21 CFR 171.6 Amendment of petition.
After a petition has been filed, the petitioner may submit additional
information or data in support thereof. In such cases, if the
Commissioner determines that the additional information or data amount
to a substantive amendment, the petition as amended will be given a new
filing date, and the time limitation will begin to run anew. 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.
(50 FR 7492, Feb. 22, 1985, as amended at 50 16668, Apr. 26, 1985)
21 CFR 171.7 Withdrawal of petition without prejudice.
(a) In some cases the Commissioner will notify the petitioner that
the petition, while technically complete, is inadequate to justify the
establishment of a regulation or the regulation requested by petitioner.
This may be due to the fact that the data are not sufficiently clear or
complete. In such cases, the petitioner may withdraw the petition
pending its clarification or the obtaining of additional data. This
withdrawal will be without prejudice to a future filing. Upon refiling,
the time limitation will begin to run anew from the date of refiling.
(b) At any time before the order provided for in 171.100(a) has been
forwarded to the Federal Register for publication, the petitioner may
withdraw the petition without prejudice to a future filing. Upon
refiling the time limitation will begin to run anew.
21 CFR 171.7 Subpart B -- Administrative Actions on Applications
21 CFR 171.100 Regulation based on petition.
(a) The Commissioner will forward for publication in the Federal
Register, within 90 days after filing of the petition (or within 180
days if the time is extended as provided for in section 409(c)(2) of the
Act), a regulation prescribing the conditions under which the food
additive may be safely used (including, but not limited to,
specifications as to the particular food or classes of food in or on
which such additive may be used, the maximum quantity that may be used
or permitted to remain in or on such food, the manner in which such
additive may be added to or used in or on such food, and any directions
or other labeling or packaging requirements for such additive deemed
necessary by him to assure the safety of such use), and prior to the
forwarding of the order to the Federal Register for publication shall
notify the petitioner of such order and the reasons for such action; or
by order deny the petition, and shall notify the petitioner of such
order and of the reasons for such action.
(b) If the Commissioner determines that additional time is needed to
study and investigate the petition, he shall by written notice to the
petitioner extend the 90-day period for not more than 180 days after the
filing of the petition.
21 CFR 171.102 Effective date of regulation.
A regulation published in accordance with 171.100(a) shall become
effective upon publication in the Federal Register.
21 CFR 171.110 Procedure for objections and hearings.
Objections and hearings relating to food additive regulations under
section 409(c), (d), or (h) of the Act shall be governed by part 12 of
this chapter.
(42 FR 14491, Mar. 15, 1977, as amended at 42 FR 15674, Mar. 22,
1977)
21 CFR 171.130 Procedure for amending and repealing tolerances or
exemptions from tolerances.
(a) The Commissioner, on his own initiative or on the petition of any
interested person, pursuant to part 10 of this chapter, may propose the
issuance of a regulation amending or repealing a regulation pertaining
to a food additive or granting or repealing an exception for such
additive.
(b) Any such petition shall include an assertion of facts, supported
by data, showing that new information exists with respect to the food
additive or that new uses have been developed or old uses abandoned,
that new data are available as to toxicity of the chemical, or that
experience with the existing regulation or exemption may justify its
amendment or repeal. New data shall be furnished in the form specified
in 171.1 and 171.100 for submitting petitions.
(42 FR 14491, Mar. 15, 1977, as amended at 42 FR 15674, Mar. 22,
1977)
21 CFR 171.130 Pt. 172
21 CFR 171.130 PART 172 -- FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION
21 CFR 171.130 Subpart A -- General Provisions
Sec.
172.5 General provisions for direct food additives.
21 CFR 171.130 Subpart B -- Food Preservatives
172.105 Anoxomer.
172.110 BHA.
172.115 BHT.
172.120 Calcium disodium EDTA.
172.130 Dehydroacetic acid.
172.133 Dimethyl dicarbonate.
172.135 Disodium EDTA.
172.140 Ethoxyquin.
172.145 Heptylparaben.
172.150 4-Hydroxymethyl-2,6-di-tert-butyl-phenol.
172.155 Natamycin (pimaricin).
172.160 Potassium nitrate.
172.165 Quaternary ammonium chloride combination.
172.170 Sodium nitrate.
172.175 Sodium nitrite.
172.177 Sodium nitrite used in processing smoked chub.
172.180 Stannous chloride.
172.185 TBHQ.
172.190 THBP.
21 CFR 171.130 Subpart C -- Coatings, Films and Related Substances
172.210 Coatings on fresh citrus fruit.
172.215 Coumarone-indene resin.
172.225 Methyl esters of fatty acids produced from edible fats and
oils.
172.230 Microcapsules for flavoring substances.
172.235 Morpholine.
172.250 Petroleum naphtha.
172.255 Polyacrylamide.
172.260 Oxidized polyethylene.
172.275 Synthetic paraffin and succinic derivatives.
172.280 Terpene resin.
21 CFR 171.130 Subpart D -- Special Dietary and Nutritional Additives
172.310 Aluminum nicotinate.
172.315 Nicotinamide-ascorbic acid complex.
172.320 Amino acids.
172.325 Bakers yeast protein.
172.330 Calcium pantothenate, calcium chloride double salt.
172.335 D-Pantothenamide.
172.340 Fish protein isolate.
172.345 Folic acid (folacin).
172.350 Fumaric acid and salts of fumaric acids.
172.365 Kelp.
172.370 Iron-choline citrate complex.
172.372 N-Acetyl-L-methionine.
172.375 Potassium iodide.
172.385 Whole fish protein concentrate.
172.395 Xylitol.
172.399 Zinc methionine sulfate.
21 CFR 171.130 Subpart E -- Anticaking Agents
172.410 Calcium silicate.
172.430 Iron ammonium citrate.
172.480 Silicon dioxide.
172.490 Yellow prussiate of soda.
21 CFR 171.130 Subpart F -- Flavoring Agents and Related Substances
172.510 Natural flavoring substances and natural substances used in
conjunction with flavors.
172.515 Synthetic flavoring substances and adjuvants.
172.520 Cocoa with dioctyl sodium sulfoccinate for manufacturing.
172.530 Disodium guanylate.
172.535 Disodium inosinate.
172.540 DL-Alanine.
172.560 Modified hop extract.
172.575 Quinine.
172.580 Safrole-free extract of sassafras.
172.585 Sugar beet extract flavor base.
172.590 Yeast-malt sprout extract.
21 CFR 171.130 Subpart G -- Gums, Chewing Gum Bases and Related
Substances
172.610 Arabinogalactan.
172.615 Chewing gum base.
172.620 Carrageenan.
172.623 Carrageenan with polysorbate 80.
172.626 Salts of carrageenan.
172.655 Furcelleran.
172.660 Salts of furcelleran.
172.665 Gellan gum.
172.695 Xanthan gum.
21 CFR 171.130 Subpart H -- Other Specific Usage Additives
172.710 Adjuvants for pesticide use dilutions.
172.715 Calcium lignosulfonate.
172.720 Calcium lactobionate.
172.725 Gibberellic acid and its potassium salt.
172.730 Potassium bromate.
172.735 Glycerol ester of wood rosin.
172.755 Stearyl monoglyceridyl citrate.
172.765 Succistearin (stearoyl propylene glycol hydrogen succinate).
172.770 Ethylene oxide polymer.
172.775 Methacrylic acid-divinylbenzene copolymer.
21 CFR 171.130 Subpart I -- Multipurpose Additives
172.800 Acesulfame potassium.
172.802 Acetone peroxides.
172.804 Aspartame.
172.806 Azodicarbonamide.
172.808 Copolymer condensates of ethylene oxide and propylene oxide.
172.810 Dioctyl sodium sulfosuccinate.
172.811 Glyceryl tristearate.
172.812 Glycine.
172.814 Hydroxylated lecithin.
172.816 Methyl glucoside-coconut oil ester.
172.818 Oxystearin.
172.820 Polyethylene gylcol (mean molecular weight 200-9,500).
172.822 Sodium lauryl sulfate.
172.824 Sodium mono- and dimethyl naphthalene sulfonates.
172.826 Sodium stearyl fumarate.
172.828 Acetylated monoglycerides.
172.830 Succinylated monoglycerides.
172.832 Monoglyceride citrate.
172.834 Ethoxylated mono- and diglycerides.
172.836 Polysorbate 60.
172.838 Polysorbate 65.
172.840 Polysorbate 80.
172.841 Polydextrose.
172.842 Sorbitan monostearate.
172.844 Calcium stearoyl-2-lactylate.
172.846 Sodium stearoyl-2-lactylate.
172.848 Lactylic esters of fatty acids.
172.850 Lactylated fatty acid esters of glycerol and propylene
glycol.
172.852 Glyceryl-lacto esters of fatty acids.
172.854 Polyglycerol esters of fatty acids.
172.856 Propylene glycol mono- and diesters of fats and fatty acids.
172.858 Propylene glycol alginate.
172.859 Sucrose fatty acid esters.
172.860 Fatty acids.
172.861 Cocoa butter substitute from coconut oil, palm kernel oil, or
both oils.
172.862 Oleic acid derived from tall oil fatty acids.
172.863 Salts of fatty acids.
172.864 Synthetic fatty alcohols.
172.866 Synthetic glycerin produced by the hydrogenolysis of
carbohydrates.
172.868 Ethyl cellulose.
172.870 Hydroxypropyl cellulose.
172.872 Methyl ethyl cellulose.
172.874 Hydroxypropyl methylcellulose.
172.876 Castor oil.
172.878 White mineral oil.
172.880 Petrolatum.
172.882 Synthetic isoparaffinic petroleum hydrocarbons.
172.884 Odorless light petroleum hydrocarbons.
172.886 Petroleum wax.
172.888 Synthetic petroleum wax.
172.890 Rice bran wax.
172.892 Food starch-modified.
172.894 Modified cottonseed products intended for human consumption.
172.896 Dried yeasts.
172.898 Bakers yeast glycan.
Authority: Secs. 201, 401, 402, 409, 701, 706 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321, 341, 342, 348, 371, 376).
Source: 42 FR 14491, Mar. 15, 1977, unless otherwise noted.
21 CFR 171.130 Subpart A -- General Provisions
21 CFR 172.5 General provisions for direct food additives.
(a) Regulations prescribing conditions under which food additive
substances may be safely used predicate usage under conditions of good
manufacturing practice. For the purposes of this part, good
manufacturing practice shall be defined to include the following
restrictions.
(1) The quantity of the substance added to food does not exceed the
amount reasonably required to accomplish its intended physical,
nutritive, or other technical effect in food.
(2) Any substance intended for use in or on food is of appropriate
food grade and is prepared and handled as a food ingredient.
(b) The existence of a regulation prescribing safe conditions of use
for a food additive shall not be construed to relieve the use of the
substance from compliance with any other provision of the Act.
(c) The existence of any regulation prescribing safe conditions of
use for a nutrient substance does not constitute a finding that the
substance is useful or required as a supplement to the diet of humans.
21 CFR 172.5 Subpart B -- Food Preservatives
21 CFR 172.105 Anoxomer.
Anoxomer as identified in this section may be safely used in
accordance with the following conditions:
(a) Anoxomer is 1,4-benzenediol, 2-(1,1-dimethylethyl)-polymer with
diethenylbenzene, 4-(1,1-dimethyl-ethyl)phenol, 4- methoxyphenol,
4,4'-(1-methylethylidene)bis(phenol) and 4-methylphenol (CAS Reg. No.
60837-57-2) prepared by condensation polymerization of divinylbenzene
(m- and p-) with tert-butylhydroquinone, tert-butylphenol,
hydroxyanisole, p-cresol and 4,4'-isopropylidenediphenol.
(b) The polymeric antioxidant meets the following specifications:
(1) Polymer, not less than 98.0 percent as determined by an
ultraviolet method entitled ''Ultraviolet Assay, ''1982, which is
incorporated by reference. Copies are available from the Division of
Food and Color Additives, Center for Food Safety and Applied Nutrition
(HFF-330), 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.
(2) Molecular weight: Total monomers, dimers and trimers below 500
not more than 1 percent as determined by a method entitled ''Low
Molecular Weight Anoxomer Analysis,'' 1982, which is incorporated by
reference. Copies are available from the Division of Food and Color
Additives, Center for Food Safety and Applied Nutrition (HFF-330), 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.
(3) Phenol content: Not less than 3.2 milliequivalent/gram and not
more than 3.8 milliequivalent/gram as determined by a method entitled
''Total Phenols,'' 1982, which is incorporated by reference. Copies are
available from the Division of Food and Color Additives, Center for Food
Safety and Applied Nutrition (HFF-330), 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.
(4) Heavy metals as 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.
(c) Anoxomer may be safely used as an antioxidant in food at a level
of not more than 5,000 parts per million based on fat and oil content of
the food.
(48 FR 18798, Apr. 26, 1983, as amended at 54 FR 24896, June 12,
1989)
21 CFR 172.110 BHA.
The food additive BHA (butylated hydroxyanisole) alone or in
combination with other antioxidants permitted in food for human
consumption in this Subpart B may be safely used in or on specified
foods, as follows:
(a) The BHA meets the following specification:
Assay (total BHA), 98.5 percent minimum. Melting point 48 C
minimum.
(b) The BHA is used alone or in combination with BHT, as an
antioxidant in foods, as follows:
(c) To assure safe use of the additive:
(1) The label of any market package of the additive shall bear, in
addition to the other information required by the Act, the name of the
additive.
(2) When the additive is marketed in a suitable carrier, in addition
to meeting the requirement of paragraph (c)(1) of this section, the
label shall declare the percentage of the additive in the mixture.
(3) The label or labeling of dry mixes for beverages and desserts
shall bear adequate directions for use to provide that beverages and
desserts prepared from the dry mixes contain no more than 2 parts per
million BHA.
21 CFR 172.115 BHT.
The food additive BHT (butylated hydroxytoluene), alone or in
combination with other antioxidants permitted in this Subpart B may be
safely used in or on specified foods, as follows:
(a) The BHT meets the following specification: Assay (total BHT) 99
percent minimum.
(b) The BHT is used alone or in combination with BHA, as an
antioxidant in foods, as follows:
(c) To assure safe use of the additive:
(1) The label of any market package of the additive shall bear, in
addition to the other information required by the Act, the name of the
additive.
(2) When the additive is marketed in a suitable carrier, in addition
to meeting the requirement of paragraph (c)(1) of this section, the
label shall declare the percentage of the additive in the mixture.
21 CFR 172.120 Calcium disodium EDTA.
The food additive calcium disodium EDTA (calcium disodium
ethylene-diaminetetraacetate) may be safely used in designated foods for
the purposes and in accordance with the conditions prescribed, as
follows:
(a) The additive contains a minimum of 99 percent by weight of either
the dihydrate C10H12O8N2CaNa2 2H2O or the trihydrate C10H12O8N2CaNa2
3H2O, or any mixture of the two.
(b) It is used or intended for use as follows:
(1) Alone, in the following foods at not to exceed the levels
prescribed, calculated as the anhydrous compound:
(2) With disodium EDTA (disodium ethylenediaminetetraacetate) in the
following foods at not to exceed, in combination, the levels prescribed,
calculated as anhydrous C10H12O8N2CaNa2:
(c) To assure safe use of the additive:
(1) The label and labeling of the additive container shall bear, in
addition to the other information required by the Act, the name of the
additive.
(2) The label or labeling of the additive container shall bear
adequate use directions to provide a final food product that complies
with the limitations provided in paragraph (b) of this section.
(d) In the standardized foods listed in paragraph (b) of this
section, the additives are used only in compliance with the applicable
standards of identity for such foods.
(42 FR 14491, Mar. 15, 1977, as amended at 48 FR 10815, Mar. 15,
1983)
21 CFR 172.130 Dehydroacetic acid.
The food additive dehydroacetic acid and/or its sodium salt may be
safely used in accordance with the following prescribed conditions:
(a) The food additive meets the following specifications:
Dehydroacetic acid: Melting point, 109 C-111 C; assay, minimum 98
percent (dry basis).
Sodium salt of dehydroacetic acid: Assay, minimum 98 percent (dry
basis).
(b) It is used or intended for use as a preservative for cut or
peeled squash, and is so used that no more than 65 parts per million
expressed as dehydroacetic acid remains in or on the prepared squash.
(c) The label or labeling of any package of the additive intended for
use in food shall bear adequate directions for use to insure compliance
with this section.
21 CFR 172.133 Dimethyl dicarbonate.
Dimethyl dicarbonate (CAS Reg. No. 4525-33-1) may be safely used in
wine in accordance with the following prescribed conditions:
(a) The additive meets the following specifications:
(1) The additive has a purity of not less than 99.8 percent as
determined by the following titration method:
21 CFR 172.133 Principles of Method
Dimethyl dicarbonate (DMDC) is mixed with excess diisobutylamine with
which it reacts quantitatively. The excess amine is backtitrated with
acid.
250-milliliter (mL) Beaker
100-mL Graduate cylinder
25-mL Pipette
10-mL Burette (automatic, eg., Metrohm burette)
Stirrer
Device for potentiometric titration
Reference electrode
Glass electrode
Acetone, analytical-grade
Solution of 1 N diisobutylamine in chlorobenzene, distilled
1 N Acetic Acid
Accurately weigh in about 2 grams of the sample (W) and dissolve in
100 mL acetone. Add accurately 25 mL of the 1 N diisobutylamine
solution by pipette and allow to stand for 5 minutes. Subsequently,
titrate the reaction mixture potentiometrically with 1 N hydrochloric
acid (consumption=a mL) while stirring. For determining the blank
consumption, carry out the analysis without a sample (consumption=b mL).
