in paragraph (c) of this section with one or more
of the optional dairy ingredients prescribed in paragraph (d) of this
section, into a homogeneous plastic mass. One or more of the optional
ingredients specified in paragraph (e) of this section may be used.
(2) All cheeses used in a cold-pack cheese food are made from
pasteurized milk, or are held for not less than 60 days at a temperature
of not less than 35 F before being comminuted.
(3) The moisture content of a cold-pack cheese food is not more than
44 percent, and the fat content is not less than 23 percent.
(4) Moisture and fat are determined by the methods prescribed in
133.5 (a), (b), and (d), except that in determining moisture the loss in
weight which occurs in drying for 5 hours, under the conditions
prescribed in such method, is taken as the weight of moisture.
(5) The weight of the cheese ingredient prescribed by paragraph
(a)(1) of this section constitutes not less than 51 percent of the
weight of the finished cold-pack cheese food.
(6) The weight of each variety of cheese in the cold-pack cheese food
made with two varieties of cheese is not less than 25 percent of the
total weight of both, except that the weight of blue cheese, nuworld
cheese, roquefort cheese, gorgonzola cheese, or limburger cheese is not
less than 10 percent of the total weight of both. The weight of each
variety of cheese in the cold-pack cheese food made with three or more
varieties of cheese is not less than 15 percent of the total weight of
all, except that the weight of blue cheese, nuworld cheese, roquefort
cheese, gorgonzola cheese, or limburger cheese is not less than 5
percent of the total weight of all. These limits do not apply to the
quantity of cheddar cheese, washed curd cheese, colby cheese, and
granular cheese in mixtures which are designated as ''American cheese''
as prescribed in paragraph (h)(5) of this section. Such mixtures are
considered as one variety of cheese for the purposes of this paragraph
(a)(6).
(b) Cold-pack cheese food may be smoked, or the cheese or cheeses
from which it is made may be smoked, before comminuting and mixing, or
it may contain substances prepared by condensing or precipitating wood
smoke.
(c) The optional cheese ingredients referred to in paragraph (a) of
this section are: One or more cheeses of the same or two or more
varieties, except that cream cheese, neufchatel cheese, cottage cheese,
creamed cottage cheese, cook cheese, and skim-milk cheese for
manufacturing are not used, and except that semisoft part-skim cheese,
part-skim spiced cheese, and hard grating cheese may not be used, alone
or in combination with each other, as the cheese ingredient.
(d) The optional dairy ingredients referred to in paragraph (a) of
this section are: Cream, milk, skim milk, buttermilk, cheese whey, any
of the foregoing from which part of the water has been removed,
anhydrous milkfat, dehydrated cream, skim milk cheese for manufacturing,
and albumin from cheese whey. All optional dairy ingredients used in
cold-pack cheese food are pasteurized or made from products that have
been pasteurized.
(e) The other optional ingredients referred to in paragraph (a) of
this section are:
(1) An acidifying agent consisting of one or any mixture of two or
more of the following: A vinegar, lactic acid, citric acid, acetic
acid, and phosphoric acid, in such quantity that the pH of the finished
cold-pack cheese food is not below 4.5.
(2) Water.
(3) Salt.
(4) Harmless artificial coloring.
(5) Spices or flavorings, other than any which singly or in
combination with other ingredients simulate the flavor of cheese of any
age or variety.
(6) A sweetening agent consisting of one or any mixture of two or
more of the following: Sugar, dextrose, corn sugar, corn sirup, corn
sirup solids, glucose sirup, glucose sirup solids, maltose, malt sirup,
and hydrolyzed lactose, in a quantity necessary for seasoning.
(7) Cold-pack cheese food in consumer-sized packages may contain an
optional mold-inhibiting ingredient consisting of sorbic acid, potassium
sorbate, sodium sorbate, or any combination of two or more of these, in
an amount not to exceed 0.3 percent by weight, calculated as sorbic acid
or consisting of not more than 0.3 percent by weight of sodium
propionate, calcium propionate, or a combination of sodium propionate
and calcium propionate.
(8) In the preparation of cold-pack cheese food, guar gum or xanthan
gum, or both, may be used, but the total quantity of such ingredient or
combination is not to exceed 0.3 percent of the weight of the finished
food. When one or both such optional ingredients is used, dioctyl
sodium sulfosuccinate complying with the requirements of 172.810 of
this chapter may be used in a quantity not in excess of 0.5 percent by
weight of such ingredient or ingredients.
(f) The name of the food is ''cold-pack cheese food''. The full name
of the food shall appear on the principal display panel of the label in
type of uniform size, style, and color. Wherever any word or statement
emphasizing the name of (other than in an ingredient statement any
ingredient appears on the label as specified in paragraph (h) of this
section) so conspicuously as to be easily seen under customary
conditions of purchase, the full name of the food shall immediately and
conspicuously precede or follow such word or statement in type of at
least the same size as the type used in such word or statement.
(g) The name of the food shall include a declaration of any
flavoring, including smoke and substances prepared by condensing or
precipitating wood smoke, that characterizes the product as specified in
101.22 of this chapter and a declaration of any spice that
characterizes the product.
(h) The common name of each of the ingredients used shall be declared
on the label as required by the applicable sections of Part 101 of this
chapter, except that:
(1) Plastic cream and dried cream may be declared as ''cream''.
(2) Concentrated milk and dried milk may be declared as ''milk''.
(3) Concentrated skim milk and nonfat dry milk may be declared as
''skim milk''.
(4) Cheese whey, concentrated cheese whey, and dried cheese whey may
be declared as ''whey''.
(5) If the cheese ingredient contains cheddar cheese, washed cheese,
colby cheese, granular cheese, or any mixture of two or more of these,
such cheese or such mixture may be designated as ''American cheese''.
(42 FR 14366, Mar. 15, 1977, as amended at 49 FR 10093, Mar. 19,
1984)
21 CFR 133.125 Cold-pack cheese food with fruits, vegetables, or meats.
(a) Cold-pack cheese food with fruits, vegetables, or meats or
mixtures of these is the food which conforms to the definition and
standard of identity, and is subject to the requirements for label
statement of optional ingredients, prescribed for cold-pack cheese food
by 133.124, except that:
(1) Its milk fat content is not less than 22 percent.
(2) It contains one or any mixture of two or more of the following:
Any properly prepared fresh, cooked, canned, or dried vegetable; any
properly prepared cooked or canned meat.
(3) When the added fruits, vegetables, or meats contain fat, the
method prescribed for the determination of fat by 133.5(b) and (d) is
not applicable.
(b) The name of a cold-pack cheese food with fruits, vegetables or
meats is ''Cold-pack cheese food with ------ '', the blank being filled
in with the common or usual name or names of the fruits, vegetables, or
meats used, in order of predominance by weight.
(42 FR 14366, Mar. 15, 1977, as amended at 49 FR 10093, Mar. 19,
1984)
21 CFR 133.127 Cook cheese, koch kaese.
(a) Description. (1) Cook cheese, koch kaese, is the food prepared
by the procedure set forth in paragraph (a)(3) of this section or by any
other procedure which produces a finished cheese having the same
physical and chemical properties. The maximum moisture content is 80
percent by weight, as determined by the method described in 133.5. The
dairy ingredients used may be pasteurized.
(2) The phenol equivalent value of 0.25 gram of cook cheese is not
more than 3 micrograms as determined by the method described in 133.5.
(3) One or more of the dairy ingredients specified in paragraph
(b)(1) of this section may be warmed and is subjected to the action of a
lactic acid-producing bacterial culture. One or more of the clotting
enzymes specified in paragraph (b)(2) of this section is added to set
the dairy ingredients to a semisolid mass. The mass is cut, stirred,
and heated with continued stirring, so as to separate the curd and whey.
The whey is drained from the curd and the curd is cured for 2 or 3
days. It is then heated to a temperature of not less than 180 F until
the hot curd will drop from a ladle with a consistency like that of
honey. The hot cheese is filled into packages and cooled. One or more
of the other optional ingredients specified in paragraph (b)(3) of this
section may be added during the procedure.
(b) Optional ingredients. The following safe and suitable
ingredients may be used:
(1) Dairy ingredients. Nonfat milk as defined in 133.3.
(2) Clotting enzymes. Rennet and/or other clotting enzymes of
animal, plant, or microbial origin.
(3) Other optional ingredients. (i) Calcium chloride in an amount
not more than 0.02 percent (calculated as anhydrous calcium chloride) of
the weight of the dairy ingredients, used as a coagulation aid.
(ii) Culture of white mold.
(iii) Pasteurized cream.
(iv) Caraway seed.
(v) Salt.
(c) Nomenclature. The name of the food is ''cook cheese'' or,
alternatively, ''koch kaese''.
(d) Label declaration. The common or usual name of each of the
ingredients used in the food shall be declared on the label as required
by the applicable sections of Part 101, except that enzymes of animal,
plant, or microbial origin may be declared as ''enzymes''.
(54 FR 32053, Aug. 4, 1989, as amended at 55 FR 51409, Dec. 14, 1990)
21 CFR 133.128 Cottage cheese.
(a) Cottage cheese is the soft uncured cheese prepared by mixing
cottage cheese dry curd with a creaming mixture as provided in paragraph
(b) of this section. The milkfat content is not less than 4 percent by
weight of the finished food, within limits of good manufacturing
practice. The finished food contains not more than 80 percent of
moisture, as determined by the method prescribed in 133.129(a).
(b) The creaming mixture is prepared from safe and suitable
ingredients including, but not limited to, milk or substances derived
from milk. Any ingredients used that are not derived from milk shall
serve a useful function other than building the total solids content of
the finished food, and shall be used in a quantity not greater than is
reasonably required to accomplish their intended effect. The creaming
mixture shall be pasteurized; however, heat labile ingredients, such as
bacterial starters, may be added following pasteurization.
(c) The name of the food consists of the following two phrases which
shall appear together:
(1) The words ''cottage cheese'' which shall appear in type of the
same size and style.
(2) The statement ''not less than ---- percent milkfat'' or '' ----
percent milkfat minimum'', the blank being filled in with the whole
number that is closest to, but does not exceed, the actual fat content
of the product. This statement of fat content shall appear in letters
not less than one-half of the height of the letters in the phrase
specified in paragraph (c)(1) of this section, but in no case less than
one-eighth of an inch in height.
(d) When the optional process described in 133.129(b)(1) (ii) or
(iii) is used to make the cottage cheese dry curd used in cottage
cheese, the label shall bear the statement ''Directly set'' or ''Curd
set by direct acidification''. Wherever the name of the food appears on
the label so conspicuously as to be seen under customary conditions of
purchase, the statement specified in this paragraph, showing the
optional process used, shall immediately and conspicuously precede or
follow such name without intervening written, printed, or graphic
matter.
(e) The common or usual name of each of the ingredients used in the
food shall be declared on the label as required by the applicable
sections of Part 101 of this chapter, except that:
(1) Concentrated milk, dried milk, and reconstituted milk prepared by
addition of water to concentrated milk or dried milk may be declared as
''milk''.
(2) Concentrated skim milk, nonfat dry milk, and reconstituted skim
milk prepared by addition of water to concentrated skim milk or nonfat
dry milk may be declared as ''skim milk''.
(3) Bacterial cultures may be declared by the word ''cultured''
followed by the name of the substrate, e.g., ''made from cultured skim
milk''.
(4) Milk-clotting enzymes may be declared by the word ''enzymes''.
21 CFR 133.129 Dry curd cottage cheese.
(a) Cottage cheese dry curd is the soft uncured cheese prepared by
the procedure set forth in paragraph (b) of this section. The finished
food contains less than 0.5 percent milkfat. It contains not more than
80 percent of moisture, as determined by the method prescribed in
133.5(a).
(b)(1) One or more of the dairy ingredients specified in paragraph
(b)(2) of this section is pasteurized; calcium chloride may be added in
a quantity of not more than 0.02 percent (calculated as anhydrous
calcium chloride) of the weight of the mix; thereafter one of the
following methods is employed:
(i) Harmless lactic-acid-producing bacteria, with or without rennet
and/or other safe and suitable milk-clotting enzyme that produces
equivalent curd formation, are added and it is held until it becomes
coagulated. The coagulated mass may be cut; it may be warmed; it may
be stirred; it is then drained. The curd may be washed with water and
further drained; it may be pressed, chilled, worked, seasoned with
salt; or
(ii) Food grade phosphoric acid, lactic acid, citric acid, or
hydrochloric acid, with or without rennet and/or other safe and suitable
milk-clotting enzyme that produces equivalent curd formation, is added
in such amount as to reach a pH of between 4.5 and 4.7; coagulation to
a firm curd is achieved while heating to a maximum of 120 F without
agitation during a continuous process. The coagulated mass may be cut;
it may be warmed; it may be stirred; it is then drained. The curd is
washed with water, stirred, and further drained. It may be pressed,
chilled, worked, seasoned with salt.
(iii) Food grade acids as provided in paragraph (b)(1)(ii) of this
section, D-Glucono-delta-lactone with or without rennet, and/or other
safe and suitable milk clotting enzyme that produces equivalent curd
formation, are added in such amounts as to reach a final pH value in the
range of 4.5-4.8, and it is held until it becomes coagulated. The
coagulated mass may be cut; it may be warmed; it may be stirred; it
is then drained. The curd is then washed with water, and further
drained. It may be pressed, chilled, worked, and seasoned with salt.
(2) The dairy ingredients referred to in paragraph (b)(1) of this
section are sweet skim milk, concentrated skim milk, and nonfat dry
milk. If concentrated skim milk or nonfat dry milk is used, water may
be added in a quantity not in excess of that removed when the skim milk
was concentrated or dried.
(3) For the purposes of this section the term ''skim milk'' means the
milk of cows from which the milk fat has been separated, and
''concentrated skim milk'' means skim milk from which a portion of the
water has been removed by evaporation.
(c) The name of the food consists of the following two phrases which
shall appear together:
(1) The words ''cottage cheese dry curd'' or alternatively ''dry curd
cottage cheese'' which shall all appear in type of the same size and
style.
(2) The words ''less than 1/2% milkfat'' which shall all appear in
letters not less than one-half of the height of the letters in the
phrase specified in paragraph (c)(1) of this section, but in no case
less than one-eighth of an inch in height.
(d) When either of the optional processes described in paragraph
(b)(1) (ii) or (iii) of this section is used to make cottage cheese dry
curd, the label shall bear the statement ''Directly set'' or ''Curd set
by direct acidification''. Wherever the name of the food appears on the
label so conspicuously as to be seen under customary conditions of
purchase, the statement specified in this paragraph, showing the
optional process used, shall immediately and conspicuously precede or
follow such name without intervening written, printed, or graphic
matter.
(e) The common or usual name of each of the ingredients used in the
food shall be declared on the label as required by the applicable
sections of Part 101 of this chapter, except that:
(1) Concentrated skim milk, nonfat dry milk, and reconstituted skim
milk prepared by addition of water to concentrated skim milk or nonfat
dry milk may be declared as ''skim milk''.
(2) Bacterial cultures may be declared by the word ''cultured''
followed by the name of the substrate, e.g., ''made from cultured skim
milk''.
(3) Milk-clotting enzymes may be declared by the word ''enzymes''.
(42 FR 14366, Mar. 15, 1977, as amended at 47 FR 11826, Mar. 19,
1982; 49 FR 10093, Mar. 19, 1984)
21 CFR 133.131 Lowfat cottage cheese.
Lowfat cottage cheese is the food prepared from the same ingredients
and in the same manner prescribed in 133.128 for cottage cheese and
complies with all the provisions of 133.128 (including requirements for
the label statement of optional ingredients), except that:
(a) Its content of milkfat is not less than 0.5 percent and not more
than 2 percent by weight, within limits of good manufacturing practice.
(b) Its moisture content is not more than 82.5 percent.
(c) The name of the food consists of the following two phrases which
shall appear together:
(1) The words ''lowfat cottage cheese'' which shall appear in type of
the same size and style.
(2) The words '' ------ % milkfat'', the blank being filled in with
the fraction '' 1/2'' or multiple thereof closest to the actual fat
content of the product. This statement of fat content shall appear in
letters not less than one-half of the height of the letters in the
phrase specified in paragraph (c)(1) of this section, but in no case
less than one-eighth of an inch in height.
21 CFR 133.133 Cream cheese.
(a) Description. (1) Cream cheese is the soft, uncured cheese
prepared by the procedure set forth in paragraph (a)(2) of this section,
or by any other procedure which produces a finished cheese having the
same physical and chemical properties. The minimum milkfat content is
33 percent by weight of the finished food, and the maximum moisture
content is 55 percent by weight, as determined by the methods described
in 133.5. The dairy ingredients used are pasteurized.
(2) One or more of the dairy ingredients specified in paragraph
(b)(1) of this section may be homogenized and is subjected to the action
of lactic acid-producing bacterial culture. One or more of the clotting
enzymes specified in paragraph (b)(2) of this section is added to
coagulate the dairy ingredients. The coagulated mass may be warmed and
stirred and it is drained. The moisture content may be adjusted with
one or more of the optional ingredients specified in paragraph
(b)(3)(ii) of this section. The curd may be pressed, chilled, and
worked and it may be heated until it becomes fluid. It may then be
homogenized or otherwise mixed. One or more of the optional dairy
ingredients specified in paragraph (b)(1) and the other optional
ingredients specified in paragraph (b)(3) of this section may be added
during the procedure.
(b) Optional ingredients. The following safe and suitable
ingredients may be used:
(1) Dairy ingredients. Milk, nonfat milk, or cream, as defined in
133.3, used alone or in combination.
(2) Clotting enzymes. Rennet and/or other clotting enzymes of
animal, plant, or microbial origin.
(3) Other optional ingredients. (i) Salt.
(ii) Cheese whey, concentrated cheese whey, dried cheese whey, or
reconstituted cheese whey prepared by addition of water to concentrated
cheese whey or dried cheese whey.
(iii) Stabilizers, in a total amount not to exceed 0.5 percent of the
weight of the finished food, with or without the addition of dioctyl
sodium sulfosuccinate in a maximum amount of 0.5 percent of the weight
of the stabilizer(s) used.
(c) Nomenclature. The name of the food is ''cream cheese''.
(d) Label declaration. The common or usual name of each of the
ingredients used in the food shall be declared on the label as required
by the applicable sections of Part 101 of this chapter, except that:
(1) Enzymes of animal, plant, or microbial original may be declared
as ''enzymes''; and
(2) The dairy ingredients may be declared, in descending order of
predominance, by the use of the terms ''milkfat and nonfat milk'' or
''nonfat milk and milkfat'', as appropriate.
(54 FR 32053, Aug. 4, 1989)
21 CFR 133.134 Cream cheese with other foods.
(a) Description. Cream cheese with other foods is the class of foods
prepared by mixing, with or without the aid of heat, cream cheese with
one or a mixture of two or more types of foods (except other cheeses)
listed in paragraph (b)(1) of this section, in an amount sufficient to
differentiate the mixture from cream cheese. One or more of the other
optional ingredients in paragraph (b)(2) of this section may be used.
The maximum moisture content of the mixture is 60 percent by weight.
The minimum milkfat is 33 percent by weight of the cream cheese and in
no case less than 27 percent of the finished food. The moisture and fat
contents will be determined by the methods described in 133.5, except
that the method for determination of fat content is not applicable when
the added food contains fat.
(b) Optional ingredients. The following safe and suitable optional
ingredients may be used:
(1) Foods. Properly prepared fresh, cooked, canned, or dried fruits
or vegetables; cooked or canned meats, relishes, pickles, or other
suitable foods.
(2) Other optional ingredients. (i) Stabilizers, in a total amount
not to exceed 0.8 percent, with or without the addition of dioctyl
sodium sulfosuccinate in a maximum amount of 0.5 percent of the weight
of the stabilizer(s) used.
(ii) Coloring.
(c) Nomenclature. The name of the food is ''cream cheese with XXXX
'' or, alternatively, ''cream cheese and XXXX '', the blank being filled
in with the name of the foods used in order of predominance by weight.
(d) Labeling. The common or usual name of each of the ingredients
used in the food shall be declared on the label as required by the
applicable sections of Part 101 of this chapter, except that:
(1) Enzymes of animal, plant, or microbial origin may be declared as
''enzymes''; and
(2) The dairy ingredients may be declared, in descending order of
predominance, by the use of the terms ''milkfat and nonfat milk'' or
''nonfat milk and milkfat'', as appropriate.
(54 FR 32053, Aug. 4, 1989)
21 CFR 133.136 Washed curd and soaked curd cheese.
(a) Description. (1) Washed curd, soaked curd cheese is the food
prepared by the procedure set forth in paragraph (a)(3) of this section
or by any other procedure which produces a finished cheese having the
same physical and chemical properties. The minimum milkfat content is
50 percent by weight of the solids and the maximum moisture content is
42 percent by weight, as determined by the methods described in 133.5.
If the dairy ingredients used are not pasteurized, the cheese is cured
at a temperature of not less than 35 F for at least 60 days.
(2) If pasteurized dairy ingredients are used, the phenol equivalent
value of 0.25 gram of washed curd cheese is not more than 3 micrograms
as determined by the method described in 133.5.
(3) One or more of the dairy ingredients specified in paragraph
(b)(1) of this section may be warmed, treated with hydrogen
peroxide/catalase, and is subjected to the action of a lactic
acid-producing bacterial culture. One or more of the clotting enzymes
specified in paragraph (b)(2) of this section is added to set the dairy
ingredients to a semisolid mass. The mass is so cut, stirred, and
heated with continued stirring, as to promote and regulate the
separation of whey and curd. The whey is drained off, and the curd is
matted into a cohesive mass. The mass is cut into slabs, which are so
piled and handled as to promote the drainage of whey and the development
of acidity. The slabs are then cut into pieces, cooled in water, and
soaked therein until the whey is partly extracted and water is absorbed.
The curd is drained, salted, stirred, and pressed into forms. One or
more of the other optional ingredients specified in paragraph (b)(3) of
this section may be added during the procedure.
(b) Optional ingredients. The following safe and suitable
ingredients may be used:
(1) Dairy ingredients. Milk, nonfat milk, or cream, as defined in
133.3, used alone or in combination.
(2) Clotting enzymes. Rennet and/or other clotting enzymes of
animal, plant, or microbial origin.
(3) Other optional ingredients. (i) Coloring.
(ii) Calcium chloride in an amount not more than 0.02 percent
(calculated as anhydrous calcium chloride) of the weight of the dairy
ingredients, used as a coagulation aid.
(iii) Enzymes of animal, plant, or microbial origin, used in curing
or flavor development.
(iv) Antimycotic agents, the cumulative levels of which shall not
exceed current good manufacturing practice, may be added to the surface
of the cheese.
(v) Hydrogen peroxide, followed by a sufficient quantity of catalase
preparation to eliminate the hydrogen peroxide. The weight of the
hydrogen peroxide shall not exceed 0.05 percent of the weight of the
dairy ingredients and the weight of the catalase shall not exeed 20
parts per million of the weight of dairy ingredients treated.
(c) Nomenclature. The name of the food is ''washed curd cheese'' or,
alternatively, ''soaked curd cheese''.
(d) Label declaration. The common or usual name of each of the
ingredients used in the food shall be declared on the label as required
by the applicable sections of Part 101 of this chapter, except that:
(1) Enzymes of animal, plant or microbial origin may be declared as
''enzymes''; and
(2) The dairy ingredients may be declared, in descending order of
predominance, by the use of the terms ''milkfat and nonfat milk'' or
''nonfat milk and milkfat'', as appropriate.
(54 FR 32054, Aug. 4, 1989)
21 CFR 133.137 Washed curd cheese for manufacturing.
Washed curd cheese for manufacturing conforms to the definition and
standard of identity prescribed for washed curd cheese by 133.136,
except that the dairy ingredients are not pasteurized and curing is not
required.
(54 FR 32054, Aug. 4, 1989)
21 CFR 133.138 Edam cheese.
(a) Description. (1) Edam cheese is the food prepared by the
procedure set forth in paragraph (a)(3) of this section or by any other
procedure which produces a finished cheese having the same physical and
chemical properties. The minimum milkfat content is 40 percent by
weight of the solids and the maximum moisture content is 45 percent by
weight, as determined by the methods described in 133.5. If the dairy
ingredients used are not pasturized, the cheese is cured at a
temperature of not less than than 35 F for at least 60 days.
(2) If pasteurized dairy ingredients are used, the phenol equivalent
value of 0.25 gram of edam cheese is not more than 3 micrograms, as
determined by the method described in 133.5.
(3) One or more of the dairy ingredients specified in paragraph
(b)(1) of this section may be warmed and is subjected to the action of a
lactic acid-producing bacterial culture. One or more of the clotting
enzymes specified in paragraph (b)(2) of this section is added to set
the dairy ingredients to a semisolid mass. After coagulation the mass
is cut into small cube-shaped pieces with sides approximately
three-eighths-inch long. The mass is stirred and heated to about 90 F.
and so handled by further stirring, heating, dilution with water or
salt brine, and salting as to promote and regulate the separation of
curd and whey. When the desired curd is obtained, it is transferred to
forms permitting drainage of whey. During drainage the curd is pressed
and turned. After drainage the curd is removed from the forms and is
salted and cured. One or more of the other optional ingredients
specified in paragraph (b)(3) of this section may be added during the
procedures.
(b) Optional ingredients. The following safe and suitable
ingredients may be used:
(1) Dairy ingredients. Milk, nonfat milk, or cream, as defined in
133.3, used alone or in combination.
(2) Clotting enzymes. Rennet and/or other clotting enzymes of
animal, plant, or microbial origin.
(3) Other optional ingredients. (i) Coloring.
(ii) Calcium chloride in an amount not more than 0.02 percent
(calculated as anhydrous calcium chloride) of the weight of the dairy
ingredients, used as a coagulation aid.
(iii) Enzymes of animal, plant, or microbial origin, used in curing
or flavor development.
(iv) Antimycotic agents, the cumulative levels of which shall not
exceed current good manufacturing practice, may be added to the surface
of the cheese.
(c) Nomenclature. The name of the food is ''edam cheese.''
(d) Label declaration. The common or usual name of each of the
ingredients used in the food shall be declared on the label as required
by the applicable sections of Part 101 of this chapter, except that:
(1) Enzymes of animal, plant, or microbial origin may be declared as
''enzymes''; and
(2) The dairy ingredients may be declared, in descending order of
predominance, by the use of the terms ''milkfat and nonfat milk'' or
''nonfat milk and milkfat,'' as appropriate.
(48 FR 2743, Jan. 21, 1983; 48 FR 11426, Mar. 18, 1983, as amended
at 55 FR 6795, Feb. 27, 1990)
21 CFR 133.140 Gammelost cheese.
(a) Description. (1) Gammelost cheese is the food prepared from
nonfat milk, as defined in 133.3, by the procedure set forth in
paragraph (a)(2) of this section, or by any other procedure which
produces a finished cheese having the same physical and chemical
properties. The maximum moisture content is 52 percent by weight, as
determined by the methods described in 133.5.
(2) The dairy ingredients are subjected to the action of a lactic
acid-producing bacterial culture. The development of acidity is
continued until the dairy ingredients coagulate to a semisolid mass.
The mass is stirred and heated until a temperature of about 145 F is
reached, and is held at that temperature for at least 30 minutes. The
whey is drained off and the curd removed and placed in forms and
pressed. The shaped curd is placed in whey and heated for 3 or 4 hours,
and may again be pressed. It is then stored under conditions suitable
for curing.
(b) Nomenclature. The name of the food is ''gammelost cheese''.
(c) Label declaration. The common or usual name of each of the
ingredients used in the food shall be declared on the label as required
by the applicable sections of Part 101 of this chapter.
(54 FR 32054, Aug. 4, 1989)
21 CFR 133.141 Gorgonzola cheese.
(a) Description. (1) Gorgonzola cheese is the food prepared by the
procedure set forth in paragraph (a)(2) of this section or by any other
procedure which produces a finished cheese having the same physical and
chemical properties. It is characterized by the presence of
bluish-green mold, Penicillium roquefortii, throughout the cheese. The
minimum milkfat content is 50 percent by weight of the solids and the
maximum moisture content is 42 percent by weight, as determined by the
methods described in 133.5. The dairy ingredients used may be
pasteurized. Gorgonzola cheese is at least 90 days old.
(2) One or more of the dairy ingredients specified in paragraph
(b)(1) of this section may be warmed and is subjected to the action of a
lactic acid-producing bacterial culture. One or more of the clotting
enzymes specified in paragraph (b)(2) of this section is added to set
the dairy ingredients to a semisolid mass. The mass is cut into smaller
portions and allowed to stand for a time. The mixed curd and whey is
placed into forms permitting further drainage. While being placed in
forms, spores of the mold Penicillium roquefortii are added. The forms
are turned several times during drainage. When sufficiently drained,
the shaped curd is removed from the forms and salted with dry salt or
brine. Perforations are then made in the shaped curd and it is held at
a temperature of approximately 50 F at 90 to 95 percent relative
humidity, until the characteristic mold growth has developed. During
storage, the surface of the cheese may be scraped to remove surface
growth of undesirable microorganisms. One or more of the other optional
ingredients specified in paragraph (b)(3) of this section may be added
during the procedure.
(b) Optional ingredients. The following safe and suitable
ingredients may be used:
(1) Dairy ingredients. Milk, nonfat milk, or cream, as defined in
133.3, or corresponding products of goat origin, used alone or in
combination.
(2) Clotting enzymes. Rennet and/or other clotting enzymes of
animal, plant, or microbial origin.
(3) Other optional ingredients. (i) Blue or green color in an amount
to neutralize the natural yellow color of the curd.
(ii) Calcium chloride in an amount not more than 0.02 percent
(calculated as anhydrous calcium chloride) of the weight of the dairy
ingredients, used as a coagulation aid.
(iii) Enzymes of animal, plant, or microbial origin, used in curing
or flavor development.
(iv) Antimycotic agents, the cumulative levels of which shall not
exceed current good manufacturing practice, may be added to the surface
of the cheese.
(v) Benzoyl peroxide, or a mixture of benzoyl peroxide with potassium
alum, calcium sulfate, and magnesium carbonate used to bleach the dairy
ingredients. The weight of the benzoyl peroxide is not more than 0.002
percent of the weight of the dairy ingredients being bleached, and the
weight of the potassium alum, calcium sulfate, and magnesium carbonate,
singly or combined, is not more than six times the weight of the benzoyl
peroxide used. If the dairy ingredients are bleached in this manner,
vitamin A is added to the curd in such quantity as to compensate for the
vitamin A or its precursors destroyed in the bleaching process, and
artificial coloring is not used.
(vi) Vegetable fats or oil which may be hydrogenated, used as a
coating for the rind.
(c) Nomenclature. The name of the food is ''gorgonzola cheese''.
(d) Label declaration. The common or usual name of each of the
ingredients used in the food shall be declared on the label as required
by the applicable sections of Part 101 of this chapter, except that:
(1) Enzymes of animal, plant, or microbial origin may be declared as
''enzymes''; and
(2) The dairy ingredients may be declared, in descending order of
predominance, by the use of the terms ''milkfat and nonfat milk'' or
''nonfat milk and milkfat'', as appropriate; ''milkfat from goat's milk
and nonfat goat's milk'', etc.
(54 FR 32054, Aug. 4, 1989)
21 CFR 133.142 Gouda cheese.
Gouda cheese conforms to the definition and standard of identity and
complies with the requirements for label declaration of ingredients
prescribed for edam cheese by 133.138, except that the minimum milkfat
content is 46 percent by weight of the solids, as determined by the
methods described in 133.5 and the maximum moisture content is 45
percent by weight.
(48 FR 2744, Jan. 21, 1983)
21 CFR 133.144 Granular and stirred curd cheese.
(a) Description. (1) Granular cheese, stirred curd cheese is the
food prepared by the procedure set forth in paragraph (a)(3) of this
section or by any other procedure which produces a finished cheese
having the same physical and chemical properties. The minimum milkfat
content is 50 percent by weight of the solids and the maximum moisture
content is 39 percent by weight as determined by the methods described
in 133.5. If the dairy ingredients used are not pasteurized, the cheese
is cured at a temperature of not less than 35 F for at least 60 days.
(2) If pasteurized dairy ingredients are used, the phenol equivalent
value of 0.25 gram of granular cheese is not more than 3 micrograms as
determined by the method described in 133.5.
(3) One or more of the dairy ingredients specified in paragraph
(b)(1) of this section may be warmed, treated with hydrogen
peroxide/catalase, and is subjected to the action of a lactic
acid-producing bacterial culture. One or more of the clotting enzymes
specified in paragraph (b)(2) of this section is added to set the dairy
ingredients to a semisolid mass. The mass is so cut, stirred, and
heated with continued stirring, as to promote and regulate the
separation of whey and curd. A part of the whey is drained off. The
curd is then alternately stirred and drained to prevent matting and to
remove whey from curd. The curd is then salted, stirred, drained, and
pressed into forms. One or more of the other optional ingredients
specified in paragraph (b)(3) of this section may be added during the
procedure.
(b) Optional ingredients. The following safe and suitable
ingredients may be used:
(1) Dairy ingredients. Milk, nonfat milk, or cream, as defined in
133.3, used alone or in combination.
(2) Clotting enzymes. Rennet and/or other clotting enzymes of
animal, plant, or microbial origin.
(3) Other optional ingredients. (i) Coloring.
(ii) Calcium chloride in an amount not more than 0.02 percent
(calculated as anhydrous calcium chloride) by weight of the dairy
ingredients, used as a coagulation aid.
(iii) Enzymes of animal, plant, or microbial origin, used in curing
or flavor development.
(iv) Antimycotic agents, the cumulative levels of which shall not
exceed current good manufacturing practice, may be added to the surface
of the cheese.
(v) Hydrogen peroxide, followed by a sufficient quantity of catalase
preparation to eliminate the hydrogen peroxide. The weight of the
hydrogen peroxide shall not exceed 0.05 percent of the weight of the
dairy ingredients and the weight of the catalase shall not exceed 20
parts per million of the weight of the dairy ingredients treated.
(c) Nomenclature. The name of the food is ''granular cheese'' or,
alternatively, ''stirred curd cheese''.
(d) Label declaration. The common or usual name of each of the
ingredients used in the food shall be declared on the label as required
by the applicable sections of Part 101 of this chapter, except that:
(1) Enzymes of animal, plant, or microbial origin may be declared as
''enzymes''; and
(2) The dairy ingredients may be declared, in descending order of
predominance, by the use of the terms ''milkfat and nonfat milk'' or
''nonfat milk and milkfat'', as appropriate.
(54 FR 32055, Aug. 4, 1989)
21 CFR 133.145 Granular cheese for manufacturing.
Granular cheese for manufacturing conforms to the definition and
standard of identity prescribed for granular cheese by 133.144, except
that the dairy ingredients are not pasteurized and curing is not
required.
(54 FR 32056, Aug. 4, 1989)
21 CFR 133.146 Grated cheeses.
(a) Description. Grated cheeses is the class of foods prepared by
grinding, grating, shredding, or otherwise comminuting cheese of one
variety or a mixture of two or more varieties. The cheese varieties
that may be used are those for which there are definitions and standards
of identity, except that cream cheese, neufchatel cheese, cottage
cheese, creamed cottage cheese, cook cheese, and skim milk cheese for
manufacturing may not be used. All cheese ingredients used are either
made from pasteurized milk or held at a temperature of not less than 35
F for at least 60 days. Moisture may be removed from the cheese
ingredients in the manufacture of the finished food, but no moisture is
added. One or more of the optional ingredients specified in paragraph
(c) of this section may be used.
(b) Composition. (1) Each cheese ingredient used is present at a
minimum level of 2 percent of the weight of the finished food.
(2) When one variety of cheese is used, the minimum milkfat content
of the food is not more than 1 percent lower than the minimum prescribed
by the standard of identity for that cheese.
(3) When two or more varieties of cheese are used, the minimum
milkfat content is not more than 1 percent below the arithmetical
average of the minimum fat content percentages prescribed by the
standards of identity for the varieties of cheese used, and in no case
is the milkfat content less than 31 percent.
(4) Milkfat and moisture contents are determined by the methods
described in 133.5.
(c) Optional ingredients. The following safe and suitable
ingredients may be used:
(1) Antimycotics.
(2) Anticaking agents.
(3) Spices.
(4) Flavorings other than those which, singly or in combination with
other ingredients, simulate the flavor of cheese of any age or variety.
(d) Nomenclature. (1) The name of the food is ''grated cheese'' or
''grated cheeses'', as appropriate. The name of the food shall be
accompanied by a declaration of the specific variety of cheese(s) used
in the food and by a declaration indicating the presence of any added
spice or flavoring.
(2) Any cheese varietal names used in the name of the food are those
specified by applicable standards of identity, except that the
designation ''American cheese'' may be used for cheddar, washed curd,
colby, or granular cheese or for any mixture of these cheeses.
(3) The following terms may be used in place of the name of the food
to describe specific types of grated cheese:
(i) If only one variety of cheese is used, the name of the food is
''grated XXXXXX cheese'', the name of the cheese filling the blank.
(ii) If only parmesan and romano cheeses are used and each is present
at a level of not less than 25 percent by weight of the finished food,
the name of the food is ''grated XXXXXX and XXXXXX cheese'', the blanks
being filled with the names ''parmesan'' and ''romano'' in order of
predominance by weight. The name ''reggiano'' may be used for
''parmesan''.
(iii) If a mixture of cheese varieties (not including parmesan or
romano) is used and each variety is present at a level of not less than
25 percent of the weight of the finished food, the name of the food is
''grated XXXXXX cheese'', the blank being filled in with the names of
the varieties in order of predominance by weight.
(iv) If a mixture of cheese varieties in which one or more varieties
(not including parmesan or romano) are each present at a level of not
less than 25 percent by weight of the finished food, and one or more
other varieties (which may include parmesan and romano cheese) are each
present at a level of not less than 2 percent but in the aggregate not
more than 10 percent of the weight of the finished food, the name of the
food is ''grated XXXXXX cheese with other grated cheese'' or ''grated
XXXXXX cheese with other grated cheeses'', as appropriate, the blank
being filled in with the name or names of those cheese varieties present
at levels of not less than 25 percent by weight of the finished food in
order of predominance, in letters not more than twice as high as the
letters in the phrase ''with other grated cheese(s)''.
(4) The following terms may be used in place of ''grated'' to
describe alternative forms of cheese:
(i) ''Shredded'', if the particles of cheese are in the form of
cylinders, shreds, or strings.
(ii) ''Chipped'' or ''chopped'', if the particles of cheese are in
the form of chips.
(e) Label declaration. The common or usual name of each of the
ingredients used in the food shall be declared on the label as required
by the applicable sections of Part 101 of this chapter, except that:
(1) Enzymes of animal, plant, or microbial origin may be declared as
''enzymes''; and
(2) The dairy ingredients may be declared, in descending order of
predominance, by the use of the terms ''milkfat and nonfat milk'' or
''nonfat milk and milkfat'', ''milkfat from goat's milk and nonfat
goat's milk'', ''milkfat from sheep's milk and nonfat sheep's milk'',
etc., as appropriate.
(54 FR 32056, Aug. 4, 1989; 54 FR 35756, Aug. 29, 1989)
21 CFR 133.147 Grated American cheese food.
(a)(1) Grated American cheese food is the food prepared by mixing,
with or without the aid of heat, one or more of the optional cheese
ingredients prescribed in paragraph (b) of this section with one or more
of the optional ingredients prescribed in paragraph (c) of this section,
into a uniformly blended, partially dehydrated, powdered, or granular
mixture.
(2) Grated American cheese food contains not less than 23 percent of
milkfat, as determined by the method prescribed in 133.5(b).
(b) The optional cheese ingredients referred to in paragraph (a) of
this section are cheddar cheese, washed curd cheese, colby cheese, and
granular cheese.
(c) The other optional ingredients referred to in paragraph (a) of
this section are:
(1) Nonfat dry milk.
(2) Dried whey.
(3) An emulsifying agent consisting of one or any mixture of two or
more of the emulsifying ingredients named in 133.173(e)(1), in such
quantity that the weight of the solids thereof is not more than 3
percent of the weight of the grated American cheese food.
(4) An acidifying agent consisting of one or more of the
acid-reacting ingredients named in 133.173(e)(2).
(5) Salt.
(6) Artificial coloring.
(d) The name of the food is ''Grated American cheese food''. The
full name of the food shall appear on the principal display panel of the
label in type of uniform size, style, and color. Wherever any word or
statement emphasizing the name of any ingredient appears on the label
(other than in an ingredient statement as specified in paragraph (e) of
this section) so conspicuously as to be easily seen under customary
conditions of purchase, the full name of the food shall immediately and
conspicuously precede or follow such word or statement in type of at
least the same size as the type used in such word or statement.
(e) The common name of each of the ingredients used shall be declared
on the label as required by the applicable sections of Part 101 of this
chapter, except that cheddar cheese, washed curd cheese, colby cheese,
granular cheese, or any mixture of two or more of these may be
designated ''American cheese''.
(42 FR 14366, Mar. 15, 1977, as amended at 49 FR 10094, Mar. 19,
1984)
21 CFR 133.148 Hard grating cheeses.
(a) The cheeses for which definitions and standards of identity are
prescribed by this section are hard grating cheeses for which
specifically applicable definitions and standards of identity are not
prescribed by other sections of this part. They are made from milk and
the other ingredients specified in this section, by the procedure set
forth in paragraph (b) of this section. They contain not more than 34
percent of moisture, and their solids contain not less than 32 percent
of milkfat, as determined by the methods prescribed in 133.5(a), (b),
and (d). Hard grating cheeses are cured for not less than 6 months.
(b) Milk, which may be pasteurized or clarified or both, and which
may be warmed, is subjected to the action of harmless
lactic-acid-producing bacteria or other harmless flavor-producing
bacteria, present in such milk or added thereto. Sufficient rennet,
rennet paste, extract of rennet paste, or other safe and suitable
milk-clotting enzyme that produces equivalent curd formation, singly or
in any combination (with or without purified calcium chloride in a
quantity not more than 0.02 percent, calculated as anhydrous calcium
chloride, of the weight of the milk) is added to set the milk to a
semisolid mass. Harmless artificial coloring may be added. The mass is
cut into small particles, stirred, and heated. The curd is separated
from the whey, drained, shaped into forms, pressed, salted, and cured.
The rind may be colored or rubbed with vegetable oil or both. A
harmless preparation of enzymes of animal or plant origin capable of
aiding in the curing or development of flavor of hard grating cheese may
be added during the procedure, in such quantity that the weight of the
solids of such preparation is not more than 0.1 percent of the weight of
the milk used.
(c) For the purposes of this section, the word ''milk'' means cow's
milk or goat's milk or sheep's milk or mixtures of two or all of these.
Such milk may be adjusted by separating part of the fat therefrom or (in
the case of cow's milk) by adding one or more of the following: Cream,
skim milk, concentrated skim milk, nonfat dry milk; (in the case of
goat's milk) the corresponding products from goat's milk; (in the case
of sheep's milk) the corresponding products from sheep's milk; water in
a quantity sufficient to reconstitute any such concentrated or dried
products used.
(d) Safe and suitable antimycotic agent(s), the cumulative levels of
which shall not exceed current good manufacturing practice, may be added
to the surface of the cheese.
(e) The name of each hard grating cheese for which a definition and
standard of identity is prescribed by this section is ''Hard grating
cheese'', preceded or followed by:
(1) The specific common or usual name of such hard grating cheese, if
any such name has become generally recognized therefor; or
(2) If no such specific common or usual name has become generally
recognized therefor, an arbitrary or fanciful name that is not false or
misleading in any particular.
(3) When milk other than cow's milk is used, in whole or in part, the
statement ''made from ------ '', the blank being filled in with the name
or names of the milk used, in order of predominance by weight.
(f) Label declaration: The common or usual name of each of the
ingredients used in the food shall be declared on the label as required
by the applicable sections of Part 101 of this chapter, except that:
(1) When milk other than cow's milk is used, in whole or in part, the
common or usual name of each such milk ingredient shall be declared in
order of predominance by weight; and
(2) Enzymes of the animal, plant, or microbial origin may be declared
as ''enzymes''.
(42 FR 14366, Mar. 15, 1977, as amended at 48 FR 49013, Oct. 24,
1983; 49 FR 10094, Mar. 19, 1984)
21 CFR 133.149 Gruyere cheese.
(a) Description. (1) Gruyere cheese is the food prepared by the
procedure set forth in paragraph (a)(3) of this section or by any other
procedure which produces a finished cheese having the same physical and
chemical properties. It contains small holes or eyes. It has a mild
flavor, due in part to the growth of surface-curing agents. The minimum
milkfat content is 45 percent by weight of the solids and the maximum
moisture content is 39 percent by weight, as determined by the methods
described in 133.5. The dairy ingredients used may be pasteurized. The
cheese is at least 90 days old.
(2) If pasteurized dairy ingredients are used, the phenol equivalent
value of 0.25 gram of gruyere cheese is not more than 3 micrograms as
determined by the method described in 133.5.
(3) One or more of the dairy ingredients specified in paragraph
(b)(1) of this section may be warmed and is subjected to the action of
lactic acid-producing and propionic acid-producing bacterial cultures.
One or more of the clotting enzymes specified in paragraph (b)(2) of
this section is added to set the dairy ingredients to a semisolid mass.
The mass is cut into particles similar in size to wheat kernels. For
about 30 minutes the particles are alternately stirred and allowed to
settle. The temperature is raised to about 126 F. Stirring is
continued until the curd becomes firm. The curd is transferred to hoops
or forms, and pressed until the desired shape and firmness are obtained.
The cheese is surface-salted while held at a temperature of 48 to 54
F for a few days. It is soaked for 1 day in a saturated salt solution.
It is then held for 3 weeks in a salting cellar and wiped every 2 days
with brine cloth to insure growth of biological curing agents on the
rind. It is then removed to a heating room and held at progressively
higher temperatures, finally reaching 65 F with a relative humidity of
85 to 90 percent, for several weeks, during which time small holes, or
so-called eyes, form. The cheese is then stored at a lower temperature
for further curing. One or more of the other optional ingredients
specified in paragraph (b)(3) of this section may be added during the
procedure.
(b) Optional ingredients. The following safe and suitable
ingredients may be used:
(1) Dairy ingredients. Milk, nonfat milk, or cream, as defined in
133.3, used alone or in combination.
(2) Clotting enzymes. Rennet and/or other clotting enzymes of
animal, plant, or microbial origin.
(3) Other optional ingredients. (i) Calcium chloride in an amount
not more than 0.02 percent (calculated as anhydrous calcium chloride) of
the weight of the dairy ingredients, used as a coagulation aid.
(ii) Enzymes of animal, plant, or microbial origin, used in curing or
flavor development.
(iii) Antimycotic agents, applied to the surface of slices or cuts in
consumer-sized packages.
(c) Nomenclature. The name of the food is''gruyere cheese''.
(d) Label declaration. The common or usual name of each of the
ingredients used in the food shall be declared on the label as required
by the applicable sections of Part 101 of this chapter, except that:
(1) Enzymes of animal, plant, or microbial origin may be declared as
''enzymes''; and
(2) The dairy ingredients may be declared, in descending order of
predominance, by the use of the terms ''milkfat and nonfat milk'' or
''nonfat milk and milkfat'', as appropriate.
(48 FR 2744, Jan. 21, 1983; 48 FR 11426, Mar. 18, 1983)
21 CFR 133.150 Hard cheeses.
(a) The cheeses for which definitions and standards of identity are
prescribed by this section are hard cheeses for which specifically
applicable definitions and standards of identity are not prescribed by
other sections of this part. They are made from milk and the other
ingredients specified in this section, by the procedure set forth in
paragraph (b) of this section. They contain not more than 39 percent of
moisture, and their solids contain not less than 50 percent of milkfat,
as determined by the methods prescribed in 133.5 (a), (b), and (d). If
the milk used is not pasteurized, the cheese so made is cured at a
temperature of not less than 35 F for not less than 60 days.
(b) Milk, which may be pasteurized or clarified or both, and which
may be warmed, is subjected to the action of harmless
lactic-acid-producing bacteria, with or without other harmless
flavor-producing bacteria, present in such milk or added thereto.
Harmless artificial coloring may be added. Sufficient rennet, rennet
paste, extract of rennet paste, or other safe and suitable milk-clotting
enzyme that produces equivalent curd formation, singly or in any
combination (with or without purified calcium chloride in a quantity not
more than 0.02 percent, calculated as anhydrous calcium chloride, of the
weight of the milk) is added to set the milk to a semisolid mass. The
mass is cut into small particles, stirred, and heated. The curd is
separated from the whey, drained, and shaped into forms, and may be
pressed. The curd is salted at some stage of the manufacturing process.
The shaped curd may be cured. The rind may be coated with paraffin or
rubbed with vegetable oil. A harmless preparation of enzymes of animal
or plant origin capable of aiding in the curing or development of flavor
of hard cheese may be added during the procedure, in such quantity that
the weight of the solids of such preparation is not more than 0.1
percent of the weight of the milk used. Harmless flavor-producing
microorganisms may be added, and curing may be conducted under suitable
conditions for the development of biological curing agents.
(c) For the purposes of this section:
(1) The word ''milk'' means cow's milk or goat's milk or sheep's milk
or mixtures of two or all of these. Such milk may be adjusted by
separating part of the fat therefrom, or (in the case of cow's milk) by
adding one or more of the following: Cream, skim milk, concentrated
skim milk, nonfat dry milk; (in the case of goat's milk) the
corresponding products from goat's milk; (in the case of sheep's milk)
the corresponding products from sheep's milk; water in a quantity
sufficient to reconstitute any concentrated or dried products used.
(2) Milk shall be deemed to have been pasteurized if it has been held
at a temperature of not less than 143 F for a period of not less than
30 minutes, or for a time and at a temperature equivalent thereto in
phosphatase destruction. A hard cheese shall be deemed not to have been
made from pasteurized milk if 0.25 gram shows a phenol equivalent of
more than 3 micrograms when tested by the method prescribed in
133.5(c).
(d) Safe and suitable antimycotic agent(s), the cumulative levels of
which shall not exceed current good manufacturing practice, may be added
to the surface of the cheese.
(e) The name of each hard cheese for which a definition and standard
of identity is prescribed by this section is ''Hard cheese'', preceded
or followed by:
(1) The specific common or unusual name of such hard cheese, if any
such name has become generally recognized therefor; or
(2) If no such specific common or usual name has become generally
recognized, therefor, an arbitrary or fanciful name that is not false or
misleading in any particular.
(3) When milk other than cow's milk is used, in whole or in part, the
statement ''made from ------ '', the blank being filled in with the name
or names of the milk used, in order of predominance by weight.
(f) Label declaration: The common or usual name of each of the
ingredients used in the food shall be declared on the label as required
by the applicable sections of Part 101 of this chapter, except that:
(1) When milk other than cow's milk is used, in whole or in part, the
common or usual name of each such milk ingredient shall be declared in
order of predominance by weight; and
(2) Enzymes of animal, plant, or microbial origin may be declared as
''enzymes''.
(42 FR 14366, Mar. 15, 1977, as amended at 48 FR 49013, Oct. 24,
1983; 49 FR 10094, Mar. 19, 1984)
21 CFR 133.152 Limburger cheese.
(a) Description. (1) Limburger cheese is the food prepared by one of
the procedures set forth in paragraph (a)(3) of this section, or by any
other procedure which produces a finished cheese having the same
physical and chemical properties. The minimum milkfat content is 50
percent by weight of the solids and the maximum moisture content is 50
percent by weight, as determined by the methods described in 133.5. If
the dairy ingredients used are not pasteurized, the cheese is cured at a
temperature of not less than 35 F for at least 60 days.
(2) If pasteurized dairy ingredients are used, the phenol equivalent
value of 0.25 gram of limburger cheese is not more than 4 micrograms as
determined by the method described in 133.5.
(3) One of the following procedures may be followed for producing
limburger cheese:
(i) One or more of the dairy ingredients, unpasteurized, specified in
paragraph (b)(1) of this section is warmed to about 92 F and subjected
to the action of a lactic acid-producing bacterial culture. One or more
of the clotting enzymes specified in paragraph (b)(2) of this section is
added to set the dairy ingredients to a semisolid mass. The mass is cut
into cubes with sides approximately one-half inch long. After a few
minutes the mass is stirred and heated, gradually raising the
temperature to 96 to 98 F. The curd is then allowed to settle, most
of the whey is drained off, and the remaining curd and whey dipped into
molds. During drainage the curd may be pressed. It is turned at
regular intervals. After drainage the curd is cut into pieces of
desired size and dry-salted at intervals for 24 to 48 hours. The cheese
is then cured with frequent applications of a weak brine solution to the
surface, until the proper growth of surface-curing organisms is
obtained. It is then wrapped and held in storage for development of as
much additional flavor as is desired. One or more of the other optional
ingredients specified in paragraph (b)(3) of this section may be added
during the procedure.
(ii) One or more of the dairy ingredients specified in paragraph
(b)(1) of this section is pasteurized, brought to a temperature of 89
to 90 F. after pasteurization, and is subjected to the action of a
lactic acid-producing bacterial culture. The procedure is then the same
as in paragraph (a)(3)(i) of this section, except that heating is to 94
F. After most of the whey is drained off, salt brine at a temperature
of 66 to 70 F is added, so that the pH of the curd is about 4.8. The
mixed curd, whey, and brine is dipped into molds, and the remaining
procedure specified in paragraph (a)(3)(i) of this section is followed.
(b) Optional ingredients. The following safe and suitable
ingredients may be used:
(1) Dairy ingredients. Milk, nonfat milk, or cream, as defined in
133.3, used alone or in combination.
(2) Clotting enzymes. Rennet and/or other clotting enzymes of
animal, plant, or microbial origin.
(3) Other optional ingredients. (i) Coloring.
(ii) Calcium chloride in an amount not more than 0.02 percent
(calculated as anhydrous calcium chloride) by weight of the dairy
ingredients, used as a coagulation aid.
(iii) Enzymes of animal, plant, or microbial origin, used in curing
or flavor development.
(c) Nomenclature. The name of the food is ''limburger cheese''.
(d) Label declaration. The common or usual name of each of the
ingredients used in the food shall be declared on the label as required
by the applicable sections of Part 101 of this chapter, except that:
(1) Enzymes of animal, plant, or microbial origin may be declared as
''enzymes''; and
(2) The dairy ingredients may be declared, in descending order of
predominance, by the use of the terms ''milkfat and nonfat milk'' or
''nonfat milk and milkfat'', as appropriate.
(48 FR 2744, Jan. 21, 1983; 48 FR 11426, Mar. 18, 1983)
21 CFR 133.153 Monterey cheese and monterey jack cheese.
(a) Description. (1) Monterey cheese, monterey jack cheese is the
food prepared by the procedure set forth in paragraph (a)(3) of this
section, or by any other procedure which produces a finished cheese
having the same physical and chemical properties. The minimum milkfat
content is 50 percent by weight of the solids, and the maximum moisture
content is 44 percent by weight, as determined by the methods described
in 133.5. The dairy ingredients used are pasteurized.
(2) The phenol equivalent of 0.25 gram of monterey cheese is not more
than 3 micrograms, as determined by the method described in 133.5.
(3) One or more of the dairy ingredients specified in paragraph
(b)(1) of this section is subjected to the action of a lactic
acid-producing bacterial culture. One or more of the clotting enzymes
specified in paragraph (b)(2) of this section is added to set the dairy
ingredients to a semisolid mass. The mass is so cut, stirred, and
heated with continued stirring, as to promote and regulate the
separation of whey and curd. Part of the whey is drained off, and water
or salt brine may be added. The curd is drained and placed in a muslin
or sheeting cloth, formed into a ball, and pressed; or the curd is
placed in a cheese hoop and pressed. Later, the cloth bandage is
removed, and the cheese may be covered with a suitable coating. One or
more of the other optional ingredients specified in paragraph (b)(3) of
this section may be added during the procedure.
(b) Optional ingredients. The following safe and suitable
ingredients may be used:
(1) Dairy ingredients. Milk, nonfat milk, or cream, as defined in
133.3, used alone or in combination.
(2) Clotting enzymes. Rennet and/or other clotting enzymes of
animal, plant, or microbial origin.
(3) Other optional ingredients. (i) Calcium chloride in an amount
not more than 0.02 percent (calculated as anhydrous calcium chloride) by
weight of the dairy ingredients, used as a coagulation aid.
(ii) Enzymes of animal, plant, or microbial origin, used in curing or
flavor development.
(iii) Salt.
(iv) Antimycotic agents, the cumulative levels of which shall not
exceed current good manufacturing practice, may be added to the surface
of the cheese.
(v) Vegetable oil, with or without rice flour sprinkled on the
surface, used as a coating for the rind.
(c) Nomenclature. The name of the food is ''monterey cheese'' or
alternatively, ''monterey jack cheese''.
(d) Label declaration. The common or usual name of each of the
ingredients used in the food shall be declared on the label as required
by the applicable sections of Part 101 of this chapter, except that:
(1) Enzymes of animal, plant, or microbial origin may be declared as
''enzymes'', and
(2) The dairy ingredients may be declared, in descending order of
predominance, by the use of the terms ''milkfat and nonfat milk'' or
''nonfat milk and milkfat'', as appropriate.
(54 FR 32056, Aug. 4, 1989)
21 CFR 133.154 High-moisture jack cheese.
High-moisture jack cheese conforms to the definition and standard of
identity and is subject to the requirement for label statement of
optional ingredients prescribed for monterey cheese by 133.153, except
that its moisture content is more than 44 percent but less than 50
percent.
21 CFR 133.155 Mozzarella cheese and scamorza cheese.
(a) Description. (1) Mozzarella cheese, scamorza cheese is the food
prepared from dairy ingredients and other ingredients specified in this
section by the procedure set forth in paragraph (a) (3) of this section,
or by any other procedure which produces a finished cheese having the
same physical and chemical properties. It may be molded into various
shapes. The minimum milkfat content is 45 percent by weight of the
solids, and the moisture content is more than 52 percent but not more
than 60 percent by weight as determined by the methods described in
133.5. The dairy ingredients are pasteurized.
(2) The phenol equivalent value of 0.25 gram of mozzarella cheese is
not more than 3 micrograms as determined by the method described in
133.5.
(3) One or more of the dairy ingredients specified in paragraph
(b)(1) of this section is warmed to approximately 88 F (31.1 C) and
subjected to the action of a lactic acid-producing bacterial culture.
One or more of the clotting enzymes specified in paragraph (b)(2) of
this section is added to set the dairy ingredients to a semisolid mass.
The mass is cut, and it may be stirred to facilitate separation of whey
from the curd. The whey is drained, and the curd may be washed with
cold water and the water drained off. The curd may be collected in
bundles for further drainage and for ripening. The curd may be iced, it
may be held under refrigeration, and it may be permitted to warm to room
temperature and ripen further. The curd may be cut. It is immersed in
hot water or heated with steam and is kneaded and stretched until smooth
and free of lumps. It is then cut and molded. The molded curd is
firmed by immersion in cold water and drained. One or more of the other
optional ingredients specified in paragraph (b)(3) of this section may
be added during the procedure.
(b) Optional ingredients. The following safe and suitable
ingredients may be used:
(1) Dairy ingredients. Cow's milk, nonfat milk, or cream, as defined
in 133.3, or the corresponding products of water buffalo origin, except
that cow's milk products are not combined with water buffalo products.
(2) Clotting enzymes. Rennet and/or other clotting enzymes of
animal, plant, or microbial origin.
(3) Other optional ingredients. (i) Vinegar.
(ii) Coloring to mask any natural yellow color in the curd.
(ii) Salt.
(iv) Antimycotics, the cumulative levels of which shall not exceed
current good manufacturing practice, may be added to the cheese during
the kneading and stretching process and/or applied to the surfact of the
cheese.
(c) Nomenclature. The name of the food is ''mozzarella cheese'' or,
alternatively, ''scamorza cheese''. When the food is made with water
buffalo milk, the name of the food is accompanied by the phrase ''made
with water buffalo milk''.
(d) Label declaration. The common or usual name of each of the
ingredients used in the food shall be declared on the lable as required
by the applicable sections of Part 101 of this chapter, except that:
(1) Enzymes of animal, plant, or microbial origin may be declared as
''enzymes''; and
(2) The dairy ingredients may be declared, in descending order of
predominance, by the use of the terms ''milkfat and nonfat milk'' or
''nonfat milk and milkfat'', ''milkfat from water buffalo milk and
nonfat buffalo milk'' or ''nonfat water buffalo milk and milkfat from
water buffalo milk,'' as appropriate.
(53 FR 3743, Feb. 9, 1988)
21 CFR 133.156 Low-moisture mozzarella and scamorza cheese.
(a) Description. (1) Low-moisture mozzarella cheese, low-moisture
scamorza cheese is the food prepared from dairy ingredients and other
ingredients specified in this section by the procedure set forth in
paragraph (a)(3) of this section, or by any other procedure which
produces a finished cheese having the same physical and chemical
properties. It may be molded into various shapes. The minimum milkfat
content is 45 percent by weight of the solids and the moisture content
is more than 45 percent but not more than 52 percent by weight as
determined by the methods described in 133.5. The dairy ingredients are
pasteurized.
(2) The phenol equivalent value of 0.25 gram of low-moisture
mozzarella cheese is not more than 3 micrograms as determined by the
method described in 133.5.
(3) One or more of the dairy ingredients specified in paragraph
(b)(1) of this section may be warmed and is subjected to the action of a
lactic acid-producing bacterial culture. One or more of the clotting
enzymes specified in paragraph (b)(2) of this action is added to set the
dairy ingredients to a semisolid mass. The mass is cut, stirred, and
allowed to stand. It may be reheated and again stirred. The whey is
drained and the curd may be cut and piled to promote further separation
of whey. It may be washed with cold water and the water drained off.
The curd may be collected in bundles for further drainage and for
ripening. The curd may be iced, it may be held under refrigeration, and
it may be permitted to warm to room temperature and ripen further. The
curd may be cut. It is immersed in hot water or heated with steam and
is kneaded and stretched until smooth and free of lumps. It is then cut
and molded. In molding, the curd is kept sufficiently warm to cause
proper sealing of the surface. The molded curd is firmed by immersion
in cold water and drained. One or more of the other optional
ingredients specified in paragraph (b)(3) of this section may be added
during the procedure.
(b) Optional ingredients. The following safe and suitable
ingredients may be used:
(1) Dairy ingredients. Cow's milk, nonfat milk, or cream, as defined
in 133.3, or the corresponding products of water buffalo origin, except
that cow's milk products are not combined with water buffalo products.
(2) Clotting enzymes. Rennet and/or clotting enzymes of animal,
plant, or microbial origin.
(3) Other optional ingredients. (i) Vinegar.
(ii) Coloring to mask any natural yellow color in the curd.
(iii) Salt.
(iv) Calcium chloride in an amount not more than 0.02 percent
(calculated as anhydrous calcium chloride) of the weight of the dairy
ingredients, used as a coagulation aid.
(v) Antimycotics, the cumulative levels of which shall not exceed
current good manufacturing practices, may be added to the cheese during
the kneading and stretching process and/or applied to the surface of the
cheese.
(c) Nomenclature. The names of the food is ''low-moisture mozzarella
cheese'' or, alternatively, ''low-moisture scamorza cheese''. When the
food is made with water buffalo milk, the name of the food is
accompanied by the phrase ''made with water buffalo milk''.
(d) Label declaration. The common or usual name of each of the
ingredients used in the food shall be declared on the label as required
by the applicable sections of Part 101 of the chapter, except that:
(1) Enzymes of animal, plant, or microbial origin may be declared as
''enzymes''; and
(2) The dairy ingredients may be declared, in descending order of
predominance, by the use of the terms ''milkfat and nonfat milk'' or
''nonfat milk and milkfat'', ''milkfat from water buffalo milk and
nonfat water buffalo milk'' or ''nonfat water buffalo ) The dairy
ingredients may be declared, in descending order of predominance, by the
use of the terms ''milkfat and nonfat milk'' or ''nonfat milk and
milkfat'', ''milkfat from water buffalo milk and nonfat water buffalo
milk'' or ''nonfat water buffalo milk and milkfat from water buffalo
milk'', as appropriate.
(53 FR 3743, Feb. 9, 1988)
21 CFR 133.157 Part-skim mozzarella and scamorza cheese.
Part-skim mozzarella cheese, part-skim scamorza cheese conforms to
the definition and standard of identity as prescribed for mozzarella
cheese by 133.155, except that its milk fat content, calculated on the
solids basis, is less than 45 percent but not less than 30 percent.
21 CFR 133.158 Low-moisture part-skim mozzarella and scamorza cheese.
Low moisture part-skim mozzarella cheese, low moisture part-skim
scamorza cheese conforms to the definition and standard of identity and
complies with the requirements for label declaration of optional
ingredients prescribed for low moisture mozzarella cheese, low moisture
scamorza cheese by 133.156, except that its milk fat content,
calculated on the solids basis, is less than 45 percent but not less
than 30 percent.
21 CFR 133.160 Muenster and munster cheese
(a) Description. (1) Muenster cheese, munster cheese, is the food
prepared by the procedure set forth in paragraph (a)(3) of this section
or by any other procedure which produces a finished cheese having the
same physical and chemical properties. The minimum milkfat content is
50 percent by weight of the solids and the maximum moisture content is
46 percent by weight, as determined by the methods decribed in 133.5.
The dairy ingredients used are pasteurized.
(2) The phenol equivalent of 0.25 gram of muenster cheese is not more
than 3 micrograms, as determined by the methods described in 133.5.
(3) One of more of the dairy ingredients specified in paragraph
(b)(1) of this section may be warmed and is subjected to the action of a
harmless lactic acid-producing bacterial culture. One or more of the
clotting enzymes specified in paragraph (b)(2) of this section is added
to set the dairy ingredients to a semisolid mess. After coagulation the
mass is divided into small portions, stirred, and heated, with or
without dilution with water or salt brine, so as to promote and regulate
the separation of whey and curd. The curd is transferred to forms
permitting drainage of the whey. During drainage the curd may be
pressed and turned. After drainage the curd is removed from the forms
and is salted. One or more of the other optional ingredients specified
in paragraph (b)(3) of this section may be added during the procedure.
(b) Optional ingredients. The following safe and suitable
ingredients may be used:
(1) Dairy ingredients. Milk, nonfat milk, or cream, as defined in
133.3, used alone or in combination.
(2) Clotting enzymes. Rennet and/or other clotting enzymes of
animal, plant, or microbial origin.
(3) Other optional ingredients. (i) Coloring.
(ii) Calcium chloride in an amount not more than 0.02 percent
(calculated as anhydrous calcium chloride) of the weight of the dairy
ingredients, used as a coagulation aid.
(iii) Enzymes of animal, plant, or microbial origin used in curing or
flavor development.
(iv) Antimycotic agents, the cumulative levels of which shall not
exceed current good manufacturing practice, may be added to the surface
of the cheese.
(v) Vegetable oil, used as a coating for the rind.
(c) Nomenclature. The name of the food is ''muenster cheese'' or,
alternatively, ''munster cheese''.
(d) Label declaration. The common or usual name of each of the
ingredients used in the food shall be declared on the label as required
by the applicable sections of Part 101 of this chapter, except that:
(1) Enzymes of animal, plant, or microbial origin may be declared as
''enzymes''; and
(2) The dairy ingredients may be declared, in descending order of
predominance, by the use of the terms ''milkfat and nonfat milk'' or
''nonfat milk and milkfat'', as appropriate.
(54 FR 32057, Aug. 4, 1989; 54 FR 35756, Aug. 29, 1989; 54 FR
37531, Sept. 11, 1989)
21 CFR 133.161 Muenster and munster cheese for manufacturing.
Muenster cheese for manufacturing conforms to the definition and
standard of identity for muenster cheese prescribed by 133.160, except
that the dairy ingredients are not pasteurized.
(54 FR 32057, Aug. 4, 1989)
21 CFR 133.162 Neufchatel cheese.
(a) Description. (1) Neufchatel cheese is the soft uncured cheese
prepared by the procedure set forth in paragraph (a)(2) of this section
or by any other procedure which produces a finished cheese having the
same physical and chemical properties. The milkfat content is not less
than 20 percent but less than 33 percent by weight of the finished food
and the maximum moisture content is 65 percent by weight, as determined
by the methods described in 133.5. The dairy ingredients used are
pasteurized.
(2) One or more of the dairy ingredients specified in paragraph
(b)(1) of this section is subjected to the action of a harmless lactic
acid-producing bacterial culture, with or without one or more of the
clotting enzymes specified in paragraph (b)(2) of this section. The
mixture is held until the dairy ingredients coagulate. The coagulated
mass may be warmed and stirred and it is drained. The moisture content
may be adjusted with one of the optional ingredients in paragraph
(b)(3)(ii) of this section. The curd may be pressed, chilled, worked,
and heated until it becomes fluid. It may then be homogenized or
otherwise mixed. One or more of the dairy ingredients specified in
paragraph (b)(1) of this section or the other optional ingredients
specified in paragraph (b)(3) of this section may be added during the
procedure.
(b) Optional ingredients. The following safe and suitable
ingredients may be used:
(1) Dairy ingredients. Milk, nonfat milk, or cream, as defined in
133.3.
(2) Clotting enzymes. Rennet and/or other clotting enzymes of
animal, plant, or microbial origin.
(3) Other optional ingredients. (i) Salt.
(ii) Cheese whey, concentrated cheese whey, dried cheese whey, or
reconstituted cheese whey prepared by addition of water to concentrated
cheese whey or dried cheese whey.
(iii) Stabilizers, in a total amount not to exceed 0.5 percent of the
weight of the finished food, with or without the addition of dioctyl
sodium sulfosuccinate in a maximum amount of 0.5 percent of the weight
of the stabilizer(s) used.
(c) Nomenclature. The name of the food is ''neufchatel cheese''.
(d) Label declaration. The common or usual name of each of the
ingredients used in the food shall be declared on the label as required
by the applicable sections of Part 101 of this chapter, except that:
(1) Enzymes of animal, plant, or microbial origin may be declared as
''enzymes''; and
(2) The dairy ingredients may be declared, in descending order of
predominance, by use of the terms ''milkfat and nonfat milk'' or
''nonfat milk and milkfat'', as appropriate.
(54 FR 32057, Aug. 4, 1989)
21 CFR 133.164 Nuworld cheese.
(a) Description. (1) Nuworld cheese is the food prepared by the
procedure set forth in paragraph (a)(2) of this section or by any other
procedure which produces a finished cheese having the same physical and
chemical properties. It is characterized by the presence of
creamy-white mold, a white mutant of Penicillium roquefortii, throughout
the cheese. The minimum milkfat content is 50 percent by weight of the
solids and the maximum moisture content is 46 percent by weight, as
determined by the methods described in 133.5. The dairy ingredients
used may be pasteurized. Nuworld cheese is at least 60 days old.
(2) One or more of the dairy ingredients specified in paragraph
(b)(1) of this section may be warmed and is subjected to the action of a
lactic acid-producing bacterial culture. One or more of the clotting
enzymes specified in paragraph (b)(2) of this section is added to set
the dairy ingredients to a semisolid mass. The mass is cut into smaller
portions and allowed to stand for a time. The mixed curd and whey is
placed into forms permitting further drainage. While being placed in
forms, spores of a white mutant of the mold Penicillium roquefortii are
added. The forms are turned several times during drainage. When
sufficiently drained, the shaped curd is removed from the forms and
salted with dry salt or brine. Perforations are then made in the shaped
curd and it is held at a temperature of approximately 50 F at 90 to 95
percent relative humidity, until the characteristic mold growth has
developed. During storage, the surface of the cheese may be scraped to
remove surface growth of undesirable microorganisms. One or more of the
other optional ingredients specified in paragraph (b)(3) of this section
may be added during the procedure.
(b) Optional ingredients. The following safe and suitable
ingredients may be used:
(1) Dairy ingredients. Milk, nonfat milk, or cream, as defined in
133.3, used alone or in combination.
(2) Clotting enzymes. Rennet and/or other clotting enzymes of
animal, plant, or microbial origin.
(3) Other optional ingredients. (i) Blue or green color in an amount
to neutralize the natural yellow color of the curd.
(ii) Calcium chloride in an amount not more than 0.02 percent
(calculated as anhydrous calcium chloride) of the weight of the dairy
ingredients, used as a coagulation aid.
(iii) Enzymes of animal, plant, or microbial origin, used in curing
or flavor development.
(c) Nomenclature. The name of the food is ''nuworld cheese''.
(d) Label declaration. The common or usual name of each of the
ingredients used in the food shall be declared on the label as required
by the applicable sections of Part 101 of this chapter, except that:
(1) Enzymes of animal, plant, or microbial origin may be declared as
''enzymes''; and
(2) The dairy ingredients may be declared, in descending order of
predominance, by the use of the terms ''milkfat and nonfat milk'' or
''nonfat milk and milkfat'', as appropriate.
(54 FR 32058, Aug. 4, 1989)
21 CFR 133.165 Parmesan and reggiano cheese.
(a) Parmesan cheese, reggiano cheese, is the food prepared from milk
and other ingredients specified in this section, by the procedure set
forth in paragraph (b) of this section, or by another procedure which
produces a finished cheese having the same physical and chemical
properties as the cheese produced when the procedure set forth in
paragraph (b) of this section is used. It is characterized by a
granular texture and a hard and brittle rind. It grates readily. It
contains not more than 32 percent of moisture, and its solids contain
not less than 32 percent of milkfat, as determined by the methods
prescribed in 133.5 (a), (b), and (d). It is cured for not less than
10 months.
(b) Milk, which may be pasteurized or clarified or both, and which
may be warmed, is subjected to the action of harmless
lactic-acid-producing bacteria, present in such milk or added thereto.
Sufficient rennet, or other safe and suitable milk-clotting enzyme that
produces equivalent curd formation, or both, with or without purified
calcium chloride in a quantity not more than 0.02 percent (calculated as
anhydrous calcium chloride) of the weight of the milk, is added to set
the milk to a semisolid mass. Harmless artificial coloring may be
added. The mass is cut into pieces no larger than wheat kernels,
heated, and stirred until the temperature reaches between 115 F and 125
F. The curd is allowed to settle and is then removed from the kettle
or vat, drained for a short time, placed in hoops, and pressed. The
pressed curd is removed and salted in brine, or dry-salted. The cheese
is cured in a cool, ventilated room. The rind of the cheese may be
coated or colored. A harmless preparation of enzymes of animal or plant
origin capable of aiding in the curing or development of flavor of
parmesan cheese may be added during the procedure, in such quantity that
the weight of the solids of such preparation is not more than 0.1
percent of the weight of the milk used.
(c)(1) For the purposes of this section, the word ''milk'' means
cow's milk, which may be adjusted by separating part of the fat
therefrom or by adding thereto one or more of the following: Cream,
skim milk, concentrated skim milk, nonfat dry milk, water in a quantity
sufficient to reconstitute any concentrated skim milk or nonfat dry milk
used.
(2) Such milk may be bleached by the use of benzoyl peroxide or a
mixture of benzoyl peroxide with potassium alum, calcium sulfate, and
magnesium carbonate; but the weight of the benzoyl peroxide is not more
than 0.002 percent of the weight of the milk bleached, and the weight of
the potassium alum, calcium sulfate, and magnesium carbonate, singly or
combined, is not more than six times the weight of the benzoyl peroxide
used. If milk is bleached in this manner, sufficient vitamin A is added
to the curd to compensate for the vitamin A or its precursors destroyed
in the bleaching process, and artificial coloring is not used.
(d) Safe and suitable antimycotic agent(s), the cumulative levels of
which shall not exceed current good manufacturing practice may be added
to the surface of the cheese.
(e) Label declaration: The common or usual name of each of the
ingredients used in the food shall be declared on the label as required
by the applicable sections of Part 101 of this chapter, except that
enzymes of animal, plant, or microbial origin may be declared as
''enzymes''.
(42 FR 14366, Mar. 15, 1977, as amended at 48 FR 49014, Oct. 24,
1983; 49 FR 10095, Mar. 19, 1984)
21 CFR 133.167 Pasteurized blended cheese.
Pasteurized blended cheese conforms to the definition and standard of
identity, and is subject to the requirements for label statement of
optional ingredients, prescribed for pasteurized process cheese by
133.169, except that:
(a) In mixtures of two or more cheeses, cream cheese or neufchatel
cheese may be used.
(b) None of the ingredients prescribed or permitted for pasteurized
process cheese by 133.169 (c) and (d)(1) is used.
(c) In case of mixtures of two or more cheeses containing cream
cheese or neufchatel cheese, the moisture content is not more than the
arithmetical average of the maximum moisture contents prescribed by the
definitions and standards of identity for the varieties of cheeses
blended, for which such limits have been prescribed.
(d) The word ''process'' is replaced by the word ''blended'' in the
name prescribed by 133.169(e).
21 CFR 133.168 Pasteurized blended cheese with fruits, vegetables, or
meats.
(a) Pasteurized blended cheese with fruits, vegetables, or meats or
mixtures of these is the food which conforms to the definition and
standard of identity, and is subject to the requirements for label
statement of optional ingredients, prescribed for pasteurized blended
cheese by 133.167, except that:
(1) Its moisture content may be 1 percent more, and the milk fat
content of its solids may be 1 percent less, than the limits prescribed
by 133.167 for moisture and milk fat in the corresponding pasteurized
blended cheese.
(2) It contains one or any mixture of two or more of the following:
Any properly prepared cooked, canned, or dried fruit; any properly
prepared cooked, canned, or dried vegetable; any properly prepared
cooked or canned meat.
(3) When the added fruits, vegetables, or meats contain fat, the
method prescribed for the determination of fat by 133.5(b) is not
applicable.
(b) The name of a pasteurized blended cheese with fruits, vegetables,
or meats is the name prescribed by 133.167 for the applicable
pasteurized blended cheese, followed by the term ''with ------ '', the
blank being filled in with the common or usual name or names of the
fruits, vegetables, or meats used, in order of predominance by weight.
(42 FR 14366, Mar. 15, 1977, as amended at 49 FR 10095, Mar. 19,
1977)
21 CFR 133.169 Pasteurized process cheese.
(a)(1) Pasteurized process cheese is the food prepared by comminuting
and mixing, with the aid of heat, one or more cheeses of the same or two
or more varieties, except cream cheese, neufchatel cheese, cottage
cheese, lowfat cottage cheese, cottage cheese dry curd, cook cheese,
hard grating cheese, semisoft part-skim cheese, part-skim spiced cheese,
and skim milk cheese for manufacturing with an emulsifying agent
prescribed by paragraph (c) of this section into a homogeneous plastic
mass. One or more of the optional ingredients designated in paragraph
(d) of this section may be used.
(2) During its preparation, pasteurized process cheese is heated for
not less than 30 seconds at a temperature of not less than 150 F. When
tested for phosphatase by the method prescribed in 133.5(c), the phenol
equivalent of 0.25 gram of pasteurized process cheese is not more than 3
micrograms.
(3)(i) The moisture content of a pasteurized process cheese made from
a single variety of cheese is not more than 1 percent greater than the
maximum moisture content prescribed by the definition and standard of
identity, if any there be, for the variety of cheese used; but in no
case is more than 43 percent, except that the moisture content of
pasteurized process washed curd cheese or pasteurized process colby
cheese is not more than 40 percent; the moisture content of pasteurized
process swiss cheese or pasteurized process gruyere cheese is not more
than 44 percent; and the moisture content of pasteurized process
limburger cheese is not more than 51 percent.
(ii) The fat content of the solids of a pasteurized process cheese
made from a single variety of cheese is not less than the minimum
prescribed by the definition and standard of identity, if any there be,
for the variety of cheese used, but in no case is less than 47 percent;
except that the fat content of the solids of pasteurized process swiss
cheese is not less than 43 percent, and the fat content of the solids of
pasteurized process gruyere cheese is not less than 45 percent.
(4)(i) The moisture content of a pasteurized process cheese made from
two or more varieties of cheese is not more than 1 percent greater than
the arithmetical average of the maximum moisture contents prescribed by
the definitions and standards of identity, if any there be, for the
varieties of cheese used; but in no case is the moisture content more
than 43 percent, except that the moisture content of a pasteurized
process cheese made from two or more of the varieties cheddar cheese,
washed curd cheese, colby cheese, and granular cheese is not more than
40 percent, and the moisture content of a mixture of swiss cheese and
gruyere cheese is not more than 44 percent.
(ii) The fat content of the solids of a pasteurized process cheese
made from two or more varieties of cheese is not less than the
arithmetical average of the minimum fat contents prescribed by the
definitions and standards of identity, if any there be, for the
varieties of cheese used, but in no case is less than 47 percent, except
that the fat content of the solids of a pasteurized process gruyere
cheese made from a mixture of swiss cheese and gruyere cheese is not
less than 45 percent.
(5) Moisture and fat are determined by the methods prescribed in
133.5(a), (b), and (d).
(6) The weight of each variety of cheese in a pasteurized process
cheese made from two varieties of cheese is not less than 25 percent of
the total weight of both, except that the weight of blue cheese, nuworld
cheese, roquefort cheese, or gorgonzola cheese is not less than 10
percent of the total weight of both, and the weight of limburger cheese
is not less than 5 percent of the total weight of both. The weight of
each variety of cheese in a pasteurized process cheese made from three
or more varieties of cheese is not less than 15 percent of the total
weight of all, except that the weight of blue cheese, nuworld cheese,
roquefort cheese, or gorgonzola cheese is not less than 5 percent of the
total weight of all, and the weight of limburger cheese is not less than
3 percent of the total weight of all. These limits do not apply to the
quantity of cheddar cheese, washed curd cheese, colby cheese and
granular cheese in mixtures which are designated as ''American cheese''
as prescribed in paragraph (e)(2)(ii) of this section. Such mixtures
are considered as one variety of cheese for the purposes of this
paragraph (a)(6).
(7) For the purposes of this section, cheddar cheese for
manufacturing, washed curd cheese for manufacturing, colby cheese for
manufacturing, granular cheese for manufacturing, brick cheese for
manufacturing, muenster cheese for manufacturing, and swiss cheese for
manufacturing are considered as cheddar cheese, washed curd cheese,
colby cheese, granular cheese, brick cheese, muenster cheese, and swiss
cheese, respectively.
(b) Pasteurized process cheese may be smoked, or the cheese or
cheeses from which it is made may be smoked, before comminuting and
mixing, or it may contain substances prepared by condensing or
precipitating wood smoke.
(c) The emulsifying agent referred to in paragraph (a) of this
section is one or any mixture of two or more of the following:
Monosodium phosphate, disodium phosphate, dipotassium phosphate,
trisodium phosphate, sodium metaphosphate (sodium hexametaphosphate),
sodium acid pyrophosphate, tetrasodium pyrophosphate, sodium aluminum
phosphate, sodium citrate, potassium citrate, calcium citrate, sodium
tartrate, and sodium potassium tartrate, in such quantity that the
weight of the solids of such emulsifying agent is not more than 3
percent of the weight of the pasteurized process cheese.
(d) The optional ingredients referred to in paragraph (a) of this
section are:
(1) An acidifying agent consisting of one or any mixture of two or
more of the following: A vinegar, lactic acid, citric acid, acetic
acid, and phosphoric acid, in such quantity that the pH of the
pasteurized process cheese is not below 5.3.
(2) Cream, anhydrous milkfat, dehydrated cream, or any combination of
two or more of these, in such quantity that the weight of the fat
derived therefrom is less than 5 percent of the weight of the
pasteurized process cheese.
(3) Water.
(4) Salt.
(5) Harmless artificial coloring.
(6) Spices or flavorings, other than any which singly or in
combination with other ingredients simulate the flavor of a cheese of
any age or variety.
(7) Pasteurized process cheese in the form of slices or cuts in
consumer-sized packages may contain an optional mold-inhibiting
ingredient consisting of not more than 0.2 percent by weight of sorbic
acid, potassium sorbate, sodium sorbate, or any combination of two or
more of these, or consisting of not more than 0.3 percent by weight of
sodium propionate, calcium propionate, or a combination of sodium
propionate and calcium propionate.
(8) Pasteurized process cheese in the form of slices or cuts in
consumer-sized packages may contain lecithin as an optional
anti-sticking agent in an amount not to exceed 0.03 percent by weight of
the finished product.
(9) Safe and suitable enzyme modified cheese.
(e) The name of a pasteurized process cheese for which a definition
and standard of identity is prescribed by this section is as follows:
(1) In case it is made from a single variety of cheese, its name is
''Pasteurized process ------------ cheese'', the blank being filled in
with the name of the variety of cheese used.
(2) In case it is made from two or more varieties of cheese, its name
is ''Pasteurized process ------------ and ------------ cheese'', or
''Pasteurized process ------------ blended with ------------ cheese'',
or ''Pasteurized process blend of ------------ and ------------
cheese'', the blanks being filled in with the names of the varieties of
cheeses used, in order of predominance by weight; except that:
(i) In case it is made from gruyere cheese and swiss cheese, and the
weight of gruyere cheese is not less than 25 percent of the weight of
both, it may be designated ''Pasteurized process gruyere cheese''; and
(ii) In case it is made of cheddar cheese, washed curd cheese, colby
cheese, or granular cheese or any mixture of two or more of these, it
may be designated ''Pasteurized process American cheese''; or when
cheddar cheese, washed curd cheese, colby cheese, granular cheese, or
any mixture of two or more of these is combined with other varieties of
cheese in the cheese ingredient, any of such cheeses or such mixture may
be designated as ''American cheese''.
The full name of the food shall appear on the principal display panel
of the label in type of uniform size, style, and color. Wherever any
word or statement emphasizing the name of any ingredient appears on the
label (other than in an ingredient statement as specified in paragraph
(g) of this section) so conspicuously as to be easily seen under
customary conditions of purchase, the full name of the food shall
immediately and conspicuously precede or follow such word or statement
in type of at least the same size as the type used in such word or
statement.
(f) The name of the food shall include a declaration of any
flavoring, including smoke and substances prepared by condensing or
precipitating wood smoke, that characterizes the product as specified in
101.22 of this chapter and a declaration of any spice that
characterizes the product.
(g) The common name of each of the ingredients used shall be declared
on the label as required by the applicable sections of Part 101 of this
chapter except that:
(1) Artificial coloring need not be declared.
(2) If the cheese ingredient contains cheddar cheese, washed curd
cheese, colby cheese, granular cheese, or any mixture of two or more of
these, such cheese or such mixture may be designated as ''American
cheese''.
(42 FR 14366, Mar. 15, 1977, as amended at 49 FR 10095, Mar. 19,
1984)
21 CFR 133.170 Pasteurized process cheese with fruits, vegetables, or
meats.
(a) Unless a definition and standard of identity specifically
applicable is established by another section of this part, a pasteurized
process cheese with fruits, vegetables, or meats or mixture of these is
a food which conforms to the definition and standard of identity, and is
subject to the requirements for label statement of optional ingredients,
prescribed for pasteurized process cheese by 133.169, except that:
(1) Its moisture content may be 1 percent more, and the milk fat
content of its solids may be 1 percent less than the limits prescribed
by 133.169 for moisture and fat in the corresponding pasteurized
process cheese.
(2) It contains one or any mixture of two or more of the following:
Any properly prepared cooked, canned, or dried fruit; any properly
prepared cooked, canned, or dried vegetable; any properly prepared
cooked or canned meat.
(3) When the added fruits, vegetables, or meats contain fat, the
method prescribed for the determination of fat by 133.5(b) is not
applicable.
(b) The name of a pasteurized process cheese with fruits, vegetables,
or meats is the name prescribed by 133.169 for the applicable
pasteurized process cheese, followed by the term ''with ------------ '',
the blank being filled in with the common or usual name or names of the
fruits, vegetables, or meats used, in order of predominance by weight.
(42 FR 14366, Mar. 15, 1977, as amended at 49 FR 10095, Mar. 19,
1984)
21 CFR 133.171 Pasteurized process pimento cheese.
Pasteurized process pimento cheese is the food which conforms to the
definition and standard of identity for pasteurized process cheese with
fruits, vegetables, or meats, and is subject to the requirement for
label statement of optional ingredients, except that:
(a) Its moisture content is not more than 41 percent, and the fat
content of its solids is not less than 49 percent.
(b) The cheese ingredient is cheddar cheese, washed curd cheese,
colby cheese, granular cheese or any mixture of two or more of these in
any proportion.
(c) For the purposes of this section, cheddar cheese for
manufacturing, washed curd cheese for manufacturing, colby cheese for
manufacturing, and granular cheese for manufacturing shall be considered
as cheddar cheese, washed curd cheese, colby cheese, and granular
cheese, respectively.
(d) The only fruit, vegetable, or meat ingredient is pimentos in such
quantity that the weight of the solids thereof is not less than 0.2
percent of the weight of the finished pasteurized process pimento
cheese.
(e) The optional ingredients designated in 133.169(b) and (d)(6) are
not used.
(f) The mandatory ingredient pimento need not be declared in the
ingredient statement required by 133.169(g).
21 CFR 133.173 Pasteurized process cheese food.
(a)(1) A pasteurized process cheese food is the food prepared by
comminuting and mixing, with the aid of heat, one or more of the
optional cheese ingredients prescribed in paragraph (c) of this section,
with one or more of the optional dairy ingredients prescribed in
paragraph (d) of this section, into a homogeneous plastic mass. One or
more of the optional ingredients specified in paragraph (e) of this
section may be used.
(2) During its preparation, a pasteurized process cheese food is
heated for not less than 30 seconds, at a temperature of not less than
150 F. When tested for phosphatase by the method prescribed in
133.5(c), the phenol equivalent of 0.25 gram of pasteurized process
cheese food is not more than 3 micrograms.
(3) The moisture content of a pasteurized process cheese food is not
more than 44 percent, and the fat content is not less than 23 percent.
(4) Moisture and fat are determined by the methods prescribed in
133.5(a) and (b), except that in determining moisture the loss in weight
which occurs in drying for 5 hours, under the conditions prescribed in
such method, is taken as the weight of the moisture.
(5) The weight of the cheese ingredient prescribed by paragraph
(a)(1) of this section constitutes not less than 51 percent of the
weight of the finished pasteurized process cheese food.
(6) The weight of each variety of cheese in a pasteurized process
cheese food made with two varieties of cheese is not less than 25
percent of the total weight of both, except that the weight of blue
cheese, nuworld cheese, roquefort cheese, gorgonzola cheese, or
limburger cheese is not less than 10 percent of the total weight of
both. The weight of each variety of cheese in a pasteurized process
cheese food made with three or more varieties of cheese is not less than
15 percent of the total weight of all, except that the weight of blue
cheese, nuworld cheese, roquefort cheese, gorgonzola cheese, or
limburger cheese is not less than 5 percent of the total weight of all.
These limits do not apply to the quantity of cheddar cheese, washed curd
cheese, colby cheese, and granular cheese in mixtures which are
designated as ''American cheese'' as prescribed in paragraph (h)(5) of
this section. Such mixtures are considered as one variety of cheese for
the purposes of this subparagraph.
(7) For the purposes of this section, cheddar cheese for
manufacturing, washed curd cheese for manufacturing, colby cheese for
manufacturing, granular cheese for manufacturing, brick cheese for
manufacturing, muenster cheese for manufacturing, and swiss cheese for
manufacturing are considered as cheddar cheese, washed curd cheese,
colby cheese, granular cheese, brick cheese, muenster cheese, and swiss
cheese, respectively.
(b) Pasteurized process cheese food may be smoked, or the cheese or
cheeses from which it is made may be smoked, before comminuting and
mixing, or it may contain substances prepared by condensing or
precipitating wood smoke.
(c) The optional cheese ingredients referred to in paragraph (a) of
this section are one or more cheeses of the same or two or more
varieties, except cream cheese, neufchatel cheese, cottage cheese,
creamed cottage cheese, cook cheese, and skim-milk cheese for
manufacturing, and except that hard grating cheese, semisoft part skim
cheese, and part-skim spiced cheese are not used alone or in combination
with each other as the cheese ingredient.
(d) The optional dairy ingredients referred to in paragraph (a) of
this section are cream, milk, skim milk, buttermilk, cheese whey, any of
the foregoing from which part of the water has been removed, anhydrous
milkfat, dehydrated cream, albumin from cheese whey, and skim milk
cheese for manufacturing.
(e) The other optional ingredients referred to in paragraph (a) of
this section are:
(1) An emulsifying agent consisting of one or any mixture of two or
more of the following: Monosodium phosphate, disodium phosphate,
dipotassium phosphate, trisodium phosphate, sodium metaphosphate (sodium
hexametaphosphate), sodium acid pyrophosphate, tetrasodium
pyrophosphate, sodium aluminum phosphate, sodium citrate, potassium
citrate, calcium citrate, sodium tartrate, and sodium potassium
tartrate, in such quantity that the weight of the solids of such
emulsifying agent is not more than 3 percent of the weight of the
pasteurized process cheese food.
(2) An acidifying agent consisting of one or any mixture of two or
more of the following: A vinegar, lactic acid, citric acid, acetic
acid, and phosphoric acid in such quantity that the pH of the
pasteurized process cheese food is not below 5.0.
(3) Water.
(4) Salt.
(5) Harmless artificial coloring.
(6) Spices or flavorings other than any which singly or in
combination with other ingredients simulate the flavor of cheese of any
age or variety.
(7) Pasteurized process cheese food in the form of slices or cuts in
consumer-sized packages may contain an optional mold-inhibiting
ingredient consisting of not more than 0.2 percent by weight of sorbic
acid, potassium sorbate, sodium sorbate, or any combination of two or
more of these, or consisting of not more than 0.3 percent by weight of
sodium propionate, calcium propionate, or a combination of sodium
propionate and calcium propionate.
(8) Pasteurized process cheese food in the form of slices or cuts in
consumer-sized packages may contain lecithin as an optional
anti-sticking agent in an amount not to exceed 0.03 percent by weight of
the finished product.
(9) Safe and suitable enzyme modified cheese.
(f) The name of the food is ''Pasteurized process cheese food''. The
full name of the food shall appear on the principal display panel of the
label in type of uniform size, style, and color. Wherever any word or
statement emphasizing the name of any ingredient appears on the label
(other than in an ingredient statement as specified in paragraph (h) of
this section) so conspicuously as to be easily seen under customary
conditions of purchase, the full name of the food shall immediately and
conspicuously precede or follow such word or statement in type of at
least the same size as the type used in such word or statement.
(g) The name of the food shall include a declaration of any
flavoring, including smoke and substances prepared by condensing or
precipitating wood smoke, that characterizes the product as specified in
101.22 of this chapter and a declaration of any spice that
characterizes the product.
(h) The common name of each of the ingredients used shall be declared
on the label as required by the applicable sections of Part 101 of this
chapter, except that:
(1) Plastic cream and dried cream may be declared as ''cream''.
(2) Concentrated milk and dried milk may be declared as ''milk''.
(3) Concentrated skim milk and nonfat dry milk may be declared as
''skim milk''.
(4) Cheese whey, concentrated cheese whey, and dried cheese whey may
be declared as ''whey''.
(5) If the cheese ingredient contains cheddar cheese, washed curd
cheese, colby cheese, granular cheese, or any mixture of two or more of
these, such cheese or such mixture may be designated as ''American
cheese''.
(42 FR 14366, Mar. 15, 1977, as amended at 49 FR 10095, Mar. 19,
1984)
21 CFR 133.174 Pasteurized process cheese food with fruits, vegetables,
or meats.
(a) Pasteurized process cheese food with fruits, vegetables, or
meats, or mixtures of these is the food which conforms to the definition
and standard of identity, and is subject to the requirements for label
statement of optional ingredients, prescribed for pasteurized process
cheese food by 133.173, except that:
(1) Its milk fat content is not less than 22 percent.
(2) It contains one or any mixture of two or more of the following:
Any properly prepared cooked, canned, or dried fruit; any properly
prepared cooked, canned, or dried vegetable; any properly prepared
cooked or canned meat.
(3) When the added fruits, vegetables, or meats contain fat, the
method prescribed for the determination of fat by 133.5(b) is not
applicable.
(b) The name of a pasteurized process cheese food with fruits,
vegetables, or meats is ''Pasteurized process cheese food with
------------ '', the blank being filled in with the common or usual name
or names of the fruits, vegetables, or meats used, in order of
predominance by weight.
(c) If the only vegetable ingredient is pimento, and no meat or fruit
ingredient is used, the weight of the solids of such pimentos is not
less than 0.2 percent of the weight of the finished food. The name of
this food is ''Pimento pasteurized process cheese food'' or
''Pasteurized process pimento cheese food''.
(42 FR 14366, Mar. 15, 1977, as amended at 49 FR 10095, Mar. 19,
1984)
21 CFR 133.175 Pasteurized cheese spread.
Pasteurized cheese spread is the food which conforms to the
definition and standard of identity, and is subject to the requirements
of label statement of optional ingredients, prescribed for pasteurized
process cheese spread by 133.179, except that no emulsifying agent as
prescribed by 133.179(e) is used.
21 CFR 133.176 Pasteurized cheese spread with fruits, vegetables, or
meats.
(a) Pasteurized cheese spread with fruits, vegetables, or meats or
mixtures of these is the food which conforms to the definition and
standard of identity and is subject to the requirements for label
statement of optional ingredients prescribed for pasteurized cheese
spread by 133.175, except that:
(1) It contains one or any mixture of two or more of the following:
Any properly prepared cooked, canned, or dried fruit; any properly
prepared cooked, canned, or dried vegetable; any properly prepared
cooked or canned meat.
(2) When the added fruits, vegetables, or meats contain fat, the
method prescribed for the determination of fat by 133.5(b) is not
applicable.
(b) The name of a pasteurized cheese spread with fruits, vegetables,
or meats is ''Pasteurized cheese spread with ------------ '', the blank
being filled in with the name or names of the fruits, vegetables, or
meats used, in order of predominance by weight.
(42 FR 14366, Mar. 15, 1977, as amended at 49 FR 10095, Mar. 19,
1984)
21 CFR 133.178 Pasteurized neufchatel cheese spread with other foods.
(a)(1) Pasteurized neufchatel cheese spread with other foods is the
class of foods each of which is prepared by mixing, with the aid of
heat, neufchatel cheese with one or a mixture of two or more properly
prepared foods (except other cheeses), such as fresh, cooked, canned, or
dried fruits or vegetables; cooked or canned meats; relishes, pickles
or other foods suitable for blending with neufchatel cheese. It may
contain one or any mixture of two or more of the optional ingredients
named in paragraph (b) of this section. The amount of the added food or
foods must be sufficient to so differentiate the blend that it does not
simulate neufchatel cheese. It is spreadable at 70 F.
(2) During its preparation the mixture is heated for not less than 30
seconds at a temperature of not less than 150 F. When tested for
phosphatase by the method prescribed in 133.5(c), the phenol equivalent
of 0.25 gram of such food is not more than 3 micrograms.
(3)(i) No water other than that contained in the ingredients used is
added to this food, but the moisture content in no case is more than 65
percent.
(ii) The milk fat is not less than 20 percent by weight of the
finished food.
(b) The optional ingredients referred to in paragraph (a) of this
section are:
(1)(i) One or any mixture of two or more of the following: Gum
karaya, gum tragacanth, carob bean gum, gelatin, algin (sodium
alginate), propylene glycol alginate, guar gum, sodium
carboxymethylcellulose (cellulose gum), carrageenan, oat gum, or xanthan
gum. The total quantity of any such substances, including that
contained in the neufchatel cheese, is not more than 0.8 percent by
weight of the finished food.
(ii) When one or more of the optional ingredients in paragraph
(b)(1)(i) of this section are used, dioctyl sodium sulfosuccinate
complying with the requirements of 172.810 of this chapter may be used
in a quantity not in excess of 0.5 percent by weight of such
ingredients.
(2) Artificial coloring, unless such addition conceals damage or
inferiority or makes the finished food appear better or of greater value
than it is.
(3) An acidifying agent consisting of one or a mixture of two or more
of the following: A vinegar, acetic acid, lactic acid, citric acid,
phosphoric acid.
(4) A sweetening agent consisting of one or a mixture of two or more
of the following: Sugar, dextrose, corn sirup, corn sirup solids,
glucose sirup, glucose sirup solids, maltose, malt sirup, hydrolyzed
lactose.
(5) Cream, milk, skim milk, buttermilk, cheese whey, any of the
foregoing from which part of the water has been removed, anhydrous
milkfat, dehydrated cream, and albumin from cheese whey.
(c) The name of the food is ''pasteurized Neufchatel cheese spread
with ------------ '' or ''pasteurized Neufchatel cheese spread and
------------ '', the blank being filled in with the common names of the
foods added, in order of predominance by weight. The full name of the
food shall appear on the principal display panel of the label in type of
uniform size, style, and color. Wherever any word or statement
emphasizing the name of any ingredient appears on the label (other than
in an ingredient statement as specified in paragraph (d) of this
section) so conspicuously as to be easily seen under customary
conditions of purchase, the full name of the food shall immediately and
conspicuously precede or follow such word or statement in type of at
least the same size as the type used in such word or statement.
(d) The common name of each of the ingredients used shall be declared
on the label as required by the applicable sections of Part 101 of this
chapter, except that:
(1) Plastic cream and dried cream may be declared as ''cream''.
(2) Concentrated milk and dried milk may be declared as ''milk''.
(3) Concentrated skim milk and nonfat dry milk may be declared as
''skim milk''.
(42 FR 14366, Mar. 15, 1977, as amended at 49 FR 10095, Mar. 19,
1984)
21 CFR 133.179 Pasteurized process cheese spread.
(a)(1) Pasteurized process cheese spread is the food prepared by
comminuting and mixing, with the aid of heat, one or more of the
optional cheese ingredients prescribed in paragraph (c) of this section,
with or without one or more of the optional dairy ingredients prescribed
in paragraph (d) of this section, with one or more of the emulsifying
agents prescribed in paragraph (e) of this section, and with or without
one or more of the optional ingredients prescribed by paragraph (f) of
this section, into a homogeneous plastic mass, which is spreadable at 70
F.
(2) During its preparation, a pasteurized process cheese spread is
heated for not less than 30 seconds at a temperature of not less than
150 F. When tested for phosphatase by the method prescribed in
133.5(c), the phenol equivalent of 0.25 gram of pasteurized process
cheese spread is not more than 3 micrograms.
(3) The moisture content of a pasteurized process cheese spread is
more than 44 percent but not more than 60 percent, and the milk fat
content is not less than 20 percent.
(4) Moisture and fat are determined by the methods prescribed in
133.5(a) and (b), except that in determining moisture the loss in weight
which occurs in drying for 5 hours, under the conditions prescribed in
such method, is taken as the weight of the moisture.
(5) The weight of the cheese ingredient referred to in paragraph
(a)(1) of this section constitutes not less than 51 percent of the
weight of the pasteurized process cheese spread.
(6) The weight of each variety of cheese in a pasteurized process
cheese spread made with two varieties of cheese is not less than 25
percent of the total weight of both, except that the weight of blue
cheese, nuworld cheese, roquefort cheese, gorgonzola cheese, or
limburger cheese is not less than 10 percent of the total weight of
both. The weight of each variety of cheese in a pasteurized process
cheese spread made with three or more varieties of cheese is not less
than 15 percent of the total weight of all, except that the weight of
blue cheese, nuworld cheese, roquefort cheese, gorgonzola cheese, or
limburger cheese is not less than 5 percent of the total weight of all.
These limits do not apply to the quantity of cheddar cheese, washed curd
cheese, colby cheese, and granular cheese in mixtures which are
designated as ''American cheese'' as prescribed in paragraph (i)(5) of
this section. Such mixtures are considered as one variety of cheese for
the purposes of this paragraph (a)(6).
(7) For the purposes of this section, cheddar cheese for
manufacturing, washed curd cheese for manufacturing, colby cheese for
manufacturing, granular cheese for manufacturing, brick cheese for
manufacturing, muenster cheese for manufacturing, and swiss cheese for
manufacturing are considered as cheddar cheese, washed curd cheese,
colby cheese, granular cheese, brick cheese, muenster cheese, and swiss
cheese, respectively.
(b) Pasteurized process cheese spread may be smoked, or the cheese or
cheeses from which it is made may be smoked, before comminuting and
mixing, or it may contain substances prepared by condensing or
precipitating wood smoke.
(c) The optional cheese ingredients referred to in paragraph (a) of
this section are one or more cheeses of the same or two or more
varieties, except that skim-milk cheese for manufacturing may not be
used, and except that cream cheese, neufchatel cheese, cottage cheese,
creamed cottage cheese, cook cheese, hard grating cheese, semisoft
part-skim cheese, and part-skim spiced cheese are not used, alone or in
combination with each other, as the cheese ingredient.
(d) The optional dairy ingredients referred to in paragraph (a) of
this section are cream, milk, skim milk, buttermilk, cheese whey, any of
the foregoing from which part of the water has been removed, anhydrous
milkfat, dehydrated cream, albumin from cheese whey, and skim milk
cheese for manufacturing.
(e) The emulsifying agents prescribed in paragraph (a) of this
section are one or any mixture of two or more of the following:
Monosodium phosphate, disodium phosphate, dipotassium phosphate,
trisodium phosphate, sodium metaphosphate (sodium hexametaphosphate),
sodium acid pyrophosphate, tetrasodium pyrophosphate, sodium aluminum
phosphate, sodium citrate, potassium citrate, calcium citrate, sodium
tartrate, and sodium potassium tartrate, in such quantity that the
weight of the solids of such emulsifying agent is not more than 3
percent of the weight of the pasteurized process cheese spread.
(f) The other optional ingredients referred to in paragraph (a) of
this section are:
(1)(i) One or any mixture of two or more of the following: Carob
bean gum, gum karaya, gum tragacanth, guar gum, gelatin, sodium
carboxymethylcellulose (cellulose gum), carrageenan, oat gum, algin
(sodium alginate), propylene glycol alginate, or xanthan gum. The total
weight of such substances is not more than 0.8 percent of the weight of
the finished food.
(ii) When one or more of the optional ingredients in paragraph
(f)(1)(i) of this section are used, dioctyl sodium sulfosuccinate
complying with the requirements of 172.810 of this chapter may be used
in a quantity not in excess of 0.5 percent by weight of such
ingredients.
(2) An acidifying agent consisting of one or any mixture of two or
more of the following: A vinegar, lactic acid, citric acid, acetic
acid, and phosphoric acid, in such quantity that the pH of the
pasteurized process cheese spread is not below 4.0.
(3) A sweetening agent consisting of one or any mixture of two or
more of the following: Sugar, dextrose, corn sugar, corn sirup, corn
sirup solids, glucose sirup, glucose sirup solids, maltose, malt sirup,
and hydrolyzed lactose, in a quantity necessary for seasoning.
(4) Water.
(5) Salt.
(6) Harmless artificial coloring.
(7) Spices or flavorings other than any which singly or in
combination with other ingredients simulates the flavor of a cheese of
any age or variety.
(8) Pasteurized process cheese spread in consumer-sized packages may
contain an optional mold-inhibiting ingredient consisting of sorbic
acid, potassium sorbate, sodium sorbate, or any combination of two or
more of these, in an amount not to exceed 0.2 percent by weight,
calculated as sorbic acid or consisting of not more than 0.3 percent by
weight of sodium propionate, calcium propionate, or a combination of
sodium propionate and calcium propionate.
(9) Pasteurized process cheese spread in consumer-sized packages may
contain lecithin as an optional anti-sticking agent in an amount not to
exceed 0.03 percent by weight of the finished product.
(10) Safe and suitable enzyme modified cheese.
(11) Nisin preparation in an amount which results in not more than
250 parts per million nisin in the food.
(g) The name of the food is ''pasteurized process cheese spread''.
The full name of the food shall appear on the principal display panel of
the label in type of uniform size, style, and color. Wherever any word
or statement emphasizing the name of any ingredient appears on the label
(other than in an ingredient statement as specified in paragraph (i) of
this section) so conspicuously as to be easily seen under customary
conditions of purchase, the full name of the food shall immediately and
conspicuously precede or follow such word or statement in type of at
least the same size as the type used in such word or statement.
(h) The name of the food shall include a declaration of any
flavoring, including smoke and substances prepared by condensing or
precipitating wood smoke, that characterizes the product as specified in
101.22 of this chapter and a declaration of any spice that
characterizes the product.
(i) The common name of each of the ingredients used shall be declared
on the label as required by the applicable sections of Part 101 of this
chapter, except that:
(1) Plastic cream and dried cream may be declared as ''cream''.
(2) Concentrated milk and dried milk may be declared as ''milk''.
(3) Concentrated skim milk and nonfat dry milk may be declared as
''skim milk''.
(4) Cheese whey, concentrated cheese whey, and dried cheese whey may
be declared as ''whey''.
(5) If the cheese ingredient contains cheddar cheese, washed curd
cheese, colby cheese, granular cheese, or any mixture of two or more of
these, such cheese or such mixture may be designated as ''American
cheese''.
(42 FR 14366, Mar. 15, 1977, as amended at 49 FR 10095, Mar. 19,
1984; 54 FR 6121, Feb. 8, 1989; 54 FR 22741, May 26, 1989)
21 CFR 133.180 Pasteurized process cheese spread with fruits,
vegetables, or meats.
(a) Pasteurized process cheese spread with fruits, vegetables, or
meats or mixtures of these is the food which conforms to the definition
and standard of identity, and is subject to the requirements for label
statement of optional ingredients, prescribed for pasteurized process
cheese spread by 133.179, except that:
(1) It contains one or any mixture of two or more of the following:
Any properly prepared cooked, canned, or dried fruit; any properly
prepared cooked, canned, or dried vegetable; any properly prepared
cooked or canned meat.
(2) When the added fruits, vegetables, or meats contain fat, the
method prescribed for the determination of fat by 133.5(b) is not
applicable.
(b) The name of a pasteurized process cheese spread with fruits,
vegetables, or meats is ''Pasteurized process cheese spread with
------------ '', the blank being filled in with the name or names of the
fruits, vegetables, or meats used, in order of predominance by weight.
(42 FR 14366, Mar. 15, 1977, as amended at 49 FR 10095, Mar. 19,
1984)
21 CFR 133.181 Provolone cheese.
(a) Description. (1) Provolone, a pasta filata or stretched
curd-type cheese, is the food prepared by the procedure set forth in
paragraph (a)(3) of this section, or by any other method which produces
a finished cheese having the same physical and chemical properties. It
has a stringy texture. The minimum milkfat content is 45 percent by
weight of the solids, as determined by the methods described in 133.5
and the maximum moisture content is 45 percent by weight. If the dairy
ingredients used are not pasteurized, the cheese is cured at a
temperature of not less than 35 F for at least 60 days.
(2) If pasteurized dairy ingredients are used, the phenol equivalent
value of 0.25 gram of provolone cheese is not more than 3 micrograms as
determined by the method described in 133.5.
(3) One or more of the dairy ingredients specified in paragraph
(b)(1) of this section may be bleached, warmed, and is subjected to the
action of a lactic acid-producing bacterial culture. One or more of the
clotting enzymes specified in paragraph (b)(2) of this section is added
to set the dairy ingredients to a semisolid mass. The mass is cut,
stirred, and heated so as to promote and regulate the separation of whey
from the curd. The whey is drained off, and the curd is matted and cut,
immersed in hot water, and kneaded and stretched until it is smooth and
free from lumps. Antimycotics may be added to the curd during the
kneading and stretching process. Then it is cut and molded. During the
molding the curd is kept sufficiently warm to cause proper sealing of
the surface. The molded curd is then firmed by immersion in cold water,
salted in brine, and dried. It is given some additional curing.
Provolone cheese may be smoked, and one or more of the other optional
ingredients specified in paragraph (b)(3) of this section may be added
during the procedure.
(b) Optional ingredients. The following safe and suitable
ingredients may be used:
(1) Dairy ingredients. Milk, nonfat milk, or cream, as defined in
133.3, used alone or in combination.
(2) Clotting enzymes. Rennet and/or other clotting enzymes of
animal, plant, or microbial origin.
(3) Other optional ingredients. (i) Blue or green color in an amount
to neutralize the natural yellow color of the curd.
(ii) Calcium chloride in an amount not more than 0.02 percent
(calculated as anhydrous calcium chloride) by weight of the dairy
ingredients, used as a coagulation aid.
(iii) Enzymes of animal, plant, or microbial origin, used in curing
or flavor development.
(iv) Safe and suitable antimycotic agent(s), the cumulative levels of
which shall not exceed current good manufacturing practice, may be added
to the cheese during the kneading and stretching process and/or applied
to the surface of the cheese.
(v) Benzoyl peroxide or a mixture of benzoyl peroxide with potassium
alum, calcium sulfate, and magnesium carbonate used to bleach the dairy
ingredients. The weight of the benzoyl peroxide is not more than 0.002
percent of the weight of the milk being bleached, and the weight of the
potassium alum, calcium sulfate, and magnesium carbonate, singly or
combined, is not more than six times the weight of the benzoyl peroxide
used. If milk is bleached in this manner, vitamin A is added to the
curd in such quantity as to compensate for the vitamin A or its
precursors destroyed in the bleaching process, and artificial coloring
is not used.
(c) Nomenclature. (1) The name of the food is ''provolone cheese''.
The name of the food may include the common name of the shape of the
cheese, such as ''salami provolone''.