Note: For adding the diisobutylamine solution, always use the same
pipette and wait for a further three drops to fall when the flow has
stopped.
(2) The additive contains not more than 2,000 ppm (0.2 percent)
dimethyl carbonate as determined by a method entitled ''Gas
Chromatography Method for Dimethyl Carbonate Impurity in Dimethyl
Dicarbonate,'' which is incorporated by reference in accordance with 5
U.S.C. 552(a). Copies are available from the Division of Food and Color
Additives, Center for Food Safety and Applied Nutrition (HFF-334), 200 C
Street SW., Washington, DC 20204, or available for inspection at the
Office of the Federal Register, 1100 L Street NW., Washington, DC 20408.
(b) The additive is used or intended for use as an inhibitor of yeast
in wine under normal circumstances of bottling where the viable yeast
count has been reduced to 500 per milliliter or less by current good
manufacturing practices such as flash pasteurization or filtration. The
additive may be added to wine in an amount not to exceed 200 parts per
million (ppm).
(c) To ensure the safe use of the food additive, the label of the
package containing the additive shall bear, in addition to other
information required by the Federal Food, Drug, and Cosmetic Act:
(1) The name of the additive ''dimethyl dicarbonate.''
(2) Directions to provide that not more than 200 ppm of dimethyl
dicarbonate will be added to the wine.
(53 FR 41329, Oct. 21, 1988)
21 CFR 172.135 Disodium EDTA.
The food additive disodium EDTA (disodium
ethylenediaminetetraace-tate) may be safely used in designated foods for
the purposes and in accordance with the following prescribed conditions:
(a) The additive contains a minimum of 99 percent disodium
ethylenedia-minetetraacetate dihydrate (C10H14O8N2Na2 2H2O).
(b) It is used or intended for use as follows:
(1) Alone, in the following foods at not to exceed the levels
prescribed, calculated as anhydrous calcium disodium EDTA:
(2) With calcium disodium EDTA (calcium disodium
ethylenediaminetetraacetate; calcium disodium (ethylenedinitrilo)
tetraacetate), in the following foods at not to exceed, in combination,
the levels prescribed, calculated as anhydrous C10H12O8N2CaNa2:
(3) Alone, as a sequestrant in the nonnutritive sweeteners that are
listed in 180.37 of this chapter and that, in addition, are designed
for aqueous solution: Provided, That the amount of the additive,
calculated as anhydrous calcium disodium EDTA, does not exceed 0.1
percent by weight of the dry nonnutritive sweetener.
(c) To assure the safe use of the additive:
(1) The label and labeling of the additive container shall bear, in
addition to the other information required by the act, the name of the
additive.
(2) The label or labeling of the additive container shall bear
adequate use directions to provide a final food product that complies
with the limitations provided in paragraph (b) of this section.
(d) In the standardized foods listed in paragraphs (b)(1) and (2) of
this section the additives are used only in compliance with the
applicable standards of identity for such foods.
21 CFR 172.140 Ethoxyquin.
(a) Ethoxyquin (1,2-dihydro-6-ethoxy-2,2,4-trimethylquinoline) may be
safely used as an antioxidant for preservation of color in the
production of chili powder, paprika, and ground chili at levels not in
excess of 100 parts per million.
(b) In order to provide for the safe use of the additive in feed
prepared in accordance with 573.380 and 573.400 of this chapter,
tolerances are established for residues of ethoxyquin in or on edible
products of animals as follows:
5 parts per million in or on the uncooked fat of meat from animals
except poultry.
3 parts per million in or on the uncooked liver and fat of poultry.
0.5 part per million in or on the uncooked muscle meat of animals.
0.5 part per million in poultry eggs.
Zero in milk.
21 CFR 172.145 Heptylparaben.
(a) The food additive heptylparaben is the chemical n-heptyl
p-hydroxybenzoate.
(b) It may be safely used to inhibit microbiological spoilage in
accordance with the following prescribed conditions:
(1) In fermented malt beverages in amounts not to exceed 12 parts per
million.
(2) In noncarbonated soft drinks and fruit-based beverages in amounts
not to exceed 20 parts per million, when standards of identity
established under section 401 of the Act (21 U.S.C. 341) do not preclude
such use.
21 CFR 172.150 4-Hydroxymethyl-2,6-di-tert-butylphenol.
The food additive 4-hydroxymethyl-2,6-di-tert-butylphenol may be
safely used in food in accordance with the following prescribed
conditions:
(a) The additive has a solidification point of 140 C-141 C.
(b) The additive is used as an antioxidant alone or in combination
with other permitted antioxidants.
(c) The total amount of all antioxidants added to such food shall not
exceed 0.02 percent of the oil or fat content of the food, including the
essential (volatile) oil content of the food.
21 CFR 172.155 Natamycin (pimaricin).
(a) Natamycin (CAS Reg. No. 7681-93-8), also known as pimaricin, is a
polyene macrolide antimycotic substance possessing an empirical formula
of C33H47NO13 and a molecular weight of 665.7.
(b) The additive shall conform to the following specifications:
Purity: 97 percent 2 percent on an anhydrous basis.
Arsenic: Not more than 1 part per million.
Heavy metals (as Pb): Not more than 20 parts per million.
(c) The additive may be applied to the surface of cuts and slices of
cheese to inhibit mold spoilage with the following limitations:
(1) The additive may be applied by dipping or by spraying, using an
aqueous solution containing 200 to 300 parts per million of the
additive.
(2) The additive may be applied to the surface of those cuts and
slices of cheese(s) listed in part 133 of this chapter only if the
cheese standards provide for the use of ''safe and suitable''
mold-inhibiting ingredients.
(47 FR 26823, June 22, 1982, as amended at 50 FR 49536, Dec. 3, 1985)
21 CFR 172.160 Potassium nitrate.
The food additive potassium nitrate may be safely used as a curing
agent in the processing of cod roe, in an amount not to exceed 200 parts
per million of the finished roe.
21 CFR 172.165 Quaternary ammonium chloride combination.
The food additive, quaternary ammonium chloride combination, may be
safely used in food in accordance with the following conditions:
(a) The additive contains the following compounds: n-dodecyl
dimethyl benzyl ammonium chloride (CAS Reg. No. 139-07-1); n-dodecyl
dimethyl ethylbenzyl ammonium chloride (CAS Reg. No. 27479-28-3);
n-hexadecyl dimethyl benzyl ammonium chloride (CAS Reg. No. 122-18-9);
n-octadecyl dimethyl benzyl ammonium chloride (CAS Reg. No. 122-19-0);
n-tetradecyl dimethyl benzyl ammonium chloride (CAS Reg. No. 139-08-2);
n-tetradecyl dimethyl ethylbenzyl ammonium chloride (CAS Reg. No.
27479-29-4).
(b) The additive meets the following specifications: pH (5 percent
active solution) 7.0-8.0; total amines, maximum 1 percent as combined
free amines and amine hydrochlorides.
(c) The additive is used as an antimicrobial agent, as defined in
170.3(o)(2) of this chapter, in raw sugar cane juice. It is added prior
to clarification when further processing of the sugar cane juice must be
delayed.
(d) The additive is applied to the sugar juice in the following
quantities, based on the weight of the raw cane:
(50 FR 3890, Jan. 29, 1985)
21 CFR 172.170 Sodium nitrate.
The food additive sodium nitrate may be safely used in or on
specified foods in accordance with the following prescribed conditions:
(a) It is used or intended for use as follows:
(1) As a preservative and color fixative, with or without sodium
nitrite, in smoked, cured sablefish, smoked, cured salmon, and smoked,
cured shad, so that the level of sodium nitrate does not exceed 500
parts per million and the level of sodium nitrite does not exceed 200
parts per million in the finished product.
(2) As a preservative and color fixative, with or without sodium
nitrite, in meat-curing preparations for the home curing of meat and
meat products (including poultry and wild game), with directions for use
which limit the amount of sodium nitrate to not more than 500 parts per
million in the finished meat product and the amount of sodium nitrite to
not more than 200 parts per million in the finished meat product.
(b) To assure safe use of the additive, in addition to the other
information required by the Act:
(1) The label of the additive or of a mixture containing the additive
shall bear:
(i) The name of the additive.
(ii) A statement of the concentration of the additive in any mixture.
(2) If in a retail package intended for household use, the label and
labeling of the additive, or of a mixture containing the additive, shall
bear adequate directions for use to provide a final food product that
complies with the limitations prescribed in paragraph (a) of this
section.
(3) If in a retail package intended for household use, the label of
the additive or of a mixture containing the additive, shall bear the
statement ''Keep out of the reach of children''.
21 CFR 172.175 Sodium nitrite.
The food additive sodium nitrite may be safely used in or on
specified foods in accordance with the following prescribed conditions:
(a) It is used or intended for use as follows:
(1) As a color fixative in smoked cured tunafish products so that the
level of sodium nitrite does not exceed 10 parts per million (0.001
percent) in the finished product.
(2) As a preservative and color fixative, with or without sodium
nitrate, in smoked, cured sablefish, smoked, cured salmon, and smoked,
cured shad so that the level of sodium nitrite does not exceed 200 parts
per million and the level of sodium nitrate does not exceed 500 parts
per million in the finished product.
(3) As a preservative and color fixative, with sodium nitrate, in
meat-curing preparations for the home curing of meat and meat products
(including poultry and wild game), with directions for use which limit
the amount of sodium nitrite to not more than 200 parts per million in
the finished meat product, and the amount of sodium nitrate to not more
than 500 parts per million in the finished meat product.
(b) To assure safe use of the additive, in addition to the other
information required by the Act:
(1) The label of the additive or of a mixture containing the additive
shall bear:
(i) The name of the additive.
(ii) A statement of the concentration of the additive in any mixture.
(2) If in a retail package intended for household use, the label and
labeling of the additive, or of a mixture containing the additive, shall
bear adequate directions for use to provide a final food product which
complies with the limitations prescribed in paragraph (a) of this
section.
(3) If in a retail package intended for household use, the label of
the additive, or of a mixture containing the additive, shall bear the
statement ''Keep out of the reach of children''.
21 CFR 172.177 Sodium nitrite used in processing smoked chub.
The food additive sodium nitrite may be safely used in combination
with salt (NaCl) to aid in inhibiting the outgrowth and toxin formation
from Clostridium botulinum type E in the commercial processing of smoked
chub in accordance with the following prescribed conditions:
(a) All fish in smoking establishments shall be clean and wholesome
and shall be expeditiously processed, packed, and stored under adequate
sanitary conditions in accordance with good manufacturing practice.
(b) The brining procedure is controlled in such a manner that the
water phase portion of the edible portion of the finished smoked product
has a salt (NaCl) content of not less than 3.5 percent, as measured in
the loin muscle, and the sodium nitrite content of the edible portion of
the finished smoked product is not less than 100 parts per million and
not greater than 200 parts per million, as measured in the loin muscle.
(c) Smoked chub shall be heated by a controlled heat process which
provides a monitoring system positioned in as many strategic locations
in the smokehouse as necessary to assure a continuous temperature
throughout each fish of at least 160 F for a minimum of 30 minutes.
(d) The finished product shall be cooled to a temperature of 50 F or
below within 3 hours after smoking and further cooled to a temperature
of 38 F or below within 12 hours after smoking. A temperature of 38 F
or below shall be maintained during all subsequent storage and
distribution. All shipping containers, retail packages, and shipping
records shall indicate with appropriate notice the perishable nature of
the product and specify that the product shall be held under
refrigeration (38 F or below) until consumed.
(e) To assure safe use of the additive:
(1) The label and labeling of the additive container shall bear, in
addition to the other information required by the Act, the name of the
additive.
(2) The label or labeling of the additive container shall bear
adequate directions to assure use in compliance with the provisions of
this section.
21 CFR 172.180 Stannous chloride.
The food additive stannous chloride may be safely used for color
retention in asparagus packed in glass, with lids lined with an inert
material, in an amount not to exceed 20 parts per million calculated as
tin (Sn).
21 CFR 172.185 TBHQ.
The food additive TBHQ, which is the chemical
2-(1,1-dimethylethyl)-1,4-benzenediol (Chemical Abstracts Service
Registry Number 1948-33-0), also known as tertiary butylhydroquinone,
may be safely used in food in accordance with the following prescribed
conditions:
(a) The food additive has a melting point of 126.5 C-128.5 C.
(b) It is used as an antioxidant alone or in combination with BHA
and/or BHT.
(c) The total antioxidant content of a food containing the additive
will not exceed 0.02 percent of the oil or fat content of the food,
including the essential (volatile) oil content of the food.
21 CFR 172.190 THBP.
The food additive THBP (2,4,5-trihydroxybutyrophenone) may be safely
used in food in accordance with the following prescribed conditions:
(a) The food additive has a melting point of 149 C-153 C.
(b) It is used as an antioxidant alone or in combination with other
permitted antioxidants.
(c) The total antioxidant content of a food containing the additive
will not exceed 0.02 percent of the oil or fat content of the food,
including the essential (volatile) oil content of the food.
21 CFR 172.190 Subpart C -- Coatings, Films and Related Substances
21 CFR 172.210 Coatings on fresh citrus fruit.
Coatings may be applied to fresh citrus fruit for protection of the
fruit in accordance with the following conditions:
(a) The coating is applied in the minimum amount required to
accomplish the intended effect.
(b) The coating may be formulated from the following components, each
used in the minimum quantity required to accomplish the intended effect:
(1) Substances generally recognized as safe for the purpose or
previously sanctioned for the purpose.
(2) One or more of the following:
(3) In lieu of the components listed in paragraph (b)(2) and (4) of
this section, the following copolymer and one or more of the listed
adjuvants.
(4) In lieu of the components listed in paragraph (b)(2) and (3) of
this section, the following rosin derivative and either or both of the
listed adjuvants:
(42 FR 14491, Mar. 15, 1977; 49 FR 5747, Feb. 15, 1984, as amended
at 51 FR 2693, Jan. 21, 1986; 52 FR 18911, May 20, 1987)
21 CFR 172.215 Coumarone-indene resin.
The food additive coumarone-indene resin may be safely used on
grapefruit, lemons, limes, oranges, tangelos, and tangerines in
accordance with the following prescribed conditions:
(a) The food additive is manufactured by the polymerization of a
crude, heavy coal-tar solvent naphtha meeting the following
specifications:
(1) It is a mixture of indene, indan (hydrindene), substituted
benzenes, and related compounds.
(2) It contains no more than 0.25 percent tar bases.
(3) 95 percent distills in the range 167 C-184 C.
(b) The food additive meets the following specifications:
(1) Softening point, ring and ball: 126 C minimum as determined by
ASTM method E28-67 (Reapproved 1982), ''Standard Test Method for
Softening Point by Ring-and-Ball Apparatus,'' which is incorporated by
reference. Copies may be obtained from the American Society for Testing
Materials, 1916 Race St., Philadelphia, PA 19103, or may be examined at
the Office of the Federal Register, 1100 L St. NW., Washington, DC
20408.
(2) Refractive index (n25/D) 1.63-1.64.
(c) It is used or intended for use as a protective coating for
grapefruit, lemons, limes, oranges, tangelos, and tangerines whereby the
maximum amount of the resin remaining on the fruit does not exceed 200
parts per million on a fresh-weight basis.
(d) To assure safe use of the additive:
(1) The label of the market package or any intermediate premix of the
additive shall bear, in addition to the other information required by
the act:
(i) The name of the additive, coumarone-indene resin.
(ii) A statement of the concentration of the additive therein.
(2) The label or accompanying labeling shall bear adequate directions
that, if followed, will result in a finished food not in conflict with
the requirements of this section.
(42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10103, Mar. 19,
1984)
21 CFR 172.225 Methyl esters of fatty acids produced from edible fats
and oils.
Methyl esters of fatty acids produced from edible fats and oils may
be safely used in food, subject to the following prescribed conditions:
(a) The additive consists of a mixture of methyl esters of fatty
acids produced from edible fats and oils and meets the following
specifications:
(1) Not less than 90 percent methyl esters of fatty acids.
(2) Not more than 1.5 percent unsaponifiable matter.
(b) The additive is used or intended for use at a level not to exceed
3 percent by weight in an aqueous emulsion in dehydrating grapes to
produce raisins, whereby the residue of the additive on the raisins does
not exceed 200 parts per million.
21 CFR 172.230 Microcapsules for flavoring substances.
Microcapsules may be safely used for encapsulating discrete particles
of flavoring substances that are generally recognized as safe for their
intended use or are regulated under this part, in accordance with the
following conditions:
(a) The microcapsules may be formulated from the following
components, each used in the minimum quantity required to accomplish the
intended effect:
(1) Substances generally recognized as safe for the purpose.
(2) One or more of the following components:
Succinylated gelatin -- Not to exceed 15 percent by combined weight
of the microcapsule and flavoring oil. Succinic acid content of the
gelatin is 4.5 to 5.5 percent.
Arabinogalactan -- Complying with 172.610; as adjuvant.