(2) One of the following terms, in letters not less than one-half the
height of the letters used in the name of the food, shall accompany the
name of the food wherever it appears on the principal display panel or
panels:
(i) ''Smoked'' if the food has been smoked.
(ii) ''Not smoked'' if the food has not been smoked.
(d) Label declaration. The common or usual name of each of the
ingredients used in the food shall be declared on the label as required
by the applicable sections of Part 101 of this chapter, except that:
(1) Enzymes of animal, plant, or microbial origin may be declared as
''enzymes''; and
(2) The dairy ingredients may be declared, in descending order of
predominance, by the use of the terms ''milkfat and nonfat milk'' or
''nonfat milk and milkfat'', as appropriate.
(48 FR 2745, Jan. 21, 1983, as amended at 48 FR 49014, Oct. 24, 1983)
21 CFR 133.182 Soft ripened cheeses.
(a) The cheeses for which definitions and standards of identity are
prescribed by this section are soft ripened cheeses for which
specifically applicable definitions and standards of identity are not
prescribed by other sections of this part. They are made from milk and
other ingredients specified in this section, by the procedure set forth
in paragraph (b) of this section. Their solids contain not less than 50
percent of milkfat, as determined by the methods prescribed in
133.5(a), (b), and (d). If the milk used is not pasteurized, the cheese
so made is cured at a temperature of not less than 35 F for not less
than 60 days.
(b) Milk, which may be pasteurized or clarified or both, and which
may be warmed, is subjected to the action of harmless
lactic-acid-producing bacteria or other harmless flavor-producing
bacteria, present in such milk or added thereto. Sufficient rennet,
rennet paste, extract of rennet paste, or other safe and suitable
milk-clotting enzyme that produces equivalent curd formation, singly or
in any combination (with or without purified calcium chloride in a
quantity not more than 0.02 percent, calculated as anhydrous calcium
chloride, of the weight of the milk) is added to set the milk to a
semisolid mass. Harmless artificial coloring may be added. After
coagulation the mass is so treated as to promote and regulate the
separation of whey and curd. Such treatment may include one or more of
the following: Cutting, stirring, heating, dilution with water or
brine. The whey, or part of it, is drained off, and the curd is
collected and shaped. It may be placed in forms, and may be pressed.
Harmless flavor-producing microorganisms may be added. It is cured
under conditions suitable for development of biological curing agents on
the surface of the cheese, and the curing is conducted so that the
cheese cures from the surface toward the center. Salt may be added
during the procedure. A harmless preparation of enzymes of animal or
plant origin capable of aiding in the curing or development of flavor of
soft ripened cheeses may be added, in such quantity that the weight of
the solids of such preparation is not more than 0.1 percent of the
weight of the milk used.
(c) For the purposes of this section:
(1) The word ''milk'' means cow's milk or goat's milk or sheep's milk
or mixtures of two or all of these. Such milk may be adjusted by
separating part of the fat therefrom or (in the case of cow's milk) by
adding one or more of the following: Cream, skim milk, concentrated
skim milk, nonfat dry milk; (in the case of goat's milk) the
corresponding products from goat's milk; (in the case of sheep's milk)
the corresponding products from sheep's milk; water, in a quantity
sufficient to reconstitute any such concentrated or dried products used.
(2) Milk shall be deemed to have been pasteurized if it has been held
at a temperature of not less than 143 F for a period of not less than
30 minutes, or for a time and at a temperature equivalent thereto in
phosphatase destruction.
(d) The name of each soft ripened cheese for which a definition and
standard of identity is prescribed by this section is ''Soft ripened
cheese'', preceded or followed by:
(1) The specific common or usual name of such soft ripened cheese, if
any such name has become generally recognized therefor; or
(2) If no such specific common or usual name has become generally
recognized therefor, an arbitrary or fanciful name which is not false or
misleading in any particular.
(e) When milk other than cow's milk is used in whole or in part, the
name of the cheese includes the statement ''made from ------------ '',
the blank being filled in with the name or names of the milk used, in
order of predominance by weight.
(42 FR 14366, Mar. 15, 1977, as amended at 49 FR 10095, Mar. 19,
1984)
21 CFR 133.183 Romano cheese.
(a) Romano cheese is the food prepared from cow's milk or sheep's
milk or goat's milk or mixtures of two or all of these and other
ingredients specified in this section, by the procedure set forth in
paragraph (b) of this section, or by another procedure which produces a
finished cheese having the same physical and chemical properties as the
cheese produced when the procedure set forth in paragraph (b) of this
section is used. It grates readily, and has a granular texture and a
hard and brittle rind. It contains not more than 34 percent of
moisture, and its solids contain not less than 38 percent of milkfat, as
determined by the methods prescribed in 133.5(a), (b), and (d). It is
cured for not less than 5 months.
(b) Milk, which may be pasteurized or clarified or both, and which
may be warmed, is subjected to the action of harmless
lactic-acid-producing bacteria present in such milk or added thereto.
Harmless artificial blue or green coloring in a quantity which
neutralizes any natural yellow coloring in the curd may be added.
Rennet, rennet paste, extract of rennet paste, or other safe and
suitable milk-clotting enzyme that produces equivalent curd formation,
singly or in any combination (with or without purified calcium chloride
in a quantity not more than 0.02 percent, calculated as anhydrous
calcium chloride, of the weight of the milk) is added to set the milk to
be a semisolid mass. The mass is cut into particles no larger than corn
kernels, stirred, and heated to a temperature of about 120 F. The curd
is allowed to settle to the bottom of the kettle or vat, and is then
removed and drained for a short time, packed in forms or hoops, and
pressed. The pressed curd is salted by immersing in brine for about 24
hours and is then removed from the brine and the surface allowed to dry.
It is then alternately rubbed with salt and washed at intervals. It
may be perforated with needles. It is finally drycured. During curing
it is turned and scraped. The surface may be rubbed with vegetable oil.
A harmless preparation of enzymes of animal or plant origin capable of
aiding in the curing or development of flavor of romano cheese may be
added during the procedure, in such quantity that the weight of the
solids of such preparation is not more than 0.1 percent of the weight of
the milk used.
(c)(1) For the purposes of this section, the word ''milk'' means
cow's milk or goat's milk or sheep's milk or mixtures of two or all of
these. Such milk may be adjusted by separating part of the fat
therefrom or (in the case of cow's milk) by adding one or more of the
following: Cream, skim milk, concentrated skim milk, nonfat dry milk;
(in the case of goat's milk) the corresponding products from goat's
milk; (in the case of sheep's milk) the corresponding products from
sheep's milk; water in a quantity sufficient to reconstitute any such
concentrated or dried products used.
(2) Such milk may be bleached by the use of benzoyl peroxide or a
mixture of benzoyl peroxide with potassium alum, calcium sulfate, and
magnesium carbonate; but the weight of the benzoyl peroxide is not more
than 0.002 percent of the weight of the milk bleached, and the weight of
the potassium alum, calcium, sulfate, and magnesium carbonate, singly or
combined, is not more than six times the weight of the benzoyl peroxide
used. If milk is bleached in this manner, sufficient vitamin A is added
to the curd to compensate for the vitamin A or its precursors destroyed
in the bleaching process, and artificial coloring is not used.
(d) Safe and suitable antimycotic agent(s), the cumulative levels of
which shall not exceed current good manufacturing practice, may be added
to the surface of the cheese.
(e) When romano cheese is made solely from cow's milk, the name of
such cheese is ''Romano cheese made from cow's milk'', and may be
preceded by the word ''Vaccino'' (or ''Vacchino''); when made solely
from sheep's milk, the name is ''Romano cheese made from sheep's milk'',
and may be preceded by the word ''Pecorina''; when made solely from
goat's milk, the name is ''Romano cheese made from goat's milk'', and
may be preceded by the word ''Caprino''; and when a mixture of two or
all of the milks specified in this section is used, the name of the
cheese is ''Romano cheese made from ------------ '', the blank being
filled in with the names of the milks used, in order of predominance by
weight.
(f) Label declaration: The common or usual name of each of the
ingredients used in the food shall be declared on the label as required
by the applicable sections of Part 101 of this chapter, except that:
(1) When milk other than cow's milk is used, in whole or in part, the
common or usual name of each such milk ingredient shall be declared in
order of predominance by weight; and
(2) Enzymes of animal, plant, or microbial origin may be declared as
''enzymes''.
(42 FR 14366, Mar. 15, 1977, as amended at 48 FR 49014, Oct. 24,
1983; 49 FR 10095, Mar. 19, 1984)
21 CFR 133.184 Roquefort cheese, sheep's milk blue-mold, and blue-mold
cheese from sheep's milk.
(a) Description. (1) Roquefort cheese, sheep's milk blue-mold
cheese, blue-mold cheese from sheep's milk, is the food prepared by the
procedure set forth in paragraph (a)(2) of this section or by any other
procedure which produces a finished cheese having the same physical and
chemical properties. It is characterized by the presence of
bluish-green mold, Penicillium roquefortii, throughout the cheese. The
minimum milkfat content is 50 percent by weight of the solids and the
maximum moisture content is 45 percent by weight, as determined by the
methods described in 133.5. The dairy ingredients used may be
pasteurized. Roquefort cheese is at least 60 days old.
(2) One or more of the dairy ingredients specified in paragraph
(b)(1) of this section may be warmed and is subjected to the action of a
lactic acid-producing bacterial culture. One or more of the clotting
enzymes specified in paragraph (b)(2) of this section is added to set
the dairy ingredients to a semisolid mass. The mass is cut into smaller
portions and allowed to stand for a time. The mixed curd and whey is
placed into forms permitting further drainage. While being placed in
forms, spores of the mold Penicillium roquefortii are added. The forms
are turned several times during drainage. When sufficiently drained,
the shaped curd is removed from the forms and salted with dry salt or
brine. Perforations are then made in the shaped curd and it is held at
a temperature of approximately 50 F at 90 to 95 percent relative
humidity, until the characteristic mold growth has developed. During
storage, the surface of the cheese may be scraped to remove surface
growth of undesirable microorganisms. One or more of the other optional
ingredients specified in paragraph (b)(3) of this section may be added
during the procedure.
(b) Operational ingredients. The following safe and suitable
ingredients may be used:
(1) Dairy ingredients. Forms of milk, nonfat milk, or cream, as
defined in 133.3, of sheep origin, used alone or in combination.
(2) Clotting enzymes. Rennet and/or other clotting enzymes of
animal, plant, or microbial origin.
(3) Other optional ingredients. Enzymes of animal, plant, or
microbial origin, used in curing or flavor development.
(c) Nomenclature. The name of the food is ''roquefort cheese'', or
alternatively, ''sheep's milk blue-mold cheese'' or ''blue-mold cheese
from sheep's milk.
(d) Label declaration. The common or usual name of each of the
ingredients used in the food shall be declared on the label as required
by the applicable sections of Part 101 of this chapter, except that:
(1) Enzymes of animal, plant, or microbial origin may be declared as
''enzymes''; and
(2) The dairy ingredients may be declared, in descending order of
predominance, by the use of the terms ''milkfat from sheep's milk and
nonfat sheep's milk'' or ''nonfat sheep's milk and milkfat from sheep's
milk'', as appropriate.
(54 FR 32058, Aug. 4, 1989)
21 CFR 133.185 Samsoe cheese.
(a) Description. (1) Samsoe cheese is the food prepared by the
procedure set forth in paragraph (a)(3) of this section or by any other
procedure which produces a finished cheese having the same physical and
chemical properties. It has a small amount of eye formation of
approximately uniform size of about five-sixteenths inch (8
millimeters). The minimum milkfat content is 45 percent by weight of
the solids and the maximum moisture content is 41 percent by weight, as
determined by the methods described in 133.5. The dairy ingredients
used may be pasteurized. Samsoe cheese is cured at not less than 35 F
for at least 60 days.
(2) If pasteurized dairy ingredients are used, the phenol equivalent
value of 0.25 gram of samsoe cheese is not more than 3 micrograms as
determined by the method described in 133.5.
(3) One or more of the dairy ingredients specified in paragraph
(b)(1) of this section may be warmed and is subjected to the action of a
lactic acid-producing bacterial culture. One or more of the clotting
enzymes specified in paragraph (b)(2) of this section is added to set
the dairy ingredients to a semisolid mass. After coagulation the mass
is cut into small cube-shaped pieces with sides approximately
three-eighths inch (1 centimeter). The mass is stirred and heated to
about 102 F, and so handled by further stirring, heating, dilution with
water, and salting as to promote and regulate the separation of curd and
whey. When the desired curd is obtained, it is transferred to forms
permitting drainage of whey. During drainage, the curd is pressed.
After drainage, the curd is removed from the forms and is further salted
by immersing in a concentrated salt solution for about 3 days. The curd
is then cured at a temperature of from 60 to 70 F for 3 to 5 weeks to
obtain the desired eye formation. Further curing is conducted at a
lower temperature. One or more of the other optional ingredients
specified in paragraph (b)(3) of this section may be added during the
procedure.
(b) Optional ingredients. The following safe and suitable
ingredients may be used:
(1) Dairy ingredients. Milk, nonfat milk, or cream, as defined in
133.3, used alone or in combination.
(2) Clotting enzymes. Rennet and/or other clotting enzymes of
animal, plant, or microbial origin.
(3) Other optional ingredients. (i) Coloring.
(ii) Calcium chloride in an amount not more than 0.02 percent
(calculated as anhydrous calcium chloride) by weight of the dairy
ingredients, used as a coagulation aid.
(iii) Enzymes of animal, plant, or microbial origin, used in curing
or flavor development.
(iv) Antimycotic agents, applied to the surface of slices or cuts in
consumer-sized packages.
(c) Nomenclature. The name of the food is ''samsoe cheese''.
(d) Label declaration. The common or usual name of each of the
ingredients used in the food shall be declared on the label as required
by the applicable sections of Part 101 of this chapter, except that:
(1) Enzymes of animal, plant, or microbial origin may be declared as
''enzymes''; and
(2) The dairy ingredients may be declared, in descending order of
predominance, by the use of the terms ''milkfat and nonfat milk'' or
''nonfat milk and milkfat'', as appropriate.
(48 FR 2745, Jan. 21, 1983; 48 FR 11426, Mar. 18, 1983)
21 CFR 133.186 Sap sago cheese.
(a) Description. (1) Sap sago cheese is the food prepared by the
procedure set forth in paragraph (a)(2) of this section or by any other
procedure which produces a finished cheese having the same physical and
chemical properties. The cheese is pale green in color and has the
shape of a truncated cone. The maximum moisture content is 38 percent
by weight, as determined by the method described in 133.5. Sap sago
cheese is not less than 5 months old.
(2) One or more of the dairy ingredients specified in paragraph
(b)(1) of this section is allowed to become sour, and is heated to
boiling temperature, with stirring. Sufficient sour whey is added to
precipitate the casein. The curd is removed, spread out in boxes, and
pressed, and while under pressure is allowed to drain and ferment. It
is ripened for not less than 5 weeks. The ripened curd is dried and
ground; salt and dried clover of the species Melilotus coerulea are
added. The mixture is shaped into truncated cones and ripened. The
optional ingredient in paragraph (b)(2) of this section may be added
during this procedure.
(b) Optional ingredients. The following safe and suitable
ingredients may be used:
(1) Dairy ingredients. Nonfat milk, as defined in 133.3.
(2) Other optional ingredients. Buttermilk.
(c) Nonmenclature. The name of the food is ''sap sago cheese''.
(d) Label declaration. The common or usual name of each of the
ingredients used in the food shall be declared on the label as required
by the applicable sections of Part 101 of this chapter.
(54 FR 32058, Aug. 4, 1989)
21 CFR 133.187 Semisoft cheeses.
(a) The cheeses for which definitions and standards of identity are
prescribed by this section are semisoft cheeses for which specifically
applicable definitions and standards of identity are not prescribed by
other sections of this part. They are made from milk and other
ingredients specified in this section, by the procedure set forth in
paragraph (b) of this section. They contain more than 39 percent, but
not more than 50 percent, of moisture, and their solids contain not less
than 50 percent of milkfat, as determined by the methods prescribed in
133.5 (a), (b), and (d). If the milk used is not pasteurized, the
cheese so made is cured at a temperature of not less than 35 F for not
less than 60 days.
(b) Milk, which may be pasteurized or clarified or both, and which
may be warmed, is subjected to the action of harmless
lactic-acid-producing bacteria or other harmless flavor-producing
bacteria, present in such milk or added thereto. Sufficient rennet,
rennet paste, extract of rennet paste, or other safe and suitable
milk-clotting enzyme that produces equivalent curd formation, singly or
in any combination (with or without purified calcium chloride in a
quantity not more than 0.02 percent, calculated as anhydrous calcium
chloride, of the weight of the milk) is added to set the milk to a
semisolid mass. Harmless artificial coloring may be added. After
coagulation the mass is so treated as to promote and regulate the
separation of whey and curd. Such treatment may include one or more of
the following: cutting, stirring, heating, dilution with water or
brine. The whey, or part of it, is drained off, and the curd is
collected and shaped. It may be placed in forms, and may be pressed.
Harmless flavor-producing microorganisms may be added. It may be cured
in a manner to promote the growth of biological curing agents. Salt may
be added during the procedure. A harmless preparation of enzymes of
animal or plant origin capable of aiding in the curing or development of
flavor of semisoft cheese may be added, in such quantity that the weight
of the solids of such preparation is not more than 0.1 percent of the
weight of the milk used.
(c) For the purposes of this section:
(1) The word ''milk'' means cow's milk or goat's milk or sheep's milk
or mixtures of two or all of these. Such milk may be adjusted by
separating part of the fat therefrom, or (in the case of cow's milk) by
adding one or more of the following: Cream, skim milk, concentrated
skim milk, nonfat dry milk; (in the case of goat's milk) the
corresponding products from goat's milk; (in the case of sheep's milk)
the corresponding products from sheep's milk; water in a quantity
sufficient to reconstitute any concentrated or dried products used.
(2) Milk shall be deemed to have been pasteurized if it has been held
at a temperature of not less than 143 F for a period of not less than
30 minutes, or for a time and at a temperature equivalent thereto in
phosphatase destruction. A semisoft cheese shall be deemed not to have
been made from pasteurized milk if 0.25 gram shows a phenol equivalent
of more than 5 micrograms when tested by the method prescribed in
133.5(c).
(d) Semisoft cheeses in the form of slices or cuts in consumer-sized
packages may contain an optional mold-inhibiting ingredient consisting
of sorbic acid, potassium sorbate, sodium sorbate, or any combination of
two or more of these, in an amount not to exceed 0.3 percent by weight,
calculated as sorbic acid.
(e) The name of each semisoft cheese for which a definition and
standard of identity is prescribed by this section is ''Semisoft
cheese'', preceded or followed by:
(1) The specific common or usual name of such semisoft cheese, if any
such name has become generally recognized therefor; or
(2) If no such specific common or usual name has become generally
recognized therefor, an arbitrary or fanciful name which is not false or
misleading in any particular.
(f)(1) When milk other than cow's milk is used in whole or in part,
the name of the cheese includes the statement ''made from ------------
'', the blank being filled in with the name or names of the milk used,
in order of predominance by weight.
(2) If semisoft cheese in sliced or cut form contains an optional
mold-inhibiting ingredient as specified in paragraph (d) of this
section, the label shall bear the statement '' ------------ added to
retard mold growth'' or '' ------------ added as a preservative'', the
blank being filled in with the common name or names of the
mold-inhibiting ingredient or ingredients used.
(3) Wherever the name of the food appears on the label so
conspicuously as to be easily seen under customary conditions of
purchase, the words and statements prescribed by this section, showing
the optional ingredient used, shall immediately and conspicuously
precede or follow such name, without intervening written, printed, or
graphic matter.
(42 FR 14366, Mar. 15, 1977, as amended at 49 FR 10096, Mar. 19,
1984)
21 CFR 133.188 Semisoft part-skim cheeses.
(a) The cheeses for which definitions and standards of identity are
prescribed by this section are semisoft part-skim cheeses for which
specifically applicable definitions and standards of identity are not
prescribed by other sections of this part. They are made from partly
skimmed milk and other ingredients specified in this section, by the
procedure set forth in paragraph (b) of this section. They contain not
more than 50 percent of moisture, and their solids contain not less than
45 percent, but less than 50 percent, of milkfat, as determined by the
methods set forth in 133.5 (a), (b), and (d). If the milk used is not
pasteurized, the cheese so made is cured at a temperature of not less
than 35 F, for not less than 60 days.
(b) Milk, which may be pasteurized or clarified or both, and which
may be warmed, is subjected to the action of harmless
lactic-acid-producing bacteria or other harmless flavor-producing
bacteria, present in such milk or added thereto. Sufficient rennet,
rennet paste, extract of rennet paste, or other safe and suitable
milk-clotting enzyme that produces equivalent curd formation singly or
in any combination (with or without purified calcium chloride in a
quantity not more than 0.02 percent, calculated as anhydrous calcium
chloride, of the weight of the milk) is added to set the milk to a
semisolid mass. Harmless artificial coloring may be added. After
coagulation the mass is so treated as to promote and regulate the
separation of whey and curd. Such treatment may include one or more of
the following: Cutting, stirring, heating, dilution with water or
brine. The whey, or part of it, is drained off, and the curd is
collected and shaped. It may be placed in forms, and it may be pressed.
Harmless flavor-producing microorganisms may be added. It may be cured
in a manner to promote the growth of biological curing agents. Salt may
be added during the procedure. A harmless preparation of enzymes of
animal or plant origin capable of aiding in the curing or development of
flavor of semisoft part-skim cheese may be added in such quantity that
the weight of the solids of such preparation is not more than 0.1
percent of the weight of the milk used.
(c) For the purposes of this section:
(1) The word ''milk'' means cow's milk or goat's milk or sheep's milk
or mixtures of two or all of these. Such milk may be adjusted by
separating part of the fat therefrom or (in the case of cow's milk) by
adding one or more of the following: Cream, skim milk, concentrated
skim milk, nonfat dry milk; (in the case of goat's milk) the
corresponding products from goat's milk; (in the case of sheep's milk)
the corresponding products from sheep's milk; water in a quantity
sufficient to reconstitute any such concentrated or dried products used.
(2) Milk shall be deemed to have been pasteurized if it has been held
at a temperature of not less than 143 F for a period of not less than
30 minutes, or for a time and at a temperature equivalent thereto in
phosphatase destruction. A semisoft part-skim cheese shall be deemed
not to have been made from pasteurized milk if 0.25 gram shows a phenol
equivalent of more than 5 micrograms when tested by the method
prescribed in 133.5(c).
(d) Semisoft part-skim cheeses in the form of slices or cuts in
consumer-sized packages may contain an optional mold-inhibiting
ingredient consisting of sorbic acid, potassium sorbate, sodium sorbate,
or any combination of two or more of these, in an amount not to exceed
0.3 percent by weight, calculated as sorbic acid.
(e) The name of each semisoft part-skim cheese for which a definition
and standard of identity is prescribed by this section is ''Semisoft
part-skim cheese,'' preceded or followed by:
(1) The specific common or usual name of such semisoft cheese, if any
such name has become generally recognized therefor; or
(2) If no such specific common or usual name has become generally
recognized therefor, an arbitrary or fanciful name which is not false or
misleading in any particular.
(f)(1) When milk other than cow's milk is used in whole or in part,
the name of the cheese includes the statement ''made from ------------
'', the blank being filled in with the name or names of the milk used,
in order of predominance by weight.
(2) If semi-soft part-skim cheese in sliced or cut form contains an
optional mold-inhibiting ingredient as specified in paragraph (d) of
this section, the label shall bear the statement '' -------- added to
retard mold growth'' or '' -------- added as a preservative'', the blank
being filled in with the common name or names of the mold-inhibiting
ingredient or ingredients used.
(3) Wherever the name of the food appears on the label so
conspicuously as to be easily seen under customary conditions of
purchase, the words and statements prescribed by this section, showing
the optional ingredient used, shall immediately and conspicuously
precede or follow such name, without intervening written, printed, or
graphic matter.
(42 FR 14366, Mar. 19, 1977, as amended at 49 FR 10096, Mar. 19,
1984)
21 CFR 133.189 Skim milk cheese for manufacturing.
(a) Skim milk cheese for manufacturing is the food prepared from skim
milk and other ingredients specified in this section, by the procedure
set forth in paragraph (b) of this section, or by another procedure
which produces a finished cheese having the same physical and chemical
properties as the cheese produced when the procedure set forth in
paragraph (b) of this section is used. It contains not more than 50
percent of moisture, as determined by the method prescribed in 133.5
(a). It is coated with blue-colored paraffin or other tightly adhering
coating, colored blue.
(b) Skim milk or the optional dairy ingredients specified in
paragraph (c) of this section, which may be pasteurized, and which may
be warmed, are subjected to the action of harmless lactic-acid-producing
bacteria, present in such milk or added thereto. Harmless artificial
coloring may be added. Sufficient rennet, or other safe and suitable
milk-clotting enzyme that produces equivalent curd formation, or both,
with or without purified calcium chloride in a quantity not more than
0.02 percent (calculated as anhydrous calcium chloride) of the weight of
the skim milk, is added to set the skim milk to a semisolid mass. The
mass is so cut, stirred, and heated with continued stirring, as to
promote and regulate the separation of whey and curd. The whey is
drained off, and the curd is matted into a cohesive mass. Proteins from
the whey may be incorporated. The mass is cut into slabs which are so
piled and handled as to promote the drainage of whey and the development
of acidity. The slabs are then cut into pieces, which may be rinsed by
pouring or sprinkling water over them, with free and continuous
drainage; but the duration of such rinsing is so limited that only the
whey on the surface of such pieces is removed. The curd is salted,
stirred, further drained, and pressed into forms. A harmless
preparation of enzymes of animal or plant origin capable of aiding in
the curing or development of flavor of skim milk cheese for
manufacturing may be added during the procedure, in such quantity that
the weight of the solids of such preparation is not more than 0.1
percent of the weight of the milk used.
(c) The optional dairy ingredients referred to in paragraph (b) of
this section are: Skim milk or concentrated skim milk or nonfat dry
milk or a mixture of any two or more of these, with water in a quantity
not in excess of that sufficient to reconstitute any concentrated skim
milk or nonfat dry milk used.
(d) For the purposes of this section, ''skim milk'' means cow's milk
from which the milk fat has been separated.
(42 FR 14366, Mar. 15, 1977, as amended at 49 FR 10096, Mar. 19,
1984)
21 CFR 133.190 Spiced cheeses.
(a) Description. (1) Spiced cheeses are cheeses for which
specifically applicable definitions and standards of identity are not
prescribed by other sections of this part. The food is prepared by the
procedure set forth in paragraph (a)(3) of this section or by any other
procedure which produces a finished cheese having the same physical and
chemical properties. The minimum milkfat content is 50 percent by
weight of the solids, as determined by the method described in 133.5.
The food contains spices, in a minimum amount of 0.015 ounce per pound
of cheese, and may contain spice oils. If the dairy ingredients are not
pasteurized, the cheese is cured at a temperature of not less than 35 F
for at least 60 days.
(2) The phenol equivalent of 0.25 gram of spiced cheese is not more
than 3 micrograms, as determined by the method described in 133.5.
(3) One or more of the dairy ingredients specified in paragraph
(b)(1) of this section may be warmed and is subjected to the action of a
harmless lactic acid-producing bacterial culture. One or more of the
clotting enzymes specified in paragraph (b)(2) of this section is added
to set the dairy ingredients to a semisolid mass. The mass is divided
into smaller portions and so handled by stirring, heating, and diluting
with water or salt brine as to promote and regulate the separation of
whey and curd. The whey is drained off. The curd is removed and may be
further drained. The curd is then shaped into forms, and may be
pressed. At some time during the procedure, spices are added so as to
be evenly distributed throughout the finished cheese. One or more of
the other optional ingredients specified in paragraph (b)(3) of this
section may be added during the procedure.
(b) Optional ingredients. The following safe and suitable
ingredients may be used:
(1) Dairy ingredients. Milk, nonfat milk, or cream, as defined in
133.3, or corresponding products of goat or sheep origin, used alone or
in combination.
(2) Clotting enzymes. Rennet and/or other clotting enzymes of
animal, plant, or microbial origin.
(3) Other optional ingredients. (i) Coloring.
(ii) Calcium chloride in an amount not more than 0.02 percent
(calculated as anhydrous calcium chloride) of the weight of the dairy
ingredients, used as a coagulation aid.
(iii) Salt.
(iv) Spice oils which do not, alone or in combination with other
ingredients, simulate the flavor of cheese of any age or variety.
(v) Enzymes of animal, plant, or microbial origin, used in curing or
flavor development.
(vi) Antimycotic agents, applied to the surface of slices or cuts in
consumer-sized packages.
(c) Nomenclature. The name of the food is ''spiced cheese''. The
following terms shall accompany the name of the food, as appropriate:
(1) The specific common or usual name of the spiced cheese, if any
such name has become generally recognized; or
(2) An arbitrary or fanciful name that is not false or misleading in
any particular.
(d) Label declaration. The common or usual name of each of the
ingredients used in the food shall be declared on the label as required
by the applicable sections of Part 101 of this chapter, except that:
(1) Enzymes of animal, plant, or microbial origin may be declared as
''enzymes''; and
(2) The dairy ingredients may be declared, in descending order of
predominance, by the use of the terms ''milkfat and nonfat milk'' or
''nonfat milk and milkfat'', or ''milkfat from goat's milk and nonfat
goat's milk'', etc., as appropriate.
(54 FR 32059, Aug. 4, 1989)
21 CFR 133.191 Part-skim spiced cheeses.
Part-skim spiced cheeses conform to the definition and standard of
identity, and are subject to the requirements for label statement of
optional ingredients, prescribed for spiced cheeses by 133.190, except
that their solids contain less than 50 percent, but not less than 20
percent, of milk fat.
21 CFR 133.193 Spiced, flavored standardized cheeses.
(a) Except as otherwise provided for herein and in applicable
sections in this part, a spiced or flavored standardized cheese conforms
to the applicable definitions, standard of identity and requirements for
label statement of optional ingredients prescribed for that specific
natural cheese variety promulgated pursuant to section 401 of the act.
In addition a spiced and/or flavored standardized cheese shall contain
one or more safe and suitable spices and/or flavorings, in such
proportions as are reasonably required to accomplish their intended
effect: Provided, That no combination of ingredients shall be used to
simulate the flavor of cheese of any age or variety.
(b) The name of a spiced or flavored standardized cheese shall
include in addition to the varietal name of the natural cheese, a
declaration of any flavor and/or spice that characterizes the food, in
the manner prescribed in 101.22 of this chapter.
21 CFR 133.195 Swiss and emmentaler cheese.
(a) Description. (1) Swiss cheese, emmentaler cheese, is the food
prepared by the procedure set forth in paragraph (a)(3) of this section,
or by any other procedure which produces a finished cheese having the
same physical and chemical properties. It has holes or eyes developed
throughout the cheese. The minimum milkfat content is 43 percent by
weight of the solids and the maximum moisture content is 41 percent by
weight, as determined by the methods described in 133.5. The dairy
ingredients used may be pasteurized. Swiss cheese is at least 60 days
old.
(2) If pasteurized dairy ingredients are used, the phenol equivalent
value of 0.25 gram of swiss cheese is not more than 3 micrograms as
determined by the method described in 133.5.
(3) One or more of the dairy ingredients specified in paragraph
(b)(1) of this section may be bleached, warmed, or treated with hydrogen
peroxide/catalase, and is subjected to the action of lactic
acid-producing and propionic acid-producing bacterial cultures. One or
more of the clotting enzymes specified in paragraph (b)(2) of this
section is added to set the dairy ingredients to a semisolid mass. The
mass is cut into particles similar in size to wheat kernels. For about
30 minutes the particles are alternately stirred and allowed to settle.
The temperature is raised to about 126 F. Stirring is continued until
the curd becomes firm. The acidity of the whey at this point,
calculated as lactic acid, does not exceed 0.13 percent. The curd is
transferred to hoops or forms and pressed until the desired shape and
firmness are obtained. The cheese is then salted by immersing it in a
saturated salt solution for about 3 days. It is then held at a
temperature of about 50 to 60 F. for a period of 5 to 10 days, after
which it is held at a temperature of about 75 F. until it is
approximately 30 days old, or until the so-called eyes form. Salt, or a
solution of salt in water, is added to the surface of the cheese at some
time during the curing process. The cheese is then stored at a lower
temperature for further curing. One or more of the optional ingredients
specified in paragraph (b)(3) of this section may be added during the
procedure.
(b) Optional ingredients. The following safe and suitable
ingredients may be used:
(1) Dairy ingredients. Milk, nonfat milk, or cream, as defined in
133.3, used alone or in combination.
(2) Clotting enzymes. Rennet and/or other clotting enzymes of
animal, plant, or microbial origin.
(3) Other optional ingredients. (i) Coloring.
(ii) Calcium chloride in an amount not more than 0.02 percent
(calculated as anhydrous calcium chloride) by weight of the dairy
ingredients, used as a coagulation aid.
(iii) Enzymes of animal, plant, or microbial origin, used in curing
or flavor development.
(iv) Antimycotic agents, the cumulative levels of which shall not
exceed good manufacturing practice, may be added to the surface of the
cheese.
(v) Benzoyl peroxide or a mixture of benzoyl peroxide with potassium
alum, calcium sulfate, and magnesium carbonate used to bleach the dairy
ingredients. The weight of the benzoyl peroxide is not more than 0.002
percent of the weight of the milk being bleached, and the weight of the
potassium alum, calcium sulfate, and magnesium carbonate, singly or
combined, is not more than six times the weight of the benzoyl peroxide
used. If milk is bleached in this manner, vitamin A is added to the
curd in such quantity as to compensate for the vitamin A or its
precursors destroyed in the bleaching process, and artificial coloring
is not used.
(vi) Hydrogen peroxide, followed by a sufficient quantity of catalase
preparation to eliminate the hydrogen peroxide. The weight of the
hydrogen peroxide shall not exceed 0.05 percent of the weight of the
milk and the weight of the catalase shall not exceed 20 parts per
million of the weight of the milk treated.
(c) Nomenclature. The name of the food is ''swiss cheese'', or
alternatively, ''emmentaler cheese''.
(d) Label declaration. The common or usual name of each of the
ingredients used in the food shall be declared on the label as required
by the applicable sections of Part 101 of this chapter, except that:
(1) Enzymes of animal, plant, or microbial origin may be declared as
''enzymes''; and
(2) The dairy ingredients may be declared, in descending order of
predominance, by the use of the terms ''milkfat and nonfat milk'' or
''nonfat milk and milkfat'', as appropriate.
(48 FR 2746, Jan. 21, 1983; 48 FR 11426, Mar. 18, 1983, as amended
at 55 FR 6795, Feb. 27, 1990)
21 CFR 133.196 Swiss cheese for manufacturing.
Swiss cheese for manufacturing conforms to the definition and
standard of identity prescribed for swiss cheese by 133.195, except
that the holes, or eyes, have not developed throughout the entire
cheese.
(55 FR 6795, Feb. 27, 1990)
21 CFR 133.196 PART 135 -- FROZEN DESSERTS
21 CFR 133.196 Pt. 135
21 CFR 133.196 Subpart A -- General Provisions
Sec.
135.3 Definitions.
21 CFR 133.196 Subpart B -- Requirements for Specific Standardized
Frozen Desserts
135.110 Ice cream and frozen custard.
135.115 Goat's milk ice cream.
135.120 Ice milk.
135.125 Goat's milk ice milk.
135.130 Mellorine.
135.140 Sherbet.
135.160 Water ices.
Authority: Secs. 201, 401, 403, 409, 701, 706 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321, 341, 343, 348, 371, 376).
21 CFR 133.196 Subpart A -- General Provisions
21 CFR 135.3 Definitions.
For the purposes of this part, a pasteurized mix is one in which
every particle of the mix has been heated in properly operated equipment
to one of the temperatures specified in the table in this section and
held continuously at or above that temperature for the specified time
(or other time/temperature relationship which has been demonstrated to
be equivalent thereto in microbial destruction):
(42 FR 19132, Apr. 12, 1977)
21 CFR 135.3 Subpart B -- Requirements for Specific Standardized Frozen Desserts
21 CFR 135.110 Ice cream and frozen custard.
(a) Description. (1) Ice cream is a food produced by freezing, while
stirring, a pasteurized mix consisting of one or more of the optional
dairy ingredients specified in paragraph (b) of this section, and may
contain one or more of the optional caseinates specified in paragraph
(c) of this section subject to the conditions hereinafter set forth, and
other safe and suitable nonmilk-derived ingredients; and excluding
other food fats, except such as are natural components of flavoring
ingredients used or are added in incidental amounts to accomplish
specific functions. Ice cream is sweetened with nutritive carbohydrate
sweeteners and may or may not be characterized by the addition of
flavoring ingredients.
(2) Ice cream contains not less than 1.6 pounds of total solids to
the gallon, and weighs not less than 4.5 pounds to the gallon. Ice
cream contains not less than 10 percent milkfat, nor less than 10
percent nonfat milk solids, except that when it contains milkfat at 1
percent increments above the 10 percent minimum, it may contain the
following milkfat-to-nonfat milk solids levels:
Except that when one or more bulky flavors are used, the weights of
milkfat and total milk solids are not less than 10 percent and 20
percent, respectively, of the remainder obtained by subtracting the
weight of the bulky flavors from the weight of the finished food; but
in no case is the weight of milkfat or total milk solids less than 8
percent and 16 percent, respectively, of the weight of the finished
food. Except in the case of frozen custard, ice cream contains less
than 1.4 percent egg yolk solids by weight of the food, exclusive of the
weight of any bulky flavoring ingredients used. Frozen custard shall
contain 1.4 percent egg yolk solids by weight of the finished food:
Provided, however, That when bulky flavors are added the egg yolk solids
content of frozen custard may be reduced in proportion to the amount by
weight of the bulky flavors added, but in no case is the content of egg
yolk solids in the finished food less than 1.12 percent. A product
containing egg yolk solids in excess of 1.4 percent, the maximum set
forth in this paragraph for ice cream, may be marketed if labeled as
specified by paragraph (e)(1) of this section.
(3) When calculating the minimum amount of milkfat and nonfat milk
solids required in the finished food, the solids of chocolate or cocoa
used shall be considered a bulky flavoring ingredient. In order to make
allowance for additional sweetening ingredients needed when certain
bulky ingredients are used, the weight of chocolate or cocoa solids used
may be multiplied by 2.5; the weight of fruit or nuts used may be
multiplied by 1.4; and the weight of partially or wholly dried fruits
or fruit juices may be multiplied by appropriate factors to obtain the
original weights before drying and this weight may be multiplied by 1.4.
(b) Optional dairy ingredients. The optional dairy ingredients
referred to in paragraph (a) of this section are: Cream, dried cream,
plastic cream (sometimes known as concentrated milkfat), butter, butter
oil, milk, concentrated milk, evaporated milk, sweetened condensed milk,
superheated condensed milk, dried milk, skim milk, concentrated skim
milk, evaporated skim milk, condensed skim milk, superheated condensed
skim milk, sweetened condensed skim milk, sweetened condensed part-skim
milk, nonfat dry milk, sweet cream buttermilk, condensed sweet cream
buttermilk, dried sweet cream buttermilk, skim milk that has been
concentrated and from which part of the lactose has been removed by
crystallization, skim milk in concentrated or dried form that has been
modified by treating the concentrated skim milk with calcium hydroxide
and disodium phosphate, and whey and those modified whey products (e.g.,
reduced lactose whey, reduced minerals whey, and whey protein
concentrate) that have been determined by FDA to be generally recognized
as safe (GRAS) for use in this type of food. Water may be added, or
water may be evaporated from the mix. The sweet cream buttermilk and
the concentrated sweet cream buttermilk or dried sweet cream buttermilk,
when adjusted with water to a total solids content of 8.5 percent, has a
titratable acidity of not more than 0.17 percent, calculated as lactic
acid. The term ''milk'' as used in this section means cow's milk. Any
whey and modified whey products used contribute, singly or in
combination, not more than 25 percent by weight of the total nonfat milk
solids content of the finished food. The modified skim milk, when
adjusted with water to a total solids content of 9 percent, is
substantially free of lactic acid as determined by titration with 0.1N
NaOH, and it has a pH value in the range of 8.0 to 8.3.
(c) Optional caseinates. The optional caseinates referred to in
paragraph (a) of this section that may be added to ice cream mix
containing not less than 20 percent total milk solids are: Casein
prepared by precipitation with gums, ammonium caseinate, calcium
caseinate, potassium caseinate, and sodium caseinate. Caseinate may be
added in liquid or dry form, but must be free of excess alkali.
(d) Methods of analysis. The fat content shall be determined by the
method prescribed in ''Official Methods of Analysis of the Association
of Official Analytical Chemists,'' 13th Ed. (1980), sections 16.287 and
16.059, under ''Fat, Roese-Gottlieb Method -- Official Final Action,''
which is incorporated by reference. Copies may be obtained from the
Association of Official Analytical Chemists, 2200 Wilson Blvd., Suite
400, Arlington, VA 22201-3301, or may be examined at the Office of the
Federal Register, 1100 L St. NW., Washington, DC 20408.
(e) Nomenclature. (1) The name of the food is ''ice cream''; except
that when the egg yolk solids content of the food is in excess of that
specified for ice cream by paragraph (a) of this section, the name of
the food is ''frozen custard'' or ''french ice cream'' or ''french
custard ice cream''.
(2) (i) If the food contains no artificial flavor, the name on the
principal display panel or panels of the label shall be accompanied by
the common or usual name of the characterizing flavor, e.g.,
''vanilla'', in letters not less than one-half the height of the letters
used in the words ''ice cream''.
(ii) If the food contains both a natural characterizing flavor and an
artificial flavor simulating it, and if the natural flavor predominates,
the name on the principal display panel or panels of the label shall be
accompanied by the common name of the characterizing flavor, in letters
not less than one-half the height of the letters used in the words ''ice
cream'', followed by the word ''flavored'', in letters not less than
one-half the height of the letters in the name of the characterizing
flavor, e.g., ''Vanilla flavored'', or ''Peach flavored'', or ''Vanilla
flavored and Strawberry flavored''.
(iii) If the food contains both a natural characterizing flavor and
an artificial flavor simulating it, and if the artificial flavor
predominates, or if artificial flavor is used alone the name on the
principal display panel or panels of the label shall be accompanied by
the common name of the characterizing flavor in letters not less than
one-half the height of the letters used in the words ''ice cream'',
preceded by ''artificial'' or ''artificially flavored'', in letters not
less than one-half the height of the letters in the name of the
characterizing flavor, e.g., ''artificial Vanilla'', or ''artifically
flavored Strawberry'' or ''artificially flavored Vanilla and
artificially flavored Strawberry''.
(3)(i) If the food is subject to the requirements of paragraph
(e)(2)(ii) of this section or if it contains any artificial flavor not
simulating the characterizing flavor, the label shall also bear the
words ''artificial flavor added'' or ''artificial -------- flavor
added'', the blank being filled with the common name of the flavor
simulated by the artificial flavor in letters of the same size and
prominence as the words that precede and follow it.
(ii) Wherever the name of the characterizing flavor appears on the
label so conspicuously as to be easily seen under customary conditions
of purchase, the words prescribed by this paragraph shall immediately
and conspicuously precede or follow such name, in a size reasonably
related to the prominence of the name of the characterizing flavor and
in any event the size of the type is not less than 6-point on packages
containing less than 1 pint, not less than 8-point on packages
containing at least 1 pint but less than one-half gallon, not less than
10-point on packages containing at least one-half gallon but less than 1
gallon, and not less than 12-point on packages containing 1 gallon or
over: Provided, however, That where the characterizing flavor and a
trademark or brand are presented together, other written, printed, or
graphic matter that is a part of or is associated with the trademark or
brand, may intervene if the required words are in such relationship with
the trademark or brand as to be clearly related to the characterizing
flavor: And provided further, That if the finished product contains
more than one flavor of ice cream subject to the requirements of this
paragraph, the statements required by this paragraph need appear only
once in each statement of characterizing flavors present in such ice
cream, e.g., ''Vanilla flavored, Chocolate, and Strawberry flavored,
artificial flavors added''.
(4) If the food contains both a natural characterizing flavor and an
artificial flavor simulating the characterizing flavor, any reference to
the natural characterizing flavor shall, except as otherwise authorized
by this paragraph, be accompanied by a reference to the artificial
flavor, displayed with substantially equal prominence, e.g.,
''strawberry and artificial strawberry flavor''.
(5) An artificial flavor simulating the characterizing flavor shall
be deemed to predominate:
(i) In the case of vanilla beans or vanilla extract used in
combination with vanillin if the amount of vanillin used is greater than
1 ounce per unit of vanilla constituent, as that term is defined in
169.3(c) of this chapter.
(ii) In the case of fruit or fruit juice used in combination with
artificial fruit flavor, if the quantity of the fruit or fruit juice
used is such that, in relation to the weight of the finished ice cream,
the weight of the fruit or fruit juice, as the case may be (including
water necessary to reconstitute partially or wholly dried fruits or
fruit juices to their original moisture content) is less than 2 percent
in the case of citrus ice cream, 6 percent in the case of berry or
cherry ice cream, and 10 percent in the case of ice cream prepared with
other fruits.
(iii) In the case of nut meats used in combination with artificial
nut flavor, if the quantity of nut meats used is such that, in relation
to the finished ice cream the weight of the nut meats is less than 2
percent.
(iv) In the case of two or more fruits or fruit juices, or nut meats,
or both, used in combination with artificial flavors simulating the
natural flavors and dispersed throughout the food, if the quantity of
any fruit or fruit juice or nut meat is less than one-half the
applicable percentage specified in paragraph (e)(5) (ii) or (iii) of
this section. For example, if a combination ice cream contains less
than 5 percent of bananas and less than 1 percent of almonds it would be
''artificially flavored banana-almond ice cream''. However, if it
contains more than 5 percent of bananas and more than 1 percent of
almonds it would be ''banana-almond flavored ice cream''.
(6) If two or more flavors of ice cream are distinctively combined in
one package, e.g., ''Neapolitan'' ice cream, the applicable provisions
of this paragraph shall govern each flavor of ice cream comprising the
combination.
(f) Label declaration. Each of the optional ingredients used shall
be declared on the label as required by the applicable sections of Part
101 of this chapter, except that sources of milkfat or milk solids not
fat may be declared in descending order of predominance either by the
use of all the terms ''milkfat and nonfat milk'' when one or any
combination of two or more of the ingredients listed in 101.4(b) (3),
(4), (8), and (9) of this chapter are used or alternatively as permitted
in 101.4 of this chapter. Under section 403(k) of the Federal Food,
Drug, and Cosmetic Act, artificial color need not be declared in ice
cream, except as required by 101.22(c) of this chapter. Voluntary
declaration of all colors used in ice cream and frozen custard is
recommended.
(43 FR 4598, Feb. 3, 1978, as amended at 45 FR 63838, Sept. 26, 1980;
46 FR 44433, Sept. 4, 1981; 47 FR 11826, Mar. 19, 1982; 49 FR 10096,
Mar. 19, 1984; 54 FR 24894, June 12, 1989)
21 CFR 135.115 Goat's milk ice cream.
(a) Description. Goat's milk ice cream is the food prepared in the
same manner prescribed in 135.110 for ice cream, and complies with all
the provisions of 135.110, except that the only optional dairy
ingredients that may be used are those in paragraph (b) of this section;
caseinates may not be used; and paragraphs (e)(1) and (f) of 135.110
shall not apply.
(b) Optional dairy ingredients. The optional dairy ingredients
referred to in paragraph (a) of this section are goat's skim milk,
goat's milk, and goat's cream. These optional dairy ingredients may be
used in liquid, concentrated, and/or dry form.
(c) Nomenclature. The name of the food is ''goat's milk ice cream''
or, alternatively, ''ice cream made with goat's milk'', except that when
the egg yolk solids content of the food is in excess of that specified
for ice cream in paragraph (a) of 135.110, the name of the food is
''goat's milk frozen custard'' or, alternatively, ''frozen custard made
with goat's milk'', or ''goat's milk french ice cream'', or,
alternatively, ''french ice cream made with goat's milk'', or ''goat's
milk french custard ice cream'', or, alternatively, ''french custard ice
cream made with goat's milk''.
(d) Label declaration. Each of the optional ingredients used shall
be declared on the label as required by the applicable sections of Part
101 of this chapter.
(47 FR 41526, Sept. 21, 1982)
21 CFR 135.120 Ice milk.
(a) Description. Ice milk is the food prepared from the same
ingredients and in the same manner prescribed in 135.110 for ice cream
and complies with all the provisions of 135.110 (including the
requirements for label statement of optional ingredients), except that:
(1) Its content of milkfat is more than 2 percent but not more than 7
percent.
(2) Its content of total milk solids is not less than 11 percent.
(3) Caseinates may be added when the content of total milk solids is
not less than 11 percent.
(4) The provision for reduction in milkfat and nonfat milk solids
content from the addition of bulky flavors in 135.110(a) applies,
except that in no case will the milkfat content be less than 2 percent,
nor the nonfat milk solids content be less than 4 percent. When the
milkfat content increases in increments of 1 percent above the 2 percent
minimum, it may contain the following milkfat-to-nonfat milk solids
levels:
(5) The quantity of food solids per gallon is not less than 1.3
pounds.
(6) When any artificial coloring is used in ice milk, directly or as
a component of any other ingredient, the label shall bear the statement
''artificially colored'', ''artificial coloring added'', ''with added
artificial color'', or '' ------------ , an artificial color added'',
the blank being filled in with the common or usual name of the
artificial color; or in lieu thereof, in case the artificial color is a
component of another ingredient, '' ------------ artificially colored''.
(7) If both artificial color and artificial flavoring are used, the
label statements may be combined.
(b) Nomenclature. The name of the food is ''ice milk''.
(43 FR 4599, Feb. 3, 1978, as amended at 48 FR 13024, Mar. 29, 1983)
21 CFR 135.125 Goat's milk ice milk.
(a) Description. Goat's milk ice milk is the food prepared in the
same manner prescribed in 135.115 for goat's milk ice cream, except
that paragraph (c) shall not apply, and which complies with all the
requirements of 135.120(a) (1), (2), (4), (5), (6), and (7) for ice
milk.
(b) Nomenclature. The name of the food is ''goat's milk ice milk''
or, alternatively, ''ice milk made with goat's milk''.
(47 FR 41526, Sept. 21, 1982)
21 CFR 135.130 Mellorine.
(a) Description. (1) Mellorine is a food produced by freezing, while
stirring, a pasteurized mix consisting of safe and suitable ingredients
including, but not limited to, milk-derived nonfat solids and animal or
vegetable fat, or both, only part of which may be milkfat. Mellorine is
sweetened with nutritive carbohydrate sweetener and is characterized by
the addition of flavoring ingredients.
(2) Mellorine contains not less than 1.6 pounds of total solids to
the gallon, and weighs not less than 4.5 pounds to the gallon.
Mellorine contains not less than 6 percent fat and 2.7 percent protein
having a protein efficiency ratio (PER) not less than that of whole milk
protein (108 percent of casein) by weight of the food, exclusive of the
weight of any bulky flavoring ingredients used. In no case shall the
fat content of the finished food be less than 4.8 percent or the protein
content be less than 2.2 percent. The protein to meet the minimum
protein requirements shall be provided by milk solids, not fat and/or
other milk-derived ingredients.
(3) When calculating the minimum amount of milkfat and protein
required in the finished food, the solids of chocolate or cocoa used
shall be considered a bulky flavoring ingredient. In order to make
allowance for additional sweetening ingredients needed when certain
bulky ingredients are used, the weight of chocolate or cocoa solids used
may be multiplied by 2.5; the weight of fruit or nuts used may be
multiplied by 1.4; and the weight of partially or wholly dried fruits
or fruit juices may be multiplied by appropriate factors to obtain the
original weights before drying and this weight may be multiplied by 1.4.
(b) Fortification. Vitamin A is present in a quantity which will
ensure that 40 international units (IU) are available for each gram of
fat in mellorine, within limits of good manufacturing practice.
(c) Methods of analysis. Fat and protein content, and the PER shall
be determined by following the methods contained in ''Official Methods
of Analysis of the Association of Official Analytical Chemists,'' 13th
Ed. (1980), which is incorporated by reference. Copies may be obtained
from the Association of Official Analytical Chemists, 2200 Wilson Blvd.,
Suite 400, Arlington, VA 22201-3301, or may be examined at the Office of
the Federal Register, 1100 L St. NW., Washington, DC 20408.
(1) Fat content shall be determined by the method: ''Fat,
Roese-Gottlieb Method -- Official Final Action,'' section 16.287.
(2) Protein content shall be determined by one of the following
methods: ''Nitrogen -- Official Final Action,'' Kjeldahl Method,
section 16.285, or Dye Binding Method, section 16.286.
(3) PER shall be determined by the method: ''Biological Evaluation
of Protein Quality -- Official Final Action,'' sections 43.212-43.216.
(d) Nomenclature. The name of the food is ''mellorine''. The name
of the food on the label shall be accompanied by a declaration
indicating the presence of characterizing flavoring in the same manner
as is specified in 135.110(c).
(e) Label declaration. The common or usual name of each of the
ingredients used shall be declared on the label as required by the
applicable sections of Part 101 of this chapter, except that sources of
milkfat or milk solids not fat may be declared, in descending order of
predominance, either by the use of the terms ''milkfat, and nonfat
milk'' when one or any combination of two or more ingredients listed in
101.4(b) (3), (4), (8), and (9) of this chapter are used, or
alternatively as permitted in 101.4 of this chapter.
(42 FR 19137, Apr. 12, 1977, as amended at 47 FR 11826, Mar. 19,
1982; 49 FR 10096, Mar. 19, 1984; 54 FR 24894, June 12, 1989)
21 CFR 135.140 Sherbet.
(a) Description. (1) Sherbet is a food produced by freezing, while
stirring, a pasteurized mix consisting of one or more of the optional
dairy ingredients specified in paragraph (b) of this section, and may
contain one or more of the optional caseinates specified in paragraph
(c) of this section subject to the conditions hereinafter set forth, and
other safe and suitable nonmilk-derived ingredients; and excluding
other food fats, except such as are added in small amounts to accomplish
specific functions or are natural components of flavoring ingredients
used. Sherbet is sweetened with nutritive carbohydrate sweeteners and
is characterized by the addition of one or more of the characterizing
fruit ingredients specified in paragraph (d) of this section or one or
more of the nonfruit-characterizing ingredients specified in paragraph
(e) of this section.
(2) Sherbet weighs not less than 6 pounds to the gallon. The milkfat
content is not less than 1 percent nor more than 2 percent, the nonfat
milk-derived solids content not less than 1 percent, and the total milk
or milk-derived solids content is not less than 2 percent nor more than
5 percent by weight of the finished food. Sherbet that is characterized
by a fruit ingredient shall have a titratable acidity, calculated as
lactic acid, of not less than 0.35 percent.
(b) Optional dairy ingredients. The optional dairy ingredients
referred to in paragraph (a) of this section are: Cream, dried cream,
plastic cream (sometimes known as concentrated milkfat), butter, butter
oil, milk, concentrated milk, evaporated milk, superheated condensed
milk, sweetened condensed milk, dried milk, skim milk, concentrated skim
milk, evaporated skim milk, condensed skim milk, sweetened condensed
skim milk, sweetened condensed part-skim milk, nonfat dry milk, sweet
cream buttermilk, condensed sweet cream buttermilk, dried sweet cream
buttermilk, skim milk that has been concentrated and from which part of
the lactose has been removed by crystallization, and whey and those
modified whey products (e.g., reduced lactose whey, reduced minerals
whey, and whey protein concentrate) that have been determined by FDA to
be generally recognized as safe (GRAS) for use in this type of food.
Water may be added, or water may be evaporated from the mix. The sweet
cream buttermilk and the concentrated sweet cream buttermilk or dried
sweet cream buttermilk, when adjusted with water to a total solids
content of 8.5 percent, has a titratable acidity of not more than 0.17
percent calculated as lactic acid. The term ''milk'' as used in this
section means cow's milk.
(c) Optional caseinates. The optional caseinates referred to in
paragraph (a) of this section which may be added to sherbet mix are:
Casein prepared by precipitation with gums, ammonium caseinate, calcium
caseinate, potassium caseinate, and sodium caseinate. Caseinates may be
added in liquid or dry form, but must be free of excess alkali, such
caseinates are not considered to be milk solids.
(d) Optional fruit-characterizing ingredients. The optional
fruit-characterizing ingredients referred to in paragraph (a) of this
section are any mature fruit or the juice of any mature fruit. The
fruit or fruit juice used may be fresh, frozen, canned, concentrated, or
partially or wholly dried. The fruit may be thickened with pectin or
other optional ingredients. The fruit is prepared by the removal of
pits, seeds, skins, and cores, where such removal is usual in preparing
that kind of fruit for consumption as fresh fruit. The fruit may be
screened, crushed, or otherwise comminuted. It may be acidulated. In
the case of concentrated fruit or fruit juices, from which part of the
water is removed, substances contributing flavor volatilized during
water removal may be condensed and reincorporated in the concentrated
fruit or fruit juice. In the case of citrus fruits, the whole fruit,
including the peel but excluding the seeds, may be used, and in the case
of citrus juice or concentrated citrus juices, cold-pressed citrus oil
may be added thereto in an amount not exceeding that which would have
been obtained if the whole fruit had been used. The quantity of fruit
ingredients used is such that, in relation to the weight of the finished
sherbet, the weight of fruit or fruit juice, as the case may be
(including water necessary to reconstitute partially or wholly dried
fruits or fruit juices to their original moisture content), is not less
than 2 percent in the case of citrus sherbets, 6 percent in the case of
berry sherbets, and 10 percent in the case of sherbets prepared with
other fruits. For the purpose of this section, tomatoes and rhubarb are
considered as kinds of fruit.
(e) Optional nonfruit characterizing ingredients. The optimal
nonfruit characterizing ingredients referred to in paragraph (a) of this
section include but are not limited to the following:
(1) Ground spice or infusion of coffee or tea.
(2) Chocolate or cocoa, including sirup.
(3) Confectionery.
(4) Distilled alcoholic beverage, including liqueurs or wine, in an
amount not to exceed that required for flavoring the sherbet.
(5) Any natural or artificial food flavoring (except any having a
characteristic fruit or fruit-like flavor).
(f) Nomenclature. (1) The name of each sherbet is as follows:
(i) The name of each fruit sherbet is '' ------ sherbet'', the blank
being filled in with the common name of the fruit or fruits from which
the fruit ingredients used are obtained. When the names of two or more
fruits are included, such names shall be arranged in order of
predominance, if any, by weight of the respective fruit ingredients
used.
(ii) The name of each nonfruit sherbet is '' ------ sherbet'', the
blank being filled in with the common or usual name or names of the
characterizing flavor or flavors; for example, ''peppermint'', except
that if the characterizing flavor used is vanilla, the name of the food
is '' ------ sherbet'', the blank being filled in as specified by
135.110(e)(2) and (5)(i).
(2) When the optional ingredients, artificial flavoring, or
artificial coloring are used in sherbet, they shall be named on the
label as follows:
(i) If the flavoring ingredient or ingredients consists exclusively
of artificial flavoring, the label designation shall be ''artificially
flavored''.
(ii) If the flavoring ingredients are a combination of natural and
artificial flavors, the label designation shall be ''artificial and
natural flavoring added''.
(iii) The label shall designate artificial coloring by the statement
''artificially colored'', ''artificial coloring added'', ''with added
artificial coloring'', or '' ------ , an artificial color added'', the
blank being filled in with the name of the artificial coloring used.
(g) Characterizing flavor(s). Wherever there appears on the label
any representation as to the characterizing flavor or flavors of the
food and such flavor or flavors consist in whole or in part of
artificial flavoring, the statment required by paragraph (f)(2) (i) and
(ii) of this section, as apprpriate, shall immediately and conspicuously
precede or follow such representation, without intervening written,
printed, or graphic matter (except that the word ''sherbet'' may
intervene) in a size reasonably related to the prominence of the name of
the characterizing flavor and in any event the size of the type is not
less than 6-point on packages containing less than 1 pint, not less than
8-point on packages containing at least 1 pint but less than one-half
gallon, not less than 10-point on packages containing at least one-half
gallon but less than 1 gallon, and not less than 12-point on packages
containing 1 gallon or over.
(h) Display of statements required by paragraph (f)(2). Except as
specified in paragraph (g) of this section, the statements required by
paragraph (f)(2) of this section shall be set forth on the principal
display panel or panels of the label with such prominence and
conspicuousness as to render them likely to be read and understood by
the ordinary individual under customary conditions of purchase and use.
(i) Label declaration. Each of the optional ingredients used shall
be declared on the label as required by the applicable sections of Part
101 of this chapter.
(43 FR 4599, Feb. 3, 1978, as amended at 46 FR 44434, Sept. 4, 1981)
21 CFR 135.160 Water ices.
(a) Description. Water ices are the foods each of which is prepared
from the same ingredients and in the same manner prescribed in 135.140
for sherbets, except that the mix need not be pasteurized, and complies
with all the provisions of 135.140 (including the requirements for
label statement of optional ingredients) except that no milk or
milk-derived ingredient and no egg ingredient, other than egg white, is
used.
(b) Nomenclature. The name of the food is '' ------ ice'', the blank
being filled in, in the same manner as specified in 135.140(f)(1) (i)
and (ii), as appropriate.
(42 FR 19132, Apr. 12, 1977)
21 CFR 135.160 PART 136 -- BAKERY PRODUCTS
21 CFR 135.160 Pt. 136
21 CFR 135.160 Subpart A -- General Provisions
Sec.
136.3 Definitions.
21 CFR 135.160 Subpart B -- Requirements for Specific Standardized
Bakery Products
136.110 Bread, rolls, and buns.
136.115 Enriched bread, rolls, and buns.
136.130 Milk bread, rolls, and buns.
136.160 Raisin bread, rolls, and buns.
136.180 Whole wheat bread, rolls, and buns.
Authority: Secs. 201, 401, 403, 409, 701, 706 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321, 341, 343, 348, 371, 376).
Source: 42 FR 14400, Mar. 15, 1977, unless otherwise noted.
21 CFR 135.160 Subpart A -- General Provisions
21 CFR 136.3 Definitions.
For purposes of this part, the following definitions apply:
(a) The word ''bread'' when used in the name of the food means the
unit weighs one-half pound or more after cooling.
(b) The words ''rolls'' and ''buns'' when used in the name of the
food mean the unit weighs less than one-half pound after cooling.
21 CFR 136.3 Subpart B -- Requirements for Specific Standardized Bakery Products
21 CFR 136.110 Bread, rolls, and buns.
(a) Bread, white bread, and rolls, white rolls, or buns, and white
buns are the foods produced by baking mixed yeast-leavened dough
prepared from one or more of the farinaceous ingredients listed in
paragraph (c)(1) of this section and one or more of the moistening
ingredients listed in paragraphs (c) (2), (6), (7), and (8) of this
section and one or more of the leavening agents provided for by
paragraph (c)(3) of this section. The food may contain additional
ingredients as provided for by paragraph (c) of this section. Each of
the finished foods contains not less than 62 percent total solids as
determined by the method prescribed in paragraph (d) of this section.
(b) All ingredients from which the food is fabricated shall be safe
and suitable.
(c) The following optional ingredients are provided for:
(1) Flour, bromated flour, phosphated flour, or a combination of two
or more of these. The potassium bromate in any bromated flour used and
the monocalcium phosphate in any phosphated flour used are deemed to be
additional optional ingredients in the bread, rolls, or buns. All
ingredients in any flour, bromated flour, or phosphated flour used are
deemed to be optional ingredients of the bread, rolls, or buns prepared
therefrom.
(2) Water.
(3) Yeast -- any type which produces the necessary leavening effect.
(4) Salt.
(5) Shortening, in which or in conjunction with which may be used one
or any combination of two or more of the following:
(i) Lecithin, hydroxylated lecithin complying with the provisions of
Part 172 of this chapter, either of which may include related
phosphatides derived from the corn oil or soybean oil from which such
ingredients were obtained.
(ii) Mono- and diglycerides of fat-forming fatty acids, diacetyl
tartaric acid esters of mono- and diglycerides of fat-forming fatty
acids, propylene glycol mono- and diesters of fat-forming fatty acids,
and other ingredients that perform a similar function.
(6) Milk and/or other dairy products in such quantity and composition
as not to meet the requirements for milk and/or other dairy products
prescribed for milk bread by 136.130. Whenever nonfat milk solids in
any form are used, carrageenan or salts of carrageenan complying with
the provisions of Part 172 of this chapter may be used in a quantity not
in excess of 0.8 percent by weight of such nonfat milk solids.
(7) Egg products.
(8) Nutritive carbohydrate sweeteners.
(9) Enzyme active preparations.
(10) Lactic-acid-producing bacteria.
(11) Nonwheat flours, nonwheat meals, nonwheat grits, wheat and
nonwheat starches, any of which may be wholly or in part dextrinized,
dextrinized wheat flour, or any combination of 2 or more of these, if
the total quantity is not more than 3 parts for each 100 parts by weight
of flour used.
(12) Ground dehulled soybeans which may be heat-treated, and from
which oil may be removed, but which retain enzymatic activity, if the
quantity is not more than 0.5 part for each 100 parts by weight of flour
used.
(13) Yeast nutrients and calcium salts, if the total quantity of such
ingredients, with the exception of monocalcium phosphate and calcium
propionate, is not more than 0.25 part for each 100 parts by weight of
flour used. The quantity of monocalcium phosphate, including any
quantity in the flour used, is not more than 0.75 part for each 100
parts by weight of flour used. Any calcium propionate used as a
preservative in bread, rolls, or buns is not subject to the limitation
prescribed in this paragraph.
(14)(i) Potassium bromate, calcium bromate, potassium iodate, calcium
iodate, calcium peroxide, or any combination of 2 or more of these if
the total quantity, including the potassium bromate in any bromated
flour used, is not more than 0.0075 part for each 100 parts by weight of
flour used.
(ii) Azodicarbonamide, if the total quantity, including any quantity
in the flour used, is not more than 0.0045 part for each 100 parts by
weight of flour used.
(15) Dough strengtheners and other dough conditioners not listed or
referred to in this paragraph, if the total quantities of such
ingredients or combination is not more than 0.5 part for each 100 parts
by weight of flour used.
(16) Spices, spice oil, and spice extract.
(17) Coloring may not be added as such or as part of another
ingredient except as permitted by paragraph (c)(16) of this section and
except that coloring which may be present in butter or margarine if the
intensity of the butter or margarine color does not exceed ''medium
high'' (MH) when viewed under diffused light (7400 Kelvin) against the
Munsell Butter Color Comparator. The MH designation corresponds to the
Munsell renotation of 3.8Y7.9/7.6.
(18) Other ingredients that do not change the basic identity or
adversely affect the physical and nutritional characteristics of the
food.
(d) Total solids are determined by the method prescribed in
''Official Methods of Analysis of the Association of Official Analytical
Chemists,'' 13th Ed. (1980), section 14.091(a), which is incorporated
by reference, except that if the baked unit weighs 454 grams (1 pound)
or more, one entire unit is used for the determination; if the baked
unit weighs less than 454 grams, enough units to weigh 454 grams or more
are used. Copies of the material incorporated by reference may be
obtained from the Association of Official Analytical Chemists, 2200
Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may be examined at
the Office of the Federal Register, 1100 L St. NW., Washington, DC
20408.
(e)(1) The name of the food is ''bread'', ''white bread'', ''rolls'',
''white rolls'', ''buns'', ''white buns'', as applicable. When the food
contains not less than 2.56 percent by weight of whole egg solids, the
name of the food may be ''egg bread'', ''egg rolls'', or ''egg buns'',
as applicable, accompanied by the statement ''Contains ---- medium-sized
egg(s) per pound'' in the manner prescribed by 102.5(c)(3) of this
chapter, the blank to be filled in with the number which represents the
whole egg content of the food expressed to the nearest one-fifth egg but
not greater than the amount actually present. For the purpose of this
regulation, whole egg solids are the edible contents of eggs calculated
on a moisture-free basis and exclusive of any nonegg solids which may be
present in standardized and other commercial egg products. One
medium-sized egg is equivalent to 0.41 ounce of whole egg solids.
(2) When the label bears any representation, other than in the
ingredient listing, of the presence of egg in the food, e.g., the word
egg or any phonetic equivalent spelling of the word egg, or a picture of
an egg, the food shall contain not less than 2.56 percent of whole egg
solids.
(f) All ingredients used in the food shall be declared on the label
as required by the applicable sections of Part 101 of this chapter.
(42 FR 14400, Mar. 15, 1977, as amended at 43 FR 47177, Oct. 13,
1978; 47 FR 11826, Mar. 19, 1982; 49 FR 10096, Mar. 19, 1984; 49 FR
13692, Apr. 6, 1984; 54 FR 24894, June 12, 1989)
21 CFR 136.115 Enriched bread, rolls, and buns.
(a) Each of the foods enriched bread, enriched rolls, and enriched
buns conforms to the definition and standard of identity and is subject
to the requirements for label statement of ingredients prescribed for
bread, rolls or buns by 136.110, except that:
(1) Each such food contains in each pound 1.8 milligrams of thiamine,
1.1 milligrams of riboflavin, 15 milligrams of niacin, and 12.5
milligrams of iron.
(2) Each such food may contain added calcium in such quantity that
the total calcium content is 600 milligrams per pound. If insufficient
calcium is added to meet the 600-milligram level per pound of the
finished food, no claim may be made on the label for calcium as a
nutrient except as a part of nutrition labeling.
(3) The requirements of paragraphs (a) (1) and (2) of this section
will be deemed to have been met if reasonable overages of the vitamins
and minerals, within the limits of good manufacturing practice, are
present to ensure that the required levels of the vitamins and minerals
are maintained throughout the expected shelf life of the food under
customary conditions of distribution and storage. The quantitative
content of the following vitamins shall be calculated in terms of the
following chemically identifiable reference forms:
(4) Each such food may also contain wheat germ or partly defatted
wheat germ, but the total quantity thereof, including any wheat germ or
partly defatted wheat germ in any enriched flour used, shall not be more
than 5 percent of the flour ingredient.
(5) Enriched flour may be used, in whole or in part, instead of
flour. As used in this section, the term ''enriched flour'' includes
enriched bromated flour.
(6) The limitation prescribed by 136.110(c)(6) on the quantity and
composition of milk and/or other dairy products does not apply.
(7) The vitamins and minerals added to the food for enrichment
purposes may be supplied by any safe and suitable substances. Niacin
equivalents as derived from tryptophan content shall not be used in
determining total niacin content.
(b) The name of the food is ''enriched bread'', ''enriched rolls'',
or ''enriched buns'', as applicable. When the food contains not less
than 2.56 percent by weight of whole egg solids, the name of the food
may be ''enriched egg bread'', ''enriched egg rolls'', or ''enriched egg
buns'', as applicable, accompanied by the statement ''Contains ----
medium-sized egg(s) per pound'' in the manner prescribed by 102.5(c)(3)
of this chapter, the blank to be filled in with the number which
represents the whole egg content of the food expressed to the nearest
one-fifth egg but not greater than the amount actually present. For the
purpose of this regulation, whole egg solids are the edible contents of
eggs calculated on a moisture-free basis and exclusive of any non-egg
solids which may be present in standardized and other commercial egg
products. One medium-sized egg is equivalent to 0.41 ounce of whole egg
solids. When the food complies with the requirements for milk and/or
other dairy products content in 136.130 for milk bread, the name of the
food may be ''enriched milk bread'', ''enriched milk rolls'', or
''enriched milk buns'', as applicable. When the food complies with the
requirements for both enriched egg bread and enriched milk bread in this
section, the name of the food may be ''enriched milk and egg bread'',
''enriched milk and egg rolls'', or ''enriched milk and egg buns'', as
applicable accompanied by the statement ''Contains ---- medium-sized
egg(s) per pound'' in the manner prescribed by 102.5(c)(3) of this
chapter, the blank to be filled in with the number which represents the
whole egg content of the food expressed to the nearest one-fifth egg but
no greater than the amount actually present. For purposes of this
regulation, whole egg solids are the edible contents of eggs calculated
on a moisture-free basis and exclusive of any non-egg solids which may
be present in standardized or other commercial egg products. One
medium-sized egg is equivalent to 0.41 ounce of whole egg solids.
(42 FR 14400, Mar. 15, 1977, as amended at 43 FR 38578, Aug. 29,
1978; 46 FR 43413, Aug. 28, 1981)
21 CFR 136.130 Milk bread, rolls, and buns.
(a) Each of the foods milk bread, milk rolls, and milk buns conforms
to the definition and standard of identity and is subject to the
requirements for label statement of ingredients prescribed for bread,
rolls or buns by 136.110 except that:
(1) The only moistening ingredient permitted in the preparation of
the dough is milk or, as an alternative, a combination of dairy products
in such a proportion that the weight of the nonfat milk solids is not
more than 2.3 times and not less than 1.2 times the weight of the
milkfat therein, with or without water, in a quantity that provides not
less than 8.2 parts milk solids for each 100 parts by weight of flour.
(2) No buttermilk, buttermilk product, cheese whey, cheese whey
product, or milk protein is used.
(b) The name of the food is ''milk bread'', ''milk rolls'', ''milk
buns'', as applicable.
21 CFR 136.160 Raisin bread, rolls, and buns.
(a) Each of the foods raisin bread, raisin rolls, and raisin buns
conforms to the definition and standard of identity and is subject to
the requirements for label statement of ingredients prescribed for
bread, rolls or buns by 136.110, except that:
(1) Not less than 50 parts by weight of seeded or seedless raisins
are used for each 100 parts by weight of flour used.
(2) Water extract of raisins may be used, but not to replace raisins.
(3) The baked units may bear icing or frosting.
(4) The limitation prescribed by 136.110(c)(6) on the quantity and
composition of milk and/or other dairy products does not apply.
(5) The total solids are determined by the method prescribed in
136.110(d), except that section 14.091(b) of ''Official Methods of
Analysis of the Association of Official Analytical Chemists,'' 13th Ed.
(1980), which is incorporated by reference, will apply. Copies may be
obtained from the Association of Official Analytical Chemists, 2200
Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may be examined at
the Office of the Federal Register, 1100 L St. NW., Washington, DC
20408.
(b) The name of the food is ''raisin bread'', ''raisin rolls'',
''raisin buns'', as applicable. When the food contains not less than
2.56 percent by weight of whole egg solids, the name of the food may be
''raisin and egg bread'', ''raisin and egg rolls'', or ''raisin and egg
buns'', as applicable, accompanied by the statement ''Contains ----
medium-sized egg(s) per pound'' in the manner prescribed by 102.5(c)(3)
of this chapter, the blank to be filled in with the number which
represents the whole egg content of the food expressed to the nearest
one-fifth egg but not greater than the amount actually present. For
purposes of this regulation, whole egg solids are the edible contents of
eggs calculated on a moisture-free basis and exclusive of any nonegg
solids which may be present in standardized and other commercial egg
products. One medium-sized egg is equivalent to 0.41 ounce of whole egg
solids.
(42 FR 14400, Mar. 15, 1977, as amended at 47 FR 11826, Mar. 19,
1982; 49 FR 10096, Mar. 19, 1984; 54 FR 24894, June 12, 1989)
21 CFR 136.180 Whole wheat bread, rolls, and buns.
(a) Each of the foods whole wheat bread, graham bread, entire wheat
bread, whole wheat rolls, graham rolls, entire wheat rolls, whole wheat
buns, graham buns, and entire wheat buns conforms to the definition and
standard of identity and is subject to the label statement of
ingredients prescribed for bread, rolls and buns by 136.110, except
that:
(1) The dough is made from the optional ingredient whole wheat flour,
bromated whole wheat flour, or a combination of these. No flour,
bromated flour, or phosphated flour is used. The potassium bromate in
any bromated whole wheat flour used is deemed to be an additional
optional ingredient in the whole wheat bread, whole wheat rolls, or
whole wheat buns.
(2) The limitation prescribed by 136.110(c)(6) on the quantity and
composition of milk and/or other dairy products does not apply.
(b) The name of the food is ''whole wheat bread'', ''graham bread'',
''entire wheat bread'', ''whole wheat rolls'', ''graham rolls'',
''entire wheat rolls'', ''whole wheat buns'', ''graham buns'', ''entire
wheat buns'', as applicable.
21 CFR 136.180 PART 137 -- CEREAL FLOURS AND RELATED PRODUCTS
21 CFR 136.180 Pt. 137
21 CFR 136.180 Subpart A -- (Reserved)
21 CFR 136.180 Subpart B -- Requirements for Specific Standardized
Cereal Flours and Related Products
Sec.
137.105 Flour.
137.155 Bromated flour.
137.160 Enriched bromated flour.
137.165 Enriched flour.
137.170 Instantized flours.
137.175 Phosphated flour.
137.180 Self-rising flour.
137.185 Enriched self-rising flour.
137.190 Cracked wheat.
137.195 Crushed wheat.
137.200 Whole wheat flour.
137.205 Bromated whole wheat flour.
137.211 White corn flour.
137.215 Yellow corn flour.
137.220 Durum flour.
137.225 Whole durum flour.
137.230 Corn grits.
137.235 Enriched corn grits.
137.240 Quick grits.
137.245 Yellow grits.
137.250 White corn meal.
137.255 Bolted white corn meal.
137.260 Enriched corn meals.
137.265 Degerminated white corn meal.
137.270 Self-rising white corn meal.
137.275 Yellow corn meal.
137.280 Bolted yellow corn meal.
137.285 Degerminated yellow corn meal.
137.290 Self-rising yellow corn meal.
137.300 Farina.
137.305 Enriched farina.
137.320 Semolina.
137.350 Enriched rice.
Authority: Secs. 201, 401, 403, 409, 701, 706 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321, 341, 343, 348, 371, 376).
Source: 42 FR 14402, Mar. 15, 1977, unless otherwise noted.
21 CFR 136.180 Subpart A -- (Reserved)
21 CFR 136.180 Subpart B -- Requirements for Specific Standardized Cereal Flours and Related Products
21 CFR 137.105 Flour.
(a) Flour, white flour, wheat flour, plain flour, is the food
prepared by grinding and bolting cleaned wheat, other than durum wheat
and red durum wheat. To compensate for any natural deficiency of
enzymes, malted wheat, malted wheat flour, malted barley flour, or any
combination of two or more of these, may be used; but the quantity of
malted barley flour so used is not more than 0.75 percent. Harmless
preparations of -amylase obtained from Aspergillus oryzae, alone or in
a safe and suitable carrier, may be used. When tested for granulation
as prescribed in paragraph (c)(4) of this section, not less than 98
percent of the flour passes through a cloth having openings not larger
than those of woven wire cloth designated ''212 m (No. 70)'' complying
with the specifications for such cloth set forth in ''Official Methods
of Analysis of the Association of Official Analytical Chemists'' (AOAC),
13th Ed. (1980), Table 1, ''Nominal Dimensions of Standard Test Sieves
(U.S.A. Standard Series),'' under the heading ''Definitions of Terms and
Explanatory Notes,'' which is incorporated by reference. Copies may be
obtained from the Association of Official Analytical Chemists, 2200
Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may be examined at
the Office of the Federal Register, 1100 L St. NW., Washington, DC
20408. The flour is freed from bran coat, or bran coat and germ, to
such extent that the percent of ash therein, calculated to a
moisture-free basis, is not more than the sum of 1/20 of the percent of
protein therein, calculated to a moisture-free basis, plus 0.35. Its
moisture content is not more than 15 percent. It may contain ascorbic
acid in a quantity not to exceed 200 parts per million as a dough
conditioner. Unless such addition conceals damage or inferiority or
makes the flour appear to be better or of greater value than it is, one
or any combination of two or more of the following optional bleaching
ingredients may be added in a quantity not more than sufficient for
bleaching or, in case such ingredient has an artificial aging effect, in
a quantity not more than sufficient for bleaching and such artificial
aging effect:
(1) Oxides of nitrogen.
(2) Chlorine.
(3) Nitrosyl chloride.
(4) Chlorine dioxide.
(5) One part by weight of benzoyl peroxide mixed with not more than
six parts by weight of one or any mixture of two or more of the
following: potassium alum, calcium sulfate, magnesium carbonate, sodium
aluminum sulfate, dicalcium phosphate, tricalcium phosphate, starch,
calcium carbonate.
(6) Acetone peroxides complying with the provisions of 172.802 of
this chapter.
(7) Azodicarbonamide (complying with the requirements of 172.806 of
this chapter, including the quantitative limit of not more than 45 parts
per million).
(b)(1) All optional ingredients used in the food shall be declared on
the label as required by the applicable sections of Part 101 of this
chapter.
(2) When ascorbic acid is added, the label shall bear the statement
''Ascorbic acid added as a dough conditioner''. When the optional
ingredient -amylase obtained from Aspergillus oryzae'' is used, it may
alternatively be declared in the list of ingredients as ''Fungal
alpha-amylase,'' ''Fungal -amylase'', ''Enzyme'', or ''Enzyme added for
improved baking''. When any optional bleaching ingredient is used, the
label shall bear the word ''Bleached''. Wherever the name of the food
appears on the label so conspicuously as to be easily seen under
customary conditions of purchase, the word ''Bleached'' shall
immediately and conspicuously precede or follow such name, without
intervening written, printed, or graphic matter; except that where such
name is a part of a trademark or brand, other written, printed, or
graphic matter, which is also a part of such trademark or brand, may so
intervene if the word ''Bleached'' is in such juxtaposition with such
trademark or brand as to be conspicuoulsy related to such name.
(c) For the purposes of this section:
(1) Ash is determined by the method prescribed in the AOAC, 13th Ed.
(1980), section 14.006, ''Direct Method -- Official Final Action,''
under the heading ''Ash (5),'' which is incorporated by reference. The
availability of this incorporation by reference is given in paragraph
(a) of this section. Ash is calculated to a moisture-free basis by
subtracting the percent of moisture in the flour from 100, dividing the
remainder into the percent of ash, and multiplying the quotient by 100.
(2) Protein is 5.7 times the nitrogen as determined by the method
prescribed in section 2.057, ''Improved Kjeldahl Methods for
Nitrate-Free Samples (20) -- Official Final Action,'' AOAC, 13th Ed.
(1980), which is incorporated by reference. The availability of this
incorporation by reference is given in paragraph (a) of this section.
Protein is calculated to a moisture-free basis by subtracting the
percent of moisture in the flour from 100, dividing the remainder into
the percent of protein, and multiplying the quotient by 100.
(3) Moisture is determined by the method prescribed in the AOAC, 13th
Ed. (1980), sections 14.002 and 14.003, ''Vacuum Oven Method (2) --
Official Final Action,'' under the heading ''Total Solids Moisture,
Indirect Method,'' which is incorporated by reference. The availability
of this incorporation by reference is given in paragraph (a) of this
section.
(4) Granulation is determined as follows: Use No. 70 sieve
complying with the specifications for ''Nominal Dimensions of Standard
Test Sieves (U.S.A. Standard Series)'' prescribed in paragraph (a) of
this section. Attach bottom pan to sieve in Ro-Tap sifter (or an
equivalent sifter). Place half of a rubber ball or other sieving aid in
the sieve. Pour 100 grams of the sample in the sieve and turn on the
sifter with knocker. Sift exactly 5 minutes. Weigh the residue on the
No. 70 sieve and convert to percentage.
(42 FR 14402, Mar. 15, 1977, as amended at 47 FR 11827, Mar. 19,
1982; 47 FR 24693, June 8, 1982; 47 FR 43363, Oct. 1, 1982; 49 FR
10097, Mar. 19, 1984; 54 FR 24894, June 12, 1989)
21 CFR 137.155 Bromated flour.
Bromated flour conforms to the definition and standard of identity,
and is subject to the requirements for label statement of optional
ingredients, prescribed for flour by 137.105, except that potassium
bromate is added in a quantity not exceeding 50 parts to each million
parts of the finished bromated flour, and is added only to flours whose
baking qualities are improved by such addition.
21 CFR 137.160 Enriched bromated flour.
Enriched bromated flour conforms to the definition and standard of
identity, and is subject to the requirements for label statement of
optional ingredients, prescribed or enriched flour by 137.165, except
that potassium bromate is added in a quantity not exceeding 50 parts to
each million parts of the finished enriched bromated flour, and is added
only to enriched flours whose baking qualities are improved by such
addition.
21 CFR 137.165 Enriched flour.
Enriched flour conforms to the definition and standard of identity,
and is subject to the requirements for label statement of optional
ingredients, prescribed for flour by 137.105 except that:
(a) It contains in each pound 2.9 milligrams of thiamine, 1.8
milligrams of riboflavin, 24 milligrams of niacin, and 20 milligrams of
iron.
(b) It may contain added calcium in such quantity that the total
calcium content is 960 milligrams per pound. Enriched flour may be
acidified with monocalcium phosphate within the limits prescribed by
137.175 for phosphated flour, but, if insufficient additional calcium is
present to meet the 960 milligram level, no claim may be made on the
label for calcium as a nutrient;
(c) The requirement of paragraphs (a) and (b) of this section will be
deemed to have been met if reasonable overages of the vitamins and
minerals, within the limits of good manufacturing practice, are present
to insure that the required levels of the vitamins and minerals are
maintained throughout the expected shelf life of the food under
customary conditions of distribution and storage. The quantitative
content of the following vitamins shall be calculated in terms of the
following chemically identifiable reference forms:
(d) It may contain not more than 5 percent by weight of wheat germ or
partly defatted wheat germ;
(e) In determining whether the ash content complies with the
requirements of this section, ash resulting from any added iron or salts
of iron or calcium or wheat germ is excluded in calculating ash content.
(f) All ingredients from which the food is fabricated shall be safe
and suitable. The vitamins and minerals added to the food for
enrichment purposes may be supplied by any safe and suitable substance.
Niacin equivalents as derived from tryptophan content shall not be used
in determining total niacin content.
(42 FR 14402, Mar. 15, 1977, as amended at 43 FR 38578, Aug. 29,
1978; 46 FR 43414, Aug. 28, 1981)
21 CFR 137.170 Instantized flours.
(a) Instantized flours, instant blending flours, quick-mixing flours,
are the foods each of which conforms to the definition and standard of
identity and is subject to the requirement for label statement of
optional ingredients prescribed for the corresponding kind of flour by
137.105, 137.155, 137.160, 137.165, 137.175, 137.180, and 137.185,
except that each such flour has been made by one of the optional
procedures set forth in paragraph (b) of this section, and is thereby
made readily pourable. Such flour will all pass through a No. 20 mesh
U.S. standard sieve (840-micron opening), and not more than 20 percent
will pass through a 200 mesh U.S. standard sieve (74-micron opening).
(b) The optional procedures referred to in paragraph (a) of this
section are:
(1) A selective grinding and bolting procedure or other milling
procedure, whereby controlled techniques are used to obtain a food too
fine to meet the granulation specification prescribed in 137.300(a) for
farina.
(2) An agglomerating procedure, whereby flour that originally meets
the granulation specification prescribed in 137.105(a) has been
modified by further processing, so that a number of the individual flour
particles have been combined into agglomerates conforming to the
granulation specifications set out in paragraph (a) of this section.
(c) The name of each product covered by this section is the name
prescribed by the definition and standard of identity for the
corresponding kind of flour as referred to in paragraph (a) of this
section, preceded immediately and conspicuously by the words
''Instantized'', ''Instant blending'', or ''Quick-mixing''.
21 CFR 137.175 Phosphated flour.
Phosphated flour, phosphated white flour, phosphated wheat flour,
conforms to the definition and standard of identity, and is subject to
the requirements for label declaration of optional ingredients,
prescribed for flour by 137.105, except that:
(a) Monocalcium phosphate is added in a quantity not less than 0.25
percent and not more than 0.75 percent of the weight of the finished
phosphated flour; and
(b) In determining whether the ash content complies with the
requirements of this section allowance is made for the added monocalcium
phosphate.
21 CFR 137.180 Self-rising flour.
(a) Self-rising flour, self-rising white flour, self-rising wheat
flour, is an intimate mixture of flour, sodium bicarbonate, and one or
more of the acid-reacting substances monocalcium phosphate, sodium acid
pyrophosphate, and sodium aluminum phosphate. It is seasoned with salt.
When it is tested by the method prescribed in paragraph (c) of this
section not less than 0.5 percent of carbon dioxide is evolved. The
acid-reacting substance is added in sufficient quantity to neutralize
the sodium bicarbonate. The combined weight of such acid-reacting
substance and sodium bicarbonate is not more than 4.5 parts to each 100
parts of flour used. Subject to the conditions and restrictions
prescribed by 137.105(a), the bleaching ingredients specified in such
section may be added as optional ingredients. If the flour used in
making the self-rising flour is bleached, the optional bleaching
ingredient used therein (see 137.105(a)) is also an optional ingredient
of the self-rising flour.
(b) All optional ingredients in self-rising flour, including any
contributed by the flour used, shall be declared on the label as
required by the applicable sections of Part 101 of this chapter and
137.105(b)(2), as appropriate.
(c) The method referred to in paragraph (a) of this section is the
method prescribed in ''Official Methods of Analysis of the Association
of Official Analytical Chemists'' (AOAC), 13th Ed. (1980), section
8.002, ''Reagent (Displacement soln.),'' and section 8.003, ''Chittick
apparatus,'' under the heading ''Total Carbon Dioxide (1) -- Official
Final Action,'' which is incorporated by reference. Copies may be
obtained from the Association of Official Analytical Chemists, 2200
Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may be examined at
the Office of the Federal Register, 1100 L St. NW., Washington, DC
20408. The following procedure is substituted for the procedure
specified in the AOAC, under section 8.004, ''Determination'':
(1) Weigh 17 grams of the official sample into flask A, add 15-20
glass beads (4-6 mm. diameter), and connect this flask with the
apparatus (fig. 22). Open stopcock C and by means of the leveling bulb E
bring the displacement solution to the 25 cc. graduation above the zero
mark. (This 25 cc. is a partial allowance for the volume of acid to be
used in the decomposition.) Allow the apparatus to stand 1-2 minutes to
insure that the temperature and pressure within the apparatus are the
same as those of the room. Close the stopcock, lower the leveling bulb
somewhat to reduce the pressure within the apparatus, and slowly run
into the decomposition flask from burette F 45 cc. of sulfuric acid
(1+5). To prevent the liberated carbon dioxide from escaping through
the acid burette into the air, keep the displacement solution in the
leveling bulb at all times during the decomposition at a lower level
than that in the gas-measuring tube. Rotate and then vigorously agitate
the decomposition flask for three minutes to mix the contents
intimately. Allow to stand for 10 minutes to bring to equilibrium.
Equalize the pressure in the measuring tube by means of the leveling
bulb and read the volume of gas from the zero point on the tube. Deduct
20 cc. from this reading (this 20 cc. together with previous allowance
of 25 cc. compensates for the 45 cc. acid used in the decomposition).
Observe the temperature of the air surrounding the apparatus and also
the barometric pressure and multiply the number of mL of gas evolved by
the factor given in section 52.007, ''Correction factors for gasometric
determination of carbon dioxide,'' AOAC, 13th Ed. (1980), which is
incorporated by reference (the availability of this incorporation by
reference is given in paragraph (c) of this section), for the
temperature and pressure observed. Divide the corrected reading by 100
to obtain the apparent percent by weight of carbon dioxide in the
official sample.
(2) Correct the apparent percent of carbon dioxide to compensate for
varying atmospheric conditions by immediately assaying a synthetic
sample by the same method in the same apparatus.
(3) Prepare the synthetic sample with 16.2 grams of flour, 0.30 gram
of monocalcium phosphate, 0.30 gram of salt, and a sufficient quantity
of sodium bicarbonate U.S.P. (dried over sulfuric acid) to yield the
amount of carbon dioxide recovered in assay of official sample.
Determine this quantity by multiplying weight of carbon dioxide
recovered in assay of official sample by 1.91.
(4) Divide the weight of carbon dioxide recovered from synthetic
sample by weight of carbon dioxide contained in sodium bicarbonate used.
(5) Divide the quotient into the apparent percent of carbon dioxide
in official sample to obtain percent of carbon dioxide evolved from the
official sample.
(42 FR 14402, Mar. 15, 1977, as amended at 47 FR 11827, Mar. 19,
1982; 49 FR 10097, Mar. 19, 1984; 54 FR 24894, June 12, 1989)
21 CFR 137.185 Enriched self-rising flour.
Enriched self-rising flour conforms to the definition and standard of
identity, and is subject to the requirements for label statement of
optional ingredients, prescribed for self-rising flour by 137.180,
except that:
(a) It contains in each pound 2.9 milligrams of thiamine, 1.8
milligrams of riboflavin, 24 milligrams of niacin, and 20 milligrams of
iron.
(b) It contains added calcium in such quantity that the total calcium
content is 960 milligrams per pound. If a calcium compound is added for
technical purposes to give self-rising characteristics to the flour, the
amount of calcium per pound of flour may exceed 960 milligrams provided
that the excess is no greater than necessary to accomplish the intended
effect. However, if such calcium is insufficient to meet the
960-milligram level, no claim may be made on the label for calcium as a
nutrient.
(c) The requirements of paragraphs (a) and (b) of this section will
be deemed to have been met if reasonable overages of the vitamins and
minerals, within the limits of good manufacturing practice, are present
to insure that the required levels of the vitamins and minerals are
maintained throughout the expected shelf life of the food under
customary conditions of distribution and storage. The quantitative
content of the following vitamins shall be calculated in terms of the
following chemically identifiable reference forms:
(d) It may contain not more than 5 percent by weight of wheat germ or
partly defatted wheat germ;
(e) When calcium is added as dicalcium phosphate, such dicalcium
phosphate is also considered to be an acid-reacting substance;
(f) When calcium is added as carbonate, the method set forth in
137.180(c) does not apply as a test for carbon dioxide evolved; but in
such case the quantity of carbon dioxide evolved under ordinary
conditions of use of the enriched self-rising flour is not less than 0.5
percent of the weight thereof;
(g) All ingredients from which the food is fabricated shall be safe
and suitable. The vitamins and minerals added to the food for
enrichment purposes may be supplied by any safe and suitable substances.
Niacin equivalents as derived from tryptophan content shall not be used
in determining total niacin content.
(42 FR 14402, Mar. 15, 1977, as amended at 43 FR 38578, Aug. 29,
1978; 46 FR 43414, Aug. 28, 1981)
21 CFR 137.190 Cracked wheat.
Cracked wheat is the food prepared by so cracking or cutting into
angular fragments cleaned wheat other than durum wheat and red durum
wheat that, when tested by the method prescribed in 137.200(c)(2), not
less than 90 percent passes through a No. 8 sieve and not more than 20
percent passes through a No. 20 sieve. The proportions of the natural
constituents of such wheat, other than moisture, remain unaltered.
Cracked wheat contains not more than 15 percent of the moisture as
determined by the method prescribed in ''Official Methods of Analysis of
the Association of Official Analytical Chemists,'' 13th Ed. (1980),
section 7.002 under ''Preparation of Sample -- Official Final Action,''
and section 7.003 under ''Moisture -- Official Final Action. I. Drying
in Vacuo at 95-100 (2),'' which is incorporated by reference. Copies
may be obtained from the Association of Official Analytical Chemists,
2200 Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may be
examined at the Office of the Federal Register, 1100 L St. NW.,
Washington, DC 20408.
(42 FR 14402, Mar. 15, 1977, as amended at 47 FR 11827, Mar. 19,
1982; 49 FR 10097, Mar. 19, 1984; 54 FR 24894, June 12, 1989)
21 CFR 137.195 Crushed wheat.
Crushed wheat, coarse ground wheat, is the food prepared by so
crushing cleaned wheat other than durum wheat and red durum wheat that,
when tested by the method prescribed in 137.200(c)(2), 40 percent or
more passes through a No. 8 sieve and less than 50 percent passes
through a No. 20 sieve. The proportions of the natural constituents of
such wheat, other than moisture, remain unaltered. Crushed wheat
contains not more than 15 percent of moisture as determined by the
method prescribed in ''Official Methods of Analysis of the Association
of Official Analytical Chemists,'' 13th Ed. (1980), section 7.002 under
''Preparation of Sample -- Official Final Action,'' and section 7.003
under ''Moisture -- Official Final Action. I. Drying in Vacuo at 95-100
(2),'' which is incorporated by reference. Copies may be obtained from
the Association of Official Analytical Chemists, 2200 Wilson Blvd.,
Suite 400, Arlington, VA 22201-3301, or may be examined at the Office of
the Federal Register, 1100 L St. NW., Washington, DC 20408.
(42 FR 14402, Mar. 15, 1977, as amended at 47 FR 11827, Mar. 19,
1982; 49 FR 10097, Mar. 19, 1984; 54 FR 24894, June 12, 1989)
21 CFR 137.200 Whole wheat flour.
(a) Whole wheat flour, graham flour, entire wheat flour is the food
prepared by so grinding cleaned wheat, other than durum wheat and red
durum wheat, that when tested by the method prescribed in paragraph
(c)(2) of this section, not less than 90 percent passes through a 2.36
mm (No. 8) sieve and not less than 50 percent passes through a 850 m
(No. 20) sieve. The proportions of the natural constituents of such
wheat, other than moisture, remain unaltered. To compensate for any
natural deficiency of enzymes, malted wheat, malted wheat flour, malted
barley flour, or any combination of two or more of these, may be used;
but the quantity of malted barley flour so used is not more than 0.75
percent. It may contain harmless preparations of -amylase obtained from
Aspergillus oryzae, alone or in a safe and suitable carrier. The
moisture content of whole wheat flour is not more than 15 percent. It
may contain ascorbic acid in a quantity not to exceed 200 parts per
million as a dough conditioner. Unless such addition conceals damage or
inferiority or makes the whole wheat flour appear to be better or of
greater value than it is, the optional bleaching ingredient
azodicarbonamide (complying with the requirements of 172.806 of this
chapter, including the quantitative limit of not more than 45 parts per
million) or chlorine dioxide, or chlorine, or a mixture of nitrosyl
chloride and chlorine, may be added in a quantity not more than
sufficient for bleaching and artificial aging effects.
(b)(1) All optional ingredients used in the food shall be declared on
the label as required by the applicable sections of Part 101 of this
chapter.
(2) When ascorbic acid is added, the label shall bear the statement
''Ascorbic acid added as a dough conditioner''. When the optional
ingredient '' ''-amylase obtained from Aspergillus oryzae'' is used, it
may alternatively be declared in the list of ingredients as ''Fungal
alpha-amylase,'' ''Fungal -amylase'', ''Enzyme'', or ''Enzyme added for
improved baking''. When any optional bleaching ingredient is used, the
label shall bear the word ''Bleached''. Wherever the name of the food
appears on the label so conspicuously as to be easily seen under
customary conditions of purchase, the word ''Bleached'' shall
immediately and conspicuously precede or follow such name, without
intervening written, printed, or graphic matter; except that where such
name is a part of a trademark or brand, other written, printed or
graphic matter, which is also a part of such trademark or brand, may so
intervene if the word ''Bleached'' is in such juxtaposition with such
trademark or brand as to be conspicuously related to such name.
(c) For the purposes of this section:
(1) Moisture is determined by the method prescribed in ''Official
Methods of Analysis of the Association of Official Analytical Chemists''
(AOAC), 13th Ed. (1980), section 14.002. ''Vacuum Oven Method --
Official Final Action,'' and section 14.003, ''Determination,'' which is
incorporated by reference. Copies may be obtained from the Association
of Official Analytical Chemists, 2200 Wilson Blvd., Suite 400,
Arlington, VA 22201-3301, or may be examined at the Office of the
Federal Register, 1100 L St. NW., Washington, DC 20408.
(2) The method referred to in paragraph (a) of this section is as
follows: Use No. 8 and No. 20 sieves, having standard 8-inch
full-height frames, complying with the specifications set forth in the
AOAC, Table 1, ''Nominal Dimensions of Standard Test Sieves (U.S.A.
Standard Series),'' under the heading ''Definitions of Terms and
Explanatory Notes,'' which is incorporated by reference. The
availability of this incorporation by reference is given in paragraph
(c)(1) of this section. Fit a No. 8 sieve into a No. 20 sieve.
Attach bottom pan to the No. 20 sieve. Pour 100 gm. of the sample
into the No. 8 sieve. Attach cover and hold the assembly in a slightly
inclined position with one hand. Shake the sieves by striking the sides
against the other hand with an upward stroke, at the rate of about 150
times per minute. Turn the sieves about one-sixth of a revolution each
time in the same direction, after each 25 strokes. Continue shaking for
2 minutes. Weigh the material which fails to pass through the No. 8
sieve and the material which passes through the No. 20 sieve.
(42 FR 14402, Mar. 15, 1977, as amended at 47 FR 11827, Mar. 19,
1982; 47 FR 24693, June 8, 1982; 47 FR 43364, Oct. 1, 1982; 49 FR
10097, Mar. 19, 1984; 54 FR 24894, June 12, 1989)
21 CFR 137.205 Bromated whole wheat flour.
Bromated whole wheat flour conforms to the definition and standard of
identity, and is subject to the requirements for label statement of
optional ingredients, prescribed for whole wheat flour by 137.200,
except that potassium bromate is added in a quantity not exceeding 75
parts to each million parts of finished bromated whole wheat flour.
21 CFR 137.211 White corn flour.
(a) White corn flour is the food prepared by so grinding and bolting
cleaned white corn that when tested by the method prescribed in
paragraph (b)(2) of this section, not less than 98 percent passes
through a No. 50 sieve and not less than 50 percent passes through No.
70 woven-wire cloth. Its moisture content is not more than 15 percent.
In its preparation, part of the ground corn may be removed, but in any
such case, the content (on a moisture-free basis) of neither the crude
fiber nor fat in the finished white corn flour exceeds the content (on a
moisture-free basis) of such substance in the cleaned corn from which it
was ground.
(b)(1) For the purpose of this section, moisture, fat, and crude
fiber are determined by methods therefore referred to in 137.250(b)(1).
(2) The method referred to in paragraph (a) of this section is as
follows: Weigh 5 grams of sample into a tared truncated metal cone (top
diameter 5 centimeters, bottom diameter 2 centimeters, height 4
centimeters), fitted at bottom with 70-mesh wire cloth complying with
the specifications for No. 70 wire cloth in ''Official Methods of
Analysis of the Association of Official Analytical Chemists,'' 13th Ed.
(1980), Table 1, ''Nominal Dimensions of Standard Test Sieves (U.S.A.
Standard Series),'' under the heading ''Definitions of Terms and
Explanatory Notes,'' which is incorporated by reference. Copies may be
obtained from the Association of Official Analytical Chemists, 2200
Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may be examined at
the Office of the Federal Register, 1100 L St. NW., Washington, DC
20408. Attach cone to a suction flask. Wash with 150 ml. of petroleum
ether applied in a small stream without suction, while gently stirring
the sample with a small glass rod. Apply suction for 2 minutes after
washing is completed, then shake the cone for 2 minutes with a vigorous
horizontal motion, striking the side against the hand, and then weigh.
The decrease in weight of sample, calculated as percent by weight of
sample shall be considered the percent passing through No. 70 wire
cloth. Transfer the residue from cone to a No. 50 sieve having a
standard 20.3 centimeter (8-inch) diameter full-height frame, complying
with the specifications for wire cloth and sieve frame in ''Nominal
Dimensions of Standard Test Sieves (U.S.A. Standard Series).'' Shake for
2 minutes with a vigorous horizontal motion, striking the side against
the hand; remove and weigh the residue; calculate the weight of
residue as percent by weight of sample, and subtract from 100 percent to
obtain the percent of sample passing through the No. 50 sieve.
(42 FR 14402, Mar. 15, 1977, as amended at 47 FR 11827, Mar. 19,
1982; 49 FR 10098, Mar. 19, 1984; 54 FR 24894, June 12, 1989)
21 CFR 137.215 Yellow corn flour.
Yellow corn flour conforms to the definition and standard of identity
prescribed by 137.211 for white corn flour except that cleaned yellow
corn is used instead of clean white corn.
21 CFR 137.220 Durum flour.
(a) Durum flour is the food prepared by grinding and bolting cleaned
durum wheat. When tested for granulation as prescribed in
137.105(c)(4), not less than 98 percent of such flour passes through the
No. 70 sieve. It is freed from bran coat, or bran coat and germ, to
such extent that the percent of ash therein, calculated to a
moisture-free basis, is not more than 1.5 percent. Its moisture content
is not more than 15 percent.
(b) For the purpose of this section, ash, moisture, and granulation
are determined by the methods prescribed in 137.105(c).
21 CFR 137.225 Whole durum flour.
Whole durum wheat flour conforms to the definition and standard of
identity, and is subject to the requirements for label statement of
optional ingredients, prescribed for whole wheat flour by 137.200,
except that cleaned durum wheat, instead of cleaned wheat other than
durum wheat and red durum wheat, is used in its preparation.
21 CFR 137.230 Corn grits.
(a) Grits, corn grits, hominy grits, is the food prepared by so
grinding and sifting cleaned white corn, with removal of corn bran and
germ, that:
(1) On a moisture-free basis its crude fiber content is not more than
1.2 percent and its fat content is not more than 2.25 percent; and
(2) When tested by the method prescribed in paragraph (b)(2) of this
section not less than 95 percent passes through a No. 10 sieve but not
more than 20 percent through a No. 25 sieve.
(b)(1) For the purposes of this section moisture, fat, and crude
fiber are determined by methods therefor referred to in 137.250(b)(1).
(2) The method referred to in paragraph (a) of this section is as
follows: Use No. 10 and No. 25 Sieves, having standard 20.3
centimeter (8-inch) diameter full-height frames, complying with the
specifications for wire cloth and sieve frames in ''Official Methods of
Analysis of the Association of Official Analytical Chemists'', 13th Ed.
(1980), Table 1, ''Nominal Dimensions of Standard Test Sieves (U.S.A.
Standard Series),'' under the heading ''Definitions of Terms and
Explanatory Notes,'' which is incorporated by reference. Copies may be
obtained from the Association of Official Analytical Chemists, 2200
Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may be examined at
the Office of the Federal Register, 1100 L St. NW., Washington, DC
20408. Attach bottom pan to No. 25 sieve. Fit the No. 10 sieve into
the No. 25 sieve. Pour 100 grams of sample into the No. 10 sieve,
attach cover and hold assembly in a slightly inclined position, shake
the sieves by striking the sides against one hand with an upward stroke,
at the rate of about 150 times per minute. Turn the sieves about
one-sixth of a revolution each time in the same direction after each 25
strokes. Continue shaking for 2 minutes. Weigh separately the material
remaining on the No. 10 sieve and in the pan, and calculate each weight
as percent of sample. The percent of sample passing through a No. 10
sieve shall be determined by subtracting from 100 percent the percent
remaining on the No. 10 sieve. The percent of material in the pan
shall be considered as the percent passing through a No. 25 sieve.
(42 FR 14402, Mar. 15, 1977, as amended at 47 FR 11828, Mar. 19,
1982; 49 FR 10098, Mar. 19, 1984; 54 FR 24894, June 12, 1989)
21 CFR 137.235 Enriched corn grits.
(a) Enriched corn grits are the foods, each of which conforms to the
definition and standard of identity prescribed for grits, yellow grits,
or quick cooking grits by 137.230, 137.240, and 137.245, except that:
(1) It contains in each pound not less than 2.0 mg. and not more than
3.0 mg. of thiamine, not less than 1.2 mg. and not more than 1.8 mg. of
riboflavin, not less than 16 mg. and not more than 24 mg. of niacin or
niacinamide, not less than 13 mg. and not more than 26 mg. of iron
(Fe);
(2) It may contain in each pound not less than 250 U.S.P. units and
not more than 1,000 U.S.P. units of vitamin D; and
(3) It may contain in each pound not less than 500 mg. and not more
than 750 mg. of calcium (Ca). Iron and calcium may be added only in
forms which are harmless and assimilable. The vitamins referred to in
paragraph (a)(1) of this section may be combined with harmless
substances to render them insoluble in water if the water-insoluble
products are assimilable. The substances referred to in this
subparagraph and in paragraphs (a) (1) and (2) of this section may be
added in a harmless carrier; such carrier is used only in the quantity
necessary to effect an intimate and uniform admixture of such substances
with the kind of corn grits used. Dried yeast in quantities not
exceeding 1.5 percent by weight of the finished food may be used.
(b) The name of each kind of enriched corn grits is the word
''Enriched'' followed by the name of the kind of corn grits used which
is prescribed in the definition and standard of identity therefor.
21 CFR 137.240 Quick grits.
(a) Quick grits, quick cooking grits are the foods, each of which
conforms to the definition and standard of identity prescribed for a
kind of grits by 137.230 or 137.245, except that in process of
preparation the grits are lightly steamed and slightly compressed so as
to fracture the particles.
(b) The name of each kind of grits is ''Quick'' or ''Quick cooking''
followed by the name of the kind of grits used which is prescribed in
the definition and standard of identity therefor.
21 CFR 137.245 Yellow grits.
Yellow grits, yellow corn grits, yellow hominy grits, conforms to the
definition and standard of identity prescribed by 137.230 for grits
except that cleaned yellow corn is used instead of cleaned white corn.
21 CFR 137.250 White corn meal.
(a) White corn meal is the food prepared by so grinding cleaned white
corn that when tested by the method prescribed in paragraph (b)(2) of
this section not less than 95 percent passes through a No. 12 sieve,
not less than 45 percent through a No. 25 sieve, but not more than 35
percent through a No. 72 grits gauze. Its moisture content is not more
than 15 percent. In its preparation coarse particles of the ground corn
may be separated and discarded, or reground and recombined with all or
part of the material from which they were separated, but in any such
case the crude fiber content of the finished corn meal is not less than
1.2 percent and not more than that of the cleaned corn from which it was
ground, and its fat content does not differ more than 0.3 percent from
that of such corn. The contents of crude fiber and fat in all the
foregoing provisions relating thereto are on a moisture-free basis.
(b)(1) For the purposes of this section, moisture, fat, and crude
fiber content will be determined by the following methods of analysis
from ''Official Methods of Analysis of the Association of Official
Analytical Chemists,'' 13th Ed. (1980), which is incorporated by
reference (copies may be obtained from the Association of Official
Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA
22201-3301, or may be examined at the Office of the Federal Register,
1100 L St. NW., Washington, DC 20408):
(i) Moisture content -- sections 14.062 and 14.063 (Official Final
Action).
(ii) Fat content -- sections 14.062 and 14.067 (Official Final
Action).
(iii) Crude fiber content -- sections 14.062 and 14.065 (Official
Final Action).
(2) The method referred to in paragraph (a) of this section is as
follows: Use No. 12 and No. 25 sieves, having standard 20.3
centimeter (8-inch) diameter full-height frames, complying with the
specifications for wire cloth and sieve frames in ''Nominal Dimensions
of Standard Test Sieves (U.S.A. Standard Series)'' prescribed in
137.105(a), which is incorporated by reference. Copies may be obtained
from the Association of Official Analytical Chemists, 2200 Wilson Blvd.,
Suite 400, Arlington, VA 22201-3301, or may be examined at the Office of
the Federal Register, 1100 L St. NW., Washington, DC 20408. A sieve
with frame of the same dimensions as the Nos. 12 and 25 and fitted with
72 XXX grits gauze is used as the third sieve. It is referred to
hereafter as the No. 72 sieve. The 72 XXX grits gauze has openings
equivalent in size with those of No. 70 woven-wire cloth, complying
with specifications for such cloth contained in such ''Standard
Specifications for Sieves.'' Attach bottom pan to No. 72 sieve. Fit
the No. 25 sieve into the No. 72 sieve and the No. 12 sieve into the
No. 25 sieve. Pour 100 grams of sample into the No. 12 sieve, attach
cover and hold the assembly in a slightly inclined position and shake
the assembly of sieves by striking the sides against one hand with an
upward stroke, at the rate of about 150 times per minute. Turn the
assembly of sieves about one-sixth of a revolution, each time in the
same direction, after each 25 strokes. Continue shaking for 2 minutes.
Weigh separately the material remaining on each sieve and in the pan,
and calculate each weight as percent of sample. Sometimes when meals
are tested, fine particles clog the sieve openings. If any sieve is
clogged by fine material smaller than its openings, empty the contents
onto a piece of paper. Remove the entrapped material on the bottom of
the sieve by a hair brush and add to the sieve below. In like manner,
clean the adhering material from inside the sieve and add to the
material on the paper. Return mixture on the paper to the sieve,
reassemble the sieves, and shake in the same manner as before for 1
minute. Repeat cleaning procedure if necessary until a 5-gram or less
loss in weight occurs in any sieve during a 1-minute shaking. The
percent of sample passing through No. 12 sieve shall be determined by
subtracting from 100 percent, the percent of material remaining on the
No. 12 sieve. The percent passing through a No. 25 sieve shall be
determined by adding the percents remaining on the No. 72 sieve and the
percent in pan. The percent in the pan shall be considered as the
percent passing through a No. 72 XXX grits gauze.