Silicon dioxide -- Complying with 172.480; as adjuvant.
(3) In lieu of the components listed in paragraph (a)(2) of this
section, the following components:
Glutaraldehyde -- As cross-linking agent for insolubilizing a
coacervate of gum arabic and gelatin.
n-Octyl alcohol -- As a defoamer.
(4) In lieu of the components listed in paragraphs (a)(2) and (3) of
this section, the following component:
Petroleum wax -- Complying with 172.886. Not to exceed 50 percent by
combined weight of the microcapsule and spice-flavoring substance.
(b) The microcapsules produced from the components listed in
paragraphs (a) (1), (2), and (3) of this section may be used for
encapsulating authorized flavoring oils for use, in accordance with good
manufacturing practice, in foods for which standards of identity
established under section 401 of the Act do not preclude such use,
except that microcapsules formulated from components listed in paragraph
(a)(2) of this section may be used only for encapsulating lemon oil,
distilled lime oil, orange oil, peppermint oil, and spearmint oil for
use in dry mixes for puddings and gelatin desserts.
(c) The microcapsules produced from the components listed in
paragraphs (a) (1) and (4) of this section may be used only for
encapsulating authorized spice-flavoring substances for use, in
accordance with good manufacturing practice, in frozen pizzas which are
to be further processed by heat. Such pizzas shall bear labels or
labeling including adequate directions for use to ensure heating to
temperatures which will melt the wax to release the spice-flavoring
substances.
(45 FR 48123, July 18, 1980)
21 CFR 172.235 Morpholine.
Morpholine may be safely used as a component of food, subject to the
following restrictions.
(a) It is used as the salt(s) of one or more of the fatty acids
meeting the requirements of 172.860, as a component of protective
coatings applied to fresh fruits and vegetables.
(b) It is used at a level not in excess of that reasonably required
to produce its intended effect.
21 CFR 172.250 Petroleum naphtha.
Petroleum naphtha may be safely used in food in accordance with the
following conditions:
(a) The additive is a mixture of liquid hydrocarbons, essentially
paraffinic and naphthenic in nature obtained from petroleum,
(b) The additive is refined to meet the following specifications when
subjected to the procedures described in this paragraph.
(1) Boiling-point range: 175 F-300 F.
(2) Nonvolatile residue: 0.002 gram per 100 milliliters maximum.
(3) Ultraviolet absorbance limits, as follows:
All glassware should be scrupulously cleaned to remove all organic
matter such as oil, grease, detergent residues, etc. Examine all
glassware, including stoppers and stopcocks, under ultraviolet light to
detect any residual fluorescent contamination. As a precautionary
measure, it is recommended practice to rinse all glassware with purified
isooctane immediately before use. No grease is to be used on stopcocks
or joints. Great care to avoid contamination of petroleum naphtha
samples in handling and to assure absence of any extraneous material
arising from inadequate packaging is essential. Because some of the
polynuclear hydrocarbons sought in this test are very susceptible to
photo-oxidation, the entire procedure is to be carried out under subdued
light.
Separatory funnels. 250-milliliter, and 2,000-milliliter capacity,
equipped with tetrafluoroethylene polymer stopcocks.
Erlenmeyer flask. 125-milliliter with 24/40 standard taper neck.
Evaporation flask. 250-milliliter capacity all-glass flask equipped
with 24/40 standard taper stopper having inlet and outlet tubes to
permit passage of nitrogen across the surface of the container liquid to
be evaporated.
Condenser. 24/40 joints, fitted with drying tube, length optional.
Spectrophotometric cells. Fused quartz cells, optical path length in
the range of 5,000 centimeters 0.005 centimeter; also for checking
spectrophotometer performance only, optical path length in the range
1,000 centimeter 0.005 centimeter. With distilled water in the cells,
determine any absorbance difference.
Spectrophotometer. Spectral range 250-400 m with spectral slit width
of 2 m or less; under instrument operating conditions for these
absorbance measurements, the spectrophotometer shall also meet the
following performance requirements:
Absorbance repeatability, 0.01 at 0.4 absorbance.
Absorbance accuracy,1 0.05 at 0.4 absorbance.
Wavelength repeatability, 0.2 millimicron.
Wavelength accuracy, 1.0 millimicron.
Ultraviolet lamp. Long wavelength (3400-3800A ).
Isooctane (2,2,4-trimethylpentane). Use 180 milliliters in a
250-milliliter Erlenmeyer flask, add 1 milliliter of purified
n-hexadecane, insert the head assembly, allow nitrogen gas to flow into
the inlet tube and connect the outlet tube to a solvent trap and vacuum
line in such a way as to prevent any back flow of condensate into the
flask. The contents of the flask are evaporated on a steam bath until 1
milliliter of residue remains. Dissolve the 1 milliliter of hexadecane
residue in isooctane and make up to 25 milliliters. Determine the
absorbance in a 5-centimeter path length cell compared to isooctane as
reference. The absorbance should not exceed 0.01 per centimeter path
length between 280-400 m . If necessary, isooctane may be purified by
passage through a column of activated silica gel (Grade 12, Davidson
Chemical Co., Baltimore, Md., or equivalent) or by distillation.
Methyl alcohol, A.C.S. reagent grade. Use 10 milliliters and proceed
as with isooctane. The absorbance per centimeter of path length should
be 0.00 between 280-400 m . Methyl alcohol may be purified by simple
distillation or by refluxing in the presence of potassium hydroxide (10
grams/2 liters) and zinc dust (25 grams/2 liters) for 3 hours followed
by distillation.
n-Hexadecane, 99 percent olefin-free. Dilute 1.0 milliliter of
n-hexadecane to 25 milliliters with isooctane and determine the
absorbance in a 5-centimeter cell compared to isooctane as reference
between 280-400 m . The absorbance per centimeter path length shall not
exceed 0.00 in this range. Purify, if necessary, by percolation through
activated silica gel or by distillation.
Sodium borohydride. 98 percent.
Water. All distilled water must be extracted with isooctane before
use. A series of three successive extracts of 1.5 liters of distilled
water with 100-milliliter portions of isooctane is satisfactory.
Determination of ultraviolet absorbance. Add a 25-milliliter aliquot
of the hydrocarbon solvent together with 1 milliliter of hexadecane to
the 125-milliliter Erlenmeyer flask. While flushing with nitrogen,
evaporate to 1 milliliter on a steam bath. Nitrogen is admitted through
a 8 1-milliliter outer-diameter tube, drawn out into a 2 1-centimeter
long and 1 0.5-millimeter inner-diameter capillary tip. This is
positioned so that the capillary tip extends 4 centimeters into the
flask. The nitrogen flow rate is such that the surface of the liquid is
barely disturbed. After the volume is reduced to that of the 1
milliliter of hexadecane, the flask is left on the steam bath for 10
more minutes before removing. Add 10 milliliters of purified isooctane
to the flask and reevaporate the solution to a 1-milliliter volume in
the same manner as described above, except do not heat for an added 10
minutes. Repeat this operation twice more. Let the flask cool.
Add 10 milliliters of methyl alcohol and about 0.3 gram of sodium
borohydride. (Minimize exposure of the borohydride to the atmosphere;
a measuring dipper may be used.) Immediately fit a water-cooled
condenser equipped with a 24/40 joint and with a drying tube into the
flask, mix until the sodium borohydride is dissolved, and allow to stand
for 30 minutes at room temperature, with intermittent swirling. At the
end of this time, disconnect the flask and evaporate the methyl alcohol
on the steam bath under nitrogen until sodium borohydride begins to drop
out of solution. Remove the flask and let it cool.
Add 6 milliliters of isooctane to the flask and swirl to wash the
crystalline slurry. Carefully transfer the isooctane extract to a
250-milliliter separatory funnel. Dissolve the crystals in the flask
with about 25 milliliters of distilled water and pour this also into the
separatory funnel. Adjust the water volume in the separatory funnel to
about 100 milliliters and shake for 1 minute. After separation of the
layers, draw off the aqueous layer into a second 250-milliliter
separatory funnel. Transfer the hydrocarbon layer in the first funnel
to a 25-milliliter volumetric flask.
Carefully wash the Erlenmeyer flask with an additional 6 milliliters
of isooctane, swirl, and transfer to the second separatory funnel.
Shake the funnel for 1 minute. After separation of the layers, draw off
the aqueous layer into the first separatory funnel. Transfer the
isooctane in the second funnel to the volumetric flask. Again wash the
Erlenmeyer flask with an additional 6 milliliters of isooctane, swirl,
and transfer to the first separatory funnel. Shake the funnel for 1
minute. After separation of the layers, draw off the aqueous layer and
discard. Transfer the isooctane layer to the volumetric flask and
adjust the volume to 25 milliliters of isooctane. Mix the contents
well, then transfer to the first separatory funnel and wash twice with
50-milliliter portions of distilled water. Discard the aqueous layers
after each wash.
Determine the ultraviolet absorbance of the isooctane extract in
5-centimeter path length cells compared to isooctane as reference
between 280-400 m . Determine a reagent blank concurrently with the
sample, using 25 milliliters of purified isooctane instead of a solvent
sample and measuring the ultraviolet absorbance of the blank between
280-400m .
The reagent blank absorbance should not exceed 0.04 per centimeter
path length between 280-289 m ; 0.020 between 290-359 m ; and 0.010
between 360-400 m .
Determination of boiling-point range. Use ASTM method D86-82,
''Standard Method for Distillation of Petroleum Products,'' which is
incorporated by reference. Copies may be obtained from the American
Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or
may be examined at the Office of the Federal Register, 1100 L St. NW.,
Washington, DC 20408.
Determination of nonvolatile residue. For hydrocarbons boiling below
121 C, determine the nonvolatile residue by ASTM method D1353-78,
''Standard Test Method for Nonvolatile Matter in Volatile Solvents for
Use in Paint, Varnish, Lacquer, and Related Products;'' for those
boiling above 121 C, use ASTM method D381-80, ''Standard Test Method
for Existent Gum in Fuels by Jet Evaporation,'' which methods are
incorporated by reference. Copies may be obtained from the American
Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or
may be examined at the Office of the Federal Register, 1100 L St. NW.,
Washington, DC 20408.
(c) Petroleum naphtha containing antioxidants shall meet the
specified ultraviolet absorbance limits after correction for any
absorbance due to the antioxidants. Petroleum naphtha may contain
antioxidants authorized for use in food in an amount not to exceed that
reasonably required to accomplish the intended effect or to exceed any
prescribed limitations.
(d) Petroleum naphtha is used or intended for use as a solvent in
protective coatings on fresh citrus fruit in compliance with 172.210.
(42 FR 14491, Mar. 15, 1977, as amended at 47 FR 11835, Mar. 19,
1982; 49 FR 10104, Mar. 19, 1984; 54 FR 24896, June 12, 1989)
0421As determined by procedure using potassium chromate for reference
standard and described in National Bureau of Standards Circular 484,
Spectrophotometry, U.S. Department of Commerce, (1949). The accuracy is
to be determined by comparison with the standard values at 290, 345, and
400 millimicrons. The procedure is incorporated by reference. Copies
of the material incorporated by reference are available from the
Division of Food and Color Additives, Center for Food Safety and Applied
Nutrition (HFF-330), 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.
21 CFR 172.255 Polyacrylamide.
Polyacrylamide containing not more than 0.2 percent of acrylamide
monomer may be safely used as a film former in the imprinting of
soft-shell gelatin capsules when the amount used is not in excess of the
minimum required to produce the intended effect.
21 CFR 172.260 Oxidized polyethylene.
Oxidized polyethylene may be safely used as a component of food,
subject to the following restrictions:
(a) Oxidized polyethylene is the basic resin produced by the mild air
oxidation of polyethylene. The polyethylene used in the oxidation
process conforms to the density, maximum n-hexane extractable fraction,
and maximum xylene soluble fraction specifications prescribed in item
2.3 of the table in 177.1520(c) of this chapter. The oxidized
polyethylene has a minimum number average molecular weight of 1,200, as
determined by high temperature vapor pressure osmometry; contains a
maximum of 5 percent by weight of total oxygen; and has an acid value
of 9 to 19.
(b) The additive is used or intended for use as a protective coating
or component of protective coatings for fresh avocados, bananas, beets,
coconuts, eggplant, garlic, grapefruit, lemons, limes, mango,
muskmelons, onions, oranges, papaya, peas (in pods), pineapple,
plantain, pumpkin, rutabaga, squash (acorn), sweetpotatoes, tangerines,
turnips, watermelon, Brazil nuts, chestnuts, filberts, hazelnuts,
pecans, and walnuts (all nuts in shells).
(c) The additive is used in accordance with good manufacturing
practice and in an amount not to exceed that required to produce the
intended effect.
21 CFR 172.275 Synthetic paraffin and succinic derivatives.
Synthetic paraffin and succinic derivatives identified in this
section may be safely used as a component of food, subject to the
following restrictions:
(a) The additive is prepared with 50 percent Fischer-Tropsch process
synthetic paraffin, meeting the definition and specifications of
172.615, and 50 percent of such synthetic paraffin to which is bonded
succinic anhydride and succinic acid derivatives of isopropyl alcohol,
polyethylene glycol, and polypropylene glycol. It consists of a mixture
of the Fischer-Tropsch process paraffin (alkane), alkyl succinic
anhydride, alkyl succinic anhydride isopropyl half ester, dialkyl
succinic anhydride polyethylene glycol half ester, and dialkyl succinic
anhydride polypropylene glycol half ester, where the alkane (alkyl) has
a chain length of 30-70 carbon atoms and the polyethylene and
polypropylene glycols have molecular weights of 600 and 260,
respectively.
(b) The additive meets the following specifications: Molecular
weight, 880-930; melting point, 215 -217 F; acid number, 43-47; and
saponification number, 75-78.
(c) It is used or intended for use as a protective coating or
component of protective coatings for fresh grapefruit, lemons, limes,
muskmelons, oranges, sweetpotatoes, and tangerines.
(d) It is used in an amount not to exceed that required to produce
the intended effect.
21 CFR 172.280 Terpene resin.
The food additive terpene resin may be safely used in accordance with
the following prescribed conditions:
(a) The food additive is the betapinene polymer obtained by
polymerizing terpene hydrocarbons derived from wood. It has a softening
point of 112 C-118 C, as determined by ASTM method E28-67 (Reapproved
1982), ''Standard Test Method for Softening Point By Ring-and-Ball
Apparatus,'' which is incorporated by reference. Copies may be obtained
from the American Society for Testing Materials, 1916 Race St.,
Philadelphia, PA 19103, or may be examined at the Office of the Federal
Register, 1100 L St. NW., Washington, DC 20408.
(b) It is used or intended for use as follows:
(1) As a moisture barrier on soft gelatin capsules in an amount not
to exceed 0.07 percent of the weight of the capsule.
(2) As a moisture barrier on powders of ascorbic acid or its salts in
an amount not to exceed 7 percent of the weight of the powder.
(42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10104, Mar. 19,
1984)
21 CFR 172.280 Subpart D -- Special Dietary and Nutritional Additives
21 CFR 172.310 Aluminum nicotinate.
Aluminum nicotinate may be safely used as a source of niacin in foods
for special dietary use. A statement of the concentration of the
additive, expressed as niacin, shall appear on the label of the food
additive container or on that of any intermediate premix prepared
therefrom.
21 CFR 172.315 Nicotinamide-ascorbic acid complex.
Nicotinamide-ascorbic acid complex may be safely used in accordance
with the following prescribed conditions:
(a) The additive is the product of the controlled reaction between
ascorbic acid and nicotinamide, melting in the range 141 C to 145 C.
(b) It is used as a source of ascorbic acid and nicotinamide in
multivitamin preparations.
21 CFR 172.320 Amino acids.
The food additive amino acids may be safely used as nutrients added
to foods in accordance with the following conditions:
(a) The food additive consists of one or more of the following
individual amino acids in the free, hydrated or anhydrous form or as the
hydrochloride, sodium or potassium salts:
L-Alanine
L-Arginine
L-Asparagine
L-Aspartic acid
L-Cysteine
L-Cystine
L-Glutamic acid
L-Glutamine
Aminoacetic acid (glycine)
L-Histidine
L-Isoleucine
L-Leucine
L-Lysine
DL-Methionine (not for infant foods)
L-Methionine
L-Phenylalanine
L-Proline
L-Serine
L-Threonine
L-Tryptophan
L-Tyrosine
L-Valine
(b) The food additive meets the following specifications:
(1) As found in ''Food Chemicals Codex,'' National Academy of
Sciences/National Research Council (NAS/NRC), 3d Ed. (1981), which is
incorporated by reference (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) for the following:
L-Alanine
L-Arginine
L-Arginine Monohydrochloride
L-Cysteine Monohydrochloride
L-Cystine
Aminoacetic acid (glycine)
L-Leucine
L-Methionine
L-Methionine
L-Tryptophan
L-Phenylalanine
L-Proline
L-Serine
L-Threonine
Glutamic Acid Hydrochloride
L-Isoleucine
L-Lysine Monohydrochloride
Monopotassium L-glutamate
L-Tyrosine
L-Valine
(2) As found in ''Specifications and Criteria for Biochemical
Compounds,'' NAS/NRC Publication, 3rd Ed. (1972), which is incorporated
by reference (copies are available from the Division of Food and Color
Additives, Center for Food Safety and Applied Nutrition (HFF-330), 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) for the following:
L-Asparagine
L-Aspartic acid
L-Glutamine
L-Histidine
(c) The additive(s) is used or intended for use to significantly
improve the biological quality of the total protein in a food containing
naturally occurring primarily-intact protein that is considered a
significant dietary protein source, provided that:
(1) A reasonable daily adult intake of the finished food furnishes at
least 6.5 grams of naturally occurring primarily intact protein (based
upon 10 percent of the daily allowance for the ''reference'' adult male
recommended by the National Academy of Sciences in ''Recommended Dietary
Allowances,'' NAS Publication No. 1694, 7th Ed. (1968), which is
incorporated by reference. Copies are available from the Division of
Food and Color Additives, Center for Food Safety and Applied Nutrition
(HFF-330), 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.
(2) The additive(s) results in a protein efficiency ratio (PER) of
protein in the finished ready-to-eat food equivalent to casein as
determined by the method specified in paragraph (d) of this section.
(3) Each amino acid (or combination of the minimum number necessary
to achieve a statistically significant increase) added results in a
statistically significant increase in the PER as determined by the
method described in paragraph (d) of this section. The minimum amount
of the amino acid(s) to achieve the desired effect must be used and the
increase in PER over the primarily-intact naturally occurring protein in
the food must be substantiated as a statistically significant difference
with at least a probability (P) value of less than 0.05.
(4) The amount of the additive added for nutritive purposes plus the
amount naturally present in free and combined (as protein) form does not
exceed the following levels of amino acids expressed as percent by
weight of the total protein of the finished food:
(d) Compliance with the limitations concerning PER under paragraph
(c) of this section shall be determined by the method described in
sections 43.212-43.216, ''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. Each
manufacturer or person employing the additive(s) under the provisions of
this section shall keep and maintain throughout the period of his use of
the additive(s) and for a minimum of 3 years thereafter, records of the
tests required by this paragraph and other records required to assure
effectiveness and compliance with this regulation and shall make such
records available upon request at all reasonable hours by any officer or
employee of the Food and Drug Administration, or any other officer or
employee acting on behalf of the Secretary of Health and Human Services
and shall permit such officer or employee to conduct such inventories of
raw and finished materials on hand as he deems necessary and otherwise
to check the correctness of such records.
(e) To assure safe use of the additive, the label and labeling of the
additive and any premix thereof shall bear, in addition to the other
information required by the Act, the following:
(1) The name of the amino acid(s) contained therein including the
specific optical and chemical form.
(2) The amounts of each amino acid contained in any mixture.
(3) Adequate directions for use to provide a finished food meeting
the limitations prescribed by paragraph (c) of this section.
(f) The food additive amino acids added as nutrients to special
dietary foods that are intended for use solely under medical supervision
to meet nutritional requirements in specific medical conditions and
comply with the requirements of part 105 of this chapter are exempt from
the limitations in paragraphs (c) and (d) of this section and may be
used in such foods at levels not to exceed good manufacturing practices.
(42 FR 14491, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977, as amended
at 47 FR 11836, Mar. 19, 1982; 49 FR 10104, Mar. 19, 1984; 54 FR
24897, June 12, 1989)
21 CFR 172.325 Bakers yeast protein.
Bakers yeast protein may be safely used in food in accordance with
the following conditions:
(a) Bakers yeast protein is the insoluble proteinaceous material
remaining after the mechanical rupture of yeast cells of Saccharomyces
cerevisiae and removal of whole cell walls by centrifugation and
separation of soluble cellular materials.
(b) The additive meets the following specifications on a dry weight
basis:
(1) Zinc salts less than 500 parts per million (ppm) as zinc.
(2) Nucleic acid less than 2 percent.
(3) Less than 0.3 ppm arsenic, 0.1 ppm cadmium, 0.4 ppm lead, 0.05
ppm mercury, and 0.3 ppm selenium.
(c) The viable microbial content of the finished ingredient is:
(1) Less than 10,000 organisms/gram by aerobic plate count.
(2) Less than 10 yeasts and molds/gram.
(3) Negative for Salmonella, E. coli, coagulase positive
Staphylococci, Clostridium perfringens, Clostridium botulinum, or any
other recognized microbial pathogen or any harmful microbial toxin.
(d) The ingredient is used in food as a nutrient supplement as
defined in 170.3(o)(20) of this chapter.
21 CFR 172.330 Calcium pantothenate, calcium chloride double salt.
The food additive calcium chloride double salt of calcium
pantothenate may be safely used in foods for special dietary uses in
accordance with good manufacturing practice and under the following
prescribed conditions:
(a) The food additive is of the d (dextrorotatory) or the dl
(racemic) form.
(b) To assure safe use of the additive, the label and labeling of the
food additive container, or that of any intermediate premixes prepared
therefrom, shall bear, in addition to the other information required by
the Act, the following:
(1) The name of the additive ''calcium chloride double salt of
d-calcium pantothenate'' or ''calcium chloride double salt of dl-calcium
pantothenate'', whichever is appropriate.
(2) A statement of the appropriate concentration of the additive,
expressed as pantothenic acid.
21 CFR 172.335 D-Pantothenamide.
The food additive D-pantothenamide as a source of pantothenic acid
activity, may be safely used in foods for special dietary use in an
amount not in excess of that reasonably required to produce its intended
effect.
21 CFR 172.340 Fish protein isolate.
(a) The food additive fish protein isolate may be safely used as a
food supplement in accordance with the following prescribed conditions:
(1) The additive shall consist principally of dried fish protein
prepared from the edible portions of fish after removal of the heads,
fins, tails, bones, scales, viscera, and intestinal contents.
(2) The additive shall be derived only from species of bony fish that
are generally recognized by qualified scientists as safe for human
consumption and that can be processed as prescribed to meet the required
specifications.
(3) Only wholesome fresh fish otherwise suitable for human
consumption may be used. The fish shall be handled expeditiously under
sanitary conditions. These conditions shall be in accordance with
recognized good manufacturing practice for fish to be used as human
food.
(4) The additive shall be prepared by extraction with hexane and
food-grade ethanol to remove fat and moisture. Solvent residues shall
be reduced by drying.
(b) The food additive meets the following specifications: (Where
methods of determination are specified, they are Association of Official
Analytical Chemists Methods, 13th ed., 1980, which are incorporated by
reference). 1
(1) Protein content, as N X 6.25, shall not be less than 90 percent
by weight of the final product, as determined by the method described in
section 2.057, Improved Kjeldahl Method for Nitrate-Free Samples (20) --
Official Final Action.
(2) Moisture content shall not be more than 10 percent by weight of
the final product, as determined by the method described in section
24.003, Air Drying (1) -- Official First Action.
(3) Fat content shall not be more than 0.5 percent by weight of the
final product, as determined by the method described in section 24.005,
Crude Fat or Ether Extract -- Official Final Action.
(4) Solvent residues in the final product shall not be more than 5
parts per million of hexane and 3.5 percent ethanol by weight.
(46 FR 38072, July 24, 1981, as amended at 47 FR 53344, Nov. 26,
1982; 54 FR 24897, June 12, 1989)
1Copies are available from: Association of Official Analytical
Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or
examined at the Office of the Federal Register, 1100 L St. NW,
Washington, DC 20408.
21 CFR 172.345 Folic acid (folacin).
Folic acid (folacin) may be safely added to a food for its vitamin
property, provided the maximum intake of the food as may be consumed
during a period of 1 day, or as directed for use in the case of a
dietary supplement, will not result in daily ingestion of the additive
in excess of 0.4 milligram for foods labeled without reference to age or
physiological state; and when age or the conditions of pregnancy or
lactation are specified, in excess of 0.1 milligram for infants, 0.3
milligram for children under 4 years of age, 0.4 milligram for adults
and children 4 or more years of age, and 0.8 milligram for pregnant or
lactating women.
21 CFR 172.350 Fumaric acid and salts of fumaric acid.
Fumaric acid and its calcium, ferrous, magnesium, potassium, and
sodium salts may be safely used in food in accordance with the following
prescribed conditions:
(a) The additives meet the following specifications:
(1) Fumaric acid contains a minimum of 99.5 percent by weight of
fumaric acid, calculated on the anhydrous basis.
(2) The calcium, magnesium, potassium, and sodium salts contain a
minimum of 99 percent by weight of the respective salt, calculated on
the anhydrous basis. Ferrous fumarate contains a minimum of 31.3
percent total iron and not more than 2 percent ferric iron.
(b) With the exception of ferrous fumarate, fumaric acid and the
named salts are used singly or in combination in food at a level not in
excess of the amount reasonably required to accomplish the intended
effect.
(c) Ferrous fumarate is used as a source of iron in foods for special
dietary use, when the use is consistent with good nutrition practice.
21 CFR 172.365 Kelp.
Kelp may be safely added to a food as a source of the essential
mineral iodine, provided the maximum intake of the food as may be
consumed during a period of one day, or as directed for use in the case
of a dietary supplement, will not result in daily ingestion of the
additive so as to provide a total amount of iodine in excess of 225
micrograms for foods labeled without reference to age or physiological
state; and when age or the conditions of pregnancy or lactation are
specified, in excess of 45 micrograms for infants, 105 micrograms for
children under 4 years of age, 225 micrograms for adults and children 4
or more years of age, and 300 micrograms for pregnant or lactating
women. The food additive kelp is the dehydrated, ground product
prepared from Macrocystis pyrifera, Laminaria digitata, Laminaria
saccharina, and Laminaria cloustoni.
21 CFR 172.370 Iron-choline citrate complex.
Iron-choline citrate complex made by reacting approximately
equimolecular quantities of ferric hydroxide, choline, and citric acid
may be safely used as a source of iron in foods for special dietary use.
21 CFR 172.372 N-Acetyl-L-methionine.
The food additive N-acetyl-L-methionine may be safely added to food
(except infant foods and foods containing added nitrites/nitrates) as a
source of L-methionine for use as a nutrient in accordance with the
following conditions:
(a) N-Acetyl-L-methionine (Chemical Abstracts Service Registry No.
65-82-7) is the derivative of the amino acid methionine formed by
addition of an acetyl group to the alpha-amino group of methionine. It
may be in the free, hydrated or anhydrous form, or as the sodium or
potassium salts.
(b) The additive meets the following specifications:
(1) Purity assay, on a dry basis: Minimum 99 percent.
(2) Residue on ignition: Maximum 0.1 percent.
(3) Specific optical rotation (alpha)20D: Between ^19 and ^23 .
(4) The additive may contain residues of not more than 500 ppm ethyl
acetate; 50 ppm ethyl alcohol; 10 ppm methyl alcohol; and 10 ppm
acetone, when used as processing solvents.
(c) The additive is used or intended for use as a source of
L-methionine to improve significantly the biological quality of the
total protein in a food containing naturally occurring primarily intact
vegetable protein that is considered a significant dietary protein
source, provided that:
(1) A reasonable daily adult intake of the finished food furnishes at
least 6.5 grams of naturally occurring primarily intact vegetable
protein.
(2) The additive results in a protein efficiency ratio (PER) of
protein in the finished ready-to-eat food equivalent to casein as
determined by the method specified in paragraph (d) of this section.
(3) The use of the additive results in a statistically significant
increase in the PER as determined by the method described in paragraph
(d) of this section. The minimum amount of the additive to achieve the
desired effect must be used, and the increase in PER over the primarily
intact naturally occurring vegetable protein in the food must be
substantiated as a statistically significant difference with at least a
probability (P) value of less than 0.05.
(4) The amount of the additive added for nutritive purpose shall not
exceed the level that will provide a total of 3.1 percent L- and
DL-methionine (expressed as the free amino acid) by weight of the total
protein of the finished food, including the amount naturally present in
free and combined (as protein) form.
(5) The additive shall not be added to infant foods or to foods
containing added nitrites/nitrates.
(d) Compliance with the limitations concerning PER under paragraph
(c) of the section shall be determined by the method described in
sections 43.212-43.216, ''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. Each
manufacturer or person employing the additive under the provisions of
this section shall keep and maintain throughout the period of use of the
additive and for a minimum of 3 years thereafter, records of the tests
required by this paragraph and other records required to assure
effectiveness and compliance with this regulation. Those records shall
be made available upon request at all reasonable hours by any officer or
employee acting on behalf of the Secretary of Health and Human Services.
Those officers or employees shall be permitted to conduct inventories
of raw and finished materials on hand as are deemed necessary to verify
the records.
(e) To assure safe use of the additive, the label and labeling of the
additive and any premix thereof shall bear, in addition to the other
information required by the Act, the following:
(1) The name of the additive contained therein.
(2) The amounts of additive and each amino acid contained in any
mixture.
(3) Adequate directions for use to provide a finished food meeting
the limitations prescribed by paragraph (c) of this section.
(f) When the food additive is added as a nutrient to special dietary
foods that are intended for use solely under medical supervision to meet
nutritional requirements in specific medical conditions and these foods
comply with the requirements of part 105 of this chapter, the food
additive is exempt from the limitations in paragraphs (c)(1) through (4)
and (d) of this section and may be used in those foods at levels not to
exceed good manufacturing practices.
(43 FR 27784, June 27, 1978, as amended at 46 FR 59968, Dec. 8, 1981;
49 FR 10104, Mar. 19, 1984; 54 FR 24897, June 12, 1989)
21 CFR 172.375 Potassium iodide.
The food additive potassium iodide may be safely used in accordance
with the following prescribed conditions:
(a) Potassium iodide may be safely added to a food as a source of the
essential mineral iodine, provided the maximum intake of the food as may
be consumed during a period of one day, or as directed for use in the
case of a dietary supplement, will not result in daily ingestion of the
additive so as to provide a total amount of iodine in excess of 225
micrograms for foods labeled without reference to age or physiological
state; and when age or the conditions of pregnancy or lactation are
specified, in excess of 45 micrograms for infants, 105 micrograms for
children under 4 years of age, 225 micrograms for adults and children 4
or more years of age, and 300 micrograms for pregnant or lactating
women.
(b) To assure safe use of the additive, in addition to the other
information required by the Act, the label of the additive shall bear:
(1) The name of the additive.
(2) A statement of the concentration of the additive in any mixture.
21 CFR 172.385 Whole fish protein concentrate.
The food additive whole fish protein concentrate may be safely used
as a food supplement in accordance with the following prescribed
conditions:
(a) The additive is derived from whole, wholesome hake and hakelike
fish, herring of the genera Clupea, menhaden, and anchovy of the species
Engraulis mordax, handled expeditiously and under sanitary conditions in
accordance with good manufacturing practices recognized as proper for
fish that are used in other forms for human food.
(b) The additive consists essentially of a dried fish protein
processed from the whole fish without removal of heads, fins, tails,
viscera, or intestinal contents. It is prepared by solvent extraction
of fat and moisture with isopropyl alcohol or with ethylene dichloride
followed by isopropyl alcohol, except that the additive derived from
herring, menhaden and anchovy is prepared by solvent extraction with
isopropyl alcohol alone. Solvent residues are reduced by conventional
heat drying and/or microwave radiation and there is a partial removal of
bone.
(c) The food additive meets the following specifications:
(1) Protein content (N x 6.25) shall not be less than 75 percent by
weight of the final product, as determined by the method described in
section 2.057 in ''Official Methods of Analysis of the Association of
Official Analytical Chemists'' (AOAC), 13th Ed. (1980). Protein quality
shall not be less than 100, as determined by the method described in
sections 43.212-43.216 of the AOAC. The 13th Ed. is incorporated by
reference, and 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) Moisture content shall not exceed 10 percent by weight of the
final product, as determined by the method described in section 24.003
of the AOAC. See paragraph (c)(1) of this section for availability of
the material incorporated by reference.
(3) Fat content shall not exceed 0.5 percent by weight of the final
product, as determined by the method described in section 24.005 of the
AOAC. See paragraph (c)(1) of the this section for availability of the
material incorporated by reference.
(4) The additive may contain residues of isopropyl alcohol and
ethylene dichloride not in excess of 250 parts per million and 5 parts
per million, respectively, when used as solvents in the extraction
process.
(5) Microwave radiation meeting the requirements of 179.30 of this
chapter may be used to reduce residues of the solvents used in the
extraction process.
(6) The additive shall contain not in excess of 100 parts per million
fluorides (expressed as F).
(7) The additive shall be free of Escherichia coli and pathogenic
organisms, including Salmonella, and shall have a total bacterial plate
count of not more than 10,000 per gram.
(8) The additive shall have no more than a faint characteristic fish
odor and taste.
(d) When the additive is used or intended for use in the household as
a protein supplement in food for regular consumption by children up to 8
years of age, the amount of the additive from this source shall not
exceed 20 grams per day (about one heaping tablespoon).
(e) When the additive is used as a protein supplement in manufactured
food, the total fluoride content (expressed as F) of the finished food
shall not exceed 8 ppm based on the dry weight of the food product.
(f) To assure safe use of the additive, in addition to the other
information required by the Act:
(1) The label of consumer-sized or bulk containers of the additive
shall bear the name ''whole fish protein concentrate''.
(2) The label or labeling of containers of the additive shall bear
adequate directions for use to comply with the limitations prescribed by
paragraphs (d) and (e) of this section.