(42 FR 14402, Mar. 15, 1977, as amended at 47 FR 11828, Mar. 19,
1982; 49 FR 10098, Mar. 19, 1984; 54 FR 24894, June 12, 1989)
21 CFR 137.255 Bolted white corn meal.
(a) Bolted white corn meal is the food prepared by so grinding and
sifting cleaned white corn that:
(1) Its crude fiber content is less than 1.2 percent but its fat
content is not less than 2.25 percent; and
(2) When tested by the method prescribed in 137.250(b)(2), except
that a No. 20 standard sieve is used instead of the No. 12 sieve, not
less than 95 percent passes through a No. 20 sieve, not less than 45
percent through a No. 25 sieve, but not more than 25 percent through
No. 72 XXX grits gauze. Its moisture content is not more than 15
percent. In its preparation particles of ground corn which contain germ
may be separated, reground, and recombined with all or part of the
material from which it was separated, but in any such case the fat
content of the finished bolted white corn meal does not exceed by more
than 0.3 percent the fat content of the cleaned corn from which it was
ground. The contents of crude fiber and fat in all the foregoing
provisions relating thereto are on a moisture-free basis.
(b) For the purposes of this section, moisture, fat and crude fiber
are determined by the methods therefor referred to in 137.250(b)(1).
21 CFR 137.260 Enriched corn meals.
(a) Enriched corn meals are the foods, each of which conforms to the
definition and standard of identity prescribed for a kind of corn meal
by 137.250, 137.255, 137.265, 137.270, 137.275, 137.280, 137.285, and
137.290, except that:
(1) It contains in each pound not less than 2.0 mg. and not more than
3.0 mg. of thiamine, not less than 1.2 mg. and not more than 1.8 mg. of
riboflavin, not less than 16 mg. and not more than 24 mg. of niacin or
niacinamide, and not less than 13 mg. and not more than 26 mg. of iron
(Fe);
(2) It may contain in each pound not less than 250 U.S.P. units and
not more than 1,000 U.S.P. units of vitamin D; and
(3) It may contain in each pound not less than 500 milligrams and not
more than 750 milligrams of calcium (Ca); Provided, however, That
enriched self-rising corn meals shall contain in each pound not more
than 1,750 milligrams of calcium (Ca). Iron and calcium may be added
only in forms which are harmless and assimilable. The substances
referred to in this paragraph (a)(3) and in paragraphs (a) (1) and (2)
of this section may be added in a harmless carrier which does not impair
the enriched corn meal; such carrier is used only in the quantity
necessary to effect an intimate and uniform admixture of such substances
with the kind of corn meal used. Dried yeast in quantities not
exceeding 1.5 percent by weight of the finished food may be used.
(b) The name of each kind of enriched corn meal is the word
''Enriched'' followed by the name of the kind of corn meal used which is
prescribed in the definition and standard of identity therefor.
21 CFR 137.265 Degerminated white corn meal.
(a) Degerminated white corn meal, degermed white corn meal, is the
food prepared by grinding cleaned white corn and removing bran and germ
so that:
(1) On a moisture-free basis, its crude fiber content is less than
1.2 percent and its fat content is less than 2.25 percent; and
(2) When tested by the method prescribed in 137.250(b)(2), except
that a No. 20 standard sieve is used instead of a No. 12 sieve, not
less than 95 percent passes through a No. 20 sieve, not less than 45
percent through a No. 25 sieve, but not more than 25 percent through
No. 72 XXX grits gauze. Its moisture content is not more than 15
percent.
(b) For the purposes of this section, moisture, fat and crude fiber
are determined by methods therefor referred to in 137.250(b)(1).
21 CFR 137.270 Self-rising white corn meal.
(a) Self-rising white corn meal is an intimate mixture of white corn
meal, sodium bicarbonate, and one or both of the acid-reacting
substances monocalcium phosphate and sodium aluminum phosphate. It is
seasoned with salt. When it is tested by the method prescribed in
paragraph (b) of this section, not less than 0.5 percent of carbon
dioxide is evolved. The acid-reacting substance is added in sufficient
quantity to neutralize the sodium bicarbonate. The combined weight of
such acid-reacting substance and sodium bicarbonate is not more than 4.5
parts to each 100 parts of white corn meal used.
(b) The method referred to in paragraph (a) of this section is the
method prescribed in ''Official Methods of Analysis of the Association
of Official Analytical Chemists'' (AOAC), 13th Ed. (1980), section
8.002, ''Reagent (Displacement soln.),'' and section 8.003, ''Chittick
apparatus,'' under the heading ''Total Carbon Dioxide (1) -- Official
Final Action,'' which is incorporated by reference. Copies may be
obtained from the Association of Official Analytical Chemists, 2200
Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may be examined at
the Office of the Federal Register, 1100 L St. NW., Washington, DC
20408. The following procedure is substituted for the procedure
specified in the AOAC, under section 8.004, ''Determination'':
(1) Weigh 17 grams of the official sample into flask A, add 15-20
glass beads (4-6 mm. diameter), and connect this flask with the
apparatus (fig. 25). Open stopcock C and by means of the leveling bulk E
bring the displacement solution to the 25 cc. graduation above the zero
mark. (This 25 cc. is a partial allowance for the volume of acid to be
used in the decomposition.) Allow the apparatus to stand 1-2 minutes to
insure that the temperature and pressure within the apparatus are the
same as those of the room. Close the stopcock, lower the leveling bulb
somewhat to reduce the pressure within the apparatus, and slowly run
into the decomposition flask from burette F 45 cc. of sulfuric acid
(1+5). To prevent the liberated carbon dioxide from escaping through
the acid burette into the air keep the displacement solution in the
leveling bulb at all times during the decomposition at a lower level
than that in the gas-measuring tube. Rotate and then vigorously agitate
the decomposition flask for 3 minutes to mix the contents intimately.
Allow to stand for 10 minutes to bring to equilibrium. Equalize the
pressure in the measuring tube by means of the leveling bulb and read
the volume of gas from the zero point on the tube. Deduct 20 cc. from
this reading (this 20 cc. together with previous allowance of 25 cc.
compensates for the 45 cc. acid used in the decomposition). Observe
the temperature of the air surrounding the apparatus and also the
barometric pressure and multiply the number of mL of gas evolved by the
factor given in the AOAC, 13th Ed. (1980), section 52.007 under
Reference Tables for the temperature and pressure observed, which is
incorporated by reference. The availability of this incorporation by
reference is given in paragraph (b) of this section. Divide the
corrected reading by 100 to obtain the apparent percent by weight of
carbon dioxide in the official sample.
(2) Correct the apparent percent of carbon dioxide to compensate for
varying atmospheric conditions by immediately assaying a synthetic
sample by the same method in the same apparatus.
(3) Prepare the synthetic sample with 16.2 grams of corn meal, 0.30
gram of monocalcium phosphate, 0.30 gram of salt, and a sufficient
quantity of sodium bicarbonate U.S.P. (dried over sulfuric acid) to
yield the amount of carbon dioxide recovered in assay of official
sample. Determine this quantity by multiplying weight of carbon dioxide
recovered in assay of official sample by 1.91.
(4) Divide the weight of carbon dioxide recovered from synthetic
sample by weight of carbon dioxide contained in sodium bicarbonate used.
(5) Divide the quotient into the apparent percent of carbon dioxide
in official sample to obtain percent of carbon dioxide evolved from the
official sample.
(42 FR 14402, Mar. 15, 1977, as amended at 47 FR 11828, Mar. 19,
1982; 49 FR 10098, Mar. 19, 1984; 54 FR 24894, June 12, 1989)
21 CFR 137.275 Yellow corn meal.
Yellow corn meal conforms to the definition and standard of identity
prescribed by 137.250 for white corn meal except that cleaned yellow
corn is used instead of cleaned white corn.
21 CFR 137.280 Bolted yellow corn meal.
Bolted yellow corn meal conforms to the definition and standard of
identity prescribed by 137.255 for bolted white corn meal except that
cleaned yellow corn is used instead of cleaned white corn.
21 CFR 137.285 Degerminated yellow corn meal.
Degerminated yellow corn meal, degermed yellow corn meal, conforms to
the definition and standard of identity prescribed by 137.265 for
degerminated white corn meal except that cleaned yellow corn is used
instead of cleaned white corn.
21 CFR 137.290 Self-rising yellow corn meal.
Self-rising yellow corn meal conforms to the definition and standard
of identity prescribed by 137.270 for self-rising white corn meal
except that yellow corn meal is used instead of white corn meal.
21 CFR 137.300 Farina.
(a) Farina is the food prepared by grinding and bolting cleaned
wheat, other than durum wheat and red durum wheat, to such fineness
that, when tested by the method prescribed in paragraph (b)(2) of this
section, it passes through a No. 20 sieve, but not more than 3 percent
passes through a No. 100 sieve. It is freed from bran coat, or bran
coat and germ, to such extent that the percent of ash therein,
calculated to a moisture-free basis, is not more than 0.6 percent. Its
moisture content is not more than 15 percent.
(b) For the purposes of this section:
(1) Ash and moisture are determined by the methods therefor referred
to in 137.105(c).
(2) The method referred to in paragraph (a) of this section is as
follows: Use No. 20 and No. 100 sieves, having standard 20.3
centimeter (8-inch) full-height frames, complying with the
specifications for such cloth set forth in ''Official Methods of
Analysis of the Association of Official Analytical Chemists,'' 13th Ed.
(1980), Table 1, ''Nominal Dimensions of Standard Test Sieves (U.S.A.
Standard Series),'' under the heading ''Definitions of Terms and
Explanatory Notes,'' which is incorporated by reference. Copies may be
obtained from the Association of Official Analytical Chemists, 2200
Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may be examined at
the Office of the Federal Register, 1100 L St. NW., Washington, DC
20408. Fit a No. 20 sieve into a No. 100 sieve. Attach bottom pan to
the No. 100 sieve. Pour 100 grams of the sample into the No. 20
sieve. Attach cover and hold the assembly in a slightly inclined
position with one hand. Shake the sieves by striking the sides against
the other hand with an upward stroke, at the rate of about 150 times per
minute. Turn the sieves about one-sixth of a revolution, each time in
the same direction, after each 25 strokes. Continue shaking for 2
minutes. Weigh the material which fails to pass through the No. 20
sieve and the material which passes through the No. 100 sieve.
(42 FR 14402, Mar. 15, 1977, as amended at 47 FR 11828, Mar. 19,
1982; 49 FR 10098, Mar. 19, 1984; 54 FR 24894, June 12, 1989)
21 CFR 137.305 Enriched farina.
(a) Enriched farina conforms to the definition and standard of
identity prescribed for farina by 137.300, except that:
(1) It contains in each pound not less than 2.0 milligrams and not
more than 2.5 milligrams of thiamine, not less than 1.2 milligrams and
not more than 1.5 milligrams of riboflavin, not less than 16.0
milligrams and not more than 20.0 milligrams of niacin or niacinamide,
and not less than 13.0 milligrams of iron (Fe).
(2) Vitamin D may be added in such quantity that each pound of the
finished enriched farina contains not less than 250 U.S.P. units of the
optional ingredient vitamin D.
(3) Calcium may be added in such quantity that each pound of the
finished enriched farina contains not less than 500 milligrams of the
optional ingredient calcium (Ca).
(4) It may contain not more than 8 percent by weight of the optional
ingredient wheat germ or partly defatted wheat germ.
(5)(i) It may contain not less than 0.5 percent and not more than 1
percent by weight of the optional ingredient disodium phosphate; or
(ii) It may be treated with one of the proteinase enzymes papain or
pepsin to reduce substantially the time required for cooking. In such
treatment papain or pepsin, in an amount not to exceed 0.1 percent by
weight, is added to the farina, which is moistened, warmed, and
subsequently heated sufficiently to inactivate the enzyme and to dry the
product to comply with the limit for moisture prescribed by 137.300(a).
(6) In determining whether the ash content complies with the
requirements of this section allowance is made for ash resulting from
any added iron or salts of iron or calcium, or from any added disodium
phosphate, or from any added wheat germ or partly defatted wheat germ.
Iron and calcium may be added only in forms which are harmless and
assimilable. Dried irradiated yeast may be used as a source of vitamin
D. The substances referred to in paragraphs (a) (1) and (2) of this
section may be added in a harmless carrier which does not impair the
enriched farina; such carrier is used only in the quantity necessary to
effect an intimate and uniform admixture of such substances with the
farina.
(b)(1) All optional ingredients used in the food shall be declared on
the label as required by the applicable sections of Part 101 of this
chapter.
(2)(i) When the optional ingredient disodium phosphate is used, the
label shall bear the statement ''Disodium phosphate added for quick
cooking''.
(ii) When the proteinase enzyme treatment is used, the label shall
bear the statement ''Enzyme treated for quicker cooking''.
(3) Wherever the name of the food appears on the label so
conspicuously as to be easily seen under customary conditions of
purchase, the statements prescribed by paragraph (b)(2) of this section
shall immediately and conspicuously precede or follow such name without
intervening written, printed, or graphic matter; except that where the
name of the food is a part of a trademark or brand, then other written,
printed, or graphic matter that is also a part of the trademark or brand
may so intervene, if such statement is in such juxtaposition with the
trademark or brand as to be conspicuously related to the name of the
food.
21 CFR 137.320 Semolina.
(a) Semolina is the food prepared by grinding and bolting cleaned
durum wheat to such fineness that, when tested by the method prescribed
in 137.300(b)(2), it passes through a No. 20 sieve, but not more than
3 percent passes through a No. 100 sieve. It is freed from bran coat,
or bran coat and germ, to such extent that the percent of ash therein,
calculated to a moisture-free basis, is not more than 0.92 percent. Its
moisture content is not more than 15 percent.
(b) For the purpose of this section, ash and moisture are determined
by the methods therefor referred to in 137.105(c).
21 CFR 137.350 Enriched rice.
(a) The foods for which definitions and standards of identity are
prescribed by this section are forms of milled rice (except rice coated
with talc and glucose and known as coated rice), to which nutrients have
been added so that each pound of the rice contains:
(1) Not less than 2.0 milligrams and not more than 4.0 milligrams of
thiamine; not less than 1.2 milligrams and not more than 2.4 milligrams
of riboflavin; not less than 16 milligrams and not more than 32
milligrams of niacin or niacinamide; and not less than 13 milligrams
and not more than 26 milligrams of iron (Fe).
(2) Each pound may contain not less than 250 U.S.P. units and not
more than 1,000 U.S.P. units of vitamin D.
(3) Each pound may contain not less than 500 milligrams and not more
than 1,000 milligrams of calcium (Ca). Calcium carbonate derived from
the use of this substance in milling rice, when present in quantities
that furnish less than 500 milligrams of calcium (Ca) per pound, is
considered a normal ingredient of the milled rice used and not an
optional ingredient of the enriched rice unless such enriched rice is
labeled to show it contains the optional ingredient calcium. Iron and
calcium may be added only in forms that are harmless and assimilable.
The vitamins referred to in paragraphs (a) (1) and (2) of this section
may be combined with harmless substances to render them insoluble in
water, if the water-insoluble products are assimilable.
(4) In the case of enriched parboiled rice, butylated hydroxytoluene
may be added as an optional ingredient in an amount not to exceed 0.0033
percent by weight of the finished food.
(b) The substances referred to in paragraphs (a) (1), (2), and (3) of
this section may be added in a harmless carrier. Such carrier is used
only in the quantity necessary to effect an intimate and uniform mixture
of such substances with the rice.
(c) Unless the label of the food bears the statement ''To retain
vitamins do not rinse before or drain after cooking'' immediately
preceding or following the name of the food and in letters not less than
one-fourth the point size of type used for printing the name of the food
(but in no case less than 8-point type) and the label bears no cooking
directions calling for washing or draining or unless the food is
precooked and it is packaged in consumer packages which are
conspicuously and prominently labeled with directions for preparation
which, if followed, will avoid washing away or draining off enriching
ingredients, the substances named in paragraphs (a) (1), (2), and (3) of
this section shall be present in such quantity or in such form that when
the enriched rice is washed as prescribed in paragraph (e) of this
section, the washed rice contains not less than 85 percent of the
minimum quantities of the substances named in paragraph (a)(1) of this
section, as required for enriched rice; and in case any optional
ingredients named in paragraphs (a) (2) and (3) of this section are
used, the washed rice also contains not less than 85 percent of the
minimum quantity specified for the substance or substances used.
(d) The name specified for each food for which a definition and
standard of identity is prescribed by this section is the common name of
the kind of milled rice to which the enriching substances are added,
preceded by the word ''enriched'' as, for example, ''Enriched rice'' or
''Enriched parboiled rice''.
(e) The method referred to in paragraph (c) of this section is as
follows: Mix the contents of one or more containers and transfer 1/2
pound thereof to a 4-liter flask containing 2 liters of distilled water
at room temperature (but not below 20 C). Stopper the flask and swirl
it moderately for 1/2 minute so that the rice is in motion and in
uniform suspension. Allow the rice to settle for 1/2 minute, then pour
off 1,600 milliliters of the water, together with any floating and
suspended matter, and discard. To the contents of the flask, add 1,600
milliliters of distilled water and 20 milliliters of 10 N hydrochloric
acid. Agitate vigorously and wash down the sides of the flask with 150
milliliters of 0.1 N hydrochloric acid. In order to avoid excess
foaming during the extraction, heat the mixture slowly to about 100 C,
agitate if necessary, and maintain at this temperature until air is
expelled. Again wash down the sides of the flask with 150 milliliters
of 0.1 N hydrochloric acid. Heat the mixture in an autoclave at 120 C
to 123 C for 30 minutes, remove and cool to room temperature. Dilute
the mixture with distilled water so that the total volume is 2,500
milliliters. Swirl the flask, and while the solids are in uniform
suspension pour off about 250 milliliters of the mixture for later
determination of iron (and calcium, if this is to be determined). With
filter paper that has been shown not to adsorb thiamine, riboflavin, or
niacin, filter enough of the remaining mixture for determination of
thiamine, riboflavin, and niacin. (In the case of a mixture difficult
to filter, centrifuging or filtering through fritted glass, or both,
using a suitable analytical filter-aid, may be substituted for, or may
precede, filtering through paper.) Dilute an aliquot of filtrate with
0.1 N hydrochloric acid, so that each milliliter contains about 0.2
microgram of thiamine, and determine thiamine by the ''Rapid
Fluorometric Method -- Official Final Action,'' in section 43.034 of
''Official Methods of Analysis of the Association of Official Analytical
Chemists'' (AOAC), 13th Ed. (1980), which is incorporated by reference.
Copies may be obtained from the Association of Official Analytical
Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may
be examined at the Office of the Federal Register, 1100 L St. NW.,
Washington, DC 20408. With a suitable aliquot determine riboflavin by
the method prescribed in section 43.041(a) by the ''Fluorometric Method
-- Official Final Action,'' AOAC, 13th Ed. (1980), beginning with the
third sentence of the second paragraph, ''Adjust, with vigorous
agitation * * *.'' Determine niacin in a 200-milliliter aliquot of the
filtrate by the ''Colorimetric Method -- Official Final Action,'' in
section 43.045, AOAC, 13th Ed. (1980), beginning with the sixth
sentence of the first paragraph, ''Adjust to pH 4.5 with * * *.''
Evaporate to dryness a 100-milliliter aliquot of the nonfiltered
material withdrawn while agitating, and determine iron using the method
''Iron -- Official Final Action,'' in sections 14.011, 14.012, and
14.013, AOAC, 13th Ed. (1980), and, if required, determine calcium as
directed in section 14.014 under the heading ''Calcium -- Official Final
Action,'' AOAC, 13th Ed. (1980).
(f) When the optional ingredient specified in paragraph (a)(4) of
this section is added, the statement ''Butylated hydroxytoluene added as
a preservative'' shall be placed on the label prominently and with such
conspicuousness (as compared with other words, statements, designs, or
devices in the label) as to render it likely to be read and understood
by the ordinary individual under customary conditions of purchase.
Note: The Order of the Commissioner of Food and Drugs appearing at
23 FR 1170, Feb. 25, 1958, amending paragraphs (a)(1) and (c) provides
in part as follows: The regulations in 137.350 (formerly 15.525) are
stayed insofar as they require each pound of the food to contain not
less than 1.2 milligrams and not more than 2.4 milligrams of riboflavin.
This stay shall continue until final action is taken disposing of the
objections, after public hearing thereon.
(42 FR 14402, Mar. 15, 1977, as amended at 47 FR 11828, Mar. 19,
1982; 49 FR 10098, Mar. 19, 1984; 54 FR 24894, June 12, 1989)
21 CFR 137.350 PART 139 -- MACARONI AND NOODLE PRODUCTS
21 CFR 137.350 Subpart A -- (Reserved)
21 CFR 137.350 Subpart B -- Requirements for Specific Standardized
Macaroni and Noodle Products
Sec.
139.110 Macaroni products.
139.115 Enriched macaroni products.
139.117 Enriched macaroni products with fortified protein.
139.120 Milk macaroni products.
139.121 Nonfat milk macaroni products.
139.122 Enriched nonfat milk macaroni products.
139.125 Vegetable macaroni products.
139.135 Enriched vegetable macaroni products.
139.138 Whole wheat macaroni products.
139.140 Wheat and soy macaroni products.
139.150 Noodle products.
139.155 Enriched noodle products.
139.160 Vegetable noodle products.
139.165 Enriched vegetable noodle products.
139.180 Wheat and soy noodle products.
Authority: Secs. 201, 401, 403, 409, 701, 706 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321, 341, 343, 348, 371, 376).
Source: 42 FR 14409, Mar. 15, 1977, unless otherwise noted.
21 CFR 137.350 Subpart A -- (Reserved)
21 CFR 137.350 Subpart B -- Requirements for Specific Standardized Macaroni and Noodle Products
21 CFR 139.110 Macaroni products.
(a) Macaroni products are the class of food each of which is prepared
by drying formed units of dough made from semolina, durum flour, farina,
flour, or any combination of two or more of these, with water and with
or without one or more of the optional ingredients specified in
paragraphs (a) (1) to (6), inclusive, of this section.
(1) Egg white, frozen egg white, dried egg white, or any two or all
of these, in such quantity that the solids thereof are not less than 0.5
percent and not more than 2.0 percent of the weight of the finished
food.
(2) Disodium phosphate, in a quantity not less than 0.5 percent and
not more than 1.0 percent of the weight of the finished food.
(3) Onions, celery, garlic, bay leaf, or any two or more of these, in
a quantity which seasons the food.
(4) Salt, in a quantity which seasons the food.
(5) Gum gluten, in such quantity that the protein content of the
finished food is not more than 13 percent by weight. The finished
macaroni product contains not less than 87 percent of total solids as
determined by the method prescribed in ''Official Methods of Analysis of
the Association of Official Analytical Chemists,'' 13th Ed. (1980), in
section 14.133, under the heading ''Vacuum Oven Method -- Official Final
Action,'' which is incorporated by reference. Copies may be obtained
from the Association of Official Analytical Chemists, 2200 Wilson Blvd.,
Suite 400, Arlington, VA 22201-3301, or may be examined at the Office of
the Federal Register, 1100 L St. NW., Washington, DC 20408.
(6) Concentrated glyceryl monostearate (containing not less than 90
percent monoester), in a quantity not exceeding 2 percent by weight of
the finished food.
(b) Macaroni is the macaroni product the units of which are
tube-shaped and more than 0.11 inch but not more than 0.27 inch in
diameter.
(c) Spaghetti is the macaroni product the units of which are
tube-shaped or cord-shaped (not tubular) and more than 0.06 inch but not
more than 0.11 inch in diameter.
(d) Vermicelli is the macaroni product the units of which are
cord-shaped (not tubular) and not more than 0.06 inch in diameter.
(e) The name of each food for which a definition and standard of
identity is prescribed by this section is ''Macaroni product''; or
alternatively, the name is ''Macaroni'', ''Spaghetti'', or
''Vermicelli'', as the case may be, when the units of the food are of
the shapes and sizes specified in paragraph (b), (c), or (d),
respectively, of this section.
(f) (1) When disodium phosphate is used the label shall bear the
statement ''Disodium phosphate added for quick cooking''.
(2) When any ingredient specified in paragraph (a)(3) of this section
is used the label shall bear the statement ''Seasoned with ------ '',
the blank being filled in with the common name of the ingredient; or in
the case of bay leaves the statement ''Spiced'', ''Spice added'', or
''Spiced with bay leaves''.
(3) When the ingredient specified in paragraph (a)(6) of this section
is used, the label shall bear the statement ''Glyceryl monostearate
added'' or the statement ''With added glyceryl monostearate''.
(4) Wherever the name of the food appears on the label so
conspicuously as to be easily seen under customary conditions of
purchase, the words and statements prescribed in this section, showing
the optional ingredients used, shall immediately and conspicuously
precede or follow, or in part precede and in part follow, such name,
without intervening written, printed, or graphic matter.
(42 FR 14409, Mar. 15, 1977, as amended at 47 FR 11828, Mar. 19,
1982; 49 FR 10099, Mar. 19, 1984; 54 FR 24894, June 12, 1989)
21 CFR 139.115 Enriched macaroni products.
(a) Enriched macaroni products are the class of food each of which
conforms to the definition and standard of identity and is subject to
the requirements for label statement of optional ingredients, prescribed
for macaroni products by 139.110 (a) and (f), except that:
(1) Each such food contains in each pound not less than 4 mg. and
not more than 5 mg. of thiamine, not less than 1.7 mg. and not more
than 2.2 mg. of riboflavin, not less than 27 mg. and not more than 34
mg. of niacin or niacinamide, and not less than 13 mg. and not more
than 16.5 mg. of iron (Fe);
(2) Each such food may also contain as an optional ingredient added
vitamin D in such quantity that each pound of the finished food contains
not less than 250 U.S.P. units and not more than 1000 U.S.P. units of
vitamin D.
(3) Each such food may also contain as an optional ingredient added
calcium in such quantity that each pound of the finished food contains
not less than 500 mg. and not more than 625 mg. of calcium (Ca);
(4) Each such food may also contain as an optional ingredient partly
defatted wheat germ but the amount thereof does not exceed 5 percent of
the weight of the finished food;
(5) Each such food may be supplied, wholly or in part, with the
prescribed quantity of any substance referred to in paragraphs (a) (1),
(2), and (3) of this section through the use of dried yeast, dried
torula yeast, partly defatted wheat germ, enriched farina, or enriched
flour, or through the direct additions of any of the substances
prescribed in paragraphs (a) (1), (2), and (3) of this section.
Iron and calcium may be added only in forms which are harmless and
assimilable. The substances referred to in paragraphs (a) (1) and (2)
of this section may be added in a harmless carrier which does not impair
the enriched macaroni product, such carrier being used only in the
quantity reasonably necessary to effect an intimate and uniform
distribution of such substances in the finished enriched macaroni
product.
(b) Enriched macaroni is the enriched macaroni product the units of
which conform to the specifications of shape and size prescribed for
macaroni by 139.110(b).
(c) Enriched spaghetti is the enriched macaroni product the units of
which conform to the specifications of shape and size prescribed for
spaghetti by 139.110(c).
(d) Enriched vermicelli is the enriched macaroni product the units of
which conform to the specifications of shape and size prescribed for
vermicelli by 139.110(d).
(e) The name of each food for which a definition and standard of
identity is prescribed by this section is ''Enriched Macaroni product'';
or alternatively, the name is ''Enriched macaroni'', ''Enriched
spaghetti'', or ''Enriched vermicelli'', as the case may be, when the
units of the food comply with the requirements of paragraphs (b), (c),
or (d) respectively of this section.
21 CFR 139.117 Enriched macaroni products with fortified protein.
(a) (1) Each of the foods for which a standard of identity is
prescribed by this section is produced by drying formed units of dough
made with one or more of the milled wheat ingredients designated in
139.110(a) and 139.138(a), and other ingredients to enable the finished
food to meet the protein requirements set out in paragraph (a)(2)(i) of
this section. Edible protein sources, including food grade flours or
meals made from nonwheat cereals or from oilseeds, may be used. Vitamin
and mineral enrichment nutrients are added to bring the food into
conformity with the requirements of paragraph (b) of this section. Safe
and suitable ingredients, as provided for in paragraph (c) of this
section, may be added. The proportion of the milled wheat ingredient is
larger than the proportion of any other ingredient used.
(2) Each such finished food, when tested by the methods described in
the cited sections of ''Official Methods of Analysis of the Association
of Official Analytical Chemists,'' 13th Ed. (1980), which is
incorporated by reference (copies may be obtained from the Association
of Official Analytical Chemists, 2200 Wilson Blvd., Suite 400,
Arlington, VA 22201-3301, or may be examined at the Office of the
Federal Register, 1100 L St. NW., Washington, DC 20408), meets the
following specifications:
(i) The protein content (N x 6.25) is not less than 20 percent by
weight (on a 13 percent moisture basis) as determined by the method in
section 14.142. The protein quality is not less than 95 percent that of
casein as determined on the cooked food by the method in sections 43.212
through 43.216 of the official methods.
(ii) The total solids content is not less than 87 percent by weight
as determined by the method in section 14.133 of the official methods.
(b) (1) Each food covered by this section contains in each pound 5
milligrams of thiamin, 2.2 milligrams of riboflavin, 34 milligrams of
niacin or niacinamide, and 16.5 milligrams of iron.
(2) Each pound of such food may also contain 625 milligrams of
calcium.
(3) Iron and calcium may be added only in forms which are harmless
and assimilable. The enrichment nutrients may be added in a harmless
carrier used only in a quantity necessary to effect a uniform
distribution of the nutrients in the finished food. The requirements of
paragraphs (b) (1) and (2) of this section shall be deemed to have been
met if reasonable overages, within the limits of good manufacturing
practice, are present to assure that the prescribed levels of the
vitamins and mineral(s) are maintained throughout the expected shelf
life of the food under customary conditions of distribution.
(c) The safe and suitable ingredients referred to in paragraph (a) of
this section are ingredients that serve a useful purpose, e.g., to
fortify the protein or facilitate production of the food, but they do
not include color additives, artificial flavorings, artificial
sweeteners, chemical preservatives, or starches. Ingredients deemed
suitable for use by this paragraph are added in amounts that are not in
excess of those reasonably required to achieve their intended purposes.
Ingredients are deemed to be safe if they are not food additives within
the meaning of section 201(s) of the Federal Food, Drug, and Cosmetic
Act, or in case they are food additives, if they are used in conformity
with regulations established pursuant to section 409 of the act.
(d) (1) The name of any food covered by this section is ''Enriched
Wheat ------------ Macaroni Product -- with Fortified Protein'', the
blank being filled in with appropriate word(s) such as ''Soy'' to show
the source of any flours or meals used that were made from nonwheat
cereals or from oilseeds. In lieu of the words ''Macaroni Product'' the
word ''Macaroni'', ''Spaghetti'', or ''Vermicelli'', as appropriate, may
be used if the units conform in shape and size to the requirements of
139.110 (b), (c), or (d).
(2) When any ingredient, not designated in the part of the name
prescribed in paragraph (d)(1) of this section, is added in such
proportion as to contribute 10 percent or more of the quantity of
protein contained in the finished food, the name shall include the
statement ''Made with -------- '', the blank being filled in with the
name of each such ingredient, e.g., ''Made with nonfat milk''.
(3) When, in conformity with paragraph (d) (1) or (2) of this
section, two or more ingredients are listed in the name, their
designations shall be arranged in descending order of predominance by
weight.
(4) In the case of a food made to comply with another section of this
part, but which also meets the compositional requirements of this
section, it may alternatively bear the name set out in that other
section.
(e) The common name of each of the ingredients used shall be declared
on the label as required by the applicable section of Part 101 of this
chapter. Further, the declaration of ingredients as set forth in this
paragraph, shall appear in letters not less than one-half the size of
that required by 101.105 of this chapter for the declaration of net
quantity of contents, and in no case less than one-sixteenth of an inch
in height.
(42 FR 14409, Mar. 15, 1977, as amended at 47 FR 11829, Mar. 19,
1982; 49 FR 10099, Mar. 19, 1984; 54 FR 24894, June 12, 1989)
Effective Date Note: Section 139.117 was stayed in its entirety at
43 FR 11695, Mar. 21, 1978.
21 CFR 139.120 Milk macaroni products.
(a) Milk macaroni products are the class of food each of which
conforms to the definition and standard of identity, and is subject to
the requirements for label statement of optional ingredients, prescribed
for macaroni products by 139.110 (a) and (f) (2) and (3), except that:
(1) Milk is used as the sole moistening ingredient in preparing the
dough; or in lieu of milk one or more of the milk ingredients specified
in paragraph (f) of this section is used, with or without water, in such
quantity that the weight of milk solids therein is not less than 3.8
percent of the weight of the finished milk macaroni product; and
(2) None of the optional ingredients permitted by 139.110(a) (1) and
(2) is used. When the optional ingredient gum gluten ( 139.110(a)(5))
is added, the quantity is such that the protein derived therefrom,
together with the protein derived from semolina, durum flour, farina,
flour, or any combination of these used, does not exceed 13 percent of
the weight of the finished food.
(b) Milk macaroni is the milk macaroni product the units of which
conform to the specifications of shape and size prescribed for macaroni
by 139.110(b).
(c) Milk spaghetti is the milk macaroni product the units of which
conform to the specifications of shape and size prescribed for spaghetti
by 139.110(c).
(d) Milk vermicelli is the milk macaroni product the units of which
conform to the specifications of shape and size prescribed for
vermicelli by 139.110(d).
(e) The name of each food for which a definition and standard of
identity is prescribed by this section is ''Milk Macaroni Product''; or
alternatively, the name is ''Milk macaroni'', ''Milk spaghetti'', or
''Milk vermicelli'', as the case may be, when the units of the food
comply with the requirements of paragraph (b), (c), or (d),
respectively, of this section.
(f) The milk ingredients referred to in paragraph (a)(1) of this
section are concentrated milk, evaporated milk, dried milk, and a
mixture of butter with skim milk, concentrated skim milk, evaporated
skim milk, nonfat dry milk (dried skim milk), or any two or more of
these, in such proportion that the weight of nonfat milk solids in such
mixture is not more than 2.275 times the weight of milk fat therein.
21 CFR 139.121 Nonfat milk macaroni products.
(a) Each of the macaroni products made with nonfat milk for which a
definition and standard of identity is prescribed by this section
conforms to the definition and standard of identity, and is subject to
the requirements for label statement of optional ingredients, prescribed
for macaroni products by 139.110 (a) and (f) (2), (3), and (4), except
that:
(1) (i) In preparing the dough, nonfat dry milk or concentrated skim
milk, or a mixture of these, is used in an amount such that the finished
macaroni product made with nonfat milk contains by weight not less than
12 percent and not more than 25 percent of milk solids-not-fat.
Carrageenan or salts of carrageenan conforming to the requirements of
172.620 and 172.626 of this chapter may be used in a quantity not in
excess of 0.833 percent by weight of the milk solids-not-fat used.
(ii) When the ingredient carrageenan or the salts of carrageenan
specified in paragraph (a)(1)(i) of this section is used, the label
shall bear the statement, ''Carrageenan added'' or ''Salts of
carrageenan added'' or the statement ''With added carrageenan'' or
''With added salts of carrageenan'', in the manner further prescribed by
139.110(f)(4).
(2) None of the optional ingredients permitted by 139.110(a) (1),
(2), and (5) are used.
(b) The name of each food for which a definition and standard of
identity is prescribed by this section is ''Macaroni products made with
nonfat milk'' or, alternatively, the name is ''Macaroni made with nonfat
milk'', ''Spaghetti made with nonfat milk'' or ''Vermicelli made with
nonfat milk'', as the case may be when the units of the food conform to
the specifications of shape and size prescribed by 139.110 (b), (c), or
(d), respectively.
21 CFR 139.122 Enriched nonfat milk macaroni products.
(a) Each of the enriched macaroni products made with nonfat milk for
which a definition and standard of identity is prescribed by this
section conforms to the definition and standard of identity, and is
subject to the requirements for label statement of optional ingredients,
prescribed for macaroni products by 139.110 (a) and (f) (2), (3), and
(4), except that:
(1) (i) In preparing the dough, nonfat dry milk or concentrated skim
milk, or a mixture of these, is used in an amount such that the finished
enriched macaroni product made with nonfat milk contains by weight not
less than 12 percent and not more than 25 percent of milk
solids-not-fat. Carrageenan or the salts of carrageenan conforming to
the requirements of 172.620 and 172.626 of this chapter may be used in
a quantity not in excess of 0.833 percent by weight of the milk
solids-not-fat used.
(ii) When the ingredient carrageenan or the salts of carrageenan
specified in paragraph (a)(1)(i) of this section is used, the label
shall bear the statement, ''Carrageenan added'' or ''Salts of
carrageenan added'' or the statement ''With added carrageenan'' or
''With added salts of carrageenan'', in the manner further prescribed by
139.110(f)(4).
(2) None of the optional ingredients permitted by 139.110(a) (1),
(2), and (5) are used.
(3) Each such food contains in each pound not less than 4 milligrams
and not more than 5 milligrams of thiamine, not less than 1.7 milligrams
and not more than 2.2 milligrams of riboflavin, not less than 27
milligrams and not more than 34 milligrams of niacin or niacinamide, and
not less than 13 milligrams and not more than 16.5 milligrams of iron
(Fe). These substances may be added through direct addition or wholly
or in part through the use of dried yeast, dried torula yeast, partly
defatted wheat germ (as provided for in paragraph (a)(4) of this
section), enriched farina, or enriched flour. They may be added in a
harmless carrier, such carrier being used only in the quantity
reasonably necessary to effect an intimate and uniform distribution of
such substances in the finished food. Iron may be added only in a form
that is harmless and assimilable.
(4) Each such food may also contain as an optional ingredient partly
defatted wheat germ, but the amount thereof does not exceed 5 percent by
weight of the finished food.
(b) The name of each food for which a definition and standard of
identity is prescribed by this section is ''Enriched macaroni product
made with nonfat milk'' or, alternatively, the name is ''Enriched
macaroni made with nonfat milk'', ''Enriched spaghetti made with nonfat
milk'', or ''Enriched vermicelli made with nonfat milk,'' as the case
may be when the units of the food conform to the specifications of shape
and size prescribed by 139.110 (b), (c), or (d), respectively.
21 CFR 139.125 Vegetable macaroni products.
(a) Vegetable macaroni products are the class of food each of which
conforms to the definition and standard of identity, and is subject to
the requirements for label statement of optional ingredients, prescribed
for macaroni products by 139.110 (a) and (f) (2) and (3), except that:
(1) Tomato (of any red variety), artichoke, beet, carrot, parsley, or
spinach is added in such quantity that the solids thereof are not less
than 3 percent by weight of the finished vegetable macaroni product (the
vegetable used may be fresh, canned, dried, or in the form of puree or
paste); and
(2) None of the optional ingredients permitted by 139.110(a) (1) and
(2) is used. When the optional ingredient gum gluten ( 139.110(a)(5))
is added, the quantity is such that the protein derived therefrom,
together with the protein derived from the semolina, durum flour,
farina, flour or any combination of these used, does not exceed 13
percent of the weight of the finished food.
(b) Vegetable macaroni is the vegetable macaroni product the units of
which conform to the specifications of shape and size prescribed for
macaroni by 139.110(b).
(c) Vegetable spaghetti is the vegetable macaroni product the units
of which conform to the specifications of shape and size prescribed for
spaghetti by 139.110(c).
(d) Vegetable vermicelli is the vegetable macaroni product, the units
of which conform to the specifications of shape and size prescribed for
vermicelli by 139.110(d).
(e) The name of each food for which a definition and standard of
identity is prescribed by this section is '' -------- macaroni
product'', the blank being filled in with the name whereby the vegetable
used is designated in paragraph (a) of this section; or alternatively,
the name is '' -------- macaroni'', '' -------- spaghetti'', or ''
-------- vermicelli'', as the case may be, when the units of the food
comply with the requirements of paragraph (b), (c), or (d) of this
section, respectively, the blank in each instance being filled in with
the name whereby the vegetable used is designated in paragraph (a) of
this section.
21 CFR 139.135 Enriched vegetable macaroni products.
(a) Each of the macaroni products for which a definition and standard
of identity is prescribed by this section conforms to the definition and
standard of identity and is subject to the requirements for label
statement of optional ingredients prescribed for macaroni products by
139.110 (a) and (f), and in addition is enriched to meet the
requirements prescribed for enriched macaroni products by 139.115 and
contains a vegetable ingredient in compliance with the requirements
prescribed for vegetable macaroni products by 139.125.
(b) The name of each food for which a definition and standard of
identity is prescribed by this section is ''Enriched ------------
macaroni product'', or, alternatively, the name is ''Enriched
---------------- macaroni'', ''Enriched ------------ spaghetti'', or
''Enriched ------------ vermicelli'', when the units comply with the
shape and size requirements prescribed for macaroni, spaghetti, or
vermicelli in 139.110 (b), (c), or (d). The blank in each instance is
filled in with the name of the vegetable used, as specified in
139.125(a). For example, the name of an enriched macaroni product
containing the prescribed amount of spinach and made in units not
conforming in shape and size to the requirements for macaroni,
spaghetti, or vermicelli is ''Enriched spinach macaroni product''.
21 CFR 139.138 Whole wheat macaroni products.
(a) Whole wheat macaroni products are the class of food each of which
conforms to the definition and standard of identity, and is subject to
the requirements for label statement of optional ingredients, prescribed
for macaroni products by 139.110 (a) and (f) (2) and (3), except that:
(1) Whole wheat flour or whole durum wheat flour or both are used as
the sole wheat ingredient; and
(2) None of the optional ingredients permitted by 139.110(a) (1),
(2), and (5) is used.
(b) Whole wheat macaroni is the whole wheat macaroni product the
units of which conform to the specifications of shape and size
prescribed for macaroni by 139.110(b).
(c) Whole wheat spaghetti is the whole wheat macaroni product the
units of which conform to the specifications of shape and size
prescribed for spaghetti by 139.110(c).
(d) Whole wheat vermicelli is the whole wheat macaroni product the
units of which conform to the specifications of shape and size
prescribed for vermicelli by 139.110(d).
(e) The name of each food for which a definition and standard of
identity is prescribed by this section is ''Whole wheat macaroni
product''; or alternatively, the name is ''Whole wheat macaroni'',
''Whole wheat spaghetti'', or ''Whole wheat vermicelli'', as the case
may be, when the units of the food comply with the requirements of
paragraph (b), (c), or (d), respectively, of this section.
21 CFR 139.140 Wheat and soy macaroni products.
(a) Wheat and soy macaroni products are the class of food each of
which conforms to the definition and standard of identity, and is
subject to the requirements for label statement of optional ingredients,
prescribed for macaroni products by 139.110(a) and (f) (2) and (3),
except that:
(1) Soy flour is added in a quantity not less than 12.5 percent of
the combined weight of the wheat and soy ingredients used (the soy flour
used is made from heat-processed, dehulled soybeans, with or without the
removal of fat therefrom); and
(2) None of the optional ingredients permitted by 139.110(a) (1) and
(2) is used. When the optional ingredient gum gluten ( 139.110(a)(5))
is added, the quantity is such that the protein derived therefrom,
together with the protein derived from semolina, durum flour, farina,
flour or any combination of these used, does not exceed 13 percent of
the weight of the finished food.
(b) Wheat and soy macaroni is the wheat and soy macaroni product the
units of which conform to the specifications of shape and size
prescribed for macaroni by 139.110(b).
(c) Wheat and soy spaghetti is the wheat and soy macaroni product the
units of which conform to the specifications of shape and size
prescribed for spaghetti by 139.110(c).
(d) Wheat and soy vermicelli is the wheat and soy macaroni product
the units of which conform to the specifications of shape and size
prescribed for vermicelli by 139.110(d).
(e) The name of each food for which a definition and standard of
identity is prescribed by this section is ''Wheat and soy macaroni
product'', ''Wheat and soybean macaroni product'', '' ------------ and
soy macaroni product'', or '' -------- and soybean macaroni product'',
the blank in each instance being filled in with the name whereby the
wheat ingredient used is designated in 139.110(a); or alternatively,
the name is ''Wheat and soy macaroni'', ''Wheat and soybean macaroni'',
'' ------------ and soy macaroni'', or '' -------- and soybean
macaroni'' when the units of the food comply with the requirements of
paragraph (b) of this section; or ''Wheat and soy spaghetti'', ''Wheat
and soybean spaghetti'', '' ------------ and soy spaghetti'', or ''
------------ and soybean spaghetti'' when such units comply with the
requirements of paragraph (c) of this section; or ''Wheat and soy
vermicelli'', ''Wheat and soybean vermicelli'', '' ------------ and soy
vermicelli'', or '' -------- and soybean vermicelli'' when such units
comply with the requirements of paragraph (d) of this section, the blank
in each instance being filled in with the name whereby the wheat
ingredient used is designated in 139.110(a).
21 CFR 139.150 Noodle products.
(a) Noodle products are the class of food each of which is prepared
by drying formed units of dough made from semolina, durum flour, farina,
flour, or any combination of two or more of these, with liquid eggs,
frozen eggs, dried eggs, egg yolks, frozen yolks, dried yolks, or any
combination of two or more of these, with or without water and with or
without one or more of the optional ingredients specified in paragraphs
(a) (1) to (4) of this section inclusive:
(1) Onions, celery, garlic, bay leaf, or any two or more of these, in
a quantity which seasons the food.
(2) Salt, in a quantity which seasons the food.
(3) Gum gluten, in such quantity that the protein derived therefrom,
together with the protein derived from semolina, durum flour, farina,
flour or any combination of these used, does not exceed 13 percent of
the weight of the finished food.
(4) Concentrated glyceryl monostearate (containing not less than 90
percent monoester) in a quantity not exceeding 3 percent by weight of
the finished food.
The finished noodle product contains not less than 87 percent of
total solids as determined by the method prescribed in ''Official
Methods of Analysis of the Association of Official Analytical
Chemists,'' 13th Ed. (1980), in section 14.133, under the heading
''Vacuum Oven Method -- Official Final Action,'' which is incorporated
by reference. Copies may be obtained from the Association of Official
Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA
22201-3301, or may be examined at the Office of the Federal Register,
1100 L St. NW., Washington, DC 20408. The total solids of noodle
products contains not less than 5.5 percent by weight of the solids of
egg, or egg yolk.
(b) Noodles, egg noodles, is the noodle product the units of which
are ribbon-shaped.
(c) Egg macaroni is the noodle product the units of which are
tube-shaped and more than 0.11 inch but not more than 0.27 inch in
diameter.
(d) Egg spaghetti is the noodle product the units of which are
tube-shaped or cord-shaped (not tubular) and more than 0.06 inch but not
more than 0.11 inch in diameter.
(e) Egg vermicelli is the noodle product the units of which are
cord-shaped (not tubular) and not more than 0.06 inch in diameter.
(f) The name of each food for which a definition and standard of
identity is prescribed by this section is ''Noodle product'' or ''Egg
noodle product''; or alternatively, the name is ''Noodles'' or ''Egg
noodles'', ''Egg macaroni'', ''Egg spaghetti'', or ''Egg vermicelli'',
as the case may be, when the units of the food are of the shapes and
sizes specified in paragraph (b), (c), (d), or (e), respectively, of
this section.
(g)(1) When any ingredient specified in paragraph (a)(1) of this
section is used, the label of the noodle product shall bear the
statement ''Seasoned with ------------ '', the blank being filled in
with the common name of the ingredient; or in the case of bay leaves,
the statement ''Spiced'', ''Spice added'', or ''Spiced with bay
leaves''.
(2) When the ingredient specified in paragraph (a) (4) of this
section is used, the label shall bear the statement ''Glyceryl
monostearate added'' or the statement ''With added glyceryl
monostearate''.
(h) Wherever the name of the food appears on such label so
conspicuously as to be easily seen under customary conditions of
purchase, the words and statements prescribed in this section, showing
the ingredients used shall immediately and conspicuously precede or
follow, or in part precede and in part follow, such name without
intervening written, printed, or other graphic matter.
(42 FR 14409, Mar. 15, 1977, as amended at 47 FR 11829, Mar. 19,
1982; 49 FR 10099, Mar. 19, 1984; 54 FR 24894, June 12, 1989)
21 CFR 139.155 Enriched noodle products.
(a) Enriched noodle products are the class of food each of which
conforms to the definition and standard of identity, and is subject to
the requirements for label statement of optional ingredients, prescribed
for noodle products by 139.150 (a) and (g), except that:
(1) Each such food contains in each pound not less than 4 mg. and
not more than 5 mg. of thiamine, not less than 1.7 mg. and not more
than 2.2 mg. of riboflavin, not less than 27 mg. and not more than 34
mg. of niacin or niacinamide, and not less than 13 mg. and not more
than 16.5 mg. of iron (Fe);
(2) Each such food may also contain as an optional ingredient added
vitamin D in such quantity that each pound of the finished food contains
not less than 250 U.S.P. units and not more than 1000 U.S.P. units of
vitamin D;
(3) Each such food may also contain as an optional ingredient added
calcium in such quantity that each pound of the finished food contains
not less than 500 mg. and not more than 625 mg. of calcium (Ca);
(4) Each such food may also contain as an optional ingredient partly
defatted wheat germ, but the amount thereof does not exceed 5 percent of
the weight of the finished food;
(5) Each such food may be supplied, wholly or in part, with the
prescribed quantity of any substance referred to in paragraphs (a) (1),
(2), and (3) of this section through the use of dried yeast, dried
torula yeast, partly defatted wheat germ, enriched farina, or enriched
flour, or through the direct additions of any of the substances
prescribed in paragraphs (a) (1), (2), and (3) of this section.
Iron and calcium may be added only in forms which are harmless and
assimilable. The substances referred to in paragraphs (a) (1) and (2)
of this section may be added in a harmless carrier which does not impair
the enriched noodle product, such carrier being used only in the
quantity reasonably necessary to effect an intimate and uniform
distribution of such substances in the finished enriched noodle product.
(b) Enriched noodles, enriched egg noodles are the enriched noodle
products the units of which conform to the specifications of shape and
size prescribed for noodles in 139.150(b).
(c) Enriched egg macaroni is the enriched noodle product the units of
which conform to the specifications of shape and size prescribed for egg
macaroni in 139.150(c).
(d) Enriched egg spaghetti is the enriched noodle product the units
of which conform to the specifications of shape and size prescribed for
egg spaghetti in 139.150(d).
(e) Enriched egg vermicelli is the enriched noodle product the units
of which conform to the specifications of shape and size prescribed for
egg vermicelli in 139.150(e).
(f) The name of each food for which a definition and standard of
identity is prescribed by this section is ''Enriched noodle product'' or
''Enriched egg noodle product''; or alternatively, the name is
''Enriched noodles'', or ''Enriched egg noodles'', ''Enriched egg
macaroni'', ''Enriched egg spaghetti'', or ''Enriched egg vermicelli'',
as the case may be, when the units of the food comply with the
requirements of paragraph (b), (c), (d), or (e) respectively of this
section.
21 CFR 139.160 Vegetable noodle products.
(a) Vegetable noodle products are the class of food each of which
conforms to the definition and standard of identity, and is subject to
the requirements for label statement of optional ingredients, prescribed
for noodle products by 139.150 (a) and (g), except that tomato (of any
red variety), artichoke, beet, carrot, parsley, or spinach is added in
such quantity that the solids thereof are not less than 3 percent by
weight of the finished vegetable noodle product (the vegetable used may
be fresh, canned, dried, or in the form of puree or paste).
(b) Vegetable noodles, vegetable egg noodles, is the vegetable noodle
product the units of which are ribbon-shaped.
(c) Vegetable egg macaroni is the vegetable noodle product the units
of which conform to the specifications of shape and size prescribed for
egg macaroni by 139.150(c).
(d) Vegetable egg spaghetti is the vegetable noodle product the units
of which conform to the specifications of shape and size prescribed for
egg spaghetti by 139.150(d).
(e) Vegetable egg vermicelli is the vegetable noodle product the
units of which conform to the specifications of shape and size
prescribed for egg vermicelli by 139.150(e).
(f) The name of each food for which a definition and standard of
identity is prescribed by this section is '' ------------ noodle
product'' or '' ------------ egg noodle product'', the blank being
filled in with the name whereby the vegetable used is designated in
paragraph (a) of this section; or alternatively, the name is ''
-------- noodles'' or '' -------- egg noodles'', '' -------- egg
macaroni'', '' -------- egg spaghetti'', or '' -------- egg
vermicelli'', as the case may be, when the units of the food comply with
the requirements of paragraph (b), (c), (d), or (e) of this section,
respectively, the blank in each instance being filled in with the name
whereby the vegetable is designated in paragraph (a) of this section.
21 CFR 139.165 Enriched vegetable noodle products.
(a) Each of the noodle products for which a definition and standard
of identity is prescribed by this section conforms to the definition and
standard of identity and is subject to the requirements for label
declaration of optional ingredients prescribed for noodle products by
139.150 (a), (g), and (h), and in addition is enriched to meet the
requirements prescribed for enriched noodle products by 139.155 and,
except as hereinafter provided, contains a vegetable ingredient in
compliance with the requirements prescribed for vegetable noodle
products by 139.160. Carrots, because they are apt to impart an
egg-yolk color, are not used in enriched vegetable noodle products.
(b) The name of each food for which a definition and standard of
identity is prescribed by this section is ''Enriched ------------ noodle
product'', ''Enriched ------------ egg noodle product'', or,
alternatively, the name is ''Enriched ------------ noodles'', or
''Enriched ------------ egg noodles'', ''Enriched ------------ egg
macaroni'', ''Enriched ------------ egg spaghetti'', or ''Enriched
------------ egg vermicelli'', when the units comply with the size and
shape requirements for noodles, macaroni, spaghetti, or vermicelli in
139.150 (b), (c), (d), or (e). The blank in each instance is filled in
with the name of the vegetable used, as specified in 139.160(a).
21 CFR 139.180 Wheat and soy noodle products.
(a) Wheat and soy noodle products are the class of food each of which
conforms to the definition and standard of identity, and is subject to
the requirements for label statement of optional ingredients, prescribed
for noodle products by 139.150 (a) and (g), except that soy flour is
added in a quantity not less than 12.5 percent of the combined weight of
the wheat and soy ingredients used (the soy flour used is made from
heat-processed, dehulled soybeans, with or without the removal of fat
therefrom).
(b) Wheat and soy noodles, wheat and soy egg noodles, is the wheat
and soy noodle product the units of which are ribbon-shaped.
(c) Wheat and soy egg macaroni is the wheat and soy noodle product
the units of which conform to the specifications of shape and size
prescribed for egg macaroni by 139.150(c).
(d) Wheat and soy egg spaghetti is the wheat and soy noodle product
the units of which conform to the specifications of shape and size
prescribed for egg spaghetti by 139.150(d).
(e) Wheat and soy egg vermicelli is the wheat and soy noodle product
the units of which conform to the specifications of shape and size
prescribed for egg vermicelli by 139.150(e).
(f) The name of each food for which a definition and standard of
identity is prescribed by this section is ''Wheat and soy noodle
product'', ''Wheat and soy egg noodle product'', ''Wheat and soybean
noodle product'', ''Wheat and soybean egg noodle product'', '' ------
and soy noodle product'', '' ------ and soy egg noodle product'', ''
------ and soybean noodle product'', or '' ------ and soybean egg noodle
product'', the blank in each instance being filled in with the name
whereby the wheat ingredient used is designated in 139.150(a); or
alternatively, the name is ''Wheat and soy noodles'', ''Wheat and soy
egg noodles'', ''Wheat and soybean noodles'', ''Wheat and soybean egg
noodles'', '' ------ and soy noodles'', '' ------ and soy egg noodles'',
'' ------ and soybean noodles'', or '' ------ and soybean egg noodles''
when the units of the food comply with the requirements of paragraph (b)
of this section; or ''Wheat and soy egg macaroni'', ''Wheat and soybean
egg macaroni'', '' ------ and soy egg macaroni'', or '' ------ and
soybean egg macaroni'' when such units comply with the requirements of
paragraph (c) of this section; or ''Wheat and soy egg spaghetti'',
''Wheat and soybean egg spaghetti'', '' ------ and soy egg spaghetti'',
or '' ------ and soybean egg spaghetti'' when such units comply with the
requirements of paragraph (d) of this section; or ''Wheat and soy egg
vermicelli'', ''Wheat and soybean egg vermicelli'', '' ------ and soy
egg vermicelli'', or '' ------ and soybean egg vermicelli'', when such
units comply with the requirements of paragraph (e) of this section, the
blank in each instance being filled in with the name whereby the wheat
ingredient used is designated in 139.150(a).
21 CFR 139.180 Pt. 145
21 CFR 139.180 PART 145 -- CANNED FRUITS
21 CFR 139.180 Subpart A -- General Provisions
Sec.
145.3 Definitions.
21 CFR 139.180 Subpart B -- Requirements for Specific Standardized
Canned Fruits
145.110 Canned applesauce.
145.115 Canned apricots.
145.116 Artificially sweetened canned apricots.
145.120 Canned berries.
145.125 Canned cherries.
145.126 Artificially sweetened canned cherries.
145.130 Canned figs.
145.131 Artificially sweetened canned figs.
145.134 Canned preserved figs.
145.135 Canned fruit cocktail.
145.136 Artificially sweetened canned fruit cocktail.
145.140 Canned seedless grapes.
145.145 Canned grapefruit.
145.170 Canned peaches.
145.171 Artificially sweetened canned peaches.
145.175 Canned pears.
145.176 Artificially sweetened canned pears.
145.180 Canned pineapple.
145.181 Artificially sweetened canned pineapple.
145.185 Canned plums.
145.190 Canned prunes.
Authority: Secs. 201, 401, 403, 409, 701, 706 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321, 341, 343, 348, 371, 376).
Source: 42 FR 14414, Mar. 15, 1977, unless otherwise noted.
21 CFR 139.180 Subpart A -- General Provisions
21 CFR 145.3 Definitions.
For the purposes of this part:
(a) The term ''corn sirup'' means a clarified, concentrated aqueous
solution of the products obtained by the incomplete hydrolysis of
cornstarch, and includes dried corn sirup. The solids of corn sirup and
of dried corn sirup contain not less than 40 percent by weight of
reducing sugars calculated as anhydrous dextrose.
(b) The term ''dextrose'' means the hydrated or anhydrous, refined
monosaccharide obtained from hydrolyzed starch.
(c) The term ''dried glucose sirup'' means the product obtained by
drying ''glucose sirup.''
(d) The term ''glucose sirup'' means a clarified, concentrated,
aqueous solution of the products obtained by the incomplete hydrolysis
of any edible starch. The solids of glucose sirup contain not less than
40 percent by weight of reducing sugars calculated as anhydrous
dextrose.
(e) The term ''invert sugar sirup'' means an aqueous solution of
inverted or partly inverted, refined or partly refined sucrose, the
solids of which contain not more than 0.3 percent by weight of ash, and
which is colorless, odorless, and flavorless, except for sweetness.
(f) The term ''sugar'' means refined sucrose.
(g) The terms ''edible organic acid'' and ''edible organic salt''
refer to any edible organic acid and any edible organic salt added for
the purpose of flavor enhancement that either is not a food additive as
defined in section 201(s) of the Federal Food, Drug, and Cosmetic Act
or, if it is a food additive as so defined, is used in conformity with
regulations established pursuant to section 409 of the act.
(h) The term ''water'' means, in addition to water, any mixture of
water and fruit juice in which the fruit juice(s) is less than 50
percent of such mixture, including any water contributed by the use of
liquid nutritive carbohydrate sweeteners.
(i) The term ''fruit juice(s) and water'' means any mixture of fruit
juice as herein defined and water, including any water contributed by
the use of liquid nutritive carbohydrate sweeteners, in which the fruit
juice(s) is 50 percent, or more, of such mixture except that water used
in preparing equivalent single strength juice(s) from concentrate(s)
shall not be considered to be a mixture of fruit juice and water.
(j) The term ''fruit juice(s)'' means single strength expressed
juice(s) of sound, mature fruit(s). It may be fresh, frozen, canned, or
made from concentrate(s). However, if it is made from concentrate(s),
the juice(s) shall be reconstituted with water to not less than the
soluble solids that such fruit juice had before concentration. Fruit
juice(s) may be used singly or in combination. If a fruit juice(s) is
used which is regulated by a standard of identity of this chapter, it
shall conform to the compositional requirements prescribed by such
standard prior to the addition of any sweetener which may be used.
(k) The term ''clarified juice'' means the liquid expressed wholly or
in part from fruit peelings, fruit shells, fruit cores, or from the
fruit flesh or parts thereof, which is clarified and may be further
refined or concentrated.
(l) The term ''solid pack'' means the product contains practically
all fruit with only the very little free flowing liquid that is
expressed from the fruit and to which no packing media have been added.
(m) The procedure for determining the densities of the packing media
means the following: The density of the packing medium, when measured
15 days or more after packing, or the density of the blended homogenized
slurry of the comminuted entire contents of the container, when measured
less than 15 days after canning, is determined according to ''Official
Methods of Analysis of the Association of Official Analytical
Chemists,'' 13th Ed. (1980), which is incorporated by reference,
section 31.011 (Solids) ''By Means of the Refractometer -- Official
Final Action'' (and sections 52.012 and 52.015) with result expressed as
percent by weight of sucrose (degrees Brix) with correction for
temperature to the equivalent at 20 C, but without correction for
invert sugar or other substances. Copies of the material incorporated
by reference may be obtained from the Association of Official Analytical
Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may
be examined at the Office of the Federal Register, 1100 L St. NW.,
Washington, DC 20408.
(n) The procedure for determining drained weight is as follows: Tilt
the opened container so as to distribute the contents evenly over the
meshes of a circular sieve which has previously been weighed. The
diameter of the sieve is 20.3 centimeters (8 inches) if the quantity of
contents of the container is less than 1.4 kilograms (3 pounds) and 30.5
centimeters (12 inches) if such quantity is 1.4 kilograms (3 pounds) or
more. The bottom of the sieve is woven-wire cloth which complies with
the specifications for the No. 8 sieve set forth in the ''Definitions
of Terms and Explanatory Notes'' of the ''Official Methods of Analysis
of the Association of Official Analytical Chemists,'' 13th Ed. (1980),
which is incorporated by reference. The availability of this
incorporation by reference is given in paragraph (m) of this section.
Carefully invert by hand all fruits having cups or cavities if they fall
on the sieve with cups or cavities up. Cups or cavities in soft
products may be drained by tilting sieve. Without further shifting the
material on the sieve, incline the sieve at an angle of 17 to 20 to
facilitate drainage. Two minutes after the drainage begins, weigh the
sieve and drained fruit. The weight so found, less the weight of the
sieve, shall be considered to be the weight of the drained fruit.
(o) Compliance means the following: Unless otherwise provided in a
standard, a lot of canned fruits shall be deemed in compliance for the
following factors, to be determined by the sampling and acceptance
procedure as provided in paragraph (p) of this section, namely:
(1) Packing medium density. A lot shall be deemed to be in
compliance for packing medium density based on the average sucrose value
for all samples analyzed according to the sampling plans, but no
container may have a sucrose value lower than that of the next lower
category or 2 percent by weight sucrose (degrees Brix) lower if no lower
category exists.
(2) Quality. The quality of a lot shall be considered acceptable
when the number of defectives does not exceed the acceptance number in
the sampling plans.
(3) Fill of container. A lot shall be deemed to be in compliance for
fill of container (packing medium and fruit ingredient) when the number
of defectives does not exceed the acceptance number (c) in the sampling
plans.
(4) Drained weight. A lot shall be deemed to be in compliance for
drained weight based on the average value of all samples analyzed
according to the sampling plans. The sample unit shall be the entire
contents of the container.
(p) The sampling and acceptance procedure means the following:
(1) Definitions -- (i) Lot. A collection of primary containers or
units of the same size, type, and style manufactured or packed under
similar conditions and handled as a single unit of trade.
(ii) Lot size. The number of primary containers or units in the lot.
(iii) Sample size. The total number of sample units drawn for
examination from a lot.
(iv) Sample unit. A container, a portion of the contents of a
container, or a composite mixture of product from small containers that
is sufficient for the examination or testing as a single unit.
(v) Defective. Any sample unit shall be regarded as defective when
the sample unit does not meet the criteria set forth in the standards.
(vi) Acceptance number (c). The maximum number of defective sample
units permitted in the sample in order to consider the lot as meeting
the specified requirements.
(vii) Acceptable quality level (AQL). The maximum percent of
defective sample units permitted in a lot that will be accepted
approximately 95 percent of the time.
(2) Sampling plans:
(42 FR 14414, Mar. 15, 1977, as amended at 47 FR 11829, Mar. 19,
1982; 49 FR 10099, Mar. 19, 1984; 54 FR 24894, June 12, 1989)
21 CFR 145.3 Subpart B -- Requirements for Specific Standardized Canned Fruits
21 CFR 145.110 Canned applesauce.
(a) Identity -- (1) Definition. Canned applesauce is the food
prepared from comminuted or chopped apples (Malus domestica Borkhausen),
which may or may not be peeled and cored, and which may have added
thereto one or more of the optional ingredients specified in paragraph
(a)(2) of this section. The apple ingredient is heated and, in
accordance with good manufacturing practices, bruised apple particles,
peel, seed, core material, carpel tissue, and other coarse, hard, or
extraneous materials are removed. The food is sealed in containers. It
is so processed by heat, either before or after sealing, as to prevent
spoilage. The soluble solids content, measured by refractometer and
expressed as percent sucrose (degrees Brix) with correction for
temperature to the equivalent at 20 C (68 F), is not less than 9
percent (exclusive of the solids of any added optional nutritive
carbohydrate sweeteners) as determined by the method prescribed in
''Official Methods of Analysis of the Association of Official Analytical
Chemists,'' 13th Ed. (1980), section 22.024, ''Soluble Solids by
Refractometer in Fresh and Canned Fruits, Jams, Marmalades, and
Preserves -- Official First Action,'' which is incorporated by
reference, but without correction for invert sugar or other substances.
Copies may be obtained from the Association of Official Analytical
Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may
be examined at the Office of the Federal Register, 1100 L St. NW.,
Washington, DC 20408.
(2) Optional ingredients. The following safe and suitable optional
ingredients may be used:
(i) Water.
(ii) Apple juice.
(iii) Salt.
(iv) Any organic acid added for the purpose of acidification.
(Organic acids generally recognized as having a preservative effect are
not permitted in applesauce except as provided for in paragraph
(a)(2)(viii) of this section.)
(v) Nutritive carbohydrate sweeteners.
(vi) Spices.
(vii) Natural and artificial flavoring.
(viii) Either of the following:
(a) Erythorbic acid or ascorbic acid as an antioxidant preservative
in an amount not to exceed 150 parts per million; or
(b) Ascorbic acid (vitamin C) in a quantity such that the total
vitamin C in each 113 g (4 ounces) by weight of the finished food
amounts to 60 mg. This requirement will be deemed to have been met if a
reasonable overage of the vitamin, within limits of good manufacturing
practice, is present to insure that the required level is maintained
throughout the expected shelf life of the food under customary
conditions of distribution.
(ix) Color additives in such quantity as to distinctly characterize
the food unless such addition conceals damage or inferiority or makes
the finished food appear better or of greater value than it is.
(3) Nomenclature. The name of the food is ''applesauce''. The name
of the food shall include a declaration indicating the presence of any
flavoring that characterizes the product as specified in 101.22 of this
chapter and a declaration of any spice that characterizes the product.
If a nutritive sweetener as provided for in paragraph (a)(2)(v) of this
section is added and the soluble solids content of the finished food is
not less than 16.5 percent as determined by the method referred to in
paragraph (a)(1) of this section, the name may include the word
''sweetened''. If no such sweetener is added, the name may include the
word ''unsweetened''.
(4) Label declaration. Each of the optional ingredients shall be
declared on the label as required by the applicable sections of Part 101
of this chapter. However, when ascorbic acid (vitamin C) is added as
provided for in paragraph (a)(2)(viii)(b) of this section, after the
application of heat to the apples, preservative labeling requirements do
not apply.
(b) (Reserved)
(c) Fill of container -- (1) The standard of fill of container for
canned applesauce is a fill of not less than 90 percent of the total
capacity of the container, as determined by the general method for fill
of containers prescribed in 130.12(b) of this chapter; except that in
the case of glass containers having a total capacity of 192 ml (6 1/2
fluid ounces) or less, the fill is not less than 85 percent.
(2) Sampling and acceptance procedure: A lot will be deemed to fall
below the standard of fill when the number of ''defectives'' exceeds the
acceptance number ''c'' in the sampling plans prescribed in paragraph
(c)(2)(ii) of this section.
(i) Definitions of terms to be used in the sampling plans in
paragraph (c)(2)(ii) of this section are as follows:
(a) Lot. A collection of primary containers or units of the same
size, type, and style manufactured or packed under similar conditions
and handled as a single unit of trade.
(b) Lot size. The number of primary containers or units in the lot.
(c) Sample size ''n.'' The total number of sample units drawn for
examination from a lot as indicated in paragraph (c)(2)(ii) of this
section.
(d) Sample unit. A container, the entire contents of a container, a
portion of the contents of a container, or a composite mixture of
product from small containers that is sufficient for examination or
testing as a single unit.
(e) Defective. A container that falls below the requirement for
minimum fill prescribed in paragraph (c)(1) of this section is
considered a ''defective.''
(f) Acceptable number ''c.'' The maximum number of defective sample
units permitted in the sample in order to consider the lot as meeting
the specified requirements.
(g) Acceptable quality level (AQL). The maximum percent of defective
sample units permitted in a lot that will be accepted approximately 95
percent of the time.
(ii) Sampling and acceptance:
(3) If canned applesauce falls below the standard of fill of
container prescribed in paragraph (c)(1) of this section, the label
shall bear the general statement of substandard fill specified in
130.14(b) of this chapter, in the manner and form therein specified.
(42 FR 14414, Mar. 15, 1977, as amended at 47 FR 11829, Mar. 19,
1982; 49 FR 10099, Mar. 19, 1984; 54 FR 24894, June 12, 1989)
21 CFR 145.115 Canned apricots.
(a) Identity -- (1) Ingredients. Canned apricots is the food
prepared from mature apricots of one of the optional styles specified in
paragraph (a)(2) of this section, which may be packed as solid pack or
in one of the optional packing media specified in paragraph (a)(3) of
this section. Such food may also contain one, or any combination of two
or more of the following safe and suitable optional ingredients:
(i) Natural and artificial flavors.
(ii) Spice.
(iii) Vinegar, lemon juice, or organic acids.
(iv) Apricot pits, except in the cases of unpeeled whole apricots and
peeled whole apricots, in a quantity not more than 1 apricot pit to each
227 grams (8 ounces) of finished canned apricots.
(v) Apricot kernels, except in the cases of unpeeled whole apricots
and peeled whole apricots, and except when optional ingredient under
paragraph (a)(4) of this section is used.
(vi) Ascorbic acid in an amount no greater than necessary to preserve
color.
Such food is sealed in a container and before or after sealing is so
processed by heat as to prevent spoilage.
(2) Optional styles of the apricot ingredient. The optional styles
of the apricot ingredient referred to in paragraph (a) of this section
are peeled or unpeeled:
(i) Whole.
(ii) Halves.
(iii) Quarters.
(iv) Slices.
(v) Pieces or irregular pieces.
Each such ingredient, except in the cases of unpeeled whole apricots
and peeled whole apricots, is pitted.
(3) Packing media. (i) The optional packing media referred to in
paragraph (a)(1) of this section, as defined in 145.3 are:
(a) Water.
(b) Fruit juice(s) and water.
(c) Fruit juice(s).
Such packing media may be used as such or any one or any combination
of two or more safe and suitable nutritive carbohydrate sweetener(s) may
be added. Sweeteners defined in 145.3 shall be as defined therein,
except that a nutritive carbohydrate sweetener for which a standard of
identity has been established in Part 168 of this chapter shall comply
with such standard in lieu of any definition that may appear in 145.3.
(ii) When a sweetener is added as a part of any such liquid packing
medium, the density range of the resulting packing medium expressed as
percent by weight of sucrose (degrees Brix) as determined by the
procedure prescribed in 145.3(m) shall be designated by the appropriate
name for the respective density ranges, namely:
(a) When the density of the solution is 10 percent or more but less
than 16 percent, the medium shall be designated as ''slightly sweetened
water''; or ''extra light sirup''; ''slightly sweetened fruit juice(s)
and water''; or ''slightly sweetened fruit juice(s)'', as the case may
be.
(b) When the density of the solution is 16 percent or more but less
than 21 percent, the medium shall be designated as ''light sirup'';
''lightly sweetened fruit juice(s) and water''; or ''lightly sweetened
fruit juice(s)'', as the case may be.
(c) When the density of the solution is 21 percent or more but less
than 25 percent, the medium shall be designated as ''heavy sirup'';
''heavily sweetened fruit juice(s) and water''; or ''heavily sweetened
fruit juice(s)'', as the case may be.
(d) When the density of the solution is 25 percent or more but not
more than 40 percent, the medium shall be designated as ''extra heavy
sirup''; ''extra heavily sweetened fruit juice(s) and water''; or
''extra heavily sweetened fruit juice(s)'', as the case may be.
(4) Labeling requirements. (i) The name of the food is ''apricots''.
The name of the food shall also include a declaration of any flavoring
that characterizes the product as specified in 101.22 of this chapter
and a declaration of any spice or seasoning that characterizes the
product; for example, ''Spice Added'', or in lieu of the word
''Spice'', the common name of the spice, ''Seasoned with Vinegar'' or
''Seasoned with Apricot Kernels''. When two or more of the optional
ingredients specified in paragraphs (a)(1) (ii) through (iv), inclusive,
of this section are used, such words may be combined as for example,
''Seasoned with Cider Vinegar, Cloves, Cinnamon Oil and Apricot
Kernels''.
(ii) The style of the apricot ingredient as provided in paragraph
(a)(2) of this section and the name of the packing medium as used in
paragraphs (a)(3)(i) and (ii) of this section, preceded by ''In'' or
''Packed in'' or the words ''solid pack'', where applicable, shall be
included as part of the name or in close proximity to the name of the
food, except that pieces or irregular pieces shall be designated
''Pieces'', ''Irregular pieces'', or ''Mixed pieces of irregular sizes
and shapes''. The style of the apricot ingredient shall be preceded or
followed by ''Unpeeled'' or ''Peeled'', as the case may be. ''Halves''
may be alternatively designated ''Halved'', ''Quarters'' as
''Quartered'' and ''Slices'' as ''Sliced''. When the packing medium is
prepared with a sweetener(s) which imparts a taste, flavor or other
characteristic to the finished food in addition to sweetness, the name
of the packing medium shall be accompanied by the name of such
sweetener(s), as for example in the case of a mixture of brown sugar and
honey, an appropriate statement would be '' ------------ sirup of brown
sugar and honey'' the blank to be filled in with the word ''light'',
''heavy'', or ''extra heavy'' as the case may be. When the liquid
portion of the packing media provided for in paragraphs (a)(3) (i) and
(ii) of this section consists of fruit juice(s), such juice(s) shall be
designated in the name of the packing medium as:
(a) In the case of a single fruit juice, the name of the juice shall
be used in lieu of the word ''fruit''.
(b) In the case of a combination of two or more fruit juices, the
names of the juices in the order of predominance by weight shall either
be used in lieu of the word ''fruit'' in the name of the packing medium,
or be declared on the label as specified in paragraph (a)(4)(iii) of
this section, and
(c) In the case of a single fruit juice or a combination of two or
more fruit juices any of which are made from concentrate(s), the words
''from concentrate(s)'' shall follow the word ''juice(s)'' in the name
of the packing medium and in the name(s) of such juice(s) when declared
as specified in paragraph (a)(4)(iii) of this section.
(iii) Whenever the names of the fruit juices used do not appear in
the name of the packing medium as provided in paragraph (a)(4)(ii)(b) of
this section, such names and the words ''from concentrate,'' as
specified in paragraph (a)(4)(ii)(c) of this section, shall appear in an
ingredient statement pursuant to the requirements of 101.3(d) of this
chapter.
(iv) Each of the optional ingredients used shall be declared on the
label as required by the applicable sections of Part 101 of this
chapter.
(b) Quality -- (1) The standard of quality for canned apricots is as
follows:
(i) All units tested in accordance with the method prescribed in
paragraph (b)(2) of this section are pierced by a weight of not more
than 300 grams.
(ii) In the cases of whole apricots, halves, and quarters, the weight
of the largest unit in the container is not more than twice the weight
of the smallest unit therein.
(iii) Not more than 20 percent of the units in the container are
blemished with scab, hail injury, discoloration, or other abnormalities.
(iv) In the cases of whole apricots, halves, and quarters, all units
are untrimmed, or are so trimmed as to preserve normal shape.
(v) Except in the case of mixed pieces of irregular sizes and shapes,
not more than 5 percent of the units in a container of 20 or more units,
and not more than 1 unit in a container of less than 20 units, are
crushed or broken. (A unit which has lost its normal shape because of
ripeness and which bears no mark of crushing shall not be considered to
be crushed or broken.)
(2) Canned apricots shall be tested by the following method to
determine whether or not they meet the requirements of paragraph
(b)(1)(i) of this section: So trim a test piece from the unit as to
fit, with peel surface up, into a supporting receptacle. If the unit is
of different firmness in different parts of its peel surface, trim the
piece from the firmest part. If the piece is unpeeled, remove the peel.
The top of the receptacle is circular in shape, of 1 1/8 inches inside
diameter, with vertical sides; or rectangular in shape, 3/4 inch by 1
inch inside measurements, with ends vertical and sides sloping downward
and joining at the center at a vertical depth of 3/4 inch. Use the
circular receptacle for testing units of such size that a test piece can
be trimmed therefrom to fit it. Use the rectangular receptacle for
testing other units. Test no unit from which a test piece with
rectangular peel surface at least 1/2 inch by 1 inch cannot be trimmed.
Test the piece by means of a round metal rod 3/16 inch in diameter. To
the upper end of the rod is affixed a device to which weight can be
added. The rod is held vertically by a support through which it can
freely move upward or downward. The lower end of the rod is a plane
surface to which the vertical axis of the rod is perpendicular. Adjust
the combined weight of the rod and device to 100 grams. Set the
receptacle so that the surface of the test piece is held horizontally.
Lower the end of the rod to the approximate center of such surface, and
add weight to the device at a uniform, continuous rate of 12 grams per
second until the rod pierces the test piece. Weigh the rod and weighted
device. Test all units in containers of 50 units or less, except those
units too small for testing or too soft for trimming. Test at least 50
units, taken at random, in containers of more than 50 units; but if
less than 50 units are of sufficient size and firmness for testing, test
those which are of sufficient size and firmness.
(3) If the quality of canned apricots falls below the standard
prescribed in paragraph (b)(1) of this section, the label shall bear the
general statement of substandard quality specified in 130.14(a) of this
chapter, in the manner and form therein specified; but in lieu of such
general statement of substandard quality, the label may bear the
alternative statement ''Below standard in quality ------------ '', the
blank to be filled in with the words specified after the corresponding
number of each subparagraph of paragraph (b)(1) of this section which
such canned apricots fail to meet, as follows: (i) ''Not tender'';
(ii) ''Mixed sizes''; (iii) ''Blemished''; (iv) ''Unevenly trimmed'';
(v) ''Partly crushed or broken''. Such alternative statement shall
immediately and conspicuously precede or follow, without intervening
written, printed, or graphic matter, the name ''apricots'' and any words
and statements required or authorized to appear with such name by
145.115(a)(2).
(c) Fill of container. (1) The standard of fill of container for
canned apricots is the maximum quantity of the optional apricot
ingredient that can be sealed in the container and processed by heat to
prevent spoilage, without crushing or breaking such ingredient.
(2) If canned apricots fall below the standard of fill of container
prescribed in paragraph (c)(1) of this section, the label shall bear the
general statement of substandard fill specified in 130.14(b) of this
chapter, in the manner and form therein specified.
21 CFR 145.116 Artificially sweetened canned apricots.
(a) Artificially sweetened canned apricots is the food which conforms
to the definition and standard of identity prescribed for canned
apricots by 145.115(a), except that in lieu of a packing medium
specified in 145.115(a)(3), the packing medium used is water
artificially sweetened with saccharin, sodium saccharin, or a
combination of both. Such packing medium may be thickened with pectin
and may contain any mixture of any edible organic salt or salts and any
edible organic acid or acids as a flavor-enhancing agent, in a quantity
not more than is reasonably required for that purpose.
(b)(1) The specified name of the food is ''artificially sweetened
------ '', the blank being filled in with the name prescribed by
145.115(a) for canned apricots having the same optional apricot
ingredient.
(2) The artificially sweetened food is subject to the requirements
for label statement of optional ingredients used, as prescribed for
canned apricots by 145.115(a). If the packing medium is thickened with
pectin, the label shall bear the statement ''thickened with pectin''.
When any organic salt or acid or any mixture of two or more of these is
added, the label shall bear the common or usual name of each such
ingredient.
21 CFR 145.120 Canned berries.
(a) Identity -- (1) Ingredients. Canned berries is the food prepared
from any suitable variety of one of the optional berry ingredients
specified in paragraph (a)(2) of this section, which may be packed in
one of the optional packing media specified in paragraph (a)(3) of this
section, and may contain one or any combination of two or more of the
safe and suitable optional ingredients specified in paragraph (a)(4) of
this section. Such food is sealed in a container and before or after
sealing is so processed by heat to prevent spoilage.
(2) Varietal types. The optional berry ingredients referred to in
paragraph (a)(1) of this section are prepared from stemmed fruit of the
following optional varietal types of berry ingredient; namely:
(i) Raspberry varieties conforming to the characteristics of Rubus
idaeus L. or Rubus occidentalis L.
(ii) Blackberries.
(iii) Blueberries.
(iv) Boysenberries.
(v) Dewberries.
(vi) Gooseberries.
(vii) Huckleberries.
(viii) Loganberries.
(ix) Strawberry varieties conforming to the characteristics of
Fragaria.
(x) Youngberries.
(3) Packing media. (i) the optional packing media referred to in
paragraph (a)(1) of this section as defined in 145.3 are:
(a) Water.
(b) Fruit juice(s) and water.
(c) Fruit juice(s).
Such packing media may be used as such or any one or any combination
of two or more safe and suitable nutritive carbohydrate sweeteners may
be added. Sweeteners listed in 145.3 shall be as defined therein,
except that a nutritive carbohydrate sweetener for which a standard of
identity has been established in Part 168 of this chapter shall comply
with such standard in lieu of any definition that may appear in 145.3.
(ii) When a sweetener is added as a part of any such liquid packing
medium, the four density ranges of the resulting packing media
hereinafter specified for each berry ingredient, expressed as percent by
weight of sucrose (degrees Brix) as determined by the procedure
described in 145.3(m), shall be designated by the appropriate name for
each of the respective density ranges for each berry ingredient as:
(a) ''Slightly sweetened water''; or ''extra light sirup'';
''slightly sweetened fruit juice(s) and water''; or ''slightly
sweetened fruit juice(s)'', as the case may be.
(b) ''Light sirup'', when the liquid used is water, ''lightly
sweetened fruit juice(s) and water''; or ''lightly sweetened fruit
juice(s)'', as the case may be.
(c) ''Heavy sirup'', when the liquid used is water; or ''heavily
sweetened fruit juice(s) and water''; or ''heavily sweetened fruit
juice(s)'', as the case may be.
(d) ''Extra heavy sirup'', when the liquid used is water; or ''extra
heavily sweetened fruit juice(s) and water''; or ''extra heavily
sweetened fruit juice(s)'', as the case may be.
The density ranges referred to herein are:
(4) Optional ingredients. The optional ingredients referred to in
paragraph (a)(1) of this section are:
(i) Natural and artificial flavors.
(ii) Calcium salts as firming agents provided that the calcium added
is no more than 0.035 percent, calculated as calcium, of the weight of
the finished canned berries.
(iii) Organic acids.
(5) Labeling requirements. (i) The name of the food is the
appropriate name of the berry ingredient specified in paragraph (a)(2)
of this section.
(ii) The name of the packing medium, as used in paragraph (a)(3)(i)
of this section preceded by ''In'' or ''Packed in.'' as provided in
paragraph (a)(3) of this section and, in the case of raspberries other
than red raspberries provided for in paragraph (a)(2) of this section,
the name of such packing medium and the color of such raspberry shall be
included as part of the name or in close proximity to the name of the
food. When the liquid portion of the packing media provided for in
paragraphs (a)(3) (i) and (ii) of this section consists of fruit
juice(s), such juice(s) shall be designated in the name of the packing
medium as:
(a) In the cases of a single fruit juice, the name of the juice shall
be used in lieu of the word ''fruit'';
(b) In the case of a combination of two or more fruit juices, the
names of the juices in the order of predominance by weight shall either
be used in lieu of the word ''fruit'' in the name of the packing medium,
or be declared on the label as specified in paragraph (a)(3) of this
section; and
(c) In the case of a single fruit juice or a combination of two or
more fruit juices any of which are made from concentrate(s), the words
''from concentrate(s)'' shall follow the word ''juice(s)'' in the name
of the packing medium and in the name(s) of such juice(s) when declared
as specified in paragraph (a)(5)(iii) of this section.
(iii) Whenever the names of the fruit juices used do not appear in
the name of the packing medium as provided in paragraph (a)(5)(ii)(b) of
this section, such names and the words ''from concentrate'', as
specified in paragraph (a)(5)(ii)(c) of this section, shall appear in an
ingredient statement pursuant to the requirements of 101.3(d) of this
chapter.
(iv) Each of the optional ingredients used shall be declared on the
label as required by the applicable sections of Part 101 of this
chapter.
(b) (Reserved)
(46 FR 2339, Jan. 9, 1981; 47 FR 6426, Feb. 12, 1982, as amended at
48 FR 2748, Jan. 21, 1983)
21 CFR 145.125 Canned cherries.
(a) Identity -- (1) Ingredients. Canned cherries is the food
prepared from one of the optional fresh or previously canned cherry
ingredients specified in paragraph (a)(2) of this section, which may be
packed in one of the optional packing media specified in paragraph
(a)(3) of this section. Such food may also contain one, or any
combination of two or more, of the following safe and suitable optional
ingredients:
(i) Natural and artificial flavors.
(ii) Spice.
(iii) Vinegar, lemon juice, or organic acids. Such food is sealed in
a container and before or after sealing is so processed by heat as to
prevent spoilage.
(2) Varietal types and styles. The optional cherry ingredients
referred to in paragraph (a)(1) of this section are prepared from mature
pitted or unpitted cherries of the red tart or alternatively, red sour,
light sweet or dark sweet varietal group.
(3) Packing media. (i) The optional packing media referred to in
paragraph (a)(1) of this section, as defined in 145.3 are:
(a) Water.
(b) Fruit juice(s) and water.
(c) Fruit juice(s).
Such packing media may be used as such or any one or any combination
of two or more safe and suitable nutritive carbohydrate sweetener(s) may
be added. Sweeteners defined in 145.3 shall be as defined therein,
except that a nutritive carbohydrate sweetener for which a standard of
identity has been established in Part 168 of this chapter shall comply
with such standard in lieu of any definition that may appear in 145.3.
(ii) When a sweetener is added as a part of any such liquid packing
medium, the density range of the resulting packing medium expressed as
percent by weight of sucrose (degrees Brix) as determined by the
procedure prescribed in 145.3(m) shall be designated by the appropriate
name for the respective density ranges, namely:
(a) In the case of sweet cherries:
(i) When the density of the solution is less than 16 percent, the
medium shall be designated as ''slightly sweetened water''; or ''extra
light sirup''; ''slightly sweetened fruit juice(s) and water''; or
''slightly sweetened fruit juice(s)'', as the case may be.
(ii) When the density of the solution is 16 percent or more but less
than 20 percent, the medium shall be designated as ''light sirup'';
''lightly sweetened fruit juice(s) and water''; or ''lightly sweetened
fruit juice(s)'', as the case may be.
(iii) When the density of the solution is 20 percent or more but less
than 25 percent, the medium shall be designated as ''heavy sirup'';
''heavily sweetened fruit juice(s) and water''; or ''heavily sweetened
fruit juice(s)'', as the case may be.
(iv) When the density of the solution is 25 percent or more but not
more than 35 percent, the medium shall be designated as ''extra heavy
sirup''; ''extra heavily sweetened fruit juice(s) and water''; or
''extra heavily sweetened fruit juice(s)'', as the case may be.
(b) In the case of red tart cherries:
(i) When the density of the solution is less than 18 percent, the
medium shall be designated as ''slightly sweetened water''; ''slightly
sweetened fruit juice(s) and water''; or ''slightly sweetened fruit
juice(s)'', as the case may be.
(ii) When the density of the solution is 18 percent or more but less
than 22 percent, the medium shall be designated as ''light sirup'';
''lightly sweetened fruit juice(s) and water''; or ''lightly sweetened
fruit juice(s)'', as the case may be.
(iii) When the density of the solution is 22 percent or more but less
than 28 percent, the medium shall be designated as ''heavy sirup'';
''heavily sweetened fruit juice(s) and water''; or ''heavily sweetened
fruit juice(s)'', as the case may be.
(iv) When the density of the solution is 28 percent or more but not
more than 45 percent, the medium shall be designated as ''extra heavy
sirup''; ''extra heavily sweetened fruit juice(s) and water''; or
''extra heavily sweetened fruit juice(s)'', as the case may be.
(4) Labeling requirements. (i) The name of the food is ''cherries''.
The optional varietal type as set forth in paragraph (a)(2) of this
section, preceded or followed by the word ''pitted'' when this is the
fact, shall be a part of the name. The name of the food shall also
include a declaration of any flavoring that characterizes the product as
specified in 101.22 of this chapter and a declaration of any spice or
seasoning that characterizes the product; for example, ''Spice added'',
or in lieu of the word ''Spice'', the common name of the spice, or
''Seasoned with lemon juice''. When two or more of the optional
ingredients specified in paragraph (a)(1)(ii) and (iii) of this section
are used, such words may be combined as for example, ''Seasoned with
cider vinegar, cloves, and cinnamon oil''.
(ii) The color type and style of the cherry ingredient as provided in
paragraph (a)(2) of this section and the name of the packing medium
specified in paragraphs (a)(3) (i) and (ii) of this section, preceded by
''In'' or ''Packed in'' or the words ''solid pack'', where applicable,
shall be included as part of the name or in close proximity to the name
of the food. When the packing medium is prepared with a sweetener(s)
which imparts a taste, flavor or other characteristic to the finished
food in addition to sweetness, the name of the packing medium shall be
accompanied by the name of such sweetener(s), as for example in the case
of a mixture of brown sugar and honey, an appropriate statement would be
'' ------------ sirup of brown sugar and honey'' the blank to be filled
in with the word ''light'', ''heavy'', or ''extra heavy'' as the case
may be. When the liquid portion of the packing media provided for in
paragraphs (a)(3) (i) and (ii) of this section consists of fruit
juice(s), such juice(s) shall be designated in the name of the packing
medium as:
(a) In the case of a single fruit juice, the name of the juice shall
be used in lieu of the word ''fruit'';
(b) In the case of a combination of two or more fruit juices, the
names of the juices in the order of predominance by weight shall either
be used in lieu of the word ''fruit'' in the name of the packing medium,
or be declared on the label as specified in paragraph (a)(4)(iii) of
this section; and
(c) In the case of a single fruit juice or a combination of two or
more fruit juices any of which are made from concentrate(s), the words
''from concentrate(s)'' shall follow the word ''juice(s)'' in the name
of the packing medium and in the name(s) of such juice(s) when declared
as specified in paragraph (a)(4)(iii) of this section.
(iii) Whenever the names of the fruit juices used do not appear in
the name of the packing medium as provided in paragraph (a)(4)(ii)(b) of
this section, such names and the words ''from concentrate'', as
specified in paragraph (a)(4)(ii)(c) of this section, shall appear in an
ingredient statement pursuant to the requirements of 101.3(d) of this
chapter.
(iv) Each of the optional ingredients used shall be declared on the
label as required by the applicable sections of Part 101 of this
chapter.
(b) Quality. (1) The standard of quality for canned cherries is as
follows:
(i) In the case of pitted cherries, not more than 1 pit is present in
each 20 ounces of canned cherries, as determined by the method
prescribed in paragraph (b)(2)(i) of this section.
(ii) In the case of unpitted cherries, the weight of each cherry in
the container is not less than 1/10 ounce.
(iii) In the case of unpitted cherries, the weight of the largest
cherry in the container is not more than twice the weight of the
smallest cherry therein.
(iv) In the case of unpitted cherries, the total weight of pits is
not more than 12 percent of the weight of drained cherries, as
determined by the method prescribed in paragraph (b)(2)(ii) of this
section.
(v) Not more than 15 percent by count of the cherries in the
container are blemished with scab, hail injury, discoloration, scar
tissue or other abnormality. A cherry showing skin discoloration (other
than scald) having an aggregate area exceeding that of a circle 9/32
inch in diameter is considered to be blemished. A cherry showing
discoloration of any area but extending into the fruit tissue is also
considered to be blemished.
(2)(i) Pitted canned cherries shall be tested by the following method
to determine whether or not they comply with the requirements of
paragraph (b)(1)(i) of this section: Take at random such number of
containers as to have a total quantity of contents of at least 24
pounds. Open the containers and weigh the contents. Count the pits and
pieces of pit shell in such total quantity. Count a piece of pit shell
equal to or smaller than one-half pit shell as one-half pit, and a piece
of pit shell larger than one-half pit shell as one pit; but when two or
more pieces of pit shell are within or attached to a single cherry,
count such pieces as one-half pit if their combined size is equivalent
to that of one-half pit shell or less, and as one pit if their combined
size is equivalent to that of more than one-half pit shell. From the
total number of pits so counted and the combined weight of the contents
of all the containers, calculate the number of pits present in each 20
ounces of canned cherries.
(ii) Unpitted canned cherries shall be tested by the following method
to determine whether or not they comply with the requirements of
paragraph (b)(1)(iv) of this section: Tilt the opened container so as
to distribute the contents over the meshes of a circular sieve which has
previously been weighed. The diameter of the sieve is 8 inches if the
quantity of the contents of the container is less than 3 pounds, or 12
inches if such quantity is 3 pounds or more. The bottom of the sieve is
No. 8 woven-wire cloth that complies with the specifications for such
cloth set forth in the ''Official Methods of Analysis of the Association
of Official Analytical Chemists,'' 13th Ed. (1980), Table 1, ''Nominal
Dimensions of Standard Test Sieves (U.S.A. Standard Series),'' under the
heading ''Definitions of Terms and Explanatory Notes,'' which is
incorporated by reference. Copies may be obtained from the Association
of Official Analytical Chemists, 2200 Wilson Blvd., Suite 400,
Arlington, VA 22201-3301, or may be examined at the Office of the
Federal Register, 1100 L St. NW., Washington, DC 20408. Without
shifting the cherries, so incline the sieve as to facilitate drainage.
Two minutes from the time drainage begins, weigh the sieve and drained
cherries. The weight so found, less the weight of the sieve, shall be
considered to be the weight of drained cherries. Pit the cherries and
wash the pits free from adhering flesh. Drain and weigh the pits by the
method prescribed above. Divide the weight of pits so found by the
weight of drained cherries, and multiply by 100.
(3) If the quality of canned cherries falls below the standard
prescribed in paragraph (b)(1) of this section, the label shall bear the
general statement of substandard quality specified in 130.14(a) of this
chapter, in the manner and form therein specified; but in lieu of such
general statement of substandard quality, the label may bear the
alternative statement ''Below Standard in Quality ------ '', the blank
to be filled in with the words specified after the corresponding number
of each subparagraph of paragraph (b)(1) of this section which such
canned cherries fail to meet, as follows: (i) ''Partially pitted'';
(ii) ''Small''; (iii) ''Mixed sizes''; (iv) ''Thin-fleshed''; (v)
''Blemished''. Such alternative statement shall immediately and
conspicuously precede or follow, without intervening written, printed,
or graphic matter, the name ''Cherries'' and any words and statements
required or authorized to appear with such name by 145.125(a)(2).
(c) Fill of container. (1) The standard of fill of container for
canned cherries is the maximum quantity of the optional cherry
ingredient that can be sealed in the container and processed by heat to
prevent spoilage, without crushing such ingredient.
(2) If canned cherries fall below the standard of fill of container
prescribed in paragraph (c)(1) of this section, the label shall bear the
general statement of substandard fill specified in 130.14(b) of this
chapter, in the manner and form therein specified.
(42 FR 14414, Mar. 15, 1977, as amended at 47 FR 11829, Mar. 19,
1982; 49 FR 10099, Mar. 19, 1984; 54 FR 24895, June 12, 1989)
21 CFR 145.126 Artificially sweetened canned cherries.
(a) Artificially sweetened canned cherries is the food which conforms
to the definition and standard of identity prescribed for canned
cherries by 145.125(a), except that in lieu of a packing medium
specified in 145.125(a)(3), the packing medium used is water
artificially sweetened with saccharin, sodium saccharin, or a
combination of both. Such packing medium may be thickened with pectin
and may contain any mixture of any edible organic salt or salts and any
edible organic acid or acids as a flavor-enhancing agent, in a quantity
not more than is reasonably required for that purpose.
(b)(1) The specified name of the food is ''artificially sweetened
------------ '', the blank being filled in with the name prescribed by
145.125(a) for canned cherries having the same optional cherry
ingredient.
(2) The artificially sweetened food is subject to the requirements
for label statement of optional ingredients used, as prescribed for
canned cherries by 145.125(a). If the packing medium is thickened with
pectin, the label shall bear the statement ''thickened with pectin''.
When any organic salt or acid or any mixture of two or more of these is
added, the label shall bear the common or usual name of each such
ingredient.
21 CFR 145.130 Canned figs.
(a) Ingredients. Canned figs is the food prepared from one of the
optional fig ingredients specified in paragraph (b) of this section and
one of the optional packing media specified in paragraph (c) of this
section, to which lemon juice, concentrated lemon juice or organic
acid(s) is added, when necessary to reduce the pH of the finished
product to pH 4.9 or below. Such food may also contain one, or any
combination of two or more of the following safe and suitable optional
ingredients:
(1) Natural and artificial flavoring.
(2) Spice.
(3) Vinegar.
(4) Unpeeled segments of citrus fruits.
(5) Salt.
Such food is sealed in a container and before or after sealing is so
processed by heat as to prevent spoilage.
(b) Varietal types. The optional fig ingredients referred to in
paragraph (a) of this section are prepared from mature figs of the light
or dark varieties. Figs (or whole figs), split figs (or broken figs),
or any combination thereof are optional fig ingredients. A ''whole
fig'' is one which is whole, but may be slightly cracked, provided it
retains its natural conformation without exposing the interior. A
''split'' or ''broken'' fig is one that is open to such an extent that
the seed cavity is exposed. The shape of the fruit may be distorted,
and the fruit may or may not be broken apart into entirely separate
pieces.
(c) Packing media. (1) The optional packing media referred to in
paragraph (a) of this section, as defined in 145.3 are:
(i) Water.
(ii) Fruit juice(s) and water.
(iii) Fruit juice(s).
Such packing media may be used as such or any one or any combination
of two or more safe and suitable nutritive carbohydrate sweetener(s) may
be added. Sweeteners defined in 145.3 shall be as defined therein,
except that a nutritive carbohydrate sweetener for which a standard of
identity has been established in Part 168 of this chapter shall comply
with such standard in lieu of any definition that may appear in 145.3.
(2) When a sweetener is added as a part of any such liquid packing
medium, the density range of the resulting packing medium expressed as
percent by weight of sucrose (degrees Brix) as determined by the
procedure prescribed in 145.3(m) shall be designated by the appropriate
name for the respective density ranges, namely:
(i) When the density of the solution is 11 percent or more but less
than 16 percent, the medium shall be designated as ''slightly sweetened
water''; or ''extra light syrup''; ''slightly sweetened fruit juice(s)
and water''; or ''slightly sweetened fruit juice(s)'', as the case may
be.
(ii) When the density of the solution is 16 percent or more but less
than 21 percent, the medium shall be designated as ''light sirup'';
''lightly sweetened fruit juice(s) and water''; or ''lightly sweetened
fruit juice(s)'', as the case may be.
(iii) When the density of the solution is 21 percent or more but less
than 26 percent, the medium shall be designated as ''heavy sirup'';
''heavily sweetened fruit juice(s) and water''; or ''heavily sweetened
fruit juice(s)'', as the case may be.
(iv) When the density of the solution is 26 percent or more but not
more than 35 percent, the medium shall be designated as ''extra heavy
sirup''; ''extra heavily sweetened fruit juice(s) and water''; or
''extra heavily sweetened fruit juice(s)'', as the case may be.
(d) Labeling requirements. (1) The name of the food is ''figs''.
The words ''broken'' or ''split'' shall be a part of the name when the
optional fig ingredient is a broken or split fig. The name of the food
shall also include a declaration of any flavoring that characterizes the
product as specified in 101.22 of this chapter and a declaration of any
spice or seasoning that characterizes the product; for example, ''Spice
added'', or in lieu of the word ''Spice'', the common name of the spice,
''Seasoned with vinegar'' or ''Seasoned with unpeeled segments of citrus
fruits''. When two or more of the optional ingredients specified in
paragraphs (a) (2) through (5), inclusive, of this section are used,
such words may be combined as for example, ''Seasoned with cider
vinegar, cloves, cinnamon oil and unpeeled segments of citrus fruits.''
(2) The name of the packing medium as used in paragraph (c)(1) of
this section, preceded by ''In'' or ''Packed in'', as provided in
paragraph (c) of this section, shall be included as part of the name or
in close proximity to the name of the food. When the packing medium is
prepared with a sweetener(s) which imparts a taste, flavor or other
characteristic to the finished food other than sweetness, as for
example, a mixture of brown sugar and honey, the statement '' --------
sirup of brown sugar and honey'' the blank to be filled in with the word
''light'', ''heavy'', or ''extra heavy'', as the case may be, shall be
included as part of the name or in close proximity to the name of the
food. When the liquid portion of the packing media provided for in
paragraphs (c) (1) and (2) of this section consists of fruit juice(s),
such juice(s) shall be designated in the name of the packing medium as:
(i) In the case of a single fruit juice, the name of the juice shall
be used in lieu of the word ''fruit'';
(ii) In the case of a combination of two or more fruit juices, the
names of the juices in the order of predominance by weight shall either
be used in lieu of the word ''fruit'' in the name of the packing medium,
or be declared on the label as specified in paragraph (d)(3) of this
section; and
(iii) In the case of a single fruit juice or a combination of two or
more fruit juices any of which are made from concentrate(s), the words
''from concentrate(s)'' shall follow the word ''juice(s)'' in the name
of the packing medium and in the name(s) of such juice(s) when declared
as specified in paragraph (d)(3) of this section.
(3) Whenever the names of the fruit juices used do not appear in the
name of the packing medium as provided in paragraph (d)(2)(ii) of this
section, such names and the words ''from contrate'', as specified in
paragraph (d)(2)(iii) of this section, shall appear in an ingredient
statement pursuant to the requirements of 101.3(d) of this chapter.
(4) Each of the optional ingredients used shall be declared on the
label as required by the applicable sections of Part 101 of this
chapter.
21 CFR 145.131 Artificially sweetened canned figs.
(a) Artificially sweetened canned figs is the food which conforms to
the definition and standard of identity prescribed for canned figs by
145.130, except that in lieu of a packing medium specified in
145.130(c), the packing medium used is water artificially sweetened with
saccharin, sodium saccharin, or a combination of both. Such packing
medium may be thickened with pectin and may contain any mixture of any
edible organic salt or salts and any edible organic acid or acids as a
flavor-enhancing agent, in a quantity not more than is reasonably
required for that purpose.
(b)(1) The specified name of the food is ''artificially sweetened
------ '', the blank being filled in with the name prescribed by
145.130 for canned figs having the same optional fig ingredient.
(2) The artificially sweetened food is subject to the requirements
for label statement of optional ingredients used, as prescribed for
canned figs by 145.130. If the packing medium is thickened with pectin,
the label shall bear the statement ''thickened with pectin''. When any
organic salt or acid or any mixture of two or more of these is added,
the label shall bear the common or usual name of each such ingredient.
21 CFR 145.134 Canned preserved figs.
(a) Canned preserved figs is the food prepared from one of the
optional fig ingredients specified in paragraph (b) of this section and
the packing medium specified in paragraph (c) of this section, to which
citric acid or lemon juice or concentrated lemon juice is added, if
necessary, in such quantity as to reduce the pH of the finished product
to 4.9 or below. The figs are precooked in the packing medium, sealed
in a container, and so processed by heat, either before or after
sealing, as to prevent spoilage.
(b) The optional fig ingredients referred to in paragraph (a) of this
section are whole mature figs of the light or dark varieties that may be
either peeled or unpeeled.
(c)(1) The packing medium referred to in paragraph (a) of this
section is prepared from water and one of the following optional
sweetening ingredients:
(i) Sugar.
(ii) Invert sugar sirup.
(iii) Any mixture of optional sweetening ingredients designated in
paragraphs (c)(1) (i) and (ii) of this section.
(iv) Any of the optional sweetening ingredients designated in
paragraphs (c)(1) (i), (ii), and (iii) of this section with dextrose:
Provided, That the weight of the solids of dextrose does not exceed
one-third of the total weight of the solids of the combined sweetening
ingredients.
(v) Any of the optional sweetening ingredients designated in
paragraphs (c)(1) (i), (ii), and (iii) of this section with corn sirup
or with dried corn sirup or with glucose sirup or with dried glucose
sirup, or with any two or more of these: Provided, That the weight of
the solids of corn sirup, dried corn sirup, glucose sirup, dried glucose
sirup or the sum of the weights of the solids of corn sirup, dried corn
sirup, glucose sirup, and dried glucose sirup, in case two or more of
these are used, does not exceed one-fourth of the total weight of the
solids of the combined sweetening ingredients.
(vi) Any mixture of the optional ingredients designated in paragraphs
(c)(1) (iv) and (v) of this section.
(2) The density of the packing medium described in paragraph (c)(1)
of this section, as measured on the Brix hydrometer 15 days or more
after the figs are canned, is not less than 50 and not more than 55 .
(d)(1) The name of the food is ''Preserved Figs -- Precooked in
Sirup''. For the purpose of label declaration, the words ''Precooked in
Sirup'' may appear immediately below the words ''Preserved Figs'', but
there shall be no intervening written, printed, or graphic matter, and
the letters used for the words ''Precooked in Sirup'' shall be of the
same type style and not less than one-half the height of the letters in
the words ''Preserved Figs''.
(2) The label shall indicate which optional fig ingredient specified
in paragraph (b) of this section is used.
(e) Wherever the name of the food appears on the label so
conspicuously as to be easily seen under customary conditions of
purchase, the words herein specified, showing the optional fig
ingredient used, shall immediately and conspicuously precede or follow
such name without intervening written, printed, or graphic matter,
except that the varietal name of the figs may so intervene.
21 CFR 145.135 Canned fruit cocktail.
(a) Identity -- (1) Ingredients. Canned fruit cocktail, canned
cocktail fruits, canned fruits for cocktail, is the food prepared from
the mixture of fresh, frozen, or previously canned fruit ingredients of
mature fruits in the forms and proportions as provided in paragraph
(a)(2) of this section, and one of the optional packing media specified
in paragraph (a)(3) of this section. Such food may also contain one, or
any combination of two or more, of the following safe and suitable
optional ingredients:
(i) Natural and artificial flavors.
(ii) Spice.
(iii) Vinegar, lemon juice, or organic acids.
(iv) Ascorbic acid in an amount no greater than necessary to preserve
color. Such food is sealed in a container and before or after sealing
is so processed by heat as to prevent spoilage.
(2) Varietal types and styles. The fruit ingredients referred to in
paragraph (a)(1) of this section, the forms of each, and the percent by
weight of each in the mixture of drained fruit from the finished canned
fruit cocktail are as follows:
(i) Peaches. Any firm yellow variety of the species Prunus persica
L., excluding nectarine varieties, which are pitted, peeled, and diced,
not less than 30 percent and not more than 50 percent.
(ii) Pears. Any variety, of the species Pyrus communis L. or Pyrus
sinensis L., which are peeled, cored, and diced, not less than 25
percent and not more than 45 percent.
(iii) Pineapples. Any variety, of the species Ananas comosus L.,
which are peeled, cored, and cut into sectors or into dice, not less
than 6 percent and not more than 16 percent.
(iv) Grapes. Any seedless variety, of the species Vitis vinifera L.,
or Vitis labrusca L., not less than 6 percent and not more than 20
percent.
(v) Cherries. Approximate halves or whole pitted cherries of the
species Prunus cerasus L., not less than 2 percent and not more than 6
percent, of the following types:
(a) Cherries of any light, sweet variety;
(b) Cherries artificially colored red; or
(c) Cherries artificially colored red and flavored, natural or
artificial.
Provided, That each 127.5 grams (4 1/2 ounces avoirdupois) of the
finished canned fruit cocktail and each fraction thereof greater than
56.7 grams (2 ounces avoirdupois) contain not less than 2 sectors or 3
dice of pineapple and not less than 1 approximate half of the optional
cherry ingredient.
(3) Packing media. (i) The optional packing media referred to in
paragraph (a)(1) of this section, as defined in 145.3 are:
(a) Water.
(b) Fruit juice(s) and water.
(c) Fruit juice(s).
Such packing media may be used as such or any one or any combination
of two or more safe and suitable nutritive carbohydrate sweetener(s) may
be added. Sweeteners defined in 145.3 shall be as defined therein,
except that a nutritive carbohydrate sweetener for which a standard of
identity has been established in Part 168 of this chapter shall comply
with such standard in lieu of any definition that may appear in 145.3.
(ii) When a sweetener is added as a part of any such liquid packing
medium, the density range of the resulting packing medium expressed as
percent by weight of sucrose (degrees Brix) as determined by the
procedure prescribed in 145.3(m) shall be designated by the appropriate
name for the respective density ranges, namely:
(a) When the density of the solution is 10 percent or more, but less
than 14 percent, the medium shall be designated as ''slightly sweetened
water''; or ''extra light sirup''; ''slightly sweetened fruit juice(s)
and water''; or ''slightly sweetened fruit juice(s)'', as the case may
be.
(b) When the density of the solution is 14 percent or more but less
than 18 percent, the medium shall be designated as ''light sirup'';
''lightly sweetened fruit juice(s) and water''; or ''lightly sweetened
fruit juice(s)'', as the case may be.
(c) When the density of the solution is 18 percent or more but less
than 22 percent, the medium shall be designated as ''heavy sirup'';
''heavily sweetened fruit juice(s) and water''; or ''heavily sweetened
fruit juice(s)'', as the case may be.
(d) When the density of the solution is 22 percent or more but not
more than 35 percent, the medium shall be designated as ''extra heavy
sirup''; ''extra heavily sweetened fruit juice(s) and water''; or
''extra heavily sweetened fruit juice(s)'', as the case may be.
(4) Labeling requirements. (i) The name of the food is ''fruit
cocktail'', ''cocktail fruits'', or ''fruits for cocktail''. The name
of the food shall also include a declaration of any flavoring that
characterizes the product as specified in 101.22 of this chapter and a
declaration of any spice or seasoning that characterizes the product;
for example, ''Spice added'', or in lieu of the word ''Spice'', the
common name of the spice, ''Seasoned with vinegar'' or ''Seasoned with
lemon juice''. When two or more of the optional ingredients specified
in paragraphs (a)(1) (ii) and (iii) of this section are used, such words
may be combined as for example, ''Seasoned with cider vinegar, cloves,
cinnamon oil and lemon juice''.
(ii) The name of the packing medium as used in paragraphs (a)(3) (i)
and (ii) of this section, preceded by ''In'' or ''Packed in'' shall be
included as part of the name or in close proximity to the name of the
food. When the packing medium is prepared with a sweetener(s) which
imparts a taste, flavor or other characteristic to the finished food in
addition to sweetness, the name of the packing medium shall be
accompanied by the name of such sweetener(s), as for example, in the
case of a mixture of brown sugar and honey, an appropriate statement
would be '' -------- sirup of brown sugar and honey'' the blank to be
filled in with the word ''light'', ''heavy'', or ''extra heavy'' as the
case may be. When the liquid portion of the packing media provided for
in paragraphs (a)(3) (i) and (ii) of this section consists of fruit
juice(s), such juice(s) shall be designated in the packing medium as:
(a) In the case of a single fruit juice, the name of the juice shall
be used in lieu of the word ''fruit'';
(b) In the case of a combination of two or more fruit juices, the
names of the juices in the order of predominance by weight shall either
be used in lieu of the word ''fruit'' in the name of the packing medium,
or be declared on the label as specified in paragraph (a)(4)(iii) of
this section; and
(c) In the case of a single fruit juice or a combination of two or
more fruit juices any of which are made from concentrate(s), the words
''from concentrate(s)'' shall follow the word ''juice(s)'' in the name
of the packing medium and in the name(s) of such juice(s) when declared
as specified in paragraph (a)(4)(iii) of this section.
(iii) Whenever the names of the fruit juices used do not appear in
the name of the packing medium as provided in paragraph (a)(4)(ii)(b) of
this section, such names and the words ''from concentrate'', as
specified in paragraph (a)(4)(ii)(c) of this section, shall appear in an
ingredient statement pursuant to the requirements of 101.3(d) of this
chapter.
(iv) Each of the optional ingredients used shall be declared on the
label as required by the applicable sections of Part 101 of this
chapter.