(3) Labels of manufactured foods containing the additive shall bear,
in the ingredient statement, the name of the additive, ''whole fish
protein concentrate'' in the proper order of decreasing predominance in
the finished food.
(42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10104, Mar. 19,
1984; 54 FR 24897, June 12, 1989)
21 CFR 172.395 Xylitol.
Xylitol may be safely used in foods for special dietary uses,
provided the amount used is not greater than that required to produce
its intended effect.
21 CFR 172.399 Zinc methionine sulfate.
Zinc methionine sulfate, CAS Reg. No. 56329-42-1, may be safely used
in accordance with the following prescribed conditions:
(a) The additive is the product of the reaction between equimolar
amounts of zinc sulfate and DL-methionine in purified water.
(b) The additive meets the following specifications:
Zinc content -- 19 to 22 percent.
C5H11NO2S ''DL-methionine'' -- 46 to 50 percent.
Cadmium -- not more than 0.05 part per million.
(c) The additive is used in tablet form as a source of dietary zinc.
(46 FR 58297, Dec. 1, 1981)
21 CFR 172.399 Subpart E -- Anticaking Agents
21 CFR 172.410 Calcium silicate.
Calcium silicate, including synthetic calcium silicate, may be safely
used in food in accordance with the following prescribed conditions:
(a) It is used as an anticaking agent in food in an amount not in
excess of that reasonably required to produce its intended effect.
(b) It will not exceed 2 percent by weight of the food, except that
it may be present up to 5 percent by weight of baking powder.
21 CFR 172.430 Iron ammonium citrate.
Iron ammonium citrate may be safely used in food in accordance with
the following prescribed conditions:
(a) The additive is the chemical green ferric ammonium citrate.
(b) The additive is used, or intended for use as an anticaking agent
in salt for human consumption so that the level of iron ammonium citrate
does not exceed 25 parts per million (0.0025 percent) in the finished
salt.
(c) To assure safe use of the additive the label or labeling of the
additive shall bear, in addition to the other information required by
the Act:
(1) The name of the additive.
(2) Adequate directions to provide a final product that complies with
the limitations prescribed in paragraph (b) of this section.
21 CFR 172.480 Silicon dioxide.
The food additive silicon dioxide may be safely used in food in
accordance with the following conditions:
(a) The food additive is manufactured by vapor phase hydrolysis or by
other means whereby the particle size is such as to accomplish the
intended effect.
(b) It is used as an anticaking agent, subject to the following
conditions:
(1) It is used in only those foods in which the additive has been
demonstrated to have an anticaking effect.
(2) It is used in an amount not in excess of that reasonably required
to produce its intended effect.
(3) (Reserved)
(4) It is used in an amount not to exceed 2 percent by weight of the
food.
(c) It is used or intended for use as a stabilizer in the production
of beer, and is removed from the beer by filtration prior to final
processing.
(d) It is used or intended for use as an adsorbent for
dl-a-tocopheryl acetate and pantothenyl alcohol in tableted foods for
special dietary use, in an amount not greater than that required to
accomplish the intended physical or technical effect.
21 CFR 172.490 Yellow prussiate of soda.
(a) The food additive yellow prussiate of soda (sodium ferrocyanide
decahydrate; Na4FE(CN6.10H2O) contains a minimum of 99 percent by
weight of sodium ferrocyanide decahydrate.
(b) The additive is used or intended for use as an anticaking agent
in salt and as an adjuvant in the production of dendritic crystals of
salt in an amount needed to produce its intended effect but not in
excess of 13 parts per million calculated as anhydrous sodium
ferrocyanide.
21 CFR 172.490 Subpart F -- Flavoring Agents and Related Substances
21 CFR 172.510 Natural flavoring substances and natural substances used
in conjunction with flavors.
Natural flavoring substances and natural adjuvants may be safely used
in food in accordance with the following conditions.
(a) They are used in the minimum quantity required to produce their
intended physical or technical effect and in accordance with all the
principles of good manufacturing practice.
(b) In the appropriate forms (plant parts, fluid and solid extracts,
concretes, absolutes, oils, gums, balsams, resins, oleoresins, waxes,
and distillates) they consist of one or more of the following, used
alone or in combination with flavoring substances and adjuvants
generally recognized as safe in food, previously sanctioned for such
use, or regulated in any section of this part.
(42 FR 14491, Mar. 15, 1977, as amended at 43 FR 14644, Apr. 7, 1978;
49 FR 10104, Mar. 19, 1984; 54 FR 24897, June 12, 1989)
21 CFR 172.515 Synthetic flavoring substances and adjuvants.
Synthetic flavoring substances and adjuvants may be safely used in
food in accordance with the following conditions.
(a) They are used in the minimum quantity required to produce their
intended effect, and otherwise in accordance with all the principles of
good manufacturing practice.
(b) They consist of one or more of the following, used alone or in
combination with flavoring substances and adjuvants generally recognized
as safe in food, prior-sanctioned for such use, or regulated by an
appropriate section in this part.
Acetal; acetaldehyde diethyl acetal.
Acetaldehyde phenethyl propyl acetal.
Acetanisole; 4'-methoxyacetophenone.
Acetophenone; methyl phenyl ketone.
Allyl anthranilate.
Allyl butyrate.
Allyl cinnamate.
Allyl cyclohexaneacetate.
Allyl cyclohexanebutyrate.
Allyl cyclohexanehexanoate.
Allyl cyclohexaneproprionate.
Allyl cyclohexanevalerate.
Allyl disulfide.
Allyl 2-ethylbutyrate.
Allyl hexanoate; allyl caproate.
Allyl -ionone; 1-(2,6,6-trimethyl-2-cyclo-hexene-1-yl)-iene-3-one.
Allyl isothiocyanate; mustard oil.
Allyl isovalerate.
Allyl mercaptan; 2-propene-1-thiol.
Allyl nonanoate.
Allyl octanoate.
Allyl phenoxyacetate.
Allyl phenylacetate.
Allyl propionate.
Allyl sorbate; allyl 2,4-hexadienoate.
Allyl sulfide.
Allyl tiglate; allyl trans-2-methyl-2-butenoate.
Allyl 10-undecenoate.
Ammonium isovalerate.
Ammonium sulfide.
Amyl alcohol; pentyl alcohol.
Amyl butyrate.
-Amylcinnamaldehyde.
-Amylcinnamaldehyde dimethyl acetal.
-Amylcinnamyl acetate.
-Amylcinnamyl alcohol.
-Amylcinnamyl formate.
-Amylcinnamyl isovalerate.
Amyl formate.
Amyl heptanoate.
Amyl hexanoate.
Amyl octanoate.
Anisole; methoxybenzene.
Anisyl acetate.
Anisyl alcohol; p-methoxybenzyl alcohol.
Anisyl butyrate
Anisyl formate.
Anisyl phenylacetate.
Anisyl propionate.
Beechwood creosote.
Benzaldehyde dimethyl acetal.
Benzaldehyde glyceryl acetal; 2-phenyl-m-dioxan-5-ol.
Benzaldehyde propylene glycol acetal; 4-methyl-2-phenyl-m-dioxolane.
Benzenethiol; thiophenol.
Benzoin; 2-hydroxy-2-phenylacetophenone.
Benzophenone; diphenylketone.
Benzyl acetate.
Benzyl acetoacetate.
Benzyl alcohol.
Benzyl benzoate.
Benzyl butyl ether.
Benzyl butyrate.
Benzyl cinnamate.
Benzyl 2,3-dimethylcrotonate; benzyl methyl tiglate.
Benzyl disulfide; dibenzyl disulfide.
Benzyl ethyl ether.
Benzyl formate.
3-Benzyl-4-heptanone; benzyl dipropyl ketone.
Benzyl isobutyrate.
Benzyl isovalerate.
Benzyl mercaptan; -toluenethiol.
Benzyl methoxyethyl acetal; acetaldehyde benzyl -methoxyethyl
acetal.
Benzyl phenylacetate.
Benzyl propionate.
Benzyl salicylate.
Birch tar oil.
Borneol; d-camphanol.
Bornyl acetate.
Bornyl formate.
Bornyl isovalerate.
Bornyl valerate.
-Bourbonene; 1,2,3,3a,3b ,4,5,6,6a ,6b -deca-hydro-l
aa-methyl-6-methylene-cyclobuta (1,2:3,4) dicyclopentene.
2-Butanol.
2-Butanone; methyl ethyl ketone.
Butter acids.
Butter esters.
Butyl acetate.
Butyl acetoacetate.
Butyl alcohol; 1-butanol.
Butyl anthranilate.
Butyl butyrate.
Butyl butyryllactate; lactic acid, butyl ester, butyrate.
-Butylcinnamaldehyde.
Butyl cinnamate.
Butyl 2-decenoate.
Butyl ethyl malonate.
Butyl formate.
Butyl heptanoate.
Butyl hexanoate.
Butyl p-hydroxybenzoate.
Butyl isobutyrate.
Butyl isovalerate.
Butyl lactate.
Butyl laurate.
Butyl levulinate.
Butyl phenylacetate.
Butyl propionate.
Butyl stearate.
Butyl sulfide.
Butyl 10-undecenoate.
Butyl valerate.
Butyraldehyde.
Cadinene.
Camphene; 2,2-dimethyl-3-methylenenorbornane.
d-Camphor.
Carvacrol; 2-p-cymenol.
Carvacryl ethyl ether; 2-ethoxy-p-cymene.
Carveol; p-mentha-6,8-dien-2-ol.
4-Carvomenthenol; 1-p-menthen-4-ol; 4-terpinenol.
cis Carvone oxide; 1,6-epoxy-p-menth-8-en-2-one.
Carvyl acetate.
Carvyl propionate.
-Caryophyllene.
Caryophyllene alcohol.
Caryophyllene alcohol acetate.
-Caryophyllene oxide; 4-12,12-trimethyl-9-methylene-5-oxatricylo
(8.2.0.04,6) dodecane.
Cedarwood oil alcohols.
Cedarwood oil terpenes.
1,4-Cineole.
Cinnamaldehyde ethylene glycol acetal.
Cinnamic acid.
Cinnamyl acetate.
Cinnamyl alcohol; 3-phenyl-2-propen-1-ol.
Cinnamyl benzoate.
Cinnamyl butyrate.
Cinnamyl cinnamate.
Cinnamyl formate.
Cinnamyl isobutyrate.
Cinnamyl isovalerate.
Cinnamyl phenylacetate.
Cinnamyl propionate.
Citral diethyl acetal; 3,7-dimethyl-2,6-octadienal diethyl acetal.
Citral dimethyl acetal; 3,7-dimethyl-2,6-octadienal dimethyl acetal.
Citral propylene glycol acetal.
Citronellal; 3,7-dimethyl-6-octenal; rhodinal.
Citronellol; 3,7-dimethyl-6-octen-1-ol; d-citronellol.
Citronelloxyacetaldehyde.
Citronellyl acetate.
Citronellyl butyrate.
Citronellyl formate.
Citronellyl isobutyrate.
Citronellyl phenylacetate.
Citronellyl propionate.
Citronellyl valerate.
p-Cresol.
Cuminaldehyde; cuminal; p-isopropyl benzaldehyde.
Cyclohexaneacetic acid.
Cyclohexaneethyl acetate.
Cyclohexyl acetate.
Cyclohexyl anthranilate.
Cyclohexyl butyrate.
Cyclohexyl cinnamate.
Cyclohexyl formate.
Cyclohexyl isovalerate.
Cyclohexyl propionate.
p-Cymene.
-Decalactone; 4-hydroxy-decanoic acid, -lactone.
-Decalactone; 5-hydroxy-decanoic acid, -lactone.
Decanal dimethyl acetal.
1-Decanol; decylic alcohol.
2-Decenal.
3-Decen-2-one; heptylidene acetone.
Decyl actate.
Decyl butyrate.
Decyl propionate.
Dibenzyl ether.
4,4-Dibutyl- -butyrolactone; 4,4-dibutyl-4-hydroxy-butyric acid,
-lactone.
Dibutyl sebacate.
Diethyl malate.
Diethyl malonate; ethyl malonate.
Diethyl sebacate.
Diethyl succinate.
Diethyl tartrate.
2,5-Diethyltetrahydrofuran.
Dihydrocarveol; 8-p-menthen-2-ol;
6-methyl-3-isopropenylcyclohexanol.
Dihydrocarvone.
Dihydrocarvyl acetate.
m-Dimethoxybenzene.
p-Dimethoxybenzene; dimethyl hydroquinone.
2,4-Dimethylacetophenone.
, -Dimethylbenzyl isobutyrate; phenyldimethylcarbinyl isobutyrate.
2,6-Dimethyl-5-heptenal.
2,6-Dimethyl octanal; isodecylaldehyde.
3,7-Dimethyl-1-octanol; tetrahydrogeraniol.
, -Dimethylphenethyl acetate; benzylpropyl acetate;
benzyldimethylcarbinyl acetate.
, -Dimethylphenethyl alcohol; dimethylbenzyl carbinol.
, -Dimethylphenethyl butyrate; benzyldimethylcarbinyl butyrate.
, -Dimethylphenethyl formate; benzyldimethylcarbinyl formate.
Dimethyl succinate.
1,3-Diphenyl-2-propanone; dibenzyl ketone.
delta-Dodecalactone; 5-hydroxydodecanoic acid, deltalactone.
-Dodecalactone; 4-hydroxydodecanoic acid -lactone.
2-Dodecenal.
Estragole.
-Ethoxybenzaldehyde.
Ethyl acetoacetate.
Ethyl 2-acetyl-3-phenylpropionate; ethylbenzyl acetoacetate.
Ethyl aconitate, mixed esters.
Ethyl acrylate.
Ethyl -anisate.
Ethyl anthranilate.
Ethyl benzoate.
Ethyl benzoylacetate.
-Ethylbenzyl butyrate; -phenylpropyl butyrate.
Ethyl brassylate; tridecanedioic acid cyclic ethylene glycol
diester; cyclo 1,13-ethyl-enedioxytridecan-1,13-dione.
2-Ethylbutyl acetate.
2-Ethylbutyraldehyde.
2-Ethylbutyric acid.
Ethyl cinnamate.
Ethyl crotonate; trans-2-butenoic acid ethylester.
Ethyl cyclohexanepropionate.
Ethyl decanoate.
2-Ethylfuran.
Ethyl 2-furanpropionate.
4-Ethylguaiacol; 4-ethyl-2-methoxyphenol.
Ethyl heptanoate.
2-Ethyl-2-heptenal; 2-ethyl-3-butylacrolein.
Ethyl hexanoate.
Ethyl isobutyrate.
Ethyl isovalerate.
Ethyl lactate.
Ethyl laurate.
Ethyl levulinate.
Ethyl maltol; 2-ethyl-3-hydroxy-4H-pyran-4-one.
Ethyl 2-methylbutyrate.
Ethyl myristate.
Ethyl nitrite.
Ethyl nonanoate.
Ethyl 2-nonynoate; ethyl octyne carbonate.
Ethyl octanoate.
Ethyl oleate.
Ethyl phenylacetate.
Ethyl 4-phenylbutyrate.
Ethyl 3-phenylglycidate.
Ethyl 3-phenylpropionate; ethyl hydrocinnamate.
Ethyl propionate.
Ethyl pyruvate.
Ethyl salicylate.
Ethyl sorbate; ethyl 2,4-hexadienoate.
Ethyl tiglate; ethyl trans-2-methyl-2-butenoate.
Ethyl undecanoate.
Ethyl 10-undecenoate.
Ethyl valerate.
Eucalyptol; 1,8-epoxy-p-menthane; cineole.
Eugenyl acetate.
Eugenyl benzoate.
Eugenyl formate.
Eugenyl methyl ether; 4-allylveratrole; methyl eugenol.
Farnesol; 3,7,11-trimethyl-2,6,10-dodecatrien-1-ol.
d-Fenchone; d-1,3,3-trimethyl-2-norbornanone.
Fenchyl alcohol; 1,3,3-trimethyl-2-norbornanol.
Formic acid
(2-Furyl)-2-propanone; furyl acetone.
1-Furyl-2-propanone; furyl acetone.
Fusel oil, refined (mixed amyl alcohols).
Geranyl acetoacetate; trans-3,7-dimethyl-2, 6-octadien-1-yl
acetoacetate.
Geranyl acetone; 6,10-dimethyl-5,9-undecadien-2-one.
Geranyl benzoate.
Geranyl butyrate.
Geranyl formate.
Geranyl hexanoate
Geranyl isobutyrate.
Geranyl isovalerate.
Geranyl phenylacetate.
Geranyl propionate.
Glucose pentaacetate.
Guaiacol; -methoxyphenol.
Guaiacyl acetate; -methoxyphenyl acetate.
Guaiacyl phenylacetate.
Guaiene; 1,4-dimethyl-7-isopropenyl- 9,10-octahydroazulene.
Guaiol acetate; 1,4-dimethyl-7-( -hydroxy-isopropyl)- 9,roazulene
acetate.
-Heptalactone; 4-hydroxyheptanoic acid, -lactone.
Heptanal; enanthaldehyde.
Heptanal dimethyl acetal.
Heptanal 1,2-glyceryl acetal.
2,3-Heptanedione; acetyl valeryl.
3-Heptanol.
2-Heptanone; methyl amyl ketone.
3-Heptanone; ethyl butyl ketone.
4-Heptanone; dipropyl ketone.
cis-4-Heptenal; cis-4-hepten-1-al.
Heptyl acetate.
Heptyl alcohol; enanthic alcohol.
Heptyl butyrate.
Heptyl cinnamate.
Heptyl formate.
Heptyl isobutyrate.
Heptyl octanoate.
1-Hexadecanol; cetyl alcohol.
-6-Hexadecenlactone; 16-hydroxy-6-hexadecenoic acid, -lactone;
ambrettolide.
-Hexalactone; 4-hydroxyhexanoic acid, -lactone; tonkalide.
Hexanal; caproic aldehyde.
2,3-Hexanedione; acetyl butyryl.
Hexanoic acid; caproic acid.
2-Hexenal.
2-Hexen-1-ol.
3-Hexen-1-ol; leaf alcohol.
2-Hexen-1-yl acetate.
3-Hexenyl isovalerate.
3-Hexenyl 2-methylbutyrate.
3-Hexenyl phenylacetate; cis-3-hexenyl phenylacetate.
Hexyl acetate.
2-Hexyl-4-acetoxytetrahydrofuran.
Hexyl alcohol.
Hexyl butyrate.
-Hexylcinnamaldehyde.
Hexyl formate.
Hexyl hexanoate.
2-Hexylidene cyclopentanone.
Hexyl isovalerate.
Hexyl 2-methylbutyrate.
Hexyl octanoate.
Hexyl phenylacetate; n-hexyl phenylacetate.
Hexyl propionate.
Hydroxycitronellal; 3,7-dimethyl-7-hydroxy-octanal.
Hydroxycitronellal diethyl acetal.
Hydroxycitronellal dimethyl acetal.
Hydroxycitronellal; 3,7-dimethyl-1,7-octanediol.
N-(4-Hydroxy-3-methoxybenzyl)-nonanamide; pelargonyl vanillylamide.
5-Hydroxy-4-octanone; butyroin.
4-(p-Hydroxyphenyl)-2-butanone; p-hydroxybenzyl acetone.
Indole.
-Ionone; 4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one.
-Ionone; 4-(2,6,6-trimethyl-1-cyclohexen-1-yl)-3-buten-2-one.
-Irone; 4-(2,5,6,6-tetramethyl-2-cyclohexene-1-y 6-methylionone.
Isoamyl acetate.
Isoamyl acetoacetate.
Isoamyl alcohol; isopentyl alcohol; 3-methyl-1-butanol.
Isoamyl benzoate.
Isoamyl butyrate.
Isoamyl cinnamate.
Isoamyl formate.
Isoamyl 2-furanbutyrate; -isoamyl furfurylpropionate.
Isoamyl 2-furanpropionate; -isoamyl furfurylacetate.
Isoamyl hexanoate.
Isoamyl isobutyrate.
Isoamyl isovalerate.
Isoamyl laurate.
Isoamyl-2-methylbutyrate; isopentyl-2-methylbutyrate.
Isoamyl nonanoate.
Isoamyl octanoate.
Isoamyl phenylacetate.
Isoamyl propionate.
Isoamyl pyruvate.
Isoamyl salicylate.
Isoborneol.
Isobornyl acetate.
Isobornyl formate.
Isobornyl isovalerate.
Isobornyl propionate.
Isobutyl acetate.
Isobutyl acetoacetate.
Isobutyl alcohol.
Isobutyl angelate; isobutyl cis-2-methyl-2-butenoate.
Isobutyl anthranilate.
Isobutyl benzoate.
Isobutyl butyrate.
Isobutyl cinnamate.
Isobutyl formate.
Isobutyl 2-furanpropionate.
Isobutyl heptanoate.
Isobutyl hexanoate.
Isobutyl isobutyrate.
-Isobutylphenethyl alcohol; isobutyl benzyl carbinol;
4-methyl-1-phenyl-2-pentanol.
Isobutyl phenylacetate.
Isobutyl propionate.
Isobutyl salicylate.
2-Isobutylthiazole.
Isobutyraldehyde.
Isobutyric acid.
Isoeugenol; 2-methoxy-4-propenylphenol.
Isoeugenyl acetate.
Isoeugenyl benzyl ether; benzyl isoeugenol.
Isoeugenyl ethyl ether; 2-ethoxy-5-propenyl-anisole; ethyl
isoeugenol.
Isoeugenyl formate.
Isoeugenyl methyl ether; 4-propenylveratrole; methyl isoeugenol.
Isoeugenyl phenylacetate.
Isojasmone; mixture of 2-hexylidenecyclopentanone and
2-hexyl-2-cyclopenten-1-one.
-Isomethylionone;
4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-3-buten-2-one; methyl -ionone.
Isopropyl acetate.
-Isopropylacetophenone.
Isopropyl alcohol; isopropanol.
Isopropyl benzoate.
-Isopropylbenzyl alcohol; cuminic alcohol; -cymen-7-ol.
Isopropyl butyrate.
Isopropyl cinnamate.
Isopropyl formate.
Isopropyl hexanoate.
Isopropyl isobutyrate.
Isopropyl isovalerate.
-Isopropylphenylacetaldehyde; -cymen-7-carboxaldehyde.
Isopropyl phenylacetate.
3-( -Isopropylphenyl)-propionaldehyde;
-isopropylhydrocinnamaldehyde; cuminyl acetaldehyde.
Isopropyl propionate.
Isopulegol; p-menth-8-en-3-ol.
Isopulegone; p-menth-8-en-3-one.
Isopulegyl acetate.
Isoquinoline.
Isovaleric acid.
cis-Jasmone; 3-methyl-2-(2-pentenyl)-2-cyclopenten-1-one.
Lauric aldehyde; dodecanal.
Lauryl acetate.
Lauryl alcohol; 1-dodecanol.
Lepidine; 4-methylquinoline.
Levulinic acid.
Linalool oxide; cis- and
trans-2-vinyl-2-methyl-5-(1'-hydroxy-1'-ethylethyl) tetrahydrofuran.
Linalyl anthranilate; 3,7-dimethyl-1,6-octadien-3-yl anthranilate.
Linalyl benzoate.
Linalyl butyrate.
Linalyl cinnamate.
Linalyl formate.
Linalyl hexanoate.
Linalyl isobutyrate.
Linalyl isovalerate.
Linalyl octanoate.
Linalyl propionate.
Maltol; 3-hydroxy-2-methyl-4H-pyran-4-one.
Menthadienol; p-mentha-1,8(10)-dien-9-ol.
p- Mentha-1,8-dien-7-ol; perillyl alcohol.
Menthadienyl acetate; p-mentha-1,8(10)-dien-9-yl acetate.
p-Menth-3-en-1-ol.
1-p-Menthen--9-yl acetate; p-menth-1-en-9-yl acetate.
Menthol; 2-isopropyl-5-methylcyclohexanol.
Menthone; p-menthan-3-one.
Menthyl acetate; p- menth-3-yl acetate.
Menthyl isovalerate; p-menth-3-yl isovalerate.
o-Methoxybenzaldehyde.
p- Methoxybenzaldehyde; p-anisaldehyde.
o-Methoxycinnamaldehyde.
2-Methoxy-4-methylphenol; 4-methylguaiacol; 2-methoxy-p-cresol.
4-(p-Methoxyphenyl)-2-butanone; anisyl acetone.
1-(4-Methoxyphenyl)-4-methyl-1-penten-3-one; methoxystyryl isopropyl
ketone.
1-(p-Methoxyphenyl)-1-penten-3-one; -methylanisylidene acetone;
ethone.
1-(p-Methoxyphenyl)-2-propanone; anisylmethyl ketone; anisic
ketone.
2-Methoxy-4-vinylphenol; p-vinylguaiacol.
Methyl acetate.
4'-Methylacetophenone; p-methylacetophenone; methyl p-tolyl ketone.
2-Methylallyl butyrate; 2-methyl-2-propenl-yl butyrate.
Methyl anisate.
o-Methylanisole; o-cresyl methyl ether.
p-Methylanisole; p-cresyl methyl ether; p-methoxytoluene.
Methyl benzoate.
Methylbenzyl acetate, mixed o-,m-,p-.
-Methylbenzyl acetate; styralyl acetate.
-Methylbenzyl alcohol; styralyl alcohol.
-Methylbenzyl butyrate; styralyl butyrate.
-Methylbenzyl isobutyrate; styralyl isobutyrate.
-Methylbenzyl formate; styralyl formate.
-Methylbenzyl propionate; styralyl propionate.
2-Methyl-3-buten-2-ol.
2-Methylbutyl isovalerate.
Methyl p-tert-butylphenylacetate.
2-Methylbutyraldehyde; methyl ethyl acetaldehyde.
3-Methylbutyraldehyde; isovaleraldehyde.
Methyl butyrate.
2-Methylbutyric acid.
-Methylcinnamaldehyde.
p-Methylcinnamaldehyde.
Methyl cinnamate.
2-Methyl-1,3-cyclohexadiene.
Methylcyclopentenolone; 3-methylcyclopentane-1,2-dione.
Methyl disulfide; dimethyl disulfide.
Methyl ester of rosin, partially hydrogenated (as defined in
172.615); methyl dihydroabietate.
Methyl heptanoate.
2-Methylheptanoic acid.
6-Methyl-3,5-heptadien-2-one.
Methyl-5-hepten-2-ol.
6-Methyl-5-hepten-2-one.
Methyl hexanoate.
Methyl 2-hexanoate.
Methyl p-hydroxybenzoate; methylparaben.
Methyl -ionone; 5-(2,6,6-trimethyl-2-cyclohexen-1-yl)-4-one.
Methyl -ionone; 5-(2,6,6-trimethyl-1-cyclohexen-1-yl)-4-one.
Methyl -ionone; 5-(2,6,6-trimethyl-3-cyclohexen-1-yl-)-4-one.
Methyl isobutyrate.
2-Methyl-3-(p-isopropylphenyl)-propionalde-hyde;
-methyl-p-isopropylhydro- cinnamal- dehyde; cyclamen aldehyde.
Methyl isovalerate.
Methyl laurate.
Methyl mercaptan; methanethiol.
Methyl o-methoxybenzoate.
Methyl N-methylanthranilate; dimethyl anthranilate.
Methyl 2-methylbutyrate.
Methyl 2-methylthiopropionate.
Methyl 4-methylvalerate.
Methyl myristate.
Methyl -naphthyl ketone; 2'-acetonaphthone.
Methyl nonanoate.
Methyl 2-nonenoate.
Methyl 2-nonynoate; methyloctyne carbonate.
2-Methyloctanal; methyl hexyl acetaldehyde.
Methyl octanoate.
Methyl 2-octynoate; methyl heptine carbonate.
4-Methyl-2,3-pentanedione; acetyl isobutyryl.
4-Methyl-2-pentanone; methyl isobutyl ketone.
-Methylphenethyl alcohol; hydratropyl alcohol.
Methyl phenylacetate.
3-Methyl-4-phenyl-3-butene-2-one.
2-Methyl-4-phenyl-2-butyl acetate; dimethylphenylethyl carbinyl
acetate.
2-Methyl-4-phenyl-2-butyl isobutyrate; dimethylphenyl ethylcarbinyl
isobutyrate.
3-Methyl-2-phenylbutyraldehyde; -isopropyl phenylacetaldehyde.
Methyl 4-phenylbutyrate.
4-Methyl-1-phenyl-2-pentanone; benzyl isobutyl ketone.
Methyl 3-phenylpropionate; methyl hydrocinnamate.
Methyl propionate.
3-Methyl-5-propyl-2-cyclohexen-1-one.
Methyl sulfide.
3-Methylthiopropionaldehyde; methional.
2-Methyl-3-tolylpropionaldehyde, mixed o-, m-, p-.
2-Methylundecanal; methyl nonyl acetaldehyde.
Methyl 9-undecenoate.
Methyl 2-undecynoate; methyl decyne carbonate.
Methyl valerate.
2-Methylvaleric acid.
Myrcene; 7-methyl-3-methylene-1,6-octadiene.
Myristaldehyde; tetradecanal.
d-Neomenthol; 2-isopropyl-5-methylcyclohexanol.
Nerol; cis-3,7-dimethyl-2,6-octadien-1-ol.
Nerolidol; 3,7,11-trimethyl-1,6,10-dodecatrien-3-ol.
Neryl acetate.
Neryl butyrate.
Neryl formate.
Neryl isobutyrate.
Neryl isovalerate.
Neryl propionate.
2,6-Nonadien-1-ol.
-Nonalactone; 4-hydroxynonanoic acid, -lactone; aldehyde C-18.
Nonanal; pelargonic aldehyde.
1,3-Nonanediol acetate, mixed esters.
Nonanoic acid; pelargonic acid.
2-Nonanone; methylheptyl ketone.
3-Nonanon-1-yl acetate; 1-hydroxy-3-nonanone acetate.
Nonyl acetate.
Nonyl alcohol; 1-nonanol.
Nonyl octanoate.
Nonyl isovalerate.
Nootkatone; 5,6-dimethyl-8-isopropenyl-bicyclo(4,4,0ne.
Ocimene; trans- -ocimene; 3,7-dimethyl-1,3,6-octatriene.
-Octalactone; 4-hydroxyoctanoic acid, -lactone.
Octanal; caprylaldehyde.
Octanal dimethyl acetal.
1-Octanol; octyl alcohol.
2-Octanol.
3-Octanol.
2-Octanone; methyl hexyl ketone.
3-Octanone; ethyl amyl ketone.
3-Octanon-1-ol.
1-Octen-3-ol; amyl vinyl carbinol.
1-Octen-3-yl acetate.
Octyl acetate.
3-Octyl acetate.
Octyl butyrate.
Octyl formate.
Octyl heptanoate.
Octyl isobutyrate.
Octyl isovalerate.
Octyl octanoate.
Octyl phenylacetate.
Octyl propionate.
-Pentadecalactone; 15-hydroxypentadeca-noic acid, -lactone;
pentadecanolide; angelica lactone.
2,3-Pentanedione; acetyl propionyl.
2-Pentanone; methyl propyl ketone.
4-Pentenoic acid.
1-Penten-3-ol.
Perillaldehyde; 4-isopropenyl-1-cyclohexene-1-carboxaldehyde;
p-mentha-1,8-dien-7-al.
Perillyl acetate; p-mentha-1,8-dien-7-yl acetate.
-Phellandrene; -mentha-1,5-diene.
Phenethyl acetate.
Phenethyl alcohol; -phenylethyl alcohol.
Phenethyl anthranilate.
Phenethyl benzoate.
Phenethyl butyrate.
Phenethyl cinnamate.
Phenethyl formate.
Phenethyl isobutyrate.
Phenethyl isovalerate.
Phenethyl 2-methylbutyrate.
Phenethyl phenylacetate.
Phenethyl propionate.
Phenethyl salicylate.
Phenethyl senecioate; phenethyl 3,3-dimethylacrylate.
Phenethyl tiglate.
Phenoxyacetic acid.
2-Phenoxyethyl isobutyrate.
Phenylacetaldehyde; -toluic aldehyde.
Phenylacetaldehyde 2,3-butylene glycol acetal.
Phenylacetaldehyde dimethyl acetal.
Phenylacetaldehyde glyceryl acetal.
Phenylacetic acid; -toluic acid.
4-Phenyl-2-butanol; phenylethyl methyl carbinol.
4-Phenyl-3-buten-2-ol; methyl styryl carbinol.
4-Phenyl-3-buten-2-one.
4-Phenyl-2-butyl acetate; phenylethyl methyl carbinyl acetate.
1-Phenyl-3-methyl-3-pentanol; phenylethyl methyl ethyl carbinol.
1-Phenyl-1-propanol; phenylethyl carbinol.
3-Phenyl-1-propanol; hydrocinnamyl alcohol.
2-Phenylpropionaldehyde; hydratropalde-hyde.
3-Phenylpropionaldehyde; hydrocinnamaldehyde.
2-Phenylpropionalde-hyde dimethyl acetal; hydratropic aldehyde
dimethyl acetal.
3-Phenylpropionic acid; hydrocinnamic acid.
3-Phenylpropyl acetate.
2-Phenylpropyl butyrate.
3-Phenylpropyl cinnamate.
3-Phenylpropyl formate.
3-Phenylpropyl hexanoate.
2-Phenylpropyl isobutyrate.
3-Phenylpropyl isobutyrate.
3-Phenylpropyl isovalerate.
3-Phenylpropyl propionate.
2-(3-Phenylpropyl)-tetrahydrofuran.
-Pinene; 2-pinene.
-Pinene; 2(10)-pinene.
Pine tar oil.
Pinocarveol; 2(10)-pinen-3-ol.
Piperidine.
Piperine.
d-Piperitone; p-menth-1-en-3-one.
Piperitenone; p-mentha-1,4(8)-dien-3-one.
Piperitenone oxide; 1,2-epoxy-p-menth-4-(8)-en-3-one.
Piperonyl acetate; heliotropyl acetate.
Piperonyl isobutyrate.
Polylimonene.
Polysorbate 20; polyoxyethylene (20) sorbitan monolaurate.
Polysorbate 60; polyoxyethylene (20) sorbitan monostereate.
Polysorbate 80; polyoxyethylene (20) sorbitan monooleate.
Potassium acetate.
Propenylguaethol; 6-ethoxy-m-anol.