(b) Quality. (1) The standard of quality for canned fruit cocktail
is as follows:
(i) Not more than 20 percent by weight of the units in the container
of peach or pear, or of pineapple if the units thereof are diced, are
more than 3/4 inch in greatest edge dimension, or pass through the
meshes of a sieve designated as 5/16 inch that complies with the
specifications for such cloth set forth in the ''Official Methods of
Analysis of the Association of Official Analytical Chemists,'' 13th Ed.
(1980), Table 1, ''Nominal Dimensions of Standard Test Sieves (U.S.A.
Standard Series),'' under the heading ''Definitions of Terms and
Explanatory Notes,'' which is incorporated by reference. Copies may be
obtained from the Association of Official Analytical Chemists, 2200
Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may be examined at
the Office of the Federal Register, 1100 L St. NW., Washington, DC
20408. If the units of pineapple are in the form of sectors, not more
than 20 percent of such sectors in the container fail to conform to the
following dimensions: The length of the outside arc is not more than
3/4 inch but is more than 3/8 inch; the thickness is not more than 1/2
inch but is more than 5/16 inch; the length (measured along the radius
from the inside arc to the outside arc) is not more than 1 1/4 inches
but is more than 3/4 inch.
(ii) Not more than 10 percent of the grapes in a container containing
10 grapes or more, and not more than 1 grape in a container containing
less than 10 grapes, are cracked to the extent of being severed into two
parts or are crushed to the extent that their normal shape is destroyed.
(iii) Not more than 10 percent of the grapes in a container
containing 10 grapes or more, and not more than a grape in a container
containing less than 10 grapes, have the cap stem attached.
(iv) There is present in the finished canned fruit cocktail not more
than 1 square inch of pear peel per each 1 pound of drained weight of
units of pear plus the weight of a proportion of the packing medium
which is the same proportion as the drained weight of the units of pear
bears to the drained weight of the entire contents of the can. Such
drained weights shall be determined by the method prescribed in
paragraph (c) of this section.
(v) There is present in the finished canned fruit cocktail not more
than 1 square inch of peach peel per each 1 pound of drained weight of
units of peach plus the weight of a proportion of the packing medium
which is the same proportion as the drained weight of units of peach
bears to the drained weight of the entire contents of the can. Such
drained weights shall be determined by the method prescribed in
paragraph (c) of this section.
(vi) Not more than 15 percent of the units of cherry ingredient, and
not more than 20 percent of the units of peach, pear, or grape, in the
container are blemished with scab, hail injury, scar tissue or other
abnormality.
(vii) If the cherry ingredient is artificially colored, the color of
not more than 15 percent of the units thereof in a container containing
more than six units and of not more than one unit in a container
containing six units or less, is other than evenly distributed in the
unit or other than uniform with the color of the other units of the
cherry ingredient.
(2) If the quality of canned fruit cocktail falls below the standard
prescribed in paragraph (b)(1) of this section, the label shall bear the
general statement of substandard quality specified in 130.14(a) of this
chapter, in the manner and form therein specified.
(c) Fill of container. (1) The standard of fill of container for
canned fruit cocktail is a fill such that the total weight of drained
fruit is not less than 65 percent of the water capacity of the
container, as determined by the general method for water capacity of
containers prescribed in 130.12(a) of this chapter. Such total weight
of drained fruit is determined by the following method: Tilt the opened
container so as to distribute the contents evenly over the meshes of a
circular sieve which has been previously weighed. The diameter of the
sieve is 8 inches if the quantity of contents of the container is less
than 3 pounds, and 12 inches if such quantity is 3 pounds or more. The
bottom of the sieve is woven-wire cloth that complies with the
specifications for such cloth set forth under ''2.38 mm (No. 8)'' in
Table 1, ''Nominal Dimensions of Standard Test Sieves (U.S.A. Standard
Series),'' prescribed in paragraph (b)(1)(i) of this section, which is
incorporated by reference. The availability of this incorporation by
reference is given in paragraph (b)(1)(i) of this section. Without
shifting the material on the sieve so incline the sieve as to facilitate
drainage. Two minutes from the time drainage begins, weigh the sieve
and drained fruit. The weight so found, less the weight of the sieve,
shall be considered to be the total weight of drained fruit.
(2) If canned fruit cocktail falls below the standard of fill of
container prescribed in paragraph (c)(1) of this section, the label
shall bear the general statement of substandard fill specified in
130.14(b) of this chapter, in the manner and form therein prescribed.
(42 FR 14414, Mar. 15, 1977, as amended at 47 FR 11829, Mar. 19,
1982; 49 FR 10100, Mar. 19, 1984; 54 FR 24895, June 12, 1989)
21 CFR 145.136 Artificially sweetened canned fruit cocktail.
(a) Artificially sweetened canned fruit cocktail is the food which
conforms to the definition and standard of identity prescribed for
canned fruit cocktail by 145.135(a), except that in lieu of a packing
medium specified in 145.135(a)(3), the packing medium used is water
artificially sweetened with saccharin, sodium saccharin, or a
combination of both. Such packing medium may be thickened with pectin
and may contain any mixture of any edible organic salt or salts and any
edible organic acid or acids as a flavor-enhancing agent, in a quantity
not more than is reasonably required for that purpose.
(b)(1) The specified name of the food is ''artificially sweetened
fruit cocktail''.
(2) Artificially sweetened fruit cocktail is subject to the
requirements for label statement of optional ingredients used, as
prescribed for canned fruit cocktail by 145.135(a). If the packing
medium is thickened with pectin, the label shall bear the statement
''thickened with pectin''. When any organic salt or acid or any mixture
of two or more of these is added, the label shall bear the common or
usual name of each such ingredient.
21 CFR 145.140 Canned seedless grapes.
(a) Ingredients. Canned seedless grapes is the food prepared from
one of the fresh or previously canned optional grape ingredients
specified in paragraph (b) of this section which may be packed in one of
the optional packing media specified in paragraph (c) of this section.
Such food may also contain one, or any combination of two or more, of
the following safe and suitable optional ingredients:
(1) Natural and artificial flavors.
(2) Spice.
(3) Vinegar, lemon juice, or organic acids.
Such food is sealed in a container and before or after sealing is so
processed by heat as to prevent spoilage.
(b) Varietal types and styles. The optional grape ingredients
referred to in paragraph (a) of this section are prepared from stemmed
grapes of the light or dark seedless varieties or from unstemmed
clusters of such grapes. For the purposes of paragraph (d) of this
section, the names of such optional grape ingredients are ''light
seedless grapes'' or ''dark seedless grapes'', as the case may be,
preceded by the words ''unstemmed clusters'' where applicable.
(c) Packing media. (1) The optional packing media referred to in
paragraph (a) of this section, as defined in 145.3 are:
(i) Water.
(ii) Fruit juice(s) and water.
(iii) Fruit juice(s).
Such packing media may be used as such or any one or any combination
of two or more safe and suitable nutritive carbohydrate sweetener(s) may
be added. Sweeteners defined in 145.3 shall be as defined therein,
except that a nutritive carbohydrate sweetener for which a standard of
identity has been established in Part 168 of this chapter shall comply
with such standard in lieu of any definition that may appear in 145.3.
(2) When a sweetener is added as a part of any such liquid packing
medium, the density range of the resulting packing medium expressed as
percent by weight of sucrose (degrees Brix) as determined by the
procedure prescribed in 145.3(m) shall be designated by the appropriate
name for the respective density ranges, namely:
(i) When the density of the solution is less than 14 percent, the
medium shall be designated as ''slightly sweetened water''; or ''extra
light sirup''; ''slightly sweetened fruit juice(s) and water''; or
''slightly sweetened fruit juice(s)'', as the case may be.
(ii) When the density of the solution is 14 percent or more but less
than 18 percent, the medium shall be designated as ''light sirup'';
''lightly sweetened fruit juice(s) and water''; or ''lightly sweetened
fruit juice(s)'', as the case may be.
(iii) When the density of the solution is 18 percent or more but less
than 22 percent, the medium shall be designated as ''heavy sirup'';
''heavily sweetened fruit juice(s) and water''; or ''heavily sweetened
fruit juice(s)'', as the case may be.
(iv) When the density of the solution is 22 percent or more but not
more than 35 percent, the medium shall be designated as ''extra heavy
sirup''; ''extra heavily sweetened fruit juice(s) and water''; or
''extra heavily sweetened fruit juice(s)'', as the case may be.
(d) Labeling requirements. (1) The name of the food is ''seedless
grapes.'' The name of the food shall also include a declaration of any
flavoring that characterizes the product as specified in 101.22 of this
chapter and a declaration of any spice or seasoning that characterizes
the product; for example, ''Spice added'', or in lieu of the word
''Spice'', the common name of the spice, or ''Seasoned with lemon
juice''. When two or more of the optional ingredients specified in
paragraphs (a) (2) and (3) of this section are used, such words may be
combined as for example, ''Seasoned with cider vinegar, cloves, and
cinnamon oil''.
(2) The color type and style of the grape ingredient as provided in
paragraph (b) of this section and the name of the packing medium
specified in paragraphs (c) (1) and (2) of this section, preceded by
''In'' or ''Packed in'' or the words ''solid pack'', where applicable,
shall be included as part of the name or in close proximity to the name
of the food. When the packing medium is prepared with a sweetener(s)
which imparts a taste, flavor or other characteristic to the finished
food in addition to sweetness, the name of the packing medium shall be
accompanied by the name of such sweetener(s), as for example in the case
of a mixture of brown sugar and honey, an appropriate statement would be
'' ------------ sirup of brown sugar and honey'' the blank to be filled
in with the word ''light'', ''heavy'', or ''extra heavy'' as the case
may be. When the liquid portion of the packing media provided for in
paragraphs (c) (1) and (2) of this section consists of fruit juice(s),
such juice(s) shall be designated in the packing medium as:
(i) In the case of a single fruit juice, the name of the juice shall
be used in lieu of the word ''fruit'';
(ii) In the case of a combination of two or more fruit juices, the
names of the juices in the order of predominance by weight shall either
be used in lieu of the word ''fruit'' in the name of the packing medium,
or be declared on the label as specified in paragraph (d)(3) of this
section; and
(iii) In the case of a single fruit juice or a combination of two or
more fruit juices any of which are made from concentrate(s), the words
''from concentrate(s)'' shall follow the word ''juice(s)'' in the name
of the packing medium and in the name(s) of such juice(s) when declared
as specified in paragraph (d)(3) of this section.
(3) Whenever the names of the fruit juices used do not appear in the
name of the packing medium as provided in paragraph (d)(2)(ii) of this
section, such names and the words ''from concentrate'', as specified in
paragraph (d)(2)(iii) of this section, shall appear in an ingredient
statement pursuant to the requirements of 101.3(d) of this chapter.
(4) Each of the optional ingredients used shall be declared on the
label as required by the applicable sections of Part 101 of this
chapter.
21 CFR 145.145 Canned grapefruit.
(a) Identity -- (1) Product identification. Canned grapefruit is the
food prepared from one of the optional grapefruit ingredients specified
in paragraph (a)(2) of this section and one of the optional packing
media specified in paragraph (a)(3) of this section. Such food may also
contain one or more of the following safe and suitable optional
ingredients:
(i) Spices.
(ii) Natural and artificial flavoring.
(iii) Lemon juice.
(iv) Citric acid.
(v) Calcium chloride or calcium lactate or a mixture of the two
calcium salts in a quantity reasonably necessary to firm the grapefruit
sections, but in no case in a quantity such that the calcium contained
in such calcium salt or mixture is more than 0.035 percent by weight of
the finished food.
Such food is sealed in a container and, before or after sealing, is
so processed by heat as to prevent spoilage.
(2) Optional grapefruit ingredient. The optional grapefruit
ingredients referred to in paragraph (a)(1) of this section are prepared
from sound, mature grapefruit (Citrus paradisi Macfadyen) of the color
types white -- produced from white-fleshed grapefruit, and pink --
produced from pink or red-fleshed grapefruit and are in the following
forms of units: Whole sections or broken sections. Each such form of
units or a mixture of such forms of units prepared from a single
varietal group (color type) is an optional grapefruit ingredient. The
core, seeds, and major portions of membrane of such ingredient are
removed. For the purpose of this section, a grapefruit section is
considered whole when the unit is intact or an intact portion of such
unit is not less than 75 percent of its apparent original size and is
not excessively trimmed.
(i) For the purpose of paragraph (a)(4) of this section, the name of
the optional grapefruit ingredient is:
(a) ''Section'' or ''segments'', if 50 percent or more of the drained
weight of the food consists of whole sections.
(b) ''Broken sections'' or ''broken segments'', if less than 50
percent of the drained weight of the food consists of whole sections.
(ii) The drained weight is determined by the method prescribed in the
standard of fill of container for canned grapefruit set forth in
paragraph (c)(2) of this section.
(3) Packing media. (i) The optional packing media referred to in
paragraph (a)(1) of this section are:
(a) Water.
(b) Grapefruit juice and water.
(c) Grapefruit juice.
(d) Slightly sweetened sirup or slightly sweetened water.
(e) Light sirup.
(f) Heavy sirup.
(g) Slightly sweetened grapefruit juice and water.
(h) Lightly sweetened grapefruit juice and water.
(i) Heavily sweetened grapefruit juice and water.
(j) Slightly sweetened grapefruit juice.
(k) Lightly sweetened grapefruit juice.
(l) Heavily sweetened grapefruit juice.
As used in paragraph (a)(3)(i) of this section, the optional packing
medium ''water'' means, in addition to water, any mixture of water and
grapefruit juice in which there is less than 50 percent grapefruit
juice; the optional packing medium ''grapefruit juice and water'' means
the liquid packing medium in which juice of mature grapefruit and water
are combined as a liquid packing medium with not less than 50 percent
grapefruit juice and the term ''grapefruit juice'' means single strength
expressed juice of sound, mature fruit. It may be fresh, canned, or
made from concentrate. However, if it is made from concentrate, the
juice shall be reconstituted with water to not less than the soluble
solids the grapefruit juice had before concentration.
(ii) Each of the packing media in paragraph (a)(3)(i) (d) to (l) of
this section is prepared with a liquid ingredient and one or more safe
and suitable nutritive carbohydrate sweeteners. Water is the liquid
ingredient from which packing media in paragraph (a)(3)(i) (d) to (f) of
this section are prepared. Grapefruit juice and water are the liquid
ingredients from which the packing media in paragraph (a)(3)(i) (g) to
(i) of this section are prepared. Grapefruit juice is the liquid
ingredient from which the packing media in paragraph (a)(3)(i) (j) to
(l) of this section are prepared. If one or more liquid nutritive
carbohydrate sweeteners and grapefruit juice are combined as a liquid
packing medium with not less than 50 percent grapefruit juice, the
packing medium is as set forth in paragraph (a)(3)(i) (g) to (i) of this
section.
(iii) The respective densities of packing media in paragraph
(a)(3)(i) (d) to (i) of this section as measured on the refractometer,
expressed as percent by weight sucrose (degrees Brix) with correction
for temperature to the equivalent at 20 C (68 F), 15 days or more
after the grapefruit are canned or the blended homogenized slurry of the
comminuted entire contents of the container if canned for less than 15
days, according to the ''Official Methods of Analysis of the Association
of Official Analytical Chemists'' (AOAC), 13th Ed. (1980), section
31.011 under ''Solids By Means of Refractometer -- Official Final
Action,'' and Reference Tables, section 52.012 (Refractive indices (n)
of sucrose solutions at 20 ) and section 52.015 (Refractive indices of
invert sugar solutions), which is incorporated by reference (copies may
be obtained from the Association of Official Analytical Chemists, 2200
Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may be examined at
the Office of the Federal Register, 1100 L St. NW., Washington, DC
20408), but without correction for invert sugar or other substances, are
as follows:
(a) Packing media in paragraph (a)(3)(i) (d), (g), and (j) of this
section: Twelve percent or more but less than 16 percent.
(b) Packing media in paragraph (a)(3)(i) (e), (h), and (k) of this
section: Sixteen percent or more but less than 18 percent.
(c) Packing media in paragraph (a)(3)(i) (f), (i), and (l) of this
section: Eighteen percent or more. A lot shall be deemed to be in
compliance for packing medium density based on the average value for all
the samples analyzed according to paragraph (b)(2) of this section but
no container may have a value lower than that of the next lower category
or 2 percent by weight sucrose (degrees Brix) lower if no lower category
exists.
(4) Labeling requirements. (i) The name of the food is
''grapefruit'' or ''pink grapefruit'', as appropriate for the color type
of the grapefruit used. The name of the food shall also include a
declaration of any flavoring that characterizes the product as specified
in 101.22 of this chapter and a declaration of any spice or seasoning
that characterizes the product; for example, ''with added spice''.
Whenever the word ''sirup'' is used, it may be alternatively spelled
''syrup''. When two or more of the optional ingredients specified in
paragraphs (a)(1) (i), (ii), and (iii) of this section are used, such
words may be combined; for example, ''with added cloves and cinnamon
oil''.
(ii) The form and style of the grapefruit ingredient as provided for
in paragraph (a)(2) of this section and the name of the packing medium
as used in paragraph (a)(3) of this section preceded by ''In'' or
''Packed in'' shall be included as part of the name. When the packing
medium is prepared from concentrated grapefruit juice, the words ''from
concentrate'' shall follow the words ''grapefruit juice'' in the name of
the packing medium.
(iii) Each of the optional ingredients used shall be declared on the
label as required by the applicable sections of Part 101 of this
chapter.
(b) Quality. (1) The standard of quality for canned grapefruit is as
follows:
(i) The food is free from extraneous material such as leaves,
portions of leaves, and pieces of peel.
(ii) The finished food contains per 500 grams (17.6 ounces) not more
than:
(a) An aggregate area of 20 square centimeters (3.1 square inches) of
tough membrane or albedo on the units.
(b) Four developed seeds. A seed is considered a developed seed when
it measures more than 9.0 millimeters (0.35 inches) in any dimension.
(iii) Not more than 15 percent by weight of the drained grapefruit
may be blemished units. A blemished unit is a grapefruit section or any
portion thereof which is damaged by lye peeling, by discoloration, or by
other visible injury. The drained weight is determined by the method
prescribed in the standard of fill of container for canned grapefruit
set forth in paragraph (c)(2) of this section.
(2) Sampling and acceptance procedure. A lot is to be considered
acceptable when the number of ''defectives'' does not exceed the
acceptance number in the sampling plans given in paragraph (b)(2)(ii) of
this section.
(i) Definitions of terms to be used in the sampling plans in
paragraph (b)(2)(ii) of this section are as follows:
(a) Lot. A collection of primary containers or units of the same
size, type and style manufactured or packed under similar conditions and
handled as a single unit of trade.
(b) Lot size. The number of primary containers or units in the lot.
(c) Sample size (n). The total number of sample units drawn for
examination from a lot.
(d) Sample unit. A container, the entire contents of a container, a
portion of the contents of a container, or a composite mixture of
product from small containers that is sufficient for the examination or
testing as a single unit.
(e) Defective. Any sample unit shall be regarded as defective when
any of the defects or conditions specified in the quality standard
(paragraph (b)(1) of this section) and paragraph (c)(3)(i) of this
section for minimum fill of container are present in excess of the
stated tolerances.
(f) Accepted number (c). The maximum number of defective sample
units permitted in the sample in order to consider the lot as meeting
the specified requirements.
(g) Acceptable quality level (AQL). The maximum percent of defective
sample units permitted in a lot that will be accepted approximately 95
percent of the time.
(ii) Sampling plans and acceptance procedure:
(3) If the quality of canned grapefruit falls below the standard
prescribed in paragraph (b)(1) of this section, the label shall bear the
general statement of substandard quality specified in 130.14(a) of this
chapter, in the manner and form therein specified; however, if the
quality of the canned grapefruit falls below standard with respect to
only one of the factors of quality specified by paragraph (b)(1) (i),
(ii), or (iii) of this section, there may be substituted for the second
line of such general statement of substandard quality, ''Good Food --
Not High Grade'', a new line as specified after the corresponding
designation of paragraph (b)(1) of this section which the canned
grapefruit fail to meet:
(i) ''Contains extraneous material''.
(ii)(a) ''Excessive tough membrane''.
(b) ''Excessive seeds''.
(iii) ''Excessive blemished units''.
(c) Fill of container -- (1) The standard of fill of container for
canned grapefruit is:
(i) The fill of grapefruit and packing medium, as determined by the
general method for fill of container prescribed in 130.12(b) of this
chapter, is not less than 90 percent of the total capacity of the
container.
(ii) The drained weight of grapefruit ingredient is not less than 50
percent of the water capacity of the container, as determined by the
method prescribed in paragraph (c)(2) of this section and the general
method for water capacity of containers prescribed in 130.12(a) of this
chapter.
(2) Drained weight is determined by the following method: Tilt the
opened container so as to distribute the contents evenly over the meshes
of a circular sieve which has previously been weighed. The diameter of
the sieve is 20.3 centimeters (8 inches) if the quantity of contents of
the container is less than 1.4 kilograms (3 pounds) and 30.5 centimeters
(12 inches) if such quantity is 1.4 kilograms (3 pounds) or more. The
bottom of the sieve is woven-wire cloth that complies with the
specifications for the No. 8 sieve set forth in the ''Definitions of
Terms and Explanatory Notes'' of the AOAC, 13th Ed. (1980), Table 1,
which is incorporated by reference. The availability of this
incorporation by reference is given in paragraph (a)(3)(iii) of this
section. Without shifting the material on the sieve, incline the sieve
at an angle of 17 to 20 to facilitate drainage. Two minutes after the
drainage begins, weigh the sieve and drained grapefruit. The weight so
found, less the weight of the sieve, shall be considered to be the
weight of the drained grapefruit.
(3)(i) A container that falls below the requirement for minimum fill
prescribed in paragraph (c)(1)(i) of this section shall be considered a
''defective''. The food will be deemed to fall below the standard of
fill when the number of defectives exceeds the acceptance number (c) in
the sampling plans prescribed in paragraph (b)(2) of this section.
(ii) Canned grapefruit will be deemed to fall below the standard of
fill when the average drained weight of all containers analyzed when
sampled according to the sampling plans prescribed in paragraph (b)(2)
of this section is less than that prescribed in paragraph (c)(1)(ii) of
this section.
(4) If canned grapefruit falls below the standard of fill of
container prescribed in paragraph (c)(1) of this section, the label
shall bear the statement of substandard fill specified in 130.14(b) of
this chapter, in the manner and form therein specified.
(42 FR 14414, Mar. 15, 1977, as amended at 47 FR 11830, Mar. 19,
1982; 49 FR 10100, Mar. 19, 1984; 54 FR 24895, June 12, 1989)
21 CFR 145.170 Canned peaches.
(a) Identity -- (1) Ingredients. Canned peaches is the food prepared
from one of the fresh, frozen, or previously canned optional peach
ingredients Prunus persica L., of commercial canning varieties, but
excluding nectarine varieties, specified in paragraph (a)(2) of this
section, which may be packed as a solid pack or in one of the optional
packing media specified in paragraph (a)(3) of this section. Such food
may also contain one, or any combination of two or more, of the
following safe and suitable optional ingredients:
(i) Natural and artificial flavors.
(ii) Spice.
(iii) Vinegar, lemon juice, or organic acids.
(iv) Peach pits, except in the cases of peeled whole peaches, in a
quantity not more than 1 peach pit to each 227 grams (8 ounces) of
finished canned peaches.
(v) Peach kernels, except in the cases of peeled whole peaches and
except when the optional ingredient in paragraph (a)(1)(iv) of this
section is used.
(vi) Ascorbic acid in an amount no greater than necessary to preserve
color. Such food is sealed in a container and before or after sealing
is so processed by heat as to prevent spoilage.
(2) Varietal types and styles. The optional peach ingredients
referred to in paragraph (a)(1) of this section are prepared from mature
peaches of the following optional varietal and color types and styles of
peach ingredients; namely:
(i) The optional varietal types. (a) Freestone is the distinct
varietal type where the pit separates readily from the flesh.
(b) Clingstone is the distinct varietal type where the pit adheres to
the flesh.
(ii) The optional color types -- (a) Yellow -- the varietal types in
which the predominant color ranges from pale yellow to rich red orange.
(b) White -- the varietal types in which the predominant color ranges
from white to yellow-white.
(c) Red -- the varietal types in which the predominant color ranges
from pale yellow to orange red and with variegated red coloring other
than that associated with the pit cavity.
(d) Green -- varietal types in which the flesh has a green tint even
when mature.
(iii) The optional styles of the peach ingredients -- (a) Whole --
consisting of whole peeled unpitted peaches.
(b) Halves -- consisting of peeled pitted peaches cut into two
approximately equal parts.
(c) Halves and pieces -- consisting of a mixture in which the peeled
pitted peach halves are more than 50 percent by weight.
(d) Quarters -- consisting of peeled pitted peaches cut into four
approximately equal parts.
(e) Slices -- consisting of peeled pitted peaches cut into
wedge-shaped sectors.
(f) Dice -- consisting of peeled pitted peaches cut into cube-like
parts.
(g) Chunky -- consisting of peeled pitted peaches cut into parts 13
millimeters (0.5 inch) or greater in the smallest dimension and 44
millimeters (1.75 inches) or less in the largest dimension.
(h) Pieces or irregular pieces -- consisting of peeled pitted peaches
cut into parts of irregular shapes and sizes.
(3) Packing media. (i) The optional packing media referred to in
paragraph (a)(1) of this section, as defined in 145.3 are:
(a) Water.
(b) Fruit juice(s) and water.
(c) Fruit juice(s).
Such packing media may be used as such or any one or any combination
of two or more safe and suitable nutritive carbohydrate sweetener(s) may
be added. Sweeteners defined in 145.3 shall be as defined therein,
except that a nutritive carbohydrate sweetener for which a standard of
identity has been established in Part 168 of this chapter shall comply
with such standard in lieu of any definition that may appear in 145.3.
(ii) When a sweetener is added as a part of any such liquid packing
medium, the density range of the resulting packing medium, expressed as
percent by weight of sucrose (degrees Brix) as determined by the
procedure prescribed in 145.3(m), shall be designated by the
appropriate name for the respective density ranges, namely:
(a) When the density of the solution is 10 percent or more but less
than 14 percent, the medium shall be designated as ''slightly sweetened
water''; or ''extra light sirup''; ''slightly sweetened fruit juice(s)
and water''; or ''slightly sweetened fruit juice(s)'', as the case may
be.
(b) When the density of the solution is 14 percent or more but less
than 18 percent, the medium shall be designated as ''light sirup'';
''lightly sweetened fruit juice(s) and water''; or ''lightly sweetened
fruit juice(s)'', as the case may be.
(c) When the density of the solution is 18 percent or more but less
than 22 percent, the medium shall be designated as ''heavy sirup'';
''heavily sweetened fruit juice(s) and water''; or ''heavily sweetened
fruit juice(s)'', as the case may be.
(d) When the density of the solution is 22 percent or more but not
more than 35 percent, the medium shall be designated as ''extra heavy
sirup''; ''extra heavily sweetened fruit juice(s) and water''; or
''extra heavily sweetened fruit juice(s)'' as the case may be.
(4) Labeling requirements. (i) The name of the food is ''peaches''.
The optional varietal type as set forth in paragraph (a)(2)(i) of this
section shall be a part of the name. The name of the food shall also
include a declaration of any flavoring that characterizes the product as
specified in 101.22 of this chapter and a declaration of any spice or
seasoning that characterizes the product; for example, ''Spice added'',
or in lieu of the word ''Spice'', the common name of the spice,
''Seasoned with vinegar'' or ''Seasoned with peach kernels''. When two
or more of the optional ingredients specified in paragraphs (a)(1) (ii)
through (v) of this section are used, such words may be combined as for
example, ''Seasoned with cider vinegar, cloves, cinnamon oil and peach
kernels''.
(ii) The color type and style of the peach ingredient as provided for
in paragraphs (a)(2) (ii) and (iii) of this section and the name of the
packing medium specified in paragraphs (a)(3) (i) and (ii) of this
section, preceded by ''In'' or ''Packed in'' or the words ''Solid
pack'', where applicable, shall be included as part of the name or in
close proximity to the name of the food, except that ''Halves'' may be
alternately designated as ''Halved'', ''Halves and pieces'' as ''Halved
and pieces'', ''Quarters'' as ''Quartered'', ''Slices'' as ''Sliced'',
and ''Dice'' as ''Diced''. Pieces or irregular pieces shall be
designated ''Pieces'', ''Irregular pieces'', or ''Mixed pieces of
irregular sizes and shapes''. ''Chunky'' may be designated as
''Chunks''. The terms ''Cling'' and ''Free'' may be used as optional
designations for ''Clingstone'' and ''Freestone'', respectively. When
the packing medium is prepared with a sweetener(s) which imparts a
taste, flavor, or other characteristic to the finished food in addition
to sweetness, the name of the packing medium shall be accompanied by the
name of such sweetener(s); as for example in the case of a mixture of
brown sugar and honey, an appropriate statement would be '' ------ sirup
of brown sugar and honey'' the blank to be filled in with the word
''light'', ''heavy'', or ''extra heavy'' as the case may be. When the
liquid portion of the packing media provided for in paragraphs (a)(3)
(i) and (ii) of this section consists of fruit juices(s), such juice(s)
shall be designated in the name of the packing medium as:
(a) In the case of a single fruit juice, the name of the juice shall
be used in lieu of the word ''fruit'';
(b) In the case of a combination of two or more fruit juices, the
names of the juices in the order of predominance by weight shall either
be used in lieu of the word ''fruit'' in the name of the packing medium,
or be declared on the label as specified in paragraph (a)(4)(iii) of
this section; and
(c) In the case of a single fruit juice or a combination of two or
more fruit juices any of which are made from concentrate(s), the words
''from concentrate(s)'' shall follow the word ''juices(s)'' in the name
of the packing medium and in the name(s) of such juice(s) when declared
as specified in paragraph (a)(4)(iii) of this section.
(iii) Whenever the names of the fruit juices used do not appear in
the name of the packing medium as provided in paragraph (a)(4)(ii)(b) of
this section, such names and the words ''from concentrate'', as
specified in paragraph (a)(4)(ii)(c) of this section, shall appear in an
ingredient statement pursuant to the requirements of 101.3(d) of this
chapter.
(iv) Each of the optional ingredients used shall be declared on the
label as required by the applicable sections of Part 101 of this
chapter.
(b) Quality. (1) The standard of quality for canned peaches is as
follows:
(i) Maturity. All units tested in accordance with the method
prescribed in paragraph (b)(2) of this section are pierced by weight of
not more than 300 grams (10.6 ounces).
(ii) Minimum size. In the case of halves and quarters styles, the
weight of each unit is not less than 17 grams (0.6 ounce) and 8.5 grams
(0.3 ounce), respectively.
(iii) Uniformity of size -- (a) Whole, halves, and quarters. In the
case of whole, halves, and quarters styles, the diameter (width) of the
largest unit is not more than 1.5 centimeters (0.6 inch) greater than
the diameter (width) of the smallest unit. In containers with more than
20 units, 2 units may be disregarded in making the determination. Where
a unit has broken in the container, the combined broken pieces are to be
reassembled to approximate a single unit of the appropriate style.
(b) Chunky. In the case of chunky style, not more than 25 percent of
the drained weight of the contents of the container consists of units
that will pass through an opening 13 millimeters (0.5 inch) wide or that
are more than 44 millimeters (1.75 inches) along the longest cut edge.
(iv) Peel. Not more than 15 square centimeters aggregate area of
peel per 1,000 grams (1.05 square inches per 16 ounces) of net weight.
Include any peel adhering to the peach or loose in the container.
(v) Blemished units. Not more than 20 percent by count of the units
in the container are blemished, e.g., with scab, hail injury,
discoloration, or other abnormalities. Blemished units are units which
contain surface discolorations that definitely contrast with the overall
color and may penetrate into the flesh.
(vi) Trimmed units. In the case of whole, halves, quarters, and
slices styles, all units are untrimmed or are so trimmed as to preserve
normal shape of the units.
(vii) Crushed or broken units. In the case of whole, halves, halves
and pieces, quarters, slices, dice and chunky styles, not more than 5
percent by count of the units in containers of 20 or more units and not
more than 1 unit in containers of fewer than 20 units are crushed or
broken. A unit that has lost its normal shape because of ripeness and
bears no mark of crushing shall not be considered crushed or broken.
(viii) Pits and pieces of pit. In the case of all styles, except
whole peaches and when whole peach pits or peach kernels are used as
seasoning ingredients, there is not more than one loose pit or one loose
large hard piece of pit (10 millimeters ( 3/8 inch) or larger) or one
unit of peach (e.g., peach half or peach slice) to which one or more
large hard pieces of pit are attached per 5.67 kilograms (200 ounces)
net weight. In addition, there is not more than three of any one or any
combination of two or more, per 2.83 kilograms (100 ounces) net weight
of the following: (a) A unit to which one or more small hard pieces of
pit less than 10 millimeters ( 3/8 inch) but not less than 1.6
millimeters ( 1/16 inch) are attached, (b) a unit to which three or more
small pieces of pit less than 1.6 millimeters ( 1/16 inch) are attached,
or (c) a loose small hard piece of pit less than 10 millimeters ( 3/8
inch).
(2) Canned peaches shall be tested by the following method to
determine whether or not they meet the requirements of paragraph
(b)(1)(i) of this section: So trim a test piece from the unit as to
fit, with peel surface up, into a supporting receptacle. If the unit is
of different firmness in different parts of its peel surface, trim the
piece from the firmest part. If the piece is unpeeled, remove the peel.
The top of the receptacle is circular in shape, of 29 millimeters
(1.125 inches) inside diameter, with vertical sides; or rectangular in
shape, 19 millimeters (0.75 inch) by 25 millimeters (1 inch) inside
measurements, with ends vertical and sides sloping downward and joining
at the center at a vertical depth of 19 millimeters (0.75 inch). Use the
circular receptacle for testing units of such size that a test piece can
be trimmed therefrom to fit it. Use the rectangular receptacle for
testing other units. Test no unit from which a test piece with a
rectangular peel surface at least 13 millimeters (0.51 inch) by 25
millimeters (1 inch) cannot be trimmed. Test the piece by means of a
round metal rod 4 millimeters (0.16 inch) in diameter. To the upper end
of the rod is affixed a device to which weight can be added. The rod is
held vertically by a support through which it can freely move upward or
downward. The lower end of the rod is a plane surface to which the
vertical axis of the rod is perpendicular. Adjust the combined weight
of the rod and device to 100 grams (3.53 ounces). Set the receptacle so
that the surface of test piece is held horizontally. Lower the end of
the rod to the approximate center of such surface, and add weight to the
device at a uniform, continuous rate of 12 grams (0.45 ounce) per second
until the rod pierces the test piece. Weigh the rod and weighted
device. Test all units in containers of 50 units or less, except those
units too small for testing or too soft for trimming. Test at least 50
units, taken at random, in containers of more than 50 units; but if
less than 50 units are of sufficient size and firmness for testing, test
those which are of sufficient size and firmness.
(3) Determine compliance as specified in 145.3(o) except that a lot
shall be deemed to be in compliance for peel, pits, and pieces of pit
based on the average of all samples analyzed according to the sampling
plans set out in 145.3(p).
(4) If the quality of canned peaches falls below the standard
prescribed in paragraph (b)(1) of this section, the label shall bear the
general statement of substandard quality defined in 130.14(a) of this
chapter, in the manner and form therein specified; however, if the
quality of the canned peaches falls below standard with respect to only
one of the factors of quality specified in paragraph (b)(1) (i) through
(viii) of this section, there may be substituted for the second line of
such general statement of substandard quality (''Good Food -- Not High
Grade'') a new line, as specified after the corresponding designation of
paragraph (b)(1) of this section which the canned peaches fail to meet,
as follows: (i) ''Not tender''; (ii) ''Small halves'' or ''Small
quarters'' as the case may be; (iii) (a) ''Mixed sizes''; (b)
''Undersized and/or oversized pieces'', (iv) ''Excess peel''; (v)
''Blemished''; (vi) ''Unevenly trimmed''; (vii) ''Partly crushed or
broken''; (viii) ''Contains pits or pit fragments''. Such alternative
statement shall immediately and conspicuously precede or follow, without
intervening written, printed, or graphic matter, the name ''peaches''
and any words and statements required or authorized to appear with such
name by paragraph (a)(2) of this section.
(c) Fill of container. (1) The standard of fill of container for
canned peaches is the maximum quantity of the optional peach ingredient
that can be sealed in the container and processed by heat to prevent
spoilage, without crushing or breaking such ingredient.
(2) If canned peaches fall below the standard of fill of container
prescribed in paragraph (c)(1) of this section, the label shall bear the
general statement of substandard fill specified in 130.14(b) of this
chapter, in the manner and form therein specified.
(42 FR 14414, Mar. 15, 1977, as amended at 46 FR 33028, June 26,
1981; 50 FR 34677, Aug. 27, 1985; 51 FR 11434, Apr. 3, 1986)
21 CFR 145.171 Artificially sweetened canned peaches.
(a) Artificially sweetened canned peaches is the food which conforms
to the definition and standard of identity prescribed for canned peaches
by 145.170(a), except that in lieu of a packing medium specified in
145.170(a)(3), the packing medium used is water artificially sweetened
with saccharin, sodium saccharin, or a combination of both. Such
packing medium may be thickened with pectin and may contain any mixture
of any edible organic salt or salts and any edible organic acid or acids
as a flavor-enhancing agent, in a quantity not more than is reasonably
required for that purpose.
(b)(1) The specified name of the food is ''artificially sweetened
------ '', the blank being filled in with the name prescribed by
145.170(a) for canned peaches having the same optional peach ingredient.
(2) The artificially sweetened food is subject to the requirements
for label statement of optional ingredients used, as prescribed for
canned peaches by 145.170(a). If the packing medium is thickened with
pectin, the label shall bear the statement ''thickened with pectin''.
When any organic salt or acid or any mixture of two or more of these is
added, the label shall bear the common or usual name of each such
ingredient.
21 CFR 145.175 Canned pears.
(a) Identity -- (1) Ingredients. Canned pears is the food prepared
from one of the fresh or previously canned optional pear ingredients
Pyrus communis or Pyrus sinensis specified in paragraph (a)(2) of this
section which may be packed in one of the optional packing media
specified in paragraph (a)(3) of this section. Such food may also
contain one, or any combination of two or more, of the following safe
and suitable optional ingredients.
(i) Natural and artificial flavors.
(ii) Spice.
(iii) Vinegar, lemon juice, or organic acids.
(iv) Artificial colors.
Such food is sealed in a container and before or after sealing is so
processed by heat as to prevent spoilage.
(2) Styles and forms of units. The optional pear styles and forms of
units referred to in paragraph (a)(1) of this section are:
(i) Whole -- consisting of peeled or unpeeled pears with cores
removed or left in.
(ii) Halves -- consisting of peeled or unpeeled pears with cores
removed and cut into two approximately equal parts.
(iii) Quarters -- consisting of peeled pears with cores removed and
cut into four approximately equal parts.
(iv) Slices -- consisting of peeled pears with cores removed and cut
into wedge-shaped sectors.
(v) Dice -- consisting of peeled pears with cores removed and cut
into cube-like parts.
(vi) Pieces or irregular pieces -- consisting of peeled pears with
cores removed and cut into parts of irregular shapes and sizes.
(vii) Chunky -- consisting of peeled pears with cores removed and cut
into parts 13 millimeters (0.51 inch) or greater in the smallest
dimension and 44 millimeters (1.75 inches) or less in the largest
dimension.
(3) Packing media. (i) The optional packing media referred to in
paragraph (a)(1) of this section, as defined in 145.3 are:
(a) Water.
(b) Fruit juice(s) and water.
(c) Fruit juice(s).
(d) Clarified juice.
Such packing media may be used as such or any one or any combination
of two or more safe and suitable nutritive carbohydrate sweetener(s) may
be added. Sweeteners defined in 145.3 shall be as defined therein,
except that a nutritive carbohydrate sweetener for which a standard of
identity has been established in Part 168 of this chapter shall comply
with such standard in lieu of any definition that may appear in 145.30.
(ii) If the concentration of clarified juice is such that the packing
medium forms to the density range for one of the sirups under paragraph
(a)(3)(ii) (a), (b), (c), or (d) of this section, the concentrated
clarified juice is considered to be light sirup, heavy sirup, or extra
heavy sirup, as the case may be. When a sweetener is added as a part of
any such liquid packing medium, the density range of the resulting
packing medium expressed as percent by weight of sucrose (degrees Brix)
as determined by the procedure in 145.3(m) shall be designated by the
appropriate name for the respective density ranges, namely:
(a) When the density of the solution is less than 14 percent, the
medium shall be designated as ''slightly sweetened water''; or ''extra
light sirup''; ''slightly sweetened fruit juice(s) and water''; or
''slightly sweetened fruit juice(s)'', as the case may be.
(b) When the density of the solution is 14 percent or more but less
than 18 percent, the medium shall be designated as ''light sirup'';
''lightly sweetened fruit juice(s) and water''; or ''lightly sweetened
fruit juice(s)'' as the case may be.
(c) When the density of the solution is 18 percent or more but less
than 22 percent, the medium shall be designated as ''heavy sirup'';
''heavily sweetened fruit juice(s) and water''; or ''heavily sweetened
fruit juice(s)'', as the case may be.
(d) When the density of the solution is 22 percent or more but not
more than 35 percent, the medium shall be designated as ''extra heavy
sirup''; ''extra heavily sweetened fruit juice(s) and water''; or
''extra heavily sweetened fruit juice(s)'', as the case may be.
(4) Labeling requirements. (i) The name of the food is ''pears''.
The name of the food shall also include a declaration of any flavoring
that characterizes the product as specified in 101.22 of this chapter
and a declaration of any spice or seasoning that characterizes the
product; for example, ''Spice added'', or in lieu of the word
''Spice'', the common name of the spice, ''Seasoned with vinegar''.
When two or more of the optional ingredients specified in paragraphs
(a)(1) (ii) and (iii) of this section are used, such words may be
combined as for example, ''Seasoned with cider vinegar, cloves, and
cinnamon oil''.
(ii) The style and forms of units of the pear ingredient as provided
in paragraph (a)(2) of this section and the name of the packing medium
specified in paragraph (a)(3) (i) and (ii) of this section, preceded by
''In'' or ''Packed in'' or the words ''Solid pack'', where applicable,
shall be included as part of the name or in close proximity to the name
of the food, except that ''Halves'' may be alternatively designated as
''Halved'', ''Quarters'' as ''Quartered'', ''Slices'' as ''Sliced'', and
''Dice'' as ''Diced''. ''Pieces'' or ''Irregular pieces'' shall be
designated as ''Pieces'', ''Irregular pieces'', or ''Mixed pieces of
irregular sizes and shapes''. ''Chunky'' may be designated as
''Chunks''. The style of the pear ingredient shall be preceded or
followed by ''Unpeeled'' when the units are whole or halves and are
unpeeled. When the packing medium is prepared with a sweetener(s) which
imparts a taste, flavor or other characteristic to the finished food in
addition to sweetness, the name of the packing medium shall be
accompanied by the name of such sweetener(s), as for example in the case
of a mixture of brown sugar and honey, an appropriate statement would be
'' ------ sirup of brown suar and honey'' the blank to be filled in with
the word ''light'', ''heavy'', or ''extra heavy'', as the case may be.
When the liquid portion of the packing media provided for in paragraphs
(a)(3) (i) and (ii) of this section consists of fruit juice(s), such
juice(s) shall be designated in the name of the packing medium as:
(a) In the case of a single fruit juice, the name of the juice shall
be used in lieu of the word ''fruit'';
(b) In the case of a combination of two or more fruit juices, the
names of the juices in the order of predominance by weight shall either
be used in lieu of the word ''fruit'' in the name of the packing medium,
or be declared on the label as specified in paragraph (a)(4)(iii) of
this section; and
(c) In the case of a single fruit juice or a combination of two or
more fruit juices any of which are made from concentrate(s), the words
''from concentrate(s)'' shall follow the word ''juice(s)'' in the name
of the packing medium and in the name(s) of such juice(s) when declared
as specified in paragraph (a)(4)(iii) of this section.
(iii) Whenever the names of the fruit juices used do not appear in
the name of the packing medium as provided in paragraph (a)(4)(ii)(b) of
this section, such names and the words ''from concentrate'', as
specified in paragraph (a)(4)(ii)(c) of this section, shall appear in an
ingredient statement pursuant to the requirements of 101.3(d) of this
chapter.
(iv) Each of the optional ingredients used shall be declared on the
label as required by the applicable sections of Part 101 of this
chapter.
(b) Quality. (1) The standard of quality for canned pears is as
follows:
(i) Maturity. All units tested in accordance with the method
prescribed in paragraph (b)(2) of this section are pierced by a weight
of not more than 300 grams (10.6 ounces).
(ii) Minimum size. In the case of halves and quarters styles, the
weight of each unit is not less than 17 grams (0.6 ounce) and 8.5 grams
(0.3 ounce), respectively.
(iii) Uniformity of size -- (a) Whole, halves, and quarters. In the
case of whole, halves, and quarters styles, among those units comprising
95 percent by count of those present in the container that are most
uniform in size, the weight of the largest unit is not more than twice
the weight of the smallest unit. In containers with fewer than 20
units, 1 unit may be disregarded in making the determination. Where a
unit has broken in the container, reassemble the broken pieces to
approximate a single unit of the appropriate style.
(b) Chunky. In the case of chunky style, not more than 25 percent of
the drained weight of the contents of the container consists of units
that will pass through an opening 13 millimeters (0.51 inch) wide or
that are more than 44 millimeters (1.75 inches) along the longest cut
edge.
(iv) Peel (except unpeeled style). Not more than 10 square
centimeters (1.6 square inches) of peel adhering to pears or loose in
the container per kilogram (35.3 ounces) of net weight.
(v) Blemished units. Not more than 20 percent by count of the units
in the container are blemished with scab, hail injury, discoloration, or
other abnormality aggregating the area of a circle more than 6.5
millimeters (0.25 inch) in diameter; corky or hard spots on outer
surfaces aggregating the area of a circle more than 13 millimeters (0.51
inch) in diameter; or dark brown areas aggregating the area of a circle
less than 6.5 millimeters (0.25 inch) in diameter which penetrate into
the flesh or affect the appearance of the unit.
(vi) Trimmed units. In the case of whole, halves, and quarters
styles, all units are untrimmed or are so trimmed as to preserve normal
shape of the unit.
(vii) Crushed or broken units. In the case of whole, halves,
quarter, slices, dice, and chunky styles, not more than 10 percent by
count of the units in containers of 10 or more units and not more than 1
unit in containers of less than 10 units are crushed or broken. A unit
that lost its normal shape because of ripeness and bears no mark of
crushing shall not be considered to be crushed or broken.
(viii) Loose core material in all styles except uncored whole style.
Not more than two units of loose core material per kilogram (35.3
ounces) of net weight. A unit of such material is defined as a portion
of loose core, with or without seeds, aggregating approximately one-half
of a pear core.
(ix) Partially cored units in all styles except uncored whole style.
Not more than 40 percent by count partially cored units in halves,
quarters, slices, and pieces or irregular pieces styles and not more
than 5 percent by weight in dice style. A partially cored unit is a
unit of pear that contains an attached portion of the seed cell cavity.
(x) Seeds in all styles except whole uncored style. Not more than 8
seeds or the equivalent in pieces of seeds per kilogram (35.3 ounces) of
net weight. Seeds included as cored material in paragraph (b)(1) (viii)
and (ix) of this section shall not be counted a second time.
(2) Canned pears shall be tested by the following method to determine
whether they meet the requirements of paragraph (b)(1)(i) of this
section: So trim a test piece from the unit as to fit, with peel
surface up, into a supporting receptacle. If the unit is of different
firmness in different parts of its peel surface, trim the piece from the
firmest part. If the piece is unpeeled, remove the peel. The top of
the receptacle is circular in shape, of 28.6 millimeters (1.12 inches)
inside diameter, with vertical sides; or rectangular in shape, 19
millimeters (0.75 inch) by 25.4 millimeters (1 inch) inside
measurements, with ends vertical and sides sloping downward and joining
at the center at a vertical depth of 19 millimeters (0.75 inch). Use the
circular receptacle for testing units of such size that a test piece can
be trimmed therefrom to fit it. Use the rectangular receptacle for
testing other units. Test no unit from which a test piece with
rectangular peel surface at least 13 millimeters (0.51 inch) by 25.4
millimeters (1 inch) cannot be trimmed. Test the piece by means of a
round metal rod 4 millimeters (0.16 inch) in diameter. To the upper end
of the rod is affixed a device to which weight can be added. The rod is
held vertically by the support through which it can freely move upward
or downward. The lower end of the rod is a plane surface to which the
vertical axis of the rod is perpendicular. Adjust the combined weight
of the rod and device to 100 grams (3.5 ounces). Set the receptacle so
that the surface of the test piece is held horizontally. Lower the end
of the rod to the approximate center of such surface, and add weight to
the device at a uniform, continuous rate of 12 grams (0.42 ounce) per
second until the rod pierces the test piece. Weigh the rod and weighted
device. Test all units in containers of 50 units or less except those
units too small for testing or too soft for trimming. Test at least 50
units, taken at random in containers of more than 50 units; but if less
than 50 units are of sufficient size and firmness for testing, test
those which are of sufficient size and firmness.
(3) Determine compliance as specified in 145.3(o) except that a lot
shall be deemed to be in compliance for peel in all styles except
unpeeled styles and seeds in all styles except whole uncored style based
on the average of all samples analyzed according to the sampling plans
set out in 145.3(p).
(4) If the quality of canned pears falls below the standard
prescribed in paragraph (b)(1) of this section, the label shall bear the
general statement of substandard quality specified in 130.14(a) of this
chapter, in the manner and form therein specified; however, if the
quality of the canned pears falls below standard with respect to only
one of the factors of quality specified in paragraph (b)(1) (i) through
(x) of this section, there may be substituted for the second line of
such general statement of substandard quality (''Good Food -- Not High
Grade'') a new line, as specified after the corresponding designation of
paragraph (b)(1) of this section which the canned pears fail to meet, as
follows:
(i) ''Not tender'';
(ii) ''Small halves'' or ''small quarters'', as the case may be;
(iii)(a) ''Mixed sizes'';
(b) ''Undersized and/or oversized pieces'';
(iv) ''Excessive peel'';
(v) ''Blemished'';
(vi) ''Unevenly trimmed'';
(vii) ''Partly crushed or broken'';
(viii) ''Excessive core'';
(ix) ''Excessive core'';
(x) ''Excessive seeds''.
Such alternative statement shall immediately and conspicuously
precede or follow, without intervening written, printed, or graphic
matter, the name ''pears'' and any words and statements required or
authorized to appear with such name by paragraph (a)(2) of this section.
(c) Fill of container. (1) The standard of fill of container for
canned pears is the maximum quantity of the optional pear ingredient
that can be sealed in the container and processed by heat to prevent
spoilage, without crushing or breaking such ingredient.
(2) If canned pears fall below the standard of fill of container
prescribed in paragraph (c)(1) of this section, the label shall bear the
general statement of substandard fill specified in 130.14(b) of this
chapter, in the manner and form therein specified.
(42 FR 14414, Mar. 15, 1977, as amended at 47 FR 41528, 41530, Sept.
21, 1982)
21 CFR 145.176 Artificially sweetened canned pears.
(a) Artificially sweetened canned pears is the food which conforms to
the definition and standard of identity prescribed for canned pears by
145.175(a) except that in lieu of a packing medium specified in
145.175(a)(3), the packing medium used is water artificially sweetened
with saccharin, sodium saccharin, or a combination of both. Such
packing medium may be thickened with pectin and may contain any mixture
of any edible organic salt or salts and any edible organic acid or acids
as a flavor-enhancing agent, in a quantity not more than is reasonably
required for that purpose.
(b)(1) The specified name of the food is ''artificially sweetened
------ '', the blank being filled in with the name prescribed by
145.175(a) for canned pears having the same optional pear ingredient.
(2) The artificially sweetened food is subject to the requirements
for label statement of optional ingredients used, as prescribed for
canned pears by 145.175(a). If the packing medium is thickened with
pectin, the label shall bear the statement ''thickened with pectin''.
When any organic salt or acid or any mixture of two or more of these is
added, the label shall bear the common or usual name of each such
ingredient.
21 CFR 145.180 Canned pineapple.
(a) Identity -- (1) Ingredients. Canned pineapple is the food
prepared from mature, fresh or previously canned, pineapple conforming
to the characteristics of Ananas comosus (L.) Merrill and from which
peel and core have been removed. The food consists of one of the
optional styles of the pineapple ingredient specified in paragraph
(a)(2) of this section and may be packed in one of the optional packing
media specified in paragraph (a)(3) of this section, except water is not
a suitable packing medium for crushed style. Crushed style additionally
may be packed as heavy or solid pack as specified in paragraph (a)(4) of
this section. The food may also contain one, or any combination of two
or more, of the following safe and suitable optional ingredients:
(i) Natural fruit flavors.
(ii) Mint flavor.
(iii) Spices, spice oils.
(iv) Vinegar or organic acids.
(v) Dimethylpolysiloxane in an amount not greater than 10
milligrams/kilogram (10 parts per million) by weight of the finished
food as a defoaming agent.
The food is sealed in a container and, before or after sealing, is so
processed by heat as to prevent spoilage.
(2) Styles of pack. The optional styles of the pineapple ingredients
referred to in paragraph (a)(1) of this section are:
(i) Slices or whole slices or rings -- consisting of uniformly cut
circular slices or rings cut across the axis of the peeled, cored
pineapple cylinders.
(ii) Half slices -- consisting of uniformly cut, approximately
semicircular halves of slices.
(iii) Quarter slices -- consisting of uniformly cut, one-fourth
portions of slices.
(iv) Broken slices -- consisting of arc-shaped portions which may not
be uniform in size and/or shape.
(v) Spears or fingers -- consisting of long, slender pieces cut
radially and lengthwise of the cored pineapple cylinder, predominantly
65 millimeters (2.5 inches) or longer.
(vi) Tidbits -- consisting of reasonably uniform, wedge-shaped
sectors cut from slices or portions thereof, predominantly from 8
millimeters (0.31 inch) to 13 millimeters (0.51 inch) thick.
(vii) Chunks -- consisting of short, thick pieces cut from thick
slices and/or from peeled cored pineapple and predominantly more than 13
millimeters (0.51 inch) in both thickness and width, and less than 38
millimeters (1.5 inches) in length and does not include large cubes.
(viii) Small cubes or dice -- consisting of reasonably uniform,
cube-shaped pieces, predominately 14 millimeters (0.55 inch) or less in
the longest edge dimensions.
(ix) Pieces or irregular pieces -- consisting of irregular shapes and
sizes not identifiable as a specific style and does not include chunks.
(x) Crushed -- consisting of finely cut or finely shredded or grated
or diced pieces of pineapple.
(xi) Large cubes -- consisting of reasonably uniform, cube-shaped
pieces, longer than 14 millimeters (0.55 inch) along any edge, but
predominately 25 millimeters (1 inch) or less in the longest edge
dimensions.
(3) Packing media. (i) The optional packing media referred to in
paragraph (a)(1) of this section and defined in 145.3 are:
(a) Water.
(b) Pineapple juice and water.
(c) Pineapple juice.
(d) Clarified pineapple juice.
Such packing media may be used as such, or any one of the optional
sweetening ingredients specified in paragraph (a)(3)(ii) of this section
may be added.
(ii) The optional sweetening ingredients referred to in paragraph
(a)(3)(i) of this section are:
(a) Sugar.
(b) Invert sugar sirup.
(c) Any mixture of optional sweetening ingredients designated in
paragraph (a)(3)(ii)(a) and (b) of this section.
(d) Any of the optional sweetening ingredients designated in
paragraph (a)(3)(ii)(a), (b), and (c) of this section with dextrose, as
long as the weight of the solids of dextrose does not exceed one-third
of the total weight of the solids of the combined sweetening
ingredients.
(e) Any of the optional sweetening ingredients designated in
paragraph (a)(3)(ii)(a), (b), and (c) of this section with corn sirup or
with dried corn sirup or with glucose sirup or with dried glucose sirup,
or with any two or more of these, as long as the weight of the solids of
corn sirup, dried corn sirup, glucose sirup, dried glucose sirup, or the
sum of the weights of the solids of corn sirup, dried corn sirup,
glucose sirup, and dried glucose sirup, in case two or more of these are
used, does not exceed one-fourth of the total weight of the solids of
the combined sweetening ingredients.
(f) Any mixture of the optional ingredients designated in paragraph
(a)(3)(ii)(d) and (e) of this section.
(iii) If the concentration of clarified pineapple juice is such that
the packing medium conforms to the density range for one of the sirups
provided for in paragraph (a)(3)(iv)(b), (c), or (d) of this section,
the concentrated clarified juice is considered to be light sirup, heavy
sirup, or extra heavy sirup, as the case may be.
(iv) When a sweetener is added as a part of any liquid packing medium
as provided for in paragraph (a)(3)(i)(a), (b), and (c) of this section,
the density range of the resulting packing medium, expressed as percent
by weight of sucrose (degrees Brix) as determined by the procedure in
145.3(m), shall be designated by the appropriate name for the respective
density ranges, namely:
(a) When the density of the solution is 10 percent or more but less
than 14 percent, the medium shall be designated as ''slightly sweetened
water'' or ''extra light sirup''; ''slightly sweetened pineapple juice
and water''; or ''slightly sweetened pineapple juice'', as the case may
be.
(b) When the density of the solution is 14 percent or more but less
than 18 percent, the medium shall be designated as ''light sirup'';
''lightly sweetened pineapple juice and water''; or ''lightly sweetened
pineapple juice,'' as the case may be.
(c) When the density of the solution is 18 percent or more but less
than 22 percent, the medium shall be designated as ''heavy sirup'';
''heavily sweetened pineapple juice and water''; or ''heavily sweetened
pineapple juice'', as the case may be.
(d) When the density of the solution is 22 percent or more but not
more than 35 percent, the medium shall be designated as ''extra heavy
sirup''; ''extra heavily sweetened pineapple juice and water''; or
''extra heavily sweetened pineapple juice'', as the case may be.
(v) Determine compliance as specified in 145.3(o).
(4) Types of pack. The optional types of pack for crushed style
referred to in paragraph (a)(1) of this section are as follows:
(i) Heavy pack: Crushed style with or without sweetening ingredients
and containing at least 73 percent drained fruit weight, as determined
by the procedure set forth in 145.3(n).
(ii) Solid pack: Crushed style with or without sweetening
ingredients and containing at least 78 percent drained fruit weight, as
determined by the procedure set forth in 145.3(n).
(5) Labeling requirements. (i) The name of the food is
''pineapple''. The name of the food shall also include a declaration of
any flavoring that characterizes the product as specified in 101.22 of
this chapter and a declaration of any spice or seasoning that
characterizes the product; for example, ''Spice added'', or, in lieu of
the word ''Spice'', the common name of the spice; or ''Seasoned with
vinegar'' or, in lieu of the word ''vinegar'', the name of the vinegar
used. When two or more of the optional ingredients specified in
paragraph (a)(1)(i) through (iv) of this section are used, such words
may be combined, as, for example, ''Seasoned with cider vinegar, cloves,
and cinnamon oil''.
(ii) The style of the pineapple ingredient as provided for in
paragraph (a)(2) of this section and the name of the packing medium as
specified in paragraph (a)(3)(i) and (ii) of this section, preceded by
''In'' or ''Packed in'' or the words ''Heavy pack'' or ''Solid pack'' as
specified in paragraph (a)(4) of this section, where applicable, shall
be included as part of the name or in close proximity to the name of the
food. The word ''slices'' may be alternatively designated ''sliced,''
''dice'' as ''diced,'' and ''pieces'' or ''irregular pieces'' as ''mixed
pieces of irregular sizes and shapes.'' Whenever pineapple juice, as
provided for in paragraph (a)(3)(i)(c) of this section, is used, the
declaration may be preceded by an appropriate statement such as
''unsweetened''.
(iii) Each of the optional ingredients used shall be declared on the
label as required by the applicable sections of Part 101 of this
chapter.
(b) Quality. (1) The standard of quality for canned pineapple is as
follows:
(i) Core material. In the case of all styles, not more than 7
percent of the drained weight of the contents of the container consists
of core material as determined by the method prescribed in paragraph
(b)(3)(ii) of this section.
(ii) Uniformity of weight and shape.
(a) Slices. The drained weight of the largest unit in the container
is not more than 1.4 times the drained weight of the smallest unit.
(b) Half slices and quarter slices. The drained weight of the
largest unit in a container is not more than 1.75 times the drained
weight of the smallest unit, except for an occasional broken piece due
to splitting or an occasional whole slice not completely cut through.
(c) Broken slices. (1) Not more than 10 percent of the drained
weight of the contents of the container consists of pieces having an arc
of less than 90 .
(2) Not more than 5 percent of the drained weight of the contents of
the container:
(i) Consists of pieces that measure in thickness less than 8
millimeters (0.31 inch) or more than 25 millimeters (1 inch); or
(ii) Consists of pieces that measure less than 19 millimeters (0.75
inch) in width as measured from the outer edge to the inner edge.
(3) Not more than 5 percent of the drained weight of the contents of
the container consists of broken slices having an outside diameter
differing by as much as 9.5 millimeters (0.37 inch) from that of those
present in greatest proportion by weight.
(d) Spears. The drained weight of the largest unit in the container
is not more than 1.4 times the drained weight of the smallest unit.
(e) Tidbits. Not more than 15 percent of the drained weight of the
contents of the container consists of units each of which weighs less
than three-fourths as much as the average drained weight of all the
untrimmed units in the container.
(f) Chunks. Not more than 15 percent of the drained weight of the
contents of the container consists of pieces weighing less than 5 grams
(0.18 ounce) each.
(g) Cubes. (1) Not more than 10 percent of the drained weight of the
contents of the container consists of pieces that will pass through a
screen with square openings of 8 millimeters (0.31 inch) in the case of
the small cubes or large cubes.
(2) Not more than 15 percent of the drained weight consists of pieces
weighing more than 3 grams (0.11 ounce) each for small cubes and 18
grams (0.63 ounce) each for large cubes.
(h) Pieces. Not more than 20 percent of the drained weight of the
contents of the container consists of units that will pass through a
screen with square openings of 8 millimeters (0.31 inch).
(iii) Blemishes. Blemishes consist of surface areas and spots that
contrast strongly in color or texture with the normal pineapple tissue
or that may penetrate the flesh. Blemishes are normally removed in
preparation of pineapple for culinary use and include any of the
following, if in excess of 1.6 millimeters (0.06 inch) in the longest
dimension on the exposed surface of the unit: deep fruit eyes, pieces
of shell, brown spots, bruised portions, and other abnormalities.
(a) Slices, half slices, quarter slices, broken slices, spears,
tidbits, chunks, cubes, and pieces. Not more than 12.5 percent by count
of the units in the container may be blemished; but in containers
having not more than 5 units, 1 unit may be blemished; in containers
having more than 5 units, but not more than 10 units, 2 units may be
blemished and in containers having more than 10 units, but not more than
32 units, 4 units may be blemished.
(b) Crushed. Not more than 1.5 percent of the drained weight of the
contents of the container consists of fragments bearing blemishes.
(iv) Excessively trimmed. Slices, half slices, and quarter slices
are considered excessively trimmed if the portion trimmed away exceeds 5
percent of the apparent physical bulk of the perfectly formed unit and
if the trimming destroys the normal circular shape of the outer or inner
edge of the unit. Broken slices, spears, and tidbits are excessively
trimmed if the trimming destroys the normal shape of the unit.
(a) Slices, half slices, and quarter slices. Not more than 7.5
percent by count of the units in the container may be excessively
trimmed, but in containers having not more than 10 units, 1 unit may be
excessively trimmed; and in containers having more than 10 units, but
not more than 27 units, 2 units may be excessively trimmed.
(b) Broken slices and spears. Not more than 15 percent by count of
the total units in the container may be excessively trimmed.
(c) Tidbits. Not more than 15 percent of the drained weight of the
contents of the container consists of excessively trimmed units.
(v) Mashed. A unit that has lost its normal shape because of
ripeness that bears no mark of mechanical injury is not to be considered
mashed.
(a) Slices, half slices, and quarter slices. Not more than one unit
in containers of 25 units or less, and not more than 3 units in
containers of more than 25 units, are mashed.
(b) Broken slices. Not more than 5 percent by count of the units in
the container are mashed.
(c) Spears. Not more than 1 unit in the container is mashed.
(d) Tidbits. Not more than 3 units in containers of less than 150
units, and not more than 2 percent of the units in containers of 150
units or more, are mashed.
(e) Chunks. Not more than 3 units in containers of less than 70
units, and not more than 5 percent of the units in containers of 70
units or more, are mashed.
(vi) Acidity. In the case of all styles, not more than 1.35 grams of
acid, calculated as anhydrous citric acid, is contained in 100
milliliters of the liquid drained from the product 15 days or more after
the pineapple is canned.
(vii) Excessive liquid. The drained weight of crushed pineapple is
not less than 63 percent of the net weight of the contents of the
container.
(2) Sampling and acceptance: Determine compliance as specified in
145.3(o).
(3) Methodology: The method to be employed to determine whether
canned pineapple meets the requirements of paragraph (b)(1)(i) through
(vi) of this section are as follows:
(i) Determine the drained weight of the canned pineapple by the
procedure prescribed in 145.3(n).
(ii) Identify and separate any core material cleanly from each of the
units in the container, and weigh the aggregate of the core material.
Calculate the percent core material to determine compliance with
paragraph (b)(1)(i) of this section.
(iii) In the case of slices, half slices, quarter slices, spears,
tidbits, chunks, and pieces, check the weight of the units against the
requirements of paragraph (b)(1)(ii) (a), (b), (d), (e), (f), and (h) of
this section.
(iv) In the case of broken slices, check the dimensions of each unit
against the requirements of paragraph (b)(1)(ii)(c) of this section.
(v) In the case of cubes, and pieces, determine compliance with
paragraph (b)(1)(ii) (g) and (h) of this section by placing the units, a
few at a time, on the mesh of a U.S. Standard No. 8 sieve (8-millimeter
(0.31 inch)) mesh. After shaking gently, remove those units that remain
on the sieve before testing the next portion. Continue portion-wise
until all units are tested, then determine the aggregate weight of those
units that have passed through the sieve.
(vi) Except in the case of crushed pineapple, segregate and count
each unit that is blemished as defined in paragraph (b)(1)(iii) of this
section. In the case of crushed pineapple, segregate each fragment of
crushed pineapple bearing a blemish and determine the aggregate weight
of such fragments to determine compliance with paragraph (b)(1)(iii)(b)
of this section.
(vii) Except in the case of chunks, cubes, pieces, and crushed
pineapple, inspect all the units in the container to determine those
that have been excessively trimmed, as defined in paragraph (b)(1)(iv)
of this section.
(viii) Except in the case of cubes, pieces, and crushed pineapple,
count the total units in the container and the number of mashed units to
determine compliance with paragraph (b)(1)(v) of this section.
(ix) Determine the total acidity of the drained liquid by titration,
using the following method: Measure with a pipette 10 milliliters of
the unfiltered drained liquid into a 250-milliliter Erlenmeyer flask.
Add 25 milliliters of distilled or deionized water and 0.3 milliliter of
1-percent phenolphthalein solution. Titrate with one-tenth normal
sodium hydroxide solution to a faint, permanently pink coloration.
Multiply the number of milliliters of one-tenth normal sodium hydroxide
required by 0.064 to calculate the number of grams of anhydrous citric
acid per 100 milliliters of drained liquid to determine compliance with
paragraph (b)(3)(vi) of this section.
(4) If the quality of canned pineapple falls below the standard
prescribed in paragraph (b)(1) of this section, the label shall bear the
general statement of substandard quality specified in 130.14(a) of this
chapter, in the manner and form specified in that section; however, if
the quality of the canned pineapple falls below standard with respect to
only one of the factors of quality specified in paragraph (b)(1)(i)
through (vii) of this section, there may be substituted for the second
line of the general statement of substandard quality (''Good Food -- Not
High Grade'') one of the following new lines, placed after the
corresponding designation of paragraph (b)(1) of this section that the
canned pineapple fails to meet:
(i) ''Poorly cored'' or ''Excessive core''.
(ii) ''Mixed sizes'' or ''Irregular small pieces'', as appropriate.
(iii) ''Blemished'' or ''Contains blemished pieces''.
(iv) ''Excessively trimmed''.
(v) ''Mashed units'' or ''Contains mashed units''.
(vi) ''Excessively tart''.
(vii) ''Contains excess liquid''.
(c) Fill of Container. (1) The standard of fill of container for
canned crushed pineapple is a fill of not less than 90 percent of the
total capacity of the container, as determined by the general method for
fill of container prescribed in 130.12(b) of this chapter.
(2) If canned crushed pineapple falls below the standard of fill of
container prescribed in paragraph (c)(1) of this section, the label
shall bear the general statement of substandard fill specified in
130.14(b) of this chapter, in the manner and form therein specified.
(42 FR 14414, Mar. 15, 1977, as amended at 44 FR 40279, July 10,
1979; 45 FR 43391 and 43392, June 27, 1980; 46 FR 57475, Nov. 24,
1981; 48 FR 39916, Sept. 2, 1983)
21 CFR 145.181 Artificially sweetened canned pineapple.
(a) Artificially sweetened canned pineapple is the food that conforms
to the definition and standard of identity prescribed for canned
pineapple by 145.180(a), except that in lieu of a packing medium
specified in 145.180(a)(2), the packing medium used is water
artificially sweetened with saccharin, sodium saccharin, or a
combination of both. Such packing medium may be thickened with pectin.
(b)(1) The specified name of the food is ''artificially sweetened
------------ '', the blank being filled in with the name prescribed by
145.180(a) for canned pineapple having the same optional pineapple
ingredient.
(2) The artificially sweetened food is subject to the requirements
for label statement of optional ingredients used, as prescribed for
canned pineapple by 145.180(a). If the packing medium is thickened with
pectin, the label shall bear the statement ''thickened with pectin''.
21 CFR 145.185 Canned plums.
(a) Identity -- (1) Ingredients. Canned plums is the food prepared
from clean, sound, and mature fruit of plum varieties conforming to the
characteristics of Prunus domestica L., greengage varieties conforming
to the characteristics of Prunus italica L., mirabelle or damson
varieties conforming to the characteristics of Prunus insititia L., or
cherry varieties conforming to the characteristics of Prunus cerasifera
Ehrh. The food consists of one of the optional styles of the plum
ingredient, specified in paragraph (a)(2) of this section, and one of
the optional packing media specified in paragraph (a)(3) of this
section. Such food may also contain one, or any combination of two or
more of the following safe and suitable optional ingredients:
(i) Natural and artificial flavors.
(ii) Spice.
(iii) Vinegar, lemon juice, or organic acids.
(iv) Artificial coloring.
Such food is sealed in a container and before or after sealing is so
processed by heat so as to prevent spoilage.
(2) Optional styles of the plum ingredient. The optional plum
ingredients specified in paragraph (a)(1) of this section are peeled or
unpeeled:
(i) Whole.
(ii) Halves.
Peeled or unpeeled whole plums are pitted or, alternatively,
unpitted. Peeled or unpeeled plum halves are pitted.
(3) Packing media. (i) The optional packing media referred to in
paragraph (a)(1) of this section, as defined in 145.3 are:
(a) Water.
(b) Fruit juice(s) and water.
(c) Fruit juice(s).
Such packing media may be used as such or any one or any combination
of two or more safe and suitable nutritive carbohydrate sweetener(s) may
be added. Sweeteners defined in 145.3 shall be as defined therein,
except that a nutritive carbohydrate sweetener for which a standard of
identity has been established in Part 168 of this chapter shall comply
with such standard in lieu of any definition that may appear in 145.3.
(ii) When a sweetener is added as a part of any such liquid packing
medium, the density range of the resulting packing medium expressed as
percent by weight of sucrose (degrees Brix) as determined by the
procedure prescribed in 145.3(m) shall be designated by the appropriate
name for the respective density ranges, namely:
(a) When the density of the solution is 11 percent or more but less
than 15 percent, the medium shall be designated as ''slightly sweetened
water'', or ''extra light sirup'', ''slightly sweetened fruit juice(s)
and water'' or ''slightly sweetened fruit juice(s)'', as the case may
be.
(b) When the density of the solution is 15 percent or more, but less
than 19 percent, the medium shall be designated as ''light sirup'',
''lightly sweetened fruit juice(s) and water'', or ''lightly sweetened
fruit juice(s)'', as the case may be.
(c) When the density of the solution is 19 percent or more, but less
than 25 percent, the medium shall be designated as ''heavy sirup'',
''heavily sweetened fruit juice(s) and water'', or ''heavily sweetened
fruit juice(s)'', as the case may be.
(d) When the density of the solution is 25 percent or more, but less
than 35 percent, the medium shall be designated as ''extra heavy
sirup'', ''extra heavily sweetened fruit juice(s) and water'', or
''extra heavily sweetened fruit juice(s)'', as the case may be.
(4) Labeling requirements. (i) The name of the food is ''plums''
accompanied by the color designation ''yellow'' or ''golden'' or ''red''
or ''purple'', as appropriate, or the specific name of the variety or
''Greengage plums'', ''Damson plums'', ''Cherry plums'', ''Mirabelle
plums''. The name of the food shall also include a declaration of any
flavoring that characterizes the product as specified in 101.22 of this
chapter and a declaration of any spice or seasoning that characterizes
the product; for example, ''Spice added'', or in lieu of the word
''Spice'', the common name of the spice; ''Seasoned with vinegar''.
When two or more of the optional ingredients specified in paragraphs
(a)(1) (ii) and (iii) of this section are used, such words may be
combined as for example, ''Seasoned with cider vinegar, cloves, and
cinnamon oil''.
(ii) The style of the plum ingredient as provided in paragraph (a)(2)
of this section and the name of the packing medium specified in
paragraphs (a)(3) (i) and (ii) of this section, preceded by ''In'' or
''Packed in'' shall be included as part of the name or in close
proximity to the name of the food. The style of the plum ingredient
shall be preceded or followed by ''Peeled'' when the plums are peeled
and by ''Pitted'' in the case of whole pitted plums. ''Halves'' may be
alternatively designated ''Halved''. When the packing medium is
prepared with a sweetener(s) which imparts a taste, flavor or other
characteristics to the finished food in addition to sweetness, the name
of the packing medium shall be accompanied by the name of such
sweetener(s), as for example, in the case of a mixture of brown sugar
and honey, an appropriate statement would be '' -------- sirup of brown
sugar and honey'', the blank to be filled in with the word ''light'',
''heavy'', or ''extra heavy'', as the case may be. When the liquid
portion of the packing media provided for in paragraphs (a)(3) (i) and
(ii) of this section consists of fruit juice(s), such juice(s) shall be
designated in the name of the packing medium as:
(a) In the case of a single fruit juice, the name of the juice shall
be used in lieu of the word ''fruit'',
(b) In the case of a combination of two or more fruit juices, the
names of the juices in the order of predominance by weight shall either
be used in lieu of the word ''fruit'' in the name of the packing medium,
or be declared on the label as specified in paragraph (a)(4)(iii) of
this section, and
(c) In the case of a single fruit juice or a combination of two or
more fruit juices any of which are made from concentrate(s), the words
''from concentrate(s)'' shall follow the word ''juice(s)'' in the name
of the packing medium and in the name(s) of such juice(s) when declared
as specified in paragraph (a)(4)(iii) of this section.
(iii) Whenever the names of the fruit juices used do not appear in
the name of the packing medium as provided in paragraph (a)(4)(ii)(b) of
this section, such names and the words ''from concentrate'', as
specified in paragraph (a)(4)(ii)(c) of this section, shall appear in an
ingredient statement pursuant to the requirements of 101.3(d) of this
chapter.
(iv) Each of the optional ingredients used shall be declared on the
label as required by the applicable sections of Part 101 of this
chapter.
(b) Quality. (1) The standard of quality for canned plums is as
follows:
(i) Blemishes (damaged). After draining in accordance with the
procedure set out in 145.3(n) not more than 30 percent by weight of the
drained plums consists of plums which have been blemished or damaged by
any of the following factors either singly or in combination: Damaged
by insects; appearance or eating quality materially affected by
friction, disease, external stone gum or discoloration.
(ii) Crushed or broken units in whole and halves styles. In the case
of the whole styles, not more than 25 percent by weight of the drained
plums are deformed or broken to an extent that the normal shape of the
fruit is seriously affected. In the case of the halves style, not more
than 25 percent by weight of the drained plums are damaged or torn to
such an extent that they are smaller than 50 percent of a plum half.
(iii) Blemishes and crushed or broken units. Not more than 35
percent by weight of the drained plums consist of both blemishes as
specified in paragraph (b)(1)(i) of this section and crushed or broken
units in the case of the whole and halves styles as specified in
paragraph (b)(2)(ii) of this section.
(iv) Extraneous plant material. Not more than one piece of stalk or
stem from the plum tree or other harmless extraneous plant material per
200 grams (7 ounces) of drained plums.
(v) Loose pits in whole style. Not more than three loose pits per
500 grams (17.6 ounces) of drained plums.
(vi) Pits or pieces of pits in whole pitted and halves styles. Not
more than two pits or pieces of pits per 500 grams (17.8 ounces) of
drained plums.
(2) Determine compliance as specified in 145.3(o) except that a lot
shall be deemed to be in compliance for extraneous plant material, loose
pits in whole style, and pits or pieces of pits in whole pitted and
halves styles based on the average of all samples analyzed according to
the sampling plans set out in 145.3(p).
(3) If the quality of canned plums falls below the standard
prescribed in paragraph (b)(1) of this section, the label shall bear the
general statement of substandard quality specified in 130.14(a) of this
chapter, in the manner and form therein specified; however, if the
quality of the canned plums falls below standard with respect to only
one of the factors of quality specified in paragraphs (b)(1) (i) through
(vi) of this section, there may be substituted for the second line of
such general statement of substandard quality (''Good Food -- Not High
Grade'') a new line, as specified after the corresponding designation of
paragraph (b)(1) of this section which the canned plums fail to meet, as
follows:
(i) ''Blemished'';
(ii) ''Partly crushed or broken'';
(iii) ''Blemished and partly crushed or broken'';
(iv) ''Contains extraneous plant material'';
(v) ''Contains loose pits''; or
(vi) ''Contains pits'' or ''Contains pieces of pits''.
(c) Fill of container. (1) The standard of fill of container for
canned plums is:
(i) The fill of the plums and packing medium, as determined by the
general method for fill of container prescribed in 130.12(b) of this
chapter, is not less than 90 percent of the total capacity of the
container.
(ii) The drained weight of the plum ingredient as determined by the
method prescribed in 145.3(n) is not less than 50 percent for whole
styles and 55 percent for halves styles based on the water capacity of
containers as determined in 130.12(a) of this chapter.
(2) Determine compliance for fill of container as specified in
145.3(o).
(3) If canned plums fall below the standard of fill of container
prescribed in paragraph (c)(1) of this section, the label shall bear the
statement of substandard fill specified in 130.14(b) of this chapter,
in the manner and form therein specified. If canned plums fall below
the standard of fill of container in respect to drained weight, the
words ''Low drained weight'' shall follow the general statement of
substandard fill on the label.
21 CFR 145.190 Canned prunes.
(a) Ingredients. Canned prunes is the food prepared from dried
prunes, which may be packed as a solid pack or in one of the optional
packing media specified in paragraph (b) of this section. Such food may
also contain one, or any combination of two or more, of the following
safe and suitable optional ingredients:
(1) Natural and artificial flavors.
(2) Spice.
(3) Vinegar, lemon juice, or organic acids.
(4) Unpeeled pieces of citrus fruits.
Such food is sealed in a container and before or after sealing is so
processed by heat as to prevent spoilage.
(b) Packing media. (1) The optional packing media referred to in
paragraph (a) of this section, as defined in 145.3 are:
(i) Water.
(ii) Fruit juice(s) and water.
(iii) Fruit juice(s).
Such packing media may be used as such or any one or any combination
of two or more safe and suitable nutritive carbohydrate sweetener(s) may
be added. Sweeteners defined in 145.3 shall be as defined therein,
except that a nutritive carbohydrate sweetener for which a standard of
identity has been established in Part 168 of this chapter shall comply
with such standard in lieu of any definition that may appear in 145.3.
(2) When a sweetener is added as a part of any such liquid packing
medium, the density range of the resulting packing medium expressed as
percent by weight of sucrose (degrees Brix) as determined by the
procedure prescribed in 145.3(m) shall be designated by the appropriate
name for the respective density ranges, namely:
(i) When the density of the solution is less than 20 percent, the
medium shall be designated as ''slightly sweetened water''; or ''extra
light sirup''; ''slightly sweetened fruit juice(s) and water''; or
''slightly sweetened fruit juice(s)'', as the case may be.
(ii) When the density of the solution is 20 percent or more but less
than 24 percent, the medium shall be designated as ''light sirup'';
''lightly sweetened fruit juice(s) and water''; or ''lightly sweetened
fruit juice(s)'', as the case may be.
(iii) When the density of the solution is 24 percent or more but less
than 30 percent, the medium shall be designated as ''heavy sirup'';
''heavily sweetened fruit juice(s) and water''; or ''heavily sweetened
fruit juice(s)'', as the case may be.
(iv) When the density of the solution is 30 percent or more but not
more than 45 percent, the medium shall be designated as ''extra heavy
sirup''; ''extra heavily sweetened fruit juice(s) and water''; or
''extra heavily sweetened fruit juice(s)'', as the case may be.
(c) Labeling requirements. (1) The name of the food is ''prunes --
prepared from dried prunes''. The words ''prepared from dried prunes''
shall be in close proximity to the word ''prunes'' and shall be of the
same style and not less than 1/2 of the point size of the type used for
the word ''prunes''. The name of the food shall also include a
declaration of any flavoring that characterizes the product as specified
in 101.22 of this chapter and a declaration of any spice or seasoning
that characterizes the product; for example, ''Spice added'', or in
lieu of the word ''Spice'', the common name of the spice, ''Seasoned
with vinegar'' or ''Seasoned with unpeeled pieces of citrus fruit''.
When two or more of the optional ingredients specified in paragraphs (a)
(2) through (4) of this section are used, such words may be combined as
for example, ''Seasoned with cider vinegar, cloves, cinnamon oil and
unpeeled pieces of citrus fruit.''
(2) When the food is prepared with a packing medium, the name of the
packing medium specified in paragraphs (b) (1) and (2) of this section,
preceded by ''In'' or ''Packed in'' and the words ''cooked'',
''stewed'', or ''prepared'', shall be included as part of the name or in
close proximity to the name of the food. When no packing medium is
used, the words ''solid pack'' or ''moist pack'' or the word
''moistened'' followed by the words ''without sirup'' shall be included
as part of the name or in close proximity to the name of the food. When
the packing medium is prepared with a sweetener(s) which imparts a
taste, flavor or other characteristic to the finished food in addition
to sweetness, the name of the packing medium shall be accompanied by the
name of such sweetener(s), as for example in the case of a mixture of
brown sugar and honey, an appropriate statement would be '' --------
sirup of brown sugar and honey'', the blank to be filled in with the
word ''light'', ''heavy'', or ''extra heavy'' as the case may be. When
the liquid portion of the packing media provided for in paragraphs (b)
(1) and (2) of this section consists of fruit juice(s), such juice(s)
shall be designated in the name of the packing medium as:
(i) In the case of a single fruit juice, the name of the juice shall
be used in lieu of the word ''fruit'',
(ii) In the case of a combination of two or more fruit juices, the
names of the juices in the order of predominance by weight shall either
be used in lieu of the word ''fruit'' in the name of the packing medium,
or be declared on the label as specified in paragraph (c)(3) of this
section, and
(iii) In the case of the single fruit juice or a combination of two
or more fruit juices any of which are made from concentrate(s), the
words ''from concentrate(s)'' shall follow the word ''juice(s)'' in the
name of the packing medium and in the name(s) of such juice(s) when
declared as specified in paragraph (c)(3) of this section.
(3) Whenever the names of the fruit juices used do not appear in the
name of the packing medium as provided in paragraph (c)(2)(ii) of this
section, such names and the words ''from concentrate'', as specified in
paragraph (c)(2)(iii) of this section, shall appear in an ingredient
statement pursuant to the requirements of 101.3(d) of this chapter.
(4) Each of the optional ingredients used shall be declared on the
label as required by the applicable sections of Part 101 of this
chapter.
21 CFR 145.190 Pt. 146
21 CFR 145.190 PART 146 -- CANNED FRUIT JUICES
21 CFR 145.190 Subpart A -- General Provisions
Sec.
146.3 Definitions.
21 CFR 145.190 Subpart B -- Requirements for Specific Standardized
Canned Fruit Juices and Beverages
146.113 Canned fruit nectars.
146.114 Lemon juice.
146.120 Frozen concentrate for lemonade.
146.121 Frozen concentrate for artificially sweetened lemonade.
146.126 Frozen concentrate for colored lemonade.
146.132 Grapefruit juice.
146.135 Orange juice.
146.137 Frozen orange juice.
146.140 Pasteurized orange juice.
146.141 Canned orange juice.
146.145 Orange juice from concentrate.
146.146 Frozen concentrated orange juice.
146.148 Reduced acid frozen concentrated orange juice.
146.150 Canned concentrated orange juice.
146.151 Orange juice for manufacturing.
146.152 Orange juice with preservative.
146.153 Concentrated orange juice for manufacturing.
146.154 Concentrated orange juice with preservative.
146.185 Pineapple juice.
146.187 Canned prune juice.
Authority: Secs. 201, 401, 403, 409, 701, 706 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321, 341, 343, 348, 371, 376).
Source: 42 FR 14433, Mar. 15, 1977, unless otherwise noted.
21 CFR 145.190 Subpart A -- General Provisions
21 CFR 146.3 Definitions.
For the purposes of this part:
(a) The term ''corn sirup'' means a clarified, concentrated, aqueous
solution of the products obtained by the incomplete hydrolysis of
cornstarch, and includes dried corn sirup. The solids of corn sirup and
of dried corn sirup contain not less than 40 percent by weight of
reducing sugars calculated as anhydrous dextrose.
(b) The term ''dextrose'' means the hydrated or anhydrous, refined
monosaccharide obtained from hydrolyzed starch.
(c) The term ''dried glucose sirup'' means the product obtained by
drying glucose sirup.
(d) The term ''glucose sirup'' means a clarified, concentrated,
aqueous solution of the products obtained by the incomplete hydrolysis
of any edible starch. The solids of glucose sirup contain not less than
40 percent by weight of reducing sugars calculated as anhydrous
dextrose.
(e) The term ''invert sugar sirup'' means an aqueous solution of
inverted or partly inverted, refined or partly refined sucrose, the
solids of which contain not more than 0.3 percent by weight of ash, and
which is colorless, odorless, and flavorless, except for sweetness.
(f) The term ''sugar'' means refined sucrose.
(g) Compliance means the following: Unless otherwise provided in a
standard, a lot of canned fruits shall be deemed in compliance for the
following factors, to be determined by the sampling and acceptance
procedure as provided in paragraph (h) of this section, namely:
(1) Quality. The quality of a lot shall be considered acceptable
when the number of defectives does not exceed the acceptance number in
the sampling plans.
(2) Fill of container. A lot shall be deemed to be in compliance for
fill of container when the number of defectives does not exceed the
acceptance number (c) in the sampling plans.
(h) The sampling and acceptance procedure means the following:
(1) Definitions -- (i) Lot. A collection of primary containers or
units of the same size, type, and style manufactured or packed under
similar conditions and handled as a single unit of trade.
(ii) Lot size. The number of primary containers or units in the lot.
(iii) Sample size. The total number of sample units drawn for
examination from a lot.
(iv) Sample unit. A container, a portion of the contents of a
container, or a composite mixture of product from small containers that
is sufficient for the examination or testing as a single unit.
(v) Defective. Any sample unit shall be regarded as defective when
the sample unit does not meet the criteria set forth in the standards.
(vi) Acceptance number (c). The maximum number of defective sample
units permitted in the sample in order to consider the lot as meeting
the specified requirements.
(vii) Acceptable quality level (AQL). The maximum percent of
defective sample units permitted in a lot that will be accepted
approximately 95 percent of the time.
(2) Sampling plans:
21 CFR 146.3 Subpart B -- Requirements for Specific Standardized Canned Fruit Juices and Beverages
21 CFR 146.113 Canned fruit nectars.
(a) Canned fruit nectars are the pulpy, liquid foods prepared from
one or more of the optional fruit ingredients specified in paragraph (b)
of this section in an amount not less than the percentage specified in
that paragraph, water, and one or more of the optional sweetening
ingredients as provided for in paragraph (d) of this section. They may
contain one or more of the optional ingredients as provided for in
paragraph (e) of this section. The consistency of the finished product
is such that the time of flow is not less than 30 seconds when tested by
the method set forth in ''Official Methods of Analysis of the
Association of Official Analytical Chemists'' (AOAC), 13th Ed. (1980),
sections 22.009-22.011, under ''Apparent Viscosity (Consistency),
Official Final Action,'' which is incorporated by reference. Copies may
be obtained from the Association of Official Analytical Chemists, 2200
Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may be examined at
the Office of the Federal Register, 1100 L St. NW., Washington, DC
20408. Such food is sealed in a container and so processed by heat,
either before or after sealing, as to prevent spoilage.
(b)(1) The optional fruit ingredients referred to in paragraph (a) of
this section are fruit puree, pulp, juice, or concentrates thereof, as
prepared from whole, mature fruits of the following varieties: Apple,
apricot, blackberry, boysenberry, cherry guava, loganberry, mango,
nectarine, papaya, passion fruit, peach, pear, pineapple, and plum.
Apples, cherries, passion fruit, and pineapples are used only in
combination with one or more of the other fruits listed.
(2) The fruit ingredients contain finely divided insoluble fruit
solids but do not contain seeds, pits, or other coarse or hard
substances capable of being avoided by good canning practices.
(3) Single-fruit nectars are made from fruits of a single variety.
The proportion of fruit ingredient used on an equivalent single strength
basis is not less than 40 percent by weight of the finished food;
except that for apricot nectar it is not less than 35 percent, for
papaya nectar it is not less than 33 1/3 percent, and for guava nectar
it is not less than 25 percent. Multiple-fruit nectars are made from
two or more varieties of fruit, and they may be made by blending
single-fruit nectars provided that each single-fruit nectar used meets
its fruit ingredient requirement. The fruit ingredient requirements for
those fruits that by paragraph (b)(1) of this section are restricted for
use in combination with other fruits are: Apples -- not less than 40
percent, cherries -- not less than 40 percent, passion fruit -- not less
than 15 percent, and pineapples -- not less than 40 percent. Each
multiple-fruit nectar made by any procedure other than by the method of
blending single-fruit nectars shall contain no less of each fruit
ingredient than it would be required to have if made by the blending
method. In no case shall the quantity of a fruit ingredient be less
than that required to impart a definite flavor or other definite
characteristic to the nectar. The weight of any fruit ingredient shall
be determined as follows: Determine the percent of soluble solids in
such fruit ingredient by the method prescribed in the AOAC, 13th Ed.
(1980), section 31.011, under ''Solids,'' which is incorporated by
reference. The availability of this incorporation by reference is given
in paragraph (a) of this section. Use this method notwithstanding the
presence of insoluble solids. Multiply the result so found by the
weight of each fruit ingredient used and divide the product by the Brix
value for each such fruit ingredient set forth in paragraph (c)(3) of
this section. The result is the equivalent weight of the individual
single strength fruit ingredients. For example, 1,180 pounds of
concentrated peach ingredient having 30 percent soluble solids is used.
The equivalent weight of single strength peach ingredient would be:
(c) Any requirement of this section with respect to the weight of any
fruit means:
(1) In the case of fruit the proper preparation of which involves the
removal of pits, seeds, skins, cores, or other parts, the weight of such
fruit exclusive of all such substances removed therefrom; and
(2) The weight of the fruit exclusive of the weight of water or any
other substance added for any processing, packing, or canning of such
fruit, or otherwise added to such fruit.
(3) For the purposes of this section the weight of any fruit
ingredient shall be converted to the equivalent weight of single
strength fruit ingredient having a Brix value as follows:
(d) The optional sweetening ingredients referred to in paragraph (a)
of this section are: Sugar, invert sugar sirup, dextrose, corn sirup,
dried corn sirup, glucose sirup, and dried glucose sirup.
(e) Optional ingredients that may be added in making fruit nectars
are one or more of the following:
(1) Acidifiers: Lemon juice, concentrated lemon juice, citric acid,
malic acid, and fumaric acid.
(2) Ascorbic acid as an antioxidant preservative in a quantity not to
exceed 150 parts per million.
(3) Ascorbic acid (vitamin C) added in such quantity that the total
ascorbic acid in each 4 fluid ounces of the finished fruit nectar
amounts to not less than 30 milligrams and not more than 60 milligrams.
(f) The names of the fruit nectars for which standards of identity
are prescribed by this section are:
(1) If the fruit ingredient is prepared from a single variety of
fruit the name is ''nectar'' preceded by the name of the fruit; for
example, ''Apricot nectar''.
(2) If the fruit ingredient is a combination of two or more fruits
and the weight of each is not less than one-tenth of the weight of the
combination, the name is ''nectar'' preceded by the names of the fruits
arranged in descending order of predominance; for example, ''Apricot
and papaya nectar''.
(3) If the fruit ingredient is a combination, the nectar shall be so
named as to differentiate those fruits furnishing one-tenth or more to
the weight of the combination from those fruits furnishing less than
one-tenth to such weight. The names of those fruits furnishing
one-tenth or more to the combination shall be shown as prescribed in
paragraph (f)(2) of this section; or, alternatively, in the case of
combinations wherein each of four or more fruits furnishes one-tenth or
more to the weight of the combination, their names may be listed in
descending order of predominance immediately following the words
''Blended fruit nectar''. The names of any fruits furnishing less than
one-tenth of the weight of the combination shall be shown immediately
following the rest of the name of the nectar by listing them in the
blank of the statement ''with added ------------ '' or '' ------------
added''. For example, nectar made with a combination containing: 35
percent pear, 25 percent peach, 20 percent plum, 15 percent apricot, and
5 percent passion fruit may be named ''Pear, peach, plum, apricot
nectar, passion fruit added'', or alternatively, it may be named
''Blended fruit nectar -- pear, peach, plum, apricot, with added passion
fruit''.
(g) The common names of optional ingredients used shall be shown on
the principal display panel or panels of the label with such prominence
and conspicuousness that they are likely to be read and understood by
ordinary individuals under customary conditions of purchase. The term
''sweetener added'' may be used in lieu of the name or names of the
sweetening ingredient. When ascorbic acid is added as provided for in
paragraph (e)(2) of this section, it shall be declared on the label by
the statement ''ascorbic acid added ------------ '', the blank being
filled in with ''to preserve color and flavor'' or ''as a
preservative''. A fruit nectar containing ascorbic acid (vitamin C) as
provided for in paragraph (e)(3) of this section shall bear on the
label, in addition to the preservative declaration required by this
paragraph, the statement ''vitamin C added'' or ''with added vitamin C''
and such statement shall be accompanied by labeling conforming to the
requirements prescribed in the regulations established pursuant to
section 403(j) of the Federal Food, Drug, and Cosmetic Act.
(42 FR 14433, Mar. 15, 1977, as amended at 47 FR 11830, Mar. 19,
1982; 49 FR 10100, Mar. 19, 1984; 54 FR 24895, June 12, 1989)
Effective Date Note: Section 146.113 (formerly 27.126) was stayed
in its entirety at 33 FR 10713, July 27, 1968.
21 CFR 146.114 Lemon juice.
(a) Identity -- (1) Description. Lemon juice is the unfermented
juice, obtained by mechanical process, from sound, mature lemons (Citrus
limon (L.) Burm. f.), from which seeds (except embryonic seeds and small
fragments of seed which cannot be separated by good manufacturing
practice) and excess pulp are removed. The juice may be adjusted by the
addition of the optional concentrated lemon juice ingredient specified
in paragraph (a)(2) of this section in such quantity so that the
increase in acidity, calculated as anhydrous citric acid, does not
exceed 15 percent of the acidity of the finished food. The lemon oil
and lemon essence (derived from lemons) content may be adjusted in
accordance with good manufacturing practice. The juice may have been
concentrated and later reconstituted. When prepared from concentrated
lemon juice, the finished food contains not less than 6 percent, by
weight, of soluble solids taken as the refractometric sucrose value (of
the filtrate), corrected to 20 C, but uncorrected for acidity, in
accordance with the ''International Scale of Refractive Indices of
Sucrose Solutions'' in section 52.012 of ''Official Methods of Analysis
of the Association of Official Analytical Chemists,'' 13th Ed. (1980),
which is incorporated by reference, and has a titratable acidity content
of not less than 4.5 percent, by weight, calculated as anhydrous citrus
acid. Copies of the incorporation by reference may be obtained from the
Association of Official Analytical Chemists, 2200 Wilson Blvd., Suite
400, Arlington, VA 22201-3301, or may be examined at the Office of the
Federal Register, 1100 L St. NW., Washington, DC 20408. The food may
contain one or any combination of the safe and suitable optional
ingredients specified in paragraph (a)(2) of this section. Lemon juice,
as defined in this paragraph, may be preserved by heat sterilization
(canning), refrigeration, freezing, or by the addition of safe and
suitable preservatives. When sealed in a container to be held at
ambient temperatures, it is preserved by the addition of safe and
suitable preservatives or so processed by heat, before or after sealing,
as to prevent spoilage.
(2) Optional ingredients. The optional safe and suitable ingredients
referred to in paragraph (a)(1) of this section are:
(i) Concentrated lemon juice (lemon juice from which part of the
water has been removed).
(ii) Water and/or lemon juice to reconstitute concentrated lemon
juice in the manufacture of lemon juice from concentrate.
(iii) Preservatives.
(3) Labeling. (i) The name of the food is:
(a) ''Lemon juice'' (1) if the food is prepared from unconcentrated,
undiluted liquid extracted from mature lemons; or (2) if the food is
prepared from unconcentrated, undiluted liquid extracted from mature
lemons to which concentrated lemon juice is added to adjust acidity as
provided for in paragraph (a)(1) of this section.
(b) ''Lemon juice from concentrate'' or ''reconstituted lemon juice''
(1) if the food is prepared from concentrated lemon juice and water
and/or lemon juice; or (2) if the food is prepared from lemon juice
from concentrate and lemon juice. The words ''from concentrate'' or
''reconstituted'' shall be shown in letters not less than one-half the
height of the letters in the word ''lemon juice.''
(ii) Each of the optional ingredients used shall be declared on the
label as required by the applicable sections of Part 101 of this
chapter.
(b) (Reserved)
(c) Fill of container. (1) The standard of fill of container for
lemon juice, except when the food is frozen, is not less than 90 percent
of the total capacity of the container as determined by the general
method for fill of container prescribed in 130.12(b) of this chapter,
except (i) when the food is frozen or (ii) when the food is packaged in
individual serving-size packages, containing 1/2 fluid ounce or less,
for use as described in 1.24(a)(3) of this chapter.
(2) Compliance is determined as specified in 146.3(g)(2).
(3) If the lemon juice fails to meet the standard of fill as
prescribed in paragraph (c)(1) and (2) of this section, the label shall
bear the general statement of substandard fill specified in 130.14(b)
of this chapter, in the manner and form therein prescribed.
(45 FR 7786, Feb. 5, 1980, as amended at 47 FR 11830, Mar. 19, 1982;
49 FR 10100, Mar. 19, 1984; 54 FR 24895, June 12, 1989)
21 CFR 146.120 Frozen concentrate for lemonade.
(a) Frozen concentrate for lemonade is the frozen food prepared from
one or both of the lemon juice ingredients specified in paragraph (b) of
this section together with one or any mixture of safe and suitable
nutritive carbohydrate sweeteners. The product contains not less than
48.0 percent by weight of soluble solids taken as the sucrose value
determined by refractometer and corrected for acidity prescribed in
''Official Methods of Analysis of the Association of Official Analytical
Chemists,'' 13th Ed. (1980), section 22.025, ''Frozen Concentrate for
Lemonade (12),'' under the heading ''Soluble Solids by Refractometer --
Official First Action,'' which is incorporated by reference. Copies may
be obtained from the Association of Official Analytical Chemists, 2200
Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may be examined at
the Office of the Federal Register, 1100 L St. NW., Washington, DC
20408. When the product is diluted according to directions for making
lemonade which shall appear on the label, the acidity of the lemonade,
calculated as anhydrous citric acid, shall be not less than 0.70 gram
per 100 milliliters, and the soluble solids, measured as described for
the concentrate, shall be not less than 10.5 percent by weight.
(b) The lemon juice ingredients referred to in paragraph (a) of this
section are:
(1) Lemon juice or frozen lemon juice or a mixture of these.
(2) Concentrated lemon juice or frozen concentrated lemon juice or a
mixture of these.
For the purposes of this section, lemon juice is the undiluted juice
expressed from mature lemons of an acid variety; and concentrated lemon
juice is lemon juice from which part of the water has been removed. In
the preparation of the lemon juice ingredients, the lemon oil content
may be adjusted by the addition of lemon oil or concentrated lemon oil
in accordance with good manufacturing practice, and the lemon pulp in
the juice as expressed may be left in the juice or may be separated.
Lemon pulp that has been separated, which may have been preserved by
freezing, may be added in preparing frozen concentrate for lemonade,
provided that the amount of pulp added does not raise the proportion of
pulp in the finished food to a level in excess of that which would be
present by using lemon juice ingredients from which pulp has not been
separated. The lemon juice ingredients may be treated by heat, either
before or after the other ingredients are added, to reduce the enzymatic
activity and the number of viable microorganisms.
(c) Each of the ingredients used shall be declared on the label as
required by the applicable sections of Part 101 of this chapter.
(42 FR 14433, Mar. 15, 1977, as amended at 47 FR 11830, Mar. 19,
1982; 49 FR 10100, Mar. 19, 1984; 54 FR 24895, June 12, 1989)
21 CFR 146.121 Frozen concentrate for artificially sweetened lemonade.
(a) Frozen concentrate for artificially sweetened lemonade conforms
to the definition and standard of identity prescribed for frozen
concentrate for lemonade by 146.120, except that in lieu of nutritive
sweeteners it is sweetened with one or more of the artificial sweetening
ingredients listed in and complying with the requirements of Parts 172,
180 or 184 of this chapter, and the soluble solids specifications
prescribed in 146.120(a) do not apply. When the product is diluted
according to directions which shall appear on the label, the acidity of
the artificially sweetened lemonade, calculated as anhydrous citric
acid, shall be not less than 0.70 gram per 100 milliliters. It may
contain one or more safe and suitable dispersing ingredients serving the
function of distributing the lemon oil throughout the food. It may also
contain one or more safe and suitable thickening ingredients. Such
dispersing and thickening ingredients are not food additives as defined
in section 201(s) of the Federal Food, Drug, and Cosmetic Act; or if
they are food additives as so defined, they are used in conformity with
regulations established pursuant to section 409 of the act.
(b) (Reserved)
(c) The name of the food is ''Frozen concentrate for artificially
sweetened lemonade''. The words ''artificially sweetened'' shall be of
the same size and style of type as the word ''lemonade''.
(d) If an optional thickening or dispersing ingredient referred to in
paragraph (a) of this section is used, the label shall bear the
statement '' -------- added'' or ''with added -------- '', the blank
being filled in with the common name of the thickening or dispersing
agent used. Such statement shall be set forth on the label with such
prominence and conspicuousness as to render it likely to be read and
understood by the ordinary individual under customary conditions of
purchase.
(e) Frozen concentrate for artificially sweetened lemonade is labeled
to conform to the labeling requirements prescribed for foods which
purport to be or are represented for special dietary use by regulations
promulgated pursuant to section 403(j) of the act.
21 CFR 146.126 Frozen concentrate for colored lemonade.
(a) Frozen concentrate for colored lemonade conforms to the
definition and standard of identity prescribed for frozen concentrate
for lemonade by 146.120, except that it is colored with a safe and
suitable fruit juice, vegetable juice, or any such juice in concentrated
form, or with any other color additive ingredient suitable for use in
food, including artificial coloring, used in conformity with regulations
established pursuant to section 706 of the Federal Food, Drug, and
Cosmetic Act.
(b) The name of the food is ''Frozen concentrate for ------------
lemonade'', the blank being filled in with the word describing the
color: for example, ''Frozen concentrate for pink lemonade''.
(c) Each of the ingredients specified in paragraph (a) of this
section shall be declared on the label as required by the applicable
sections of Part 101 of this chapter.
21 CFR 146.132 Grapefruit juice.
(a) Identity -- (1) Description. Grapefruit juice is the unfermented
juice, intended for direct consumption, obtained by mechanical process
from sound, mature grapefruit (Citrus paradisi Macfadyen) from which
seeds and peel (except embryonic seeds and small fragments of seeds and
peel which cannot be separated by good manufacturing practice) and
excess pulp are removed and to which may be added not more than 10
percent by volume of the unfermented juice obtained from mature hybrids
of grapefruit. The juice may be adjusted by the addition of the
optional concentrated grapefruit juice ingredients specified in
paragraph (a)(2) of this section, but the quantity of such concentrated
grapefruit juice ingredient added shall not contribute more than 15
percent of the grapefruit juice soluble solids in the finished food.
The grapefruit pulp, grapefruit oil, and grapefuit essence (components
derived from grapefruit) content may be adjusted in accordance with good
manufacturing practice. The juice may have been concentrated and later
reconstituted with water suitable for the purpose of maintaining
essential composition and quality factors of the juice. It may be
sweetened with the dry nutritive sweeteners referred to in paragraph
(a)(2)(iii) of this section. If the grapefruit juice is prepared from
concentrate, such sweeteners, in liquid form, referred to in paragraph
(a)(2)(iii) of this section, also may be used. When prepared from
concentrated grapefruit juice, exclusive of added sweeteners, the
finished food contains not less than 10 percent, by weight, of soluble
solids taken as the refractometric sucrose value (of the filtrate),
corrected to 20 C, and corrected for acidity by adding
(0.012+0.193x-0.0004x /2/ ), where x equals the percent anhydrous citric
acid in the sample, to the refractometrically obtained sucrose value by
the first method prescribed in ''Correction of Refractometer Sucrose
Readings for Citric Acid Content for Lemonade,'' by Yeatman, Senzel, and
Springer,'' Journal of the Association of Official Analytical
Chemists,'' vol. 59 p. 368 (1976). Copies are available from the
Association of Official Analytical Chemists, 1111 N. 19th St., Suite
210, Arlington, VA 22209, or available for inspection at the Office of
the Federal Register, 1100 L St. NW., Washington, DC 20408. The food
may contain one or any combination of the optional ingredients specified
in paragraph (a)(2) of this section. Grapefruit juice, as defined in
this paragraph, may be preserved by heat sterlization (canning),
refrigeration, or freezing. When sealed in a container to be held at
ambient temperatures, it is so processed by heat, before or after
sealing, as to prevent spoilage.
(2) Optional ingredients. The optional ingredients referred to in
paragraph (a)(1) of this section are:
(i) Concentrated grapefruit juice (grapefruit juice from which part
of the water has been removed).
(ii) Water and/or grapefruit juice to reconstitute concentrated
grapefruit juice in the manufacture of grapefruit juice from
concentrate.
(iii) One or any combination of two or more of the dry or liquid
forms of sugar, invert sugar sirup, dextrose, glucose sirup, and
fructose. Sweeteners defined in Part 168 of this chapter shall be as
defined therein.
(3) Labeling. (i) The name of the food is:
(a) ''Grapefruit juice'' (1) if the food is prepared from
unconcentrated, undiluted liquid extracted from mature grapefruit; or
(2) if the food is prepared from unconcentrated, undiluted liquid
extracted from mature grapefruit to which concentrated grapefruit juice
is added to adjust soluble solids as provided for in paragraph (a)(1) of
this section.
(b) ''Grapefruit juice from concentrate'' (1) if the food is prepared
from concentrated grapefruit juice and water and/or grapefruit juice;
or (2) if the food is prepared from grapefuit juice from concentrate and
grapefruit juice. The words ''from concentrate'' shall be shown in
letters not less than one-half the height of the letters in the words
''grapefruit juice.''
(ii) If any nutritive sweetener is added, the principal display panel
of the label shall bear the statement ''Sweetener added.'' If no
sweetener is added, the word ''unsweetened'' may immediately precede or
follow the words ''Grapefruit Juice'' or ''Grapefruit Juice from
Concentrate.''
(iii) Each of the optional ingredients used shall be declared on the
label as required by the applicable sections of Part 101 of this
chapter.
(b) (Reserved)
(c) Fill of container. (1) The standard of fill of container for
grapefruit juice, except when the food is frozen, is not less than 90
percent of the total capacity of the container as determined by the
general method for fill of container prescribed in 130.12(b) of this
chapter.
(2) Compliance is determined as specified in 146.3(g)(2).
(3) If the grapefruit juice fails to meet the standard of fill as
prescribed in paragraphs (c) (1) and (2) of this section, the label
shall bear the general statement of substandard fill specified in
130.14(b) of this chapter, in the manner and form therein prescribed.
(46 FR 8464, Jan. 27, 1981; 46 FR 21359, Apr. 10, 1981; 46 FR
26300, May 12, 1981, as amended at 47 FR 11830, Mar. 19, 1982; 47 FR
24287, June 4, 1982; 47 FR 43364, Oct. 1, 1982)
21 CFR 146.135 Orange juice.
(a) Orange juice is the unfermented juice obtained from mature
oranges of the species Citrus sinensis. Seeds (except embryonic seeds
and small fragments of seeds that cannot be separated by good
manufacturing practice) and excess pulp are removed. The juice may be
chilled, but it is not frozen.
(b) The name of the food is ''orange juice''. The name ''orange
juice'' may be preceded on the label by the varietal name of the oranges
used, and if the oranges grew in a single State, the name of such State
may be included in the name, as for example, ''California Valencia
orange juice''.
21 CFR 146.137 Frozen orange juice.
(a) Frozen orange juice is orange juice as defined in 146.135,
except that it is frozen.
(b) The name of the food is ''Frozen orange juice''. Such name may
be preceded on the label by the varietal name of the oranges used, and
if the oranges grew in a single State, the name of such State may be
included in the name, as for example, ''California Valencia frozen
orange juice''.
21 CFR 146.140 Pasteurized orange juice.
(a) Pasteurized orange juice is the food prepared from unfermented
juice obtained from mature oranges as specified in 146.135, to which
may be added not more than 10 percent by volume of the unfermented juice
obtained from mature oranges of the species Citrus reticulata or hybrids
thereof. Seeds (except embryonic seeds and small fragments of seeds
that cannot be separated by good manufacturing practice) are removed,
and pulp and orange oil may be adjusted in accordance with good
manufacturing practice. If the adjustment involves the addition of
pulp, then such pulp shall not be of the washed or spent type. The
solids may be adjusted by the addition of one or more of the optional
concentrated orange juice ingredients specified in paragraph (b) of this
section. One or more of the optional sweetening ingredients listed in
paragraph (c) of this section may be added in a quantity reasonably
necessary to raise the Brix or the Brix-acid ratio to any point within
the normal range usually found in unfermented juice obtained from mature
oranges as specified in 146.135. The orange juice is so treated by heat
as to reduce substantially the enzymatic activity and the number of
viable microorganisms. Either before or after such heat treatment, all
or a part of the product may be frozen. The finished pasteurized orange
juice contains not less than 10.5 percent by weight of orange juice
soluble solids, exclusive of the solids of any added optional sweetening
ingredients, and the ratio of the Brix hydrometer reading to the grams
of anhydrous citric acid per 100 milliliters of juice is not less than
10 to 1.
(b) The optional concentrated orange juice ingredients referred to in
paragraph (a) of this section are frozen concentrated orange juice as
specified in 146.146 and concentrated orange juice for manufacturing as
specified in 146.153 when made from mature oranges; but the quantity
of such concentrated orange juice ingredients added shall not contribute
more than one-fourth of the total orange juice solids in the finished
pasteurized orange juice.
(c) The optional sweetening ingredients referred to in paragraph (a)
of this section are sugar, invert sugar, dextrose, dried corn sirup,
dried glucose sirup.
(d) (1) The name of the food is ''Pasteurized orange juice''. If the
food is filled into containers and preserved by freezing, the label
shall bear the name ''Frozen pasteurized orange juice''. The words
''pasteurized'' or ''frozen pasteurized'' shall be shown on labels in
letters not less than one-half the height of the letters in the words
''orange juice''.
(2) If the pasteurized orange juice is filled into containers and
refrigerated, the label shall bear the name of the food, ''chilled
pasteurized orange juice''. If it does not purport to be either canned
orange juice or frozen pasteurized orange juice, the word ''chilled''
may be omitted from the name. The words ''pasteurized'' or ''chilled
pasteurized'' shall be shown in letters not less than one-half the
height of the letters in the words ''orange juice''.
(e) (1) If a concentrated orange juice ingredient specified in
paragraph (b) of this section is used in adjusting the orange juice
solids of the pasteurized orange juice, the label shall bear the
statement ''prepared in part from concentrated orange juice'' or ''with
added concentrated orange juice'' or ''concentrated orange juice
added''.
(2) If one or more of the sweetening ingredients specified in
paragraph (c) of this section are added to the pasteurized orange juice,
the label shall bear the statement '' ---- added'', the blank being
filled in with the name or an appropriate combination of the names of
the sweetening ingredients used. However, for the purpose of this
section, the name ''sweetener'' may be used in lieu of the specific name
or names of the sweetening ingredients.
(f) Wherever the name of the food appears on the label so
conspicuously as to be easily seen under customary conditions of
purchase, the statements specified in this section for naming the
optional ingredients used shall immediately and conspicuously precede or
follow the name of the food, without intervening written, printed, or
graphic matter.
21 CFR 146.141 Canned orange juice.
(a) Canned orange juice is the food prepared from orange juice as
specified in 146.135 or frozen orange juice as specified in 146.137,
or a combination of both, to which may be added not more than 10 percent
by volume of the unfermented juice obtained from mature oranges of the
species Citrus reticulata or hybrids thereof. Seeds (except embryonic
seeds and small fragments of seeds that cannot be separated by good
manufacturing practice) are removed. Orange oil and pulp may be
adjusted in accordance with good manufacturing practice. The adjustment
of pulp referred to in this paragraph does not permit the addition of
washed or spent pulp. Liquid condensate recovered from the deoiling
operation may be added back. One or more of the optional sweetening
ingredients named in paragraph (b) of this section may be added, in a
quantity reasonably necessary to raise the Brix or the Brix-acid ratio
to any point within the normal range usually found in unfermented juice
obtained from mature oranges as specified in 146.135. The food is
sealed in containers and so processed by heat, either before or after
sealing, as to prevent spoilage. The finished canned orange juice tests
not less than 10 Brix, and the ratio of the Brix hydrometer reading to
the grams of anhydrous citric acid per 100 milliliters of juice is not
less than 9 to 1.
(b) The optional sweetening ingredients referred to in paragraph (a)
of this section are sugar, invert sugar, dextrose, dried corn sirup,
dried glucose sirup.
(c) The name of the food is ''Canned orange juice''. All the words
in the name shall appear in the same size, color, and style of type and
on the same color-contrasting background. If the food is not sold under
refrigeration and if it does not purport to be chilled pasteurized
orange juice or frozen pasteurized orange juice, the word ''canned'' may
be omitted from the name.
(d) If one or more of the sweetening ingredients specified in
paragraph (b) of this section are added to the canned orange juice, the
label shall bear the statement '' -------- added'', the blank being
filled in with the name or an appropriate combination of the names of
the sweetening ingredients used. However, for the purpose of this
section, the name ''sweetener'' may be used in lieu of the specific name
or names of the sweetening ingredients.
(e) Wherever the name of the food appears on the label so
conspicuously as to be easily seen under customary conditions of
purchase, the statement specified in this section for naming the
optional ingredients used shall immediately and conspicuously precede or
follow the name of the food, without intervening written, printed, or
graphic matter.
21 CFR 146.145 Orange juice from concentrate.
(a) Orange juice from concentrate is the food prepared by mixing
water with frozen concentrated orange juice as defined in 146.146 or
with concentrated orange juice for manufacturing as defined in 146.153
(when made from mature oranges), or both. To such mixture may be added
orange juice as defined in 146.135, frozen orange juice as defined in
146.137, pasteurized orange juice as defined in 146.140, orange juice
for manufacturing as defined in 146.151 (when made from mature oranges
and preserved by chilling or freezing but not by canning), orange oil,
orange pulp, and one or more of the sweetening ingredients listed in
paragraph (b) of this section. The finished orange juice from
concentrate contains not less than 11.8 percent orange juice soluble
solids, exclusive of solids of any added optional sweetening
ingredients. It may be so treated by heat as to reduce substantially
the enzymatic activity and the number of viable microorganisms.
(b) The sweetening ingredients referred to in paragraph (a) of this
section are sugar, sugar sirup, invert sugar, invert sugar sirup,
dextrose, corn sirup, dried corn sirup, glucose sirup, dried glucose
sirup.
(c) The name of the food is ''Orange juice from concentrate''. The
words ''from concentrate'' shall be shown in letters not less than
one-half the height of the letters in the words ''orange juice''.
(d) When orange juice from concentrate contains any optional
sweetening ingredient as listed in paragraph (b) of this section,
whether added directly as such or indirectly as an added ingredient of
any orange juice product used, the label shall bear the statement ''
-------- added'', the blank being filled in with the name or an
appropriate combination of the names of the sweetening ingredients
added. However, for the purposes of this section the name ''sweetener''
may be used in lieu of the specific name or names of the sweetening
ingredients.
(e) Wherever the name of the food appears on the label so
conspicuously as to be easily seen under customary conditions of
purchase, the statements specified in this section for naming the
optional ingredients used shall immediately and conspicuously precede or
follow the name of the food, without intervening written, printed, or
graphic matter.
21 CFR 146.146 Frozen concentrated orange juice.
(a) Frozen concentrated orange juice is the food prepared by removing
water from the juice of mature oranges as provided in 146.135, to which
juice may be added unfermented juice obtained from mature oranges of the
species Citrus reticulata, or hybrids thereof, or of Citrus aurantium,
or both. However, in the unconcentrated blend the volume of juice from
Citrus reticulata shall not exceed 10 percent and from Citrus aurantium
shall not exceed 5 percent. The concentrate so obtained is frozen. In
its preparation, seeds (except embryonic seeds and small fragments of
seeds that cannot be separated by good manufacturing practice) and
excess pulp are removed, and a properly prepared water extract of the
excess pulp so removed may be added. Orange oil, orange pulp, orange
essence (obtained from orange juice), orange juice and other orange
juice concentrate as provided in this section or concentrated orange
juice for manufacturing provided in 146.153 (when made from mature
oranges), water, and one or more of the optional sweetening ingredients
specified in paragraph (b) of this section may be added to adjust the
final composition. The juice of Citrus reticulata and Citrus aurantium,
as permitted by this paragraph, may be added in single strength or
concentrated form prior to concentration of the Citrus sinensis juice,
or in concentrated form during adjustment of the composition of the
finished food. The addition of concentrated juice from Citrus
reticulata or Citrus aurantium, or both, shall not exceed, on a
single-strength basis, the 10 percent maximum for Citrus reticulata and
the 5 percent maximum for Citrus aurantium prescribed by this paragraph.
Any of the ingredients of the finished concentrate may have been so
treated by heat as to reduce substantially the enzymatic activity and
the number of viable microorganisms. The finished food is of such
concentration that when diluted according to label directions the
diluted article will contain not less than 11.8 percent by weight of
orange juice soluble solids, exclusive of the solids of any added
optional sweetening ingredients. The dilution ratio shall be not less
than 3 plus 1. For the purposes of this section and 146.150, the term
''dilution ratio'' means the whole number of volumes of water per volume
of frozen concentrate required to produce orange juice from concentrate
having orange juice soluble solids of not less than 11.8 percent by
weight exclusive of the solids of any added optional sweetening
ingredients.
(b) The optional sweetening ingredients referred to in paragraph (a)
of this section are sugar, sugar sirup, invert sugar, invert sugar
sirup, dextrose, corn sirup, dried corn sirup, glucose sirup, and dried
glucose sirup.
(c) If one or more of the sweetening ingredients specified in
paragraph (b) of this section are added to the frozen concentrated
orange juice, the label shall bear the statement '' -------- added'',
the blank being filled in with the name or an appropriate combination of
names of the sweetening ingredients used. However, for the purpose of
this section, the name ''sweetener'' may be used in lieu of the specific
name or names of the sweetening ingredients.
(d) The name of the food concentrated to a dilution ratio of 3 plus 1
is ''frozen concentrated orange juice'' or ''frozen orange juice
concentrate''. The name of the food concentrated to a dilution ratio
greater than 3 plus 1 is ''frozen concentrated orange juice, --------
plus 1'' or ''frozen orange juice concentrate, -------- plus 1'', the
blank being filled in with the whole number showing the dilution ratio;
for example, ''frozen orange juice concentrate, 4 plus 1''. However,
where the label bears directions for making 1 quart of orange juice from
concentrate (or multiples of a quart), the blank in the name may be
filled in with a mixed number; for example, ''frozen orange juice
concentrate, 4 1/3 plus 1''. For containers larger than 1 pint, the
dilution ratio in the name may be replaced by the concentration of
orange juice soluble solids in degrees Brix; for example, a 62 Brix
concentrate in 3 1/2-gallon cans may be named on the label ''frozen
concentrated orange juice, 62 Brix''.
(e) Wherever the name of the food appears on the label so
conspicuously as to be easily seen under customary conditions of
purchase, the statements specified in this section for naming the
optional ingredients used shall immediately and conspicuously precede or
follow the name of the food, without intervening written, printed, or
graphic matter.
(f) Nothing in this section is intended to interfere with the
adoption and enforcement by any State, in regulating the production of
frozen concentrated orange juice in such State, of State standards,
consistent with this section, but which impose higher or more
restrictive requirements than those set forth in this section.
21 CFR 146.148 Reduced acid frozen concentrated orange juice.
(a) Reduced acid frozen concentrated orange juice is the food that
complies with the requirements for composition and label declaration of
optional ingredients prescribed for frozen concentrated orange juice by
146.146, except that it may not contain any added sweetening ingredient.
A process involving the use of anionic ion-exchange resins permitted by
173.25 of this chapter is used to reduce the acidity of the food so
that the ratio of the Brix reading to the grams of acid, expressed as
anhydrous citric acid, per 100 grams of juice is not less than 21 to 1
or more than 26 to 1.
(b) The name of the food is ''Reduced acid frozen concentrated orange
juice''.
(45 FR 12414, Feb. 26, 1980)
21 CFR 146.150 Canned concentrated orange juice.
(a) Canned concentrated orange juice complies with the requirements
for composition, definition of dilution ratio, and labeling of optional
ingredients prescribed for frozen concentrated orange juice by 146.146,
except that it is not frozen and it is sealed in containers and so
processed by heat, either before or after sealing, as to prevent
spoilage.
(b) The name of the food when concentrated to a dilution ratio of 3
plus 1 is ''Canned concentrated orange juice'' or ''Canned orange juice
concentrate''. The name of the food when concentrated to a dilution
ratio greater than 3 plus 1 is ''Canned concentrated orange juice,
------------ plus 1'' or ''Canned orange juice concentrate, --------
plus 1'', the blank being filled in with the whole number showing the
dilution ratio; for example, ''Canned orange juice concentrate, 4 plus
1''. However, where the label bears directions for making 1 quart of
single-strength diluted product (or multiples of a quart) the blank in
the name may be filled in with a mixed number; for example, ''Canned
orange juice concentrate, 4 1/3 plus 1''. For containers larger than 1
pint, the dilution ratio in the name may be replaced by the
concentration of orange juice soluble solids in degrees Brix; for
example, a 62 Brix concentrate in 1-gallon cans may be named on the
label ''canned concentrated orange juice, 62 Brix''. If the food does
not purport to be frozen concentrated orange juice, the word ''canned''
may be omitted from the name.
21 CFR 146.151 Orange juice for manufacturing.
(a) Orange juice for manufacturing is the food prepared for further
manufacturing use. It is prepared from unfermented juice obtained from
oranges as provided in 146.135, except that the oranges may deviate
from the standards for maturity in that they are below the minimum for
Brix and Brix-acid ratio for such oranges, and to which juice may be
added not more than 10 percent by volume of the unfermented juice
obtained from oranges of the species Citrus reticulata or the hybrids
thereof. Seeds (except embryonic seeds and small fragments of seeds
that cannot be separated by good manufacturing practice) are removed,
and pulp and orange oil may be adjusted in accordance with good
manufacturing practice. If pulp is added it shall be other than washed
or spent pulp. The juice or portions thereof may be so treated by heat
as to reduce substantially the enzymatic activity and number of viable
microorganisms, and it may be chilled or frozen, or it may be so treated
by heat, either before or after sealing in containers, as to prevent
spoilage.
(b) The name of the food is ''Orange juice for manufacturing''.
21 CFR 146.152 Orange juice with preservative.
(a) Orange juice with preservative is the food prepared for further
manufacturing use. It complies with the requirements for composition of
orange juice for manufacturing as provided for in 146.151, except that
a preservative is added to inhibit spoilage. It may be heat-treated to
reduce substantially the enzymatic activity and the number of viable
microorganisms.
(b) The preservatives referred to in paragraph (a) of this section
are any safe and suitable preservatives or combinations thereof.
(c) The name of the food is ''Orange juice with preservative''.
(d) Each of the optional ingredients used shall be declared on the
label as required by the applicable sections of Part 101 of this
chapter. In addition, the name of each preservative shall be preceded
by a statement of the percent by weight of the preservative used. If
the food is packed in container sizes that are less than 19 liters (5
gallons), the label shall bear a statement indicating that the food is
for further manufacturing use only.
(e) Wherever the name of the food appears on the label so
conspicuously as to be easily seen under customary conditions of
purchase, the statement specified in paragraph (d) of this section for
naming the preservative ingredient used shall immediately and
conspicuously precede or follow the name of the food, without
intervening written, printed, or graphic matter.
(42 FR 14414, Mar. 15, 1977, as amended at 44 FR 36378, June 22,
1979)
21 CFR 146.153 Concentrated orange juice for manufacturing.
(a) Concentrated orange juice for manufacturing is the food that
complies with the requirements for composition and labeling of optional
ingredients prescribed for frozen concentrated orange juice by 146.146,
except that it is either not frozen, or it is less concentrated, or
both, and the oranges from which the juice is obtained may deviate from
the standards for maturity in that they are below the minima for Brix
and Brix-acid ratio for such oranges: Provided, however, That the
concentration of orange juice soluble solids is not less than 20 Brix.
(b) The name of the food is ''Concentrated orange juice for
manufacturing, -------- '' or '' -------- orange juice concentrate for
manufacturing'', the blank being filled in with the figure showing the
concentration of orange juice soluble solids in degrees Brix.
21 CFR 146.154 Concentrated orange juice with preservative.
(a) Concentrated orange juice with preservative complies with the
requirements for composition and labeling of optional ingredients
prescribed for concentrated orange juice for manufacturing by 146.153,
except that a preservative is added to inhibit spoilage.
(b) The preservatives referred to in paragraph (a) of this section
are any safe and suitable preservatives or combinations thereof.
(c) The name of the food is ''Concentrated orange juice with
preservative, ------------ '', the blank being filled in with the figure
showing the concentration of orange juice soluble solids in degrees
Brix.
(d) Each of the optional ingredients used shall be declared on the
label as required by the applicable sections of Part 101 of this
chapter. In addition, the name of each preservative shall be preceded
by a statement of the percent by weight of the preservative used. If
the food is packed in container sizes that are less than 19 liters (5
gallons), the label shall bear a statement indicating that the food is
for further manufacturing use only.
(e) Wherever the name of the food appears on the label so
conspicuously as to be easily seen under customary conditions of
purchase, the statement specified in paragraph (d) of this section for
naming the preservative ingredient used shall immediately and
conspicuously precede or follow the name of the food, without
intervening written, printed, or graphic matter.
(42 FR 14414, Mar. 15, 1977, as amended at 44 FR 36378, June 22,
1979)
21 CFR 146.185 Pineapple juice.
(a) Identity. (1) Pineapple juice is the juice, intended for direct
consumption, obtained by mechanical process from the flesh or parts
thereof, with or without core material, of sound, ripe pineapple (Ananas
comosus L. Merrill). The juice may have been concentrated and later
reconstituted with water suitable for the purpose of maintaining
essential composition and quality factors of the juice. Pineapple juice
may contain finely divided insoluble solids, but it does not contain
pieces of shell, seeds, or other coarse or hard substances or excess
pulp. It may be sweetened with any safe and suitable dry nutritive
carbohydrate sweetener. However, if the pineapple juice is prepared
from concentrate, such sweeteners, in liquid form, also may be used. It
may contain added vitamin C in a quantity such that the total vitamin C
in each 4 fluid ounces of the finished food amounts to not less than 30
milligrams and not more than 60 milligrams. In the processing of
pineapple juice, dimethylpolysiloxane complying with the requirements of
173.340 of this chapter may be employed as a defoaming agent in an
amount not greater than 10 parts per million by weight of the finished
food. Such food is prepared by heat sterilization, refrigeration, or
freezing. When sealed in a container to be held at ambient
temperatures, it is so processed by heat, before or after sealing, as to
prevent spoilage.
(2) The name of the food is ''Pineapple juice'' if the juice from
which it is prepared has not been concentrated and/or diluted with
water. The name of the food is ''Pineapple juice from concentrate'' if
the finished juice has been made from pineapple juice concentrate as
specified in paragraph (a) of this section. If a nutritive sweetener is
added, the label shall bear the statement ''Sweetener added.'' If no
sweetener is added, the word ''Unsweetened'' may immediately precede or
follow the words ''Pineapple juice'' or ''Pineapple juice from
concentrate.''
(3) Each of the optional ingredients shall be declared on the label
as required by the applicable sections of Part 101 of this chapter.
(b) Quality. (1) The standard of quality for pineapple juice is as
follows:
(i) The soluble solids content of pineapple juice (exclusive of added
sugars) without added water shall not be less than 10.5 Brix as
determined by refractometer at 20 C uncorrected for acidity and read as
degrees Brix on International Sucrose Scales. Where the juice has been
obtained using concentrated juice with addition of water, the soluble
pineapple juice solids content (exclusive of added sugars) shall be not
less than 12.8 Brix, uncorrected for acidity and read as degrees Brix
on the International Sucrose Scales.
(ii) The acidity, as determined by the method prescribed in paragraph
(b)(2)(ii) of this section, is not more than 1.35 grams of anhydrous
citric acid per 100 milliliters of the juice.
(iii) The ratio of the degrees Brix to total acidity, as determined
by the method prescribed in paragraph (b)(2)(iii) of this section, is
not less than 12.
(iv) The quantity of finely divided ''insoluble solids'', as
determined by the method prescribed in paragraph (b)(2)(iv) of this
section, is not less than 5 percent nor more than 30 percent.
(2) The methods referred to in paragraph (b)(1) of this section are
as follows:
(i) Determine the degrees Brix of the pineapple juice by the method
prescribed in ''Official Methods of Analysis of the Association of
Official Analytical Chemists,'' 13th Ed. (1980), section 31.009,
''Solids by Means of Spindle -- Official Final Action,'' which is
incorporated by reference. Copies may be obtained from the Association
of Official Analytical Chemists, 2200 Wilson Blvd., Suite 400,
Arlington, VA 22201-3301, or may be examined at the Office of the
Federal Register, 1100 L St. NW., Washington, DC 20408.
(ii) Determine the total acidity of the pineapple juice by titration
by the method prescribed in 145.180(b)(2)(ix) of this chapter.
(iii) Divide the degrees Brix determined as prescribed in paragraph
(b)(2)(i) of this section by the grams of anhydrous citric acid per 100
milliliters of juice, determined as prescribed in paragraph (b)(2)(ii)
of this section, and report the results as ratio of degrees Brix to
total acidity.
(iv) Determine the quantity of ''insoluble solids'' in pineapple
juice as follows: Measure 50 milliliters of thoroughly stirred
pineapple juice into a cone-shaped graduated tube of the long-cone type,
measuring approximately 4 3/16 inches from tip to top calibration and
having a capacity of 50 milliliters. Place the tube in a suitable
centrifuge the approximate speed of which is related to diameter of
swing in accordance with the table immediately below. The word
''diameter'' means the over-all distance between the tips of opposing
centrifuge tubes in operating position.
The milliliter reading at the top of the layer of ''insoluble
solids,'' after centrifuging 3 minutes, is multiplied by two to obtain
the percentage of ''insoluble solids.''
(3) If the quality of pineapple juice falls below the standard
prescribed in paragraph (b)(1) of this section, the label shall bear the
general statement of substandard quality specified in 130.14 (a) of
this chapter, in the manner and form therein specified.
(c) Fill of container. (1) The standard of fill of container for
pineapple juice, except when the food is frozen, is not less than 90
percent of the total capacity of the container, as determined by the
general method for fill of container prescribed in 130.12(b) of this
chapter.
(2) If pineapple juice falls below the standard of fill of container
prescribed in paragraph (c)(1) of this section, the label shall bear the
statement of substandard fill specified in 130.14(b) of this chapter,
in the manner and form therein specified.
(42 FR 14433, Mar. 15, 1977, as amended at 47 FR 11831, Mar. 19,
1982; 47 FR 52694, Nov. 23, 1982; 49 FR 10101, Mar. 19, 1984; 50 FR
19524, May 9, 1985; 54 FR 24895, June 12, 1989)
21 CFR 146.187 Canned prune juice.
(a) Canned prune juice is the food prepared from a water extract of
dried prunes and contains not less than 18.5 percent by weight of
water-soluble solids extracted from dried prunes. The quantity of prune
solids may be adjusted by the concentration, dilution, or both, of the
water extract or extracts made. Such food may contain one or more of
the optional acidifying ingredients specified in paragraph (b)(1) of
this section, in a quantity sufficient to render the food slightly tart;
it may contain honey added within the quantitative limits prescribed by
paragraph (b)(2) of this section; and it may contain added vitamin C in
a quantity prescribed by paragraph (b)(3) of this section. Such food is
sealed in a container and so processed by heat, before or after sealing,
as to prevent spoilage.
(b) The optional ingredients referred to in paragraph (a) of this
section are:
(1) One or any combination of two or more of the following acidifying
ingredients:
(i) Lemon juice.
(ii) Lime juice.
(iii) Citric acid.
(2) Honey, in a quantity not less than 2 percent and not more than 3
percent by weight of the finished food.
(3) Vitamin C, in a quantity such that the total vitamin C in each 6
fluid ounces of the finished food amounts to not less than 30 milligrams
and not more than 50 milligrams.
(c)(1) The name of the food is ''Prune juice -- a water extract of
dried prunes''. For the purposes of the Federal Food, Drug, and
Cosmetic Act concerning the label declaration of the name of the food,
the explanatory statement ''A water extract of dried prunes'' may appear
immediately below the words ''prune juice'', but there shall be no
intervening written, printed, or graphic matter, and the type used for
the words ''A water extract of dried prunes'' shall be of the same style
and not less than half the print size of the type used for the words
''prune juice''.
(2)(i) When one or more of the acidifying ingredients specified in
paragraph (b)(1) of this section are used, the label shall bear the
statement '' ------------ added'' or ''with added ------------ '', the
blank being filled in with the name or names of the optional ingredients
used.
(ii) When honey, as specified in paragraph (b)(2) of this section, is
used the label shall bear the statement ''with ------------ honey'' or
'' ------------ honey added'', the blank to be filled in with the
percent by weight of the honey in the finished food or with the
statement ''between 2 and 3%''.
(iii) When one or more of the ingredients designated in paragraph
(b)(1) of this section and the ingredient designated in paragraph (b)(2)
of this section are used, the statements specified in paragraphs (c)(2)
(i) and (ii) of this section may be combined, as for example, ''with
lemon juice and between 2 and 3% honey added''.
(iv) When vitamin C is added as provided in paragraph (b)(3) of this
section, it shall be designated on the label as ''vitamin C added'' or
''with added vitamin C''.
(3) Wherever the name of the food appears on the label so
conspicuously as to be easily seen under customary conditions of
purchase, the words specified in this paragraph, showing the optional
ingredients used, shall immediately and conspicuously precede or follow
such name, without intervening written, printed, or graphic matter.
21 CFR 146.187 PART 150 -- FRUIT BUTTERS, JELLIES, PRESERVES, AND RELATED PRODUCTS
21 CFR 146.187 Pt. 150
21 CFR 146.187 Subpart A (Reserved)
21 CFR 146.187 Subpart B -- Requirements for Specific Standardized
Fruit Butters, Jellies, Preserves, and Related Products
Sec.
150.110 Fruit butter.
150.140 Fruit jelly.
150.141 Artificially sweetened fruit jelly.
150.160 Fruit preserves and jams.
150.161 Artificially sweetened fruit preserves and jams.
Authority: Secs. 201, 401, 403, 409, 701, 706 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321, 341, 343, 348, 371, 376).
Source: 42 FR 14445, Mar. 15, 1977, unless otherwise noted.
21 CFR 146.187 Subpart A (Reserved)
21 CFR 146.187 Subpart B -- Requirements for Specific Standardized Fruit Butters, Jellies, Preserves, and Related Products
21 CFR 150.110 Fruit butter.
(a) The fruit butters for which definitions and standards of identity
are prescribed by this section are the smooth, semisolid foods each of
which is made from a mixture of one or a permitted combination of the
optional fruit ingredients specified in paragraph (b) of this section
and one or any combination of the optional ingredients specified in
paragraph (c) of this section, which meets the specifications in
paragraph (d) of this section, and which is labeled in accordance with
paragraph (e) of this section. Such mixture is concentrated with or
without heat. The volatile flavoring materials or essence from such
mixture may be captured during concentration, separately concentrated,
and added back to any such mixture, together with any concentrated
essence accompanying any optional fruit ingredient.
(b)(1) Each of the optional fruit ingredients referred to in
paragraph (a) of this section is prepared by cooking one of the
following fresh, frozen, canned, and/or dried (evaporated) mature
fruits, with or without added water, and screening out skins, seeds,
pits, and cores:
(2) The permitted combinations are of two, three, four, and five of
the fruit ingredients specified in paragraph (b) (1) of this section;
the weight of each is not less than one-fifth of the weight of the
combination. Each such fruit ingredient in any such combination is an
optional ingredient.
(c) The following safe and suitable optional ingredients may be used:
(1) Nutritive carbohydrate sweeteners.
(2) Spice.
(3) Flavoring (other than artificial flavoring).
(4) Salt.
(5) Acidifying agents.
(6) Fruit juice or diluted fruit juice or concentrated fruit juice,
in a quantity not less than one-half the weight of the optional fruit
ingredient.
(7) Preservatives.
(8) Antifoaming agents except those derived from animal fats.
(9) Pectin, in a quantity which reasonably compensates for
deficiency, if any, of the natural pectin content of the fruit
ingredient.
(d) For the purposes of this section:
(1) The mixture referred to in paragraph (a) of this section shall
contain not less than five parts by weight of the fruit ingredient as
measured in accordance with paragraph (d)(2) of this section to each two
parts by weight of nutritive carbohydrate sweetener as measured in
accordance with paragraph (d)(4) of this section.
(2) Any requirement with respect to the weight of any optional fruit
ingredient, whether concentrated, unconcentrated, or diluted, means the
weight determined by the following method: (i) Determine the percent of
soluble solids in the optional fruit ingredient by the method for
soluble solids referred to in paragraph (d)(3) of this section; (ii)
multiply the percent so found by the weight of such fruit ingredient;
(iii) divide the result by 100; (iv) subtract from the quotient the
weight of any nutritive sweetener solids or other added solids; and (v)
multiply the remainder by the factor for such ingredient prescribed in
paragraph (b)(1) of this section. The result is the weight of the
optional fruit ingredient.
(3) The soluble solids content of the finished fruit butter is not
less than 43 percent, as determined by the method prescribed in
''Official Methods of Analysis of the Association of Official Analytical
Chemists'' (AOAC), 13th Ed. (1980), section 22.024, under ''Soluble
Solids by Refractometer in Fresh and Canned Fruits, Fruit Jellies,
Marmalades, and Preserves -- Official Final Action,'' which is
incorporated by reference, except that no correction is made for
water-insoluble solids. Copies may be obtained from the Association of
Official Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington,
VA 22201-3301, or may be examined at the Office of the Federal Register,
1100 L St. NW., Washington, DC 20408.
(4) The weight of any nutritive carbohydrate sweetener means the
weight of the solids of such ingredient.
(5) The weight of fruit juice or diluted fruit juice or concentrated
fruit juice (optional ingredient, paragraph (c)(6)) from a fruit
specified in paragraph (b)(1) of this section is the weight of such
juice, as determined by the method prescribed in paragraph (d)(2) of
this section, except that the percent of soluble solids is determined by
the method prescribed in the AOAC, 13th Ed. (1980), section 31.011,
under ''Solids by Means of Refractometer -- Official Final Action,''
which is incorporated by reference; the weight of diluted concentrated
juice from any other fruits is the original weight of the juice before
it was diluted or concentrated. The availability of this incorporation
by reference is given in paragraph (d)(3) of this section.
(e)(1) The name of each fruit butter for which a definition and
standard of identity is prescribed by this section is as follows:
(i) In case the fruit butter is made from a single fruit ingredient,
the name is ''Butter'', preceded by the name where by such fruit is
designated in paragraph (b)(1) of this section.
(ii) In case the fruit butter is made from a combination of two,
three, four, or five fruit ingredients, the name is ''Butter'', preceded
by the words ''Mixed fruit'' or by the names whereby such fruits are
designated in paragraph (b)(1) of this section, in the order of
predominance, if any, of the weight of such fruit ingredients in the
combination.
(2) Each of the optional ingredients specified in paragraphs (b) and
(c) of this section shall be declared on the label as required by the
applicable sections of Part 101 of this chapter, except that:
(i) Other than in the case of dried (evaporated) fruit the name(s) of
the fruit or fruits used may be declared without specifying the
particular form of the fruit or fruits used. When the optional fruit
ingredient is prepared in whole or in part from dried fruit, the label
shall bear the words ''prepared from'' or ''prepared in part from'', as
the case may be, followed by the word ''evaporated'' or ''dried'',
followed by the name whereby such fruit is designated in paragraph (c)
of this section. When two or more such optional fruit ingredients are
used, such names, each preceded by the word ''evaporated'' or ''dried'',
shall appear in the order of predominance, if any, of the weight of such
ingredients in the combination.
(ii) If sugar or invert sugar is the sweetener used, the term
''sugar'' may be used, and if the sweetener used is derived from corn
the term ''corn sweetener'' may be used.
(42 FR 14445, Mar. 15, 1977, as amended at 47 FR 11831, Mar. 19,
1982; 49 FR 10101, Mar. 19, 1984; 54 FR 24895, June 12, 1989)
21 CFR 150.140 Fruit jelly.
(a) The jellies for which definitions and standards of identity are
prescribed by this section are the jelled foods each of which is made
from a mixture of one or a permitted combination of the fruit juice
ingredients specified in paragraph (b) of this section and one or any
combination of the optional ingredients specified in paragraph (c) of
this section, which meets the specifications in paragraph (d) of this
section and which is labeled in accordance with paragraph (e) of this
section. Such mixture is concentrated with or without heat. The
volatile flavoring materials or essence from such mixture may be
captured during concentration, separately concentrated, and added back
to any such mixture, together with any concentrated essence accompanying
any optional fruit ingredient.
(b)(1) Each of the fruit juice ingredients referred to in paragraph
(a) of this section is the filtered or strained liquid extracted with or
without the application of heat and with or without the addition of
water, from one of the following mature, properly prepared fruits which
are fresh, frozen and/or canned:
(2) The permitted combinations are of two, three, four, or five of
the fruit juice ingredients specified in paragraph (b)(1) of this
section, the weight of each is not less than one-fifth of the weight of
the combination. Each such fruit juice ingredient in any such
combination is an optional ingredient.
(c) The following safe and suitable optional ingredients may be used:
(1) Nutritive carbohydrate sweeteners.
(2) Spice.
(3) Acidifying agents.
(4) Pectin, in a quantity which reasonably compensates for
deficiency, if any, of the natural pectin content of the fruit juice
ingredient.
(5) Buffering agents.
(6) Preservatives.
(7) Antifoaming agents except those derived from animal fats.
(8) Mint flavoring and artificial green coloring, in case the fruit
juice ingredient or combination of fruit juice ingredients is extracted
from apple, crabapple, pineapple, or two or all of such fruits.
(9) Cinnamon flavoring, other than artificial flavoring, and
artificial red coloring in case the fruit juice ingredient or
combination of fruit juice ingredients is extracted from apple or
crabapple or both such fruits.
(d) For the purposes of this section:
(1) The mixture referred to in paragraph (a) of this section shall
contain not less than 45 parts by weight of the fruit juice ingredients
as measured in accordance with paragraph (d)(2) of this section to each
55 parts by weight of saccharine ingredient as measured in accordance
with paragraph (d)(4) of this section.
(2) Any requirement with respect to the weight of any fruit juice
ingredient, whether prepared from concentrated, unconcentrated, or
diluted fruit juice means the weight determined by the following method:
(i) Determine the percent of soluble solids in such fruit juice
ingredient by the method for soluble solids referred to in paragraph
(d)(3) of this section; (ii) multiply the percent so found by the
weight of such fruit juice ingredient; (iii) divide the result by 100;
(iv) subtract from the quotient the weight of any added saccharine
ingredient solids or other added solids; and (v) multiply the remainder
by the factor for such fruit juice ingredient prescribed in paragraph
(b) of this section. The result is the weight of the fruit juice
ingredient.
(3) The soluble-solids content of the finished jelly is not less than
65 percent, as determined by the method prescribed in ''Official Methods
of Analysis of the Association of Official Analytical Chemists,'' 13th
Ed. (1980), section 31.011, under ''Solids by Means of Refractometer --
Official Final Action,'' which is incorporated by reference. Copies may
be obtained from the Association of Official Analytical Chemists, 2200
Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may be examined at
the Office of the Federal Register, 1100 L St. NW., Washington, DC
20408.
(4) The weight of any optional saccharine ingredient means the weight
of the solids of such ingredient.
(e)(1) The name of each jelly for which a definition and standard of
identity is prescribed by this section is as follows:
(i) In case the jelly is made with a single fruit juice ingredient,
the name is ''Jelly'', preceded or followed by the name or synonym
whereby the fruit from which such fruit juice ingredient was extracted
is designated in paragraph (b) of this section.
(ii) In case the jelly is made with a combination of two, three,
four, or five fruit juice ingredients, the name is ''Jelly'', preceded
or followed by the words ''Mixed fruit'' or by the names or synonyms
whereby the fruits from which the fruit juice ingredients were extracted
are designated in paragraph (b) of this section, in the order of
predominance, if any, of the weights of any such fruit juice ingredients
in the combination.
(2) Each of the optional ingredients specified in paragraphs (b) and
(c) of this section shall be declared on the label as required by the
applicable sections of Part 101 of this chapter, except that:
(i) The name(s) of the fruit or fruits used may be declared without
specifying the particular form of the fruit or fruits used.
(ii) When the optional ingredients listed in paragraphs (c) (3), (4),
and (5) of this section are declared on the label, the declaration may
be followed by the statement ''Used as needed'' on all jellies to which
they are customarily, but not always, added to compensate for natural
variations in the fruit juice ingredients used.
(42 FR 14445, Mar. 15, 1977, as amended at 47 FR 11831, Mar. 19,
1982; 49 FR 10101, Mar. 19, 1984; 54 FR 24895, June 12, 1989)
21 CFR 150.141 Artificially sweetened fruit jelly.
(a) The artificially sweetened fruit jellies for which definitions
and standards of identity are prescribed by this section are the jellied
foods made from a fruit juice ingredient as specified in paragraph (b)
of this section and an artificial sweetening ingredient as specified in
paragraph (c) of this section, with a jelling ingredient as specified in
paragraph (d) of this section. Water may be added. The quantity of the
fruit juice ingredient, calculated as set out in 150.140(b), amounts to
not less than 55 percent by weight of the finished food. The article is
sealed in containers and so processed by heat, either before or after
sealing, as to prevent spoilage. Such food may also contain one or more
of the following optional ingredients:
(1) Spice, spice oil, spice extract.
(2) A vinegar, lemon juice, lime juice, citric acid, lactic acid,
malic acid, tartaric acid, fumaric acid, or any combination of two or
more of these, in a quantity which reasonably compensates for
deficiency, if any, of the natural acidity of the fruit juice
ingredient.
(3) Sodium citrate, sodium acetate, sodium tartrate, monosodium
phosphate, disodium phosphate, trisodium phosphate, sodium potassium
tartrate, potassium citrate, potassium acid tartrate, or any combination
thereof, in an amount not exceeding 2 ounces avoirdupois per 100 pounds
of the finished food.
(4) Sodium hexametaphosphate in an amount not exceeding 8 ounces
avoirdupois per 100 pounds of the finished food.
(5) Purified calcium chloride, calcium citrate, calcium gluconate,
calcium lactate, calcium sulfate, monocalcium phosphate, potassium
chloride, or any combination of two or more of these salts, in a
quantity reasonably necessary to enable the jelling ingredients to
produce a jellied finished product.
(6) Ascorbic acid, sorbic acid, sodium sorbate, potassium sorbate,
sodium propionate, calcium propionate, sodium benzoate, benzoic acid,
methylparaben (methyl-p-hydroxybenzoate), propylparaben
(propyl-p-hydroxybenzoate), or any combination of two or more of these,
in a quantity reasonably necessary as a preservative, but not to exceed
0.1 percent by weight of the finished food.
(b) The fruit juice ingredient referred to in paragraph (a) of this
section is any one, or any combination of two, three, four, or five of
the fruit juice ingredients complying with the requirements of
150.140(c). Except as paragraph (d) of this section permits the use of
pectin, carrageenan, or salts of carrageenan standardized with nutritive
sweetener, no nutritive sweetening ingredient is added, either directly
or indirectly, to the fruit juice ingredient used to make artificially
sweetened fruit jelly.
(c) The artificial sweetening ingredients referred to in paragraph
(a) of this section are saccharin, sodium saccharin, calcium saccharin,
or any combination of two or more of these.
(d) The jelling ingredients referred to in paragraph (a) of this
section are pectin, agar-agar, carob bean gum (also called locust bean
gum), guar gum, gum karaya, gum tragacanth, algin (sodium alginate),
sodium carboxymethylcellulose (cellulose gum), methylcellulose (meeting
U.S.P. requirements and with methoxy content not less than 27.5 percent
and not more than 31.5 percent on a dry-weight basis), carrageenan or
salts of carrageenan complying with the requirements of 172.620 or
172.626 of this chapter, or any combination of two or more of these.
Pectin may be standardized with a nutritive sweetening ingredient, but
such sweetening ingredient shall not amount to more than 44 percent by
weight of the standardized pectin and the quantity of such standardized
pectin used shall not exceed 3 percent by weight of the finished food.
Carrageenan or salts of carrageenan may be standardized with a nutritive
sweetening ingredient, but such sweetening ingredient shall not amount
to more than 25 percent by weight of the standardized carrageenan or
salts of carrageenan and the quantity of such standardized carrageenan
or salts of carrageenan used shall not exceed 2 percent by weight of the
finished food.
(e) The name of each artificially sweetened fruit jelly for which a
definition and standard of identity is prescribed by this section
consists of the words ''artificially sweetened'', immediately followed
by the name prescribed by 150.140(e)(1) for the fruit jelly which
corresponds in its fruit ingredient to the artificially sweetened
article. The words ''artificially sweetened'' shall be prominently and
conspicuously displayed in letters not smaller than the largest letter
used in any other word in the name of the food.
(f)(1) The jelling ingredient used shall be named on the label by a
statement '' ------------ added'' or ''with added ------------ '', the
blank being filled in with the common name of the jelling ingredient
used; for example, ''pectin and methylcellulose added''.
(2) When one of the optional ingredients specified in paragraph
(a)(1) of this section is used, the label shall bear the statement ''
------------ added'' or ''with added -------- '', the blank being filled
in with the words ''spice'', ''spice oil'', or ''spice extract'' as
appropriate, but in lieu of the word ''spice'' in such statement the
common name of the spice may be used.
(3) When the optional ingredient specified in paragraph (a)(4) of
this section is used, the label shall bear the words ''sodium
hexametaphosphate added'' or ''with added sodium hexametaphosphate''.
(4) When any optional ingredient listed in paragraph (a)(6) of this
section is used, the label shall bear the statement '' ------------
added as a preservative'', the blank being filled in with the common
name of the preservative ingredient used as designated in paragraph
(a)(6) of this section.
(g) Wherever the name of the food appears on the label of the
artificially sweetened fruit jelly so conspicuously as to be easily seen
under customary conditions of purchase, the words and statements
specified in this section, showing the optional ingredients used, shall
immediately and conspicuously precede or follow such name, without
intervening written, printed, or graphic matter, except that the
varietal name of the fruit source of the fruit juice ingredient used in
preparing such jelly may so intervene.
21 CFR 150.160 Fruit preserves and jams.
(a) The preserves or jams for which definitions and standards of
identity are prescribed by this section are the viscous or semi-solid
foods, each of which is made from a mixture composed of one or a
permitted combination of the fruit ingredients specified in paragraph
(b) of this section and one or any combination of the optional
ingredients specified in paragraph (c) of this section which meets the
specifications in paragraph (d) of this section, and which is labeled in
accordance with paragraph (e) of this section. Such mixture, with or
without added water, is concentrated with or without heat. The volatile
flavoring material from such mixture may be captured during
concentration, separately concentrated, and added back to any such
mixture, together with any concentrated essence accompanying any
optional fruit ingredient.
(b)(1) The fruit ingredients referred to in paragraph (a) of this
section are the following mature, properly prepared fruits which are
fresh, concentrated, frozen and/or canned:
Blackberry (other than dewberry), Black raspberry, Blueberry,
Boysenberry, Cherry, Crabapple, Dewberry (other than boysenberry,
loganberry, and youngberry) Elderberry, Grape, Grapefruit, Huckleberry,
Loganberry, Orange, Pineapple, Raspberry, red raspberry, Rhubarb,
Strawberry, Tangerine, Tomato, Yellow tomato, Youngberry
Apricot, Cranberry, Damson, damson plum, Fig, Gooseberry, Greengage,
greengage plum, Guava, Nectarine, Peach, Pear, Plum (other than
greengage plum and damson plum), Quince, Red currant, currant (other
than black currant)
(2) The following combinations of fruit ingredients may be used:
(i) Any combination of two, three, four, or five of such fruits in
which the weight of each is not less than one-fifth of the weight of the
combination; except that the weight of pineapple may be not less than
one-tenth of the weight of the combination.
(ii) Any combination of apple and one, two, three, or four of such
fruits in which the weight of each is not less than one-fifth and the
weight of apple is not more than one-half of the weight of the
combination; except that the weight of pineapple may be not less than
one-tenth of the weight of the combination.
In any combination of two, three, four, or five fruits, each such
fruit is an optional ingredient. For the purposes of this section the
word ''fruit'' includes the vegetables specified in this paragraph.
(c) The following safe and suitable optional ingredients may be used:
(1) Nutritive carbohydrate sweeteners.
(2) Spice.
(3) Acidifying agents.
(4) Pectin, in a quantity which reasonably compensates for
deficiency, if any, of the natural pectin content of the fruit
ingredient.
(5) Buffering agents.
(6) Preservatives.
(7) Antifoaming agents, except those derived from animal fat.
(d) For the purposes of this section:
(1) The mixture referred to in paragraph (a) of this section shall be
composed of not less than: (i) In the case of a fruit ingredient
consisting of a Group I fruit or a permitted combination exclusively of
Group I fruits, 47 parts by weight of the fruit ingredient to each 55
parts by weight of the saccharine ingredient; and (ii) in all other
cases, 45 parts by weight of the fruit ingredient to each 55 parts by
weight of the saccharine ingredient. The weight of the fruit ingredient
shall be determined in accordance with paragraph (d)(2) of this section,
and the weight of the saccharine ingredient shall be determined in
accordance with paragraph (d)(5) of this section.
(2) Any requirement with respect to the weight of any fruit,
combination of fruits, or fruit ingredient means:
(i) The weight of fruit exclusive of the weight of any sugar, water,
or other substance added for any processing or packing or canning, or
otherwise added to such fruit.
(ii) In the case of fruit prepared by the removal, in whole or in
part, of pits, seeds, skins, cores, or other parts; the weight of such
fruit, exclusive of the weight of all such substances removed therefrom.
(iii) In the cases of apricots, cherries, grapes, nectarines,
peaches, and all varieties of plums, whether or not pits and seeds are
removed therefrom; the weight of such fruit, exclusive of the weight of
such pits and seeds.
(iv) In the case of concentrated fruit, the weight of the properly
prepared fresh fruit used to produce such concentrated fruit.
(3) The term ''concentrated fruit'' means a concentrate made from the
properly prepared edible portion of mature fresh or frozen fruits by
removal of moisture with or without the use of heat or vacuum, but not
to the point of drying. Such concentrate is canned or frozen without
the addition of sugar or other sweetening agents and is identified to
show or permit the calculation of the weight of the properly prepared
fresh fruit used to produce any given quantity of such concentrate. The
volatile flavoring material or essence from such fruits may be captured
during concentration and separately concentrated for subsequent addition
to the concentrated fruit either directly or during manufacture of the
preserve or jam, in the original proportions present in the fruit.
(4) The weight of any optional saccharine ingredient means the weight
of the solids of such ingredient.
(5) The soluble-solids content of the finished jam or preserve is not
less than 65 percent, as determined by the method prescribed in
''Official Methods of Analysis of the Association of Official Analytical
Chemists,'' 13th Ed. (1980), section 22.024, under ''Soluble Solids by
Refractometer in Fresh and Canned Fruits, Jellies, Marmalades, and
Preserves -- Official Final Action,'' which is incorporated by
reference, except that no correction is made for water-insoluble solids.
Copies may be obtained from the Association of Official Analytical
Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may
be examined at the Office of the Federal Register, 1100 L St. NW.,
Washington, DC 20408.
(e)(1) The name of each preserve or jam for which a definition and
standard of identity is prescribed by this section is as follows:
(i) If the fruit ingredient is a single fruit, the name is
''Preserve'' or ''Jam'', preceded or followed by the name or synonym
whereby such fruit is designated in paragraph (b) of this section.
(ii) If the fruit ingredient is a combination of two, three, four, or
five fruits, the name is ''Preserve'' or ''Jam'', preceded or followed
by the words ''Mixed fruit'' or by the names or synonyms whereby such
fruits are designated in paragraph (b) of this section, in the order of
predominance, if any, of the weights of such fruits in the combination.
(2) Each of the optional ingredients specified in paragraphs (b) and
(c) of this section shall be declared on the label as required by the
applicable sections of Part 101 of this chapter, except that:
(i) The name(s) of the fruit or fruits used may be declared without
specifying the particular form of the fruit or fruits used.
(ii) When the optional ingredients listed in paragraphs (c) (3), (4),
and (5) of this section are declared on the label, the declaration may
be followed by the statement ''used as needed'' on all preserves or jams
to which they are customarily, but not always, added to compensate for
natural variations in the fruit ingredients used.
(42 FR 14445, Mar. 15, 1977, as amended at 47 FR 11831, Mar. 19,
1982; 49 FR 10101, Mar. 19, 1984; 54 FR 24895, June 12, 1989)
21 CFR 150.161 Artificially sweetened fruit preserves and jams.
(a) The artificially sweetened fruit preserves or artificially
sweetened fruit jams for which definitions and standards of identity are
prescribed by this section are the viscous or semisolid foods made from
a fruit ingredient as specified in paragraph (b) of this section and an
artificial sweetening ingredient as specified in paragraph (c) of this
section, and with or without water and a jelling ingredient as specified
in paragraph (d) of this section. The quantity of the fruit ingredient
amounts to not less than 55 percent by weight of the finished food. The
article is sealed in containers and so processed by heat, either before
or after sealing, as to prevent spoilage. Such food may also contain
one or more of the following optional ingredients:
(1) Spice, spice oil, spice extract.
(2) A vinegar, lemon juice, lime juice, citric acid, lactic acid,
malic acid, tartaric acid, fumaric acid, or any combination of two or
more of these, in a quantity which reasonably compensates for
deficiency, if any, of the natural acidity of the fruit ingredient.
(3) Sodium citrate, sodium acetate, sodium tartrate, monosodium
phosphate, disodium phosphate, trisodium phosphate, sodium potassium
tartrate, potassium citrate, potassium acid tartrate, or any combination
thereof, in an amount not exceeding 2 ounces avoirdupois per 100 pounds
of the finished food.
(4) Sodium hexametaphosphate in an amount not exceeding 8 ounces
avoirdupois per 100 pounds of the finished food.
(5) Purified calcium chloride, calcium citrate, calcium gluconate,
calcium lactate, calcium sulfate, monocalcium phosphate, potassium
chloride, or any combination of two or more of these salts, in a
quantity reasonably necessary to enable the jelling ingredients to
produce a jelled finished product.
(6) Ascorbic acid, sorbic acid, sodium sorbate, potassium sorbate,
sodium propionate, calcium propionate, sodium benzoate, benzoic acid,
methylparaben (methyl-p-hydroxybenzoate), propylparaben
(propyl-p-hydroxybenzoate), or any combination of two or more of these,
in a quantity reasonably necessary as a preservative but not to exceed
0.1 percent by weight of the finished food.
(b) The fruit ingredient referred to in paragraph (a) of this section
is any one, or any combination of two, three, four, or five of the fruit
ingredients complying with the requirements of 150.160 (b) and (c).
Except as paragraph (d) of this section permits the use of pectin,
carrageenan, or salts of carrageenan standardized with nutritive
sweetener, no nutritive sweetening ingredient is added, either directly
or indirectly, to the fruit ingredient used to make artificially
sweetened fruit preserves or artificially sweetened fruit jam.
(c) The artificial sweetening ingredients referred to in paragraph
(a) of this section are saccharin, sodium saccharin, calcium saccharin,
or any combination of two or more of these.
(d) The jelling ingredients referred to in paragraph (a) of this
section are pectin, agar-agar, carob bean gum (also called locust bean
gum), guar gum, gum karaya, gum tragacanth, algin (sodium alginate),
sodium carboxymethylcellulose (cellulose gum), methylcellulose (meeting
U.S.P. requirements and with methoxy content not less than 27.5 percent
and not more than 31.5 percent on a dry-weight basis), carrageenan or
salts of carrageenan complying with the requirements of 172.620 or
172.626 of this chapter, or any combination of two or more of these.
Pectin may be standardized with a nutritive sweetening ingredient, but
such sweetening ingredient shall not amount to more than 44 percent by
weight of the standardized pectin and the quantity of such standardized
pectin used shall not exceed 3 percent by weight of the finished food.
Carrageenan or salts of carrageenan may be standardized with a nutritive
sweetening ingredient, but such sweetening ingredient shall not amount
to more than 25 percent by weight of the standardized carrageenan or
salts of carrageenan and the quantity of such standardized carrageenan
or salts of carrageenan used shall not exceed 2 percent by weight of the
finished food.
(e) The name of each artificially sweetened fruit preserve or
artificially sweetened fruit jam for which a definition and standard of
identity is prescribed by this section consists of the words
''artificially sweetened'' immediately followed by the name prescribed
by 150.160(e)(1) for the fruit preserves or jams which correspond in
fruit ingredient to the artificially sweetened article. The words
''artificially sweetened'' shall be prominently and conspicuously
displayed in letters not smaller than the largest letter used in any
other word in the name of the food.
(f)(1) The jelling ingredient used shall be named on the label by a
statement '' ------------ added'' or ''with added ------------ '', the
blank being filled in with the common name of the jelling ingredient
used.
(2) When one of the optional ingredients specified in paragraph
(a)(1) of this section is used, the label shall bear the statement, ''
------------ added'' or ''with added ------------ '', the blank being
filled in with the words ''spice'', ''spice oil'', or ''spice extract''
as appropriate, but in lieu of the word ''spice'' in such statement the
common name of the spice may be used.
(3) When the optional ingredient specified in paragraph (a)(4) of
this section is used, the label shall bear the words ''sodium
hexametaphosphate added'' or ''with added sodium hexametaphosphate''.
(4) When any optional ingredient listed in paragraph (a)(6) of this
section is used, the label shall bear the statement '' ------------
added as a preservative'', the blank being filled in with the common
name by which the preservative ingredient used is designated in
paragraph (a)(6) of this section.
(g) Wherever the name of the food appears on the label of the
artificially sweetened fruit preserve or artificially sweetened fruit
jam so conspicuously as to be easily seen under customary conditions of
purchase, the words and statements specified in this section, showing
the optional ingredients used, shall immediately and conspicuously
precede or follow such name without intervening written, printed, or
graphic matter, except that the varietal name of the fruit used in
preparing such preserve or jam may so intervene.
21 CFR 150.161 Pt. 152
21 CFR 150.161 PART 152 -- FRUIT PIES
Authority: Secs. 201, 401, 403, 409, 701, 706 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321, 341, 343, 348, 371, 376)
21 CFR 150.161 Subpart A (Reserved)
21 CFR 150.161 Subpart B -- Requirements for Specific Standardized Fruit Pies
21 CFR 152.126 Frozen cherry pie.
(a) Identity. (1) Frozen cherry pie (excluding baked and then
frozen) is the food prepared by incorporating in a filling contained in
a pastry shell mature, pitted, stemmed cherries that are fresh, frozen,
and/or canned. The top of the pie may be open or it may be wholly or
partly covered with pastry or other suitable topping. Filling, pastry,
and topping components of the food consist of optional ingredients as
prescribed by paragraph (a)(2) of this section. The finished food is
frozen.
(2) The optional ingredients referred to in paragraph (a)(1) of this
section consist of suitable substances that are not food additives as
defined in section 201(s) of the Federal Food, Drug, and Cosmetic Act or
color additives as defined in section 201(t) of the act; or if they are
food additives or color additives as so defined, they are used in
conformity with regulations established pursuant to section 409 or 706
of the act. Ingredients that perform a useful function in the
formulation of the filling, pastry, and topping components, when used in
amounts reasonably required to accomplish their intended effect, are
regarded as suitable except that artificial sweeteners are not suitable
ingredients of frozen cherry pie.
(3) The name of the food for which a definition and standard of
identity is established by this section is frozen cherry pie; however,
if the maximum diameter of the food (measured across opposite outside
edges of the pastry shell) is not more than 4 inches, the food
alternatively may be designated by the name frozen cherry tart. The
word ''frozen'' may be omitted from the name on the label if such
omission is not misleading.
(4)(i) Each of the optional ingredients used shall be declared on the
label as required by the applicable sections of Part 101 of this
chapter.
(ii) The label shall not bear any misleading pictorial representation
of the cherries in the pie.
(b) Quality. (1) The standard of quality for frozen cherry pie is as
follows:
(i) The fruit content of the pie is such that the weight of the
washed and drained cherry content is not less than 25 percent of the
weight of the pie when determined by the procedure prescribed by
paragraph (b)(2) of this section.
(ii) Not more than 15 percent by count of the cherries in the pie are
blemished with scab, hail injury, discoloration, scar tissue, or other
abnormality. A cherry showing skin discoloration (other than scald)
having an aggregate area exceeding that of a circle nine thirty-seconds
of an inch in diameter is considered to be blemished. A cherry showing
discoloration of any area but extending into the fruit tissue is also
considered to be blemished.
(2) Compliance with the requirement for the weight of the washed and
drained cherry content of the pie, as prescribed by paragraph (b)(1)(i)
of this section, is determined by the following procedure:
(i) Select a random sample from a lot:
(a) At least 24 containers if they bear a weight declaration of 16
ounces or less.
(b) Enough containers to provide a total quantity of declared weight
of at least 24 pounds if they bear a weight declaration of more than 16
ounces.
(ii) Determine net weight of each frozen pie.
(iii) Temper the pie until the top crust can be removed.
(iv) Remove the filling and cherries from the pie and transfer to the
surface of a previously weighed 12-inch diameter U.S. No. 8 sieve
(0.094-inch openings) stacked on a U.S. No. 20 sieve (0.033-inch
openings).
(v) Distribute evenly over the surface and wash with a gentle spray
of water at 70 -75 F to free the cherries and cherry fragments from the
adhering material.
(vi) Remove the U.S. No. 8 sieve and examine the U.S. No. 20 sieve
and transfer all cherry fragments to the U.S. No. 8 sieve.
(vii) Drain the cherry contents on the No. 8 sieve for 2 minutes in
an inclined position (15 -30 slope). Weigh the U.S. No. 8 sieve and
the washed and drained cherries to the nearest 0.01 ounce.
(viii) The weight of the washed and drained cherries is the weight of
the sieve and the cherry material less the weight of the sieve.
Calculate the percent of the cherry content of each pie with the
following formula, and then calculate the average percent of the entire
random sample:
Percent of the cherry content of the pie=((Weight of washed and
drained cherries)/(Net weight of pie)) 100.
(3) If the quality of the frozen cherry pie falls below the standard
of quality prescribed by paragraph (b)(1) of this section, the label
shall bear the general statement of substandard quality specified in
130.14(a) of this chapter, in the manner and form specified therein;
but in lieu of the words prescribed for the second line inside the
rectangle, the label may bear the alternative statement ''Below standard
in quality ------------ '', the blank being filled in with the following
words, as applicable: ''too few cherries'', or ''blemished cherries''.
Such alternative statement shall immediately and conspicuously precede
or follow, without intervening written, printed, or graphic matter, the
name of the food as prescribed by paragraph (a) of this section.
(42 FR 14449, Mar. 15, 1977)
21 CFR 152.126 PART 155 -- CANNED VEGETABLES
21 CFR 152.126 Subpart A -- General Provisions
Sec.
155.3 Definitions.
21 CFR 152.126 Subpart B -- Requirements for Specific Standardized
Canned Vegetables
155.120 Canned green beans and canned wax beans.
155.130 Canned corn.
155.131 Canned field corn.
155.170 Canned peas.
155.172 Canned dry peas.
155.190 Canned tomatoes.
155.191 Tomato concentrates.
155.194 Catsup.
155.200 Certain other canned vegetables.
155.201 Canned mushrooms.
Authority: Secs. 201, 401, 403, 409, 701, 706 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321, 341, 343, 348, 371, 376).
Source: 42 FR 14449, Mar. 15, 1977, unless otherwise noted.
21 CFR 152.126 Subpart A -- General Provisions
21 CFR 155.3 Definitions.
For the purposes of this part:
(a) The procedure for determining drained weight is set forth in the
''Official Methods of Analysis of the Association of Official Analytical
Chemists,'' 13th Ed. (1980), sections 32.001-32.003, which is
incorporated by reference. Copies are available from the Association of
Official Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington,
VA 22201-3301, or available for inspection at the Office of the Federal
Register, 1100 L St. NW., Washington, DC 20408.
(b) Compliance means the following: Unless otherwise provided in a
standard, a lot of canned vegetables shall be deemed in compliance for
the following factors, to be determined by the sampling and acceptance
procedure as provided in paragraph (c) of this section, namely:
(1) Quality. The quality of a lot shall be considered acceptable
when the number of defectives does not exceed the acceptance number (c)
in the sampling plans.
(2) Fill of container. A lot shall be deemed to be in compliance for
fill of container (packing medium and vegetable ingredient) when the
number of defectives does not exceed the acceptance number (c) in the
sampling plans.
(3) Drained weight. A lot shall be deemed to be in compliance for
drained weight based on the average value of all samples analyzed
according to the sampling plans.
(c) The sampling and acceptance procedure means the following:
(1) Definitions -- (i) Lot. A collection of primary containers or
units of the same size, type, and style manufactured or packed under
similar conditions and handled as a single unit of trade.
(ii) Lot size. The number of primary containers or units in the lot.
(iii) Sample size. The total number of sample units drawn for
examination from a lot.
(iv) Sample unit. A container, a portion of the contents of a
container, or a composite mixture of product from small containers that
is sufficient for the examination or testing as a single unit. For fill
of container, the sample unit shall be the entire contents of the
container.
(v) Defective. Any sample unit shall be regarded as defective when
the sample unit does not meet the criteria set forth in the standards.
(vi) Acceptance number (c). The maximum number of defective sample
units permitted in the sample in order to consider the lot as meeting
the specified requirements.
(vii) Acceptable quality level (AQL). The maximum percent of
defective sample units permitted in a lot that will be accepted
approximately 95 percent of the time.
(2) Sampling plans.
(d) ''Strength and redness of color'' means at least as much red as
is obtained by comparison of the prepared product, with the blended
color produced by spinning a combination of the following concentric
Munsell color discs of equal diameter, or the color equivalent of such
discs:
Disc 1 -- Red (5R 2.6/13) (glossy finish)
Disc 2 -- Yellow (2.5 YR 5/12) (glossy finish)
Disc 3 -- Black (N1) (glossy finish)
Disc 4 -- Grey (N4) (mat finish)
Such comparison is to be made in full diffused daylight or under a
diffused light source of approximately 2691 lux (250 footcandles) and
having a spectral quality approximating that of daylight under a
moderately overcast sky, with a correlated color temperature of 7,500
degrees Kelvin 200 degrees. With the light source directly over the
disc and product, observation is made at an angle of 45 degrees from a
distance of about 24 inches from the product. Electronic color meters
may be used as an alternate means of determining the color of tomato
concentrates. Such meters shall be calibrated to indicate that the
color of the product is as red or more red than that produced by
spinning the Munsell color discs in the combination as set out above.
(e) ''Tomato soluble solids'' means the sucrose value as determined
by the method prescribed in the ''Official Methods of Analysis of the
Association of Official Analytical Chemists,'' 13th Ed., 1980, sections
32.014 to 32.016 and 52.012, under the headings ''Soluble Solids in
Tomato Products Official Final Action'' and ''Refractive Indices (n) of
Sucrose Solutions at 20 ,'' which is incorporated by reference. Copies
are available from the Association of Official Analytical Chemists, 2200
Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or are available for
inspection at the Office of the Federal Register, 1100 L St. NW.,
Washington, DC 20408. If no salt has been added, the sucrose value
obtained from the referenced tables shall be considered the percent of
tomato soluble solids. If salt has been added either intentionally or
through the application of the acidified break, determine the percent of
such added sodium chloride as specified in paragraph (f) of this
section. Subtract the percentage so found from the percentage of total
soluble solids found (sucrose value from the refractive index tables)
and multiply the difference by 1.016. The resultant value is considered
the percent of ''tomato soluble solids.''
(f) ''Salt'' means sodium chloride, determined as chloride and
calculated as percent sodium chloride, by the method prescribed in
''Official Methods of Analysis of the Association of Official Analytical
Chemists,'' 13th Ed., 1980, sections 32.025 to 32.030, under the heading
''Method III (Potentiometric Method),'' which is incorporated by
reference.
(45 FR 43398, June 27, 1980, as amended at 47 FR 11831, Mar. 19,
1982; 48 FR 3954, Jan. 28, 1983; 54 FR 24895, June 12, 1989)
21 CFR 155.3 Subpart B -- Requirements for Specific Standardized Canned Vegetables
21 CFR 155.120 Canned green beans and canned wax beans.
(a) Identity. (1) Definition. Canned green beans and canned wax
beans are the foods prepared from succulent pods of fresh green bean or
wax bean plants conforming to the characteristics of Phaseolus vulgaris
L. and Phaseolus coccineus L. The optional color and varietal types
and styles of the bean ingredient are set forth in paragraph (a)(2) of
this section. The product is packed with water or other suitable
aqueous liquid medium to which may be added one or more of the other
optional ingredients set forth in paragraph (a)(3) of this section.
Such food is so processed by heat, in an appropriate manner before or
after being sealed in a container, as to prevent spoilage.
(2) Optional color and varietal types and styles of pack. The
optional color and varietal types and styles of the bean ingredient
referred to in paragraph (a)(1) of this section are:
(i) Optional color types. The beans shall be one of the following
distinct color types: (a) Green; or (b) Wax.
(ii) Optional varietal types -- (a) Round. Beans having a width not
greater than 1 1/2 times the thickness of the bean; or
(b) Flat. Beans having a width greater than 1 1/2 times the
thickness of the bean.
(iii) Optional styles of pack -- (a) Whole. Whole pods of any
length.
(b) Shoestring or sliced lengthwise or French style. Pods sliced
lengthwise.
(c) Cuts. Transversely cut pods not less than 19 mm (0.75 in) long
as measured along the longitudinal axis, which may contain the shorter
end pieces that result from cutting such pods.
(d) Short cuts. Pieces of pods cut transversely of which 75 percent,
by count, or more are less than 19 mm (0.75 in) in length and not more
than 1 percent by count are more than 32 mm (1 1/4 in) in length.
(e) Diagonal cuts. Pods cut in lengths as specified in paragraph
(a)(2)(iii)(c) of this section, except the pods are cut at an angle
approximately 45 to the longitudinal axis.
(f) Diagonal short cuts. Pods cut in lengths as specified in
paragraph (a)(2)(iii)(d) of this section, except the pods are cut at an
angle approximately 45 to the longitudinal axis.
(g) Mixture. Any mixture of two or more of the styles specified in
paragraph (a)(2)(iii)(a) to (f), inclusive, of this section.
(3) Optional ingredients. In addition to the optional packing media
listed in paragraph (a)(1) of this section and the optional types and
styles of beans ingredient listed in paragraph (a)(2) of this section,
the following safe and suitable optional ingredients may be used:
(i) Salt.
(ii) Monosodium glutamate.
(iii) Disodium inosinate.
(iv) Disodium guanylate.
(v) Hydrolyzed vegetable protein.
(vi) Autolyzed yeast extract.
(vii) Nutritive carbohydrate sweeteners.
(viii) Spice.
(ix) Flavoring (except artificial).
(x) Pieces of green or red peppers or mixtures of both, either of
which may be dried, or other vegetables not exceeding in total 15
percent by weight of the finished product.
(xi) Vinegar.
(xii) Lemon juice or concentrated lemon juice.
(xiii) Mint leaves.
(xiv) Butter or margarine in a quantity of not less than 3 percent by
weight of the finished product. When butter or margarine is added,
emulsifiers or stabilizers, or both, may be added. No spice or
flavoring simulating the color or flavor imparted by butter or margarine
is used.
(4) Labeling. (i) The name of the food is ''green beans'' or ''wax
beans'' as appropriate. Wax beans may be additionally designated
''golden'' or ''yellow''.
(ii) The following shall be included as part of the name or in
conjunction with the name of the food:
(a) A declaration of any flavoring that characterizes the product as
specified in 101.22 of this chapter.
(b) A declaration of any spice, seasoning, or garnishing that
characterizes the product, e.g., ''with added spice'', or, in lieu of
the word ''spice'', the common name of the spice, e.g., ''seasoned with
green peppers''.
(c) The words ''vacuum pack'' or ''vacuum packed'' when the weight of
the liquid in the container, as determined by the method prescribed in
paragraph (b)(2)(i) of this section is not more than 25 percent of the
net weight, and the container is closed under conditions creating a high
vacuum in the container.
(d) The name of the optional style of bean ingredient as set forth in
paragraph (a)(2)(iii) of this section or, if a product consists of a
mixture of such styles, the words ''mixture of '' the blank to be filled
in with the names of the styles present, arranged in the order of
decreasing predominance, if any, by weight of such ingredients. If the
product consists of whole beans and the pods are packed parallel to the
sides of the container, the word ''whole'' may be preceded or followed
by the words ''vertical pack'', or if the pods are cut at both ends and
are of substantially equal lengths, the words ''asparagus style'' may be
used in lieu of the words ''vertical pack''. If the product consists of
short cuts or diagonal short cuts, a numerical expression indicating the
predominate length of cut in the finished food may be used in lieu of
the word ''short'', e.g., '' 1/2 inch cut''.
(iii) The following may be included in the name of the food:
(a) The word ''stringless'' where the beans are in fact stringless.
(b) The name of the optional varietal type as specified in paragraph
(a)(2)(ii) of this section, or the specific varietal name, e.g., ''Blue
Lake Green Beans'', or both.
(iv) If a term designating diameter is used, it shall be supported by
an exact graphic representation of the cross section of the bean pod or
by a statement of the maximum diameter in common or decimal fractions of
an inch and, optionally, by the millimeter equivalent stated
parenthetically. The diameter of a whole, cut, diagonal cut, or short
cut is determined by measuring the thickest portion of the pod at the
shorter diameter of the bean perpendicular to the longitudinal axis.
(5) Ingredient statement. The name of each optional ingredient used
shall be declared on the label as required by the applicable sections of
Part 101 of this chapter.
(b) Quality. (1) When tested by the method prescribed in paragraph
(b)(2) of this section:
(i) In the case of cut beans and diagonal cut beans under paragraphs
(a)(2)(iii) (c) and (d) of this section and mixtures of two or more
optional forms under paragraph (a)(2)(iii)(g) of this section, not more
than 60 units per 340 g (12 oz) drained weight are less than 13 mm (0.50
in) long: Provided, That where the number of units per 340 g (12 oz)
drained weight exceeds 240, not more than 25 percent by count of the
total units are less than 13 mm (0.50 in) long.
(ii) In case there are present pods or pieces of pods 10.7 mm (
27/64-inch) or more in diameter, there are not more than 12 strings per
340 gm (12 ounces) of drained weight which will support 227 gm (one-half
pound) for 5 seconds or longer.
(iii) The deseeded pods contain not more than 0.15 percent by weight
of fibrous material.
(iv) There are not more than 10 percent by weight of blemished units
of which amount not more than one-half may be materially damaged by
insect or pathological injury. A unit is considered blemished when the
aggregate blemished area exceeds the area of a circle 3 mm ( 1/8 in) in
diameter. Materially damaged means that the unit is damaged to the
extent that the appearance or eating quality of the unit is seriously
affected.
(v) There are not more than 8 unstemmed units per 340 g (12 oz)
drained weight.
(vi) The combined number of leaves, detached stems, and other
extraneous vegetable matter shall not average more than 3 pieces per 340
g (12 oz) drained beans.
(2) Canned beans shall be tested by the following method to determine
whether they meet the requirements of paragraph (b)(1) of this section:
(i) Determine the gross weight of the container. Open and distribute
the contents of the container over the meshes of a U.S. No. 8 circular
sieve with openings of 2.36 mm (0.0937 in), which has been previously
weighed. The diameter of the sieve is 20.3 cm (8 in) if the quantity of
the contents of the container is less than 1.36 kg (3 lb) and 30.5 cm
(12 in) if such quantity is 1.36 kg (3 lb) or more. The bottom of the
sieve is woven-wire cloth that complies with the specifications for such
cloth set forth in ''Official Methods of Analysis of the Association of
Official Analytical Chemists,'' 13th Ed. (1980), Table 1, ''Nominal
Dimensions of Standard Test Sieves (U.S.A. Standard Series),'' under the
heading ''Definitions of Terms and Explanatory Notes,'' which is
incorporated by reference. Copies may be obtained from the Association
of Official Analytical Chemists, 2200 Wilson Blvd., Suite 400,
Arlington, VA 22201-3301, or may be examined at the Office of the
Federal Register, 1100 L St. NW., Washington, DC 20408. Without
shifting the material on the sieve, incline the sieve 17 to 20 degrees
to facilitate drainage. Two minutes after drainage begins, weigh the
sieve and the drained material. Record in grams (ounces) the weight so
found, less the weight of the sieve, as the drained weight. Dry and
weigh the empty container and subtract this weight from the gross weight
to obtain the net weight. Calculate the percent of drained liquid in
the net weight.
(ii) Pour the drained material from the sieve into a flat tray and
spread it in a layer of fairly uniform thickness. Count the total
number of units. For the purpose of this count, loose seeds, pieces of
seed, loose stems, and extraneous material are not to be included.
Divide the number of units by the drained weight recorded in paragraph
(b)(2)(i) of this section and multiply by 340 to obtain the number of
units per 340 g (12 oz) drained weight.
(iii) Examine the drained material in the tray, weigh and record
weight of blemished units, count and record the number of unstemmed
units; and, in case the material consists of the optional ingredient
specified in paragraph (a)(2)(iii) (c), (d) or (f) of this section,
count and record the number of units which are less than 13 mm (0.50
in.) long. If the number of units per 340 g (12 oz.) is 240 or less,
divide the number of units which are less than 13 mm (0.50 in.) by the
drained weight recorded in paragraph (b)(2)(i) of this section and
multiply by 340 to obtain the number of such units per 340 g (12 oz.)
drained weight. If the number of units per 340 g (12 oz.) exceeds 240,
divide the number of units less than 13 mm (0.50 in.) long by the total
number of units and multiply by 100 to determine the percentage by count
of the total units which are less than 13 mm (0.50 in.) long.
(a) Divide the weight of blemished units by the drained weight
recorded in paragraph (b)(2)(i) of this section and multiply by 100 to
obtain the percentage by weight of blemished units in the container.
(b) Divide the number of unstemmed units by the drained weight
recorded in paragraph (b)(2)(i) of this section and multiply by 340 to
obtain the number of unstemmed units per 340 g (12 oz.) of drained
weight.
(iv) Remove from the tray the extraneous vegetable material, count,
record count, and return to tray.
(v) Remove from the tray one or more representative samples of 99 to
113 g (3 1/2 to 4 ounces) covering each sample as taken to prevent
evaporation.
(vi) From each representative sample selected in paragraph (b)(2)(v)
of this section, discard any loose seed and extraneous vegetable
material and detach and discard any attached stems. Except with
optional style of ingredient specified in paragraph (a)(2)(iii)(b) of
this section (pods sliced lengthwise), trim off, as far as the end of
the space formerly occupied by the seed, any portion of pods from which
the seed has become separated. Remove and discard any portions of seed
from the trimmings and reserve the trimmings for paragraph (b)(2)(viii)
of this section. Weigh and record the weight of the trimmed pods.
Deseed the trimmed pods and reserve the deseeded pods for paragraph
(b)(2)(viii) of this section. Remove strings from the pods during the
deseeding operation. Reserve these strings for testing as prescribed in
paragraph (b)(2)(vii) of this section. In the case of pods sliced
lengthwise, remove seed and pieces of seed and reserve the deseeded pods
for use as prescribed in paragraph (b)(2)(viii) of this section.
(vii) If strings have been removed for testing, as prescribed in
paragraph (b)(2)(vi) of this section, test them as follows:
Fasten clamp, weighted to 250 g (8.8 oz.), to one end of the string,
grasp the other end with the fingers (a cloth may be used to aid in
holding the string), and lift gently. Count the string as tough if it
supports the 250 g (8.8 oz.) weight for at least 5 seconds. If the
string breaks before 5 seconds, test such parts into which it breaks as
are 13 mm ( 1/2 in.) or more in length; and if any such part of the
string supports the 250 g (8.8 oz.) weight for at least 5 seconds, count
the string as tough. Divide the number of tough strings by the weight
of the sample recorded in paragraph (b)(2)(v) of this section and
multiply by 340 to obtain the number of tough strings per 340 g (12 oz.)
drained weight.
(viii) Combine the deseeded pods with the trimmings reserved in
paragraph (b)(2)(vi) of this section, and, if strings were tested as
prescribed in paragraph (b)(2)(vii) of this section, add such strings
broken or unbroken. Weigh and record weight of combined material.
Transfer to the metal cup of a malted-milk stirrer and mash with a
pestle. Wash material adhering to the pestle back into cup with 200 cc
of boiling water. Bring mixture nearly to a boil, add 25 cc of 50
percent (by weight) sodium hydroxide solution and bring to a boil. (If
foaming is excessive, 1 cc of capryl alcohol may be added.) Boil for 5
minutes, then stir for 5 minutes with a malted-milk stirrer capable of a
no-load speed of at least 7,200 rpm. Use a rotor with two scalloped
buttons shaped as shown in Exhibit 1 as follows:
Insert Illus. 9A
Transfer the material from the cup to a previously weighed 30-mesh
monel metal screen having a diameter of about 9-10 cm (3 1/2 to 4 in.)
and side walls about 2.5 cm (1 in.) high, and wash fiber on the screen
with a stream of water using a pressure not exceeding a head (vertical
distance between upper level of water and outlet of glass tube) of 152
cm (60 in.), delivered through a glass tube 7.6 cm (3 in.) long and 3 mm
( 1/8 in.) inside diameter inserted into a rubber tube of 6 mm ( 1/4
in.) inside diameter. Wash the pulpy portion of the material through
the screen and continue washing until the remaining fibrous material,
moistened with phenolphthalein solution, does not show any red color
after standing 5 minutes. Again wash to remove phenolphthalein. Dry
the screen containing the fibrous material for 2 hours at 100 C, cool,
weigh, and deduct weight of screen. Divide the weight of fibrous
material by the weight of combined deseeded pods, trimmings, and strings
and multiply by 100 to obtain the percentage of fibrous material.
(ix) If the drained weight recorded in paragraph (b)(2)(i) of this
section was less than 340 g (12 oz.), open and examine separately for
extraneous material, as directed in paragraph (b)(2)(iv) of this
section, additional containers until a total of not less than 340 g (12
oz.) of drained material is obtained. To determine the number of pieces
of extraneous vegetable material per 340 g (12 oz.) of drained weight,
total the number of pieces of extraneous vegetable material found in all
containers opened, divide this sum by the sum of the drained weights in
these containers and multiply by 340.
(3) Determine compliance as specified in 155.3(b) except that a lot
shall be deemed to be in compliance for extraneous plant material based
on an average of all containers examined.
(4) If the quality of the canned green beans or canned wax beans
falls below the standard of quality prescribed by paragraph (b)(1) of
this section, the label shall bear the general statement of substandard
quality specified in 130.14(a) of this chapter, in the manner and form
therein specified; but in lieu of the words prescribed for the second
line inside the rectangle the following words may be used, when the
quality of canned green beans or canned wax beans falls below the
standard in one only of the following respects:
(i) ''Excessive number very short pieces'', if the canned green beans
or canned wax beans fail to meet the requirements of paragraph (b)(1)(i)
of this section.
(ii) ''Excessive number blemished units'', if they fail to meet the
requirements of paragraph (b)(1)(iv) of this section.
(iii) ''Excessive number unstemmed units'', if they fail to meet the
requirements of paragraph (b)(1)(v) of this section.
(iv) ''Excessive foreign material'', if they fail to meet the
requirements of paragraph (b)(1)(vi) of this section.
(42 FR 14449, Mar. 15, 1977, as amended at 42 FR 30359, 30360, June
14, 1977; 45 FR 43398, June 27, 1980; 47 FR 11831, Mar. 19, 1982; 49
FR 10101, Mar. 19, 1984; 54 FR 24895, June 12, 1989)
21 CFR 155.130 Canned corn.
(a) Identity -- (1) Definition. Canned sweet corn is the product
prepared from clean, sound kernels of sweet corn packed with a suitable
liquid packing medium which may include water and the creamy component
from corn kernels. The tip caps are removed. The product is of the
optional styles specified in paragraph (a)(2) of this section. It may
contain one, or any combination of two or more, of the optional
ingredients set forth in paragraph (a)(3) of this section. Such food is
processed by heat, in an appropriate manner, before or after being
sealed in a container, so as to prevent spoilage.
(2) Styles. The optional styles referred to in paragraph (a)(1) of
this section consist of succulent sweet corn of the yellow (golden) or
white color type, conforming to Zea mays L. having the sweet corn
characteristic as follows:
(i) Whole kernel or whole grain or cut kernel consisting of whole or
substantially whole cut kernels packed with a liquid medium.
(ii) Cream style consisting of whole or partially whole cut kernels
packed in a creamy component from the corn kernels and other liquid or
other ingredients to form a product of creamy consistency.
(3) Optional ingredients. The following safe and suitable optional
ingredients may be used:
(i) Salt.
(ii) Monosodium glutamate.
(iii) Disodium inosinate.
(iv) Disodium guanylate.
(v) Hydrolyzed vegetable protein.
(vi) Autolyzed yeast extract.
(vii) Nutritive carbohydrate sweeteners.
(viii) Spice.
(ix) Flavoring (except artificial).
(x) Citric acid.
(xi) Starch or food starch-modified in cream style corn when
necessary to ensure smoothness.
(xii) Seasonings and garnishes.
(a) Mint leaves.
(b) Pieces of green peppers or red peppers, or mixtures of both,
either of which may be sweet or hot and may be dried, or other
vegetables, not exceeding 15 percent by weight of the finished food.
(c) Lemon juice or concentrated lemon juice.
(d) Butter or margarine in a quantity not less than 3 percent by
weight of the finished food. When butter or margarine is added,
emulsifiers or stabilizers, or both, may be added. When butter or
margarine is added, no spice, or flavoring simulating the color or
flavor imparted by butter or margarine is used.
(4) Labeling. The name of the food is ''corn'' or ''sweet corn'' or
''sugar corn'' and shall include a declaration of any flavoring that
characterizes the product as specified in 101.22 of this chapter and a
declaration of any spice, seasoning or garnishing that characterizes the
product; for example, ''With added spice'', ''Seasoned with red
peppers'', ''Seasoned with butter''. The name of the food shall also
include the following:
(i) The optional style of the corn ingredient as specified in
paragraph (a)(2) of this section.
(ii) The words ''vacuum pack'' or ''vacuum packed'' when the corn
ingredient is as specified in paragraph (a)(2)(i) of this section and
the weight of the liquid in the container, as determined by the method
prescribed in paragraph (b)(2)(i) of this section, is not more than 20
percent of the net weight, and the container is closed under conditions
creating a high vacuum in the container.
(iii) The color type used only when the product consists of white
corn.
(iv) The color type used only when the product consists of white
corn.
(5) Ingredient statement. Each of the optional ingredients used
shall be declared on the label as required by the applicable sections of
Part 101 of this chapter.
(b) Quality. (1) The standard of quality for canned corn is as
follows:
(i) When tested by the method prescribed in paragraph (b)(2) of this
section, canned whole-kernel corn (paragraph (a)(2)(i) of this section):
(a) Contains not more than seven brown or black discolored kernels or
pieces of kernel per 400 g. (14 ounces) of drained weight;
(b) Contains not more than 1 cubic centimeter of pieces of cob for
each 400 g. (14 ounces) of drained weight;
(c) Contains not more than 7 square centimeters (1.1 square inch) of
husk per 400 g. (14 ounces) of drained weight; and
(d) Contains not more than 180 mm. (7 inches) of silk per 28 g. (1
ounce) of drained weight.
(ii) When tested by the method prescribed in paragraph (b)(3) of this
section, canned cream style corn (paragraph (a)(2)(ii) of this section):
(a) Contains not more than 10 brown or black discolored kernels or
pieces of kernel per 600 g. (21.4 ounces) of net weight;
(b) Contains not more than 1 cubic centimeter of pieces of cob per
600 g. (21.4 ounces) of net weight;
(c) Contains not more than 7 square centimeters (1.1 square inch) of
husk per 600 g. (21.4 ounces) of net weight;
(d) Contains not more than 150 mm. (6 inches) of silk for each 28 g.
(1 ounce) of net weight; and
(e) Has a consistency such that the average diameter of the
approximately circular area over which the prescribed sample spreads
does not exceed 30.5 cm. (12 inches), except that when the washed
drained material contains more than 20 percent of alcohol-insoluble
solids, the average diameter of the approximately circular area over
which the prescribed sample spreads does not exceed 25.4 cm. (10
inches).
(iii) (a) The weight of the alcohol-insoluble solids of whole-kernel
corn (paragraph (a)(2)(i) of this section) does not exceed 27 percent of
the drained weight, when tested by the method prescribed in paragraph
(b)(2) of this section.
(b) The weight of the alcohol-insoluble solids of the washed drained
material of cream style corn (paragraph (a)(2)(ii) of this section) does
not exceed 27 percent of the drained weight of such material, when
tested by the method prescribed in paragraph (b)(3) of this section.
(2) The method referred to in paragraph (b)(1) of this section for
testing whole-kernel corn (paragraph (a)(2)(i) of this section) is as
follows:
(i) Determine the gross weight of the container. Open and distribute
the contents of the container over the meshes of a U.S. No. 8 circular
sieve which has previously been weighed. The diameter of the sieve is
20.3 cm. (8 inches) if the quantity of the contents of the container is
less than 1.36 kg. (3 pounds), and 30.5 cm. (12 inches) if such quantity
is 1.36 kg. (3 pounds) or more. The bottom of the sieve is woven-wire
cloth that complies with the specifications for such sieve set forth in
the ''Definitions of Terms and Explanatory Notes'' prescribed in
''Official Methods of Analysis of the Association of Official Analytical
Chemists,'' 13th Ed. (1980), Table 1, ''Nominal Dimensions of Standard
Test Sieves (U.S.A. Standard Series),'' under the heading ''Definitions
of Terms and Explanatory Notes,'' which is incorporated by reference.
Copies may be obtained from the Association of Official Analytical
Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may
be examined at the Office of the Federal Register, 1100 L St. NW.,
Washington, DC 20408. Without shifting the material on the sieve, so
incline the sieve at approximately 17-20 angle to facilitate drainage.
Two minutes from the time drainage begins, weigh the sieve and the
drained material. Record, in g. (ounces), the weight so found, less
the weight of the sieve, as the drained weight. Dry and weigh the empty
container and subtract this weight from the gross weight to obtain the
net weight. Calculate the percent of drained liquid in the net weight.
(ii) Pour the drained material from the sieve into a flat tray and
spread it in a layer of fairly uniform thickness. Count, but do not
remove, the brown or black discolored kernels or pieces of kernel and
calculate the number per 400 g. (14 ounces) of drained material.
Remove pieces of silk more than 12.7 mm. (one-half inch) long, husk,
cob, and any pieces of material other than corn. Measure the aggregate
length of such pieces of silk and calculate the length of silk per 28 g.
(1 ounce) of drained weight. Spread the husk flat, measure its
aggregate area, and calculate the area of husk per 400 g. (14 ounces)
of drained weight. Place all pieces of cob under a measured amount of
water in a cylinder which is so graduated that the volume can be
measured to 0.1 cubic centimeter. Take the increase in volume as the
aggregate volume of the cob and calculate the volume of cob per 400 g.
(14 ounces) of drained weight.
(iii) Comminute representative 100 g. sample of the drained corn
from which the silk, husk, cob, and other material which is not corn
(i.e., peppers) have been removed. An equal amount of water is used to
facilitate this operation. Weigh to nearest 0.01 g. a portion of the
comminuted material equivalent to approximately 10 g. of the drained
corn into a 600 cubic centimeter beaker. Add 300 cubic centimeters of
80 percent alcohol (by volume), stir, cover beaker, and bring to a boil.
Simmer slowly for 30 minutes. Fit a Buchner funnel with a previously
prepared filter paper of such sizes that its edges extend 12.7 mm.
(one-half inch) or more up the vertical sides of the funnel. The
previous preparation of the filter paper consists of drying it in a
flat-bottomed dish for 2 hours at 100 C, covering the dish with a tight
fitting cover, cooling it in a desiccator, and promptly weighing to the
nearest 0.001 g. After the filter paper is fitted to the funnel, apply
suction and transfer the contents of the beaker to the funnel. Do not
allow any of the material to run over the edge of the paper. Wash the
material on the filter with 80 percent alcohol (by volume) until the
washings are clear and colorless. Transfer the filter paper with the
material retained thereon to the dish used in preparing the filter
paper. Dry the material in a ventilated oven, without covering the
dish, for 2 hours at 100 C. Place the cover on the dish, cool it in a
desiccator, and promptly weigh to the nearest 0.001 g. From this weight
subtract the weight of the dish, cover, and paper as previously found.
Calculate the remainder to percentage.
(3) The method referred to in paragraph (b)(1) of this section for
testing cream-style corn (paragraph (a)(2)(ii) of this section) is as
follows:
(i) Allow the container to stand at least 24 hours at a temperature
of 68 F to 85 F. Determine the gross weight, open, transfer the
contents into a pan, and mix thoroughly in such a manner as not to
incorporate air bubbles. (If the net contents of a single container is
less than 510 g. (18 ounces) determine the gross weight, open, and mix
the contents of the least number of containers necessary to obtain 510
g. (18 ounces). Fill level full a hollow, truncated cone so placed on a
polished horizontal plate as to prevent leakage. The cone has an inside
bottom diameter of 7.62 cm. (3 inches), inside top diameter of 5.08 cm.
(2 inches), and height of 12.30 cm. (4 27/32 inches). As soon as the
cone is filled, lift it vertically. Determine the average of the longest
and shortest diameters of the approximately circular area on the plate
covered by the sample 30 seconds after lifting the cone. Dry and weigh
each empty container and subtract the weight so found from the gross
weight to obtain the net weight.
(ii) Transfer the material from the plate, cone, and pan onto a U.S.
No. 8 sieve as prescribed in paragraph (b)(2)(i) of this section. The
diameter of the sieve is 20.3 cm. (8 inches) if the quantity of the
contents of the container is less than 1.36 kg. (3 pounds), and 30.5 cm.
(12 inches) if such quantity is 1.36 kg. (3 pounds) or more. Set the
sieve in a pan. Add enough water to bring the level within 9.53 mm.
(three-eighth inch) to 6.35 mm. (one-fourth inch) of the top of the
sieve. Gently wash the material on the sieve by combined up-and-down
and circular motion for 30 seconds. Repeat washing with a second
portion of water. Remove sieve from pan, incline to facilitate
drainage, and drain for 2 minutes.
(iii) From the material remaining on the U.S. No. 8 sieve, count, but
do not remove, the brown or black discolored kernels or pieces of kernel
and calculate the number per 600 g. (21.4 ounces) of net weight.
Remove pieces of silk more than 12.7 mm. (one-half inch) long, husk,
cob, and other material which is not corn (i.e., peppers). Measure
aggregate length of such pieces of silk and calculate the length per 28
g. (ounce) of net weight. Spread the husk flat and measure its
aggregate area and calculate the area per 600 g. (21.4 ounces) of net
weight. Place all pieces of cob under a measured amount of water in a
cylinder which is so graduated that the volume may be measured to 0.1
cubic centimeter. Take the increase in volume as the aggregate volume
of the cob and calculate the volume of cob per 600 g. (21.4 ounces) of
net weight. Take a representative 100 g. sample of the material
remaining on the U.S. No. 8 sieve (if such material weighs less than 100
g. take all of it) and determine the alcohol-insoluble solids as
prescribed in paragraph (b)(2)(iii) of this section for whole kernel
corn.
(4) Determine compliance as specified in 155.3(b).
(5) If the quality of canned corn falls below the standard prescribed
in paragraph (b)(1) of this section, the label shall bear the general
statement of substandard quality specified in 130.14(a) of this
chapter, in the manner and form therein specified; however, if the
quality of the canned corn falls below standard with respect to only one
of the factors of quality specified by paragraphs (b)(1)(i) (a) to (d)
of this section, or by paragraphs (b)(1)(ii) (a) to (e) of this section,
there may be substituted for the second line of such general statement
of substandard quality, ''Good food -- not high grade'', a new line as
specified after the corresponding subdivision designation of paragraph
(b)(1) of this section, which the canned corn fails to meet:
(i)(a) or (ii)(a) ''Excessive discolored kernels''.
(i)(b) or (ii)(b) ''Excessive cob''.
(i)(c) or (ii)(c) ''Excessive husk''.
(i)(d) or (ii)(d) ''Excessive silk''.
(ii)(e) ''Excessively liquid''.
(c) Fill of container -- (1) The standard of fill of container for
canned corn is:
(i) Except in the case of vacuum pack corn the fill of the corn
ingredient and packing medium, as determined by the general method for
fill of container prescribed in 130.12(b) of this chapter, is not less
than 90 percent of the total capacity of the container.
(ii) In whole kernel corn, the drained weight of the corn ingredient,
determined by the procedure set forth in 155.3, shall not be less than
61 percent of the water capacity of the container.
(2) Determine compliance as specified in 155.3(b).
(3) If canned corn falls below the standard of fill of container
prescribed in paragraphs (c)(1) and (2) of this section, the label shall
bear the general statement of substandard fill specified in 130.14(b)
of this chapter, in the manner and form therein specified.
(42 FR 14449, Mar. 15, 1977, as amended at 45 FR 43398, June 27,
1980; 47 FR 11831, 11832, Mar. 19, 1982; 49 FR 10101, Mar. 19, 1984;
54 FR 24895, June 12, 1989)
21 CFR 155.131 Canned field corn.
(a) Identity. (1) Canned field corn conforms to the definition and
standard of identity, and is subject to the requirements for label
statement of optional ingredients, prescribed for canned corn by
155.130(a), except that the corn ingredient consists of succulent field
corn or a mixture of succulent field corn and succulent sweet corn.
(2) The name of the food conforms to the name specified in
155.130(a)(5), except that the words ''Corn'', ''Sweet corn'', and
''Sugar corn'' are replaced by the words ''Field corn'', and the term
''Golden field corn'' is not used.
(b) (Reserved)
(c) Fill of container. Canned cream-style field corn conforms to the
standard of fill of container and label statement of substandard fill
prescribed for canned cream-style corn by 155.130(c).
21 CFR 155.170 Canned peas.
(a) Identity -- (1) Definition. Canned peas is the food prepared
from fresh or frozen succulent seeds of the pea plant of the species
Pisum sativum L. but excluding the subspecies macrocarpum. Only sweet
wrinkled varieties, smooth-skin varieties, or hybrids thereof may be
used. The product is packed with water or other suitable aqueous liquid
medium to which may be added one or more of the other optional
ingredients set forth in paragraph (a)(2) of this section. Such food is
sealed in a container and, before or after sealing, is so processed by
heat as to prevent spoilage.
(2) Optional ingredients. In addition to the optional packing media
provided for in paragraph (a)(1) of this section, the following safe and
suitable optional ingredients may be used:
(i) Salt.
(ii) Monosodium glutamate.
(iii) Disodium inosinate.
(iv) Disodium guanylate.
(v) Hydrolyzed vegetable protein.
(vi) Autolyzed yeast extract.
(vii) One or any combination of two or more of the dry or liquid
forms of sugar, invert sugar sirup, dextrose, glucose sirup, and
fructose.
(viii) Spice.
(ix) Flavoring (except artificial).
(x) Color additives.
(xi) Calcium salts, the total amount of which added to firm the peas
shall not result in more than 350 milligrams/kilogram (0.01 ounce/2.2
pounds) of calcium in the finished food.
(xii) Magnesium hydroxide, magnesium oxide, magnesium carbonate, or
any mixture or combination of these in such quantity that the pH of the
finished canned peas is not more than 8, as determined by the glass
electrode method for the hydrogen ion concentration.
(xiii) Seasonings and garnishes:
(a) Pieces of green or red peppers or mixtures of both, either of
which may be dried, or other vegetables not exceeding in total 15
percent of the drained weight of the finished food.
(b) Lemon juice or concentrated lemon juice.
(c) Mint leaves.
(d) Butter or margarine in a quantity not less that 3 percent by
weight of the finished food, or other vegetable or animal fats or oils
in a quantity not less than 2.4 percent by weight of the finished foods.
When butter, margarine, or other vegetable or animal fats or oils are
added, emulsifiers or stabilizers or both may be added, but no color,
spice, or flavoring simulating the color or flavor imparted by butter or
margarine may be used.
(3) Labeling. (i) The name of the food is ''peas'' and may include
the designation ''green.'' The term ''early,'' ''June,'' or ''early
June'' shall precede or follow the name in the case of smooth-skin peas
or substantially smooth-skin peas, such as Alaska-type peas or hybrids
having similar characteristics. Where the peas are of sweet green
wrinkled varieties or hybrids having similar characteristics, the name
may include the designation ''sweet,'' ''wrinkled,'' or any combination
thereof. The term ''petit pois'' may be used in conjunction with the
name of the food when an average of 80 percent or more of the peas will
pass through a circular opening of a diameter of 7.1 millimeters (0.28
inch). If any color additive has been added, the name of the food shall
include the term ''artificially colored.''
(ii) The following shall be included as part of the name or in close
proximity to the name of the food:
(a) A declaration of any flavoring that characterizes the food, as
specified in 101.22 of this chapter.
(b) A declaration of any spice, seasoning, or garnishing that
characterizes the product, e.g., ''seasoned with green peppers'',
''seasoned with butter'', ''seasoned with ------ oil'', the blank to be
filled in with the common or usual name of the oil, ''with added
spice'', or, in lieu of the word spice, the common or usual name of the
spice.
(c) The words ''vacuum pack'' or ''vacuum packed'' when the weight of
the liquid in the container, as determined by the method prescribed in
155.3(a) is not more than 20 percent of the net weight, and the
container is closed under conditions creating a high vacuum in the
container.
(4) Ingredient statement. Each of the optional ingredients used
shall be declared on the label as required by the applicable sections of
Part 101 of this chapter.
(b) Quality. (1) The standard of quality for canned peas is as
follows:
(i) Blond and yellow peas. Not more than 2 percent of the drained
weight is blond and/or yellow peas, i.e., white or yellow but edible
peas.
(ii) Blemished peas. Not more than 5 percent of the drained weight
is blemished peas, i.e., slightly stained or spotted peas.
(iii) Seriously blemished peas. Not more than 1 percent of the
drained weight is seriously blemished peas, i.e., peas that are hard,
shrivelled, spotted, discolored, or otherwise blemished to an extent
that the appearance or eating quality is seriously affected.
(iv) Pea fragments. Not more than 10 percent of the drained weight
is pea fragments, i.e., portions of peas, separated or individual
cotyledons, crushed, partial or broken cotyledons, and loose skins, but
excluding entire intact peas with skins detached.
(v) Extraneous vegetable material. Not more than 0.5 percent of the
drained weight is extraneous vegetable material, i.e., vine or leaf or
pod material from the pea plant or other such material.
(vi) Alcohol-insoluble solids. The alcohol-insoluble solids of
smooth-skin or substantially smooth-skin peas, such as Alaska-type peas
or hybrids having similar characteristics, may not be more than 23.5
percent and, of sweet green wrinkled varieties or hybrids having similar
characteristics, not more than 21 percent based on the procedure set
forth in the ''Official Methods of Analysis of the Association of
Official Analytical Chemists,'' 13th Ed. (1980), section 30.012, which
is incorporated by reference. Copies are available from the Association
of Official Analytical Chemists, 2200 Wilson Blvd., Suite 400,
Arlington, VA 22201-3301, or available for inspection at the Office of
the Federal Register, 1100 L St. NW., Washington, DC 20408.
(vii) Limitation. The sum of the pea material described in
paragraphs (b)(1) (i), (ii), (iii), (iv), and (v) of this section shall
not exceed 12 percent.
(2) Determine compliance as specified in 155.3(b).
(3) If the quality of canned peas falls below the standard prescribed
in paragraph (b)(1) of this section, the label shall bear the general
statement of substandard quality specified in 130.14(a) of this
chapter, in the manner and form therein specified; but in lieu of such
general statement of substandard quality when the quality of canned peas
falls below the standard in only one respect, the label may bear the
alternative statement, ''Below standard in quality '', the blank to be
filled in with the words specified after the corresponding paragraph
under paragraph (b)(1) of this section which such canned peas fail to
meet, as follows: (i) ''Excessive blond and/or yellow peas''; (ii)
''Excessive blemished peas''; (iii) ''Excessive seriously blemished
peas''; (iv) ''Excessive pea fragments''; (v) ''Excessive vegetable
material''; (vi) ''Excessive mealy''. Such alternative statement shall
immediately and conspicuously precede or follow without intervening
written, printed, or graphic matter, the name ''peas'' and any words and
statements required or authorized to appear with such name by paragraph
(a)(3) of this section.
(c) Fill of container. (1) Except in the case of vacuum pack peas,
the fill of pea ingredient and packing medium, as determined by the
general method for fill of container prescribed in 130.12(b) of this
chapter, is not less than 90 percent of the total capacity of the
container.
(2) When the peas and liquid are removed from the container and
returned thereto, the leveled peas (irrespective of the quantity of the
liquid), 15 seconds after they are so returned, completely fill the
container. A container with lid attached by double seam shall be
considered to be completely filled when it is filled to 5 millimeters
(0.2 inch) vertical distance below the top of the double seam; and a
glass container shall be considered to be completely filled when it is
filled to 13 millimeters (0.5 inch) vertical distance below the top of
the container.
(3) Determine compliance for fill of container as specified in
155.3(b).
(4) If canned peas fall below the standard of fill of container
prescribed in paragraph (c)(1) and/or (2) of this section, the label
shall bear the general statement of substandard fill specified in
130.14(b) of this chapter, in the manner and form therein specified.
(45 FR 43398, June 27, 1980, as amended at 47 FR 11832, Mar. 19,
1982; 48 FR 15241, Apr. 8, 1983; 54 FR 24895, June 12, 1989)
Effective Date Note: In 155.170, those portions of paragraph (a)(2)
pertaining to the deletion of magnesium, hydroxide, magnesium oxide, and
magnesium carbonate were stayed until further notice at 46 FR 35086,
July 1, 1981, effective June 30, 1981.
21 CFR 155.172 Canned dry peas.
(a) Identity. Canned dry peas conforms to the definition and
standard of identity, and is subject to requirements for label statement
of optional ingredients prescribed for canned peas by 155.170(a),
except that:
(1) The optional pea ingredient is the dry seeds of the pea plant of
the species Pisum sativum L. but excluding the subspecies macrocarpum.
(2) The optional ingredients specified in 155.170(a)(2)(xii) shall
not be used.
(3) The name of the food is ''cooked dry peas'' or ''soaked dry
peas''. The optional terms specified by 155.170(a)(3), ''early'',
''June'', ''sweet'', ''green'', ''wrinkled'', or any combination
thereof, shall not be used on the labels.
(b) Quality. (1) The standard of quality for canned dry peas is that
specified for canned peas by 155.170(b) except that:
(i) The alcohol-insoluble solids maximums specified in
155.170(b)(1)(vi) do not apply.
(ii) The skins of not more than 25 percent by count of the peas in
the container are ruptured to a width of 1.6 millimeters (0.06 inch) or
more.
(2) If the quality of canned dry peas falls below the standard of
quality prescribed by paragraph (b)(1) of this section, the label shall
bear the statement of substandard quality in the manner and form
specified in 155.170(b)(3) for canned peas, except that the words
''Excessively mealy'' shall not be used.
(c) Fill of container. (1) The standard of fill of container for
canned dry peas is that prescribed for canned peas by 155.170(c).
(2) If canned dry peas fall below the standard of fill of container
prescribed by paragraph (c)(1) of this section, the label shall bear the
general statement of substandard fill specified in 130.14(b) of this
chapter, in the manner and form therein specified.
(45 FR 43399, June 27, 1980, as amended at 48 FR 15241, Apr. 8, 1983)
21 CFR 155.190 Canned tomatoes.
(a) Identity -- (1) Description. (i) Canned tomatoes is the food
prepared from mature tomatoes conforming to the characteristics of the
fruit Lycopersicum esculentum P. Mill, of red or reddish varieties.
The tomatoes may or may not be peeled, but shall have had the stems and
calicies removed and shall have been cored, except where the internal
core is insignificant to texture and appearance.
(ii) Canned tomatoes may contain one or more of the safe and suitable
optional ingredients specified in paragraph (a)(2) of this section, be
packed without any added liquid or in one of the optional packing media
specified in paragraph (a)(3) of this section and be prepared in one of
the styles specified in paragraph (a)(4) of this section. Such food is
sealed in a container and before or after sealing is so processed by
heat as to prevent spoilage.
(2) Optional ingredients. One or more of the following safe and
suitable ingredients may be used:
(i) Calcium salts in a quantity reasonably necessary to firm the
tomatoes, but the amount of calcium in the finished canned tomatoes is
not more than 0.045 percent of the weight, except that when the tomatoes
are prepared in one of the styles specified in paragraphs (a)(4) (ii) to
(iv) of this section the amount of calcium is not more than 0.08 percent
of the weight of the food.
(ii) Organic acids for the purpose of acidification.
(iii) Dry nutritive carbohydrate sweeteners whenever any organic acid
provided for in paragraph (a)(2)(ii) of this section is used, in a
quantity reasonably necessary to compensate for the tartness resulting
from such added acid.
(iv) Salt.
(v) Spices, spice oils.
(vi) Flavoring and seasoning.
(vii) Vegetable ingredients such as onion, peppers, and celery, that
may be fresh or preserved by physical means, in a quantity not more than
10 percent by weight of the finished food.
(3) Packing media. (i) The liquid draining from the tomatoes during
or after peeling or coring.
(ii) The liquid strained from the residue from preparing tomatoes for
canning consisting of peels and cores with or without tomatoes or pieces
thereof.
(iii) The liquid strained from mature tomatoes (tomato juice).
(iv) Tomato paste, or tomato puree, or tomato pulp complying with the
compositional requirements of 155.191 and 155.192.
(4) Styles. (i) Whole.
(ii) Diced.
(iii) Sliced.
(iv) Wedges.
(5) Name of the food. (i) The name of the food is ''tomatoes'',
except that when the tomatoes are not peeled the name is ''unpeeled
tomatoes''.
(ii) The following shall be included as part of the name or in close
proximity to the name of the food:
(a) A declaration of any flavoring that characterizes the product as
specified in 101.22 of this chapter.
(b) A declaration of any added spice, seasoning, or vegetable
ingredient that characterizes the product, (e.g., ''with added --------
'' or, ''with -------- '' the blank to be filled in with the word(s)
''spice(s)'', ''seasoning(s)'', or the name(s) of the vegetable(s) used
or in lieu of the word(s) ''spice(s)'' or ''seasoning (s)'' the common
or usual name(s) of the spice(s) or seasoning(s) used) except that no
declaration of the presence of onion, peppers, and celery is required
for stewed tomatoes.
(c) The word ''stewed'' if the tomatoes contain characterizing
amounts of at least the three optional vegetables listed in paragraph
(a)(2)(vii) of this section.
(d) The styles: ''Diced'', ''sliced'', or ''wedges'' as appropriate.
(e) The name of the packing medium: ''tomato paste'', ''tomato
puree'', or ''tomato pulp'' as provided in paragraph (a)(3)(iv) of this
section, or ''strained residual tomato material from preparation for
canning'' as provided for in paragraph (a)(3)(ii) of this section, as
appropriate. The name of the packing medium shall be preceded by the
word ''with''.
(iii) The following may be included as part of the name or in close
proximity to the name:
(a) The word ''whole'' if the tomato ingredient is whole or almost
whole, and the weight of such ingredient is not less than 80 percent of
the drained weight of the finished food as determined in accordance with
the method prescribed in paragraph (b)(2) of this section.
(b) The words ''solid pack'' when none of the optional packing media
specified in paragraph (a)(3) of this section are used.
(c) The words ''in tomato juice'' if the packing medium specified in
paragraph (a)(3)(iii) of this section is used.
(6) Label declaration of optional ingredients. The name of each
optional ingredient used shall be declared on the label as required by
the applicable sections of Part 101 of this chapter.
(b) Quality. (1) The standard of quality for canned tomatoes is as
follows:
(i) The drained weight, as determined by the method prescribed in
paragraph (b)(2)(i) of this section, is not less than 50 percent of the
weight of water required to fill the container, as determined by the
general method for water capacity of containers prescribed in 130.12(a)
of this chapter;
(ii) The strength and redness of color as determined by the method
prescribed in paragraph (b)(2) of this section, are not less than that
of the blended color of any combination of the color discs described in
such method in which one-third the area of disc 1, and not more than
one-third the area of disc 2, is exposed;
(iii) Peel per kilogram (2.2 pounds) of the finished food covers an
area of not more than 15 cm2 (2.3 square inches) which is equivalent to
6.8 cm2 (1.06 square inches) per pound based on an average of all
containers examined provided, however, that the area of peel is not a
factor of quality for canned unpeeled tomatoes labeled in accordance
with paragraph (a)(5)(i) of this section; and
(iv) Blemishes per kilogram (2.2 pounds) of the finished food cover
an area of not more than 3.5 cm2 (0.54 square inch) which is equivalent
to 1.6 cm2 (0.25 square inch) per pound based on an average of all
containers examined.
(2) Canned tomatoes shall be tested by the following method to
determine whether or not they meet the requirements of paragraphs (b)(1)
(i) and (ii) of this section:
(i) Remove lid from container, but in the case of a container with
lid attached by double seam, do not remove or alter the height of the
double seam. Tilt the opened container so as to distribute the contents
over the meshes of a circular sieve which has previously been weighed.
The diameter of the sieve used is 20.3 centimeters (8 inches) if the
quantity of the contents of the container is less than 1.4 kilograms (3
pounds) or 30.5 centimeters (12 inches) if such quantity is 1.4
kilograms (3 pounds) or more. The meshes of such sieve are made by so
weaving wire of 1.4 mm (0.054 inch) diameter as to form square openings
11.3 mm by 11.3 mm (0.446 inch by 0.446 inch). Without shifting the
tomatoes, so incline the sieve as to facilitate drainage of the liquid.
Two minutes from the time drainage begins, weigh the sieve and drained
tomatoes. The weight so found, less the weight of the sieve, shall be
considered to be the drained weight.
(ii) Remove from the sieve the drained tomatoes, cut out and
segregate successively those portions of least redness until 50 percent
of the drained weight has been so segregated. Comminute the segregated
portions to a uniform mixture without removing or breaking the seeds.
Fill the mixture into a black container to a depth of at least 25.4 mm
(1 inch). Free the mixture from air bubbles, and skim off or press
below the surface all visible seeds. Compare the color of the mixture,
in full diffused daylight or its equivalent, with the blended color of
combinations of the following concentric Munsell color discs of equal
diameter, or the color equivalent of such discs:
(a) Red -- Munsell 5 R 2.6/13 (glossy finish).
(b) Yellow -- Munsell 2.5 YR 5/12 (glossy finish).
(c) Black -- Munsell N 1/ (glossy finish).
(d) Grey -- Munsell N 4 (mat finish).
(3) Determine compliance as specified in 155.3(b).
(4) If the quality of canned tomatoes falls below the standard
prescribed in paragraph (b)(1) of this section, the label shall bear the
general statement of substandard quality specified in 130.14(a) of this
chapter in the manner and form therein specified; if, however, the
quality of canned tomatoes falls below standard with respect to only one
of the factors of quality specified by paragraphs (b)(1) (i) to (iii) of
this section, there may be substituted for the second line of such
general statement of substandard quality (''Good Food -- Not High
Grade'') a new line, appropriate for the corresponding subparagraph
designation of paragraph (b)(1) of this section which the canned
tomatoes fail to meet, to read as follows: (i) ''Poor color'' or (ii)
''Excessive peel'' or (iii) ''Excessive blemishes''.
(c) Fill of container. (1) The standard of fill of container for
canned tomatoes is a fill of not less than 90 percent of the total
capacity of the container, as determined by the general method for fill
of containers prescribed in 130.12(b) of this chapter.
(2) Determine compliance as specified in 155.3(b).
(3) If canned tomatoes fall below the standard of fill of container
prescribed in paragraph (c)(1) of this section, the label shall bear the
general statement of substandard fill specified in 130.14(b) of this
chapter, in the manner and form therein specified.
(42 FR 14449, Mar. 15, 1977, as amended at 43 FR 12858, Mar. 28,
1978; 43 FR 30274, July 14, 1978; 45 FR 43400, June 27, 1980)
21 CFR 155.191 Tomato concentrates.
(a) Identity -- (1) Definition. Tomato concentrates are the class of
foods each of which is prepared by concentrating one or any combination
of two or more of the following optional tomato ingredients:
(i) The liquid obtained from mature tomatoes of the red or reddish
varieties (Lycopersicum esculentum P. Mill).
(ii) The liquid obtained from the residue from preparing such
tomatoes for canning, consisting of peelings and cores with or without
such tomatoes or pieces thereof.
(iii) The liquid obtained from the residue from partial extraction of
juice from such tomatoes.
Such liquid is obtained by so straining the tomatoes, with or without
heating, as to exclude skins (peel), seeds, and other coarse or hard
substances in accordance with good manufacturing practice. Prior to
straining, food-grade hydrochloric acid may be added to the tomato
material in an amount to obtain a pH no lower than 2.0. Such acid is
then neutralized with food-grade sodium hydroxide so that the treated
tomato material is restored to a pH of 4.2 0.2. Water may be added to
adjust the final composition. The food contains not less than 8.0
percent tomato soluble solids as defined in 155.3(e). The food is
preserved by heat sterilization (canning), refrigeration, or freezing.
When sealed in a container to be held at ambient temperatures, it is so
processed by heat, before or after sealing, as to prevent spoilage.
(2) Optional ingredients. One or any combination of two or more of
the following safe and suitable ingredients may be used in the foods:
(i) Salt (sodium chloride formed during acid neutralization shall be
considered added salt).
(ii) Lemon juice, concentrated lemon juice, or organic acids.
(iii) Sodium bicarbonate.
(iv) Water, as provided for in paragraph (a)(1) of this section.
(v) Spices.
(vi) Flavoring.
(3) Labeling. (i) The name of the food is:
(a) ''Tomato puree'' or ''tomato pulp'' if the food contains not less
than 8.0 percent but less than 24.0 percent tomato soluble solids.
(b) ''Tomato paste'' if the food contains not less than 24.0 percent
tomato soluble solids.
(c) The name ''tomato concentrate'' may be used in lieu of the name
''tomato puree,'' ''tomato pulp,'' or ''tomato paste'' whenever the
concentrate complies with the requirements of such foods; except that
the label shall bear the statement ''for remanufacturing purposes only''
when the concentrate is packaged in No. 10 containers (3.1 kilograms or
109 avoirdupois ounces total water capacity) or containers that are
smaller in size.
(d) ''Concentrated tomato juice'' if the food is prepared from the
optional tomato ingredient described in paragraph (a)(1)(i) of this
section and is of such concentration that upon diluting the food
according to label directions as set forth in paragraph (a)(3)(iii) of
this section, the diluted article will contain not less than 5.0 percent
by weight tomato soluble solids.
(ii) The following shall be included as part of the name or in close
proximity to the name of the food:
(a) The statement ''Made from'' or ''Made in part from,'' as the case
may be, ''residual tomato material from canning'' if the optional tomato
ingredient specified in paragraph (a)(1)(ii) of this section is present.