Propionaldehyde.
Propyl acetate.
Propyl alcohol; 1-propanol.
p-Propyl anisole; dihydroanethole.
Propyl benzoate.
Propyl butyrate.
Propyl cinnamate.
Propyl disulfide.
Propyl formate.
Propyl 2-furanacrylate.
Propyl heptanoate.
Propyl hexanoate.
Propyl p-hydroxybenzoate; propylparaben.
3-Propylidenephthalide.
Propyl isobutyrate.
Propyl isovalerate.
Propyl mercaptan.
-Propylphenethyl alcohol.
Propyl phenylacetate.
Propyl propionate.
Pulegone; p-menth-4(8)-en-3-one.
Pyridine.
Pyroligneous acid extract.
Pyruvaldehyde.
Pyruvic acid.
Rhodinol; 3,7-dimethyl-7-octen-1-ol; l-citronellol.
Rhodinyl acetate.
Rhodinyl butyrate.
Rhodinyl formate.
Rhodinyl isobutyrate.
Rhodinyl isovalerate.
Rhodinyl phenylacetate.
Rhodinyl propionate.
Rum ether; ethyl oxyhydrate.
Salicylaldehyde.
Santalol, and .
Santalyl acetate.
Santalyl phenylacetate.
Skatole.
Sorbitan monostearate.
Styrene.
Sucrose octaacetate.
-Terpinene.
-Terpinene.
-Terpineol; p-menth-1-en-8-ol.
-Terpineol.
Terpinolene; p-menth-1,4(8)-diene.
Terpinyl acetate.
Terpinyl anthranilate.
Terpinyl butyrate.
Terpinyl cinnamate.
Terpinyl formate.
Terpinyl isobutyrate.
Terpinyl isovalerate.
Terpinyl propionate.
Tetrahydrofurfuryl acetate.
Tetrahydrofurfuryl alcohol.
Tetrahydrofurfuryl butyrate.
Tetrahydrofurfuryl propionate.
Tetrahydro-pseudo-ionone; 6,10-dimethyl-9-undecen-2-one.
Tetrahydrolinalool; 3,7-dimethyloctan-3-ol.
Tetramethyl ethylcyclohexenone; mixture of
5-ethyl-2,3,4,5-tetramethyl-2-cyclohexen-1-one and
5-ethyl-3,4,5,6-tetramethyl-2-cyclohexen-1-one.
2-Thienyl mercaptan; 2-thienylthiol.
Thymol.
Tolualdehyde glyceryl acetal, mixed o, m, p.
Tolualdehydes, mixed o, m, p.
p-Tolylacetaldehyde.
o-Tolyl acetate; o-cresyl acetate.
p-Tolyl acetate; p-cresyl acetate.
4-(p-Tolyl)-2-butanone; p-methylbenzylacetone.
p-Tolyl isobutyrate.
p-Tolyl laurate.
p-Tolyl phenylacetate.
2-(p-Tolyl)-propionaldehyde; p-methylhydratropic aldehyde.
Tributyl acetylcitrate.
2-Tridecenal.
2,3-Undecadione; acetyl nonyryl.
-Undecalactone; 4-hydroxyundecanoic acid -lactone; peach
aldehyde; aldehyde C-14.
Undecenal.
2-Undecanone; methyl nonyl ketone.
9-Undecenal; undecenoic aldehyde.
10-Undecenal.
Undecen-1-ol; undecylenic alcohol.
10-Undecen-1-yl acetate.
Undecyl alcohol.
Valeraldehyde; pentanal.
Valeric acid; pentanoic acid.
Vanillin acetate; acetyl vanillin.
Veratraldehyde.
Verbenol; 2-pinen-4-ol.
Zingerone; 4-(4-hydroxy-3-methoxyphenyl)-2-butanone.
(c) D-Decalactone and D-dodecalactone when used separately or in
combination in oleomargarine are used at levels not to exceed 10 parts
per million and 20 parts per million, respectively, in accordance with
166.110 of this chapter.
(d) BHA (butylated hydroxyanisole) may be used as an antioxidant in
flavoring substances whereby the additive does not exceed 0.5 percent of
the essential (volatile) oil content of the flavoring substance.
(42 FR 14491, Mar. 15, 1977, as amended at 42 FR 23148, May 6, 1977;
43 FR 19843, May 9, 1978; 45 FR 22915, Apr. 4, 1980; 47 FR 27810, June
25, 1982; 48 FR 10812, Mar. 15, 1983; 48 FR 51907, Nov. 15, 1983; 49
FR 5747, Feb. 15, 1984; 50 FR 42932, Oct. 23, 1985; 54 FR 7402, Feb.
21, 1989)
21 CFR 172.520 Cocoa with dioctyl sodium sulfosuccinate for
manufacturing.
The food additive ''cocoa with dioctyl sodium sulfosuccinate for
manufacturing,'' conforming to 163.117 of this chapter and 172.810, is
used or intended for use as a flavoring substance in dry beverage mixes
whereby the amount of dioctyl sodium sulfosuccinate does not exceed 75
parts per million of the finished beverage. The labeling of the dry
beverage mix shall bear adequate directions to assure use in compliance
with this section.
21 CFR 172.530 Disodium guanylate.
Disodium guanylate may be safely used as a flavor enhancer in foods,
at a level not in excess of that reasonably required to produce the
intended effect.
21 CFR 172.535 Disodium inosinate.
The food additive disodium inosinate may be safely used in food in
accordance with the following prescribed conditions:
(a) The food additive is the disodium salt of inosinic acid,
manufactured and purified so as to contain no more than 150 parts per
million of soluble barium in the compound disodium inosinate with seven
and one-half molecules of water of crystallization.
(b) The food additive is used as a flavoring adjuvant in food.
21 CFR 172.540 DL-Alanine.
DL-Alanine (a racemic mixture of D- and L-alanine; CAS Reg. No.
302-72-7) may be safely used as a flavor enhancer for sweeteners in
pickling mixtures at a level not to exceed 1 percent of the pickling
spice that is added to the pickling brine.
(56 FR 6968, Feb. 21, 1991)
21 CFR 172.560 Modified hop extract.
The food additive modified hop extract may be safely used in beer in
accordance with the following prescribed conditions:
(a) The food additive is used or intended for use as a flavoring
agent in the brewing of beer.
(b) The food additive is manufactured by one of the following
processes:
(1) The additive is manufactured from a hexane extract of hops by
simultaneous isomerization and selective reduction in an alkaline
aqueous medium with sodium borohydride, whereby the additive meets the
following specifications:
(i) A solution of the food additive solids is made up in
approximately 0.012 n alkaline methyl alcohol (6 milliliters of 1 n
sodium hydroxide diluted to 500 milliliters with methyl alcohol) to show
an absorbance at 253 millimicrons of 0.6 to 0.9 per centimeter. (This
absorbance is obtained by approximately 0.03 milligram solids
permilliliter.) The ultraviolet absorption spectrum of this solution
exhibits the following characteristics: An absorption peak at 253
millimicrons; no absorption peak at 325 to 330 millimicrons; the
absorbance at 268 millimicrons does not exceed the absorbance at 272
millimicrons.
(ii) The boron content of the food additive does not exceed 310 parts
per million (0.0310 percent), calculated as boron.
(2) The additive is manufactured from hops by a sequence of
extractions and fractionations, using benzene, light petroleum spirits,
and methyl alcohol as solvents, followed by isomerization by potassium
carbonate treatment. Residues of solvents in the modified hop extract
shall not exceed 1.0 part per million of benzene, 1.0 part per million
of light petroleum spirits, and 250 parts per million of methyl alcohol.
The light petroleum spirits and benzene solvents shall comply with the
specifications in 172.250 except that the boiling point range for light
petroleum spirits is 150 F-300 F.
(3) The additive is manufactured from hops by a sequence of
extractions and fractionations, using methylene chloride, hexane, and
methyl alcohol as solvents, followed by isomerization by sodium
hydroxide treatment. Residues of the solvents in the modified hop
extract shall not exceed 5 parts per million of methylene chloride, 25
parts per million of hexane, and 100 parts per million of methyl
alcohol.
(4) The additive is manufactured from hops by a sequence of
extractions and fractionations, using benzene, light petroleum spirits,
methyl alcohol, n-butyl alcohol, and ethyl acetate as solvents, followed
by isomerization by potassium carbonate treatment. Residues of solvents
in the modified hop extract shall not exceed 1.0 part per million of
benzene, 1.0 part per million of light petroleum spirits, 50 parts per
million of methyl alcohol, 50 parts per million of n-butyl alcohol, and
1 part per million of ethyl acetate. The light petroleum spirits and
benzene solvents shall comply with the specifications in 172.250 except
that the boiling point range for light petroleum spirits is 150 F to
300 F.
(5) The additive is manufactured from hops by an initial extraction
and fractionation using one or more of the following solvents: Ethylene
dichloride, hexane, isopropyl alcohol, methyl alcohol, methylene
chloride, trichloroethylene, and water; followed by isomerization by
calcium chloride or magnesium chloride treatment in ethylene dichloride,
methylene chloride, or trichloroethylene and a further sequence of
extractions and fractionations using one or more of the solvents set
forth in this paragraph. Residues of the solvents in the modified hop
extract shall not exceed 125 parts per million of hexane; 150 parts per
million of ethylene dichloride, methylene chloride, or
trichloroethylene; or 250 parts per million of isopropyl alcohol or
methyl alcohol.
(6) The additive is manufactured from hops by an initial extraction
and fractionation using one or more of the solvents listed in paragraph
(b)(5) of this section followed by: Hydrogenation using palladium as a
catalyst in methyl alcohol, ethyl alcohol, or isopropyl alcohol
acidified with hydrochloric or sulfuric acid; oxidation with peracetic
acid; isomerization by calcium chloride or magnesium chloride treatment
in ethylene dichloride, methylene chloride, or trichloroethylene
(alternatively, the hydrogenation and isomerization steps may be
performed in reverse order); and a further sequence of extractions and
fractionations using one or more of the solvents listed in paragraph
(b)(5) of this section. The additive shall meet the residue limitations
as prescribed in paragraph (b)(5) of this section.
(7) The additive is manufactured from hops as set forth in paragraph
(b)(6) of this section followed by reduction with sodium borohydride in
aqueous alkaline methyl alcohol, and a sequence of extractions and
fractionations using one or more of the solvents listed in paragraph
(b)(5) of this section. The additive shall meet the residue limitations
as prescribed in paragraph (b)(5) of this section, and a boron content
level not in excess of 300 parts per million (0.0300 percent),
calculated as boron.
(8) The additive is manufactured from hops as a nonisomerizable
nonvolatile hop resin by an initial extraction and fractionation using
one or more of the solvents listed in paragraph (b)(5) of this section
followed by a sequence of aqueous extractions and removal of nonaqueous
solvents to less than 0.5 percent. The additive is added to the wort
before or during cooking in the manufacture of beer.
21 CFR 172.575 Quinine.
Quinine, as the hydrochloride salt or sulfate salt, may be safely
used in food in accordance with the following conditions:
21 CFR 172.580 Safrole-free extract of sassafras.
The food additive safrole-free extract of sassafras may be safely
used in accordance with the following prescribed conditions:
(a) The additive is the aqueous extract obtained from the root bark
of the plant Sassafras albidum (Nuttall) Nees (Fam. Lauraceae).
(b) It is obtained by extracting the bark with dilute alcohol, first
concentrating the alcoholic solution by vacuum distillation, then
diluting the concentrate with water and discarding the oily fraction.
(c) The purified aqueous extract is safrole-free.
(d) It is used as a flavoring in food.
21 CFR 172.585 Sugar beet extract flavor base.
Sugar beet extract flavor base may be safely used in food in
accordance with the provisions of this section.
(a) Sugar beet extract flavor base is the concentrated residue of
soluble sugar beet extractives from which sugar and glutamic acid have
been recovered, and which has been subjected to ion exchange to minimize
the concentration of naturally occurring trace minerals.
(b) It is used as a flavor in food.
21 CFR 172.590 Yeast-malt sprout extract.
Yeast-malt sprout extract, as described in this section, may be
safely used in food in accordance with the following prescribed
conditions:
(a) The additive is produced by partial hydrolysis of yeast extract
(derived from Saccharomyces cereviseae, Saccharomyces fragilis, or
Candida utilis) using the sprout portion of malt barley as the source of
enzymes. The additive contains a maximum of 6 percent 5' nucleotides by
weight.
(b) The additive may be used as a flavor enhancer in food at a level
not in excess of that reasonably required to produce the intended
effect.
21 CFR 172.590 Subpart G -- Gums, Chewing Gum Bases and Related Substances
21 CFR 172.610 Arabinogalactan.
Arabinogalactan may be safely used in food in accordance with the
following conditions:
(a) Arabinogalactan is a polysaccharide extracted by water from
Western larch wood, having galactose units and arabinose units in the
approximate ratio of six to one.
(b) It is used in the following foods in the minimum quantity
required to produce its intended effect as an emulsifier, stabilizer,
binder, or bodying agent: Essential oils, nonnutritive sweeteners,
flavor bases, nonstandardized dressings, and pudding mixes.
21 CFR 172.615 Chewing gum base.
The food additive chewing gum base may be safely used in the
manufacture of chewing gum in accordance with the following prescribed
conditions:
(a) The food additive consists of one or more of the following
substances that meet the specifications and limitations prescribed in
this paragraph, used in amounts not to exceed those required to produce
the intended physical or other technical effect.
(b) In addition to the substances listed in paragraph (a) of this
section, chewing gum base may also include substances generally
recognized as safe in food.
(c) To assure safe use of the additive, in addition to the other
information required by the act, the label and labeling of the food
additive shall bear the name of the additive, ''chewing gum base.'' As
used in this paragraph, the term ''chewing gum base'' means the
manufactured or partially manufactured nonnutritive masticatory
substance comprised of one or more of the ingredients named and so
defined in paragraph (a) of this section.
(42 FR 14491, Mar. 15, 1977, as amended at 45 FR 56051, Aug. 22,
1980; 49 FR 5747, Feb. 15, 1984; 49 FR 10105, Mar. 19, 1984)
21 CFR 172.620 Carrageenan.
The food additive carrageenan may be safely used in food in
accordance with the following prescribed conditions:
(a) The food additive is the refined hydrocolloid prepared by aqueous
extraction from the following members of the families Gigartinaceae and
Solieriaceae of the class Rodophyceae (red seaweed):
Chondrus crispus.
Chondrus ocellatus.
Eucheuma cottonii.
Eucheuma spinosum.
Gigartina acicularis.
Gigartina pistillata.
Gigartina radula.
Gigartina stellata.
(b) The food additive conforms to the following conditions:
(1) It is a sulfated polysaccharide the dominant hexose units of
which are galactose and anhydrogalactose.
(2) Range of sulfate content: 20 percent to 40 percent on a
dry-weight basis.
(c) The food additive is used or intended for use in the amount
necessary for an emulsifier, stabilizer, or thickener in foods, except
for those standardized foods that do not provide for such use.
(d) To assure safe use of the additive, the label and labeling of the
additive shall bear the name of the additive, carrageenan.
21 CFR 172.623 Carrageenan with polysorbate 80.
Carrageenan otherwise meeting the definition and specifications of
172.620 (a) and (b) and salts of carrageenan otherwise meeting the
definition of 172.626(a) may be safely produced with the use of
polysorbate 80 meeting the specifications and requirements of 172.840
(a) and (b) in accordance with the following prescribed conditions:
(a) The polysorbate 80 is used only to facilitate separation of
sheeted carrageenan and salts of carrageenan from drying rolls.
(b) The carrageenan and salts of carrageenan contain not more than 5
percent by weight of polysorbate 80, and the final food containing the
additives contains polysorbate 80 in an amount not to exceed 500 parts
per million.
(c) The carrageenan and salts of carrageenan so produced are used
only in producing foods in gel form and only for the purposes defined in
172.620(c) and 172.626(b), respectively.
(d) The carrageenan and salts of carrageenan so produced are not used
in foods for which standards of identity exist unless the standards
provide for the use of carrageenan, or salts of carrageenan, combined
with polysorbate 80.
(e) The carrageenan and salts of carrageenan produced in accordance
with this section, and foods containing the same, in addition to the
other requirements of the Act, are labeled to show the presence of
polysorbate 80, and the label or labeling of the carrageenan and salts
of carrageenan so produced bear adequate directions for use.
21 CFR 172.626 Salts of carrageenan.
The food additive salts of carrageenan may be safely used in food in
accordance with the following prescribed conditions:
(a) The food additive consists of carrageenan, meeting the provisions
of 172.620, modified by increasing the concentration of one of the
naturally occurring salts (ammonium, calcium, potassium, or sodium) of
carrageenan to the level that it is the dominant salt in the additive.
(b) The food additive is used or intended for use in the amount
necessary for an emulsifier, stabilizer, or thickener in foods, except
for those standardized foods that do not provide for such use.
(c) To assure safe use of the additive, the label and labeling of the
additive shall bear the name of the salt of carrageenan that dominates
the mixture by reason of the modification, e.g., ''sodium carrageenan'',
''potassium carrageenan'', etc.
21 CFR 172.655 Furcelleran.
The food additive furcelleran may be safely used in food in
accordance with the following prescribed conditions:
(a) The food additive is the refined hydrocolloid prepared by aqueous
extraction of furcellaria fastigiata of the class Rodophyceae (red
seaweed).