(b) The statement ''Made from'' or ''Made in part from,'' as the case
may be, ''residual tomato material from partial extraction of juice'' if
the optional tomato ingredient specified in paragraph (a)(1)(iii) of
this section is present.
(c) A declaration of any flavoring that characterizes the product as
specified in 101.22 of this chapter and a declaration of any spice that
characterizes the product, e.g., ''Seasoned with ------ ,'' the blank to
be filled in with the words ''added spice'' or, in lieu of the word
''spice,'' the common name of the spice.
(iii) The label of concentrated tomato juice shall bear adequate
directions for dilution to result in a diluted article containing not
less than 5.0 percent by weight tomato soluble solids; except that
alternative methods may be used to convey adequate dilution directions
for containers that are larger than No. 10 containers (3.1 kilograms or
109 avoirdupois ounces total water capacity).
(iv) Each of the optional ingredients used shall be declared on the
label as required by the applicable sections of Part 101 of this
chapter; except that water need not be declared in the ingredient
statement when added to adjust the tomato soluble solids content of
tomato concentrates within the range of soluble solids levels permitted
for these foods.
(v) Determine percent tomato soluble solids as specified in
155.3(e). Determine compliance as specified in 155.3(b). A lot shall be
deemed to be in compliance for tomato soluble solids as follows:
(a) The sample average meets or exceeds the required minimum.
(b) The number of sample units that are more than 1 percent tomato
soluble solids below the minimum required does not exceed the acceptance
number in the sampling plans set forth in 155.3(c)(2).
(b) Quality. (1) The standard of quality for tomato concentrate
(except for concentrated tomato juice, which when diluted to 5.0 percent
tomato soluble solids shall conform to the standard of quality for
tomato juice set forth in 156.145 of this chapter) is as follows:
(i) The strength and redness of color of the food, when diluted with
water (if necessary) to 8.1 0.1 percent tomato soluble solids is not
less than the composite color produced by spinning the Munsell color
discs in the following combination:
53 percent of the area of Disc 1;
28 percent of the area of Disc 2; and
19 percent of the area of either Disc 3 or Disc 4; or
9 1/2 percent of the area of Disc 3 and 9 1/2 percent of the area of
Disc 4, whichever most nearly matches the appearance of the sample.
(ii) Not more than one whole seed per 600 grams (21 ounces).
(iii) Not more than 36 of the following defects, either singly or in
combination, per 100 grams (3.5 ounces) of the product when diluted with
water to 8.1 0.1 percent tomato soluble solids:
(a) Pieces of peel 5 millimeters (0.20 inch) or greater in length
(without unrolling).
(b) Pieces of seed (seed particles) 1 millimeter (0.039 inch) or
greater in length.
(c) Blemishes, such as dark brown or black particles (specks) -- not
more than four exceed 1.6 millimeters (0.0625 inch) in length of which
not more than one exceeds 3.2 millimeters (0.125 inch) and none exceed
6.4 millimeters (0.25 inch).
(2) Methodology. Dilute with water, if necessary, to 8.1 0.1 percent
tomato soluble solids.
(i) Determine strength and redness of color as prescribed in
155.3(d).
(ii) Whole seeds -- Weigh out 600 grams (21 ounces) of the
well-mixed, diluted concentrate; place a U.S. No. 12 screen (1.68
millimeters (0.066 inch) openings) over the sink drain; transfer the
product sample onto the screen; rinse container thoroughly with water
and pour through screen; flush sample through screen by using an
adequate spray of water; check screen for whole seeds; apply the
appropriate allowance.
(iii) Peel, pieces of seed, and blemishes -- Spread the prepared
concentrate evenly on a large white tray and remove the individual
defects, identify, classify, and measure.
(3) Sampling and acceptance. Determine compliance as specified in
155.3(b).
(4) If the quality of the tomato concentrate falls below the standard
prescribed in paragraph (b) (1) and (3) of this section, the label shall
bear the general statement of substandard quality specified in
130.14(a) of this chapter, in the manner and form therein specified, but
in lieu of such general statement of substandard quality when the
quality of the tomato concentrate falls below the standard in one or
more respects, the label may bear the alternative statement, ''Below
Standard in Quality -------- ,'' the blank to be filled in with the
words specified after the corresponding paragraph(s) under paragraph
(b)(1) of this section which such tomato concentrate fails to meet, as
follows:
(i) ''Poor color.''
(ii) ''Excessive seeds.''
(iii)(a) ''Excessive pieces of peel.''
(b) ''Excessive pieces of seed.''
(c) ''Excessive blemishes.''
(c) Fill of container. (1) The standard of fill of container for
tomato concentrate, as determined by the general method for fill of
container prescribed in 130.12(b) of this chapter, is not less than 90
percent of the total capacity, except when the food is frozen.
(2) Determine compliance as specified in 155.3(b).
(3) If the tomato concentrate falls below the standard of fill
prescribed in paragraph (c) (1) and (2) of this section, the label shall
bear the general statement of substandard fill specified in 130.14(b)
of this chapter, in the manner and form therein prescribed.
(48 FR 3954, Jan. 28, 1983, as amended at 49 FR 15073, Apr. 17, 1984)
Effective Date Note: The information collection requirements
contained in 155.91 have been submitted to the Office of Management and
Budget for approval. These requirements will not be effective until FDA
obtains OMB approval. FDA will publish a notice concerning OMB approval
of these requirements in the Federal Register.
21 CFR 155.194 Catsup.
(a) Identity -- (1) Definition. Catsup, ketchup, or catchup is the
food prepared from one or any combination of two or more of the
following optional tomato ingredients:
(i) Tomato concentrate as defined in 155.191(a)(1), except that
lemon juice, concentrated lemon juice, or safe and suitable organic
acids may be used in quantities no greater than necessary to adjust the
pH, and in compliance with 155.191(b).
(ii) The liquid derived from mature tomatoes of the red or reddish
varieties Lycopersicum esculentum P. Mill.
(iii) The liquid obtained from the residue from preparing such
tomatoes for canning, consisting of peelings and cores with or without
such tomatoes or pieces thereof.
(iv) The liquid obtained from the residue from partial extraction of
juice from such tomatoes.
Such liquid is strained so as to exclude skins, seeds, and other
coarse or hard substances in accordance with current good manufacturing
practice. Prior to straining, food-grade hydrochloric acid may be added
to the tomato material in an amount to obtain a pH no lower than 2.0.
Such acid is then neutralized with food-grade sodium hydroxide so that
the treated tomato material is restored to a pH of 4.2 0.2. The final
composition of the food may be adjusted by concentration and/or by the
addition of water. The food may contain salt (sodium chloride formed
during acid neutralization shall be considered added salt) and is
seasoned with ingredients as specified in paragraph (a)(2) of this
section. The food is preserved by heat sterilization (canning),
refrigeration, or freezing. When sealed in a container to be held at
ambient temperatures, it is so processed by heat, before or after
sealing, as to prevent spoilage.
(2) Ingredients. One or any combination of two or more of the
following safe and suitable ingredients in each of the following
categories is added to the tomato ingredients specified in paragraph
(a)(1) of this section:
(i) Vinegars.
(ii) Nutritive carbohydrate sweeteners. Such sweeteners if defined
in Part 168 of this chapter shall be as defined therein.
(iii) Spices, flavoring, onions, or garlic.
(3) Labeling. (i) The name of the food is ''Catsup,'' ''Ketchup,''
or ''Catchup.''
(ii) The following shall be included as part of the name or in close
proximity to the name of the food:
(a) The statement ''Made from'' or ''Made in part from,'' as the case
may be, ''residual tomato material from canning'' if the optional tomato
ingredient specified in paragraph (a)(1)(iii) of this section or tomato
concentrate containing the ingredient specified in 155.191(a)(1)(ii) is
present.
(b) The statement ''Made from'' or ''Made in part from,'' as the case
may be, ''residual tomato material from partial extraction of juice'' if
the optional tomato ingredient specified in paragraph (a)(1)(iv) of this
section or tomato concentrate containing the ingredient specified in
155.191(a)(1)(iii) is present.
(iii) Each of the optional ingredients used shall be declared on the
label as required by the applicable sections of Part 101 of this chapter
except that the name ''tomato concentrate'' may be used in lieu of the
names ''tomato puree,'' ''tomato pulp,'' or ''tomato paste'' and when
tomato concentrates are used, the labeling requirements of
155.191(a)(3)(ii) (a) and (b) do not apply.
(b) Quality. (1) The standard of quality for catsup is as follows:
The consistency of the finished food is such that its flow is not more
than 14 centimeters in 30 seconds at 20 C when tested in a Bostwick
Consistometer in the following manner: Check temperature of mixture and
adjust to 20 1 C. The trough must also be at a temperature close to
20 C. Adjust end-to-end level of Bostwick Consistometer by means of
the spirit level placed in trough of instrument. Side-to-side level may
be adjusted by means of the built-in spirit level. Transfer sample to
the dry sample chamber of the Bostwick Consistometer. Fill the chamber
slightly more than level full, avoiding air bubbles as far as possible.
Pass a straight edge across top of chamber starting from the gate end to
remove excess product. Release gate of instrument by gradual pressure
on lever, holding the instrument down at the same time to prevent its
movement as the gate is released. Immediately start the stop watch or
interval timer, and after 30 seconds read the maximum distance of flow
to the nearest 0.1 centimeter. Clean and dry the instrument and repeat
the reading on another portion of sample. Do not wash instrument with
hot water if it is to be used immediately for the next determination, as
this may result in an increase in temperature of the sample. For
highest accuracy, the instrument should be maintained at a temperature
of 20 1 C. If readings vary more than 0.2 centimeter, repeat a third
time or until satisfactory agreement is obtained. Report the average of
two or more readings, excluding any that appear to be abnormal.
(2) Determine compliance as specified in 155.3(b).
(3) If the quality of catsup falls below the standard prescribed in
paragraphs (b) (1) and (2) of this section, the label shall bear the
general statement of substandard quality specified in 130.14(a) of this
chapter, in the manner and form therein specified, but in lieu of such
general statement of substandard quality when the quality of the catsup
falls below the standard, the label may bear the alternative statement,
''Below Standard in Quality -- Low Consistency.''
(c) Fill of container. (1) The standard of fill of container for
catsup, as determined by the general method for fill of container
prescribed in 130.12(b) of this chapter, is not less than 90 percent of
the total capacity except:
(i) When the food is frozen, or
(ii) When the food is packaged in individual serving-size packages
containing 56.7 grams (2 ounces) or less.
(2) Determine compliance as specified in 155.3(b).
(3) If the catsup falls below the standard of fill prescribed in
paragraphs (c) (1) and (2) of this section, the label shall bear the
general statement of substandard fill as specified in 130.14(b) of this
chapter, in the manner and form therein specified.
(48 FR 3956, Jan. 28, 1983, as amended at 49 FR 15073, Apr. 17, 1984)
Effective Date Note: The information collection requirements
contained in 155.194 have been submitted to the Office of Management
and Budget for approval. These requirements will not be effective until
FDA obtains OMB approval. FDA will publish a notice concerning OMB
approval of these requirements in the Federal Register.
21 CFR 155.200 Certain other canned vegetables.
(a) The canned vegetables for which definitions and standards of
identity are prescribed by this section are those named in column I of
the table set forth in paragraph (b) of this section. The vegetable
ingredient in each such canned vegetable is obtained by proper
preparation from the succulent vegetable prescribed in column II of such
table. If two or more forms of such ingredient are designated in column
III of such table, the vegetable in each such form is an optional
ingredient. To the vegetable ingredient additional ingredients as
required or permitted by paragraph (c) of this section are added, and
the food is sealed in a container and so processed by heat as to prevent
spoilage.
(b) The table referred to in paragraph (a) of this section is as
follows:
(c) Water is added to the vegetable ingredient, except that pimientos
may be canned with or without added water, and sweet potatoes in mashed
form are canned without added water. Asparagus may be canned with added
water, asparagus juice, or a mixture of both. For the purposes of this
section, asparagus juice is the clear, unfermented liquid expressed from
the washed and heated sprouts or parts of sprouts of the asparagus
plant, and mixtures of asparagus juice and water are considered to be
water when such mixtures are used as a packing medium for canned
asparagus. In the case of artichokes, a vinegar or any safe and
suitable organic acid, which either is not a food additive as defined in
section 201(s) of the Federal Food, Drug, and Cosmetic Act, or if it is
a food additive as so defined, is used in conformity with regulations
established pursuant to section 409 of the act, is added in such
quantity as to reduce the pH of the finished canned vegetable to 4.5 or
below. The following optional ingredients, in the case of the
vegetables specified, may be added:
(1) An edible vegetable oil, in the cases of artichokes and
pimientos.
(2) Snaps, in the cases of shelled beans, black-eyed peas, and field
peas.
(3) In the case of all vegetables (except canned mashed sweet
potatoes as regards the seasonings listed in paragraph (c)(3)(iii) of
this section) one or more of the following optional seasoning
ingredients may be added in a quantity sufficient to season the food.
(i) Refined sugar (sucrose).
(ii) Refined corn sugar (dextrose).
(iii) Corn sirup, glucose sirup.
(iv) Dried corn sirup, dried glucose sirup.
(v) Spice.
(vi) A vinegar.
(vii) Green peppers or red peppers which may be dried.
(viii) Mint leaves.
(ix) Onions, which may be dried.
(x) Garlic, which may be dried.
(xi) Horseradish.
(xii) Lemon juice or concentrated lemon juice.
(xiii) Butter or margarine in a quantity not less than 3 percent by
weight of the finished food. When butter or margarine is added, safe
and suitable emulsifiers or stabilizers, or both, may be added. When
butter or margarine is added, no spice or flavoring simulating the color
or flavor imparted by butter or margarine is used.
(4) In the case of all vegetables, the following optional ingredients
may be added:
(i) Salt.
(ii) Monosodium glutamate.
(iii) Disodium inosinate complying with the provisions of 172.535 of
this chapter.
(iv) Disodium guanylate complying with the provisions of 172.530 of
this chapter.
(v) Hydrolyzed vegetable protein.
(vi) Autolyzed yeast extract.
(5) In the case of all vegetables flavoring (except artificial) may
be added.
(6) In the case of bean sprouts, lima beans, carrots, green sweet
peppers, red sweet peppers, and potatoes, any safe and suitable calcium
salts may be added as a firming agent.
(7) In the case of canned artichokes packed in glass containers,
ascorbic acid may be added in a quantity not to exceed 32 milligrams per
100 grams of the finished food.
(8) In the case of canned asparagus, ascorbic acid, erythorbic acid,
or the sodium salts of ascorbic acid or erythorbic acid may be added in
an amount necessary to preserve color in the ''white'' and
''green-tipped and white'' color types.
(9) In the case of canned asparagus packed in glass containers,
stannous chloride may be added in a quantity not to exceed 15 parts per
million calculated as tin (Sn), except that in the case of asparagus
packed in glass containers with lids lined with an inert material the
quantity of stannous chloride added may exceed 15 parts per million but
not 20 parts per million calculated as tin (Sn).
(10) In the case of canned black-eyed peas, disodium EDTA may be
added in a quantity not to exceed 145 parts per million.
(11) In the case of potatoes, calcium disodium EDTA may be added in a
quantity not to exceed 110 parts per million.
(12) A vinegar or any safe and suitable organic acid for all
vegetables (except artichokes, in which the quantity of such optional
ingredient is prescribed by the introductory text of paragraph (c) of
this section) in a quantity which, together with the amount of any lemon
juice or concentrated lemon juice that may be added, is not more than
sufficient to permit effective processing by heat without discoloration
or other impairment of the article.
(d) The name of each canned vegetable for which a definition and
standard of identity is prescribed by this section is the name or any
synonym thereof whereby such vegetable is designated in column I of the
table in paragraph (b) of this section.
(e) When two or more forms of the vegetable are specified in column
III of the table in paragraph (b) of this section, the label shall bear
the specified word or words, or in case synonyms are so specified, one
of such synonyms, showing the form of the vegetable ingredient present;
except that in the case of canned spinach, if the whole leaf is the
optional form used, the word ''spinach'' unmodified may be used in lieu
of the words ''whole leaf spinach''.
(f)(1) If the optional ingredient specified in paragraph (c)(1) of
this section is present, the label shall bear the statement ''
---------- oil added'' or ''With added ---------- oil'', the blank being
filled in with the common or usual name of the oil.
(2) If asparagus juice is used as a packing medium in canned
asparagus, the label shall bear the statement ''Packed in asparagus
juice''.
(3) If the optional ingredient specified in paragraph (c)(2) of this
section is present, the label shall bear the statement ''With snaps''.
(g) The name of the food shall include a declaration of any flavoring
that characterizes the product as specified in 101.122 of this chapter,
and a declaration of any spice or seasoning that characterizes the
product; for example, ''with added spice'', ''seasoned with red
peppers'', ''seasoned with butter''. Wherever the name of the vegetable
appears on the label so conspicuously as to be easily seen under
customary conditions of purchase, the words and statements specified in
paragraphs (e) and (f) (1) through (3) of this section shall immediately
and conspicuously precede or follow such name, without intervening
written, printed, or graphic matter, except that the varietal name of
the vegetable may so intervene.
(h) Each of the optional ingredients used shall be declared on the
label as required by the applicable sections of Part 101 of this
chapter.
(42 FR 14449, Mar. 15, 1977, as amended at 42 FR 30358, June 14,
1977; 46 FR 56410, Nov. 17, 1981; 48 FR 10813, Mar. 15, 1983; 49 FR
6711, Feb. 23, 1984)
21 CFR 155.201 Canned mushrooms.
(a) Identity -- (1) Definition. Canned mushrooms is the food
properly prepared from the caps and stems of succulent mushrooms
conforming to the characteristics of the species Agaricus (Psalliota)
bisporus or A. bitorquis, in one of the optional styles specified in
paragraph (a)(2) of this section, packed with a suitable liquid medium
which may include water; and may contain one or more safe and suitable
optional ingredients specified in paragraph (a)(3) of this section. The
food is sealed in a container and, before or after sealing, is so
processed by heat as to prevent spoilage.
(2) Styles. The optional styles of the mushroom ingredient referred
to in paragraph (a)(1) of this section are:
(i) Buttons -- consisting of whole mushrooms with attached stems not
exceeding 5 millimeters (0.2 inch) in length, measured from the bottom
of the veil.
(ii) Whole -- consisting of whole mushrooms with attached stems cut
to a length not exceeding the diameter of the cap, measured from the
bottom of the veil.
(iii) Quarters -- consisting of buttons or whole style cut into four
approximately equal parts.
(iv) Slices or sliced -- consisting of buttons or whole style of
which not less than 50 percent are cut parallel to the longitudinal axis
of the stem and 2 millimeters to 8 millimeters (0.08 inch to 0.32 inch)
in thickness.
(v) Random sliced -- consisting of buttons or whole style sliced in a
random manner.
(vi) Pieces and stems -- consisting of pieces of caps and stems of
irregular shapes and sizes.
(3) Optional ingredients. One or any combination of two or more of
the following safe and suitable optional ingredients as provided for in
paragraph (a)(1) of this section may be used:
(i) Salt.
(ii) Monosodium glutamate.
(iii) Disodium inosinate complying with the provisions of 172.535 of
this chapter.
(iv) Disodium guanylate complying with the provisions of 172.530 of
this chapter.
(v) Hydrolyzed vegetable protein.
(vi) Autolyzed yeast extract.
(vii) Ascorbic acid (vitamin C) in a quantity not to exceed 132
milligrams for each 100 grams (37.5 milligrams for each ounce) of
drained weight of mushrooms.
(viii) Organic acids (except no vinegar is permitted), only where the
inside metal of the container is fully enamel-lined and in glass
containers with fully enamel-lined caps. Ascorbic acid as provided for
in paragraph (a)(3)(vii) of this section.
(ix) Calcium disodium ethylenediaminetetraacetate (CaNa2 EDTA) in a
quantity not to exceed 200 parts per million for use to promote color
retention.
(4) Labeling requirements. (i) The name of the food is mushrooms.
The style as provided for in paragraph (a)(2) of this section shall be
included as part of the name or in close proximity to the name of the
food.
(ii) Each of the optional ingredients used shall be declared on the
label as required by the applicable sections of Part 101 of this
chapter.
(b) (Reserved)
(c) Fill of container. (1) The standard of fill of container for
canned mushrooms is:
(i) The fill of the mushroom ingredient and packing medium, as
determined by the general method for fill of container prescribed in
130.12(b) of this chapter, is not less than 90 percent of the total
capacity of the container.
(ii) The drained weight of the mushroom ingredient is not less than
56 percent of the water capacity of the container.
(iii) Determine drained weight as specified in 155.3(a).
(2) Determine compliance for minimum fill and drained weight as
specified in 155.3(b).
(3) If the canned mushrooms fall below the standard of fill
prescribed in paragraph (c)(1)(i) and/or (ii) and (2) of this section,
the label shall bear the general statement of substandard fill specified
in 130.14(b) of this chapter, in the manner and form therein
prescribed.
(48 FR 10813, Mar. 15, 1983)
21 CFR 155.201 Pt. 156
21 CFR 155.201 PART 156 -- VEGETABLE JUICES
21 CFR 155.201 Subpart A -- General Provisions
Sec.
156.3 Definitions.
21 CFR 155.201 Subpart B -- Requirements for Specific Standardized
Vegetable Juices
156.145 Tomato juice.
Authority: Secs. 201, 401, 403, 409, 701 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321, 341, 343, 348, 371).
21 CFR 155.201 Subpart A -- General Provisions
21 CFR 156.3 Definitions.
For the purpose of this part:
(a) ''Strength and redness of color'' means at least as much red as
obtained by comparison of the prepared product, with the blended color
produced by spinning a combination of the following concentric Munsell
color discs of equal diameter, or the color equivalent of such discs:
Disc 1 -- Red (5R 2.6/13) (glossy finish)
Disc 2 -- Yellow (2.5 YR 5/12) (glossy finish)
Disc 3 -- Black (N1) (glossy finish)
Disc 4 -- Grey (N4) (mat finish)
Such comparison is to be made in full diffused daylight or under a
diffused light source of approximately 2691 lux (250 footcandles) and
having a spectral quality approximating that of daylight under a
moderately overcast sky, with a correlated color temperature of 7,500
degrees Kelvin 200 degrees. With the light source directly over the
disc and product, observation is made at an angle of 45 degrees from a
distance of about 24 inches from the product. Electronic color meters
may be used as an alternate means of determining the color of tomato
juice. Such meters shall be calibrated to indicate that the color of
the product is as red or more red than that produced by spinning the
Munsell color discs in the combination as set out above.
(b) ''Tomato soluble solids'' means the sucrose value as determined
by the method prescribed in ''Official Methods of Analysis of the
Association of Official Analytical Chemists,'' 13th Ed., 1980, sections
32.014 to 32.016 and 52.012, under the headings ''Soluble Solids in
Tomato Products Official Final Action'' and ''Refractive Indices (n) of
Sucrose Solutions at 20 ,'' which is incorporated by reference. Copies
are available from the Association of Official Analytical Chemists, 2200
Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or available for
inspection at the Office of the Federal Register, 1100 L St. NW.,
Washington, DC 20408. If no salt has been added, the sucrose value
obtained from the referenced tables shall be considered the percent of
tomato soluble solids. If salt has been added, either intentionally or
through the application of the acidified break, determine the percent of
such added sodium chloride as specified in paragraph (c) of this
section. Subtract the percentage so found from the percentage of tomato
soluble solids found (sucrose value from the refractive index tables)
and multiply the difference by 1.016. The resultant value is considered
the percent of ''tomato soluble solids.''
(c) ''Salt'' means sodium chloride, determined as chloride and
calculated as percent sodium chloride, by the method prescribed in
''Official Methods of Analysis of the Association of Official Analytical
Chemists,'' 13th Ed., 1980, sections 32.025 to 32.030, under the heading
''Method III (Potentiometric Method),'' which is incorporated by
reference.
(d) ''Compliance'' means the following: Unless otherwise provided in
a standard, a lot of canned vegetable juice shall be deemed in
compliance for the following factors, to be determined by the sampling
and acceptance procedure as provided in paragraph (e) of this section,
namely:
(1) Quality. The quality of a lot shall be considered acceptable
when the number of defectives does not exceed the acceptance number (c)
in the sampling plans.
(2) Fill of container. A lot shall be deemed to be in compliance for
fill of container when the number of defectives does not exceed the
acceptance number (c) in the sampling plans.
(e) ''Sampling and acceptance procedure'' means the following:
(1) Definitions -- (i) Lot. A collection of primary containers or
units of the same size, type, and style manufactured or packed under
similar conditions and handled as a single unit of trade.
(ii) Lot size. The number of primary containers or units in the lot.
(iii) Sample size (n). The total number of sample units drawn for
examination from a lot.
(iv) Sample unit. A container, a portion of the contents of a
container, or a composite mixture of product from small containers that
is sufficient for the examination or testing as a single unit. For fill
of container, the sample unit shall be the entire contents of the
container.
(v) Defective. Any sample unit shall be regarded as defective when
the sample unit does not meet the criteria set forth in the standards.
(vi) Acceptance number (c). The maximum number of defective sample
units permitted in the sample in order to consider the lot as meeting
the specified requirements.
(vii) Acceptable quality level (AQL). The maximum percent of
defective sample units permitted in a lot that will be accepted
approximately 95 percent of the time.
(2) Sampling plans:
(48 FR 3956, Jan. 28, 1983, as amended at 54 FR 24895, June 12, 1989)
21 CFR 156.3 Subpart B -- Requirements for Specific Standardized Vegetable Juices
21 CFR 156.145 Tomato juice.
(a) Identity -- (1) Definition. Tomato juice is the food intended
for direct consumption, obtained from the unfermented liquid extracted
from mature tomatoes of the red or reddish varieties of Lycopersicum
esculentum P. Mill, with or without scalding followed by draining. In
the extraction of such liquid, heat may be applied by any method which
does not add water thereto. Such juice is strained free from peel,
seeds, and other coarse or hard substances, but contains finely divided
insoluble solids from the flesh of the tomato in accordance with current
good manufacturing practice. Such juice may be homogenized, may be
seasoned with salt, and may be acidified with any safe and suitable
organic acid. The juice may have been concentrated and later
reconstituted with water and/or tomato juice to a tomato soluble solids
content of not less than 5.0 percent by weight as determined by the
method prescribed in 156.3(b). The food is preserved by heat
sterilization (canning), refrigeration, or freezing. When sealed in a
container to be held at ambient temperatures, it is so processed by
heat, before or after sealing, as to prevent spoilage.
(2) Labeling. (i) The name of the food is:
(a) ''Tomato juice'' if it is prepared from unconcentrated undiluted
liquid extracted from mature tomatoes of reddish varieties.
(b) ''Tomato juice from concentrate'' if the finished juice has been
prepared from concentrated tomato juice as specified in paragraph (a)(1)
of this section or if the finished juice is a mixture of tomato juice
and tomato juice from concentrate.
(ii) Each of the optional ingredients used shall be declared on the
label as required by the applicable sections of Part 101 of this
chapter.
(b) Quality. (1) The standard of quality for tomato juice is as
follows:
(i) The strength and redness of color is not less than the composite
color produced by spinning the Munsell color discs in the following
combination:
53 percent of the area of Disc 1;
28 percent of the area of Disc 2; and
19 percent of the area of either Disc 3 or Disc 4; or 9 1/2 percent
of the area of Disc 3 and 9 1/2 percent of the area of Disc 4, whichever
most nearly matches the appearance of the tomato juice.
(ii) Not more than two defects for peel and blemishes, either singly
or in combination, in addition to three defects for seeds or pieces of
seeds, defined as follows, per 500 milliliters (16.9 fluid ounces):
(a) Pieces of peel 3.2 millimeters (0.125 inch) or greater in length.
(b) Blemishes such as dark brown or black particles (specks) greater
than 1.6 millimeters (0.0625 inch) in length.
(c) Seeds or pieces of seeds 3.2 millimeters (0.125 inch) or greater
in length.
(2) Methodology. (i) Determine strength and redness of color as
specified in 156.3(a).
(ii) Examine a total of 500 milliliters for peel, blemishes, and
seeds. Divide the 500-milliliter sample into two 250-milliliter
aliquots and pour each aliquot onto separate 30.5 x 45.7 centimeters (12
x 18 inches) white grading trays. Remove defects and evaluate for color
and size as defined in paragraph (b)(1)(ii) of this section.
(3) Determine compliance as specified in 156.3(d).
(4) If the quality of the tomato juice falls below the standard
prescribed in paragraph (b)(1) and (3) of this section, the label shall
bear the general statement of substandard quality specified in
130.14(a) of this chapter, in the manner and form therein specified, but
in lieu of such general statement of substandard quality when the
quality of the tomato juice falls below the standard in one or more
respects, the label may bear the alternative statement, ''Below Standard
in Quality ------------'', the blank to be filled in with the words
specified after the corresponding paragraph (s) under paragraph (b)(1)
of this section which such tomato juice fails to meet, as follows:
(i) ''Poor color''.
(ii)(a) ''Excessive pieces of peel''.
(b) ''Excessive blemishes''.
(c) ''Excessive seeds'' or ''excessive pieces of seed''.
(c) Fill of container. (1) The standard of fill of container for
tomato juice, as determined by the general method for fill of container
prescribed in 130.12(b) of this chapter, is not less than 90 percent of
the total capacity, except when the food is frozen.
(2) Determine compliance as specified in 156.3(d).
(3) If the tomato juice falls below the standard of fill prescribed
in paragraph (c)(1) and (2) of this section, the label shall bear the
general statement of substandard fill specified in 130.14(b) of this
chapter, in the manner and form therein prescribed.
(48 FR 3957, Jan. 28, 1983)
Effective Date Note: The information collection requirements
contained in 156.145 have been submitted to the Office of Management
and Budget for approval. These requirements will not be effective until
FDA obtains OMB approval. FDA will publish a notice concerning OMB
approval of these requirements in the Federal Register.
21 CFR 156.145 PART 158 -- FROZEN VEGETABLES
21 CFR 156.145 Pt. 158
21 CFR 156.145 Subpart A -- General Provisions
Sec.
158.3 Definitions.
21 CFR 156.145 Subpart B -- Requirements for Specific Standardized
Frozen Vegetables
158.170 Frozen peas.
Authority: Secs. 201, 401, 403, 409, 701 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321, 341, 343, 348, 371).
21 CFR 156.145 Subpart A -- General Provisions
21 CFR 158.3 Definitions.
For the purposes of this part the following definitions shall apply:
(a) Lot. A collection of primary containers or units of the same
size, type and style manufactured or packed under similar conditions and
handled as a single unit of trade.
(b) Lot size. The number of primary containers or units (pounds when
in bulk) in the lot.
(c) Sample size. The total number of sample units drawn for
examination from a lot.
(d) Sample unit. A container, a portion of the contents of a
container, or a composite mixture of product from small containers that
is sufficient for the examination or testing as a single unit.
(e) Defective. Any sample unit shall be regarded as defective when
the sample unit does not meet the criteria set forth in the standards.
(f) Acceptance number. The maximum number of defective sample units
permitted in the sample in order to consider the lot as meeting the
specified requirements. The following acceptance numbers shall apply:
(g) Acceptable quality level (AQL). The maximum percent of defective
sample units permitted in a lot that will be accepted approximately 95
percent of the time.
(42 FR 14461, Mar. 15, 1977)
21 CFR 158.3 Subpart B -- Requirements for Specific Standardized Frozen Vegetables
21 CFR 158.170 Frozen peas.
(a) Identity -- (1) Product definition. Frozen peas is the food in
''package'' form as that term is defined in 1.20 of this chapter,
prepared from the succulent seed of the pea plant of the species Pisum
sativum L. Any suitable variety of pea may be used. It is blanched,
drained, and preserved by freezing in such a way that the range of
temperature of maximum crystallization is passed quickly. The freezing
process shall not be regarded as complete until the product temperature
has reached -- 18 C (0 F) or lower at the thermal center, after
thermal stabilization. Such food may contain one, or any combination of
two or more, of the following safe and suitable optional ingredients:
(i) Natural and artificial flavors.
(ii) Condiments such as spices and mint leaves.
(iii) Dry nutritive carbohydrate sweeteners.
(iv) Salt.
(v) Monosodium glutamate and other glutamic acid salts.
(2) Size specifications. If size graded, frozen peas shall contain
not less than 80 percent by weight of peas of the size declared or of
smaller sizes. The sample unit may not contain more than 20 percent by
weight of peas of the next two larger sizes, of which not more than one
quarter by weight of such peas may be of the larger of these two sizes,
and may contain no peas larger than the next two larger sizes, if such
there be. The following sizes and designations shall apply:
(3) Labeling. The name of the product is ''peas''. The term
''early'', ''June'', or ''early June'' shall precede or follow the name
in the case of smooth-skin or substantially smooth-skin peas, such as
Alaska-type peas. Where the peas are of sweet green wrinkled varieties,
the name may include the designation ''sweet'', ''green'', ''wrinkled'',
or any combination thereof. The label shall contain the words
''frozen'' or ''quick frozen''. The name of the food shall include a
declaration of any flavoring that characterizes the product as specified
in 101.22 of this chapter and a declaration of any condiment such as
spices and mint leaves that characterizes the product, e.g., ''Spice
added''. Where a statement of pea size is made, such statement shall
indicate either the size designation as specified in paragraph (a)(2) of
this section or the applicable sieve size. However, the optional
descriptive words ''petite'' or ''tiny'' may be used in conjunction with
the product name when an average of 80 percent or more of the peas will
pass through a circular opening of a diameter of 8.75 mm (0.34 in) or
less for sweet green wrinkled peas and 8.2 mm (0.32 in) for smooth-skin
or substantially smooth-skin peas, such as Alaska-type peas.
(4) Ingredient statement. The name of each of the ingredients used
shall be declared on the label as required by the applicable sections of
Part 101 of this chapter.
(b) Quality -- (1) The standard of quality for frozen peas is as
follows:
(i) Not more than 4 percent by weight blond peas, i.e., yellow or
white but edible peas;
(ii) Not more than 10 percent by weight blemished peas, i.e.,
slightly stained or spotted peas;
(iii) Not more than 2 percent by weight seriously blemished peas,
i.e., peas that are hard, shrivelled, spotted, discolored or otherwise
blemished to an extent that the appearance or eating quality is
seriously affected.
(iv) Not more than 15 percent by weight pea fragments, i.e., portions
of peas, separated or individual cotyledons, crushed, partial or broken
cotyledons and loose skins, but excluding entire intact peas with skins
detached;
(v) Not more than 0.5 percent by weight, or more than 12 sq cm (2 sq
in) in area, extraneous vegetable material, i.e., vine or leaf or pod
material from the pea plant or other such material per sample unit as
defined in paragraph (b) of this section.
(vi) The sum of the pea material described in paragraphs (b)(1) (i),
(ii), (iii), and (iv) of this section shall not exceed 15 percent.
(vii) For peas that meet the organoleptic and analytical
characteristics of sweet green wrinkled varieties:
(a) The alcohol-insoluble solids may not be more than 19 percent
based on the procedure set forth in paragraph (b)(3) of this section.
(b) Not more than 15 percent by count of the peas may sink in a
solution containing 16 percent salt by weight according to the brine
flotation test set forth in paragraph (b)(4) of this section;
(viii) For smooth-skin or substantially smooth-skin varieties the
alcohol insoluble solids may not be more than 23 percent based on the
procedure set forth in paragraph (b)(3) of this section.
(ix) The quality of a lot shall be considered acceptable when the
number of defectives does not exceed the acceptance number in the
sampling plans set forth in 158.3(f).
(2) The sample unit for determining compliance with the requirements
of paragraph (b)(1) of this section other than those of paragraphs
(b)(1)(vii)(a) and (b)(1)(viii) of this section, shall be 500 g (17.6
oz). For the determination of alcohol-insoluble solids as specified in
paragraph (b)(3) of this section, the container may be the sample unit.
(3) Alcohol-insoluble solids determination.
(i) Extracting solutions:
(a) One hundred parts of ethanol denatured with five parts of
methanol volume to volume (formula 3A denatured alcohol), or
(b) A mixture of 95 parts of formula 3A denatured alcohol and five
parts of isopropanol v/v.
(ii) Eighty percent alcohol (8 liters of extracting solutions,
specified in paragraph (b)(3)(i) (a) or (b) of this section, diluted to
9.5 liters with water).
(iii) Drying dish -- a flat-bottom dish with a tight fitting cover.
(iv) Drying oven -- a properly ventilated oven thermostatically
controlled at 100 2 C.
(v) Procedure -- Transfer frozen contents of package to plastic bag;
tie bag securely and immerse in water bath with continuous flow at room
temperature. Avoid agitation of bag during thawing by using clamps or
weights. When sample completely thaws, remove bag, blot off adhering
water, and transfer peas to U.S. No. 8 sieve, using (20 cm.) size for
container of less than 3 lb. net weight and (30.5 cm.) for larger
quantities. Without shifting peas, incline sieve to aid drainage, drain
2 minutes. With cloth wipe surplus water from lower screen surface.
Weigh 250 g. of peas into high-speed blender, add 250 g. of water and
blend to smooth paste. For less than 250 g. sample, use entire sample
with equal weight of water. Weight 20 g. 10 mg. of the paste into 250
ml. distillation flask, add 120 ml. of extracting solutions specified
in paragraph (b)(3)(i) (a) or (b) of this section, and reflux 30 minutes
on steam or water bath or hotplate. Fit into a buchner funnel a filter
paper of appropriate size (previously prepared by drying in flatbottom
dish for 2 hours in drying oven, covering, cooling in desiccator, and
weighing). Apply vacuum to buchner funnel and transfer contents of
beaker so as to avoid running over edge of paper. Aspirate to dryness
and wash material on filter with 80 percent alcohol until washings are
clear and colorless. Transfer paper and alcohol-insoluble solids to
drying dish used to prepare paper, dry uncovered for 2 hours in drying
oven, cover, cool in desiccator, and weigh at once. From this weight
deduct weight of dish, cover, and paper. Calculate percent by weight of
alcohol-insoluble solids.
(4) Brine flotation test. (i) Explanation -- The brine flotation
test utilizes salt solutions of various specific gravities to separate
the peas according to maturity. The brine solutions are based on the
percentage by weight of pure salt (NaCl) in solution at 20 C. In
making the test the brine solutions are standardized to the proper
specific gravity equivalent to the specified ''percent of salt solutions
at 20 C'' by using a salometer spindle accurately calibrated at 20 C.
A 250 ml glass beaker or similar receptacle is filled with the brine
solution to a depth of approximately 50 mm. The brine solution and
sample (100 peas per container) must be at the same temperature and
should closely approximate 20 C.
(ii) Procedure -- After carefully removing the skins from the peas,
place the peas into the solution. Pieces of peas and loose skins should
not be used in making the brine flotation test. If cotyledons divide,
use both cotyledons in the test and consider the two separated
cotyledons as 1 pea; and, if an odd cotyledon sinks, consider it as one
pea. Only peas that sink to the bottom of the receptacle within 10
seconds after immersion are counted as ''peas that sink''.
(5) If the quality of the frozen peas falls below the standard
prescribed in paragraph (b)(1) of this section, the label shall bear the
general statement of substandard quality specified in the Code of
Federal Regulations but in lieu of the words prescribed in the second
line of the rectangle the following words may be used where the frozen
peas fall below the standard in only one respect: ''Below standard in
quality ------ '', the blank to be filled in with the specific reason
for substand- ard quality as listed in the standard.
(42 FR 14461, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22,
1977)
21 CFR 158.170 Pt. 160
21 CFR 158.170 PART 160 -- EGGS AND EGG PRODUCTS
21 CFR 158.170 Subpart A -- (Reserved)
21 CFR 158.170 Subpart B -- Requirements for Specific Standardized Eggs
and Egg Products
Sec.
160.100 Eggs.
160.105 Dried eggs.
160.110 Frozen eggs.
160.115 Liquid eggs.
160.140 Egg whites.
160.145 Dried egg whites.
160.150 Frozen egg whites.
160.180 Egg yolks.
160.185 Dried egg yolks.
160.190 Frozen egg yolks.
Authority: Secs. 201, 401, 403, 409, 701, 706 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321, 341, 343, 348, 371, 376).
Source: 42 FR 14462, Mar. 15, 1977, unless otherwise noted.
21 CFR 158.170 Subpart A -- (Reserved)
21 CFR 158.170 Subpart B -- Requirements for Specific Standardized Eggs and Egg Products
21 CFR 160.100 Eggs.
No regulation shall be promulgated fixing and establishing a
reasonable definition and standard of identity for the food commonly
known as eggs.
21 CFR 160.105 Dried eggs.
(a) Dried eggs, dried whole eggs are prepared by drying liquid eggs
that conform to 160.115, with such precautions that the finished food
is free of viable Salmonella microorganisms. They may be powdered.
Before drying, the glucose content of the liquid eggs may be reduced by
one of the optional procedures set forth in paragraph (b) of this
section. Either silicon dioxide complying with the provisions of
172.480 of this chapter or sodium silicoaluminate may be added as an
optional anticaking ingredient, but the amount of silicon dioxide used
is not more than 1 percent and the amount of sodium silicoaluminate used
is less than 2 percent by weight of the finished food. The finished
food shall contain not less than 95 percent by weight total egg solids.
(b) The optional glucose-removing procedures are:
(1) Enzyme procedure. A glucose-oxidase-catalase preparation and
hydrogen peroxide solution are added to the liquid eggs. The quantity
used and the time of reaction are sufficient to substantially reduce the
glucose content of the liquid eggs. The glucose-oxidase-catalase
preparation used is one that is generally recognized as safe within the
meaning of section 201(s) of the Federal Food, Drug, and Cosmetic Act.
The hydrogen peroxide solution used shall comply with the specifications
of the United States Pharmacopeia, except that it may exceed the
concentration specified therein and it does not contain a preservative.
(2) Yeast procedure. The pH of the liquid eggs is adjusted to the
range of 6.0 to 7.0, if necessary, by the addition of dilute, chemically
pure hydrochloric acid, and controlled fermentation is maintained by
adding food-grade baker's yeast (Saccharomyces cerevisiae). The
quantity of yeast used and the time of reaction are sufficient to
substantially reduce the glucose content of the liquid eggs.
(c) The name of the food for which a definition and standard of
identity is prescribed by this section is ''Dried eggs'' or ''Dried
whole eggs'' and if the glucose content was reduced, as provided in
paragraph (b) of this section, the name shall be followed immediately by
the statement ''Glucose removed for stability'' or ''Stabilized, glucose
removed''.
(d)(1) When either of the optional anticaking ingredients specified
in paragraph (a) of this section is used, the label shall bear the
statement ''Not more than 1 percent silicon dioxide added as an
anticaking agent'' or ''Less than 2 percent sodium silicoaluminate added
as an anticaking agent'', whichever is applicable.
(2) The name of any optional ingredient used, as provided in
paragraph (d)(1) of this section, shall be listed on the principal
display panel or panels of the label with such prominence and
conspicuousness as to render such statement likely to be read and
understood by the ordinary individual under customary conditions of
purchase.
21 CFR 160.110 Frozen eggs.
(a) Frozen eggs, frozen whole eggs, frozen mixed eggs is the food
prepared by freezing liquid eggs that conform to 160.115, with such
precautions that the finished food is free of viable Salmonella
microorganisms.
(b) Monosodium phosphate or monopotassium phosphate may be added
either directly or in a water carrier, but the amount added does not
exceed 0.5 percent of the weight of the frozen eggs. If a water carrier
is used, it shall contain not less than 50 percent by weight of such
monosodium phosphate or monopotassium phosphate.
(c) When one of the optional ingredients specified in paragraph (b)
of this section is used, the label shall bear the statement ''Monosodium
phosphate (or monopotassium phosphate) added to preserve color'', or, in
case the optional ingredient used is added in a water carrier, the
statement shall be ''Monosodium phosphate (or monopotassium phosphate),
with ------ percent water as a carrier, added to preserve color'', the
blank being filled in to show the percent by weight of water used in
proportion to the weight of the finished food. The statement declaring
the optional ingredient used shall appear on the principal display panel
or panels with such prominence and conspicuousness as to render it
likely to be read and understood under customary conditions of purchase.
21 CFR 160.115 Liquid eggs.
Liquid eggs, mixed eggs, liquid whole eggs, mixed whole eggs are eggs
of the domestic hen broken from the shells and with yolks and whites in
their natural proportion as so broken. They may be mixed, or mixed and
strained, and they are pasteurized or otherwise treated to destroy all
viable Salmonella microorganisms. Pasteurization or such other
treatment is deemed to permit the adding of safe and suitable substances
(other than chemical preservatives) that are essential to the method of
pasteurization or other treatment used. For the purposes of this
paragraph, safe and suitable substances are those that perform a useful
function in the pasteurization or other treatment to render the liquid
eggs free of viable Salmonella microorganisms, and that are not food
additives as defined in section 201(s) of the Federal Food, Drug, and
Cosmetic Act; or, if they are food additives, they are used in
conformity with regulations established pursuant to section 409 of the
act.
21 CFR 160.140 Egg whites.
(a) Egg whites, liquid egg whites, liquid egg albumen is the food
obtained from eggs of the domestic hen, broken from the shells and
separated from yolks. The food may be mixed, or mixed and strained, and
is pasteurized or otherwise treated to destroy all viable Salmonella
microorganisms. Pasteurization or such other treatment is deemed to
permit the adding of safe and suitable substances (other than chemical
preservatives) that are essential to the method of pasteurization or
other treatment used. Safe and suitable substances that aid in
protecting or restoring the whipping properties of liquid egg whites may
be added. For the purposes of this paragraph, safe and suitable
substances are those that perform a useful function as whipping aids or
in the pasteurization or other treatment to render liquid egg whites
free of viable Salmonella microorganisms and that are not food additives
as defined in section 201(s) of the Federal Food, Drug, and Cosmetic
Act; or, if they are food additives, they are used in conformity with
regulations established pursuant to section 409 of the act.
(b) Any optional ingredients used as whipping aids, as provided for
in paragraph (a) of this section, shall be named on the principal
display panel or panels of labels with such prominence and
conspicuousness as to render such names likely to be read and understood
by ordinary individuals under customary conditions of purchase.
21 CFR 160.145 Dried egg whites.
(a) The food dried egg whites, egg white solids, dried egg albumen,
egg albumen solids is prepared by drying liquid egg whites conforming to
the requirements of 160.140 (or deviating from that section only by not
being Salmonella free). As a preliminary step to drying, the lysozyme
and avidin contents may be reduced. If lysozyme and avidin levels are
reduced, cation exchange resins regulated for use under 173.25 of this
chapter shall be used. As a further preliminary step to drying, the
glucose content of the liquid egg whites is reduced by adjusting the pH,
where necessary, with food-grade acid and by following one of the
optional procedures set forth in paragraph (b) of this section. If the
food is prepared from liquid egg whites conforming in all respects to
the requirements of 160.140, drying shall be done with such precautions
that the finished food is free of viable Salmonella microorganisms. If
the food is prepared from liquid egg whites that are not Salmonella
free, the dried product shall be so treated by heat or otherwise as to
render the finished food free of viable Salmonella microorganisms.
Dried egg whites may be powdered.
(b) The optional glucose-removing procedures are:
(1) Enzyme procedure. A glucose-oxidase-catalase preparation and
hydrogen peroxide solution are added to liquid egg whites. The quantity
used and the time of reaction are sufficient to substantially reduce the
glucose content. The glucose-oxidase-catalase preparation used is one
that is generally recognized as safe within the meaning of section
201(s) of the Federal Food, Drug, and Cosmetic Act. The hydrogen
peroxide solution used shall comply with the specifications of the
United States Pharmacopeia, except that it may exceed the concentration
specified therein and it does not contain a preservative.
(2) Controlled fermentation procedures -- (i) Yeast procedure.
Food-grade baker's yeast (Saccharomyces cerevisiae) is added to the
liquid egg whites and controlled fermentation is maintained. The
quantity of yeast used and the time of reaction are sufficient to
substantially reduce the glucose content.
(ii) Bacterial procedure. The liquid egg whites are subjected to the
action of a culture of glucose-fermenting bacteria either generally
recognized as safe within the meaning of section 201(s) of the Federal
Food, Drug, and Cosmetic Act or the subject of a regulation established
pursuant to section 409 of the act, and the culture is used in
conformity with such regulation. The quantity of the culture used is
sufficient to predominate in the fermentation and the time and
temperature of reaction are sufficient to substantially reduce the
glucose content.
(c)(1) Dried egg whites in which the lysozyme and avidin have been
reduced shall not be nutritionally inferior, as defined in
101.3(e)(4)(i) of this chapter, and shall be considered nutritionally
equivalent to untreated egg whites if they meet the conditions that the
biological quality of the protein contained is equal to or greater than
that of untreated egg white from the same batch of liquid egg white.
(2) Compliance with the biological quality of protein requirement of
paragraph (c)(1) of this section shall be determined by the analytical
method prescribed in ''Official Methods of Analysis of the Association
of Official Analytical Chemists,'' 14th Ed. (1984), section
43.253-43.257, ''Protein Efficiency Ratio, Rat Bioassay, Final Action,''
which is incorporated by reference. Copies may be obtained from the
Association of Official Analytical Chemists, 2200 Wilson Blvd., Suite
400, Arlington, VA 22201-3301, or may be examined at the Office of the
Federal Register, 1100 L St. NW., Washington, DC 20408.
(d) When the dried egg whites are prepared from liquid egg whites
containing any optional ingredients added as whipping aids, as provided
for in 160.140(a), the common names of such optional ingredients shall
be listed on the principal display panel or panels of the label with
such prominence and conspicuousness as to render the names likely to be
read and understood by ordinary individuals under customary conditions
of purchase.
(e) The name of the food for which a definition and standard of
identity is prescribed in this section is alternatively ''Dried egg
whites'', Egg white solids'', ''Dried egg albumen'', or ''Egg albumen
solids''. If the lysozyme and avidin content is reduced as provided in
paragraph (a) of this section, the name shall be immediately preceded or
followed by the statement ''lysozyme and avidin reduced'' when the dried
egg whites are sold as such. When the dried egg whites are used in a
fabricated food, the statement ''lysozyme and avidin reduced'' may be
omitted from any declaration of ingredients required under 101.4 of
this chapter.
(42 FR 14462, Mar. 15, 1977, as amended at 51 FR 11435, Apr. 3, 1986;
51 FR 25362, July 14, 1986; 54 FR 24895, June 12, 1989)
21 CFR 160.150 Frozen egg whites.
(a) Frozen egg whites, frozen egg albumen is the food prepared by
freezing liquid egg whites that conform to 160.140, with such
precautions that the finished food is free of viable Salmonella
microorganisms.
(b) When frozen egg whites are prepared from liquid egg whites
containing any optional ingredients added as whipping aids, as provided
for in 160.140(a), the common names of such optional ingredients shall
be listed on the principal display panel or panels of the label with
such prominence and conspicuousness as to render such names likely to be
read and understood by ordinary individuals under customary conditions
of purchase.
21 CFR 160.180 Egg yolks.
Egg yolks, liquid egg yolks, yolks, liquid yolks are yolks of eggs of
the domestic hen so separated from the whites thereof as to contain not
less than 43 percent total egg solids, as determined by the method
prescribed in ''Official Methods of Analysis of the Association of
Official Analytical Chemists,'' 13th Ed. (1980), sections 17.006 and
17.007 under ''Total Solids, Vacuum Method (3) -- Official Final
Action,'' which is incorporated by reference. Copies may be obtained
from the Association of Official Analytical Chemists, 2200 Wilson Blvd.,
Suite 400, Arlington, VA 22201-3301, or may be examined at the Office of
the Federal Register, 1100 L St. NW., Washington, DC 20408. They may
be mixed, or mixed and strained, and they are pasteurized or otherwise
treated to destroy all viable Salmonella microorganisms. Pasteurization
or such other treatment is deemed to permit the adding of safe and
suitable substances (other than chemical preservatives) that are
essential to the method of pasteurization or other treatment used. For
the purposes of this paragraph, safe and suitable substances are those
that perform a useful function in the pasteurization or other treatment
to render the egg yolks free of viable Salmonella microorganisms, and
that are not food additives as defined in section 201(s) of the Federal
Food, Drug, and Cosmetic Act; or, if they are food additives, they are
used in conformity with regulations established pursuant to section 409
of the act.
(42 FR 14462, Mar. 15, 1977, as amended at 47 FR 11832, Mar. 19,
1982; 49 FR 10102, Mar. 19, 1984; 54 FR 24895, June 12, 1989)
21 CFR 160.185 Dried egg yolks.
(a) Dried egg yolks, dried yolks is the food prepared by drying egg
yolks that conform to 160.180, with such precautions that the finished
food is free of viable Salmonella microorganisms. Before drying, the
glucose content of the liquid egg yolks may be reduced by one of the
optional procedures set forth in paragraph (b) of this section. Either
silicon dioxide complying with the provisions of 172.480 of this
chapter or sodium silicoaluminate may be added as an optional anticaking
ingredient, but the amount of silicon dioxide used is not more than 1
percent and the amount of sodium silicoaluminate used is less than 2
percent by weight of the finished food. The finished food shall contain
not less than 95 percent by weight total egg solids.
(b) The optional glucose-removing procedures are:
(1) Enzyme procedure. A glucose-oxidase-catalase preparation and
hydrogen peroxide solution are added to the liquid egg yolks. The
quantity used and the time of reaction are sufficient to substantially
reduce the glucose content of the liquid egg yolks. The
glucose-oxidase-catalase preparation used is one that is generally
recognized as safe within the meaning of section 201(s) of the Federal
Food, Drug, and Cosmetic Act. The hydrogen peroxide solution used shall
comply with the specification of the United States Pharmacopeia, except
that it may exceed the concentration specified therein and it does not
contain a preservative.
(2) Yeast procedure. The pH of the liquid egg yolks is adjusted to
the range of 6.0 to 7.0, if necessary, by the addition of dilute,
chemically pure hydrochloric acid, and controlled fermentation is
maintained by adding food-grade baker's yeast (Saccharomyces
cerevisiae). The quantity of yeast used and the time of reaction are
sufficient to substantially reduce the glucose content of the liquid egg
yolks.
(c) The name of the food for which a definition and standard of
identity is prescribed by this section is ''Dried egg yolks'', or
''Dried yolks'', and if the glucose content was reduced, as provided in
paragraph (b) of this section, the name shall be followed immediately by
the statement ''Glucose removed for stability'' or ''Stabilized, glucose
removed''.
(d)(1) When either of the optional anticaking ingredients specified
in paragraph (a) of this section is used, the label shall bear the
statement ''Not more than 1 percent silicon dioxide added as an
anticaking agent'' or ''Less than 2 percent sodium silicoaluminate added
as an anticaking agent'', whichever is applicable.
(2) The name of any optional ingredient used, as provided in
paragraph (d)(1) of this section, shall be listed on the principal
display panel or panels of the label with such prominence and
conspicuousness as to render such statement likely to be read and
understood by the ordinary individual under customary conditions of
purchase.
21 CFR 160.190 Frozen egg yolks.
Frozen egg yolks, frozen yolks is the food prepared by freezing egg
yolks that conform to 160.180, with such precautions that the finished
food is free of viable Salmonella microorga-nisms.
21 CFR 160.190 Pt. 161
21 CFR 160.190 PART 161 -- FISH AND SHELLFISH
21 CFR 160.190 Subpart A -- General Provisions
Sec.
161.30 Declaration of quantity of contents on labels for canned
oysters.
21 CFR 160.190 Subpart B -- Requirements for Specific Standardized Fish
and Shellfish
161.130 Oysters.
161.131 Extra large oysters.
161.132 Large oysters.
161.133 Medium oysters.
161.134 Small oysters.
161.135 Very small oysters.
161.136 Olympia oysters.
161.137 Large Pacific oysters.
161.138 Medium Pacific oysters.
161.139 Small Pacific oysters.
161.140 Extra small Pacific oysters.
161.145 Canned oysters.
161.170 Canned Pacific salmon.
161.173 Canned wet pack shrimp in transparent or nontransparent
containers.
161.175 Frozen raw breaded shrimp.
161.176 Frozen raw lightly breaded shrimp.
161.190 Canned tuna.
Authority: Secs. 201, 401, 403, 409, 701, 706 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321, 341, 343, 348, 371, 376).
Source: 42 FR 14464, Mar. 15, 1977, unless otherwise noted.
21 CFR 160.190 Subpart A -- General Provisions
21 CFR 161.30 Declaration of quantity of contents on labels for canned
oysters.
(a) For many years packers of canned oysters in the Gulf area of the
United States have labeled their output with a declaration of the
drained weight of oysters in the containers. Packers in other areas
have marketed canned oysters with a declaration of the total weight of
the contents of the container. Investigation reveals that under
present-day practice consumers generally do not discard the liquid
packing medium, but use it as a part of the food. Section 403(e)(2) of
the Federal Food, Drug, and Cosmetic Act and the regulations thereunder
require food in package form to bear an accurate label statement of the
quantity of food in the container.
(b) It is concluded that compliance with the label declaration of
quantity of contents requirement will be met by an accurate declaration
of the total weight of the contents of the can. The requirements of
161.145(c), establishing a standard of fill of container for canned
oysters and specifying the statement of substandard fill for those
canned oysters failing to meet that standard remain unaffected by this
interpretation.
21 CFR 161.30 Subpart B -- Requirements for Specific Standardized Fish and Shellfish
21 CFR 161.130 Oysters.
(a) Oysters, raw oysters, shucked oysters, are the class of foods
each of which is obtained by shucking shell oysters and preparing them
in accordance with the procedure prescribed in paragraph (b) of this
section. The name of each such food is the name specified in the
applicable definition and standard of identity prescribed in 161.131
to 161.140, inclusive.
(b) If water, or salt water containing less than 0.75 percent salt,
is used in any vessel into which the oysters are shucked the combined
volume of oysters and liquid when such oysters are emptied from such
vessel is not less than four times the volume of such water or salt
water. Any liquid accumulated with the oysters is removed. The oysters
are washed, by blowing or otherwise, in water or salt water, or both.
The total time that the oysters are in contact with water or salt water
after leaving the shucker, including the time of washing, rinsing, and
any other contact with water or salt water is not more than 30 minutes.
In computing the time of contact with water or salt water, the length of
time that oysters are in contact with water or salt water that is
agitated by blowing or otherwise, shall be calculated at twice its
actual length. Any period of time that oysters are in contact with salt
water containing not less than 0.75 percent salt before contact with
oysters, shall not be included in computing the time that the oysters
are in contact with water or salt water. Before packing into the
containers for shipment or other delivery for consumption the oysters
are thoroughly drained and are packed without any added substance.
(c) For the purposes of this section:
(1) ''Shell oysters'' means live oysters of any of the species,
Ostrea virginica, Ostrea gigas, Ostrea lurida, in the shell, which,
after removal from their beds, have not been floated or otherwise held
under conditions which result in the addition of water.
(2) ''Thoroughly drained'' means one of the following:
(i) The oysters are drained on a strainer or skimmer which has an
area of not less than 300 square inches per gallon of oysters, drained,
and has perforations of at least 1/4 of an inch in diameter and not more
than 1 1/4 inches apart, or perforations of equivalent areas and
distribution. The oysters are distributed evenly over the draining
surface of the skimmer and drained for not less than 5 minutes; or
(ii) The oysters are drained by any method other than that prescribed
by paragraph (c)(2)(i) of this section whereby liquid from the oysters
is removed so that when the oysters are tested within 15 minutes after
packing by draining a representative gallon of oysters on a skimmer of
the dimensions and in the manner described in paragraph (c)(2)(i) of
this section for 2 minutes, not more than 5 percent of liquid by weight
is removed by such draining.
21 CFR 161.131 Extra large oysters.
Extra large oysters, oysters counts (or plants), extra large raw
oysters, raw oysters counts (or plants), extra large shucked oysters,
shucked oysters counts (or plants), are of the species Ostrea virginica
and conform to the definition and standard of identity prescribed for
oysters by 161.130 and are of such size that 1 gallon contains not more
than 160 oysters and a quart of the smallest oysters selected therefrom
contains not more than 44 oysters.
21 CFR 161.132 Large oysters.
Large oysters, oysters extra selects, large raw oysters, raw oysters
extra selects, large shucked oysters, shucked oysters extra selects, are
of the species Ostrea virginica and conform to the definition and
standard of identity prescribed for oysters by 161.130 and are of such
size that 1 gallon contains more than 160 oysters but not more than 210
oysters; a quart of the smallest oysters selected therefrom contains
not more than 58 oysters, and a quart of the largest oysters selected
therefrom contains more than 36 oysters.
21 CFR 161.133 Medium oysters.
Medium oysters, oysters selected, medium raw oysters, raw oysters
selects, medium shucked oysters, shucked oysters selects, are of the
species Ostrea virginica and conform to the definition and standard of
identity prescribed for oysters by 161.130 and are of such size that 1
gallon contains more than 210 oysters, but not more than 300 oysters; a
quart of the smallest oysters selected therefrom contains not more than
83 oysters, and a quart of the largest oysters selected therefrom
contains more than 46 oysters.
21 CFR 161.134 Small oysters.
Small oysters, oysters standards, small raw oysters, raw oysters
standards, small shucked oysters, shucked oysters standards, are of the
species Ostrea virginica and conform to the definition and standards of
identity prescribed for oysters by 161.130 and are of such size that 1
gallon contains more than 300 oysters but not more than 500 oysters; a
quart of the smallest oysters selected therefrom contains not more than
138 oysters and a quart of the largest oysters selected therefrom
contains more than 68 oysters.
21 CFR 161.135 Very small oysters.
Very small oysters, very small raw oysters, very small shucked
oysters are of the species Ostrea virginica and conform to the
definition and standard of identity prescribed for oysters by 161.130
and are of such size that 1 gallon contains more than 500 oysters, and a
quart of the largest oysters selected therefrom contains more than 112
oysters.
21 CFR 161.136 Olympia oysters.
Olympia oysters, raw Olympia oysters, shucked Olympia oysters, are of
the species Ostrea lurida and conform to the definition and standard of
identity prescribed for oysters in 161.130.
21 CFR 161.137 Large Pacific oysters.
Large Pacific oysters, large raw Pacific oysters, large shucked
Pacific oysters, are of the species Ostrea gigas and conform to the
definitions and standards of identity prescribed for oysters by 161.130
and are of such size that 1 gallon contains not more than 64 oysters,
and the largest oyster in the container is not more than twice the
weight of the smallest oyster therein.
21 CFR 161.138 Medium Pacific oysters.
Medium Pacific oysters, medium raw Pacific oysters, medium shucked
Pacific oysters, are of the species Ostrea gigas and conform to the
definition and standard of identity prescribed for oysters by 161.130
and are of such size that 1 gallon contains more than 64 oysters and not
more than 96 oysters, and the largest oyster in the container is not
more than twice the weight of the smallest oyster therein.
21 CFR 161.139 Small Pacific oysters.
Small Pacific oysters, small raw Pacific oysters, small shucked
Pacific oysters, are of the species Ostrea gigas and conform to the
definition and standard of identity prescribed for oysters by 161.130
and are of such size that 1 gallon contains more than 96 oysters and not
more than 144 oysters, and the largest oyster in the container is not
more than twice the weight of the smallest oyster therein.
21 CFR 161.140 Extra small Pacific oysters.
Extra small Pacific oysters, extra small raw Pacific oysters, extra
small shucked Pacific oysters, are of the species Ostrea gigas and
conform to the definition and standard of identity prescribed for
oysters by 161.130 and are of such size that 1 gallon contains more
than 144 oysters, and the largest oyster in the container is not more
than twice the weight of the smallest oyster therein.
21 CFR 161.145 Canned oysters.
(a) Identity. (1) Canned oysters is the food prepared from one or
any mixture of two or all of the forms of oysters specified in paragraph
(a)(2) of this section, and a packing medium of water, or the watery
liquid draining from oysters before or during processing, or a mixture
of such liquid and water. The food may be seasoned with salt. It is
sealed in containers and so processed by heat as to prevent spoilage.
(2) The forms of oysters referred to in paragraph (a)(1) of this
section are prepared from oysters which have been removed from their
shells and washed and which may be steamed while in the shell or steamed
or blanched or both after removal therefrom, and are as follows:
(i) Whole oysters with such broken pieces of oysters as normally
occur in removing oysters from their shells, washing, and packing.
(ii) Pieces of oysters obtained by segregating pieces of oysters
broken in shucking, washing, or packing whole oysters.
(iii) Cut oysters obtained by cutting whole oysters.
(3)(i) When the form of oysters specified in paragraph (a)(2)(i) of
this section is used, the name of the food is ''Oysters'' or ''Cove
oysters'', if of the species Ostrea virginica; ''Oysters'' or ''Pacific
oysters'', if of the species Ostrea gigas; ''Oysters'' or ''Olympia
oysters'', if of the species Ostrea lurida.
(ii) When the form of oysters specified in paragraph (a)(2)(ii) of
this section is used, the name of the food is ''Pieces of -------- '',
the blank being filled in with the name ''Oysters'' or ''Cove oysters'',
if of the species Ostrea virginica; ''Oysters'' or ''Pacific oysters'',
if of the species Ostrea gigas; ''Oysters'' or ''Olympia oysters'', if
of the species Ostrea lurida.
(iii) When the form of oysters specified in paragraph (a)(2)(iii) of
this section is used, the name of the food is ''Cut ---- '', the blank
being filled in with the name ''Oysters'' or ''Cove oysters'', if of the
species Ostrea virginica; ''Oysters'' or ''Pacific oysters'', if of the
species Ostrea gigas; ''Oysters'' or ''Olympia oysters'', if of the
species Ostrea lurida.
(iv) In case a mixture of two or all such forms of oysters is used,
the name is a combination of the names specified in this paragraph
(a)(3) of the forms of oysters used, arranged in order of their
predominance by weight.
(b) (Reserved)
(c) Fill of container. (1) The standard of fill of container for
canned oysters is a fill such that the drained weight of oysters taken
from each container is not less than 59 percent of the water capacity of
the container.
(2) Water capacity of containers is determined by the general method
provided in 130.12(a) of this chapter.
(3) Drained weight is determined by the following method: Keep the
un-opened canned oyster container at a temperature of not less than 68
or more than 95 Fahrenheit for at least 12 hours immediately preceding
the determination. After opening, tilt the container so as to
distribute its contents evenly over the meshes of a circular sieve which
has been previously weighed. The diameter of the sieve is 8 inches if
the quantity of the contents of the container is less than 3 pounds, and
12 inches if such quantity is 3 pounds or more. The bottom of the sieve
is woven-wire cloth that complies with the specifications for such cloth
set forth under ''2.38 mm (No. 8)'' in ''Official Methods of Analysis of
the Association of Official Analytical Chemists,'' 13th Ed. (1980),
Table 1, ''Nominal Dimensions of Standard Test Sieves (U.S.A. Standard
Series),'' under the heading ''Definitions of Terms and Explanatory
Notes,'' which is incorporated by reference. Copies may be obtained
from the Association of Official Analytical Chemists, 2200 Wilson Blvd.,
Suite 400, Arlington, VA 22201-3301, or may be examined at the Office of
the Federal Register, 1100 L St. NW., Washington, DC 20408. Without
shifting the material on the sieve, so incline the sieve as to
facilitate drainage. Two minutes from the time drainage begins, weigh
the sieve and the drained oysters. The weight so found, less the weight
of the sieve, shall be considered to be the drained weight of the
oysters.
(4) If canned oysters fall below the standard of fill of container
prescribed in paragraph (a) of this section, the label shall bear the
general statement of substandard fill specified in 130.14(b) of this
chapter in the manner and form therein specified, followed by the
statement, ''A can of this size should contain ------ oz. of oysters.
This can contains only ------ oz.'', the blanks being filled in with the
applicable figures.
(42 FR 14464, Mar. 15, 1977, as amended at 47 FR 11832, Mar. 19,
1982; 49 FR 10102, Mar. 19, 1984; 54 FR 24895, June 12, 1989)
21 CFR 161.170 Canned Pacific salmon.
(a) Identity. (1) Canned Pacific salmon is the food prepared from
one of the species of fish enumerated in paragraph (a)(2) of this
section, prepared in one of the forms of pack specified in paragraph
(a)(3) of this section, and to which may be added one or more of the
optional ingredients specified in paragraph (a)(4) of this section. The
food is packed in hermetically sealed containers and so processed by
heat as to prevent spoilage and soften bones. The food is labeled in
accordance with paragraph (a)(5) of this section.
(2)(i) The species of fish which may be used in this food are:
(ii) For the purpose of paragraph (a) (5)(i) of this section, the
common or usual name or names of each species of fish enumerated in
paragraph (a)(2)(i) of this section is (are) the name(s) immediately
following the scientific name of each species.
(3) The optional forms of canned Pacific salmon are processed from
fish prepared by removing the head, gills, and tail, and the viscera,
blood, fins, and damaged or discolored flesh to the greatest extent
practicable in accordance with good manufacturing practice; and then
washing. Canned Pacific salmon is prepared in one of the following
forms of pack:
(i) ''Regular'' consists of sections or steaks which are cut
transversely from the fish and filled vertically into the can. In
preparation, segments of skin or large backbone may be removed. The
sections or steaks are so packed that the cut surfaces approximately
parallel the ends of the container. A small portion of salmon may be
added if necessary to complete the fill of the container.
(ii) ''Skinless and backbone removed'' consists of the regular form
of canned salmon set forth in paragraph (a)(3)(i) of this section from
which the skin and vertebrae have been removed in accordance with good
manufacturing practices.
(iii) ''Minced salmon'' consists of salmon which has been minced or
ground.
(iv) ''Salmon tips or tidbits'' consists of small pieces of salmon.
(v) ''No salt added'' consists of canned salmon to which no salt has
been added.
(4) One or more of the following optional ingredients may be added to
the food:
(i) Salt.
(ii) Edible salmon oil comparable in color, viscosity, and flavor to
the oil which would occur naturally in the species of salmon canned.
(5)(i) The name of the food is ''salmon'' together with the common or
usual name or names of the species. At least one species name shall be
printed in letters of the same style of type and not less in height than
those used for the word ''salmon''.
(ii) (a) Whenever the form of pack is that described in paragraph
(a)(3) (ii), (iii), or (iv) of this section, the word or words
describing the form of pack shall immediately precede or follow the name
of the food without intervening written, printed, or graphic matter in
the manner prescribed in 101.3(c) of this chapter; for example, ''red
salmon'' as the name of the food followed by ''skinless and backbone
removed''.
(b) Whenever the form of pack is that described in paragraph
(a)(3)(v) of this section and words describing the form of pack are
declared on the label, the label shall also bear the statements required
by 105.69 of this chapter.
(iii) The name of each of the ingredients used shall be declared on
the label as required by the applicable sections of Part 101 of this
chapter.
(b) (Reserved)
(c) Fill of container. (1) The standard of fill of container for
canned salmon is a fill including all the contents of the container and
is not less than the minimum net weight specified for the corresponding
can size in the following table:
If the can size in question is not listed, calculate the value for
Column II as follows: From the list, select as the comparable can size,
that one having the nearest water capacity of the can size in question,
multiply the net weight listed in Column II by the water capacity of the
can size in question, and divide by the water capacity of the comparable
can size. Water capacities are determined by the general method
provided in 130.12(a) of this chapter.
(2) Sampling and acceptance procedure: The sample size of the sample
representing the lot will be selected in accordance with the sampling
plan shown in paragraph (c)(2)(ii) of this section. A lot is to be
considered acceptable when the average net weight of all the sample
units is not less than the minimum net weight stated in paragraph (c)(1)
of this section for the corresponding can size.
(i) Definitions of terms to be used in the sampling plans in
paragraph (c)(2) (ii) of this section are as follows:
(a) Lot. A collection of primary containers or units of the same
size, type, and style manufactured or packed under similar conditions
and handled as a single unit of trade.
(b) Lot size. The number of primary containers or units in the lot.
(c) Sample size (n). The total number of sample units drawn for
examination from a lot.
(d) Sample unit. A container, the entire contents of a container, a
portion of the contents of a container, or a composite mixture of
product from small containers that is sufficient for examination or
testing as a single unit.
(ii) Sampling plans:
(3) If canned salmon falls below the standard of fill of container
prescribed in paragraph (c)(1) of this section, the label shall bear the
general statement of substandard fill specified in 130.14(b) of this
chapter, in the manner and form therein specified.
21 CFR 161.173 Canned wet pack shrimp in transparent or nontransparent
containers.
(a) Identity. (1) Canned wet pack shrimp is the food consisting of
the processed meat of peeled shrimp, free of heads and, to the extent
practicable under good manufacturing practice, free of shells, legs, and
antennae; in one or any combination of species enumerated in paragraph
(a)(2) of this section; prepared in one of the styles specified in
paragraph (a)(3) of this section, in sufficient water or other suitable
aqueous packing medium to fill the interstices and permit proper
processing in accordance with good manufacturing practice. Canned
shrimp may contain one or more of the optional ingredients specified in
paragraph (a)(4) of this section. It is packed in hermetically sealed
transparent or nontransparent containers and so processed by heat as to
prevent spoilage.
(2) The species of shrimp that may be used in the food are of the
families: Penaeidae, Pandalidae, Crangonidae, and Palaemonidae.
(3) Styles. Canned shrimp is prepared in one of the following
styles:
(i) Shrimp with readily visible dark vein (dorsal tract, back vein,
or sand vein).
(ii) Deveined shrimp containing not less than 95 percent by weight of
shrimp prepared by removing the dark vein from the first five segments
by deliberate cutting action.
(iii) Shrimp, other than ''deveined'' as described in paragraph
(a)(3)(ii) of this section, containing not less than 95 percent by
weight of shrimp with no readily visible dark vein within the first five
segments.
(iv) Broken shrimp, consisting of less than four segments and
otherwise conforming to one of the styles described in paragraph
(a)(3)(i), (ii), or (iii) of this section.
(4) Optional ingredients. The following safe and suitable optional
ingredients may be used:
(i) Salt.
(ii) Lemon juice.
(iii) Organic acids.
(iv) Nutritive carbohydrate sweeteners.
(v) Spices or spice oils or spice extracts.
(vi) Flavorings.
(vii) Sodium bisulfite.
(viii) Calcium disodium EDTA (calcium disodium
ethylene-diaminetetraacetate), complying with the provisions of 172.120
of this chapter.
(5) Labeling. (i) The name of the food is ''shrimp'' or ''shrimps.''
The word ''prawns'' may appear on the label in parentheses immediately
after the word ''shrimp'' or ''shrimps'' if the shrimp are of large or
extra large size as designated in paragraph (a)(5)(iv) of this section.
(ii) When the food is of the style described in paragraph (a)(3)(ii)
of this section, the words ''cleaned,'' ''cleaned (deveined),'' or
''deveined'' may be declared on the label.
(iii) When the food is of the style described in paragraph
(a)(3)(iii) of this section, the words ''contain no dark veins'' or
their equivalent may be declared on the label.
(iv) When the food is whole shrimp within a size range designated in
Table I as ''extra large,'' ''large,'' ''medium,'' or ''small'' and does
not contain broken shrimp as defined in paragraph (a)(3)(iv) of this
section in excess of the amount listed in Table II for the applicable
size, the appropriate size designation may be declared on the label.
(v) When the food consists of tiny shrimp, as designated in Table I
in paragraph (a)(5)(iv) of this section and does not contain broken
shrimp as defined in paragraph (a)(3)(iv) of this section in excess of
15 percent by weight, the name of the food on the label shall be
accompanied by the word ''tiny'' in type size equal to that used in the
name of the food.
(vi) When the food consists of tiny shrimp, as designated in Table I
in paragraph (a)(5)(iv) of this section and contains more than 15
percent by weight of broken shrimp as defined in paragraph (a)(3)(iv) of
this section, the name of the food on the label shall be accompanied by
the word ''broken'' or ''pieces'' rather than the word ''tiny,'' in type
size equal to that used in the name of the food.
(vii) When the food consists wholly or in part of sizes other than
tiny, as designated in Table I in paragraph (a)(5)(iv) of this section
and contains more than 10 percent by weight of broken shrimp as defined
in paragraph (a)(3)(iv) of this section, the name of the food on the
label shall be accompanied by the word ''broken'' or ''pieces'' in type
size equal to that used in the name of the food.
(viii) The name of the food shall include a declaration of any
flavoring that characterizes the food, as specified in 101.22 of this
chapter, and the term ''spiced'' if spice characterizes the food.
(ix) Each of the ingredients used shall be declared on the label as
required by the applicable sections of part 101 of this chapter.
(6) Sampling and acceptance procedure. A lot is to be considered
acceptable when the number of defectives does not exceed the acceptance
number in the sampling plans given in paragraph (a)(6)(ii) of this
section.
(i) Definitions of terms to be used in the sampling plans in
paragraph (a)(6)(ii) of this section are as follows:
(a) Lot. A collection of primary containers or units of the same
size, type, and style manufactured or packed under similar conditions
and handled as a single unit of trade.
(b) Lot size. The number of primary containers or units in the lot.
(c) Sample size (n). The total number of sample units drawn for
examination from a lot.
(d) Sample unit. A container, the entire contents of a container, a
portion of the contents of a container, or a composite mixture of
product from small containers that is sufficient for the examination or
testing as a single unit.
(e) Defective. Any sample unit shall be regarded as defective when
it fails to meet the minimum requirements in paragraph (a)(3) (ii) or
(iii) of this section for the applicable style, when it exceeds the
tolerances in paragraph (a)(5)(iv) of this section for the applicable
size, or when the labeling fails to meet the requirements of paragraph
(a)(5) (v), (vi), or (vii) of this section of the applicable size.
(f) Acceptance number (c). The maximum number of defective sample
units permitted in the sample in order to consider the lot as meeting
the specified requirements.
(g) Acceptable quality level (AQL). The maximum percent of defective
sample units permitted in a lot that will be accepted approximately 95
percent of the time.
(ii) Sampling plans:
(b) (Reserved)
(c) Fill of container. (1) The standard of fill of transparent or
nontransparent containers for canned wet pack shrimp is a fill such that
the cut-out weight of shrimp taken from each container is not less than
60 percent of the weight of the water required to fill the container.
The weight of the water required to fill the container is determined by
the general method provided in 130.12(a) of this chapter. Cut-out
weight is determined by the following method: Keep the unopened canned
shrimp container at a temperature of not less than 68 nor more than 75
Fahrenheit for at least 12 hours immediately preceding the
determination. After opening, distribute the shrimp evenly over the
meshes of a circular sieve that has been previously weighed. The
diameter of the sieve is 20.3 centimeters (8 inches) if the quantity of
the contents of the container is less than 1.36 kilograms (3 pounds),
and 30.5 centimeters (12 inches), if such quantity is 1.36 kilograms (3
pounds) or more. The bottom of the sieve is woven-wire cloth that
complies with the specifications for such cloth set forth as a 2.38 mm
(No. 8) sieve in the ''Definitions of Terms and Explanatory Notes'' of
the ''Official Methods of Analysis of the Association of Official
Analytical Chemists,'' 13th Ed. (1980), which is incorporated by
reference. Copies may be obtained from the Association of Official
Analytical Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA
22201-3301, or may be examined at the Office of the Federal Register,
1100 L St. NW., Washington, DC 20408. Without shifting the material on
the sieve, incline the sieve at an angle of approximately 17 to 20 to
facilitate drainage. Allow the shrimp to drain for 2 minutes, measured
from the moment the product is poured onto the sieve. Weigh the sieve
and the drained shrimp. The weight so found, less the weight of the
sieve, shall be considered to be the cut-out weight of the shrimp.
(2) Sampling and acceptance procedure: A container that falls below
the requirement for minimum fill prescribed in paragraph (c)(1) of this
section is considered a ''defective.'' Determine compliance with
paragraph (c)(1) of this section as specified in paragraph (a)(6) of
this section except that the sample unit shall be the entire contents of
the container.
(3) If canned wet pack shrimp in transparent or nontransparent
containers falls below the applicable standard of fill of container
prescribed in paragraph (c)(1) of this section, the label shall bear the
general statement of substandard fill provided in 130.14(b) of this
chapter, in the manner and form therein specified.
(43 FR 19840, May 9, 1978; 43 FR 25423, June 13, 1978, as amended at
47 FR 11833, Mar. 19, 1982; 49 FR 10102, Mar. 19, 1984; 54 FR 24896,
June 12, 1989)
Effective Date Note: Paragraphs (a) and (c) of 161.173 were stayed
until further notice by a document published at 44 FR 50328, Aug. 28,
1979.
21 CFR 161.175 Frozen raw breaded shrimp.
(a) Frozen raw breaded shrimp is the food prepared by coating one of
the optional forms of shrimp specified in paragraph (c) of this section
with safe and suitable batter and breading ingredients as provided in
paragraph (d) of this section. The food is frozen.
(b) The food tests not less than 50 percent of shrimp material as
determined by the method prescribed in paragraph (g) of this section,
except that if the shrimp are composite units the method prescribed in
paragraph (h) of this section is used.
(c) The term ''shrimp'' means the tail portion of properly prepared
shrimp of commercial species. Except for composite units, each shrimp
unit is individually coated. The optional forms of shrimp are:
(1) Fantail or butterfly: Prepared by splitting the shrimp; the
shrimp are peeled, except that tail fins remain attached and the shell
segment immediately adjacent to the tail fins may be left attached.
(2) Butterfly, tail off: Prepared by splitting the shrimp; tail
fins and all shell segments are removed.
(3) Round: Round shrimp, not split; the shrimp are peeled, except
that tail fins remain attached and the shell segment immediately
adjacent to the tail fins may be left attached.
(4) Round, tail off: Round shrimp, not split; tail fins and all
shell segments are removed.
(5) Pieces: Each unit consists of a piece or a part of a shrimp;
tail fins and all shell segments are removed.
(6) Composite units: Each unit consists of two or more whole shrimp
or pieces of shrimp, or both, formed and pressed into composite units
prior to coating; tail fins and all shell segments are removed; large
composite units, prior to coating, may be cut into smaller units.
(d) The batter and breading ingredients referred to in paragraph (a)
of this section are the fluid constituents and the solid constituents of
the coating around the shrimp. These ingredients consist of suitable
substances which are not food additives as defined in section 201(s) of
the Federal Food, Drug, and Cosmetic Act; or if they are food additives
as so defined, they are used in conformity with regulations established
pursuant to section 409 of the act. Batter and breading ingredients
that perform a useful function are regarded as suitable, except that
artificial flavorings, artificial sweeteners, artificial colors, and
chemical preservatives, other than those provided for in this paragraph,
are not suitable ingredients of frozen raw breaded shrimp. Chemical
preservatives that are suitable are:
(1) Ascorbic acid, which may be used in a quantity sufficient to
retard development of dark spots on the shrimp; and
(2) The antioxidant preservatives listed in Subpart D of Part 182 of
this chapter that may be used to retard development of rancidity of the
fat content of the food, in amounts within the limits prescribed by that
section.
(e) The label shall name the food, as prepared from each of the
optional forms of shrimp specified in paragraph (c) (1) to (6),
inclusive, of this section, and following the numbered sequence of such
subparagraph, as follows:
(1) ''Breaded fantail shrimp.'' The word ''butterfly'' may be used in
lieu of ''fantail'' in the name.
(2) ''Breaded butterfly shrimp, tail off.''
(3) ''Breaded round shrimp.''
(4) ''Breaded round shrimp, tail off.''
(5) ''Breaded shrimp pieces.''
(6) Composite units:
(i) If the composite units are in a shape similar to that of breaded
fish sticks the name is ''Breaded shrimp sticks''; if they are in the
shape of meat cutlets, the name is ''Breaded shrimp cutlets''.
(ii) If prepared in a shape other than that of sticks or cutlets, the
name is ''Breaded shrimp ------ '', the blank to be filled in with the
word or phrase that accurately describes the shape, but which is not
misleading.
In the case of the names specified in paragraphs (e) (1) through (5)
of this section, the words in each name may be arranged in any order,
provided they are so arranged as to be accurately descriptive of the
food. The word ''prawns'' may be added in parentheses immediately after
the word ''shrimp'' in the name of the food if the shrimp are of large
size; for example, ''Fantail breaded shrimp (prawns)''. If the shrimp
are from a single geographical area, the adjectival designation of that
area may appear as part of the name; for example, ''Breaded Alaskan
shrimp sticks''.
(f) The names of the optional ingredients used, as provided for in
paragraph (d) of this section, shall be listed on the principal display
panel or panels of the label with such prominence and conspicuousness as
to render them likely to be read and understood by the ordinary
individual under customary conditions of purchase. If a spice that also
imparts color is used, it shall be designated as ''spice and coloring'',
unless the spice is designated by its specific name. If ascorbic acid
is used to retard development of dark spots on the shrimp, it shall be
designated as ''Ascorbic acid added as a preservative'' or ''Ascorbic
acid added to retard discoloration of shrimp''. If any other
antioxidant preservative, as provided in paragraph (d) of this section,
is used, such preservative shall be designated by its common name
followed by the statement ''Added as a preservative''.
(g) The method for determining percentage of shrimp material for
those forms specified in paragraphs (c) (1) through (5) of this section
is as follows:
(1) Equipment needed. (i) Two-gallon container, approximately 9
inches in diameter.
(ii) Two-vaned wooden paddle, each vane measuring approximately 1 3/4
inches by 3 3/4 inches.
(iii) Stirring device capable of rotating the wooden paddle at 120
r.p.m.
(iv) Balance accurate to 0.01 ounce (or 0.1 gram).
(v) U.S. Standard Sieve No. 20, 30.5 centimeter (12 inch) diameter.
The sieves shall comply with the specifications for such cloth set forth
in ''Official Methods of Analysis of the Association of Official
Analytical Chemists'' (AOAC), 13th Ed. (1980), Table 1, ''Nominal
Dimensions of Standard Test Sieves (U.S.A. Standard Series),'' under the
heading ''Definitions of Terms and Explanatory Notes,'' which is
incorporated by reference. Copies may be obtained from the Association
of Official Analytical Chemists, 2200 Wilson Blvd., Suite 400,
Arlington, VA 22201-3301, or may be examined at the Office of the
Federal Register, 1100 L St. NW., Washington, DC 20408.
(vi) U.S. Standard sieve, 1/2-inch sieve opening, 12-inch diameter.
(vii) Forceps, blunt points.
(viii) Shallow baking pans.
(ix) Rubber-tipped glass stirring rod.
(2) Procedure. (i) Weigh the sample to be debreaded. Fill the
container three-fourths full of water at 70 -80 F. Suspend the paddle
in the container, leaving a clearance of at least 5 inches below the
paddle vanes, and adjust speed to 120 r.p.m. Add shrimp and stir for 10
minutes. Stack the sieves, the 1/2-inch mesh over the No. 20, and pour
the contents of the container onto them. Set the sieves under a faucet,
preferably with spray attached, and rinse shrimp with no rubbing of
flesh, being careful to keep all rinsings over the sieves and not having
the stream of water hit the shrimp on the sieve directly. Lay the
shrimp out singly on the sieve as rinsed. Inspect each shrimp and use
the rubber-tipped rod and the spray to remove the breading material that
may remain on any of them, being careful to avoid undue pressure or
rubbing, and return each shrimp to the sieve. Remove the top sieve and
drain on a slope for 2 minutes, then remove the shrimp to weighing pan.
Rinse contents of the No. 20 sieve onto a flat pan and collect any
particles other than breading (i.e., flesh and tail fins) and add to
shrimp on balance pan and weigh.
(ii) Calculate percent shrimp material:
Percent shrimp material=(Weight of debreaded sample)/(Weight of
sample) 100+2
(h) The method for determining percentage of shrimp material for
composite units, specified in paragraph (c) (6) of this section, is as
follows:
(1) Equipment needed. (i) Water bath (for example a 3-liter to
4-liter beaker).
(ii) Balance accurate to 0.1 gram.
(iii) Clip tongs of wire, plastic, or glass.
(iv) Stop-watch or regular watch readable to a second.
(v) Paper towels.
(vi) Spatula, 4-inch blade with rounded tip.
(vii) Nut picker.
(viii) Thermometer (immersion type) accurate to 2 F.
(ix) Copper sulfate crystals (CuSo4. 5H2O).
(2) Procedure. (i) Weigh all composite units in the sample while
they are still hard frozen.
(ii) Place each composite unit individually in a water bath that is
maintained at 63 F-86 F, and allow to remain until the breading
becomes soft and can easily be removed from the still frozen shrimp
material (between 10 seconds to 80 seconds for composite units held in
storage at 0 F). If the composite units were prepared using batters
that are difficult to remove after one dipping, redip them for up to 5
seconds after the initial debreading and remove residual batter
materials.
Note: Several preliminary trials may be necessary to determine the
exact dip time required for ''debreading'' the composite units in a
sample. For these trials only, a saturated solution of copper sulfate
(1 pound of copper sulfate in 2 liters of tap water) is necessary. The
correct dip time is the minimum time of immersion in the copper sulfate
solution required before the breading can easily be scraped off:
Provided, That the ''debreaded'' units are still solidly frozen and only
a slight trace of blue color is visible on the surface of the
''debreaded'' shrimp material.)
(iii) Remove the unit from the bath; blot lightly with double
thickness of paper toweling; and scrape off or pick out coating from
the shrimp material with the spatula or nut picker.
(iv) Weigh all the ''debreaded'' shrimp material.
(v) Calculate the percentage of shrimp material in the sample, using
the following formula:
Percent shrimp material=(Weight of debreaded shrimp sample)/Weight of
sample 100
(42 FR 14464, Mar. 15, 1977, as amended at 47 FR 11833, Mar. 19,
1982; 49 FR 10102, Mar. 19, 1984; 54 FR 24896, June 12, 1989)
21 CFR 161.176 Frozen raw lightly breaded shrimp.
Frozen raw lightly breaded shrimp complies with the provisions of
161.175, except that it contains not less than 65 percent of shrimp
material, as determined by the method prescribed in 161.175 (g) or (h),
as appropriate, and that in the name prescribed the word ''lightly''
immediately precedes the words ''breaded shrimp''.
21 CFR 161.190 Canned tuna.
(a) Identity. (1) Canned tuna is the food consisting of processed
flesh of fish of the species enumerated in paragraph (a)(2) of this
section, prepared in one of the optional forms of pack specified in
paragraph (a)(3) of this section, conforming to one of the color
designations specified in paragraph (a)(4) of this section, in one of
the optional packing media specified in paragraph (a)(5) of this
section, and may contain one or more of the seasonings and flavorings
specified in paragraph (a)(6) of this section. For the purpose of
inhibiting the development of struvite crystals, sodium acid
pyrophosphate may be added in a quantity not in excess of 0.5 percent by
weight of the finished food. It is packed in hermetically sealed
containers and so processed by heat as to prevent spoilage. It is
labeled in accordance with the provisions of paragraph (a)(8) of this
section.
(2) The fish included in the class known as tuna fish are:
Thunnus thynnus (Linnaeus, 1758) -- Northern bluefin tuna
Thunnus maccoyii (Castelnau, 1872) -- Southern bluefin tuna
Thunnus alalunga (Bonnaterre, 1788) -- Albacore
Thunnus atlanticus (Lesson, 1830) -- Blackfin tuna
Thunnus obesus (Lowe, 1839) -- Bigeye tuna
Thunnus albacares (Bonnaterre, 1788) -- Yellowfin tuna
Thunnus tonggol (Bleeker, 1851) -- Longtail tuna
Katsuwonus pelamis (Linnaeus, 1758) -- Skipjack tuna
Euthynnus alletteratus (Rafinesque, 1810) -- Spotted tunny
Euthynnus lineatus Kishinouye, 1920 -- Black skipjack tuna
Euthynnus affinis (Cantor, 1849) -- Kawakawa
Allothunnus fallai Serventy, 1948 -- Slender tuna
Auxis rochei (Risso, 1810) -- Bullet tuna
Auxis thazard (Lacepede, 1800) -- Frigate tuna
(3) The optional forms of processed tuna consist of loins and other
striated muscular tissue of the fish. The loin is the longitudinal
quarter of the great lateral muscle freed from skin, scales, visible
blood clots, bones, gills, viscera and from the nonstriated part of such
muscle, which part (known anatomically as the median superficial muscle)
is highly vascular in structure, dark in color because of retained
blood, and granular in form. Canned tuna is prepared in one of the
following forms of pack, the identity of which is determined in
accordance with the methods prescribed in paragraph (c)(2) of this
section.
(i) Solid or solid pack consists of loins freed from any surface
tissue discolored by diffused hemolyzed blood, cut in transverse
segments to which no free fragments are added. In containers of 1 pound
or less of net contents, such segments are cut in lengths suitable for
packing in one layer. In containers of more than 1 pound net contents,
such segments may be cut in lengths suitable for packing in one or more
layers of equal thickness. Segments are placed in the can with the
planes of their transverse cut ends parallel to the ends of the can. A
piece of a segment may be added if necessary to fill a container. The
proportion of free flakes broken from loins in the canning operation
shall not exceed 18 percent.
(ii) Chunk, chunks, chunk style consists of a mixture of pieces of
tuna in which the original muscle structure is retained. The pieces may
vary in size, but not less than 50 percent of the weight of the pressed
contents of a container is retained on a 1/2-inch-mesh screen.
(iii) Flake or flakes consist of a mixture of pieces of tuna in which
more than 50 percent of the weight of the pressed contents of the
container will pass through a 1/2-inch-mesh screen, but in which the
muscular structure of the flesh is retained.
(iv) Grated consists of a mixture of particles of tuna that have been
reduced to uniform size, that will pass through a 1/2-inch-mesh screen,
and in which the particles are discrete and do not comprise a paste.
(v) Any of the specified forms of pack of canned tuna may be smoked.
Canned smoked tuna shall be labeled in accordance with the provisions of
paragraph (a)(8)(v) of this section.
(4) Canned tuna, in any of the forms of pack specified in paragraph
(a)(3) of this section, falls within one of the following color
designations, measured by visual comparison with matte surface neutral
reflectance standards corresponding to the specified Munsell units of
value, determined in accordance with paragraph (a)(7) of this section.
(i) White. This color designation is limited to the species Thunnus
alalunga (albacore), and is not darker than Munsell value 6.3.
(ii) Light. This color designation includes any tuna not darker than
Munsell value 5.3.
(iii) Dark. This color designation includes all tuna darker than
Munsell value 5.3.
(iv) Blended. This color designation may be applied only to tuna
flakes specified in paragraph (a)(3)(iii) of this section, consisting of
a mixture of tuna flakes of which not less than 20 percent by weight
meet the color standard for either white tuna or light tuna, and the
remainder of which fall within the color standard for dark tuna. The
color designation for blended tuna is determined in accordance with
paragraph (a)(7) of this section.
(5) Canned tuna is packed in one of the following optional packing
media:
(i) Any edible vegetable oil other than olive oil, or any mixture of
such oils not containing olive oil.
(ii) Olive oil.
(iii) Water.
(6) Canned tuna may be seasoned or flavored with one or more of the
following:
(i) Salt.
(ii) Purified monosodium glutamate.
(iii) Hydrolyzed protein.
(iv) Hydrolyzed protein with reduced monosodium glutamate content.
(v) Spices or spice oils or spice extracts.
(vi) Vegetable broth in an amount not in excess of 5 percent of the
volume capacity of the container, such broth to consist of a minimum of
0.5 percent by weight of vegetable extractives and to be prepared from
two or more of the following vegetables: Beans, cabbage, carrots,
celery, garlic, onions, parsley, peas, potatoes, green bell peppers, red
bell peppers, spinach, and tomatoes.
(vii) Garlic.
(viii) Lemon flavoring to be prepared from lemon oil and citric acid
together with safe and suitable carriers for the lemon oil which are
present at nonfunctional and insignificant levels in the finished canned
food. When lemon flavoring is added, a safe and suitable solubilizing
and dispersing ingredient may be added in a quantity not exceeding 0.005
percent by weight of the finished food. A substance used in accordance
with this paragraph is deemed to be suitable if it is used in an amount
no greater than necessary to achieve the intended flavor effect, and is
deemed to be safe if it is not a food additive as defined in section
201(s) of the act or, if it is a food additive as so defined, it is used
in conformity with regulations established pursuant to section 409 of
the act.
(ix) Edible vegetable oil or partially hydrogenated vegetable oil,
excluding olive oil, used alone or in combination, in an amount not to
exceed 5 percent of the volume capacity of the container, with or
without any suitable form of emulsifying and suspending ingredients that
has been affirmed as GRAS or approved as a food additive to aid in
dispersion of the oil, as seasoning in canned tuna packed in water.
(7) For determination of the color designations specified in
paragraph (a) (4) of this section, the following method shall be used:
Recombine the separations of pressed cake resulting from the method
prescribed in paragraph (c)(2) of this section. Pass the combined
portions through a sieve fitted with woven-wire cloth of 1/4-inch mesh
complying with the specifications for such cloth set forth in ''Official
Methods of Analysis of the Association of Official Analytical
Chemists,'' 13th Ed. (1980), Table 1, ''Nominal Dimensions of Standard
Test Sieves (U.S.A. Standard Series),'' under the heading ''Definitions
of Terms and Explanatory Notes,'' which is incorporated by reference.
Copies may be obtained from the Association of Official Analytical
Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may
be examined at the Office of the Federal Register, 1100 L St. NW.,
Washington, DC 20408. Mix the sieved material and place a sufficient
quantity into a 307 113 size container (bearing a top seam and having
a false bottom approximately 1/2-inch deep and painted flat black inside
and outside) so that after tamping and smoothing the surface of the
sample the material will be 1/8-inch to 1/4-inch below the top of the
container. Within 10 minutes after sieving through the 1/4-inch mesh
woven-wire cloth, determine the Munsell value of sample surface.
(i) Determine the Munsell value of the sample surface so prepared.
The following method may be used, employing an optical comparator,
consisting of a lens and prism system which brings two beams of light,
reflected from equal areas of sample surface and standard surface,
respectively, together, within an eyepiece, so as to show an equally
divided optical field. The scanned areas of sample and standard surface
are not smaller than 2 square inches. Light reaching the eye is
rendered sufficiently diffuse, by design of eyepiece and comparator, so
that detail of the sample surface will remain undefined, to a degree
such as to avoid visual confusion in observation of a match of over-all
intensity of reflected light. The eyepiece contains a color filter
centering at a wavelength between 550 m and 560 m . The filter does
not pass appreciable visible radiation of wavelengths below 540 m or
above 570 m . The passed wavelength band is of a monochromaticity
sufficient to cause a sample and a neutral standard of equal reflectance
to appear of the same hue. The comparator is rigidly mounted on a
vertical stand attached to a base in which arrangement is provided for
securely and accurately positioning two cans of size 307 113 in the
two fields of view. Mounted on the base are two shaded lamps, which
direct the center of their beams of light at about a 45 angle to the
plane of the sample and standard surfaces. The lamps are so positioned
that light from one bears mainly upon the sample surface and light from
the other mainly on the standard surface, and are so placed in relation
to sample and standard that no shadows, as from the can rims, appear in
the fields of view. The lamps are strong enough to furnish adequate and
convenient illumination through eyepiece and filter. Means are provided
to alter the light intensity of one lamp in relation to the other, as
may conveniently be achieved by using a 100-watt tungsten filament bulb
in one lamp and using, in the other, a similar 150-watt bulb connected
with the power source through a suitable rheostat. The stand is
equipped with non-glossy black curtains on the side of the observer, to
exclude variation in extraneous light reflected from the person of the
observer.
(ii) To adjust the comparator, place a pair of matte surface
standards of Munsell value 5.3, mounted as described in paragraph
(a)(7)(iv) of this section, in position in the comparator base, and
adjust the intensity of the variable lamp until the two halves of the
optical field, viewed through the eyepiece, are of equal brightness.
Then remove one of the standards and replace it with the prepared
sample. Without altering any other adjustments, observe through the
eyepiece whether the sample appears lighter or darker than the standard.
In case of examination of albacore designated ''white'', conduct the
procedure using standards of Munsell value 6.3.
(iii) The standards with which comparisons are made are essentially
neutral matte-finish standards, equivalent in luminous reflectance of
light of 555 wavelength to 33.7 percent of the luminous reflectance of
magnesium oxide (for Munsell value 6.3) and 22.6 percent of the luminous
reflectance of magnesium oxide (for Munsell value 5.3), as given by the
relationship between Munsell value and luminous reflectance derived by a
subcommittee of the Optical Society of America and published in the
''Journal of the Optical Society of America,'' Vol. 33, page 406
(1943), which is incorporated by reference. Copies are available from
the Division of Food Chemistry and Technology, Center for Food Safety
and Applied Nutrition (HFF-410), Food and Drug Administration, 200 C St.
SW., Washington, DC 20204, or available for inspection at the Office of
the Federal Register, 1100 L St. N.W., Washington, DC 20408.
(iv) These standards shall be cut in circles 3 1/4 inches in diameter
and shall be mounted in 307 113 size containers, bearing a top seam
and painted flat black inside and outside, so that the surfaces of the
standards are 3/16 inch below the top of the containers in which they
are mounted.
(v) In the case of blended tuna, the foregoing method shall be varied
by first separating the tuna flakes of the two different colors before
passing them through the 1/4-inch mesh sieve, then proceeding with each
portion separately for the determination of its color value, employing,
if necessary, a sample container with false bottom greater than 1/2 inch
deep.
(8)(i) The specified names of the canned tuna for which definitions
and standards of identity are prescribed by this section, except where
water is the packing medium or where the tuna is smoked, are formed by
combining the designation of form of pack with the color designation of
the tuna; for example, ''Solid pack white tuna'', 'Grated dark tuna'',
etc. In the case of blended tuna, there shall be used both applicable
color designations of the blended flakes, in precedence determined in
accordance with the predominating portion found in the container; for
example, ''Blended white and dark tuna flakes'', ''Blended dark and
light tuna flakes''.
(ii) The specified name of canned tuna when water is used as the
packing medium is formed as described in paragraph (a)(8)(i) of this
section, followed by the words ''in water''; for example, ''Grated
light tuna in water''.
(iii) When the packing medium is vegetable oil or olive oil, the
label shall bear the name of the optional packing medium used, as
specified in paragraph (a) (5) of this section, preceded by the word
''in'' or the words ''packed in''. In case of the optional ingredient
specified in paragraph (a)(5)(i) of this section, the name or names of
the oil used may be stated, or the general term ''vegetable oil'' may be
used.
(iv) In case solid pack tuna is packed in olive oil, the designation
''Tonno'' may also appear.
(v) In case any of the specified forms of canned tuna are smoked, the
word ''smoked'' shall appear as a part of the name on the label; for
example, ''Smoked light tuna flakes''.
(vi) Where the canned tuna contains one or more of the ingredients
provided for in paragraph (a)(6) of this section, the label shall bear
the statement ''Seasoned with XXXX'', the blank being filled in with the
name or names of the ingredient or ingredients used, except that if the
ingredient designated in paragraph (a)(6)(vi) of this section is used,
the blank shall be filled in with the term ''vegetable broth'', and if
the ingredients designated in paragraph (a)(6)(ix) of this section are
used, the blank may be filled in with the term ''oil'', and if the
ingredient designated in paragraph (a)(6)(v) of this section is used
alone, the label may alternatively bear either the statement ''spiced''
or the statement ''with added spice''; and if salt is the only
seasoning ingredient used, the label may alternatively bear any of the
statements ''salted'', ''with added salt'', or ''salt added''. If the
flavoring ingredients designated in paragraph (a)(6)(viii) of this
section are used, the words ''lemon flavored'' or ''with lemon
flavoring'' shall appear as part of the name on the label; for example,
''lemon flavored chunk light tuna''. Citric acid and any optional
solubilizing and dispersing agent used as specified in paragraph
(a)(6)(viii) of this section in connection with lemon flavoring
ingredients or emulsifying and suspending ingredients used as specified
in paragraph (a)(6)(ix) of this section shall be designated on the label
by their common or usual name.
(vii) Where the canned tuna contains the optional ingredient sodium
acid pyrophosphate as provided in paragraph (a)(1) of this section, the
label shall bear the statement ''pyrophosphate added'' or ''with added
pyrophosphate''.
(viii) Wherever the name of the food appears on the label so
conspicuously as to be easily seen under customary conditions of
purchase, the names of the optional ingredients used, as specified in
paragraphs (a)(8)(iii), (vi), and (vii) of this section (except if lemon
flavoring is added, this subparagraph applies only to the terms ''lemon
flavored'' or ''with lemon flavoring'', not to the constituent
ingredients of that flavoring or to any optional solubilizing or
dispersing ingredient used in connection with lemon flavoring
ingredients), shall immediately and conspicuously precede or follow such
name without intervening, written, printed, or graphic matter except
that the common name of the species of tuna fish may so intervene; but
the species name ''albacore'' may be employed only for canned tuna of
that species which meets the color designation ''white'' as prescribed
by paragraph (a)(4)(i) of this section.
(ix) Statements of optional ingredients present required by paragraph
(a) (8)(vi) of this section, but not subject to the provisions of
paragraph (a)(8)(viii) of this section shall be set forth on the label
with such prominence and conspicuousness as to render them likely to be
read and understood by the ordinary individual under customary
conditions of purchase.
(b) (Reserved)
(c) Fill of container. (1) The standard of fill of container for
canned tuna is a fill such that the average weight of the pressed cake
from 24 cans, as determined by the method prescribed by paragraph (c)(2)
of this section, is not less than the minimum value specified for the
corresponding can size and form of tuna ingredient in the following
table:
If the can size in question is not listed, calculate the value for
column II as follows: From the list select as the comparable can size
that one having nearest the water capacity of the can size in question,
multiply the value listed in column II for the same form of tuna
ingredient by the water capacity of the can size in question, and
divided by the water capacity of the comparable can size. Water
capacities are determined by the general method provided in 130.12(a)
of this chapter. For the purposes of this section, cans of dimensions
211 109 shall be deemed to have a water capacity at 68 F of 3.55
avoirdupois ounces of water; cans of dimensions 307 113, a water
capacity of 7.05 avoirdupois ounces of water; cans of dimensions 401
206, a water capacity of 13.80 avoirdupois ounces of water; and cans of
dimensions 603 408, a water capacity of 68.15 avoirdupois ounces of
water.
(2) The methods referred to in paragraph (c)(1) of this section for
determining the weight of the pressed cake and referred to in paragraph
(a)(3)(i) of this section for determining the percent of free flakes and
the percent of pieces that pass through a 1/2-inch-mesh sieve are as
follows:
(i) Have each of the 24 cans and contents at a temperature of 75 F
within 5 F. Test each can in turn as follows:
(ii) Cut out the top of the can (code end), using a can opener that
does not remove nor distort the double seam.
(iii) With the cut top held on the can contents, invert the can, and
drain the free liquid by gentle finger pressure on the cut lid so that
most of the free liquid drains from the can.
(iv) With the cut lid still in place, cut out the bottom of the can
with the can opener, then turn the can upright and remove the cut can
top (code end). Scrape off any adhering tuna particles into the tuna
mass in the can.
(v) Place the proper size of press cylinder as provided in paragraph
(c)(3)(i) of this section in a horizontal position on a table; then,
using the cut bottom of the can as a pusher, gently force the can
contents from the can into the cylinder so that the flat side of the can
contents lies in contact with the bottom of the cylinder. Remove the
bottom of the can that was used as the pusher and scrape any adhering
particles from the can body and bottom of the can, and put them in the
cylinder.
(vi) Place the cylinder plunger on top of the can contents in the
cylinder. Remove the eyebolt and put the cylinder and plunger in
position on the press (paragraph (c)(3)(iii) of this section).
(vii) Begin the operation of the press and as soon as liquid is
observed coming from the cylinder start timing the operation. Apply
pressure to the plunger slowly and at a uniform rate, so that a full
minute is used to reach a pressure of 384 pounds per square inch of
plunger face in contact with the can contents. Hold this pressure for 1
additional minute and then release the pressure and disengage the
plunger from the press shaft. Tip the press cylinder so that any free
liquid is drained out.
(viii) Remove press cylinder with plunger from the press, insert
eyebolt in plunger and withdraw it from the cylinder. Loosen the
pressed cake from the cylinder with a thin blade and remove the entire
pressed cake as gently as possible, to keep the mass in a single cake
during this operation. Place the pressed cake and any pieces that
adhered to the plunger and cylinder in a tared receiving pan and
determine the weight of the pressed material.
(ix) For cans larger than 401 206, cut out the top of the can and
drain off free liquid from the can contents as in operations described
in paragraphs (c)(2)(ii) and (iii) of this section. Determine the gross
weight of the can and remaining contents. Using a tared core cutter as
provided for in paragraph (c)(3)(ii) of this section, cut vertically a
core of the drained material in the can. Determine the weight of the
core. With a thin spatula transfer the core to the pressing cylinder
for 401 206 cans. Determine the weight of the pressed cake as in the
operations described in paragraphs (c)(2)(v) through (viii) of this
section. Remove the remaining drained contents of the can, reserving
the contents for the determination of free flakes (paragraph (c)(2)(xi)
of this section), weigh the empty can, and calculate the weight of the
total drained material. Calculate the weight of pressed cake on the
entire can basis by multiplying the weight of the pressed cake of the
core by the ratio of the weight of the drained contents of the can to
the weight of the core before pressing.
(x) Repeat the determination of weight of pressed cake on the
remainder of the 24 cans and determine the average weight of pressed
cake for the purpose of paragraph (c)(1) of this section.
(xi) Determination of free flakes: If the optional form of tuna
ingredient is solid pack, determine the percent of free flakes. Any
flakes resulting from the operations described in this paragraph
(c)(2)(xi) or in other parts of this paragraph are to be weighed as free
flakes. Only fragments that were broken in the canning procedure are
considered to be free flakes. If the can is of such size that its
entire drained contents were pressed as described in paragraphs
(c)(2)(i) to (viii) of this section, inclusive, examine the pressed cake
carefully for free flakes. Using a spatula, scrape free flakes gently
from the outside of the cake. Weigh the aggregate free flakes that were
broken from the loin segments in the canning procedure and calculate
their percentage of the total weight of pressed cake. If the can is of
such size that a core was cut for pressing as described in paragraph
(c)(2)(ix) of this section, make the examination for free flakes on a
weighed portion of the drained material remaining after the core was
removed. The weight of the portion examined should approximately equal
the weight of the core before pressing. Calculate the weight of the
free flakes that were broken from the loins in the canning procedure as
a percentage of the weight of the portion examined.
(xii) Determination of particle size: If the optional form of tuna
ingredient is chunks, flakes, or grated, the pressed cake resulting from
the operations described in paragraphs (c)(2)(i) to (ix) of this
section, inclusive, is gently separated by hand, care being taken to
avoid breaking the pieces. The separated pieces are evenly distributed
over the top sieve of the screen separation equipment described in
paragraph (c)(3)(iv) of this section. Beginning with the top sieve,
lift and drop each sieve by its open edge three times. Each time, the
open edge of the sieve is lifted the full distance permitted by the
device. Combine and weigh the material remaining on the three top
sieves (1 1/2-inch, 1-inch, 1/2-inch screens), and determine the
combined percentage retention by weight in relation to the total weight
of the pressed cake.
(3) (i) The press cylinder and plunger referred to in paragraph
(c)(2) of this section are made of stainless steel. The press cylinders
are made with a lip to facilitate drainage of the liquid. Plungers have
a threaded center hole, about half as deep as the thickness of the
plunger, for receiving a ringbolt to assist in removing the plunger from
the press cylinder. Dimensions for press cylinders and plungers are as
follows:
Press cylinder:
Inside depth, approximately 3 3/4 inches.
Inside diameter, 2.593 inches.
Wall thickness, approximately 3/8 inch.
Plunger:
Thickness, approximately 1 inch.
Diameter, 2.568 inches.
Press cylinder:
Inside depth, approximately 4 inches.
Inside diameter, 3.344 inches.
Wall thickness, approximately 3/8 inch.
Plunger:
Thickness, approximately 1 1/4 inches.
Diameter, 3.319 inches.
Press cylinder:
Inside depth, approximately 4 1/8 inches.
Inside diameter, 3.969 inches.
Wall thickness, approximately 1/2 inch.
Plunger:
Thickness, approximately 1 1/4 inches.
Diameter, 3.944 inches.
For can sizes where the diameter is greater than 401, the core cutter
described in paragraph (c)(3)(ii) of this section shall be used and the
resulting core pressed in the press cylinder for can size 401 206. For
can sizes differing from those specified in this paragraph (c)(3)(i),
special press cylinders and plungers may be used. Special press less
than the outside diameters, at the cylinders have inside diameters
1/10-inch double seam, for the can sizes for which the cylinders are
used; plunger diameters are 0.025-inch less than the inside diameters
of the press cylinders.
(ii) The core cutter referred to in paragraph (c)(2) (ix) and (xi) of
this section and paragraph (c)(3)(i) of this section is made from a
previously sealed 300 407 can. The cover, including the top seam, is
cut out. The edge is smoothed and sharpened. A small hole to permit
passage of air is made in the bottom.
(iii) The hydraulic press referred to in paragraph (c)(2)(vi) to (x)
of this section, inclusive, is made by so mounting a hydraulic jack, in
a strong frame, that it will press horizontally against the center of
the plunger in the press cylinder used. The frame is so braced that it
does not change shape when pressure is applied. The gauge on the
hydraulic jack is so calibrated that it will indicate, for the plunger
being used, when the plunger is pressing against the contents of the
press cylinder with a pressure of 384 pounds per square inch of plunger
face.
(iv) The sieving device referred to in paragraph (c)(2)(xii) of this
section consists of three sieves, each approximately 1 foot square,
loosely mounted, one above the other, in a metal frame. The mesh in the
top sieve complies with the specifications for 1 1/2-inch woven-wire
cloth as prescribed in paragraph (a)(7) of this section. The meshes in
the sieves below comply with similar specifications for 1-inch and
1/2-inch woven-wire cloth as set forth in the same publication. The
sides of each sieve are formed, in a raised rim, from 3/4-inch
1/8-inch metal strap. The frame has tracks made of 3/8-inch angle metal
to support each sieve under each side. The tracks are so positioned as
to permit each sieve a free vertical travel of 1 3/4 inches.
(4) If canned tuna falls below the applicable standard of fill of
container prescribed in paragraph (c)(1) of this section, the label
shall bear the general statement of substandard fill provided in
130.14(b) of this chapter, in the manner and form therein specified.
(42 FR 14464, Mar. 15, 1977, as amended at 47 FR 11833, Mar. 19,
1982; 49 FR 10102, Mar. 19, 1984; 54 FR 24896, June 12, 1989; 55 FR
45797, Oct. 31, 1990; 56 FR 6263, Feb. 15, 1991)
21 CFR 161.190 PART 163 -- CACAO PRODUCTS
21 CFR 161.190 Pt. 163
21 CFR 161.190 Subpart A (Reserved)
21 CFR 161.190 Subpart B -- Requirements for Specific Standardized
Cacao Products
Sec.
163.110 Cacao nibs.
163.111 Chocolate liquor.
163.112 Breakfast cocoa.
163.113 Cocoa.
163.114 Low-fat cocoa.
163.117 Cocoa with dioctyl sodium sulfosuccinate for manufacturing.
163.123 Sweet chocolate.
163.130 Milk chocolate.
163.135 Buttermilk chocolate.
163.140 Skim milk chocolate.
163.145 Mixed dairy product chocolates.
163.150 Sweet cocoa and vegetable fat (other than cacao fat) coating.
163.153 Sweet chocolate and vegetable fat (other than cacao fat)
coating.
163.155 Milk chocolate and vegetable fat (other than cacao fat)
coating.
Authority: Secs. 201, 301, 401, 403, 409, 701, 706 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 341, 343, 348, 371,
376).
Source: 42 FR 14471, Mar. 15, 1977, unless otherwise noted.
21 CFR 161.190 Subpart A (Reserved)
21 CFR 161.190 Subpart B -- Requirements for Specific Standardized Cacao Products
21 CFR 163.110 Cacao nibs.
(a) Cacao nibs, cocoa nibs, cracked cocoa is the food prepared by
heating and cracking dried or cured and cleaned cacao beans and removing
shell therefrom. Cacao nibs or the cacao beans from which they are
prepared may be processed by heating with one or more of the following
optional alkali ingredients, added as such or in aqueous solution:
Bicarbonate, carbonate, or hydroxide of sodium, ammonium, or potassium;
or carbonate or oxide of magnesium; but for each 100 parts by weight of
cacao nibs used, as such or before shelling from the cacao beans, the
total quantity of such alkalis used is not greater in neutralizing value
(calculated from the respective combining weights of such alkalis used)
than the neutralizing value of 3 parts by weight of anhydrous potassium
carbonate. The cacao shell content of cacao nibs is not more than 1.75
percent by weight (calculated to an alkali-free basis if they or the
cacao beans from which they were prepared have been processed with
alkali), as determined by the method prescribed under ''Shell in Cacao
Nibs -- Official Final Action'' prescribed in the ''Official Methods of
Analysis of the Association of Official Analytical Chemists,'' 12th Ed.
(1975), sections 13.010-13.014, which is incorporated by reference.
Copies may be obtained from the Association of Official Analytical
Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may
be examined at the Office of the Federal Register, 1100 L St. NW.,
Washington, DC 20408.
(b) When cacao nibs or the cacao beans from which they are prepared
are processed, in whole or in part, with any optional alkali ingredient
specified in paragraph (a) of this section, the label shall bear the
statement ''Processed with alkali''; but in lieu of the word ''alkali''
in such statement the specific common name of the optional alkali
ingredient may be used. Wherever the name of the food appears on the
label so conspicuously as to be easily seen under customary conditions
of purchase, such statement shall immediately and conspicuously precede
or follow such name without intervening written, printed, or graphic
matter.
(42 FR 14471, Mar. 15, 1977, as amended at 47 FR 11833, Mar. 19,
1982; 49 FR 10102, Mar. 19, 1984; 54 FR 24896, June 12, 1989)
21 CFR 163.111 Chocolate liquor.
(a) Chocolate liquor, chocolate, baking chocolate, bitter chocolate,
cooking chocolate, chocolate coating, bitter chocolate coating is the
solid or semi-plastic food prepared by finely grinding cacao nibs. To
such ground cacao nibs, cacao fat or a cocoa or both may be added in
quantities needed to adjust the cacao fat content of the finished
chocolate liquor. (For the purposes of this section the term ''cocoa''
means breakfast cocoa, cocoa, low-fat cocoa, or any mixture of two or
more of these.) Chocolate liquor may be spiced, flavored, or otherwise
seasoned with one or more of the following optional ingredients, other
than any such ingredient or combination of ingredients specified in
paragraph (a) (1), (2), or (3) of this section which imparts a flavor
that imitates the flavor of chocolate, milk, or butter:
(1) Ground spice.
(2) Ground vanilla beans; any natural food flavoring oil, oleoresin,
or extract.
(3) Vanillin, ethyl vanillin, or other artificial food flavoring.
(4) Butter, milk fat, dried malted cereal extract, ground coffee,
ground nut meats.
(5) Salt.
Any optional ingredient used with the cacao beans or cacao nibs from
which such chocolate liquor is prepared, or used with any cocoa added in
preparing such chocolate liquor, shall be considered to be an optional
ingredient used with such chocolate liquor. The optional alkali
ingredients specified for use with cacao nibs in 163.110(a) may be used
as optional ingredients with chocolate liquor; but for each 100 parts
by weight of cacao nibs used in preparing the chocolate liquor, the
total quantity of such alkalis used is not greater in neutralizing value
(calculated from the respective combining weights of such alkalis used)
than 3 parts by weight of anhydrous potassium carbonate. The finished
chocolate liquor contains not less than 50 percent and not more than 58
percent by weight of cacao fat. Unless the chocolate liquor is seasoned
with butter, milkfat, or ground nut meats, the percentage of cacao fat
is determined by the method prescribed under ''Fat Method I -- Official
Final Action'' in the ''Official Methods of Analysis of the Association
of Official Analytical Chemists,'' 13th Ed. (1980), section 13.031,
which is incorporated by reference. Copies may be obtained from the
Association of Official Analytical Chemists, 2200 Wilson Blvd., Suite
400, Arlington, VA 22201-3301, or may be examined at the Office of the
Federal Register, 1100 L St. NW., Washington, DC 20408.
(b) Wherever the name of the food appears on the label so
conspicuously as to be easily seen under customary conditions of
purchase, the statements prescribed in this section, showing the
optional ingredients used shall immediately and conspicuously precede or
follow such name, without intervening written, printed, or graphic
matter:
(1) When the food is seasoned with an optional ingredient specified
in paragraph (a)(1) of this section the label shall bear the statement
''Spiced'', ''Spice added'', ''With added spice'', ''Spiced with ------
'', or ''With added ------ '', the blank being filled in with the
specific common name of the spice used.
(2) When the food is flavored with an optional ingredient specified
in paragraph (a)(2) of this section, the label shall bear the statement
''Flavored'', ''Flavoring added'', ''With added flavoring'', or
''Flavored with ------ '', '' ------ added'', or ''With added ------ '',
the blank being filled in with the specific common name of the flavoring
used.
(3) When the food is flavored with an optional ingredient specified
in paragraph (a)(3) of this section, the label shall bear the statement
''Artificially flavored'', ''Artificial flavoring added'', ''With
artificial flavoring'', ''Artificially flavored with ---- '', or ''With
---- , an artificial flavoring'', the blank being filled in with the
specific common name of the artificial flavoring used.
(4) When the food is seasoned with an optional ingredient specified
in paragraph (a)(4) of this section, the label shall bear the statement
''Seasoned with ---- '', the blank being filled in with the specific
common name of the substance used as seasoning.
(5) When any optional alkali ingredient specified in 163.110 (a) is
used, the label shall bear the statement ''Processed with alkali''; but
in lieu of the word ''alkali'' in such statement the specific common
name of the optional alkali ingredient may be used.
Label statements prescribed in paragraphs (b) (1) to (4), inclusive,
of this section may be combined, as for example, ''With added cinnamon,
vanilla, and ethyl vanillin, an artificial flavoring''.
(42 FR 14471, Mar. 15, 1977, as amended at 47 FR 11834, Mar. 19,
1982; 49 FR 10102, Mar. 19, 1984; 54 FR 24896, June 12, 1989)
21 CFR 163.112 Breakfast cocoa.
(a) Breakfast cocoa, high fat cocoa is the food prepared by
pulverizing the residual material remaining after part of the cacao fat
has been removed from ground cacao nibs. It may be spiced, flavored, or
otherwise seasoned with one or more of the following optional
ingredients, other than any such ingredient or combination of
ingredients which imparts a flavor that imitates the flavor of
chocolate, milk, or butter:
(1) Ground spice.
(2) Ground vanilla beans; any natural food flavoring oil, oleoresin,
or extract.
(3) Vanillin, ethyl vanillin, or other artificial food flavoring.
(4) Salt.
Any optional ingredient used with the cacao beans, cacao nibs, or
ground cacao nibs from which such breakfast cocoa is prepared shall be
considered to be an optional ingredient used with such breakfast cocoa.
The optional alkali ingredients specified for use with cacao nibs in
163.110(a) may be used as optional ingredients with breakfast cocoa;
but for each 100 parts by weight of cacao nibs used in preparing the
breakfast cocoa, the total quantity of such alkalis used is not greater
in neutralizing value (calculated from the respective combining weights
of such alkalis used) than 3 parts by weight of anhydrous potassium
carbonate. The finished breakfast cocao contains not less than 22
percent of cacao fat, as determined by the method prescribed under ''Fat
Method I -- Official Final Action'' prescribed in the ''Official Methods
of Analysis of the Association of Official Analytical Chemists,'' 13th
Ed. (1980), section 13.031, which is incorporated by reference. Copies
may be obtained from the Association of Official Analytical Chemists,
2200 Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may be
examined at the Office of the Federal Register, 1100 L St. NW.,
Washington, DC 20408.
(b) Wherever the name of the food appears on the label so
conspicuously as to be easily seen under customary conditions of
purchase, the statements prescribed in this section, showing the
optional ingredients used shall immediately and conspicuously precede or
follow such name, without intervening written, printed, or graphic
matter:
(1) When the food is seasoned with an optional ingredient specified
in paragraph (a)(1) of this section, the label shall bear the statement
''Spiced'', ''Spice added'', ''With added spice'', ''Spiced with ----
'', or ''With added ---- '', the blank being filled in with the specific
common name of the spice used.
(2) When the food is flavored with an optional ingredient specified
in paragraph (a)(2) of this section, the label shall bear the statement
''Flavored'', ''Flavoring added'', ''With added flavoring'', ''Flavored
with ---- '', '' ---- added'', or ''With added ---- '', the blank being
filled in with the specific common name of the flavoring used.
(3) When the food is flavored with an optional ingredient specified
in paragraph (a)(3) of this section, the label shall bear the statement
''Artificially flavored'', ''Artificial flavoring added'', ''With
artificial flavoring'', ''Artificially flavored with ---- '', or ''With
---- , an artificial flavoring'', the blank being filled in with the
specific common name of the artificial flavoring used.
(4) When any optional alkali ingredient specified in 163.110(a) is
used, the label shall bear the statement ''Processed with alkali''; but
in lieu of the word ''alkali'' in such statement the specific common
name of the optional alkali ingredient may be used.
Label statements prescribed by paragraphs (b) (1) to (4), inclusive,
of this section may be combined, as for example, ''With added cinnamon,
vanilla, and ethyl vanillin, an artificial flavoring''.
(42 FR 14471, Mar. 15, 1977, as amended at 47 FR 11834, Mar. 19,
1982; 49 FR 10103, Mar. 19, 1984; 54 FR 24896, June 12, 1989)
21 CFR 163.113 Cocoa.
Cocoa, medium fat cocoa conforms to the definition and standard of
identity, and is subject to the requirements for label statement of
optional ingredients, prescribed for breakfast cocoa by 163.112, except
that it contains less than 22 percent but not less than 10 percent of
cacao fat, as determined by the method referred to in 163.112(a).
21 CFR 163.114 Low-fat cocoa.
Low-fat cocoa conforms to the definition and standard of identity,
and is subject to the requirements for label statement of optional
ingredients, prescribed for breakfast cocoa by 163.112, except that it
contains less than 10 percent of cacao fat as determined by the method
referred to in 163.112(a).
21 CFR 163.117 Cocoa with dioctyl sodium sulfosuccinate for
manufacturing.
(a) Cocoa with dioctyl sodium sulfosuccinate for manufacturing is the
food additive complying with the provisions 172.520 of this chapter.
It conforms to the definition and standard of identity and is subject to
the requirements for label statement of optional ingredients prescribed
for breakfast cocoa by 163.112, or for cocoa by 163.113, or low-fat
cocoa by 163.114, except that the food additive contains dioctyl sodium
sulfosuccinate (complying with the requirements of 172.810 of this
chapter including the limit of not more than 0.4 percent by weight of
the finished food additive).
(b) The name of the food additive is ''cocoa with dioctyl sodium
sulfosuccinate for manufacturing'' to which is added any modifier of the
word ''cocoa'' required by the definition and standard of identity to
which the food additive otherwise conforms. When the food additive is
used in a fabricated food, the words ''for manufacturing'' may be
omitted from any declaration of ingredients required under 101.4 of
this chapter.
21 CFR 163.123 Sweet chocolate.
(a) Sweet chocolate, sweet chocolate coating is the solid or
semiplastic food the ingredients of which are intimately mixed and
ground, prepared from chocolate liquor (with or without the addition of
cacao fat) sweetened with one of the optional saccharine ingredients
specified in paragraph (b) of this section. It may be spiced, flavored,
or otherwise seasoned with one or more of the optional ingredients
specified in paragraph (c) of this section, other than any such
ingredient or combination of ingredients which imparts a flavor that
imitates the flavor of chocolate, milk, or butter. One of the optional
emulsifying ingredients or combinations of ingredients specified in
paragraph (d) of this section may be used, subject to the conditions
therein prescribed. One or more of the optional dairy ingredients
specified in paragraph (e) of this section may be used in such quantity
that the finished sweet chocolate contains less than 12 percent by
weight of milk constituent solids. If chocolate liquor with any
optional ingredient specified in 163.111(a) is used, such ingredient
shall be considered to be an optional ingredient used with the sweet
chocolate. The finished sweet chocolate contains not less than 15
percent by weight of chocolate liquor, calculated by subtracting from
the weight of chocolate liquor used the weight of cacao fat therein and
the weights therein of alkali and seasoning ingredients, if any,
multiplying the remainder by 2.2, dividing the result by the weight of
the finished sweet chocolate, and multiplying the quotient by 100.
Bittersweet chocolate is sweet chocolate which contains not less than 35
percent by weight of chocolate liquor, calculated in the same manner.
(b) The optional saccharine ingredients referred to in paragraph (a)
of this section are:
(1) Sugar, or partly refined cane sugar, or both.
(2) Any mixture of dextrose and sugar or partly refined cane sugar or
both in which the weight of the solids of the dextrose used is not more
than one-third of the total weight of the solids of all the saccharine
ingredients used.
(3) Any mixture of dried corn sirup or dried glucose sirup and sugar
or partly refined cane sugar or both in which the weight of the solids
of the dried corn sirup or dried glucose sirup used is not more than
one-fourth of the total weight of the solids of all the saccharine
ingredients used.
(4) Any mixture of dextrose and dried corn sirup or dried glucose
sirup and sugar or partly refined cane sugar or both in which three
times the weight of the solids of the dextrose used plus four times the
weight of the solids of the dried corn sirup or of the solids of the
dried glucose sirup used is not more than the total weight of the solids
of all the saccharine ingredients used.
(c) The optional ingredients for spicing, flavoring, or otherwise
seasoning referred to in paragraph (a) of this section are:
(1) Ground spice.
(2) Ground vanilla beans; any natural food flavoring oil or
oleoresin or extract.
(3) Ground coffee.
(4) Ground nut meats.
(5) Honey, molasses, brown sugar, maple sugar.
(6) Dried malted cereal extract.
(7) Salt.
(8) Vanillin, ethyl vanillin, or other artificial food flavoring.
(d) The optional emulsifying ingredient or combination of ingredients
referred to in paragraph (a) of this section is:
(1) Lecithin, with or without related natural phosphatides, in an
amount not to exceed 0.5 percent by weight of the finished food (with or
without a vegetable food fat carrier in an amount not to exceed
two-thirds of the weight of the emulsifying ingredient used); or
(2) Monoglycerides and diglycerides of fat-forming fatty acids in
combination with monosodium phosphate derivatives thereof, in an amount
not to exceed 0.5 percent of the weight of the finished food (with or
without a vegetable food fat carrier in an amount not to exceed
two-thirds of the weight of the emulsifying ingredient used); or
(3) Sorbitan monostearate, complying with the requirements of
172.842 of this chapter, in an amount not to exceed 1 percent of the
weight of the finished food; or
(4) Polysorbate 60, complying with the requirements of 172.836 of
this chapter, in an amount not to exceed 0.5 percent of the weight of
the finished food; or
(5) Any combination of two or more of the foregoing each within the
limits prescribed in paragraphs (d) (1), (2), (3), and (4) of this
section provided that the total quantity of any two or all three of the
emulsifiers specified in paragraphs (d) (2), (3), and (4) of this
section does not exceed 1 percent by weight of the finished food and the
total quantity of the emulsifiers specified in paragraphs (d) (1) and
(2) of this section does not exceed 0.5 percent of the weight of the
finished food.
(e) The optional dairy ingredients referred to in paragraph (a) of
this section are:
(1) Cream, milk fat, butter.
(2) Milk, concentrated milk, evaporated milk, sweetened condensed
milk, dried milk.
(3) Skim milk, concentrated skim milk, evaporated skim milk,
sweetened condensed skim milk, nonfat dry milk.
(4) Concentrated buttermilk, dried buttermilk.
(5) Malted milk.
(f) For the purpose of this section:
(1) The term ''dextrose'' means the anhydrous refined monosaccharide
obtained from hydrolyzed starch.
(2) The term ''dried corn sirup'' means the product obtained by
drying incompletely hydrolyzed cornstarch; its solids contain not less
than 40 percent by weight of reducing sugars calculated as anhydrous
dextrose.
(3) The term ''dried glucose sirup'' means the product obtained by
drying ''glucose sirup''. ''Glucose sirup'' is a clarified,
concentrated, aqueous solution of the products obtained by the
incomplete hydrolysis of any edible starch. The solids of glucose sirup
contain not less than 40 percent by weight of reducing sugars calculated
as anhydrous dextrose.
(g) ''Semisweet chocolate'', ''bittersweet chocolate'', ''semisweet
chocolate coating'', and ''bittersweet chocolate coating'' are alternate
names for sweet chocolate which contains not less than the minimum
quantity of chocolate liquor prescribed for bittersweet chocolate by
paragraph (a) of this section.
(h) Wherever the name of the food appears on the label so
conspicuously as to be easily seen under customary conditions of
purchase, the statements prescribed in this paragraph showing the
optional ingredients used shall immediately and conspicuously precede or
follow such name, without intervening written, printed, or graphic
matter:
(1) When the food is flavored with an optional ingredient specified
in paragraph (c)(8) of this section, the label shall bear the statement
''Artificially flavored'', ''Artificial flavoring added'', ''With
artificial flavoring'', ''Artificially flavored with ------------ '', or
''With ------------ , an artificial flavoring'', the blank being filled
in with the specific common name of the artificial flavoring used.
(2) When an optional emulsifying ingredient or combination of
ingredients specified in paragraph (d) of this section is used, the
label shall bear the statement ''Emulsifier added'', ''With added
emulsifier'', or '' ------------ added as (an) emulsifier(s)'', the
blank being filled in with the common name(s) of the emulsifier(s) used.
(3) When any optional alkali ingredient specified in 163.110(a) is
used, the label shall bear the statement ''Processed with alkali'', but
in lieu of the word ''alkali'' in such statement the specific common
name of the optional alkali ingredient may be used.
In cases where two or more of the statements set forth in this
paragraph are required, such statements may be combined in a manner
which is appropriate and not misleading.
21 CFR 163.130 Milk chocolate.
(a) Milk chocolate, sweet milk chocolate, milk chocolate coating,
sweet milk chocolate coating is the solid or semiplastic food the
ingredients of which are intimately mixed and ground, prepared from
chocolate liquor (with or without the addition of cacao fat) and one or
more of the optional dairy ingredients specified in paragraph (b) of
this section, sweetened with one of the optional saccharine ingredients
specified in 163.123 (b) and (f). It may be spiced, flavored, or
otherwise seasoned with one or more of the optional ingredients
specified in paragraph (c) of this section, other than any such
ingredient or combination of ingredients which imparts a flavor that
imitates the flavor of chocolate, milk, or butter. One of the optional
emulsifying ingredients or combinations of ingredients specified in
paragraph (d) of this section may be used, subject to the conditions
therein prescribed. If chocolate liquor with any optional ingredient
specified in 163.111(a) is used, such ingredient shall be considered to
be an optional ingredient used with the milk chocolate. The finished
milk chocolate contains not less than 3.66 percent by weight of milk
fat, not less than 12 percent by weight of milk solids, and not less
than 10 percent by weight of chocolate liquor as calculated by
subtracting from the weight of chocolate liquor used the weight of cacao
fat therein and the weights therein of alkali and seasoning ingredients,
if any, multiplying the remainder by 2.2, dividing the result by the
weight of the finished milk chocolate, and multiplying the quotient by
100.
(b) The optional dairy ingredients referred to in paragraph (a) of
this section are milk, concentrated milk, evaporated milk, sweetened
condensed milk, dried milk, butter, milk fat, cream, skim milk,
concentrated skim milk, evaporated skim milk, sweetened condensed skim
milk, and nonfat dry milk; but in any such ingredient or combination of
two or more of such ingredients used, the weight of nonfat milk solids
is not more than 2.43 times and not less than 1.20 times the weight of
milk fat therein.
(c) The optional ingredients for spicing, flavoring, or otherwise
seasoning referred to in paragraph (a) of this section are:
(1) Ground spice.
(2) Ground vanilla beans; any natural food flavoring oil or
oleoresin or extract.
(3) Ground coffee.
(4) Ground nut meats.
(5) Honey, molasses, brown sugar, maple sugar.
(6) Dried malted cereal extract.
(7) Salt.
(8) Vanillin, ethyl vanillin, or other artificial food flavoring.
(d) The optional emulsifying ingredient or combination of ingredients
referred to in paragraph (a) of this section is:
(1) Lecithin, with or without related natural phosphatides, in an
amount not to exceed 0.5 percent by weight of the finished food (with or
without a vegetable food fat carrier in an amount not to exceed
two-thirds of the weight of the emulsifying ingredient used); or
(2) Monoglycerides and diglycerides of fat-forming fatty acids in
combination with monosodium phosphate derivatives thereof, in an amount
not to exceed 0.5 percent of the weight of the finished food (with or
without a vegetable food fat carrier in an amount not to exceed
two-thirds of the weight of the emulsifying ingredient used); or
(3) Sorbitan monostearate, complying with the requirements of
172.842 of this chapter, in an amount not to exceed 1 percent of the
weight of the finished food; or
(4) Polysorbate 60, complying with the requirements of 172.836 of
this chapter, in an amount not to exceed 0.5 percent of the weight of
the finished food; or
(5) Any combination of two or more of the foregoing each within the
limits prescribed in paragraphs (d) (1), (2), (3), and (4) of this
section provided that the total quantity of any two or all three of the
emulsifiers specified in paragraphs (d) (2), (3), and (4) of this
section does not exceed 1 percent by weight of the finished food and the
total quantity of the emulsifiers specified in paragraphs (d) (1) and
(2) of this section does not exceed 0.5 percent of the weight of the
finished food.
(e) Wherever the name of the food appears on the label so
conspicuously as to be easily seen under customary conditions of
purchase, the statements prescribed in this paragraph showing the
optional ingredients used shall immediately and conspicuously precede or
follow such name, without intervening written, printed, or graphic
matter:
(1) When the food is flavored with an optional ingredient specified
in paragraph (c)(8) of this section, the label shall bear the statement
''Artificially flavored'', ''Artificial flavoring added'', ''With
artificial flavoring'', ''Artificially flavored with ------------ '', or
''With ------------ , an artificial flavoring'', the blank being filled
in with the specific common name of the artificial flavoring used.
(2) When an optional emulsifying ingredient or combination of
ingredients specified in paragraph (d) of this section is used, the
label shall bear the statement ''Emulsifier added'', ''With added
emulsifier'', or '' ------------ added as (an) emulsifier(s)'', the
blank being filled in with the common name(s) of the emulsifier(s) used.
(3) When any optional alkali ingredient specified in 163.110(a) is
used, the label shall bear the statement ''Processed with alkali,'' but
in lieu of the word ''alkali'' in such statement the specific common
name of the optional alkali ingredient may be used.
In cases where two or more of the statements set forth in this
paragraph are required, such statements may be combined in a manner
which is appropriate and not misleading.
21 CFR 163.135 Buttermilk chocolate.
Buttermilk chocolate, buttermilk chocolate coating conforms to the
definition and standard of identity, and is subject to the requirements
for label statement of optional ingredients, prescribed for milk
chocolate by 163.130, except that:
(a) The dairy ingredients used are limited to sweet cream buttermilk,
concentrated sweet cream buttermilk, dried sweet cream buttermilk, or
any combination of two or all of these.
(b) The finished buttermilk chocolate contains less than 3.66 percent
by weight of milk fat and, instead of milk solids, it contains not less
than 12 percent by weight of sweet cream buttermilk solids.
21 CFR 163.140 Skim milk chocolate.
Skim milk chocolate, sweet skim milk chocolate, skim milk chocolate
coating, sweet skim milk chocolate coating conforms to the definition
and standard of identity, and is subject to the requirements for label
statement of optional ingredients, prescribed for milk chocolate by
163.130, except that:
(a) The dairy ingredients used are limited to skim milk, concentrated
skim milk, evaporated skim milk, sweetened condensed skim milk, nonfat
dry milk, and any combination of two or more of these.
(b) The finished skim milk chocolate contains less than 3.66 percent
by weight of milk fat and, instead of milk solids, it contains not less
than 12 percent by weight of skim milk solids.
21 CFR 163.145 Mixed dairy product chocolates.
(a) The articles for which definitions and standards of identity are
prescribed by this section are the foods each of which conforms to the
definition and standard of identity, and is subject to the requirements
for label statement of optional ingredients, prescribed for milk
chocolate by 163.130, except that:
(1) The dairy ingredient used in each such article is a mixture of
two or more of the following four components:
(i) Any dairy ingredient or combination of such ingredients specified
in 163.130(b) which is within the limits of the ratios specified
therein for nonfat milk solids to milk fat.
(ii) One or more of the five skim milk ingredients specified in
163.140.
(iii) One or more of the three sweet cream buttermilk ingredients
specified in 163.135.
(iv) Malted milk.
(2) Each of the finished articles may contain less than 3.66 percent
by weight of milk fat and, instead of milk solids, it contains not less
than 12 percent by weight of milk constituent solids of the components
used. The quantity of each component used in any such mixture is such
that no component contributes less than one-third of the weight of milk
constituent solids contributed by that component used in largest
proportion. When any such mixture is of components (i) and (ii) of
paragraph (a)(1) of this section, the quantity of nonfat milk solids in
such mixture is more than 2.43 times the quantity of milk fat therein.
For the purposes of paragraph (b) of this section, the designation of
each of the components listed above is respectively ''Milk'', ''Skim
milk'', ''Buttermilk'', and ''Malted milk''.
(b) The name of each such article is ''Chocolate'' or ''Chocolate
coating'' preceded by the designations prescribed by paragraph (a) of
this section for each component of the dairy ingredients used, such
designations appearing in the order of predominance, if any, of the
weight of milk constituent solids in each such component, (e.g., ''Milk
and skim milk chocolate'').
21 CFR 163.150 Sweet cocoa and vegetable fat (other than cacao fat)
coating.
Sweet cocoa and vegetable fat (other than cacao fat) coating conforms
to the definition and standard of identity, and is subject to the
requirements for label statement of optional ingredients, prescribed for
sweet chocolate by 163.123, except that:
(a) In its preparation cocoa is used, instead of chocolate liquor, in
such quantity that the finished food contains not less than 6.8 percent
by weight of the nonfat cacao portion of such cocoa, calculated by
subtracting from the weight of cocoa used the weight of cacao fat
therein and the weight therein of alkali and seasoning ingredients, if
any, dividing the remainder by the weight of the finished food, and
multiplying the quotient by 100. (For the purposes of this section, the
term ''cocoa'' means breakfast cocoa, cocoa, low-fat cocoa, or any
mixture of two or more of these.)
(b) In its preparation is added one or any combination of two or more
vegetable food oils, vegetable food fats, or vegetable food stearins,
other than cacao fat, which oil, fat, stearin, or combination has a
melting point higher than that of cacao fat. Any such oil or fat may be
hydrogenated.
(c) The requirement of 163.123(a) that the milk constituent solids
be less than 12 percent by weight does not apply.
21 CFR 163.153 Sweet chocolate and vegetable fat (other than cacao fat)
coating.
(a) Sweet chocolate and vegetable fat (other than cacao fat) coating
conforms to the definition and standard of identity, and is subject to
the requirements for label statement of optional ingredients, prescribed
for sweet chocolate by 163.123, except that:
(1) In its preparation there is added one or any combination of two
or more vegetable food oils or vegetable food fats, other than cacao
fat, which oil, fat, or combination may be hydrogenated and which has a
melting point lower than that of cacao fat.
(2) Of the emulsifying ingredients and combinations of ingredients
listed in 163.123(d), only the ingredients specified in 163.123(d) (1)
and (2), alone or in combination, may be used subject to the limitation
that the total quantity of these ingredients does not exceed 0.5 percent
by weight of the finished food.
(b) The provisions of this section shall not be construed as
applicable to any article by reason of the addition thereto of a
vegetable food fat other than cacao fat as a carrier of emulsifying
ingredients, as authorized and within the limits prescribed by
163.123(d) (1) and (2).
21 CFR 163.155 Milk chocolate and vegetable fat (other than cacao fat)
coating.
(a) Milk chocolate and vegetable fat (other than cacao fat) coating,
sweet milk chocolate and vegetable fat (other than cacao fat) coating
conforms to the definition and standard of identity, and is subject to
the requirements for label statement of optional ingredients, prescribed
for milk chocolate by 163.130, except that:
(1) In its preparation there is added one or any combination of two
or more vegetable food oils or vegetable food fats, other than cacao
fat, which oil, fat, or combination may be hydrogenated and which has a
melting point lower than that of cacao fat.
(2) Of the emulsifying ingredients and combinations of ingredients
listed in 163.130(d), only the ingredients specified in 163.130(d) (1)
and (2), alone or in combination, may be used subject to the limitation
that the total quantity of these ingredients does not exceed 0.5 percent
by weight of the finished food.
(b) The provisions of this section shall not be construed as
applicable to any article by reason of the addition thereto of a
vegetable food fat other than cacao fat as a carrier of emulsifying
ingredients, as authorized and within the limits prescribed by
163.130(d) (1) and (2).
21 CFR 163.155 Pt. 164
21 CFR 163.155 PART 164 -- TREE NUT AND PEANUT PRODUCTS
21 CFR 163.155 Subpart A (Reserved)
21 CFR 163.155 Subpart B -- Requirements for Specific Standardized Tree
Nut and Peanut Products
Sec.
164.110 Mixed nuts.
164.120 Shelled nuts in rigid or semirigid containers.
164.150 Peanut butter.
Authority: Secs. 201, 401, 403, 409, 701, 706 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321, 341, 343, 348, 371, 376).
Source: 42 FR 14475, Mar. 15, 1977, unless otherwise noted.
21 CFR 163.155 Subpart A (Reserved)
21 CFR 163.155 Subpart B -- Requirements for Specific Standardized Tree Nut and Peanut Products
21 CFR 164.110 Mixed nuts.
(a) Mixed nuts is the food consisting of a mixture of four or more of
the optional shelled tree nut ingredients, with or without one or more
of the optional shelled peanut ingredients, of the kinds prescribed by
paragraph (b) of this section; except that when 2 ounces or less of the
food is packed in transparent containers, three or more of the optional
tree nut ingredients shall be present. Each such kind of nut ingredient
when used shall be present in a quantity not less than 2 percent and not
more than 80 percent by weight of the finished food. For purposes of
this section, each kind of tree nut and peanut is an optional ingredient
that may be prepared by any suitable method in accordance with good
manufacturing practice. The finished food may contain one or more of
the optional nonnut ingredients provided for in paragraph (c) of this
section.
(b) The optional shelled nut ingredients referred to in paragraph (a)
of this section are:
(1) Almonds, black walnuts, Brazil nuts, cashews, English walnuts
(alternatively ''walnuts''), filberts, pecans, and other suitable kinds
of tree nuts.
(2) Peanuts of the Spanish, Valencia, Virginia, or similar varieties,
or any combination of two or more such varieties.
(c) The optional nonnut ingredients referred to in paragraph (a) of
this section consist of suitable substances that are not food additives
as defined in section 201(s) of the Federal Food, Drug, and Cosmetic
Act; or if they are food additives as so defined, they are used in
conformity with regulations established pursuant to section 409 of the
act. Nonnut ingredients that perform a useful function are regarded as
suitable, except that color additives are not suitable ingredients of
the food.
(d) The name of the food is ''mixed nuts''. If the percentage of a
single tree nut ingredient or the total peanut content by weight of the
finished food exceeds 50 percent but not 60 percent, the statement
''contains up to 60% ------ '' or ''contains 60% ------ '' or ''60%
------ '' shall immediately follow the name ''mixed nuts'' and shall
appear on the same background, be of the same color or, in the case of
multicolors, in the color showing distinct contrast with the background,
and be in letters not less than one-half the height of the largest
letter in the words ''mixed nuts''. The blank is to be filled in with
the appropriate name of the predominant nut ingredient; for example,
''contains up to 60% pecans'' or ''contains up to 60% Spanish peanuts''.
The numbers ''70'' or ''80'' shall be substituted for the number ''60''
when the percentage of the predominant nut ingredient exceeds 60 but not
70, or exceeds 70 but not 80, respectively. Compliance with the
requirements for percentage of nut ingredients of this section and the
fill of container requirements of 164.120(c) will be determined by the
following procedure:
(1) Take at random from a lot, in the case of containers bearing a
weight declaration of 16 ounces or less, at least 24 containers, and for
containers bearing a weight declaration of more than 16 ounces, enough
containers to provide a total quantity of at least 24 pounds of nuts.
(2) If compliance with 164.120(c) is to be determined, first follow
the procedure set forth therein.
(3) Determine the percent by weight of each nut ingredient present in
each container separately. Calculate the average percentage of each nut
ingredient present. If the average percent found for each nut
ingredient present is 2 percent or more and none of the individual nut
ingredients exceeds 80 percent by weight of the finished food, the lot
will be deemed to be in compliance with the percentage requirements of
paragraph (a) of this section. If the average percent found for a
single nut ingredient exceeds 50 percent by weight of the finished food
and the average percent found is within the range indicated by the
number declared on the label in accordance with this paragraph, the lot
will be deemed to be in compliance with the labeling requirements of
this paragraph.
(e) Optional nut ingredients and optional nonnut ingredients used in
the food, as provided for in paragraphs (b) and (c) of this section,
shall be declared on the label by their common names in the order of
decreasing predominance by weight except that:
(1) If the Spanish variety of peanuts is used, it shall be declared
as ''Spanish peanuts''. Other varieties of peanuts shall be declared as
''peanuts'', or alternatively '' ------------ peanuts'', the blank being
filled in with the varietal name of the peanuts used.
(2) If the peanut ingredient or ingredients as provided for in
paragraph (b)(2) of this section are unblanched, the label shall show
that fact by such statement as ''Peanuts unblanched'', ''Peanuts skins
on'', or words of similar import, unless the vignette clearly depicts
peanuts with skins on.
(3) Vegetable oils used shall be declared by the words ''Vegetable
oil'' or ''Hydrogenated vegetable oil'', or alternatively ''
------------ oil'', or ''Hydrogenated ------------ oil'', as the case
may be, the blank being filled in with the name or names of the
vegetable source(s) of the oil. For the purposes of this section,
hydrogenated vegetable oil shall be considered to include partially
hydrogenated vegetable oil.
(4) When antioxidant preservatives are used in the finished food, the
label shall bear the statement '' ------------ added as a preservative''
or '' ------------ added to inhibit rancidity'', the blank being filled
in with the name or names of the preservative(s) used.
(f) The words and statements specified in paragraph (e) of this
section showing the optional ingredients present shall be listed on the
principal display panel or panels or any appropriate information panel
without obscuring design, vignettes, or crowding. The declaration shall
appear in conspicuous and easily legible letters of boldface print or
type the size of which shall be not less than one-half of that required
by Part 101 of this chapter for the statement of net quantity of
contents appearing on the label, but in no case less than one-sixteenth
of an inch in height. The entire ingredient statement shall appear on
at least one panel of the label. If the label bears any pictorial
representation of the mixture of nuts, it shall depict the relative
proportions of the nut ingredients of the food. If the label bears a
pictorial representation of only one of each nut ingredient present, the
nuts shall be depicted in the order of decreasing predominance by
weight. A factual statement that the food does not contain a particular
nut ingredient or ingredients may be shown on the label if the statement
is not misleading and does not result in an insufficiency of label space
for the proper declaration of information required by or under authority
of the act to appear on the label.
21 CFR 164.120 Shelled nuts in rigid or semirigid containers.
(a) -- (b) (Reserved)
(c) Fill of container. (1) The standard of fill for shelled nuts in
rigid or semirigid containers is a fill such that the average volume of
nuts, from the number of containers specified in 164.110(d)(1), is not
less than 85 percent of the container volume as determined by the method
in paragraph (c) (2) of this section.
(2) The method for determining the percent of fill is as follows:
(i) For the shelled nuts in each container, determine the loose
volume, the settled volume, and the average volume in cubic centimeters.
For the purposes of this subparagraph, consider volume in milliliters
to be numerically equal to volume in cubic centimeters. Open the
container and pour the nuts loosely into a vertical graduated cylinder
(do not tilt) of appropriate size fitted with a funnel which has been
modified, if necessary, to provide a minimum opening of 1 1/2-inch
diameter. (If the loose volume of the nuts is less than 500
milliliters, use a 500-milliliter cylinder with an inside diameter of
approximately 1 7/8 inches; but if the loose volume is 500 milliliters
or more, use a 1,000-milliliter cylinder with an inside diameter of
approximately 2 1/4 inches.) Without shaking the cylinder, estimate the
location of a horizontal plane representing the average height of the
product, read the volume of the nuts, and record as the loose volume.
Raise the cylinder 2 inches and allow it a free vertical drop onto a
level, firm, but resilient surface (do not tamp) for a total of 5 times
and observe the volume as above. Repeat in successive five-drop
increments until the nuts have so settled that the volume decreases less
than 2 percent in the last five-drop increment. Read the last volume in
the manner described above and record as the settled volume. The
arithmetical average of the loose volume and the settled volume equals
the average volume of nuts.
(ii) Classify the container by shape and determine its volume in
cubic centimeters according to one of the following methods as
appropriate:
(a) For containers of irregular shape, including glass jars, follow
the general method for water capacity of containers as prescribed in
130.12(a) of this chapter and determine the container volume,
considering the water capacity in grams to be numerically equivalent to
volume in cubic centimeters, or the water capacity in ounces
(avoirdupois) to be equivalent to 28.35 cubic centimeters per ounce.
(b) For box-shaped containers (that is, with opposite sides
parallel), measure the inside height, width, and depth and calculate the
volume as the product of these three dimensions. For such containers
used to enclose vacuum packs and containing 4 ounces or less of the
product, consider the height to be the inside height minus three-eighths
inch.
(c) For cylindrical containers, calculate the container volume in
cubic centimeters as the product of the height times the square of the
diameter, both measured in inches, times 12.87; or as the product of
the height times the square of the diameter, both measured in
centimeters, times 0.7854. For containers that do not have indented
ends, use the inside height and inside diameter as the dimensions. For
metal cans with indented ends (that is, metal cans with ends attached by
double seams), consider the height to be the outside height at the
double seam minus three-eighths inch (0.953 centimeter) and the diameter
to be the outside diameter at the double seam minus one-eighth inch
(0.318 centimeter). For fiber-bodied containers with indented ends (that
is, fiber-bodied cans with metal ends attached by double seams),
consider the height to be the outside height at the double seam minus
three-eighths inch (0.953 centimeter) and the diameter to be the outside
diameter at the double seam minus three-sixteenths inch (0.476
centimeter).
(iii) Calculate the percent fill of the container as follows: Divide
the average volume of nuts found according to paragraph (c)(2)(i) of
this section by the appropriate container volume found according to
paragraph (c)(2)(ii) of this section and multiply by 100. The result
shall be considered to be the percent fill of the container.
(3) If shelled nuts fall below the standard of fill of container
prescribed in paragraph (c)(1) of this section, the label shall bear the
general statement of substandard fill specified in 130.14(b) of this
chapter, in the manner and form therein specified.
21 CFR 164.150 Peanut butter.
(a) Peanut butter is the food prepared by grinding one of the shelled
and roasted peanut ingredients provided for by paragraph (b) of this
section, to which may be added safe and suitable seasoning and
stabilizing ingredients provided for by paragraph (c) of this section,
but such seasoning and stabilizing ingredients do not in the aggregate
exceed 10 percent of the weight of the finished food. To the ground
peanuts, cut or chopped, shelled, and roasted peanuts may be added.
During processing, the oil content of the peanut ingredient may be
adjusted by the addition or subtraction of peanut oil. The fat content
of the finished food shall not exceed 55 percent when determined as
prescribed in ''Official Methods of Analysis of the Association of
Official Analytical Chemists,'' 13th Ed. (1980), section 27.006(a)
under ''Crude Fat -- Official First Action, Direct Method,'' in
paragraph (a), which is incorporated by reference. Copies may be
obtained from the Association of Official Analytical Chemists, 2200
Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may be examined at
the Office of the Federal Register, 1100 L St., NW., Washington, DC
20408.
(b) The peanut ingredients referred to in paragraph (a) of this
section are:
(1) Blanched peanuts, in which the germ may or may not be included.
(2) Unblanched peanuts, including the skins and germ.
(c) The seasoning and stabilizing ingredients referred to in
paragraph (a) of this section are suitable substances which are not food
additives as defined in section 201(s) of the Federal Food, Drug, and
Cosmetic Act, or if they are food additives as so defined, they are used
in conformity with regulations established pursuant to section 409 of
the act. Seasoning and stabilizing ingredients that perform a useful
function are regarded as suitable, except that artificial flavorings,
artificial sweeteners, chemical preservatives, added vitamins and color
additives are not suitable ingredients of peanut butter. Oil products
used as optional stabilizing ingredients shall be hydrogenated vegetable
oils. For the purposes of this section, hydrogenated vegetable oil
shall be considered to include partially hydrogenated vegetable oil.
(d) If peanut butter is prepared from unblanched peanuts as specified
in paragraph (b)(2) of this section, the name shall show that fact by
some such statement as ''prepared from unblanched peanuts (skins left
on).'' Such statement shall appear prominently and conspicuously and
shall be in type of the same style and not less than half of the point
size of that used for the words ''peanut butter.'' This statement shall
immediately precede or follow the words ''peanut butter,'' without
intervening written, printed, or graphic matter.
(e) The label of peanut butter shall name, by their common names, the
optional ingredients used, as provided in paragraph (c) of this section.
If hydrogenated vegetable oil is used, the label statement of optional
ingredients shall include the words ''Hydrogenated ------------ oil'' or
''Hardened ------------ oil'', the blank being filled in either with the
names of the vegetable sources of the oil or, alternatively, with the
word ''vegetable''; for example, ''Hydrogenated peanut oil'' or
''Hardened peanut and cottonseed oils'' or ''Hydrogenated vegetable
oil''.
(42 FR 14475, Mar. 15, 1977, as amended at 47 FR 11834, Mar. 19,
1982; 49 FR 10103, Mar. 19, 1984; 54 FR 24896, June 12, 1989)
21 CFR 164.150 PART 165 (RESERVED)
21 CFR 164.150 PART 166 -- MARGARINE
21 CFR 164.150 Pt. 166
21 CFR 164.150 Subpart A -- General Provisions
Sec.
166.40 Labeling of margarine.
21 CFR 164.150 Subpart B -- Requirements for Specific Standardized
Margarine
166.110 Margarine.
Authority: Secs. 201, 401, 403, 407, 409, 701, 706 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 343, 347, 348, 371,
376).
21 CFR 164.150 Subpart A -- General Provisions
21 CFR 166.40 Labeling of margarine.
The Federal Food, Drug, and Cosmetic Act was amended by Pub. L.
459, 81st Congress (64 Stat. 20) on colored oleomargarine or margarine
by adding thereto a new section numbered 407. Among other things, this
section requires that there appear on the label of the package the word
''oleomargarine'' or ''margarine'' in type or lettering at least as
large as any other type or lettering on the label, and a full and
accurate statement of all the ingredients contained in such
oleomargarine or margarine. It provides that these requirements ''shall
be in addition to and not in lieu of any of the other requirements of
this Act''.
(a) Under section 403(g) of the Federal Food, Drug, and Cosmetic Act,
any article that is represented as or purports to be oleomargarine or
margarine must conform to the definition and standard of identity for
oleomargarine or margarine promulgated under section 401 of the act
(Subpart B of this part), and its label must bear the name
''oleomargarine'' or ''margarine''.
(b) The identity standard for oleomargarine or margarine applies to
both the uncolored and the colored article.
(c) In considering the requirement that the word ''oleomargarine'' or
''margarine'' be in type or lettering at least as large as any other
type or lettering on the label, it must be borne in mind that at least
three factors are involved -- the height of each letter, the area
occupied by each letter as measured by a closely fitting rectangle drawn
around it, and the boldness of letters or breadth of the lines forming
the letters. The type or lettering used should meet the following
tests:
(1) The height of each letter in the word ''oleomargarine'' or
''margarine'' should equal or exceed the height of any other letter
elsewhere on the label.
(2) The area of the closely fitting rectangle with respect to any of
the letters in the word ''oleomargarine'' or ''margarine'' should equal
or exceed the area of such rectangle applied to the same or a
corresponding letter elsewhere on the label.
(3) The letters in the word ''oleomargarine'' or ''margarine'' should
be equal to or exceed in prominence and boldness, such as breadth of
lines forming the letters, the same or corresponding letters elsewhere
on the label.
(d) (Reserved)
(e) The word ''oleomargarine'' or ''margarine'' (and thus the other
information called for by the statute) should appear on each panel of
the package label that might reasonably be selected by the grocer for
display purposes at the point of sale.
(f) The amendment covering colored oleomargarine or colored margarine
states that, ''for the purposes of * * * section 407 of the Federal
Food, Drug, and Cosmetic Act, as amended, the term 'oleomargarine' or
'margarine' includes: (1) All substances, mixtures, and compounds known
as oleomargarine or margarine; (2) all substances, mixtures, and
compounds which have a consistency similar to that of butter and which
contain any edible oils or fats other than milk fat if made in imitation
or semblance of butter''. Notwithstanding the difference between this
definition and the definition and standard of identity for oleomargarine
or margarine promulgated under section 401 of the act, it was the clear
intent of Congress that any article which is represented as or purports
to be oleomargarine or margarine is misbranded if it fails to comply
with the definition and standard of identity for oleomargarine or
margarine even though it may meet the statutory definition.
(g) Section 407(a) states that ''Colored oleomargarine or colored
margarine which is sold in the same State or Territory in which it is
produced shall be subject in the same manner and to the same extent to
the provisions of this act as if it had been introduced in interstate
commerce''.
(h) Section 407(b)(4) requires that each part of the contents of the
package be ''contained in a wrapper which bears the word 'oleomargarine'
or 'margarine' in type or lettering not smaller than 20-point type''.
The Food and Drug Administration interprets this to mean that the height
of the actual letters is no less than 20 points, or 20/72 of 1 inch.
(i) The wrappers on the subdivisions of oleomargarine or margarine
contained within the package sold at retail are labels within the
meaning of section 201(k) and shall contain all of the label information
required by sections 403 and 407 of the Federal Food, Drug, and Cosmetic
Act, just as in the case of 1-pound cartons, except that wrappers on the
subdivisions contained within the retail package shall be exempt from
compliance with the requirements of section 403 (e)(1), (g)(2), (i)(2),
and (k) of the act with respect to the requirements for label
declaration of the name and place of business of the manufacturer,
packer, or distributor and label declaration of ingredients when (1) the
subdivisions are securely enclosed within and are not intended to be
separated from the retail package under conditions of retail sale; (2)
the wrappers on the subdivisions are labeled with the statement ''This
Unit Not Labeled For Retail Sale'' in type size not less than
one-sixteenth inch in height. The word ''Individual'' may be used in
lieu of or immediately preceding the word ''Retail'' in the statement.
(42 FR 14477, Mar. 15, 1977, as amended at 46 FR 31005, June 12,
1981; 47 FR 32421, July 27, 1982)
21 CFR 166.40 Subpart B -- Requirements for Specific Standardized Margarine
21 CFR 166.110 Margarine.
(a) Margarine (or oleomargarine) is the food in plastic form or
liquid emulsion, containing not less than 80 percent fat determined by
the method prescribed in ''Official Methods of Analysis of the
Association of Official Analytical Chemists,'' 13th Ed. (1980), section
16.206, ''Indirect Method,'' under the heading ''Fat (47) -- Official
Final Action,'' which is incorporated by reference. Copies may be
obtained from the Association of Official Analytical Chemists, 2200
Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may be examined at
the Office of the Federal Register, 1100 L St. NW., Washington, DC
20408. Margarine contains only safe and suitable ingredients. It is
produced from one or more of the optional ingredients in paragraph
(a)(1) of this section, and one or more of the optional ingredients in
paragraph (a)(2) of this section, to which may be added one or more of
the optional ingredients in paragraph (b) of this section. Margarine
contains vitamin A as provided for in paragraph (a)(3) of this section.
(1) Edible fats and/or oils, or mixtures of these, whose origin is
vegetable or rendered animal carcass fats, any or all of which may have
been subjected to an accepted process of physico-chemical modification.
They may contain small amounts of other lipids such as phosphatides, or
unsaponifiable constituents and of free fatty acids naturally present in
the fat or oil.
(2) One or more of the following aqueous phase ingredients:
(i) Water and/or milk and/or milk products.
(ii) Suitable edible protein including, but not limited to, the
liquid, condensed, or dry form of whey, whey modified by the reduction
of lactose and/or minerals, nonlactose containing whey components,
albumin, casein, caseinate, vegetable proteins, or soy protein isolate,
in amounts not greater than reasonably required to accomplish the
desired effect.
(iii) Any mixture of two or more of the articles named under
paragraphs (a)(2) (i) and (ii) of this section.
(iv) The ingredients in paragraphs (a)(2) (i), (ii), and (iii) of
this section shall be pasteurized and then may be subjected to the
action of harmless bacterial starters. One or more of the articles
designated in paragraphs (a)(2) (i), (ii), and (iii) of this section is
intimately mixed with the edible fat and/or ingredients to form a
solidified or liquid emulsion.
(3) Vitamin A in such quantity that the finished margarine contains
not less than 15,000 international units per pound.
(b) Optional ingredients: (1) Vitamin D in such quantity that the
finished oleomargarine contains not less than 1,500 international units
of vitamin D per pound.
(2) Salt (sodium chloride); potassium chloride for dietary margarine
or oleomargarine.
(3) Nutritive carbohydrate sweeteners.
(4) Emulsifiers including but not limited to the following within
these maximum amounts in percent by weight of the finished food: Mono-
and diglycerides of fatty acids esterified with the following acids;
acetic, acetyltartaric, citric, lactic, tartaric, and their sodium and
calcium salts, 0.5 percent; such mono- and diglycerides in combination
with the sodium sulfo-acetate derivatives thereof, 0.5 percent;
polyglycerol esters of fatty acids, 0.5 percent; 1,2-propylene glycol
esters of fatty acids, 2 percent; lecithin, 0.5 percent.
(5) Preservatives including but not limited to the following within
these maximum amounts in percent by weight of the finished food: Sorbic
acid, benzoic acid and their sodium, potassium, and calcium salts,
individually, 0.1 percent, or in combination, 0.2 percent, expressed as
the acids; calcium disodium EDTA, 0.0075 percent; propyl, octyl, and
dodecyl gallates, BHT, BHA, ascorbyl palmitate, ascorbyl stearate, all
individually or in combination, 0.02 percent; stearyl citrate, 0.15
percent; isopropyl citrate mixture, 0.02 percent.
(6) Color additives. For the purpose of this subparagraph,
provitamin A (beta-carotene) shall be deemed to be a color additive.
(7) Flavoring substances. If the flavoring ingredients impart to the
food a flavor other than in semblance of butter, the characterizing
flavor shall be declared as part of the name of the food in accordance
with 101.22 of this chapter.
(8) Acidulants.
(9) Alkalizers.
(c) The name of the food for which a definition and standard of
identity are prescribed in this section is ''margarine'' or
''oleomargarine''.
(d) Each of the optional ingredients used shall be declared on the
label as required by the applicable sections of Part 101 of this
chapter. For the purposes of this section the use of the term ''milk''
unqualified means milk from cows. If any milk other than cow's milk is
used in whole or in part, the animal source shall be identified in
conjunction with the word milk in the ingredient statement. Colored
margarine shall be subject to the provisions of section 407 of the
Federal Food, Drug, and Cosmetic Act as amended.
(42 FR 14478, Mar. 15, 1977, as amended at 47 FR 11834, Mar. 19,
1982; 48 FR 13024, Mar. 29, 1983; 49 FR 10103, Mar. 19, 1984; 54 FR
24896, June 12, 1989)
21 CFR 166.110 Pt. 168
21 CFR 166.110 PART 168 -- SWEETENERS AND TABLE SIRUPS
21 CFR 166.110 Subpart A -- (Reserved)
21 CFR 166.110 Subpart B -- Requirements for Specific Standardized
Sweeteners and Table Sirups
Sec.
168.110 Dextrose anhydrous.
168.111 Dextrose monohydrate.
168.120 Glucose sirup.
168.121 Dried glucose sirup.
168.122 Lactose.
168.130 Cane sirup.
168.140 Maple sirup.
168.160 Sorghum sirup.
168.180 Table sirup.
Authority: Secs. 201, 401, 403, 409, 701, 706 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321, 341, 343, 348, 371, 376).
Source: 42 FR 14479, Mar. 15, 1977, unless otherwise noted.
21 CFR 166.110 Subpart A -- (Reserved)
21 CFR 166.110 Subpart B -- Requirements for Specific Standardized Sweeteners and Table Sirups
21 CFR 168.110 Dextrose anhydrous.
(a) Dextrose anhydrous is purified and crystallized D-glucose without
water of crystallization and conforms to the specifications of 168.111,
except that the total solids content is not less than 98.0 percent m/m.
(b) The name of the food is ''Dextrose anhydrous'' or ''Anhydrous
dextrose''.
21 CFR 168.111 Dextrose monohydrate.
(a) Dextrose monohydrate is purified and crystallized D-glucose
containing one molecule of water of crystallization with each molecule
of D-glucose.
(b) The food shall meet the following specifications:
(1) The total solids content is not less than 90.0 percent mass/mass
(m/m), and the reducing sugar content (dextrose equivalent), expressed
as D-glucose, is not less than 99.5 percent m/m calculated on a dry
basis.
(2) The sulfated ash content is not more than 0.25 percent m/m
(calculated on a dry basis), and the sulfur dioxide content is not more
than 20 mg/kg.
(c) The name of the food is ''Dextrose monohydrate'' or ''Dextrose''.
(d) For purposes of this section, the methods of analysis to be used
to determine if the food meets the specifications of paragraph (b)(1)
and (2) of this section are the following sections in ''Official Methods
of Analysis of the Association of Official Analytical Chemists,'' 13th
Ed. (1980), which is incorporated by reference. Copies may be obtained
from the Association of Official Analytical Chemists, 2200 Wilson Blvd.,
Suite 400, Arlington, VA 22201-3301, or may be examined at the Office of
the Federal Register, 1100 L St. NW., Washington, DC 20408.
(1) Total solids content, 31.005.
(2) Reducing sugar content, section 31.220(a).
(3) Sulfated ash content, section 31.216.
(4) Sulfur dioxide content, sections 20.106-20.111.
(42 FR 14479, Mar. 15, 1977, as amended at 47 FR 11834, Mar. 19,
1982; 49 FR 10103, Mar. 19, 1984; 54 FR 24896, June 12, 1989)
21 CFR 168.120 Glucose sirup.
(a) Glucose sirup is the purified, concentrated, aqueous solution of
nutritive saccharides obtained from edible starch.
(b) The food shall meet the following specifications:
(1) The total solids content is not less than 70.0 percent mass/mass
(m/m), and the reducing sugar content (dextrose equivalent), expressed
as D-glucose, is not less than 20.0 percent m/m calculated on a dry
basis.
(2) The sulfated ash content is not more than 1.0 percent m/m
(calculated on a dry basis), and the sulfur dioxide content is not more
than 40 mg/kg.
(c) The name of the food is ''Glucose sirup''. When the food is
derived from a specific type of starch, the name may alternatively be ''
------------ sirup'', the blank to be filled in with the name of the
starch. For example, ''Corn sirup'', ''Wheat sirup'', ''Tapioca
sirup''. When the starch is derived from sorghum grain, the alternative
name of the food is ''Sorghum grain sirup''. The word ''sirup'' may
also be spelled ''syrup''.
(d) For purposes of this section, the methods of analysis to be used
to determine if the food meets the specifications of paragraph (b)(1)
and (2) of this section are the following sections in ''Official Methods
of Analysis of the Association of Official Analytical Chemists,'' 13th
Ed. (1980), which is incorporated by reference. Copies may be obtained
from the Association of Official Analytical Chemists, 2200 Wilson Blvd.,
Suite 400, Arlington, VA 22201-3301, or may be examined at the Office of
the Federal Register, 1100 L St. NW., Washington, DC 20408.
(1) Total solids content, sections 31.208-31.209.
(2) Reducing sugar content, section 31.220(a).
(3) Sulfated ash content, section 31.216.
(4) Sulfur dioxide content, sections 20.106-20.111.
(42 FR 14479, Mar. 15, 1977, as amended at 47 FR 11834, Mar. 19,
1982; 49 FR 10103, Mar. 19, 1984; 54 FR 24896, June 12, 1989)
21 CFR 168.121 Dried glucose sirup.
(a) Dried glucose sirup is glucose sirup from which the water has
been partially removed and conforms to the specifications of 168.120,
except that:
(1) The total solids content is not less than 90.0 percent m/m when
the reducing sugar content (dextrose equivalent), expressed as
D-glucose, is not less than 88.0 percent m/m, calculated on a dry basis;
or
(2) The total solids content is not less than 93.0 percent m/m when
the reducing sugar content, (dextrose equivalent) expressed as
D-glucose, is less than 88.0 percent m/m, calculated on a dry basis.
(b) The name of the food is ''Dried glucose sirup'' or ''Glucose
sirup solids''. When the food is derived from a specific type of
starch, the name may alternatively be ''Dried ------------ sirup'' or ''
------------ sirup solids'', the blank to be filled in with the name of
the starch; for example, ''Dried corn sirup'', ''Corn sirup solids'',
''Dried wheat sirup'', ''Wheat sirup solids'', ''Dried tapioca sirup'',
''Tapioca sirup solids''. When the starch is derived from sorghum
grain, the alternative name of the food is ''Dried sorghum grain sirup''
or ''Sorghum grain sirup solids''. The word ''sirup'' may also be
spelled ''syrup''.
21 CFR 168.122 Lactose.
(a) Lactose is the carbohydrate normally obtained from whey. It may
be anhydrous or contain one molecule of water of crystallization or be a
mixture of both forms.
(b) The food shall meet the following specifications:
(1) The lactose content is not less than 98.0 percent, mass over mass
(m/m), calculated on a dry basis.
(2) The sulfated ash content is not more than 0.3 percent, m/m,
calculated on a dry basis.
(3) The pH of a 10.0-percent m/m solution is not less than 4.5 nor
more than 7.5.
(4) The loss on drying for 16 hours at 120 C is not more than 6.0
percent, m/m.
(c) The name of the food is ''Lactose'' or, alternatively, ''Milk
sugar''.
(d) The methods of analysis in paragraphs (d)(1), (d)(2), (d)(3),
(d)(4), and (d)(5) of this section are to be used to determine whether
the food meets the requirements of paragraphs (b)(1), (b)(2), (b)(3),
and (b)(4) of this section. The methods are contained in ''Official
Methods of Analysis of the Association of Official Analytical
Chemists'', 14th Ed. (1984), including the 4th Supp. (1988), which is
incorporated by reference in accordance with 5 U.S.C. 552(a). Copies of
the material incorporated by reference may be obtained from the
Association of Official Analytical Chemists, 2200 Wilson Blvd., Suite
400, Arlington, VA 22201-3301, or may be examined at the Office of the
Federal Register, 1100 L St. NW., Washington, DC.
(1) Lactose content, sections 31.064 to 31.071, ''Purity of Lactose,
Liquid Chromatographic Method,'' First Action, 14th Ed. (1984), pp.
583 and 584.
(2) Lactose content, sections 31.064 to 31.071, ''Purity of Lactose,
Liquid Chromatographic Method,'' ''Changes in Official Methods of
Analysis,'' 14th Ed., 4th Supp. (1988), p. 212. This reference
recognizes the change in status of the method from first action to final
action.
(3) Sulfated ash content, section 31.014, ''Ash of Sugars and
Sirups,'' Final Action, Sulfated Ash, 14th Ed. (1984), p. 575.
(4) pH, section 14.022, ''pH of Flour, Potentiometric Method,'' Final
Action, except that a 10-percent m/m solution of lactose in water is
used for the determination, 14th Ed. (1984), p. 252.
(5) Loss on drying at 120 C, section 31.070, 14th Ed. (1984), p.
584.
(42 FR 14479, Mar. 15, 1977, as amended at 47 FR 11834, Mar. 19,
1982; 49 FR 10103, Mar. 19, 1984; 54 FR 24896, June 12, 1989; 55 FR
8459, Mar. 8, 1990)
21 CFR 168.130 Cane sirup.
(a) Cane sirup is the liquid food derived by concentration and heat
treatment of the juice of sugarcane (Saccharum officinarum L.) or by
solution in water of sugarcane concrete made from such juice. It
contains not less than 74 percent by weight of soluble solids derived
solely from such juice. The concentration may be adjusted with or
without added water. It may contain one or more of the optional
ingredients provided for in paragraph (b) of this section. All
ingredients from which the food is fabricated shall be safe and
suitable.
(b) The optional ingredients that may be used in cane sirup are:
(1) Salt.
(2) Preservatives.
(3) Defoaming agents.
(c) The name of the food is ''Cane sirup'' or ''Sugar cane sirup''.
Alternatively, the word ''sirup'' may be spelled ''syrup''.
(d) Each of the optional ingredients used shall be declared on the
label as required by the applicable sections of Part 101 of this
chapter.
21 CFR 168.140 Maple sirup.
(a) Maple sirup is the liquid food derived by concentration and heat
treatment of the sap of the maple tree (Acer) or by solution in water of
maple sugar (mapel concrete) made from such sap. It contains not less
than 66 percent by weight of soluble solids derived solely from such
sap. The concentration may be adjusted with or without added water. It
may contain one or more of the optional ingredients provided for in
paragraph (b) of this section. All ingredients from which the food is
fabricated shall be safe and suitable.
(b) The optional ingredients that may be used in maple sirup are:
(1) Salt.
(2) Chemical preservatives.
(3) Defoaming agents.
(c) The name of the food is ''Maple sirup''. Alternatively, the word
''sirup'' may be spelled ''syrup''.
(d) Each of the optional ingredients used shall be declared on the
label as required by the applicable sections of Part 101 of this
chapter.
21 CFR 168.160 Sorghum sirup.
(a) Sorghum sirup is the liquid food derived by concentration and
heat treatment of the juice of sorghum cane (sorgos) (Sorghum vulgare).
It contains not less than 74 percent by weight of soluble solids derived
solely from such juice. The concentration may be adjusted with or
without added water. It may contain one or more of the optional
ingredients provided for in paragraph (b) of this section. All
ingredients from which the food is fabricated shall be safe and
suitable.
(b) The optional ingredients that may be used in sorghum sirup are:
(1) Salt.
(2) Chemical preservatives.
(3) Defoaming agents.
(4) Enzymes.
(5) Anticrystallizing agents.
(6) Antisolidifying agents.
(c) The name of the food is ''Sorghum sirup'' or ''Sorghum''.
Alternatively, the word ''sirup'' may be spelled ''syrup''.
(d) Each of the optional ingredients used shall be declared on the
label as required by the applicable sections of Part 101 of this
chapter.
21 CFR 168.180 Table sirup.
(a) Table sirup is the liquid food consisting of one or more of the
optional sweetening ingredients provided for in paragraph (b)(1) of this
section. The food contains not less than 65 percent soluble sweetener
solids by weight and is prepared with or without added water. It may
contain one or more of the optional ingredients prescribed in paragraphs
(b)(2) through (12) of this section. All ingredients from which the
food is fabricated shall be safe and suitable. (Vitamins, minerals, and
protein added for nutritional purposes and artificial sweeteners are not
considered to be suitable ingredients for this food.)
(b) The optional ingredients that may be used in table sirup are:
(1) One or more of the nutritive carbohydrate sweeteners provided for
in this paragraph (b)(1). When a sweetener provided for in paragraph
(b)(1)(i) or (ii) of this section is used it shall constitute not less
than 2 percent by weight of the finished food.
(i) The sirups identified by 168.130, 168.140, and 168.160, except
that the use of any such ingredient is so limited that the finished food
does not meet the requirement prescribed for any sirup by 168.130,
168.140, or 168.160.
(ii) Honey.
(iii) Other nutritive carbohydrate sweeteners.
(2) Butter, in a quantity not less than 2 percent by weight of the
finished food.
(3) Edible fats and oils, except that, in products designated as
''buttered sirups'', butter as provided for in paragraph (b)(2) of this
section is the only fat that may be used.
(4) Emulsifiers or stabilizers or both.
(5) Natural and artificial flavorings, either fruit or nonfruit,
alone or in carriers.
(6) Color additives.
(7) Salt.
(8) Chemical preservatives.
(9) Viscosity adjusting agents.
(10) Acidifying, alkalizing, or buffering agents.
(11) Defoaming agents.
(12) Any other ingredient (e.g., shredded coconut, ground orange
peel) that is not incompatible with other ingredients in the food.
(c) Except as provided for in this paragraph and in paragraphs (d)
(2) and (3) of this section, the name of the food is ''Table sirup'',
''Sirup'', ''Pancake sirup'', ''Waffle sirup'', ''Pancake and waffle
sirup'', or '' ------------ sirup'', the blank being filled in with the
word or words that designate the sweetening ingredient that
characterizes the food, except ''maple'', ''cane'', or ''sorghum''
alone, such sirups being required to comply in all respects with
168.130, 168.140, and 168.160, respectively, and in the case of more
than one sweetening ingredient, in descending order of predominance by
weight in the food. The type shall be of uniform style and size.
(1) When one of the sweeteners constitutes at least 80 percent of the
total sweetener solids, the name of the food may be designated as the
corresponding sirup, for example, ''Corn sirup'', provided that the name
is immediately and conspicuously followed, without intervening written,
printed, or graphic matter, by the statement ''with ------------ '' as
part of the name, the blank being filled in with the name or names of
each additional sweetening ingredient present, stated in a clear legible
manner in letters of uniform style and size not less than one-half the
height of, nor larger than, the letters used in the name of the
principal sweetener.
(2) When butter is used, as provided for in paragraph (b)(2) of this
section, the name of the food may be ''Buttered ------------ '', the
blank being filled in with the name otherwise prescribed in this
paragraph. The percentage by weight of butter present shall be declared
as part of the name of the food as prescribed by Part 102 of this
chapter.
(3) Alternatively, the word ''sirup'' may be spelled ''syrup''.
(d)(1) Each of the optional ingredients used shall be declared on the
label as required by the applicable sections of Part 101 of this
chapter.
(2) A statement (other than in the ingredient listing) or a vignette
identifying a flavor may be included on the label only if such flavor
contributes the primary recognizable flavor that characterizes the
sirup. When maple, honey, or both maple and honey are represented as
the characterizing flavors, the total quantity of maple sirup or honey,
singly, or of maple sirup and honey in combination, shall be not less
than 10 percent by weight of the finished food. The presence of any
natural or artificial flavor in the food shall be declared on the label
as prescribed by the applicable sections of Part 101 of this chapter.
(3) The percentage of any optional ingredient used shall be declared
as part of the name of the food as prescribed by Part 102 of this
chapter when all of the following conditions apply to the use of the
ingredient:
(i) It is one of the characterizing ingredients permitted by
paragraphs (b)(1) (i) and (ii) of this section.
(ii) The ingredient is either named on the label other than in the
list of ingredients or is suggested by vignette or other labeling.
21 CFR 168.180 Pt. 169
21 CFR 168.180 PART 169 -- FOOD DRESSINGS AND FLAVORINGS
21 CFR 168.180 Subpart A -- General Provisions
Sec.
169.3 Definitions.
21 CFR 168.180 Subpart B -- Requirements for Specific Standardized Food
Dressings and Flavorings
169.115 French dressing.
169.140 Mayonnaise.
169.150 Salad dressing.
169.175 Vanilla extract.
169.176 Concentrated vanilla extract.
169.177 Vanilla flavoring.
169.178 Concentrated vanilla flavoring.
169.179 Vanilla powder.
169.180 Vanilla-vanillin extract.
169.181 Vanilla-vanillin flavoring.
169.182 Vanilla-vanillin powder.
Authority: Secs. 201, 401, 403, 409, 701, 706 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321, 341, 343, 348, 371, 376).
Source: 42 FR 14481, Mar. 15, 1977, unless otherwise noted.
21 CFR 168.180 Subpart A -- General Provisions
21 CFR 169.3 Definitions.
For the purposes of this part:
(a) The term ''vanilla beans'' means the properly cured and dried
fruit pods of Vanilla planifolia Andrews and of Vanilla tahitensis
Moore.
(b) The term ''unit weight of vanilla beans'' means, in the case of
vanilla beans containing not more than 25 percent moisture, 13.35 ounces
of such beans; and, in the case of vanilla beans containing more than
25 percent moisture, it means the weight of such beans equivalent in
content of moisture-free vanilla-bean solids to 13.35 ounces of vanilla
beans containing 25 percent moisture. (For example, one unit weight of
vanilla beans containing 33.25 percent moisture amounts to 15 ounces.)
The moisture content of vanilla beans is determined by the method
prescribed in ''Official Methods of Analysis of the Association of
Official Analytical Chemists,'' 13th Ed. (1980), sections 7.004 and
7.005, which is incorporated by reference, except that the toluene used
is blended with 20 percent by volume of benzene and the total
distillation time is 4 hours. Copies of the material incorporated by
reference may be obtained from the Association of Official Analytical
Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or may
be examined at the Office of the Federal Register, 1100 L St. NW.,
Washington, DC 20408. To prepare samples for analysis, the pods are
chopped into pieces approximately 1/4-inch in longest dimension, using
care to avoid moisture change.
(c) The term ''unit of vanilla constituent'' means the total sapid
and odorous principles extractable from one unit weight of vanilla
beans, as defined in paragraph (b) of this section, by an aqueous
alcohol solution in which the content of ethyl alcohol by volume amounts
to not less than 35 percent.
(42 FR 14481, Mar. 15, 1977, as amended at 47 FR 11834, Mar. 19,
1982; 49 FR 10103, Mar. 19, 1984; 54 FR 24896, June 12, 1989)
21 CFR 169.3 Subpart B -- Requirements for Specific Standardized Food Dressings and Flavorings
21 CFR 169.115 French dressing.
(a) Description. French dressing is the separable liquid food or the
emulsified viscous fluid food prepared from vegetable oil(s) and one or
both of the acidifying ingredients specified in paragraph (b) of this
section. One or more of the ingredients specified in paragraph (c) of
this section may also be used. The vegetable oil(s) used may contain an
optional crystallization inhibitor as specified in paragraph (c)(11) of
this section. All the ingredients from which the food is fabricated
shall be safe and suitable. French dressing contains not less than 35
percent by weight of vegetable oil. French dressing may be mixed and
packed in an atmosphere in which air is replaced in whole or in part by
carbon dioxide or nitrogen.
(b) Acidifying ingredients. (1) Any vinegar or any vinegar diluted
with water, or any such vinegar or diluted vinegar mixed with an
optional acidifying ingredient as specified in paragraph (c)(9) of this
section. For the purpose of this paragraph, any blend of two or more
vinegars is considered to be a vinegar.
(2) Lemon juice and/or lime juice in any appropriate form, which may
be diluted with water.
(c) Other optional ingredients. The following optional ingredients
may also be used:
(1) Salt.
(2) Nutritive carbohydrate sweeteners.
(3) Spices and/or natural flavorings.
(4) Monosodium glutamate.
(5) Tomato paste, tomato puree, catsup, sherry wine.
(6) Eggs and ingredients derived from eggs.
(7) Color additives that will impart the color traditionally
expected.
(8) Stabilizers and thickeners to which calcium carbonate or sodium
hexametaphosphate may be added. Dioctyl sodium sulfosuccinate may be
added in accordance with 172.810 of this chapter.
(9) Citric and/or malic acid, in an amount not greater than 25
percent of the weight of the acids of the vinegar or diluted vinegar
calculated as acetic acid.
(10) Sequestrant(s), including but not limited to calcium disodium
EDTA (calcium disodium ethylenediamine- tetraacetate) and/or disodium
EDTA (disodium ethylenediamine-tetraacetate), may be used to preserve
color and/or flavor.
(11) Crystallization inhibitors, including but not limited to
oxystearin, lecithin, or polyglycerol esters of fatty acids.
(d) Nomenclature. The name of the food is ''French dressing''.
(e) Label declaration of ingredients. Each of the ingredients used
in the food shall be declared on the label as required by the applicable
sections of Part 101 of this chapter.
21 CFR 169.140 Mayonnaise.
(a) Description. Mayonnaise, mayonnaise dressing, is the emulsified
semisolid food prepared from vegetable oil(s), one or both of the
acidifying ingredients specified in paragraph (b) of this section, and
one or more of the egg yolk-containing ingredients specified in
paragraph (c) of this section. One or more of the ingredients specified
in paragraph (d) of this section may also be used. The vegetable oil(s)
used may contain an optional crystallization inhibitor as specified in
paragraph (d)(7) of this section. All the ingredients from which the
food is fabricated shall be safe and suitable. Mayonnaise contains not
less than 65 percent by weight of vegetable oil. Mayonnaise may be
mixed and packed in an atmosphere in which air is replaced in whole or
in part by carbon dioxide or nitrogen.
(b) Acidifying ingredients. (1) Any vinegar or any vinegar diluted
with water to an acidity, calculated as acetic acid, of not less than 2
1/2 percent by weight, or any such vinegar or diluted vinegar mixed with
an optional acidifying ingredient as specified in paragraph (d)(6) of
this section. For the purpose of this paragraph, any blend of two or
more vinegars is considered to be a vinegar.
(2) Lemon juice and/or lime juice in any appropriate form, which may
be diluted with water to an acidity, calculated as citric acid, of not
less than 2 1/2 percent by weight.
(c) Egg yolk-containing ingredients. Liquid egg yolks, frozen egg
yolks, dried egg yolks, liquid whole eggs, frozen whole eggs, dried
whole eggs, or any one or more of the foregoing ingredients listed in
this paragraph with liquid egg white or frozen egg white.
(d) Other optional ingredients. The following optional ingredients
may also be used:
(1) Salt.
(2) Nutritive carbohydrate sweeteners.
(3) Any spice (except saffron or turmeric) or natural flavoring,
provided it does not impart to the mayonnaise a color simulating the
color imparted by egg yolk.
(4) Monosodium glutamate.
(5) Sequestrant(s), including but not limited to calcium disodium
EDTA (calcium disodium ethylenediamine- tetraacetate) and/or disodium
EDTA (disodium ethylenediaminetetraacetate), may be used to preserve
color and/or flavor.
(6) Citric and/or malic acid in an amount not greater than 25 percent
of the weight of the acids of the vinegar or diluted vinegar, calculated
as acetic acid.
(7) Crystallization inhibitors, including but not limited to
oxystearin, lecithin, or polyglycerol esters of fatty acids.
(e) Nomenclature. The name of the food is ''Mayonnaise'' or
''Mayonnaise dressing''.
(f) Label declaration of ingredients. Each of the ingredients used
in the food shall be declared on the label as required by the applicable
sections of Part 101 of this chapter.
21 CFR 169.150 Salad dressing.
(a) Description. Salad dressing is the emulsified semisolid food
prepared from vegetable oil(s), one or both of the acidifying
ingredients specified in paragraph (b) of this section, one or more of
the egg yolk-containing ingredients specified in paragraph (c) of this
section, and a starchy paste prepared as specified in paragraph (e) of
this section. One or more of the ingredients in paragraph (e) of this
section may also be used. The vegetable oil(s) used may contain an
optional crystallization inhibitor as specified in paragraph (e)(8) of
this section. All the ingredients from which the food is fabricated
shall be safe and suitable. Salad dressing contains not less than 30
percent by weight of vegetable oil and not less egg yolk-containing
ingredient than is equivalent in egg yolk solids content to 4 percent by
weight of liquid egg yolks. Salad dressing may be mixed and packed in
an atmosphere in which air is replaced in whole or in part by carbon
dioxide or nitrogen.
(b) Acidifying ingredients. (1) Any vinegar or any vinegar diluted
with water, or any such vinegar or diluted vinegar mixed with an
optional acidifying ingredient as specified in paragraph (e)(6) of this
section. For the purpose of this paragraph, any blend of two or more
vinegars is considered to be a vinegar.
(2) Lemon juice and/or lime juice in any appropriate form, which may
be diluted with water.
(c) Egg yolk-containing ingredients. Liquid egg yolks, frozen egg
yolks, dried egg yolks, liquid whole eggs, frozen whole eggs, dried
whole eggs, or any one of more of the foregoing ingredients listed in
this paragraph with liquid egg white or frozen egg white.
(d) Starchy paste. It may be prepared from a food starch, food
starch-modified, tapioca flour, wheat flour, rye flour, or any two or
more of these. Water may be added in the preparation of the paste.
(e) Other optional ingredients. The following optional ingredients
may also be used:
(1) Salt.
(2) Nutritive carbohydrate sweeteners.
(3) Any spice (except saffron or turmeric) or natural flavoring,
provided it does not impart to the salad dressing a color simulating the
color imparted by egg yolk.
(4) Monosodium glutamate.
(5) Stabilizers and thickeners. Dioctyl sodium sulfosuccinate may be
added in accordance with 172.810 of this chapter.
(6) Citric and/or malic acid may be used in an amount not greater
than 25 percent of the weight of the acids of the vinegar or diluted
vinegar calculated as acetic acid.
(7) Sequestrant(s), including but not limited to calcium disodium
EDTA (calcium disodium ethylenediamine-tetraacetate) and/or disodium
EDTA (disodium ethylenediamine-tetraactetate), may be used to preserve
color and/or flavor.
(8) Crystallization inhibitors, including but not limited to
oxystearin, lecithin, or polyglycerol esters of fatty acids.
(f) Nomenclature. The name of the food is ''Salad dressing''.
(g) Label declaration of optional ingredients. Each of the
ingredients used in the food shall be declared on the label as required
by the applicable sections of Part 101 of this chapter.
(42 FR 14481, Mar. 15, 1977, as amended at 42 FR 25325, May 17, 1977)
21 CFR 169.175 Vanilla extract.
(a) Vanilla extract is the solution in aqueous ethyl alcohol of the
sapid and odorous principles extractable from vanilla beans. In vanilla
extract the content of ethyl alcohol is not less than 35 percent by
volume and the content of vanilla constituent, as defined in 169.3(c),
is not less than one unit per gallon. The vanilla constituent may be
extracted directly from vanilla beans or it may be added in the form of
concentrated vanilla extract or concentrated vanilla flavoring or
vanilla flavoring concentrated to the semisolid form called vanilla
oleo-resin. Vanilla extract may contain one or more of the following
optional ingredients:
(1) Glycerin.
(2) Propylene glycol.
(3) Sugar (including invert sugar).
(4) Dextrose.
(5) Corn sirup (including dried corn sirup).
(b)(1) The specified name of the food is ''Vanilla extract'' or
''Extract of vanilla''.
(2) When the vanilla extract is made in whole or in part by dilution
of vanilla oleoresin, concentrated vanilla extract, or concentrated
vanilla flavoring, the label shall bear the statement ''Made from
------------ '' or ''Made in part from ------------ '', the blank being
filled in with the name or names ''vanilla oleoresin'', ''concentrated
vanilla extract'', or ''concentrated vanilla flavoring'', as
appropriate. If the article contains two or more units of vanilla
constituent, the name of the food shall include the designation ''
------------ fold'', the blank being filled in with the whole number
(disregarding fractions) expressing the number of units of vanilla
constituent per gallon of the article.
(3) Wherever the name of the food appears on the label so
conspicuously as to be easily seen under customary conditions of
purchase, the labeling required by paragraph (b)(2) of this section
shall immediately and conspicuously precede or follow such name, without
intervening written, printed, or graphic matter.
21 CFR 169.176 Concentrated vanilla extract.
(a) Concentrated vanilla extract conforms to the definition and
standard of identity and is subject to any requirement for label
statement of optional ingredients prescribed for vanilla extract by
169.175, except that it is concentrated to remove part of the solvent,
and each gallon contains two or more units of vanilla constituent as
defined in 169.3(c). The content of ethyl alcohol is not less than 35
percent by volume.
(b) The specified name of the food is ''Concentrated vanilla extract
------------ fold'' or '' ------------ fold concentrated vanilla
extract'', the blank being filled in with the whole number (disregarding
fractions) expressing the number of units of vanilla constituent per
gallon of the article. (For example, ''Concentrated vanilla extract
2-fold''.)
21 CFR 169.177 Vanilla flavoring.
(a) Vanilla flavoring conforms to the definition and standard of
identity and is subject to any requirement for label statement of
optional ingredients prescribed for vanilla extract by 169.175, except
that its content of ethyl alcohol is less than 35 percent by volume.
(b) The specified name of the food is ''Vanilla flavoring''.
21 CFR 169.178 Concentrated vanilla flavoring.
(a) Concentrated vanilla flavoring conforms to the definition and
standard of identity and is subject to any requirement for label
statement of optional ingredients prescribed for vanilla flavoring by
169.177, except that it is concentrated to remove part of the solvent,
and each gallon contains two or more units of vanilla constituent as
defined in 169.3(c).
(b) The specified name of the food is ''Concentrated vanilla
flavoring ------------ fold'' or '' ------------ fold concentrated
vanilla flavoring'', the blank being filled in with the whole number
(disregarding fractions) expressing the number of units of vanilla
constituent per gallon of the article. (For example, ''Concentrated
vanilla flavoring 3-fold''.)
21 CFR 169.179 Vanilla powder.
(a) Vanilla powder is a mixture of ground vanilla beans or vanilla
oleoresin or both, with one or more of the following optional blending
ingredients:
(1) Sugar.
(2) Dextrose.
(3) Lactose.
(4) Food starch (including food starch-modified as prescribed in
172.892 of this chapter).
(5) Dried corn sirup.
(6) Gum acacia.
Vanilla powder may contain one or any mixture of two or more of the
anticaking ingredients specified in paragraph (b) of this section, but
the total weight of any such ingredient or mixture is not more than 2
percent of the weight of the finished vanilla powder. Vanilla powder
contains in each 8 pounds not less than one unit of vanilla constituent,
as defined in 169.3(c).
(b) The anticaking ingredients referred to in paragraph (a) of this
section are:
(1) Aluminum calcium silicate.
(2) Calcium silicate.
(3) Calcium stearate.
(4) Magnesium silicate.
(5) Tricalcium phosphate.
(c)(1) The specified name of the food is ''Vanilla powder
------------ fold'' or '' ------------ fold vanilla powder'', except
that if sugar is the optional blending ingredient used, the word
''sugar'' may replace the word ''powder''. The blank in the name is
filled in with the whole number (disregarding fractions) expressing the
number of units of vanilla constituent per 8 pounds of the article.
However, if the strength of the article is less than 2-fold, the term ''
------------ fold'' is omitted from the name.
(2) The label of vanilla powder shall bear the common names of any of
the optional ingredients specified in paragraphs (a) and (b) of this
section that are used, except that where the alternative name ''Vanilla
sugar'' is used for designating the food it is not required that sugar
be named as an optional ingredient.
(3) Wherever the name of the food appears on the label so
conspicuously as to be easily seen under customary conditions of
purchase, the labeling required by paragraph (c)(2) of this section
shall immediately and conspicuously precede or follow such name, without
intervening written, printed, or graphic matter.
21 CFR 169.180 Vanilla-vanillin extract.
(a) Vanilla-vanillin extract conforms to the definition and standard
of identity and is subject to any requirement for label statement of
optional ingredients prescribed for vanilla extract by 169.175, except
that for each unit of vanilla constituent, as defined in 169.3(c),
contained therein, the article also contains not more than 1 ounce of
added vanillin.
(b) The specified name of the food is ''Vanilla-vanillin extract
------------ fold'' or '' ------------ fold vanilla-vanillin extract'',
followed immediately by the statement ''contains vanillin, an artificial
flavor (or flavoring)''. The blank in the name is filled in with the
whole number (disregarding fractions) expressing the sum of the number
of units of vanilla constituent plus the number of ounces of added
vanillin per gallon of the article. However, if the strength of the
article is less than 2-fold, the term '' ------------ fold'' is omitted
from the name.
21 CFR 169.181 Vanilla-vanillin flavoring.
(a) Vanilla-vanillin flavoring conforms to the definition and
standard of identity and is subject to any requirement for label
statement of optional ingredients prescribed for vanilla-vanillin
extract by 169.180, except that its content of ethyl alcohol is less
than 35 percent by volume.
(b) The specified name of the food is ''Vanilla-vanillin flavoring
------------ fold'' or '' ------------ fold vanilla-vanillin
flavoring'', followed immediately by the statement ''contains vanillin,
an artificial flavor (or flavoring)''. The blank in the name is filled
in with the whole number (disregarding fractions) expressing the sum of
the number of units of vanilla constituent plus the number of ounces of
added vanillin per gallon of the article. However, if the strength of
the article is less than 2-fold, the term '' ------------ fold'' is
omitted from the name.
21 CFR 169.182 Vanilla-vanillin powder.
(a) Vanilla-vanillin powder conforms to the definition and standard
of identity and is subject to any requirement for label statement of
optional ingredients prescribed for vanilla powder by 169.179, except
that for each unit of vanilla constituent as defined in 169.3(c)
contained therein, the article also contains not more than 1 ounce of
added vanillin.
(b) The specified name of the food is ''Vanilla-vanillin powder
------------ fold'' or '' ------------ fold vanilla-vanillin powder'',
followed immediately by the statement ''contains vanillin, an artificial
flavor (or flavoring)''. If sugar is the optional blending ingredient
used, the word ''sugar'' may replace the word ''powder'' in the name.
The blank in the name is filled in with the whole number (disregarding
fractions) expressing the sum of the number of units of vanilla
constituent plus the number of ounces of added vanillin per 8 pounds of
the article. However, if the strength of the article is less than
2-fold the term '' ------------ fold'' is omitted from the name.
21 CFR 169.182 FINDING AIDS
A list of CFR titles, subtitles, chapters, subchapters and parts and
an alphabetical list of agencies publishing in the CFR are included in
the CFR Index and Finding Aids volume to the Code of Federal Regulations
which is published separately and revised annually.
Material Approved for Incorporation by Reference
Table of CFR Titles and Chapters
Alphabetical List of Agencies Appearing in the CFR
List of CFR Sections Affected
Title 21 -- Food and Drugs
Material Approved for Incorporation by Reference
Material Approved for Incorporation by Reference
The Director of the Federal Register has approved under 5 U.S.C.
552(a) and 1 CFR Part 51 the incorporation by reference of the following
publications. This list contains only those incorporations by reference
effective as of the revision date of this volume. Incorporations by
reference found within a regulation are effective upon the effective
date of that regulation. For more information on incorporation by
reference, see the preliminary pages of this volume.
21 CFR 169.182 21 CFR CHAPTER I (PARTS 100 TO 169)
FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR
American Society for Testing and Materials
1916 Race St. Philadelphia, PA 19103
NOTE: The following ASTM standards are available from University
Microfilm International, 300 N. Zeeb Rd., Ann Arbor, MI 48106.
ASTM E 11-70 Table 1, Annual Book of ASTM Standards, Part 30 (1972)
137.105(a)
Association of Official Analytical Chemists
2200 Wilson Blvd., Suite 400, Arlington, VA 22201-3301
Official Methods of Analysis, 14th Ed., 1984, including the 4th
Supplement (1988) 168.122(d)
Official Methods of Analysis, 14th Ed., 1984 101.100(a); 160.145
Official Methods of Analysis, 13th Ed., 1980 101.9; 101.25(e)(3);
102.23; 102.33(b); 105.65(c)(4)(i); 106.30(b)(3)(i), (ii); 114.90;
131.110; 131.111(f); 131.112(e); 131.115; 131.120; 131.122;
131.123; 131.125; 131.127; 131.130; 131.132; 131.135; 131.136(f);
131.138(e); 131.143; 131.144(f); 131.146(e); 131.147; 131.149;
131.150; 131.155; 131.157; 131.160; 131.162; 131.170(f); 131.180;
131.185; 131.187; 131.200(d); 131.203(d); 131.206(d); 133.5;
135.110; 135.130; 136.110; 136.160; 137.105; 137.180; 137.190;
137.200; 137.211; 137.230; 137.250; 137.270; 137.300; 139.110;
139.150; 145.110; 145.135; 145.145; 146.113; 146.114; 146.120;
146.132(a)(1); 146.185; 150.110; 150.140; 150.160; 155.3; 155.130;
155.170(b)(1)(vi); 156.3; 160.180; 161.145; 161.173; 161.175;
161.190; 163.111; 163.112; 164.150; 166.110; 168.111; 168.120;
168.122; 169.3
Official Methods of Analysis, 12th Ed., 1975 163.110
NOTE: The following materials are available through the Food and
Drug Administration at the addresses indicated.
Division of Food Chemistry and Technology, Center for Food Safety and
Applied Nutrition (HFF-210), Food and Drug Administration
200 C St. SW., Washington, DC 20204
Analytical Methodology for Polychlorinated Biphenyls (June 1979)
109.30
Comparative Anatomy and Systematics of the Tunas, ''Gennus Thunnus''
Fishery Bulletin Vol. 66, No. 1, (1967) pp. 65-130 161.190(a)(2)
Comparison of the Bluefin tuna, Gennus Thunnus -- Bureau of Marine
Fisheries, Fish Bulletin No. 77, 1950 161.190(a)(2)
''Descriptive Study of Certain Tuna-Like Fishes,'' by H.C. Godsil,
State of California, Department of Fish and Game, Fish Bulletin No. 97
161.190(a)(2)
Systematic Study of the Pacific Tunas, Fish Bulletin No. 60, (1944)
161.190(a)(2)
Test procedures for Determination of Permeability of Food Packaging,
Inner Wraps (September 1976, revised May 1983) 109.30
Methods for Chemical Analysis of Water and Wastes, Environmental
Monitoring and Support Laboratory, EPA-600/4-82-055, March 1983, U.S.
Environmental Protection Agency 103.35(d)(1)(ii)
Interim Radiochemical Methodology for Drinking Water, Environmental
Monitoring and Support Laboratory, EPA 600-4-75-008 (Revised), March
1976, EPA 103.35(e)(2)
Standard Methods for the Examination of Water and Wastewater (15th
Ed.) (1980) 103.35(b), (c), (d)(1)(ii), and (e)(2)
Center for Food Safety and Applied Nutrition (HFF-260), Food and Drug
Administration
200 C St. SW., Washington, DC 20204
''Energy Value of Foods -- Basis and Derivation'' USDA Handbook No.
74, 1955 101.9(c)(3)
''Folic Acid Activity of Some Milk Foods for Babies,'' Journal of
Dairy Research 35:85-90 (1968) 102.23(c)(5)
Journal of the Optical Society of America, Vol. 33, p. 406 (1943)
161.190(a)(7)(iii)
''Total Dietary Fiber in Foods, Enzymatic Gravimetric Method, First
Action,'' Journal of the Association of Official Analytical Chemists
68:399, 1985, as amended at 69:370, 1986 101.9
Chap.
21 CFR 169.182 Table of CFR Titles and Chapters
21 CFR 169.182 Title 1 -- General Provisions
I Administrative Committee of the Federal Register (Parts 1 -- 49)
II Office of the Federal Register (Parts 50 -- 299)
III Administrative Conference of the United States (Parts 300 -- 399)
IV Miscellaneous Agencies (Parts 400 -- 500)
21 CFR 169.182 Title 2 -- (Reserved)
21 CFR 169.182 Title 3 -- The President
I Executive Office of the President (Parts 100 -- 199)
21 CFR 169.182 Title 4 -- Accounts
I General Accounting Office (Parts 1 -- 99)
II Federal Claims Collection Standards (General Accounting Office --
Department of Justice) (Parts 100 -- 299)
III General Accounting Office (CASB) (Parts 300 -- 499)
21 CFR 169.182 Title 5 -- Administrative Personnel
I Office of Personnel Management (Parts 1 -- 1199)
II Merit Systems Protection Board (Parts 1200 -- 1299)
III Office of Management and Budget (Parts 1300 -- 1399)
IV Advisory Committee on Federal Pay (Parts 1400 -- 1499)
V The International Organizations Employees Loyalty Board (Parts 1500
-- 1599)
VI Federal Retirement Thrift Investment Board (Parts 1600 -- 1699)
VII Advisory Commission on Intergovernmental Relations (Parts 1700 --
1799)
VIII Office of Special Council (Parts 1800 -- 1899)
IX Appalachian Regional Commission (Parts 1900 -- 1999)
XI United States Soldiers' and Airmen's Home (Parts 2100 -- 2199)
XIV Federal Labor Relations Authority, General Counsel of the Federal
Labor Relations Authority and Federal Service Impasses Panel (Parts 2400
-- 2499)
XV Office of Administration, Executive Office of the President (Parts
2500 -- 2599)
XVI Office of Government Ethics (Parts 2600 -- 2699)
21 CFR 169.182 Title 6 -- Economic Stabilization (Reserved)
21 CFR 169.182 Title 7 -- Agriculture
Subtitle A -- Office of the Secretary of Agriculture (Parts 0 -- 26)
Subtitle B -- Regulations of the Department of Agriculture
I Agricultural Marketing Service (Standards, Inspections, Marketing
Practices), Department of Agriculture (Parts 27 -- 209)
II Food and Nutrition Service, Department of Agriculture (Parts 210
-- 299)
III Animal and Plant Health Inspection Service, Department of
Agriculture (Parts 300 -- 399)
IV Federal Crop Insurance Corporation, Department of Agriculture
(Parts 400 -- 499)
V Agricultural Research Service, Department of Agriculture (Parts 500
-- 599)
VI Soil Conservation Service, Department of Agriculture (Parts 600 --
699)
VII Agricultural Stabilization and Conservation Service (Agricultural
Adjustment), Department of Agriculture (Parts 700 -- 799)
VIII Federal Grain Inspection Service, Department of Agriculture
(Parts 800 -- 899)
IX Agricultural Marketing Service (Marketing Agreements and Orders;
Fruits, Vegetables, Nuts), Department of Agriculture (Parts 900 -- 999)
X Agricultural Marketing Service (Marketing Agreements and Orders;
Milk), Department of Agriculture (Parts 1000 -- 1199)
XI Agricultural Marketing Service (Marketing Agreements and Orders;
Miscellaneous Commodities), Department of Agriculture (Parts 1200 --
1299)
XIV Commodity Credit Corporation, Department of Agriculture (Parts
1400 -- 1499)
XV Foreign Agricultural Service, Department of Agriculture (Parts
1500 -- 1599)
XVI Rural Telephone Bank, Department of Agriculture (Parts 1600 --
1699)
XVII Rural Electrification Administration, Department of Agriculture
(Parts 1700 -- 1799)
XVIII Farmers Home Administration, Department of Agriculture (Parts
1800 -- 2099)
XXI Foreign Economic Development Service, Department of Agriculture
(Parts 2100 -- 2199)
XXII Office of International Cooperation and Development, Department
of Agriculture (Parts 2200 -- 2299)
XXV Office of the General Sales Manager, Department of Agriculture
(Parts 2500 -- 2599)
XXVI Office of Inspector General, Department of Agriculture (Parts
2600 -- 2699)
XXVII Office of Information Resources Management, Department of
Agriculture (Parts 2700 -- 2799)
XXVIII Office of Operations, Department of Agriculture (Parts 2800 --
2899)
XXIX Office of Energy, Department of Agriculture (Parts 2900 -- 2999)
XXX Office of Finance and Management, Department of Agriculture
(Parts 3000 -- 3099)
XXXI Office of Environmental Quality, Department of Agriculture
(Parts 3100 -- 3199)
XXXII Office of Grants and Program Systems, Department of Agriculture
(Parts 3200 -- 3299)
XXXIII Office of Transportation, Department of Agriculture (Parts
3300 -- 3399)
XXXIV Cooperative State Research Service, Department of Agriculture
(Parts 3400 -- 3499)
XXXVI National Agricultural Statistics Service, Department of
Agriculture (Parts 3600 -- 3699)
XXXVII Economic Research Service, Department of Agriculture (Parts
3700 -- 3799)
XXXVIII World Agricultural Outlook Board, Department of Agriculture
(Parts 3800 -- 3899)
XXXIX Economic Analysis Staff, Department of Agriculture (Parts 3900
-- 3999)
XL Economics Management Staff, Department of Agriculture (Parts 4000
-- 4099)
XLI National Agricultural Library, Department of Agriculture (Part
4100)
21 CFR 169.182 Title 8 -- Aliens and Nationality
I Immigration and Naturalization Service, Department of Justice
(Parts 1 -- 499)
21 CFR 169.182 Title 9 -- Animals and Animal Products
I Animal and Plant Health Inspection Service, Department of
Agriculture (Parts 1 -- 199)
II Packers and Stockyards Administration, Department of Agriculture
(Parts 200 -- 299)
III Food Safety and Inspection Service, Meat and Poultry Inspection,
Department of Agriculture (Parts 300 -- 399)
21 CFR 169.182 Title 10 -- Energy
I Nuclear Regulatory Commission (Parts 0 -- 199)
II Department of Energy (Parts 200 -- 699)
III Department of Energy (Parts 700 -- 999)
X Department of Energy (General Provisions) (Parts 1000 -- 1099)
XV Office of the Federal Inspector for the Alaska Natural Gas
Transportation System (Parts 1500 -- 1599)
XVII Defense Nuclear Facilities Safety Board (Parts 1700 -- 1799)
21 CFR 169.182 Title 11 -- Federal Elections
I Federal Election Commission (Parts 1 -- 9099)
21 CFR 169.182 Title 12 -- Banks and Banking
I Comptroller of the Currency, Department of the Treasury (Parts 1 --
199)
II Federal Reserve System (Parts 200 -- 299)
III Federal Deposit Insurance Corporation (Parts 300 -- 399)
IV Export-Import Bank of the United States (Parts 400 -- 499)
V Office of Thrift Supervision, Department of The Treasury (Parts 500
-- 599)
VI Farm Credit Administration (Parts 600 -- 699)
VII National Credit Union Administration (Parts 700 -- 799)
VIII Federal Financing Bank (Parts 800 -- 899)
IX Federal Housing Finance Board (Parts 900 -- 999)
XI Federal Financial Institutions Examination Council (Parts 1100 --
1199)
XIII Farm Credit System Assistance Board (Parts 1300 -- 1399)
XIV Farm Credit System Insurance Corporation (Parts 1400 -- 1499)
XV Thrift Depositor Protection Oversight Board (Parts 1500 -- 1599)
XVI Resolution Trust Corporation (Parts 1600 -- 1699)
21 CFR 169.182 Title 13 -- Business Credit and Assistance
I Small Business Administration (Parts 1 -- 199)
III Economic Development Administration, Department of Commerce
(Parts 300 -- 399)
21 CFR 169.182 Title 14 -- Aeronautics and Space
I Federal Aviation Administration, Department of Transportation
(Parts 1 -- 199)
II Office of the Secretary, Department of Transportation (Aviation
Proceedings) (Parts 200 -- 399)
III Office of Commercial Space Transportation, Department of
Transportation (Parts 400 -- 499)
V National Aeronautics and Space Administration (Parts 1200 -- 1299)
21 CFR 169.182 Title 15 -- Commerce and Foreign Trade
Subtitle A -- Office of the Secretary of Commerce (Parts 0 -- 29)
Subtitle B -- Regulations Relating to Commerce and Foreign Trade
I Bureau of the Census, Department of Commerce (Parts 30 -- 199)
II National Institute of Standards and Technology, Department of
Commerce (Parts 200 -- 299)
III International Trade Administration, Department of Commerce (Parts
300 -- 399)
IV Foreign-Trade Zones Board (Parts 400 -- 499)
VII Bureau of Export Administration, Department of Commerce (Parts
700 -- 799)
VIII Bureau of Economic Analysis, Department of Commerce (Parts 800
-- 899)
IX National Oceanic and Atmospheric Administration, Department of
Commerce (Parts 900 -- 999)
XI Technology Administration, Department of Commerce (Parts 1100 --
1199)
XII United States Travel and Tourism Administration, Department of
Commerce (Parts 1200 -- 1299)
XIII East-West Foreign Trade Board (Parts 1300 -- 1399)
XIV Minority Business Development Agency (Parts 1400 -- 1499)
Subtitle C -- Regulations Relating to Foreign Trade Agreements
XX Office of the United States Trade Representative (Parts 2000 --
2099)
Subtitle D -- Regulations Relating to Telecommunications and
Information
XXIII National Telecommunications and Information Administration,
Department of Commerce (Parts 2300 -- 2399)
21 CFR 169.182 Title 16 -- Commercial Practices
I Federal Trade Commission (Parts 0 -- 999)
II Consumer Product Safety Commission (Parts 1000 -- 1799)
21 CFR 169.182 Title 17 -- Commodity and Securities Exchanges
I Commodity Futures Trading Commission (Parts 1 -- 199)
II Securities and Exchange Commission (Parts 200 -- 399)
IV Department of the Treasury (Parts 400 -- 499)
21 CFR 169.182 Title 18 -- Conservation of Power and Water Resources
I Federal Energy Regulatory Commission, Department of Energy (Parts 1
-- 399)
III Delaware River Basin Commission (Parts 400 -- 499)
VI Water Resources Council (Parts 700 -- 799)
VIII Susquehanna River Basin Commission (Parts 800 -- 899)
XIII Tennessee Valley Authority (Parts 1300 -- 1399)
21 CFR 169.182 Title 19 -- Customs Duties
I United States Customs Service, Department of the Treasury (Parts 1
-- 199)
II United States International Trade Commission (Parts 200 -- 299)
III International Trade Administration, Department of Commerce (Parts
300 -- 399)
21 CFR 169.182 Title 20 -- Employees' Benefits
I Office of Workers' Compensation Programs, Department of Labor
(Parts 1 -- 199)
II Railroad Retirement Board (Parts 200 -- 399)
III Social Security Administration, Department of Health and Human
Services (Parts 400 -- 499)
IV Employees' Compensation Appeals Board, Department of Labor (Parts
500 -- 599)
V Employment and Training Administration, Department of Labor (Parts
600 -- 699)
VI Employment Standards Administration, Department of Labor (Parts
700 -- 799)
VII Benefits Review Board, Department of Labor (Parts 800 -- 899)
VIII Joint Board for the Enrollment of Actuaries (Parts 900 -- 999)
IX Office of the Assistant Secretary for Veterans' Employment and
Training, Department of Labor (Parts 1000 -- 1099)
21 CFR 169.182 Title 21 -- Food and Drugs
I Food and Drug Administration, Department of Health and Human
Services (Parts 1 -- 1299)
II Drug Enforcement Administration, Department of Justice (Parts 1300
-- 1399)
21 CFR 169.182 Title 22 -- Foreign Relations
I Department of State (Parts 1 -- 199)
II Agency for International Development, International Development
Cooperation Agency (Parts 200 -- 299)
III Peace Corps (Parts 300 -- 399)
IV International Joint Commission, United States and Canada (Parts
400 -- 499)
V United States Information Agency (Parts 500 -- 599)
VI United States Arms Control and Disarmament Agency (Parts 600 --
699)
VII Overseas Private Investment Corporation, International
Development Cooperation Agency (Parts 700 -- 799)
IX Foreign Service Grievance Board Regulations (Parts 900 -- 999)
X Inter-American Foundation (Parts 1000 -- 1099)
XI International Boundary and Water Commission, United States and
Mexico, United States Section (Parts 1100 -- 1199)
XII United States International Development Cooperation Agency (Parts
1200 -- 1299)
XIII Board for International Broadcasting (Parts 1300 -- 1399)
XIV Foreign Service Labor Relations Board; Federal Labor Relations
Authority; General Counsel of the Federal Labor Relations Authority;
and the Foreign Service Impasse Disputes Panel (Parts 1400 -- 1499)
XV African Development Foundation (Parts 1500 -- 1599)
XVI Japan-United States Friendship Commission (Parts 1600 -- 1699)
21 CFR 169.182 Title 23 -- Highways
I Federal Highway Administration, Department of Transportation (Parts
1 -- 999)
II National Highway Traffic Safety Administration and Federal Highway
Administration, Department of Transportation (Parts 1200 -- 1299)
III National Highway Traffic Safety Administration, Department of
Transportation (Parts 1300 -- 1399)
21 CFR 169.182 Title 24 -- Housing and Urban Development
Subtitle A -- Office of the Secretary, Department of Housing and
Urban Development (Parts 0 -- 99)
Subtitle B -- Regulations Relating to Housing and Urban Development
I Office of Assistant Secretary for Equal Opportunity, Department of
Housing and Urban Development (Parts 100 -- 199)
II Office of Assistant Secretary for Housing-Federal Housing
Commissioner, Department of Housing and Urban Development (Parts 200 --
299)
III Government National Mortgage Association, Department of Housing
and Urban Development (Parts 300 -- 399)
V Office of Assistant Secretary for Community Planning and
Development, Department of Housing and Urban Development (Parts 500 --
599)
VI Office of Assistant Secretary for Community Planning and
Development, Department of Housing and Urban Development (Parts 600 --
699)
VII Office of the Secretary, Department of Housing and Urban
Development (Section 8 Housing Assistance Programs and Public and Indian
Housing Programs) (Parts 700 -- 799)
VIII Office of the Assistant Secretary for Housing -- Federal Housing
Commissioner, Department of Housing and Urban Development (Section 8
Housing Assistance Programs and Section 202 Direct Loan Program) (Parts
800 -- 899)
IX Office of Assistant Secretary for Public and Indian Housing,
Department of Housing and Urban Development (Parts 900 -- 999)
X Office of Assistant Secretary for Housing -- Federal Housing
Commissioner, Department of Housing and Urban Development (Interstate
Land Sales Registration Program) (Parts 1700 -- 1799)
XI Solar Energy and Energy Conservation Bank, Department of Housing
and Urban Development (Parts 1800 -- 1899)
XII Office of Inspector General, Department of Housing and Urban
Development (Parts 2000 -- 2099)
XV Mortgage Insurance and Loan Programs under the Emergency
Homeowners' Relief Act, Department of Housing and Urban Development
(Parts 2700 -- 2799)
XX Office of Assistant Secretary for Housing -- Federal Housing
Commissioner, Department of Housing and Urban Development (Parts 3200 --
3699)
XXV Neighborhood Reinvestment Corporation (Parts 4100 -- 4199)
21 CFR 169.182 Title 25 -- Indians
I Bureau of Indian Affairs, Department of the Interior (Parts 1 --
299)
II Indian Arts and Crafts Board, Department of the Interior (Parts
300 -- 399)
III National Indian Gaming Commission (Parts 500 -- 599)
IV Office of Navajo and Hopi Indian Relocation (Parts 700 -- 799)
21 CFR 169.182 Title 26 -- Internal Revenue
I Internal Revenue Service, Department of the Treasury (Parts 1 --
799)
21 CFR 169.182 Title 27 -- Alcohol, Tobacco Products and Firearms
I Bureau of Alcohol, Tobacco and Firearms, Department of the Treasury
(Parts 1 -- 299)
21 CFR 169.182 Title 28 -- Judicial Administration
I Department of Justice (Parts 0 -- 199)
III Federal Prison Industries, Inc., Department of Justice (Parts 300
-- 399)
V Bureau of Prisons, Department of Justice (Parts 500 -- 599)
VI Offices of Independent Counsel, Department of Justice (Parts 600
-- 699)
VII Office of Independent Counsel (Parts 700 -- 799)
21 CFR 169.182 Title 29 -- Labor
Subtitle A -- Office of the Secretary of Labor (Parts 0 -- 99)
Subtitle B -- Regulations Relating to Labor
I National Labor Relations Board (Parts 100 -- 199)
II Bureau of Labor-Management Relations and Cooperative Programs,
Department of Labor (Parts 200 -- 299)
III National Railroad Adjustment Board (Parts 300 -- 399)
IV Office of Labor-Management Standards, Department of Labor (Parts
400 -- 499)
V Wage and Hour Division, Department of Labor (Parts 500 -- 899)
IX Construction Industry Collective Bargaining Commission (Parts 900
-- 999)
X National Mediation Board (Parts 1200 -- 1299)
XII Federal Mediation and Conciliation Service (Parts 1400 -- 1499)
XIV Equal Employment Opportunity Commission (Parts 1600 -- 1699)
XVII Occupational Safety and Health Administration, Department of
Labor (Parts 1900 -- 1999)
XX Occupational Safety and Health Review Commission (Parts 2200 --
2499)
XXV Pension and Welfare Benefits Administration, Department of Labor
(Parts 2500 -- 2599)
XXVI Pension Benefit Guaranty Corporation (Parts 2600 -- 2699)
XXVII Federal Mine Safety and Health Review Commission (Parts 2700 --
2799)
21 CFR 169.182 Title 30 -- Mineral Resources
I Mine Safety and Health Administration, Department of Labor (Parts 1
-- 199)
II Minerals Management Service, Department of the Interior (Parts 200
-- 299)
III Board of Surface Mining and Reclamation Appeals, Department of
the Interior (Parts 300 -- 399)
IV Geological Survey, Department of the Interior (Parts 400 -- 499)
VI Bureau of Mines, Department of the Interior (Parts 600 -- 699)
VII Office of Surface Mining Reclamation and Enforcement, Department
of the Interior (Parts 700 -- 999)
21 CFR 169.182 Title 31 -- Money and Finance: Treasury
Subtitle A -- Office of the Secretary of the Treasury (Parts 0 -- 50)
Subtitle B -- Regulations Relating to Money and Finance
I Monetary Offices, Department of the Treasury (Parts 51 -- 199)
II Fiscal Service, Department of the Treasury (Parts 200 -- 399)
IV Secret Service, Department of the Treasury (Parts 400 -- 499)
V Office of Foreign Assets Control, Department of the Treasury (Parts
500 -- 599)
VI Bureau of Engraving and Printing, Department of the Treasury
(Parts 600 -- 699)
VII Federal Law Enforcement Training Center, Department of the
Treasury (Parts 700 -- 799)
VIII Office of International Investment, Department of the Treasury
(Parts 800 -- 899)
21 CFR 169.182 Title 32 -- National Defense
Subtitle A -- Department of Defense
I Office of the Secretary of Defense (Parts 1 -- 399)
V Department of the Army (Parts 400 -- 699)
VI Department of the Navy (Parts 700 -- 799)
VII Department of the Air Force (Parts 800 -- 1099)
Subtitle B -- Other Regulations Relating to National Defense
XII Defense Logistics Agency (Parts 1200 -- 1299)
XVI Selective Service System (Parts 1600 -- 1699)
XIX Central Intelligence Agency (Parts 1900 -- 1999)
XX Information Security Oversight Office (Parts 2000 -- 2099)
XXI National Security Council (Parts 2100 -- 2199)
XXIV Office of Science and Technology Policy (Parts 2400 -- 2499)
XXVII Office for Micronesian Status Negotiations (Parts 2700 -- 2799)
XXVIII Office of the Vice President of the United States (Parts 2800
-- 2899)
21 CFR 169.182 Title 33 -- Navigation and Navigable Waters
I Coast Guard, Department of Transportation (Parts 1 -- 199)
II Corps of Engineers, Department of the Army (Parts 200 -- 399)
IV Saint Lawrence Seaway Development Corporation, Department of
Transportation (Parts 400 -- 499)
21 CFR 169.182 Title 34 -- Education
Subtitle A -- Office of the Secretary, Department of Education (Parts
1 -- 99)
Subtitle B -- Regulations of the Offices of the Department of
Education
I Office for Civil Rights, Department of Education (Parts 100 -- 199)
II Office of Elementary and Secondary Education, Department of
Education (Parts 200 -- 299)
III Office of Special Education and Rehabilitative Services,
Department of Education (Parts 300 -- 399)
IV Office of Vocational and Adult Education, Department of Education
(Parts 400 -- 499)
V Office of Bilingual Education and Minority Languages Affairs,
Department of Education (Parts 500 -- 599)
VI Office of Postsecondary Education, Department of Education (Parts
600 -- 699)
VII Office of Educational Research and Improvement, Department of
Education (Parts 700 -- 799)
21 CFR 169.182 Title 35 -- Panama Canal
I Panama Canal Regulations (Parts 1 -- 299)
21 CFR 169.182 Title 36 -- Parks, Forests, and Public Property
I National Park Service, Department of the Interior (Parts 1 -- 199)
II Forest Service, Department of Agriculture (Parts 200 -- 299)
III Corps of Engineers, Department of the Army (Parts 300 -- 399)
IV American Battle Monuments Commission (Parts 400 -- 499)
V Smithsonian Institution (Parts 500 -- 599)
VII Library of Congress (Parts 700 -- 799)
VIII Advisory Council on Historic Preservation (Parts 800 -- 899)
IX Pennsylvania Avenue Development Corporation (Parts 900 -- 999)
XI Architectural and Transportation Barriers Compliance Board (Parts
1100 -- 1199)
XII National Archives and Records Administration (Parts 1200 -- 1299)
21 CFR 169.182 Title 37 -- Patents, Trademarks, and Copyrights
I Patent and Trademark Office, Department of Commerce (Parts 1 --
199)
II Copyright Office, Library of Congress (Parts 200 -- 299)
III Copyright Royalty Tribunal (Parts 300 -- 399)
IV Assistant Secretary for Technology Policy, Department of Commerce
(Parts 400 -- 499)
V Under Secretary for Technology, Department of Commerce (Parts 500
-- 599)
21 CFR 169.182 Title 38 -- Pensions, Bonuses, and Veterans' Relief
I Department of Veterans Affairs (Parts 0 -- 99)
21 CFR 169.182 Title 39 -- Postal Service
I United States Postal Service (Parts 1 -- 999)
III Postal Rate Commission (Parts 3000 -- 3099)
21 CFR 169.182 Title 40 -- Protection of Environment
I Environmental Protection Agency (Parts 1 -- 799)
V Council on Environmental Quality (Parts 1500 -- 1599)
21 CFR 169.182 Title 41 -- Public Contracts and Property Management
Subtitle B -- Other Provisions Relating to Public Contracts
50 Public Contracts, Department of Labor (Parts 50-1 -- 50-999)
51 Committee for Purchase from the Blind and Other Severely
Handicapped (Parts 51-1 -- 51-99)
60 Office of Federal Contract Compliance Programs, Equal Employment
Opportunity, Department of Labor (Parts 60-1 -- 60-999)
61 Office of the Assistant Secretary for Veterans Employment and
Training, Department of Labor (Parts 61-1 -- 61-999)
Subtitle C -- Federal Property Management Regulations System
101 Federal Property Management Regulations (Parts 101-1 -- 101-99)
105 General Services Administration (Parts 105-1 -- 105-999)
109 Department of Energy Property Management Regulations (Parts 109-1
-- 109-99)
114 Department of the Interior (Parts 114-1 -- 114-99)
115 Environmental Protection Agency (Parts 115-1 -- 115-99)
128 Department of Justice (Parts 128-1 -- 128-99)
132 Department of the Air Force (Parts 132-1 -- 132-99)
Subtitle D -- Other Provisions Relating to Property Management
(Reserved)
Subtitle E -- Federal Information Resources Management Regulations
System
201 Federal Information Resources Management Regulation (Parts 201-1
-- 201-99)
Subtitle F -- Federal Travel Regulation System
301 Travel Allowances (Parts 301-1 -- 301-99)
302 Relocation Allowances (Parts 302-1 -- 302-99)
303 Payment of Expenses Connected with the Death of Certain Employees
(Parts 303-1 -- 303-2)
304 Payment from a non-Federal source for travel expenses (Parts
304-1 -- 304-99)
21 CFR 169.182 Title 42 -- Public Health
I Public Health Service, Department of Health and Human Services
(Parts 1 -- 199)
IV Health Care Financing Administration, Department of Health and
Human Services (Parts 400 -- 499)
V Office of Inspector General-Health Care, Department of Health and
Human Services (Parts 1000 -- 1999)
21 CFR 169.182 Title 43 -- Public Lands: Interior
Subtitle A -- Office of the Secretary of the Interior (Parts 1 --
199)
Subtitle B -- Regulations Relating to Public Lands
I Bureau of Reclamation, Department of the Interior (Parts 200 --
499)
II Bureau of Land Management, Department of the Interior (Parts 1000
-- 9999)
21 CFR 169.182 Title 44 -- Emergency Management and Assistance
I Federal Emergency Management Agency (Parts 0 -- 399)
IV Department of Commerce and Department of Transportation (Parts 400
-- 499)
21 CFR 169.182 Title 45 -- Public Welfare
Subtitle A -- Department of Health and Human Services, General
Administration (Parts 1 -- 199)
Subtitle B -- Regulations Relating to Public Welfare
II Office of Family Assistance (Assistance Programs), Family Support
Administration, Department of Health and Human Services (Parts 200 --
299)
III Office of Child Support Enforcement (Child Support Enforcement
Program), Family Support Administration, Department of Health and Human
Services (Parts 300 -- 399)
IV Office of Refugee Resettlement, Administration for Children and
Families Department of Health and Human Services (Parts 400 -- 499)
V Foreign Claims Settlement Commission of the United States,
Department of Justice (Parts 500 -- 599)
VI National Science Foundation (Parts 600 -- 699)
VII Commission on Civil Rights (Parts 700 -- 799)
VIII Office of Personnel Management (Parts 800 -- 899)
X Office of Community Services, Family Support Administration,
Department of Health and Human Services (Parts 1000 -- 1099)
XI National Foundation on the Arts and the Humanities (Parts 1100 --
1199)
XII ACTION (Parts 1200 -- 1299)
XIII Office of Human Development Services, Department of Health and
Human Services (Parts 1300 -- 1399)
XVI Legal Services Corporation (Parts 1600 -- 1699)
XVII National Commission on Libraries and Information Science (Parts
1700 -- 1799)
XVIII Harry S. Truman Scholarship Foundation (Parts 1800 -- 1899)
XX Commission on the Bicentennial of the United States Constitution
(Parts 2000 -- 2099)
XXI Commission on Fine Arts (Parts 2100 -- 2199)
XXII Christopher Columbus Quincentenary Jubilee Commission (Parts
2200 -- 2299)
XXIV James Madison Memorial Fellowship Foundation (Parts 2400 --
2499)
21 CFR 169.182 Title 46 -- Shipping
I Coast Guard, Department of Transportation (Parts 1 -- 199)
II Maritime Administration, Department of Transportation (Parts 200
-- 399)
III Coast Guard (Great Lakes Pilotage), Department of Transportation
(Parts 400 -- 499)
IV Federal Maritime Commission (Parts 500 -- 599)
21 CFR 169.182 Title 47 -- Telecommunication
I Federal Communications Commission (Parts 0 -- 199)
II Office of Science and Technology Policy and National Security
Council (Parts 200 -- 299)
III National Telecommunications and Information Administration,
Department of Commerce (Parts 300 -- 399)
21 CFR 169.182 Title 48 -- Federal Acquisition Regulations System
1 Federal Acquisition Regulation (Parts 1 -- 99)
2 Department of Defense (Parts 200 -- 299)
3 Department of Health and Human Services (Parts 300 -- 399)
4 Department of Agriculture (Parts 400 -- 499)
5 General Services Administration (Parts 500 -- 599)
6 Department of State (Parts 600 -- 699)
7 Agency for International Development (Parts 700 -- 799)
8 Department of Veterans Affairs (Parts 800 -- 899)
9 Department of Energy (Parts 900 -- 999)
10 Department of the Treasury (Parts 1000 -- 1099)
12 Department of Transportation (Parts 1200 -- 1299)
13 Department of Commerce (Parts 1300 -- 1399)
14 Department of the Interior (Parts 1400 -- 1499)
15 Environmental Protection Agency (Parts 1500 -- 1599)
16 Office of Personnel Management Federal Employees Health Benefits
Acquisition Regulation (Parts 1600 -- 1699)
17 Office of Personnel Management (Parts 1700 -- 1799)
18 National Aeronautics and Space Administration (Parts 1800 -- 1899)
19 United States Information Agency (Parts 1900 -- 1999)
22 Small Business Administration (Parts 2200 -- 2299)
24 Department of Housing and Urban Development (Parts 2400 -- 2499)
25 National Science Foundation (Parts 2500 -- 2599)
28 Department of Justice (Parts 2800 -- 2899)
29 Department of Labor (Parts 2900 -- 2999)
34 Department of Education Acquisition Regulation (Parts 3400 --
3499)
35 Panama Canal Commission (Parts 3500 -- 3599)
44 Federal Emergency Management Agency (Parts 4400 -- 4499)
51 Department of the Army Acquisition Regulations (Parts 5100 --
5199)
52 Department of the Navy Acquisition Regulations (Parts 5200 --
5299)
53 Department of the Air Force Federal Acquisition Regulation
Supplement (Parts 5300 -- 5399)
57 African Development Foundation (Parts 5700 -- 5799)
61 General Services Administration Board of Contract Appeals (Parts
6100 -- 6199)
63 Department of Transportation Board of Contract Appeals (Parts 6300
-- 6399)
99 Cost Accounting Standards Board, Office of Federal Procurement
Policy, Office of Management and Budget (Parts 9900 -- 9999)
21 CFR 169.182 Title 49 -- Transportation
Subtitle A -- Office of the Secretary of Transportation (Parts 1 --
99)
Subtitle B -- Other Regulations Relating to Transportation
I Research and Special Programs Administration, Department of
Transportation (Parts 100 -- 199)
II Federal Railroad Administration, Department of Transportation
(Parts 200 -- 299)
III Federal Highway Administration, Department of Transportation
(Parts 300 -- 399)
IV Coast Guard, Department of Transportation (Parts 400 -- 499)
V National Highway Traffic Safety Administration, Department of
Transportation (Parts 500 -- 599)
VI Urban Mass Transportation Administration, Department of
Transportation (Parts 600 -- 699)
VII National Railroad Passenger Corporation (AMTRAK) (Parts 700 --
799)
VIII National Transportation Safety Board (Parts 800 -- 899)
X Interstate Commerce Commission (Parts 1000 -- 1399)
21 CFR 169.182 Title 50 -- Wildlife and Fisheries
I United States Fish and Wildlife Service, Department of the Interior
(Parts 1 -- 199)
II National Marine Fisheries Service, National Oceanic and
Atmospheric Administration, Department of Commerce (Parts 200 -- 299)
III International Regulatory Agencies (Fishing and Whaling) (Parts
300 -- 399)
IV Joint Regulations (United States Fish and Wildlife Service,
Department of the Interior and National Marine Fisheries Service,
National Oceanic and Atmospheric Administration, Department of
Commerce); Endangered Species Committee Regulations (Parts 400 -- 499)
V Marine Mammal Commission (Parts 500 -- 599)
VI Fishery Conservation and Management, National Oceanic and
Atmospheric Administration, Department of Commerce (Parts 600 -- 699)
21 CFR 169.182 CFR Index and Finding Aids Subject/Agency Index
List of Agency Prepared Indexes Parallel Table of Statutory Authorities
and Rules Acts Requiring Publication in the Federal Register List of CFR
Titles, Chapters, Subchapters, and Parts
21 CFR 169.182 Alphabetical List of Agencies Appearing in the CFR
CFR Title, Subtitle or
Agency
Chapter
ACTION 45, XII
Administrative Committee of the Federal Register 1, I
Administrative Conference of the United States 1, III
Advisory Commission on Intergovernmental Relations 5, VII
Advisory Committee on Federal Pay 5, IV
Advisory Council on Historic Preservation 36, VIII
African Development Foundation 22, XV; 48, 57
Agency for International Development 22, II; 48, 7
Agricultural Marketing Service 7, I, IX, X, XI
Agricultural Research Service 7, V
Agricultural Stabilization and Conservation Service 7, VII
Agriculture Department
Agricultural Marketing Service 7, I, IX, X, XI
Agricultural Research Service 7, V
Agricultural Stabilization and Conservation Service 7, VII
Animal and Plant Health Inspection Service 7, III; 9, I
Commodity Credit Corporation 7, XIV
Cooperative State Research Service 7, XXXIV
Economic Analysis Staff 7, XXXIX
Economic Research Service 7, XXXVII
Economics Management Staff 7, XL
Energy, Office of 7, XXIX
Environmental Quality, Office of 7, XXXI
Farmers Home Administration 7, XVIII
Federal Acquisition Regulation 48, 4
Federal Crop Insurance Corporation 7, IV
Federal Grain Inspection Service 7, VIII
Finance and Management, Office of 7, XXX
Food and Nutrition Service 7, II
Food Safety and Inspection Service 9, III
Foreign Agricultural Service 7, XV
Foreign Economic Development Service 7, XXI
Forest Service 36, II
General Sales Manager, Office of 7, XXV
Grants and Program Systems, Office of 7, XXXII
Information Resources Management, Office of 7, XXVII
Inspector General, Office of 7, XXVI
International Cooperation and Development Office 7, XXII
National Agricultural Library 7, XLI
National Agricultural Statistics Service 7, XXXVI
Operations Office 7, XXVIII
Packers and Stockyards Administration 9, II
Rural Electrification Administration 7, XVII
Rural Telephone Bank 7, XVI
Secretary of Agriculture, Office of 7, Subtitle A
Soil Conservation Service 7, VI
Transportation, Office of 7, XXXIII
World Agriculture Outlook Board 7, XXXVIII
Air Force Department 32, VII; 41, Subtitle C, Ch. 132
Federal Acquisition Regulation Supplement 48, 53
Alaska Natural Gas Transportation System, Office of the Federal
Inspector 10, XV
Alcohol, Tobacco and Firearms, Bureau of 27, I
AMTRAK 49, VII
American Battle Monuments Commission 36, IV
Animal and Plant Health Inspection Service 7, III; 9, I
Appalachian Regional Commission 5, IX
Architectural and Transportation Barriers Compliance Board 36, XI
Arms Control and Disarmament Agency, U.S. 22, VI
Army Department 32, V
Engineers, Corps of 33, II; 36, III
Federal Acquisition Regulation 48, 51
Assistant Secretary for Technology Policy, Department of Commerce 37,
IV
Benefits Review Board 20, VII
Bicentennial of the United States Constitution, Commission on the 45,
XX
Bilingual Education and Minority Languages Affairs, Office of 34, V
Blind and Other Severely Handicapped, Committee for Purchase from 41,
51
Board for International Broadcasting 22, XIII
Budget, Office of Management and 5, III
Census Bureau 15, I
Central Intelligence Agency 32, XIX
Child Support Enforcement, Office of 45, III
Christopher Columbus Quincentenary Jubilee Commission 45, XXII
Civil Rights Commission 45, VII
Civil Rights, Office for (Education Department) 34, I
Claims Collection Standards, Federal 4, II
Coast Guard 33, I; 46, I, III; 49, IV
Commerce Department 44, IV
Census Bureau 15, I
Assistant Secretary for Technology Policy 37, IV
Economic Affairs, Under Secretary 37, V
Economic Analysis, Bureau of 15, VIII
Economic Development Administration 13, III
Endangered Species Committee 50, IV
Export Administration Bureau 15, VII
Federal Acquisition Regulation 48, 13
Fishery Conservation and Management 50, VI
International Trade Administration 15, III; 19, III
National Institute of Standards and Technology 15, II
National Marine Fisheries Service 50, II, IV
National Oceanic and Atmospheric Administration 15, IX; 50, II, III,
IV, VI
National Telecommunications and Information Administration 15, XXIII;
47, III
Patent and Trademark Office 37, I
Productivity, Technology and Innovation, Assistant Secretary for 37,
IV
Secretary of Commerce, Office of 15, Subtitle A
Technology Administration 15, XI
Under Secretary for Technology 37, V
United States Travel and Tourism Administration 15, XII
Commercial Space Transportation, Office of, Department of
Transportation 14, III
Commission on the Bicentennial of the United States Constitution 45,
XX
Committee for Purchase from the Blind and Other Severely Handicapped
41, 51
Commodity Credit Corporation 7, XIV
Commodity Futures Trading Commission 17, I
Community Planning and Development, Office of Assistant Secretary for
24, V, VI
Community Services, Office of 45, X
Comptroller of the Currency 12, I
Construction Industry Collective Bargaining Commission 29, IX
Consumer Product Safety Commission 16, II
Cooperative State Research Service 7, XXXIV
Copyright Office 37, II
Copyright Royalty Tribunal 37, III
Cost Accounting Standards Board, Office of Federal Procurement Policy
48, 99
Council on Environmental Quality 40, V
Customs Service, United States 19, I
Defense Department 32, Subtitle A
Air Force Department 32, VII; 41, Subtitle C, Ch. 132
Army Department 32, V; 33, II; 36, III, 48, 51
Engineers, Corps of 33, II; 36, III
Federal Acquisition Regulation 48, 2
Navy Department 32, VI; 48, 52
Secretary of Defense, Office of 32, I
Defense Logistics Agency 32, XII
Defense Nuclear Facilities Safety Board 10, XVII
Delaware River Basin Commission 18, III
Drug Enforcement Administration 21, II
East-West Foreign Trade Board 15, XIII
Economic Affairs, Under Secretary (Commerce) 37, V
Economic Analysis, Bureau of 15, VIII
Economic Analysis Staff, Department of Agriculture 7, XXXIX
Economic Development Administration 13, III
Economics Management Staff 7, XL
Economic Research Service 7, XXXVII
Education, Department of
Bilingual Education and Minority Languages Affairs, Office of 34, V
Civil Rights, Office for 34, I
Educational Research and Improvement, Office of 34, VII
Elementary and Secondary Education, Office of 34, II
Federal Acquisition Regulation 48, 34
Postsecondary Education, Office of 34, VI
Secretary of Education, Office of 34, Subtitle A
Special Education and Rehabilitative Services, Office of 34, III
Vocational and Adult Education, Office of 34, IV
Educational Research and Improvement, Office of 34, VII
Elementary and Secondary Education, Office of 34, II
Employees' Compensation Appeals Board 20, IV
Employees Loyalty Board, International Organizations 5, V
Employment and Training Administration 20, V
Employment Standards Administration 20, VI
Endangered Species Committee 50, IV
Energy, Department of 10, II, III, X; 41, 109
Federal Acquisition Regulation 48, 9
Federal Energy Regulatory Commission 18, I
Energy, Office of, Department of Agriculture 7, XXIX
Engineers, Corps of 33, II; 36, III
Engraving and Printing, Bureau of 31, VI
Environmental Protection Agency 40, I; 41, 115; 48, 15
Environmental Quality, Office of (Agriculture Department) 7, XXXI
Equal Employment Opportunity Commission 29, XIV
Equal Opportunity, Office of Assistant Secretary for 24, I
Executive Office of the President 3, I
Administration, Office of 5, XV
Export Administration Bureau 15, VII
Export-Import Bank of the United States 12, IV
Family Assistance, Office of 45, II
Family Support Administration 45, II, III, IV, X
Farm Credit Administration 12, VI
Farm Credit System Assistance Board 12, XIII
Farm Credit System Insurance Corporation 12, XIV
Farmers Home Administration 7, XVIII
Federal Acquisition Regulation 48, 1
Federal Aviation Administration 14, I
Federal Claims Collection Standards 4, II
Federal Communications Commission 47, I
Federal Contract Compliance Programs, Office of 41, 60
Federal Crop Insurance Corporation 7, IV
Federal Deposit Insurance Corporation 12, III
Federal Election Commission 11, I
Federal Emergency Management Agency 44, I; 48, 44
Federal Energy Regulatory Commission 18, I
Federal Financial Institutions Examination Council 12, XI
Federal Financing Bank 12, VIII
Federal Grain Inspection Service 7, VIII
Federal Highway Administration 23, I, II; 49, III
Federal Home Loan Mortgage Corporation 1, IV
Federal Housing Finance Board 12, IX
Federal Information Resources Management Regulations 41, Subtitle E,
Ch. 201
Federal Inspector for the Alaska Natural Gas Transportation System,
Office of 10, XV
Federal Labor Relations Authority, and General Counsel of the Federal
Labor Relations Authority 5, XIV; 22, XIV
Federal Law Enforcement Training Center 31, VII
Federal Maritime Commission 46, IV
Federal Mediation and Conciliation Service 29, XII
Federal Mine Safety and Health Review Commission 29, XXVII
Federal Pay, Advisory Committee on 5, IV
Federal Prison Industries, Inc. 28, III
Federal Procurement Policy Office 48, 99
Federal Property Management Regulations 41, 101
Federal Property Management Regulations System 41, Subtitle C
Federal Railroad Administration 49, II
Federal Register, Administrative Committee of 1, I
Federal Register, Office of 1, II
Federal Reserve System 12, II
Federal Retirement Thrift Investment Board 5, VI
Federal Service Impasses Panel 5, XIV
Federal Trade Commission 16, I
Federal Travel Regulation System 41, Subtitle F
Finance and Management, Department of Agriculture 7, XXX
Fine Arts Commission 45, XXI
Fiscal Service 31, II
Fish and Wildlife Service, United States 50, I, IV
Fishery Conservation and Management 50, VI
Fishing and Whaling, International Regulatory Agencies 50, III
Food and Drug Administration 21, I
Food and Nutrition Service 7, II
Food Safety and Inspection Service 9, III
Foreign Agricultural Service 7, XV
Foreign Assets Control, Office of 31, V
Foreign Claims Settlement Commission of United States 45, V
Foreign Economic Development Service 7, XXI
Foreign Service Grievance Board 22, IX
Foreign Service Impasse Disputes Panel 22, XIV
Foreign Service Labor Relations Board 22, XIV
Foreign-Trade Zones Board 15, IV
Forest Service 36, II
General Accounting Office 4, I, II, III
General Sales Manager, Office of 7, XXV
General Services Administration
Contract Appeals Board 48, 61
Federal Acquisition Regulation 48, 5
Federal Information Resources Management Regulations 41, Subtitle E,
Ch. 201
Federal Property Management Regulations System 41, 101, 105
Federal Travel Regulation System 41, Subtitle F
Payment of Expenses Connected With the Death of Certain Employees 41,
303
Reduction in Meeting and Training Allowance Payments 41, 304
Relocation Allowances 41, 302
Travel Allowances 41, 301
Geological Survey 30, IV
Government Ethics, Office of 5, XVI
Government National Mortgage Association 24, III
Grants and Program Systems, Office of 7, XXXII
Great Lakes Pilotage 46, III
Harry S. Truman Scholarship Foundation 45, XVIII
Health and Human Services, Department of 45, Subtitle A
Child Support Enforcement, Office of 45, III
Community Services, Office of 45, X
Family Assistance, Office of 45, II
Family Support Administration 45, II, III, IV, X
Federal Acquisition Regulation 48, 3
Food and Drug Administration 21, I
Health Care Financing Administration 42, IV
Human Development Services Office 45, XIII
Inspector General, Office of 42, V
Public Health Service 42, I
Refugee Resettlement, Office of 45, IV
Social Security Administration 20, III; 45, IV
Health Care Financing Administration 42, IV
Housing and Urban Development, Department of
Community Planning and Development, Office of Assistant Secretary for
24, V, VI
Equal Opportunity, Office of Assistant Secretary for 24, I
Federal Acquisition Regulation 48, 24
Government National Mortgage Association 24, III
Housing -- Federal Housing Commissioner, Office of Assistant
Secretary for 24, II, VIII, X, XX
Inspector General, Office of 24, XII
Mortgage Insurance and Loan Programs Under Emergency Homeowners'
Relief Act 24, XV
Public and Indian Housing, Office of Assistant Secretary for 24, IX
Secretary, Office of 24, Subtitle B, VII
Solar Energy and Energy Conservation Bank 24, XI
Housing -- Federal Housing Commissioner, Office of Assistant
Secretary for 24, II, VIII, X, XX
Human Development Services Office 45, XIII
Immigration and Naturalization Service 8, I
Indian Affairs, Bureau of 25, I
Indian Arts and Crafts Board 25, II
Information Agency, United States 22, V; 48, 19
Information Resources Management, Office of, Agriculture Department
7, XXVII
Information Security Oversight Office 32, XX
Inspector General, Office of, Agriculture Department 7, XXVI
Inspector General, Office of, Health and Human Services Department
42, V
Inspector General, Office of, Housing and Urban Development
Department 24, XII
Inter-American Foundation 22, X
Intergovernmental Relations, Advisory Commission on 5, VII
Interior Department
Endangered Species Committee 50, IV
Federal Acquisition Regulation 48, 14
Federal Property Management Regulations System 41, 114
Fish and Wildlife Service, United States 50, I, IV
Geological Survey 30, IV
Indian Affairs, Bureau of 25, I
Indian Arts and Crafts Board 25, II
Land Management Bureau 43, II
Minerals Management Service 30, II
Mines, Bureau of 30, VI
National Park Service 36, I
Reclamation Bureau 43, I
Secretary of the Interior, Office of 43, Subtitle A
Surface Mining and Reclamation Appeals, Board of 30, III
Surface Mining Reclamation and Enforcement, Office of 30, VII
United States Fish and Wildlife Service 50, I, IV
Internal Revenue Service 26, I
International Boundary and Water Commission, United States and Mexico
22, XI
International Cooperation and Development Office, Department of
Agriculture 7, XXII
International Development, Agency for 22, II
International Development Cooperation Agency 22, XII
International Development, Agency for 22, II
Overseas Private Investment Corporation 22, VII
International Joint Commission, United States and Canada 22, IV
International Organizations Employees Loyalty Board 5, V
International Regulatory Agencies (Fishing and Whaling) 50, III
International Trade Administration 15, III; 19, III
International Trade Commission, United States 19, II
Interstate Commerce Commission 49, X
Japan-United States Friendship Commission 22, XVI
Joint Board for the Enrollment of Actuaries 20, VIII
Justice Department 28, I; 41, 128
Drug Enforcement Administration 21, II
Federal Acquisition Regulation 48, 28
Federal Claims Collection Standards 4, II
Federal Prison Industries, Inc. 28, III
Foreign Claims Settlement Commission of the United States 45, V
Immigration and Naturalization Service 8, I
Offices of Independent Counsel 28, VI
Prisons, Bureau of 28, V
Labor Department
Benefits Review Board 20, VII
Employees' Compensation Appeals Board 20, IV
Employment and Training Administration 20, V
Employment Standards Administration 20, VI
Federal Acquisition Regulation 48, 29
Federal Contract Compliance Programs, Office of 41, 60
Federal Procurement Regulations System 41, 50
Labor-Management Relations and Cooperative Programs, Bureau of 29, II
Labor-Management Standards, Office of 29, IV
Mine Safety and Health Administration 30, I
Occupational Safety and Health Administration 29, XVII
Pension and Welfare Benefits Administration 29, XXV
Public Contracts 41, 50
Secretary of Labor, Office of 29, Subtitle A
Veterans' Employment and Training, Office of the Assistant Secretary
for 41, 61; 20, IX
Wage and Hour Division 29, V
Workers' Compensation Programs, Office of 20, I
Labor-Management Relations and Cooperative Programs, Bureau of 29, II
Labor-Management Standards, Office of 29, IV
Land Management, Bureau of 43, II
Legal Services Corporation 45, XVI
Library of Congress 36, VII
Copyright Office 37, II
Management and Budget, Office of 5, III; 48, 99
Marine Mammal Commission 50, V
Maritime Administration 46, II
Merit Systems Protection Board 5, II
Micronesian Status Negotiations, Office for 32, XXVII
Mine Safety and Health Administration 30, I
Minerals Management Service 30, II
Mines, Bureau of 30, VI
Minority Business Development Agency 15, XIV
Miscellaneous Agencies 1, IV
Monetary Offices 31, I
Mortgage Insurance and Loan Programs Under the Emergency Homeowners'
Relief Act, Department of Housing and Urban Development 24, XV
National Aeronautics and Space Administration 14, V; 48, 18
National Agricultural Library 7, XLI
National Agricultural Statistics Service 7, XXXVI
National Archives and Records Administration 36, XII
National Bureau of Standards 15, II
National Capital Planning Commission 1, IV
National Commission for Employment Policy 1, IV
National Commission on Libraries and Information Science 45, XVII
National Credit Union Administration 12, VII
National Foundation on the Arts and the Humanities 45, XI
National Highway Traffic Safety Administration 23, II, III; 49, V
National Indian Gaming Commission 25, III
National Institute of Standards and Technology 15, II
National Labor Relations Board 29, I
National Marine Fisheries Service 50, II, IV
National Mediation Board 29, X
National Oceanic and Atmospheric Administration 15, IX; 50, II, III,
IV, VI
National Park Service 36, I
National Railroad Adjustment Board 29, III
National Railroad Passenger Corporation (AMTRAK) 49, VII
National Science Foundation 45, VI; 48, 25
National Security Council 32, XXI
National Security Council and Office of Science and Technology Policy
47, II
National Telecommunications and Information Administration 15, XXIII;
47, III
National Transportation Safety Board 49, VIII
Navy Department 32, VI; 48, 52
Neighborhood Reinvestment Corporation 24, XXV
Nuclear Regulatory Commission 10, I
Occupational Safety and Health Administration 29, XVII
Occupational Safety and Health Review Commission 29, XX
Office of Independent Counsel 28, VII
Office of Navajo and Hopi Indian Relocation 25, IV
Offices of Independent Counsel, Department of Justice 28, VI
Operations Office, Department of Agriculture 7, XXVIII
Overseas Private Investment Corporation 22, VII
Oversight Board 12, XV
Packers and Stockyards Administration 9, II
Panama Canal Commission 48, 35
Panama Canal Regulations 35, I
Patent and Trademark Office 37, I
Payment of Expenses Connected With the Death of Certain Employees 41,
303
Peace Corps 22, III
Pennsylvania Avenue Development Corporation 36, IX
Pension and Welfare Benefits Administration, Department of Labor 29,
XXV
Pension Benefit Guaranty Corporation 29, XXVI
Personnel Management, Office of 5, I; 45, VIII; 48, 17
Federal Employees Health Benefits Acquisition Regulation 48, 16
Postal Rate Commission 39, III
Postal Service, United States 39, I
Postsecondary Education, Office of 34, VI
President's Commission on White House Fellowships 1, IV
Presidential Documents 3
Prisons, Bureau of 28, V
Productivity, Technology and Innovation, Assistant Secretary
(Commerce) 37, IV
Property Management Regulations System, Federal 41, Subtitle C
Public Contracts, Department of Labor 41, 50
Public Health Service 42, I
Railroad Retirement Board 20, II
Reclamation Bureau 43, I
Reduction in Meeting and Training Allowance Payments 41, 304
Refugee Resettlement, Office of 45, IV
Regional Action Planning Commissions 13, V
Relocation Allowances 41, 302
Research and Special Programs Administration 49, I
Resolution Trust Corporation 12, XVI
Rural Electrification Administration 7, XVII
Rural Telephone Bank 7, XVI
Saint Lawrence Seaway Development Corporation 33, IV
Science and Technology Policy, Office of 32, XXIV
Science and Technology Policy, Office of, and National Security
Council 47, II
Secret Service 31, IV
Securities and Exchange Commission 17, II
Selective Service System 32, XVI
Small Business Administration 13, I; 48, 22
Smithsonian Institution 36, V
Social Security Administration 20, III; 45, IV
Soil Conservation Service 7, VI
Solar Energy and Energy Conservation Bank, Department of Housing and
Urban Development 24, XI
Soldiers' and Airmen's Home, United States 5, XI
Special Counsel, Office of 5, VIII
Special Education and Rehabilitative Services, Office of 34, III
State Department 22, I
Federal Acquisition Regulation 48, 6
Surface Mining and Reclamation Appeals, Board of 30, III
Susquehanna River Basin Commission 18, VIII
Technology Administration 15, XI
Tennessee Valley Authority 18, XIII
Thrift Supervision Office, Department of the Treasury 12, V
Trade Representative, United States, Office of 15, XX
Transportation, Department of 44, IV
Coast Guard 33, I; 46, I, III; 49, IV
Commercial Space Transportation, Office of 14, III
Contract Appeals Board 48, 63
Federal Acquisition Regulation 48, 12
Federal Aviation Administration 14, I
Federal Highway Administration 23, I, II; 49, III
Federal Railroad Administration 49, II
Maritime Administration 46, II
National Highway Traffic Safety Administration 23, II, III; 49, V
Research and Special Programs Administration 49, I
Saint Lawrence Seaway Development Corporation 33, IV
Secretary of Transportation, Office of 14, II; 49, Subtitle A
Urban Mass Transportation Administration 49, VI
Transportation, Office of, Department of Agriculture 7, XXXIII
Travel Allowance 41, 301
Travel and Tourism Administration, United States 15, XII
Treasury Department 17, IV
Alcohol, Tobacco and Firearms, Bureau of 27, I
Comptroller of the Currency 12, I
Customs Service, United States 19, I
Engraving and Printing, Bureau of 31, VI
Federal Acquisition Regulation 48, 10
Federal Law Enforcement Training Center 31, VII
Fiscal Service 31, II
Foreign Assets Control, Office of 31, V
Internal Revenue Service 26, I
Monetary Offices 31, I
Secret Service 31, IV
Secretary of the Treasury, Office of 31, Subtitle A
Thrift Supervision Office 12, V
United States Customs Service 19, I
Truman, Harry S. Scholarship Foundation 45, XVIII
Under Secretary for Technology, Department of Commerce 37, V
United States and Canada, International Joint Commission 22, IV
United States Arms Control and Disarmament Agency 22, VI
United States Customs Service 19, I
United States Fish and Wildlife Service 50, I, IV
United States Information Agency 22, V; 48, 19
United States International Development Cooperation Agency 22, XII
United States International Trade Commission 19, II
United States Postal Service 39, I
United States Soldiers' and Airmen's Home 5, XI
United States Trade Representative, Office of 15, XX
United States Travel and Tourism Adminstration 15, XII
Urban Mass Transportation Administration 49, VI
Veterans Affairs Department 38, I; 48, 8
Veterans' Employment and Training, Office of the Assistant Secretary
for 41, 61; 20, IX
Vice President of the United States, Office of 32, XXVIII
Vocational and Adult Education, Office of 34, IV
Wage and Hour Division 29, V
Water Resources Council 18, VI
Workers' Compensation Programs, Office of 20, I
World Agriculture Outlook Board 7, XXXVIII
21 CFR 169.182 21 CFR Ch. I (4-1-92 Edition)
21 CFR 169.182 List of CFR Sections Affected
21 CFR 169.182 List of CFR Sections Affected
All changes in this volume of the Code of Federal Regulations which
were made by documents published in the Federal Register since January
1, 1986, are enumerated in the following list. Entries indicate the
nature of the changes effected. Page numbers refer to Federal Register
pages. The user should consult the entries for chapters and parts as
well as sections for revisions.
For the period before January 1, 1986, see the ''List of CFR Sections
Affected, 1949-1963, 1964-1972, and 1973-1985,'' published in seven
separate volumes.
21 CFR 169.182 1986
21 CFR
51 FR
Page
Chapter I
Mandatory compliance date 1-1-89 34085
101 Authority citation revised; section authority citations removed
25017
101.100 (a)(4) added 25017
101 Appendix A added 25017
107.50 (Subpart C) OMB number 6106
110 Revised 22475
118 Removed 22481
123 Removed 41616
131.110 (b), (c)(1), and (e)(1)(i) eff. 1-5-87 40314
131.135 (b), (c)(1), and (3), and (e)(1)(ii) eff. 1-5-87 40314
131.143 (b), (c)(1) and (3), and (e)(1)(i) eff. 1-5-87 40314
133 Authority citation revised 30210
133.146 (b)(2) revised 30210
Effective date confirmed 42088
145.170 (b) revision effective date confirmed 11434
160 Authority citation revised 11435
160.145 (a) revised; (c) redesignated as (d); new (c) and (e) added
11435
Eff. 7-1-87 25362
21 CFR 169.182 1987
21 CFR
52 FR
Page
Chapter I
101 Authority citation corrected 6971
101.9 (c)(3) amended 28691
131 Stay terminated 29509
Technical correction 31123
21 CFR 169.182 1988
21 CFR
53 FR
Page
Chapter I
Uniform compliance date 1-1-91 44861
101.2 (d)(2) introductory text revised 16068
133.155 Revised 3743
133.155 Effective date confirmed 37752
133.156 Revised 3743
133.156 Effective date confirmed 37752
21 CFR 169.182 1989
21 CFR
54 FR
Page
Chapter I
100 Authority citation revised; sectional authority citation removed
39632
101 Authority citation revised 39632
101.9 (a)(2), (c)(4), and (8) (i) and (ii) amended 24891
101.22 (a)(3) amended 24891
101.25 (e)(3) amended 24891
101.29 Authority citation removed 39632
102 Authority citation revised 39632
102.23 (c) (1) and (5) amended 24891
103 Authority citation revised 400
Effective date confirmed 38514
Authority citation revised 39632
Technical correction 41363
103.35 (a)(1) amended 400
Effective date confirmed 18651
(b) introductory text amended 24891
Authority citation removed 39632
104 Authority citation revised 39632
105 Authority citation revised; sectional authority citations
removed 39633
106 Authority citation revised 39633
106.30 (c)(2) amended 24891
106.120 (a) and (b) amended 24891
107 Technical correction 6804
Authority citation revised 39633
107.200 -- 107.280 (Subpart E) Added 4008
108 Effective date confirmed 38514
Authority citation revised 39633
Technical correction 41363
108.5 (a)(1) amended 24891
108.25 (c) (1) and (2) and (h) amended 24891
108.35 (c)(1), (2) introductory text and (ii), and (j)(1) amended
24891
109 Effective date confirmed 38514
Authority citation revised 39633
Technical correction 41363
109.30 (c) and (d) amended 24892
Authority citation removed 39633
110 Authority citation revised 39633
110.10 (b)(4) amended 24892
110.35 (b)(1) introductory text amended 24892
113 Authority citation revised 39633
114 Authority citation revised 39633
114.90 (a)(4)(ii) amended 24892
129 Authority citation revised 39633
130 Authority citation revised 39633
130.17 (c) introductory text amended 24892
131 Effective date confirmed 38514
Authority citation revised; sectional authority citations removed
39633
Technical correction 41363
131.110 (d) introductory text amended 24892
131.111 (f) introductory text amended 24892
131.112 (e) introductory text amended 24892
131.115 (d) introductory text amended 24892
131.120 (c) amended 24892
131.122 (c) amended 24892
131.123 (d) introductory text amended 24892
131.125 (c) introductory text amended 24892
131.127 (d) introductory text amended 24892
131.130 (d) introductory text amended 24892
131.132 (d) introductory text amended 24892
131.135 (d) introductory text amended 24893
131.136 (f) introductory text amended 24893
131.138 (e) introductory text amended 24893
131.143 (d) introductory text amended 24893
131.144 (f) introductory text amended 24893
131.146 (e) introductory text amended 24893
131.147 (d) introductory text amended 24893
131.149 (c) introductory text amended 24893
131.150 (c) amended 24893
131.155 (c) amended 24893
131.157 (c) amended 24893
131.160 (c) introductory text amended 24893
131.162 (c) introductory text amended 24893
131.170 (f) introductory text amended 24893
131.180 (c) amended 24893
131.185 (c) introductory text amended 24893
131.187 (c) introductory text amended 24893
131.200 (e) introductory text amended 24893
131.203 (e) introductory text amended 24893
131.206 (e) introductory text amended 24893
133 Technical correction 37531, 41363
Effective date confirmed 38514
Authority citations revised; sectional authority citations removed
39633
133.5 Introductory text amended 24893
133.106 (a)(1) amended; (a)(2) removed; (a)(3) redesignated as
(a)(2) 32052
133.108 Revised 32052
(d)(2) corrected 35756
133.109 Revised 32053
133.127 Revised 32053
133.133 Revised 32053
133.134 Revised 32053
133.136 Revised 32054
133.137 Revised 32054
133.140 Revised 32054
133.141 Revised 32054
133.144 Revised 32055
133.145 Revised 32056
133.146 Revised 32056
(d)(3)(iii) and (4)(i) corrected 35756
133.153 Revised 32056
133.160 Revised 32057
(a) and (d)(1) corrected 35756
133.161 Revised 32057
133.162 Revised 32057
133.164 Revised 32058
133.179 (f)(11) added; eff. 4-10-89 6121
Effective date confirmed 22741
133.184 Revised 32058
133.186 Revised 32058
133.190 Revised 32059
135 Effective date confirmed 38514
Authority citations revised; sectional authority citations removed
39633
Technical correction 41363
135.110 (d) amended 24894
135.130 (c) introductory text amended 24894
136 Effective date confirmed 38514
Authority citation revised; sectional authority citations removed
39633
Technical correction 41363
136.110 (d) amended 24894
136.160 (a)(5) amended 24894
137 Effective date confirmed 38514
Authority citation revised; sectional authority citations removed
39633
Technical correction 41363
137.105 (a) introductory text amended 24894
137.180 (c) introductory text amended 24894
137.190 Amended 24894
137.195 Amended 24894
137.200 (c)(1) amended 24894
137.211 (b)(2) amended 24894
137.230 (b)(2) amended 24894
137.250 (b)(1) introductory text and (2) amended 24894
137.270 (b) introductory text amended 24894
137.300 (b)(2) amended 24894
137.350 (e) amended 24894
139 Effective date confirmed 38514
Authority citation revised; sectional authority citations removed
39633
Technical correction 41363
139.110 (a)(5) amended 24894
139.117 (a)(2) introductory text amended 24894
139.150 (a) concluding text amended 24894
145 Effective date confirmed 38514
Authority citation revised; sectional authority citations removed
39633
Technical correction 41363
145.3 (m) amended 24894
145.110 (a)(1) amended 24894
145.125 (b)(2)(ii) amended 24894
145.135 (b)(1)(i) amended 24895
145.145 (a)(3)(iii) introductory text amended 24895
146 Effective date confirmed 38514
Authority citation revised; sectional authority citations removed
39633
Technical correction 41363
146.113 (a) amended 24895
146.114 (a)(1) amended 24895
146.120 (a) amended 24895
146.185 (b)(2)(i) amended 24895
150 Effective date confirmed 38514
Authority citation revised; sectional authority citations removed
39633
Technical correction 41363
150.110 (d)(3) amended 24895
150.140 (d)(3) amended 24895
150.160 (d)(5) amended 24895
152 Authority citation revised 39633
152.126 Authority citation revised 39633
155 Effective date confirmed 38514
Authority citation revised; sectional authority citations removed
39634
Technical correction 41363
155.3 (a) and (e) amended 24895
155.120 (b)(2)(i) amended 24895
155.130 (b)(2)(i) amended 24895
155.170 (b)(1)(vi) amended 24895
156 Authority citation revised 24895
Effective date confirmed 38514
Authority citation revised; sectional authority citations removed
39634
Technical correction 41363
156.3 (b) amended 24895
158 Authority citation revised; sectional authority citations
removed 39634
160 Effective date confirmed 38514
Authority citation revised 39634
Technical correction 41363
160.145 (c)(2) amended 24895
160.180 Amended 24895
Authority citation removed 39634
161 Effective date confirmed 38514
Authority citation revised; sectional authority citations removed
39634
Technical correction 41363
161.145 (c)(3) amended 24895
161.173 (c)(1) amended 24896
161.175 (g)(1)(v) amended 24896
161.190 (a)(2), (7) introductory text and (iii) amended 24896
163 Effective date confirmed 38514
Authority citation revised; sectional authority citation removed
39634
Technical correction 41363
163.110 (a) amended 24896
163.111 (a) concluding text amended 24896
163.112 (a) concluding text amended 24896
164 Effective date confirmed 38514
Authority citation revised 39634
Technical correction 41363
164.150 (a) amended 24896
Authority citation removed 39634
165 Removed 400
165.175 Effective date confirmed 18651
166 Authority citation revised 24896
Effective date confirmed 38514
Authority citation revised; sectional authority citations removed
39634
Technical correction 41363
166.110 (a) introductory text amended 24896
168 Effective date confirmed 38514
Authority citation revised; sectional authority citations removed
39634
Technical correction 41363
168.111 (d) introductory text amended 24896
168.120 (d) introductory text amended 24896
168.122 (d)(1) introductory text amended 24896
169 Effective date confirmed 38514
Authority citation revised; sectional authority citations removed
39634
Technical correction 41363
169.3 (b) amended 24896
21 CFR 169.182 1990
21 CFR
55 FR
Page
Chapter I
101.4 (a) redesignated as (a)(1); (a)(2) added 17433
102.47 Revised 45797
109 Subpart C heading redesignated as Subpart D; new Subpart C
heading added 20785
Subpart D heading redesignated from Subpart C 20785
109.4 (c) redesignated as (d); heading, (b), and new (d) revised;
new (c) added 20785
109.6 (c) and (d) redesignated as (d) and (e); (a), new (d) and (e)
revised; new (c) added 20785
109.7 (b) revised 20785
109.8 Removed 20786
133 Effective date confirmed 2510
Technical correction 6876
133.127 (a) amended 51409
133.138 (b)(3)(iv) revised eff. 4-30-90 6795
Regulation at 55 FR 6795 confirmed 48107
133.195 (b)(3)(iv) revised eff. 4-30-90 6795
Regulation at 55 FR 6795 confirmed 48107
133.196 Revised eff. 4-30-90 6795
Regulation at 55 FR 6795 confirmed 48107
161.190 (a)(2), (4)(i) and (8)(vi) revised; (a)(6)(ix) added 45797
168.122 (b)(1) and (3), and (d) revised eff. 4-10-90 8459
Regulation at 55 FR 8458 effective date confirmed 28019
21 CFR 169.182 1991
21 CFR
56 FR
Page
Chapter I
101.42 -- 101.45 (Subpart C) Added 60890
106.100 Revised; eff. 4-22-92 66571
161.190 (a)(2) corrected 6263
21 CFR 169.182 1992
21 CFR
57 FR
PageI63Chapter I
101 Technical correction 10522
101.42 -- 101.45 (Subpart C) Corrected 8174
106.100 Technical correction 6352
(k)(6) corrected 7435
21
Food and Drugs
PARTS 100 TO 169
Revised as of April 1, 1992
CONTAINING
A CODIFICATION OF DOCUMENTS
OF GENERAL APPLICABILITY
AND FUTURE EFFECT
AS OF APRIL 1, 1992
With Ancillaries
Published by
the Office of the Federal Register
National Archives and Records
Administration
as a Special Edition of
the Federal Register
Washington, DC 20402-9328
21 CFR 169.182 Table of Contents
Page
Explanation v
Title 21:
Chapter I -- Food and Drug Administration, Department of Health and
Human Services (Continued)
Finding Aids:
Material Approved for Incorporation by Reference
Table of CFR Titles and Chapters
Alphabetical List of Agencies Appearing in the CFR
List of CFR Sections Affected
21 CFR 169.182 Explanation
The Code of Federal Regulations is a codification of the general and
permanent rules published in the Federal Register by the Executive
departments and agencies of the Federal Government. The Code is divided
into 50 titles which represent broad areas subject to Federal
regulation. Each title is divided into chapters which usually bear the
name of the issuing agency. Each chapter is further subdivided into
parts covering specific regulatory areas.
Each volume of the Code is revised at least once each calendar year
and issued on a quarterly basis approximately as follows:
Title 1 through Title 16 as of January 1
Title 17 through Title 27 as of April 1
Title 28 through Title 41 as of July 1
Title 42 through Title 50 as of October 1
The appropriate revision date is printed on the cover of each volume.
LEGAL STATUS
The contents of the Federal Register are required to be judicially
noticed (44 U.S.C. 1507). The Code of Federal Regulations is prima facie
evidence of the text of the original documents (44 U.S.C. 1510).
HOW TO USE THE CODE OF FEDERAL REGULATIONS
The Code of Federal Regulations is kept up to date by the individual
issues of the Federal Register. These two publications must be used
together to determine the latest version of any given rule.
To determine whether a Code volume has been amended since its
revision date (in this case, April 1, 1992), consult the ''List of CFR
Sections Affected (LSA),'' which is issued monthly, and the ''Cumulative
List of Parts Affected,'' which appears in the Reader Aids section of
the daily Federal Register. These two lists will identify the Federal
Register page number of the latest amendment of any given rule.
EFFECTIVE AND EXPIRATION DATES
Each volume of the Code contains amendments published in the Federal
Register since the last revision of that volume of the Code. Source
citations for the regulations are referred to by volume number and page
number of the Federal Register and date of publication. Publication
dates and effective dates are usually not the same and care must be
exercised by the user in determining the actual effective date. In
instances where the effective date is beyond the cut-off date for the
Code a note has been inserted to reflect the future effective date. In
those instances where a regulation published in the Federal Register
states a date certain for expiration, an appropriate note will be
inserted following the text.
OMB CONTROL NUMBERS
The Paperwork Reduction Act of 1980 (Pub. L. 96-511) requires Federal
agencies to display an OMB control number with their information
collection request. Many agencies have begun publishing numerous OMB
control numbers as amendments to existing regulations in the CFR. These
OMB numbers are placed as close as possible to the applicable
recordkeeping or reporting requirements.
OBSOLETE PROVISIONS
Provisions that become obsolete before the revision date stated on
the cover of each volume are not carried. Code users may find the text
of provisions in effect on a given date in the past by using the
appropriate numerical list of sections affected. For the period before
January 1, 1986, consult either the List of CFR Sections Affected,
1949-1963, 1964-1972, or 1973-1985, published in seven separate volumes.
For the period beginning January 1, 1986, a ''List of CFR Sections
Affected'' is published at the end of each CFR volume.
INCORPORATION BY REFERENCE
What is incorporation by reference? Incorporation by reference was
established by statute and allows Federal agencies to meet the
requirement to publish regulations in the Federal Register by referring
to materials already published elsewhere. For an incorporation to be
valid, the Director of the Federal Register must approve it. The legal
effect of incorporation by reference is that the material is treated as
if it were published in full in the Federal Register (5 U.S.C. 552(a)).
This material, like any other properly issued regulation, has the force
of law.
What is a proper incorporation by reference? The Director of the
Federal Register will approve an incorporation by reference only when
the requirements of 1 CFR part 51 are met. Some of the elements on
which approval is based are:
(a) The incorporation will substantially reduce the volume of
material published in the Federal Register.
(b) The matter incorporated is in fact available to the extent
necessary to afford fairness and uniformity in the administrative
process.
(c) The incorporating document is drafted and submitted for
publication in accordance with 1 CFR part 51.
Properly approved incorporations by reference in this volume are
listed in the Finding Aids at the end of this volume.
What if the material incorporated by reference cannot be found? If
you have any problem locating or obtaining a copy of material listed in
the Finding Aids of this volume as an approved incorporation by
reference, please contact the agency that issued the regulation
containing that incorporation. If, after contacting the agency, you
find the material is not available, please notify the Director of the
Federal Register, National Archives and Records Administration,
Washington DC 20408, or call (202) 523-4534.
CFR INDEXES AND TABULAR GUIDES
A subject index to the Code of Federal Regulations is contained in a
separate volume, revised annually as of January 1, entitled CFR Index
and Finding Aids. This volume contains the Parallel Table of Statutory
Authorities and Agency Rules (Table I), and Acts Requiring Publication
in the Federal Register (Table II). A list of CFR titles, chapters, and
parts and an alphabetical list of agencies publishing in the CFR are
also included in this volume.
An index to the text of ''Title 3 -- The President'' is carried
within that volume.
The Federal Register Index is issued monthly in cumulative form.
This index is based on a consolidation of the ''Contents'' entries in
the daily Federal Register.
A List of CFR Sections Affected (LSA) is published monthly, keyed to
the revision dates of the 50 CFR titles.
REPUBLICATION OF MATERIAL
There are no restrictions on the republication of material appearing
in the Code of Federal Regulations.
INQUIRIES AND SALES
For a summary, legal interpretation, or other explanation of any
regulation in this volume, contact the issuing agency. Inquiries
concerning editing procedures and reference assistance with respect to
the Code of Federal Regulations may be addressed to the Director, Office
of the Federal Register, National Archives and Records Administration,
Washington, DC 20408 (telephone 202-523-3517). All mail order sales are
handled exclusively by the Superintendent of Documents, Attn: New
Orders, P.O. Box 371954, Pittsburgh, PA 15250-7954. Charge orders may
be telephoned to the Government Printing Office order desk at
202-783-3238.
Martha L. Girard,
Director,
Office of the Federal Register.
April 1, 1992.
21 CFR 169.182 THIS TITLE
Title 21 -- Food and Drugs is composed of nine volumes. The parts in
these volumes are arranged in the following order: Parts 1-99, 100-169,
170-199, 200-299, 300-499, 500-599, 600-799, 800-1299 and 1300-End. The
first eight volumes, containing parts 1-1299, comprise Chapter I -- Food
and Drug Administration, Department of Health and Human Services. The
ninth volume, containing part 1300 to End, includes Chapter II -- Drug
Enforcement Administration, Department of Justice. The contents of
these volumes represent all current regulations codified under this
title of the CFR as of April 1, 1992.
The Table of Exempted Prescription Products to part 1308 appears in
the volume containing part 1300-End.
Redesignation tables for Chapter I -- Food and Drug Administration
appear in the Finding Aids section for the volumes containing parts
170-199 and 500-599.
For this volume, Ann Worley was Chief Editor. The Code of Federal
Regulations publication program is under the direction of Richard L.
Claypoole, assisted by Alomha S. Morris.
21 CFR 0.0 21 CFR Ch. I (4-1-92 Edition)
21 CFR 0.0 Food and Drug Administration, HHS
21 CFR 0.0 Title 21 -- Food and Drugs
21 CFR 0.0 (This book contains parts 170 to 199)
Part
chapter i -- Food and Drug Administration, Department of Health and
Human Services (Continued) 170
Cross References: Food Safety and Inspection Service, Department of
Agriculture: See Meat and Poultry Inspection, 9 CFR chapter III.
Federal Trade Commission: See Commercial Practices, 16 CFR chapter
I.
United States Customs Service, Department of the Treasury: See
Customs Duties, 19 CFR chapter I.
Internal Revenue Service, Department of the Treasury: See Internal
Revenue, 26 CFR chapter I.
Bureau of Alcohol, Tobacco, and Firearms, Department of the Treasury:
See Alcohol, Tobacco Products and Firearms, 27 CFR chapter I.
21 CFR 0.0 21 CFR Ch. I (4-1-92 Edition)
21 CFR 0.0 Food and Drug Administration, HHS
21 CFR 0.0 CHAPTER I -- FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
21 CFR 0.0 (Parts 170 to 199)
Editorial Note: The Food and Drug Administration published a
document at 49 FR 41019, Oct. 19, 1984, establishing July 1, 1987, as a
uniform effective date for compliance for regulations affecting the
labeling of food products. At 51 FR 34085, Sept. 25, 1986, FDA
established January 1, 1989 as a new uniform effective date for
compliance. The new uniform effective date will apply only to final FDA
food labeling regulations published after July 1, 1986, and before
January 1, 1988. At 55 FR 276, Jan. 4, 1990, FDA established January
1, 1993 as a new uniform effective date for compliance. The new uniform
effective date will apply only to final FDA food labeling regulations
published after January 1, 1990 and before January 1, 1992.
21 CFR 0.0 SUBCHAPTER B -- FOOD FOR HUMAN CONSUMPTION (Con't.)
Part
Page
170 Food additives
171 Food additive petitions
172 Food additives permitted for direct addition to food for human
consumption
173 Secondary direct food additives permitted in food for human
consumption
174 Indirect food additives: General
175 Indirect food additives: Adhesives and components of coatings
176 Indirect food additives: Paper and paperboard components
177 Indirect food additives: Polymers
178 Indirect food additives: Adjuvants, production aids, and
sanitizers
179 Irradiation in the production, processing and handling of food
180 Food additives permitted in food on an interim basis or in
contact with food pending additional study
181 Prior-sanctioned food ingredients
182 Substances generally recognized as safe
184 Direct food substances affirmed as generally recognized as safe
186 Indirect food substances affirmed as generally recognized as safe
189 Substances prohibited from use in human food
197 Seafood inspection program
198-199 (Reserved)
21 CFR 0.0 21 CFR Ch. I (4-1-92 Edition)
21 CFR 0.0 Food and Drug Administration, HHS
21 CFR 0.0 SUBCHAPTER B -- FOOD FOR HUMAN CONSUMPTION
21 CFR 0.0 PART 170 -- FOOD ADDITIVES
21 CFR 0.0 Subpart A -- General Provisions
Sec.
170.3 Definitions.
170.6 Opinion letters on food additive status.
170.10 Food additives in standardized foods.
170.15 Adoption of regulation on initiative of Commissioner.
170.17 Exemption for investigational use and procedure for obtaining
authorization to market edible products from experimental animals.
170.18 Tolerances for related food additives.
170.19 Pesticide chemicals in processed foods.
21 CFR 0.0 Subpart B -- Food Additive Safety
170.20 General principles for evaluating the safety of food
additives.
170.22 Safety factors to be considered.
170.30 Eligibility for classification as generally recognized as safe
(GRAS).
170.35 Affirmation of generally recognized as safe (GRAS) status.
170.38 Determination of food additive status.
21 CFR 0.0 Subpart C -- Specific Administrative Rulings and Decisions
170.45 Fluorine-containing compounds.
170.50 Glycine (aminoacetic acid) in food for human consumption.
170.60 Nitrites and/or nitrates in curing premixes.
Authority: Secs. 201, 401, 402, 408, 409, 701 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321, 341, 342, 346a, 348, 371).
Source: 42 FR 14483, Mar. 15, 1977, unless otherwise noted.
21 CFR 0.0 Subpart A -- General Provisions
21 CFR 170.3 Definitions.
For the purposes of this subchapter, the following definitions apply:
(a) Secretary means the Secretary of Health and Human Services.
(b) Department means the Department of Health and Human Services.
(c) Commissioner means the Commissioner of Food and Drugs.
(d) As used in this part, the term act means the Federal Food, Drug,
and Cosmetic Act approved June 25, 1936, 52 Stat. 1040 et seq. , as
amended (21 U.S.C. 301-392).
(e) Food additives includes all substances not exempted by section
201(s) of the act, the intended use of which results or may reasonably
be expected to result, directly or indirectly, either in their becoming
a component of food or otherwise affecting the characteristics of food.
A material used in the production of containers and packages is subject
to the definition if it may reasonably be expected to become a
component, or to affect the characteristics, directly or indirectly, of
food packed in the container. ''Affecting the characteristics of food''
does not include such physical effects, as protecting contents of
packages, preserving shape, and preventing moisture loss. If there is
no migration of a packaging component from the package to the food, it
does not become a component of the food and thus is not a food additive.
A substance that does not become a component of food, but that is used,
for example, in preparing an ingredient of the food to give a different
flavor, texture, or other characteristic in the food, may be a food
additive.
(f) Common use in food means a substantial history of consumption of
a substance for food use by a significant number of consumers.
(g) The word substance in the definition of the term ''food
additive'' includes a food or food component consisting of one or more
ingredients.
(h) Scientific procedures include those human, animal, analytical,
and other scientific studies, whether published or unpublished,
appropriate to establish the safety of a substance.
(i) Safe or safety means that there is a reasonable certainty in the
minds of competent scientists that the substance is not harmful under
the intended conditions of use. It is impossible in the present state
of scientific knowledge to establish with complete certainty the
absolute harmlessness of the use of any substance. Safety may be
determined by scientific procedures or by general recognition of safety.
In determining safety, the following factors shall be considered:
(1) The probable consumption of the substance and of any substance
formed in or on food because of its use.
(2) The cumulative effect of the substance in the diet, taking into
account any chemically or pharmacologically related substance or
substances in such diet.
(3) Safety factors which, in the opinion of experts qualified by
scientific training and experience to evaluate the safety of food and
food ingredients, are generally recognized as appropriate.
(j) The term nonperishable processed food means any processed food
not subject to rapid decay or deterioration that would render it unfit
for consumption. Examples are flour, sugar, cereals, packaged cookies,
and crackers. Not included are hermetically sealed foods or
manufactured dairy products and other processed foods requiring
refrigeration.
(k) General recognition of safety shall be determined in accordance
with 170.30.
(l) Prior sanction means an explicit approval granted with respect to
use of a substance in food prior to September 6, 1958, by the Food and
Drug Administration or the United States Department of Agriculture
pursuant to the Federal Food, Drug, and Cosmetic Act, the Poultry
Products Inspection Act, or the Meat Inspection Act.
(m) Food includes human food, substances migrating to food from
food-contact articles, pet food, and animal feed.
(n) The following general food categories are established to group
specific related foods together for the purpose of establishing
tolerances or limitations for the use of direct human food ingredients.
Individual food products will be included within these categories
according to the detailed classifications lists contained in Exhibit 33B
of the report of the National Academy of Sciences/National Research
Council report, ''A Comprehensive Survey of Industry on the Use of Food
Chemicals Generally Recognized as Safe'' (September 1972), which is
incorporated by reference. Copies are available from the National
Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield,
VA 22161, or available for inspection at the Office of the Federal
Register, 1100 L St. NW., Washington, DC 20408:
(1) Baked goods and baking mixes, including all ready-to-eat and
ready-to-bake products, flours, and mixes requiring preparation before
serving.
(2) Beverages, alcoholic, including malt beverages, wines, distilled
liquors, and cocktail mix.
(3) Beverages and beverage bases, nonalcoholic, including only
special or spiced teas, soft drinks, coffee substitutes, and fruit and
vegetable flavored gelatin drinks.
(4) Breakfast cereals, including ready-to-eat and instant and regular
hot cereals.
(5) Cheeses, including curd and whey cheeses, cream, natural,
grating, processed, spread, dip, and miscellaneous cheeses.
(6) Chewing gum, including all forms.
(7) Coffee and tea, including regular, decaffeinated, and instant
types.
(8) Condiments and relishes, including plain seasoning sauces and
spreads, olives, pickles, and relishes, but not spices or herbs.
(9) Confections and frostings, including candy and flavored
frostings, marshmallows, baking chocolate, and brown, lump, rock, maple,
powdered, and raw sugars.
(10) Dairy product analogs, including nondairy milk, frozen or liquid
creamers, coffee whiteners, toppings, and other nondairy products.
(11) Egg products, including liquid, frozen, or dried eggs, and egg
dishes made therefrom, i.e., egg roll, egg foo young, egg salad, and
frozen multicourse egg meals, but not fresh eggs.
(12) Fats and oils, including margarine, dressings for salads,
butter, salad oils, shortenings and cooking oils.
(13) Fish products, including all prepared main dishes, salads,
appetizers, frozen multicourse meals, and spreads containing fish,
shellfish, and other aquatic animals, but not fresh fish.
(14) Fresh eggs, including cooked eggs and egg dishes made only from
fresh shell eggs.
(15) Fresh fish, including only fresh and frozen fish, shellfish, and
other aquatic animals.
(16) Fresh fruits and fruit juices, including only raw fruits,
citrus, melons, and berries, and home-prepared ''ades'' and punches made
therefrom.
(17) Fresh meats, including only fresh or home-frozen beef or veal,
pork, lamb or mutton and home-prepared fresh meat-containing dishes,
salads, appetizers, or sandwich spreads made therefrom.
(18) Fresh poultry, including only fresh or home-frozen poultry and
game birds and home-prepared fresh poultry-containing dishes, salads,
appetizers, or sandwich spreads made therefrom.
(19) Fresh vegetables, tomatoes, and potatoes, including only fresh
and home-prepared vegetables.
(20) Frozen dairy desserts and mixes, including ice cream, ice milks,
sherbets, and other frozen dairy desserts and specialties.
(21) Fruit and water ices, including all frozen fruit and water ices.
(22) Gelatins, puddings, and fillings, including flavored gelatin
desserts, puddings, custards, parfaits, pie fillings, and gelatin base
salads.
(23) Grain products and pastas, including macaroni and noodle
products, rice dishes, and frozen multicourse meals, without meat or
vegetables.
(24) Gravies and sauces, including all meat sauces and gravies, and
tomato, milk, buttery, and specialty sauces.
(25) Hard candy and cough drops, including all hard type candies.
(26) Herbs, seeds, spices, seasonings, blends, extracts, and
flavorings, including all natural and artificial spices, blends, and
flavors.
(27) Jams and jellies, home-prepared, including only home-prepared
jams, jellies, fruit butters, preserves, and sweet spreads.
(28) Jams and jellies, commercial, including only commercially
processed jams, jellies, fruit butters, preserves, and sweet spreads.
(29) Meat products, including all meats and meat containing dishes,
salads, appetizers, frozen multicourse meat meals, and sandwich
ingredients prepared by commercial processing or using commercially
processed meats with home preparation.
(30) Milk, whole and skim, including only whole, lowfat, and skim
fluid milks.
(31) Milk products, including flavored milks and milk drinks, dry
milks, toppings, snack dips, spreads, weight control milk beverages, and
other milk origin products.
(32) Nuts and nut products, including whole or shelled tree nuts,
peanuts, coconut, and nut and peanut spreads.
(33) Plant protein products, including the National Academy of
Sciences/National Research Council ''reconstituted vegetable protein''
category, and meat, poultry, and fish substitutes, analogs, and extender
products made from plant proteins.
(34) Poultry products, including all poultry and poultry-containing
dishes, salads, appetizers, frozen multicourse poultry meals, and
sandwich ingredients prepared by commercial processing or using
commercially processed poultry with home preparation.
(35) Processed fruits and fruit juices, including all commercially
processed fruits, citrus, berries, and mixtures; salads, juices and
juice punches, concentrates, dilutions, ''ades'', and drink substitutes
made therefrom.
(36) Processed vegetables and vegetable juices, including all
commercially processed vegetables, vegetable dishes, frozen multicourse
vegetable meals, and vegetable juices and blends.
(37) Snack foods, including chips, pretzels, and other novelty
snacks.
(38) Soft candy, including candy bars, chocolates, fudge, mints, and
other chewy or nougat candies.
(39) Soups, home-prepared, including meat, fish, poultry, vegetable,
and combination home-prepared soups.
(40) Soups and soup mixes, including commercially prepared meat,
fish, poultry, vegetable, and combination soups and soup mixes.
(41) Sugar, white, granulated, including only white granulated sugar.
(42) Sugar substitutes, including granulated, liquid, and tablet
sugar substitutes.
(43) Sweet sauces, toppings, and syrups, including chocolate, berry,
fruit, corn syrup, and maple sweet sauces and toppings.
(o) The following terms describe the physical or technical functional
effects for which direct human food ingredients may be added to foods.
They are adopted from the National Academy of Sciences/National Research
Council national survey of food industries, reported to the Food and
Drug Administration under the contract title ''A Comprehensive Survey of
Industry on the Use of Food Chemicals Generally Recognized as Safe''
(September 1972), which is incorporated by reference. Copies are
available from the National Technical Information Service (NTIS), 5285
Port Royal Rd., Springfield, VA 22161, or available for inspection at
the Office of the Federal Register, 1100 L St., NW., Washington, DC
20408:
(1) ''Anticaking agents and free-flow agents'': Substances added to
finely powdered or crystalline food products to prevent caking, lumping,
or agglomeration.
(2) ''Antimicrobial agents'': Substances used to preserve food by
preventing growth of microorganisms and subsequent spoilage, including
fungistats, mold and rope inhibitors, and the effects listed by the
National Academy of Sciences/National Research Council under
''preservatives.''
(3) ''Antioxidants'': Substances used to preserve food by retarding
deterioration, rancidity, or discoloration due to oxidation.
(4) ''Colors and coloring adjuncts'': Substances used to impart,
preserve, or enhance the color or shading of a food, including color
stabilizers, color fixatives, color-retention agents, etc.
(5) ''Curing and pickling agents'': Substances imparting a unique
flavor and/or color to a food, usually producing an increase in shelf
life stability.
(6) ''Dough strengtheners'': Substances used to modify starch and
gluten, thereby producing a more stable dough, including the applicable
effects listed by the National Academy of Sciences/National Research
Council under ''dough conditioner.''
(7) ''Drying agents'': Substances with moisture-absorbing ability,
used to maintain an environment of low moisture.
(8) ''Emulsifiers and emulsifier salts'': Substances which modify
surface tension in the component phase of an emulsion to establish a
uniform dispersion or emulsion.
(9) ''Enzymes'': Enzymes used to improve food processing and the
quality of the finished food.
(10) ''Firming agents'': Substances added to precipitate residual
pectin, thus strengthening the supporting tissue and preventing its
collapse during processing.
(11) ''Flavor enhancers'': Substances added to supplement, enhance,
or modify the original taste and/or aroma of a food, without imparting a
characteristic taste or aroma of its own.
(12) ''Flavoring agents and adjuvants'': Substances added to impart
or help impart a taste or aroma in food.
(13) ''Flour treating agents'': Substances added to milled flour, at
the mill, to improve its color and/or baking qualities, including
bleaching and maturing agents.
(14) ''Formulation aids'': Substances used to promote or produce a
desired physical state or texture in food, including carriers, binders,
fillers, plasticizers, film-formers, and tableting aids, etc.
(15) ''Fumigants'': Volatile substances used for controlling insects
or pests.
(16) ''Humectants'': Hygroscopic substances incorporated in food to
promote retention of moisture, including moisture-retention agents and
antidusting agents.
(17) ''Leavening agents'': Substances used to produce or stimulate
production of carbon dioxide in baked goods to impart a light texture,
including yeast, yeast foods, and calcium salts listed by the National
Academy of Sciences/National Research Council under ''dough
conditioners.''
(18) ''Lubricants and release agents'': Substances added to food
contact surfaces to prevent ingredients and finished products from
sticking to them.
(19) ''Non-nutritive sweeteners'': Substances having less than 2
percent of the caloric value of sucrose per equivalent unit of
sweetening capacity.
(20) ''Nutrient supplements'': Substances which are necessary for
the body's nutritional and metabolic processes.
(21) ''Nutritive sweeteners'': Substances having greater than 2
percent of the caloric value of sucrose per equivalent unit of
sweetening capacity.
(22) ''Oxidizing and reducing agents'': Substances which chemically
oxidize or reduce another food ingredient, thereby producing a more
stable product, including the applicable effect listed by the National
Academy of Sciences/National Research Council under ''dough
conditioners.''
(23) ''pH control agents'': Substances added to change or maintain
active acidity or basicity, including buffers, acids, alkalies, and
neutralizing agents.
(24) ''Processing aids'': Substances used as manufacturing aids to
enhance the appeal or utility of a food or food component, including
clarifying agents, clouding agents, catalysts, flocculents, filter aids,
and crystallization inhibitors, etc.
(25) ''Propellants, aerating agents, and gases'': Gases used to
supply force to expel a product or used to reduce the amount of oxygen
in contact with the food in packaging.
(26) ''Sequestrants'': Substances which combine with polyvalent
metal ions to form a soluble metal complex, to improve the quality and
stability of products.
(27) ''Solvents and vehicles'': Substances used to extract or
dissolve another substance.
(28) ''Stabilizers and thickeners'': Substances used to produce
viscous solutions or dispersions, to impart body, improve consistency,
or stabilize emulsions, including suspending and bodying agents, setting
agents, jellying agents, and bulking agents, etc.
(29) ''Surface-active agents'': Substances used to modify surface
properties of liquid food components for a variety of effects, other
than emulsifiers, but including solubilizing agents, dispersants,
detergents, wetting agents, rehydration enhancers, whipping agents,
foaming agents, and defoaming agents, etc.
(30) ''Surface-finishing agents'': Substances used to increase
palatability, preserve gloss, and inhibit discoloration of foods,
including glazes, polishes, waxes, and protective coatings.
(31) ''Synergists'': Substances used to act or react with another
food ingredient to produce a total effect different or greater than the
sum of the effects produced by the individual ingredients.
(32) ''Texturizers'': Substances which affect the appearance or feel
of the food.
(42 FR 14483, Mar. 15, 1977, as amended at 47 FR 11835, Mar. 19,
1982; 53 FR 16546, May 10, 1988; 54 FR 24896, June 12, 1989)
21 CFR 170.6 Opinion letters on food additive status.
(a) Over the years the Food and Drug Administration has given
informal written opinions to inquiries as to the safety of articles
intended for use as components of, or in contact with, food. Prior to
the enactment of the Food Additives Amendment of 1958 (Pub. L. 85-929;
Sept. 6, 1958), these opinions were given pursuant to section 402(a)(1)
of the Federal Food, Drug, and Cosmetic Act, which reads in part: ''A
food shall be deemed to be adulterated if it bears or contains any
poisonous or deleterious substance which may render it injurious to
health''.
(b) Since enactment of the Food Additives Amendment, the Food and
Drug Administration has advised such inquirers that an article:
(1) Is a food additive within the meaning of section 201(s) of the
act; or
(2) Is generally recognized as safe (GRAS); or
(3) Has prior sanction or approval under that amendment; or
(4) Is not a food additive under the conditions of intended use.
(c) In the interest of the public health, such articles which have
been considered in the past by the Food and Drug Administration to be
safe under the provisions of section 402(a)(1), or to be generally
recognized as safe for their intended use, or to have prior sanction or
approval, or not to be food additives under the conditions of intended
use, must be reexamined in the light of current scientific information
and current principles for evaluating the safety of food additives if
their use is to be continued.
(d) Because of the time span involved, copies of many of the letters
in which the Food and Drug Administration has expressed an informal
opinion concerning the status of such articles may no longer be in the
file of the Food and Drug Administration. In the absence of information
concerning the names and uses made of all the articles referred to in
such letters, their safety of use cannot be reexamined. For this reason
all food additive status opinions of the kind described in paragraph (c)
of this section given by the Food and Drug Administration are hereby
revoked.
(e) The prior opinions of the kind described in paragraph (c) of this
section will be replaced by qualified and current opinions if the
recipient of each such letter forwards a copy of each to the Department
of Health and Human Services, Food and Drug Administration, Center for
Food Safety and Applied Nutrition, 200 C Street SW., Washington, DC
20204, along with a copy of his letter of inquiry, on or before July 23,
1970.
(f) This section does not apply to food additive status opinion
letters pertaining to articles that were considered by the Food and Drug
Administration to be food additives nor to articles included in
regulations in parts 170 through 189 of this chapter if the articles are
used in accordance with the requirements of such regulations.
(42 FR 14483, Mar. 15, 1977, as amended at 54 FR 24896, June 12,
1989)
21 CFR 170.10 Food additives in standardized foods.
(a) The inclusion of food ingredients in parts 170 through 189 of
this chapter does not imply that these ingredients may be used in
standardized foods unless they are recognized as optional ingredients in
applicable food standards. Where a petition is received for the
issuance or amendment of a regulation establishing a definition and
standard of identity for a food under section 401 of the Act, which
proposes the inclusion of a food additive in such definition and
standard of identity, the provisions of the regulations in this part
shall apply with respect to the information that must be submitted with
respect to the food additive. Since section 409(b)(5) of the Act
requires that the Secretary publish notice of a petition for the
establishment of a food-additive regulation within 30 days after filing,
notice of a petition relating to a definition and standard of identity
shall also be published within that time limitation if it includes a
request, so designated, for the establishment of a regulation pertaining
to a food additive.
(b) If a petition for a definition and standard of identity contains
a proposal for a food-additive regulation, and the petitioner fails to
designate it as such, the Commissioner, upon determining that the
petition includes a proposal for a food-additive regulation, shall so
notify the petitioner and shall thereafter proceed in accordance with
the regulations in this part.
(c) A regulation will not be issued allowing the use of a food
additive in a food for which a definition and standard of identity is
established, unless its issuance is in conformity with section 401 of
the Act or with the terms of a temporary permit issued under 130.17 of
this chapter. When the contemplated use of such additive complies with
the terms of a temporary permit, the food additive regulation will be
conditioned on such compliance and will expire with the expiration of
the temporary permit.
21 CFR 170.15 Adoption of regulation on initiative of Commissioner.
(a) The Commissioner upon his own initiative may propose the issuance
of a regulation prescribing, with respect to any particular use of a
food additive, the conditions under which such additive may be safely
used. Notice of such proposal shall be published in the Federal
Register and shall state the reasons for the proposal.
(b) Action upon a proposal made by the Commissioner shall proceed as
provided in part 10 of this chapter.
(42 FR 14486, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22,
1977)
21 CFR 170.17 Exemption for investigational use and procedure for
obtaining authorization to market edible products from experimental
animals.
A food additive or food containing a food additive intended for
investigational use by qualified experts shall be exempt from the
requirements of section 409 of the Act under the following conditions:
(a) If intended for investigational use in vitro or in laboratory
research animals, it bears a label which states prominently, in addition
to the other information required by the act, the warning:
Caution. Contains a new food additive for investigational use only in
laboratory research animals or for tests in vitro. Not for use in
humans.
(b) If intended for use in animals other than laboratory research
animals and if the edible products of the animals are to be marketed as
food, permission for the marketing of the edible products as food has
been requested by the sponsor, and authorization has been granted by the
Food and Drug Administration in accordance with 511.1 of this chapter
or by the Department of Agriculture in accordance with 9 CFR 309.17, and
it bears a label which states prominently, in addition to the other
information required by the Act, the warning:
Caution. Contains a new food additive for use only in investigational
animals. Not for use in humans.
Edible products of investigational animals are not to be used for
food unless authorization has been granted by the U.S. Food and Drug
Administration or by the U.S. Department of Agriculture.
(c) If intended for nonclinical laboratory studies in food-producing
animals, the study is conducted in compliance with the regulations set
forth in part 58 of this chapter.
(42 FR 14483, Mar. 15, 1977, as amended at 43 FR 60021, Dec. 22,
1978)
21 CFR 170.18 Tolerances for related food additives.
(a) Food additives that cause similar or related pharmacological
effects will be regarded as a class, and in the absence of evidence to
the contrary, as having additive toxic effects and will be considered as
related food additives.
(b) Tolerances established for such related food additives may limit
the amount of a common component that may be present, or may limit the
amount of biological activity (such as cholinesterase inhibition) that
may be present or may limit the total amount of related food additives
that may be present.
(c) Where food additives from two or more chemicals in the same class
are present in or on a food, the tolerance for the total of such
additives shall be the same as that for the additive having the lowest
numerical tolerance in this class, unless there are available methods
that permit quantitative determination of the amount of each food
additive present or unless it is shown that a higher tolerance is
reasonably required for the combined additives to accomplish the
physical or technical effect for which such combined additives are
intended and that the higher tolerance will be safe.
(d) Where residues from two or more additives in the same class are
present in or on a food and there are available methods that permit
quantitative determination of each residue, the quantity of combined
residues that are within the tolerance may be determined as follows:
(1) Determine the quantity of each residue present.
(2) Divide the quantity of each residue by the tolerance that would
apply if it occurred alone, and multiply by 100 to determine the
percentage of the permitted amount of residue present.
(3) Add the percentages so obtained for all residues present.
(4) The sum of the percentage shall not exceed 100 percent.
21 CFR 170.19 Pesticide chemicals in processed foods.
When pesticide chemical residues occur in processed foods due to the
use of raw agricultural commodities that bore or contained a pesticide
chemical in conformity with an exemption granted or a tolerance
prescribed under section 408 of the Act, the processed food will not be
regarded as adulterated so long as good manufacturing practice has been
followed in removing any residue from the raw agricultural commodity in
the processing (such as by peeling or washing) and so long as the
concentration of the residue in the processed food when ready to eat is
not greater than the tolerance prescribed for the raw agricultural
commodity. But when the concentration of residue in the processed food
when ready to eat is higher than the tolerance prescribed for the raw
agricultural commodity, the processed food is adulterated unless the
higher concentration is permitted by a tolerance obtained under section
409 of the Act. For example, if fruit bearing a residue of 7 parts per
million of DDT permitted on the raw agricultural commodity is dried and
a residue in excess of 7 parts per million of DDT results on the dried
fruit, the dehydrated fruit is adulterated unless the higher tolerance
for DDT is authorized by the regulations in this part. Food that is
itself ready to eat, and which contains a higher residue than allowed
for the raw agricultural commodity, may not be legalized by blending or
mixing with other foods to reduce the residue in the mixed food below
the tolerance prescribed for the raw agricultural commodity.
21 CFR 170.19 Subpart B -- Food Additive Safety
21 CFR 170.20 General principles for evaluating the safety of food
additives.
(a) In reaching a decision on any petition filed under section 409 of
the Act, the Commissioner will give full consideration to the specific
biological properties of the compound and the adequacy of the methods
employed to demonstrate safety for the proposed use, and the
Commissioner will be guided by the principles and procedures for
establishing the safety of food additives stated in current publications
of the National Academy of Sciences-National Research Council. A
petition will not be denied, however, by reason of the petitioner's
having followed procedures other than those outlined in the publications
of the National Academy of Sciences-National Research Council if, from
available evidence, the Commissioner finds that the procedures used give
results as reliable as, or more reliable than, those reasonably to be
expected from the use of the outlined procedures. In reaching a
decision, the Commissioner will give due weight to the anticipated
levels and patterns of consumption of the additive specified or
reasonably inferrable. For the purposes of this section, the principles
for evaluating safety of additives set forth in the abovementioned
publications will apply to any substance that may properly be classified
as a food additive as defined in section 201(s) of the Act.
(b) Upon written request describing the proposed use of an additive
and the proposed experiments to determine its safety, the Commissioner
will advise a person who wishes to establish the safety of a food
additive whether he believes the experiments planned will yield data
adequate for an evaluation of the safety of the additive.
21 CFR 170.22 Safety factors to be considered.
In accordance with section 409(c)(5)(C) of the Act, the following
safety factors will be applied in determining whether the proposed use
of a food additive will be safe: Except where evidence is submitted
which justifies use of a different safety factor, a safety factor in
applying animal experimentation data to man of 100 to 1, will be used;
that is, a food additive for use by man will not be granted a tolerance
that will exceed 1/100th of the maximum amount demonstrated to be
without harm to experimental animals.
21 CFR 170.30 Eligibility for classification as generally recognized as
safe (GRAS).
(a) General recognition of safety may be based only on the views of
experts qualified by scientific training and experience to evaluate the
safety of substances directly or indirectly added to food. The basis of
such views may be either (1) scientific procedures or (2) in the case of
a substance used in food prior to January 1, 1958, through experience
based on common use in food. General recognition of safety requires
common knowledge about the substance throughout the scientific community
knowledgeable about the safety of substances directly or indirectly
added to food.
(b) General recognition of safety based upon scientific procedures
shall require the same quantity and quality of scientific evidence as is
required to obtain approval of a food additive regulation for the
ingredient. General recognition of safety through scientific procedures
shall ordinarily be based upon published studies which may be
corroborated by unpublished studies and other data and information.
(c)(1) General recognition of safety through experience based on
common use in food prior to January 1, 1958, may be determined without
the quantity or quality of scientific procedures required for approval
of a food additive regulation. General recognition of safety through
experience based on common use in food prior to January 1, 1958, shall
be based solely on food use of the substance prior to January 1, 1958,
and shall ordinarily be based upon generally available data and
information. An ingredient not in common use in food prior to January
1, 1958, may achieve general recognition of safety only through
scientific procedures.
(2) A substance used in food prior to January 1, 1958, may be
generally recognized as safe through experience based on its common use
in food when that use occurred exclusively or primarily outside of the
United States if the information about the experience establishes that
the use of the substance is safe within the meaning of the act (see
170.3(i)). Common use in food prior to January 1, 1958, that occurred
outside of the United States shall be documented by published or other
information and shall be corroborated by information from a second,
independent source that confirms the history and circumstances of use of
the substance. The information used to document and to corroborate the
history and circumstances of use of the substance must be generally
available; that is, it must be widely available in the country in which
the history of use has occurred and readily available to interested
qualified experts in this country. Persons claiming GRAS status for a
substance based on its common use in food outside of the United States
should obtain FDA concurrence that the use of the substance is GRAS.
(d) The food ingredients listed as GRAS in part 182 of this chapter
or affirmed as GRAS in part 184 or 186.1 of this chapter do not include
all substances that are generally recognized as safe for their intended
use in food. Because of the large number of substances the intended use
of which results or may reasonably be expected to result, directly or
indirectly, in their becoming a component or otherwise affecting the
characteristics of food, it is impracticable to list all such substances
that are GRAS. A food ingredient of natural biological origin that has
been widely consumed for its nutrient properties in the United States
prior to January 1, 1958, without known detrimental effects, which is
subject only to conventional processing as practiced prior to January 1,
1958, and for which no known safety hazard exists, will ordinarily be
regarded as GRAS without specific inclusion in part 182, part 184 or
186.1 of this chapter.
(e) Food ingredients were listed as GRAS in part 182 of this chapter
during 1958-1962 without a detailed scientific review of all available
data and information relating to their safety. Beginning in 1969, the
Food and Drug Administration has undertaken a systematic review of the
status of all ingredients used in food on the determination that they
are GRAS or subject to a prior sanction. All determinations of GRAS
status or food additive status or prior sanction status pursuant to this
review shall be handled pursuant to 170.35, 170.38, and 180.1 of this
chapter. Affirmation of GRAS status shall be announced in part 184 or
186.1 of this chapter.
(f) The status of the following food ingredients will be reviewed and
affirmed as GRAS or determined to be a food additive or subject to a
prior sanction pursuant to 170.35, 170.38, or 180.1 of this chapter:
(1) Any substance of natural biological origin that has been widely
consumed for its nutrient properties in the United States prior to
January 1, 1958, without known detrimental effect, for which no health
hazard is known, and which has been modified by processes first
introduced into commercial use after January 1, 1958, which may
reasonably be expected significantly to alter the composition of the
substance.
(2) Any substance of natural biological origin that has been widely
consumed for its nutrient properties in the United States prior to
January 1, 1958, without known detrimental effect, for which no health
hazard is known, that has had significant alteration of composition by
breeding or selection after January 1, 1958, where the change may be
reasonably expected to alter the nutritive value or the concentration of
toxic constituents.
(3) Distillates, isolates, extracts, and concentration of extracts of
GRAS substances.
(4) Reaction products of GRAS substances.
(5) Substances not of a natural biological origin, including those
for which evidence is offered that they are identical to a GRAS
counterpart of natural biological origin.
(6) Substances of natural biological origin intended for consumption
for other than their nutrient properties.
(g) A food ingredient that is not GRAS or subject to a prior sanction
requires a food additive regulation promulgated under section 409 of the
act before it may be directly or indirectly added to food.
(h) A food ingredient that is listed as GRAS in part 182 of this
chapter or affirmed as GRAS in part 184 or 186.1 of this chapter shall
be regarded as GRAS only if, in addition to all the requirements in the
applicable regulation, it also meets all of the following requirements:
(1) It complies with any applicable food grade specifications of the
Food Chemicals Codex, 2d Ed. (1972), or, if specifically indicated in
the GRAS affirmation regulation, the Food Chemicals Codex, 3d Ed.
(1981), which are incorporated by reference, except that any substance
used as a component of articles that contact food and affirmed as GRAS
in 186.1 of this chapter shall comply with the specifications therein,
or in the absence of such specifications, shall be of a purity suitable
for its intended use. Copies may be obtained from the National Academy
Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be
examined at the Office of the Federal Register, 1100 L St. NW.,
Washington, DC 20408.
(2) It performs an appropriate function in the food or food-contact
article in which it is used.
(3) It is used at a level no higher than necessary to achieve its
intended purpose in that food or, if used as a component of a
food-contact article, at a level no higher than necessary to achieve its
intended purpose in that article.
(i) If a substance is affirmed as GRAS in part 184 or 186.1 of this
chapter with no limitation other than good manufacturing practice, it
shall be regarded as GRAS if its conditions of use are not significantly
different from those reported in the regulation as the basis on which
the GRAS status of the substance was affirmed. If the conditions of use
are significantly different, such use of the substance may not be GRAS.
In such a case a manufacturer may not rely on the regulation as
authorizing the use but must independently establish that the use is
GRAS or must use the substance in accordance with a food additive
regulation.
(j) If an ingredient is affirmed as GRAS in part 184 or 186.1 of
this chapter with specific limitation(s), it may be used in food only
within such limitation(s) (including the category of food(s), the
functional use(s) of the ingredient, and the level(s) of use). Any use
of such an ingredient not in full compliance with each such established
limitation shall require a food additive regulation.
(k) Pursuant to 170.35, a food ingredient may be affirmed as GRAS in
part 184 or 186.1 of this chapter for a specific use(s) without a
general evaluation of use of the ingredient. In addition to the use(s)
specified in the regulation, other uses of such an ingredient may also
be GRAS. Any affirmation of GRAS status for a specific use(s), without
a general evaluation of use of the ingredient, is subject to
reconsideration upon such evaluation.
(l) New information may at any time require reconsideration of the
GRAS status of a food ingredient. Any change in part 182, part 184, or
186.1 of this chapter shall be accomplished pursuant to 170.38.
(42 FR 14483, Mar. 15, 1977, as amended at 49 FR 5610, Feb. 14, 1984;
53 FR 16546, May 10, 1988)
21 CFR 170.35 Affirmation of generally recognized as safe (GRAS)
status.
(a) The Commissioner, either on his initiative or on the petition of
an interested person, may affirm the GRAS status of substances that
directly or indirectly become components of food.
(b)(1) If the Commissioner proposes on his own initiative that a
substance is entitled to affirmation as GRAS, he will place all of the
data and information on which he relies on public file in the office of
the Dockets Management Branch and will publish in the Federal Register a
notice giving the name of the substance, its proposed uses, and any
limitations proposed for purposes other than safety.
(2) The Federal Register notice will allow a period of 60 days during
which any interested person may review the data and information and/or
file comments with the Dockets Management Branch. Copies of all
comments received shall be made available for examination in the Dockets
Management Branch's office.
(3) The Commissioner will evaluate all comments received. If he
concludes that there is convincing evidence that the substance is GRAS
as described in 170.30, he will publish a notice in the Federal
Register listing the substance as GRAS in part 182, part 184, or part
186 of this chapter, as appropriate.
(4) If, after evaluation of the comments, the Commissioner concludes
that there is a lack of convincing evidence that the substance is GRAS
and that it should be considered a food additive subject to section 409
of the Act, he shall publish a notice thereof in the Federal Register in
accordance with 170.38.
(c)(1) Persons seeking the affirmation of GRAS status of substances
as provided in 170.30(e), except those subject to the NAS/NRC GRAS list
survey (36 FR 20546; October 23, 1971), shall submit a petition for
GRAS affirmation pursuant to part 10 of this chapter. Such petition
shall contain information to establish that the GRAS criteria as set
forth in 170.30 (b) or (c) have been met, in the following form:
(i) Description of the substance, including:
(a) Common or usual name.
(b) Chemical name.
(c) Chemical Abstract Service (CAS) registry number.
(d) Empirical formula.
(e) Structural formula.
(f) Specifications for food grade material, including arsenic and
heavy metals. (Recommendation for any change in the Food Chemicals
Codex monograph should be included where applicable.)
(g) Quantitative compositions.
(h) Manufacturing process (excluding any trade secrets).
(ii) Use of the substance, including:
(a) Date when use began.
(b) Information and reports or other data on past uses in food.
(c) Foods in which used, and levels of use in such foods, and for
what purposes.
(iii) Methods for detecting the substance in food, including:
(a) References to qualitative and quantitative methods for
determining the substance(s) in food, including the type of analytical
procedures used.
(b) Sensitivity and reproducibility of such method(s).
(iv) Information to establish the safety and functionality of the
substance in food. Published scientific literature, evidence that the
substance is identical to a GRAS counterpart of natural biological
origin, and other data may be submitted to support safety. Any adverse
information or consumer complaints shall be included. Complete
bibliographic references shall be provided where a copy of the article
is not provided.
(v) A statement signed by the person responsible for the petition
that to the best of his knowledge it is a representative and balanced
submission that includes unfavorable information, as well as favorable
information, known to him pertinent to the evaluation of the safety and
functionality of the substance.
(vi) If nonclinical laboratory studies are involved, additional
information and data submitted in support of filed petitions shall
include, with respect to each nonclinical study, either a statement that
the study was conducted in compliance with the requirements set forth in
part 58 of this chapter, or, if the study was not conducted in
compliance with such regulations, a brief statement of the reason for
the noncompliance.
(vii) (Reserved)
(viii) A claim for categorical exclusion under 25.24 of this chapter
or an environmental assessment under 25.31 of this chapter.
(2) Within 30 days after the date of filing the petition, the
Commissioner will place the petition on public file in the office of the
Dockets Management Branch and will publish a notice of filing in the
Federal Register giving the name of the petitioner and a brief
description of the petition including the name of the substance, its
proposed use, and any limitations proposed for reasons other than
safety. A copy of the notice will be mailed to the petitioner at the
time the original is sent to the Federal Register.
(3) The notice of filing in the Federal Register will allow a period
of 60 days during which any interested person may review the petition
and/or file comments with the Dockets Management Branch. Copies of all
comments received shall be made available for examination in the Dockets
Management Branch's office.
(4) The Commissioner will evaluate the petition and all available
information including all comments received. If the petition and such
information provide convincing evidence that the substance is GRAS as
described in 170.30 he will publish an order in the Federal Register
listing the substance as GRAS in part 182, part 184, or part 186 of this
chapter, as appropriate.
(5) If, after evaluation of the petition and all available
information, the Commissioner concludes that there is a lack of
convincing evidence that the substance is GRAS and that it should be
considered a food additive subject to section 409 of the Act, he shall
publish a notice thereof in the Federal Register in accordance with
170.38.
(6) The notice of filing in the Federal Register will request
submission of proof of any applicable prior sanction for use of the
ingredient under conditions different from those proposed to be
determined to be GRAS. The failure of any person to come forward with
proof of such an applicable prior sanction in response to the notice of
filing will constitute a waiver of the right to assert or rely on such
sanction at any later time. The notice of filing will also constitute a
proposal to establish a regulation under part 181 of this chapter,
incorporating the same provisions, in the event that such a regulation
is determined to be appropriate as a result of submission of proof of
such an applicable prior sanction in response to the notice of filing.
(Information collection requirements were approved by the Office of
Management and Budget under control number 0910-0132)
(42 FR 14488, Mar. 15, 1977, as amended at 50 FR 7492, Feb. 22, 1985;
50 FR 16668, Apr. 26, 1985; 53 FR 16547, May 10, 1988)
21 CFR 170.38 Determination of food additive status.
(a) The Commissioner may, in accordance with 170.35(b)(4) or (c)(5),
publish a notice in the Federal Register determining that a substance is
not GRAS and is a food additive subject to section 409 of the Act.
(b)(1) The Commissioner, on his own initiative or on the petition of
any interested person, pursuant to part 10 of this chapter, may issue a
notice in the Federal Register proposing to determine that a substance
is not GRAS and is a food additive subject to section 409 of the Act.
Any petition shall include all relevant data and information of the type
described in 171.130(b). The Commissioner will place all of the data
and information on which he relies on public file in the office of the
Dockets Management Branch and will include in the Federal Register
notice the name of the substance, its known uses, and a summary of the
basis for the determination.
(2) The Federal Register notice will allow a period of 60 days during
which any interested person may review the data and information and/or
file comments with the Dockets Management Branch. Copies of all
comments shall be made available for examination in the Dockets
Management Branch's office.
(3) The Commissioner will evaluate all comments received. If he
concludes that there is a lack of convincing evidence that the substance
is GRAS or is otherwise exempt from the definition of a food additive in
section 201(s) of the Act, he will publish a notice thereof in the
Federal Register. If he concludes that there is convincing evidence
that the substance is GRAS, he will publish an order in the Federal
Register listing the substance as GRAS in part 182, part 184, or part
186 of this chapter, as appropriate.
(c) A Federal Register notice determining that a substance is a food
additive shall provide for the use of the additive in food or food
contact surfaces as follows:
(1) It may promulgate a food additive regulation governing use of the
additive.
(2) It may promulgate an interim food additive regulation governing
use of the additive.
(3) It may require discontinuation of the use of the additive.
(4) It may adopt any combination of the above three approaches for
different uses or levels of use of the additive.
(d) If the Commissioner of Food and Drugs is aware of any prior
sanction for use of the substance, he will concurrently propose a
separate regulation covering such use of the ingredient under part 181
of this chapter. If the Commissioner is unaware of any such applicable
prior sanction, the proposed regulation will so state and will require
any person who intends to assert or rely on such sanction to submit
proof of its existence. Any regulation promulgated pursuant to this
section constitutes a determination that excluded uses would result in
adulteration of the food in violation of section 402 of the Act, and the
failure of any person to come forward with proof of such an applicable
prior sanction in response to the proposal will constitute a waiver of
the right to assert or rely on such sanction at any later time. The
notice will also constitute a proposal to establish a regulation under
part 181 of this chapter, incorporating the same provisions, in the
event that such a regulation is determined to be appropriate as a result
of submission of proof of such an applicable prior sanction in response
to the proposal.
(42 FR 14488, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22,
1977; 54 FR 24896, June 12, 1989)
21 CFR 170.38 Subpart C -- Specific Administrative Rulings and Decisions
21 CFR 170.45 Fluorine-containing compounds.
The Commissioner of Food and Drugs has concluded that it is in the
interest of the public health to limit the addition of fluorine
compounds to foods (a) to that resulting from the fluoridation of public
water supplies as stated in 250.203 of this chapter, (b) to that
resulting from the fluoridation of bottled water within the limitation
established in 103.35(d) of this chapter, and (c) to that authorized by
regulations (40 CFR part 180) under section 408 of the Act.
21 CFR 170.50 Glycine (aminoacetic acid) in food for human consumption.
(a) Heretofore, the Food and Drug Administration has expressed the
opinion in trade correspondence that glycine is generally recognized as
safe for certain technical effects in human food when used in accordance
with good manufacturing practice; however:
(1) Reports in scientific literature indicate that adverse effects
were found in cases where high levels of glycine were administered in
diets of experimental animals.
(2) Current usage information indicates that the daily dietary intake
of glycine by humans may be substantially increasing due to changing use
patterns in food technology.
Therefore, the Food and Drug Administration no longer regards glycine
and its salts as generally recognized as safe for use in human food and
all outstanding letters expressing sanction for such use are rescinded.
(b) The Commissioner of Food and Drugs concludes that by May 8, 1971,
manufacturers:
(1) Shall reformulate food products for human use to eliminate added
glycine and its salts; or
(2) Shall bring such products into compliance with an authorizing
food additive regulation. A food additive petition supported by
toxicity data is required to show that any proposed level of glycine or
its salts added to foods for human consumption will be safe.
(c) The status of glycine as generally recognized as safe for use in
animal feed, as prescribed in 582.5049 of this chapter, remains
unchanged because the additive is considered an essential nutrient in
certain animal feeds and is safe for such use under conditions of good
feeding practice.
21 CFR 170.60 Nitrites and/or nitrates in curing premixes.
(a) Nitrites and/or nitrates are food additives when combined in
curing premixes with spices and/or other flavoring or seasoning
ingredients that contain or constitute a source of secondary or tertiary
amines, including but not limited to essential oils, disodium inosinate,
disodium guanylate, hydrolysates of animal or plant origin (such as
hydrolyzed vegetable protein), oleoresins of spices, soy products, and
spice extractives. Such food additives may be used only after the
establishment of an authorizing food additive regulation. A food
additive petition submitted pursuant to 171.1 and 171.100 of this
chapter, supported by data demonstrating that nitrosamines are not
formed in curing premixes containing such food additives, is required to
establish safety.
(b) Nitrites and/or nitrates, when packaged separately from flavoring
and seasoning in curing premixes, may continue to be used under prior
sanctions in the commercial curing of meat and meat products and poultry
products and in accordance with the provisions of 172.170 and 172.175
of this chapter that apply to meat curing preparations for the home
curing of meat and meat products, including poultry and wild game. To
assure safe use of such ingredients the labeling of the premixes shall
bear instructions to the user that such separately packaged ingredients
are not to be combined until just prior to use. Encapsulating or
coating some or all of the ingredients does not constitute separate
packaging.
21 CFR 170.60 PART 171 -- FOOD ADDITIVE PETITIONS
21 CFR 170.60 Subpart A -- General Provisions
Sec.
171.1 Petitions.
171.6 Amendment of petition.
171.7 Withdrawal of petition without prejudice.
21 CFR 170.60 Subpart B -- Administrative Actions on Applications
171.100 Regulation based on petition.
171.102 Effective date of regulation.
171.110 Procedure for objections and hearings.
171.130 Procedure for amending and repealing tolerances or exemptions
from tolerances.
Authority: Secs. 201, 402, 409, 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321, 342, 348, 371).
Source: 42 FR 14489, Mar. 15, 1977, unless otherwise noted.
21 CFR 170.60 Subpart A -- General Provisions
21 CFR 171.1 Petitions.
(a) Petitions to be filed with the Commissioner under the provisions
of section 409(b) of the Act shall be submitted in triplicate. If any
part of the material submitted is in a foreign language, it shall be
accompanied by an accurate and complete English translation. The
petition shall state petitioner's post office address to which published
notices or orders issued or objections filed pursuant to section 409 of
the Act may be sent.
(b) Pertinent information may be incorporated in, and will be
considered as part of, a petition on the basis of specific reference to
such information submitted to and retained in the files of the Food and
Drug Administration. However, any reference to unpublished information
furnished by a person other than the applicant will not be considered
unless use of such information is authorized in a written statement
signed by the person who submitted it. Any reference to published
information offered in support of a food additive petition should be
accompanied by reprints or photostatic copies of such references.
(c) Petitions shall include the following data and be submitted in
the following form:
(Date)
Name of petitioner
Post-office address
Date
Name of food additive and proposed use ----
Petitions Control Branch
Food and Drug Administration
Department of Health and Human Services
Washington, DC 20204.
Dear Sirs:
The undersigned, -------------------- submits this petition pursuant
to section 409(b)(1) of the Federal Food, Drug, and Cosmetic Act with
respect to ----------
(Name of the food additive and proposed use)
Attached hereto, in triplicate, and constituting a part of this
petition, are the following:
A. The name and all pertinent information concerning the food
additive, including chemical identity and composition of the food
additive, its physical, chemical, and biological properties, and
specifications prescribing the minimum content of the desired
component(s) and identifying and limiting the reaction byproducts and
other impurities. Where such information is not available, a statement
as to the reasons why it is not should be submitted.
When the chemical identity and composition of the food additive is
not known, the petition shall contain information in sufficient detail
to permit evaluation regarding the method of manufacture and the
analytical controls used during the various stages of manufacturing,
processing, or packing of the food additive which are relied upon to
establish that it is a substance of reproducible composition.
Alternative methods and controls and variations in methods and controls
within reasonable limits that do not affect the characteristics of the
substance or the reliability of the controls may be specified.
If the food additive is a mixture of chemicals, the petition shall
supply a list of all substances used in the synthesis, extraction, or
other method of preparation, regardless of whether they undergo chemical
change in the process. Each substance should be identified by its
common English name and complete chemical name, using structural
formulas when necessary for specific identification. If any proprietary
preparation is used as a component, the proprietary name should be
followed by a complete quantitative statement of composition.
Reasonable alternatives for any listed substance may be specified.
If the petitioner does not himself perform all the manufacturing,
processing, and packing operations for a food additive, the petition
shall identify each person who will perform a part of such operations
and designate the part.
The petition shall include stability data, and, if the data indicate
that it is needed to insure the identity, strength, quality, or purity
of the additive, the expiration date that will be employed.
B. The amount of the food additive proposed for use and the purposes
for which it is proposed, together with all directions, recommendations,
and suggestions regarding the proposed use, as well as specimens of the
labeling proposed for the food additive and any labeling that will be
required by applicable provisions of the Federal Food, Drug, and
Cosmetic Act on the finished food by reason of the use of the food
additive. If the additive results or may reasonably be expected to
result from the use of packaging material, the petitioner shall show how
this may occur and what residues may reasonably be anticipated.
(Typewritten or other draft-labeling copy will be accepted for
consideration of the petition, provided a statement is made that final
printed labeling identical in content to the draft copy will be
submitted as soon as available and prior to the marketing of the food
additive.)
(If the food additive is one for which a tolerance limitation is
required to assure its safety, the level of use proposed should be no
higher than the amount reasonably required to accomplish the intended
physical or other technical effect, even though the safety data may
support a higher tolerance.)
C. Data establishing that the food additive will have the intended
physical or other technical effect or that it may reasonably be expected
to become a component, or to affect the characteristics, directly or
indirectly, of food and the amount necessary to accomplish this. These
data should include information in sufficient detail to permit
evaluation with control data.
D. A description of practicable methods to determine the amount of
the food additive in the raw, processed, and/or finished food and of any
substance formed in or on such food because of its use. The test
proposed shall be one that can be used for food-control purposes and
that can be applied with consistent results by any properly equipped and
trained laboratory personnel.
E. Full reports of investigations made with respect to the safety of
the food additive.
(A petition may be regarded as incomplete unless it includes full
reports of adequate tests reasonably applicable to show whether or not
the food additive will be safe for its intended use. The reports
ordinarily should include detailed data derived from appropriate animal
and other biological experiments in which the methods used and the
results obtained are clearly set forth. The petition shall not omit
without explanation any reports of investigations that would bias an
evaluation of the safety of the food additive.)
F. Proposed tolerances for the food additive, if tolerances are
required in order to insure its safety. A petitioner may include a
proposed regulation.
G. If submitting petition to modify an existing regulation issued
pursuant to section 409(c)(1)(A) of the Act, full information on each
proposed change that is to be made in the original regulation must be
submitted. The petition may omit statements made in the original
petition concerning which no change is proposed. A supplemental
petition must be submitted for any change beyond the variations provided
for in the original petition and the regulation issued on the basis of
the original petition.
H. The petitioner is required to submit either a claim for
categorical exclusion under 25.24 of this chapter or an environmental
assessment under 25.31 of this chapter.
Yours very truly,
Petitioner
By
(Indicate authority)
(d) The petitioner will be notified of the date on which his petition
is filed; and an incomplete petition, or one that has not been
submitted in triplicate, will usually be retained but not filed as a
petition under section 409 of the Act. The petitioner will be notified
in what respects his petition is incomplete.
(e) The petition must be signed by the petitioner or by his attorney
or agent, or (if a corporation) by an authorized official.
(f) The data specified under the several lettered headings should be
submitted on separate sheets or sets of sheets, suitably identified. If
such data have already been submitted with an earlier application, the
present petition may incorporate it by specific reference to the
earlier. If part of the data have been submitted by the manufacturer of
the food additive as a master file, the petitioner may refer to the
master file if and to the extent he obtains the manufacturer's written
permission to do so. The manufacturer may authorize specific reference
to the data without disclosure to the petitioner. Nothing herein shall
prevent reference to published data.
(g) A petition shall be retained but shall not be filed if any of the
data prescribed by section 409(b) of the Act are lacking or are not set
forth so as to be readily understood.
(h)(1) The following data and information in a food additive petition
are available for public disclosure, unless extraordinary circumstances
are shown, after the notice of filing of the petition is published in
the Federal Register or, if the petition is not promptly filed because
of deficiencies in it, after the petitioner is informed that it will not
be filed because of the deficiencies involved:
(i) All safety and functionality data and information submitted with
or incorporated by reference in the petition.
(ii) A protocol for a test or study, unless it is shown to fall
within the exemption established for trade secrets and confidential
commercial information in 20.61 of this chapter.
(iii) Adverse reaction reports, product experience reports, consumer
complaints, and other similar data and information, after deletion of:
(a) Names and any information that would identify the person using
the product.
(b) Names and any information that would identify any third party
involved with the report, such as a physician or hospital or other
institution.
(iv) A list of all ingredients contained in a food additive, whether
or not it is in descending order of predominance. A particular
ingredient or group of ingredients shall be deleted from any such list
prior to public disclosure if it is shown to fall within the exemption
established in 20.61 of this chapter, and a notation shall be made that
any such ingredient list is incomplete.
(v) An assay method or other analytical method, unless it serves no
regulatory or compliance purpose and is shown to fall within the
exemption established in 20.61 of this chapter.
(2) The following data and information in a food additive petition
are not available for public disclosure unless they have been previously
disclosed to the public as defined in 20.81 of this chapter or they
relate to a product or ingredient that has been abandoned and they no
longer represent a trade secret or confidential commercial or financial
information as defined in 20.61 of this chapter:
(i) Manufacturing methods or processes, including quality control
procedures.
(ii) Production, sales, distribution, and similar data and
information, except that any compilation of such data and information
aggregated and prepared in a way that does not reveal data or
information which is not available for public disclosure under this
provision is available for public disclosure.
(iii) Quantitative or semiquantitative formulas.
(3) All correspondence and written summaries of oral discussions
relating to a food additive petition are available for public disclosure
in accordance with the provisions of part 20 of this chapter when the
food additive regulation is published in the Federal Register.
(4) For purposes of this regulation, safety and functionality data
include all studies and tests of a food additive on animals and humans
and all studies and tests on a food additive for identity, stability,
purity, potency, performance, and usefulness.
(i)(1) Within 15 days after receipt, the Commissioner will notify the
petitioner of acceptance or nonacceptance of a petition, and if not
accepted the reasons therefor. If accepted, the date of the
notification letter sent to petitioner becomes the date of filing for
the purposes of section 409(b)(5) of the Act. If the petitioner
desires, he may supplement a deficient petition after being notified
regarding deficiencies. If the supplementary material or explanation of
the petition is deemed acceptable, petitioner shall be notified. The
date of such notification becomes the date of filing. If the petitioner
does not wish to supplement or explain the petition and requests in
writing that it be filed as submitted, the petition shall be filed and
the petitioner so notified. The date of such notification becomes the
date of filing.
(2) The Commissioner will publish in the Federal Register within 30
days from the date of filing of such petition, a notice of the filing,
the name of the petitioner, and a brief description of the proposal in
general terms. In the case of a food additive which becomes a component
of food by migration from packaging material, the notice shall include
the name of the migratory substance, and where it is different from that
of one of the original components, the name of the parent component, the
maximum quantity of the migratory substance that is proposed for use in
food, and the physical or other technical effect which the migratory
substance or its parent component is intended to have in the packaging
material. A copy of the notice will be mailed to the petitioner when
the original is forwarded to the Federal Register for publication.
(j) The Commissioner may request a full description of the methods
used in, and the facilities and controls used for, the production of the
food additive, or a sample of the food additive, articles used as
components thereof, or of the food in which the additive is proposed to
be used, at any time while a petition is under consideration. The
Commissioner shall specify in the request for a sample of the food
additive, or articles used as components thereof, or of the food in or
on which the additive is proposed to be used, a quantity deemed adequate
to permit tests of analytical methods to determine quantities of the
food additive present in foods for which it is intended to be used or
adequate for any study or investigation reasonably required with respect
to the safety of the food additive or the physical or technical effect
it produces. The date used for computing the 90-day limit for the
purposes of section 409(c)(2) of the Act shall be moved forward 1 day
for each day after the mailing date of the request taken by the
petitioner to submit the sample. If the information or sample is
requested a reasonable time in advance of the 180 days, but is not
submitted within such 180 days after filing of the petition, the
petition will be considered withdrawn without prejudice.
(k) If nonclinical laboratory studies are involved, petitions filed
with the Commissioner under section 409(b) of the act shall include,
with respect to each nonclinical study contained in the petition, either
a statement that the study has been, or will be, conducted in compliance
with the good laboratory practice regulations as set forth in part 58 of
this chapter, or, if any such study was not conducted in compliance with
such regulations, a brief statement of the reason for the noncompliance.
(l) (Reserved)
(m) If clinical investigations involving human subjects are involved,
petitions filed with the Commissioner under section 409(b) of the Act
shall include statements regarding each such clinical investigation
relied upon in the petition that it either was conducted in compliance
with the requirements for institutional review set forth in part 56 of
this chapter, or was not subject to such requirements in accordance with
56.104 or 56.105, and that it was conducted in compliance with the
requirements for informed consent set forth in part 50 of this chapter.
(42 FR 14489, Mar. 15, 1977, as amended at 42 FR 15674, Mar. 22,
1977; 46 FR 8952, Jan. 27, 1981; 50 FR 7492, Feb. 22, 1985; 50 16668,
Apr. 26, 1985)