(b) The food additive conforms to the following:
(1) It is a sulfated polysaccharide the dominant hexose units of
which are galactose and anhydrogalactose.
(2) Range of sulfate content: 8 percent to 19 percent, on a
dry-weight basis.
(c) The food additive is used or intended for use in the amount
necessary for an emulsifier, stabilizer, or thickener in foods, except
for those standardized foods that do not provide for such use.
(d) To assure safe use of the additive, the label and labeling of the
additive shall bear the name of the additive, furcelleran.
21 CFR 172.660 Salts of furcelleran.
The food additive salts of furcelleran may be safely used in food in
accordance with the following prescribed conditions:
(a) The food additive consists of furcelleran, meeting the provisions
of 172.655, modified by increasing the concentration of one of the
naturally occurring salts (ammonium, calcium, potassium, or sodium) of
furcelleran to the level that it is the dominant salt in the additive.
(b) The food additive is used or intended for use in the amount
necessary for an emulsifier, stabilizer, or thickener in foods, except
for those standardized foods that do not provide for such use.
(c) To assure safe use of the additive, the label and labeling of the
additive shall bear the name of the salt of furcelleran that dominates
the mixture by reason of the modification, e.g., ''sodium furcelleran'',
''potassium furcelleran'', etc.
21 CFR 172.665 Gellan gum.
The food additive gellan gum may be safely used in food in accordance
with the following prescribed conditions:
(a) The additive is a high molecular weight polysaccharide gum
produced from Pseudomonas elodea by a pure culture fermentation process
and purified by recovery with isopropyl alcohol. It is composed of
tetrasaccharide repeat units, each containing one molecule of rhamnose
and glucuronic acid, and two molecules of glucose. The glucuronic acid
is neutralized to a mixed potassium, sodium, calcium, and magnesium
salt. The polysaccharide may contain up to 5 percent of acyl (glyceryl
and acetyl) groups as the 0-glycosidically linked esters.
(b) The strain of P. elodea is nonpathogenic and nontoxic in man and
animals.
(c) The additive is produced by a process that renders it free of
viable cells of P. elodea.
(d) The additive meets the following specifications:
(1) Positive for gellan gum when subjected to the following
identification tests:
(i) A 1-percent solution is made by hydrating 1 gram of gellan gum in
99 milliliters of distilled water. The mixture is stirred for about 2
hours, using a motorized stirrer and a propeller-type stirring blade. A
small amount of the above solution is drawn into a wide bore pipet and
transferred into a solution of 10-percent calcium chloride. A tough
worm-like gel will form instantly.
(ii) To the 1-percent distilled water solution prepared for
identification test (i), 0.50 gram of sodium chloride is added. The
solution is heated to 80 C with stirring, held at 80 C for 1 minute,
and allowed to cool to room temperature without stirring. A firm gel
will form.
(2) Residual isopropyl alcohol (IPA) not to exceed 0.075 percent as
determined by the procedure described in the Xanthan Gum monograph, the
''Food Chemicals Codex,'' 3d Ed. (1981), p. 347, which reads:
IPA Standard Solution. Transfer 500.0 milligrams (mg)
chromatographic quality isopropyl alcohol into a 50-milliliter (ml)
volumetric flask, dilute to volume with water, and mix. Pipet 10 ml of
this solution into a 100-ml volumetric flask, dilute to volume with
water, and mix.
Tert-Butyl Alcohol (TBA) Standard Solution. Transfer 500.0 mg of
chromatographic quality tert-butyl alcohol into a 50-ml volumetric
flask, dilute to volume with water, and mix. Pipet 10 ml of this
solution into a 100-ml volumetric flask, dilute to volume with water,
and mix.
Mixed Standard Solution. Pipet 4 ml each of the IPA Standard
Solution and of the TBA Standard Solution into a 125-ml graduated
Erlenmeyer flask, dilute to about 100 ml with water, and mix. This
solution contains approximately 40 micrograms ( g) each of isopropyl
alcohol and tert-butyl alcohol per ml.
Sample Preparation. Disperse 1 ml of a suitable antifoam emulsion,
such as Dow-Corning G-10 or equivalent, in 200 ml of water contained in
a 1000-ml 24/40 round-bottom distilling flask. Add about 5 grams (g) of
the sample, accurately weighed. and shake for 1 hour on a wrist-action
mechanical shaker. Connect the flask to a fractionating column and
distill about 100 ml, adjusting the heat so that foam does not enter the
column. Add 4.0 ml of TBA Standard Solution to the distillate to obtain
the Sample Preparation.
Procedure. Inject about 5 microliters ( l) of the Mixed Standard
Solution into a suitable gas chromatograph equipped with a
flame-ionization detector and a 1.8 meters (m) 3.2 millimeters (mm)
stainless steel column packed with 80/100-mesh Porapak QS or equivalent.
The carrier is helium flowing at 80 ml per minute (min). The injection
port temperature is 200 C, the column temperature is 165 C, and the
detector temperature is 200 C. The retention time of isopropyl alcohol
is about 2 min, and that of tert-butyl alcohol about 3 min.
Determine the areas of IPA and TBA peaks, and calculate the response
factor, f, by the formula AIPA/ATBA, in which AIPA is the area of the
isopropyl alcohol peak, and ATBA is the area of the tert-butyl alcohol
peak.
Similarly, inject about 5 l of the Sample Preparation, and determine
the peak areas, recording the area of the isopropyl alcohol peak as a
aIPA, and that of the tert-butyl alcohol peak as aTBA. Calculate the
isopropyl alcohol content, in parts per million (ppm), in the sample
taken by the formula (aIPA 4000)/(f aTBA W), in which W is the weight of
the sample taken in grams.
(e) The additive is used or intended for use in accordance with
current good manufacturing practice as a stabilizer and thickener as
defined in 170.3(o)(28) of this chapter. The additive may be used in
the following foods when standards of identity established under section
401 of the Federal Food, Drug, and Cosmetic Act do not preclude such
use:
(1) Glazes, icings, and frostings and
(2) Jams and jellies.
(f) To assure safe use of the additive:
(1) The label of its container shall bear, in addition to other
information required by the Federal Food, Drug, and Cosmetic Act, the
name of the additive and the designation ''food grade''.
(2) The label or labeling of the food additive container shall bear
adequate directions for use.
(55 FR 39614, Sept. 28, 1990)
21 CFR 172.695 Xanthan gum.
The food additive xanthan gum may be safely used in food in
accordance with the following prescribed conditions:
(a) The additive is a polysaccharide gum derived from Xanthomonas
campestris by a pure-culture fermentation process and purified by
recovery with isopropyl alcohol. It contains D-glucose, D-mannose, and
D-glucuronic acid as the dominant hexose units and is manufactured as
the sodium, potassium, or calcium salt.
(b) The strain of Xanthomonas campestris is nonpathogenic and
nontoxic in man or other animals.
(c) The additive is produced by a process that renders it free of
viable cells of Xanthomonas campestris.
(d) The additive meets the following specifications:
(1) Residual isopropyl alcohol not to exceed 750 parts per million.
(2) An aqueous solution containing 1 percent of the additive and 1
percent of potassium chloride stirred for 2 hours has a minimum
viscosity of 600 centipoises at 75 F, as determined by Brookfield
Viscometer, Model LVF (or equivalent), using a No. 3 spindle at 60
r.p.m., and the ratio of viscosities at 75 F and 150 F is in the range
of 1.02 to 1.45.
(3) Positive for xanthan gum when subjected to the following
procedure:
Blend on a weighing paper or in a weighing pan 1.0 gram of powdered
locust bean gum with 1.0 gram of the powdered polysaccharide to be
tested. Add the blend slowly (approximately 1/2 minute) at the point of
maximum agitation to a stirred solution of 200 milliliters of distilled
water previously heated to 80 C in a 400-milliliter beaker. Continue
mechanical stirring until the mixture is in solution, but stir for a
minimum time of 30 minutes. Do not allow the water temperature to drop
below 60 C.
Set the beaker and its contents aside to cool in the absence of
agitation. Allow a minimum time of 2 hours for cooling. Examine the
cooled beaker contents for a firm rubbery gel formation after the
temperature drops below 40 C.
In the event that a gel is obtained, make up a 1 percent solution of
the polysaccharide to be tested in 200 milliliters of distilled water
previously heated to 80 C (omit the locust bean gum). Allow the
solution to cool without agitation as before. Formation of a gel on
cooling indicates that the sample is a gelling polysaccharide and not
xanthan gum.
Record the sample as ''positive'' for xanthan gum if a firm, rubbery
gel forms in the presence of locust bean gum but not in its absence.
Record the sample as ''negative'' for xanthan gum if no gel forms or if
a soft or brittle gel forms both with locust bean gum and in a 1 percent
solution of the sample (containing no locust bean gum).
(4) Positive for xanthan gum when subjected to the following
procedure:
Pipet 10 milliliters of an 0.6 percent solution of the polysaccharide
in distilled water (60 milligrams of water-soluble gum) into a
50-milliliter flask equipped with a standard taper glass joint. Pipet
in 20 milliliters of 1N hydrochloric acid. Weigh the flask. Reflux the
mixture for 3 hours. Take precautions to avoid loss of vapor during the
refluxing. Cool the solution to room temperature. Add distilled water
to make up any weight loss from the flask contents.
Pipet 1 milliliter of a 2,4-dinitrophenylhydrazine reagent (0.5
percent in 2N hydrochloric acid) into a 30-milliliter separatory funnel
followed by a 2-milliliter aliquot (4 milligrams of water-soluble gum)
of the polysaccharide hydrolyzate. Mix and allow the reaction mixture
to stand at room temperature for 5 minutes. Extract the mixture with 5
milliliters of ethyl acetate. Discard the aqueous layer.
Extract the hydrazone from the ethyl acetate with three 5 milliliter
portions of 10 percent sodium carbonate solution. Dilute the combined
sodium carbonate extracts to 100 milliliters with additional 10 percent
sodium carbonate in a 10-milliliter volumetric flask. Measure the
optical density of the sodium carbonate solution at 375 millimicrons.
Compare the results with a curve of the optical density versus
concentration of an authentic sample of pyruvic acid that has been run
through the procedure starting with the preparation of the hydrazone.
Record the percent by weight of pyruvic acid in the test
polysaccharide. Note ''positive'' for xanthan gum if the sample
contains more than 1.5 percent of pyruvic acid and ''negative'' for
xanthan gum if the sample contains less than 1.5 percent of pyruvic acid
by weight.
(e) The additive is used or intended for use in accordance with good
manufacturing practice as a stabilizer, emulsifier, thickener,
suspending agent, bodying agent, or foam enhancer in foods for which
standards of identity established under section 401 of the Act do not
preclude such use.
(f) To assure safe use of the additive:
(1) The label of its container shall bear, in addition to other
information required by the Act, the name of the additive and the
designation ''food grade''.
(2) The label or labeling of the food additive container shall bear
adequate directions for use.
21 CFR 172.695 Subpart H -- Other Specific Usage Additives
21 CFR 172.710 Adjuvants for pesticide use dilutions.
The following surfactants and related adjuvants may be safely added
to pesticide use dilutions by a grower or applicant prior to application
to the growing crop:
n-Alkyl (C8-C18) amine acetate, where the alkyl groups (C8-C18) are
derived from coconut oil, as a surfactant in emulsifier blends at levels
not in excess of 5 percent by weight of the emulsifier blends that are
added to herbicides for application to corn and sorghum.
Di-n-alkyl (C8-C18) dimethyl ammonium chloride, where the alkyl
groups (C8-C18) are derived from coconut oil, as surfactants in
emulsifier blends at levels not in excess of 5 percent by weight of
emulsifier blends that are added to herbicides for application to corn
or sorghum.
Diethanolamide condensate based on a mixture of saturated and
unsaturated soybean oil fatty acids (C16-C18) as a surfactant in
emulsifier blends that are added to the herbicide atrazine for
application to corn.
Diethanolamide condensate based on stripped coconut fatty acids
(C10C18) as a surfactant in emulsifier blends that are added to the
herbicide atrazine for application to corn.
-(p-Dodecylphenyl)-omega-hydroxypoly (oxyethylene) produced by the
condensation of 1 mole of dodecylphenol (dodecyl group is a proplyene
tetramer isomer) with an average of 4-14 or 30-70 moles of ethylene
oxide; if a blend of products is used, the average number of moles of
ethylene oxide reacted to produce any product that is a component of the
blend shall be in the range of 4-14 or 30-70.
Ethylene dichloride.
Polyglyceryl phthalate ester of coconut oil fatty acids.
-(p-(1,1,3,3-Tetramethylbutyl)
phenyl)-omega-hydroxypoly(oxyethylene) produced by the condensation of 1
mole of p-(1,1,3,3-tetramethylbutyl) phenol with an average of 4-14 or
30-70 moles of ethylene oxide; if a blend of products is used, the
average number of moles of ethylene oxide reacted to produce any product
that is a component of the blend shall be in the range of 4-14 or 30-70.
-(p-(1,1,3,3-Tetramethylbutyl)
phenyl)-omega-hydroxypoly(oxyethylene) produced by the condensation of 1
mole of p-(1,1,3,3-tetramethylbutyl) phenol with 1 mole of ethylene
oxide.
Sodium acrylate and acrylamide copolymer with a minimum average
molecular weight of 10,000,000 in which 30 percent of the polymer is
comprised of acrylate units and 70 percent acrylamide units, for use as
a drift control agent in herbicide formulations applied to crops at a
level not to exceed 0.5 ounces of the additive per acre.
21 CFR 172.715 Calcium lignosulfonate.
Calcium lignosulfonate may be safely used in or on food, subject to
the provisions of this section.
(a) Calcium lignosulfonate consists of sulfonated lignin, primarily
as calcium and sodium salts.
(b) It is used in an amount not to exceed that reasonably required to
accomplish the intended physical or technical effect when added as a
dispersing agent and stabilizer in pesticides for preharvest or
postharvest application to bananas.
21 CFR 172.720 Calcium lactobionate.
The food additive calcium lactobionate may be safely used in food in
accordance with the following prescribed conditions:
(a) The food additive is the calcium salt of lactobionic acid (4-( ,
D-galactosido)-D-gluconic acid) produced by the oxidation of lactose.
(b) It is used or intended for use as a firming agent in dry pudding
mixes at a level not greater than that required to accomplish the
intended effect.
21 CFR 172.725 Gibberellic acid and its potassium salt.
The food additives gibberellic acid and its potassium salt may be
used in the malting of barley in accordance with the following
prescribed conditions:
(a) The additives meet the following specifications:
(1) The gibberellic acid is produced by deep-culture fermentation of
a suitable nutrient medium by a strain of Fusarium moniliforme or a
selection of this culture.
(2) The gibberellic acid produced is of 80 percent purity or better.
(3) The empirical formula of gibberellic acid is represented by
C19H22O6.
(4) Potassium gibberellate is the potassium salt of the specified
gibberellic acid.
(5) The potassium gibberellate is of 80 percent purity or better.
(6) The gibberellic acid or potassium gibberellate may be diluted
with substances generally recognized as safe in foods or with salts of
fatty acids conforming to 172.863.
(b) They are used or intended for use in the malting of barley under
conditions whereby the amount of either or both additives present in the
malt is not in excess of 2 parts per million expressed as gibberellic
acid, and the treated malt is to be used in the production of fermented
malt beverages or distilled spirits only, whereby the finished distilled
spirits contain none and the finished malt beverage contains not more
than 0.5 part per million of gibberellic acid.
(c) To insure the safe use of the food additives the label of the
package shall bear, in addition to the other information required by the
Act:
(1) The name of the additive, ''gibberellic acid'' or ''potassium
gibberellate'', whichever is appropriate.
(2) An accurate statement of the concentration of the additive
contained in the package.
(3) Adequate use directions to provide not more than 2 parts per
million of gibberellic acid in the finished malt.
(4) Adequate labeling directions to provide that the final malt is
properly labeled as described in paragraph (d) of this section.
(d) To insure the safe use of the additive the label of the treated
malt shall bear, in addition to the other information required by the
Act, the statements:
(1) ''Contains not more than 2 parts per million ------------ '', the
blank being filled in with the words ''gibberellic acid'' or ''potassium
gibberellate'', whichever is appropriate; and
(2) ''Brewer's malt -- To be used in the production of fermented malt
beverages only'' or ''Distiller's malt -- To be used in the production
of distilled spirits only'', whichever is appropriate.
21 CFR 172.730 Potassium bromate.
The food additive potassium bromate may be safely used in the malting
of barley under the following prescribed conditions:
(a)(1) It is used or intended for use in the malting of barley under
conditions whereby the amount of the additive present in the malt from
the treatment does not exceed 75 parts per million of bromate
(calculated as Br), and the treated malt is used only in the production
of fermented malt beverages or distilled spirits.
(2) The total residue of inorganic bromides in fermented malt
beverages, resulting from the use of the treated malt plus additional
residues of inorganic bromides that may be present from uses in
accordance with other regulations in this chapter promulgated under
sections 408 and/or 409 of the act, does not exceed 25 parts per million
of bromide (calculated as Br). No tolerance is established for bromide
in distilled spirits because there is evidence that inorganic bromides
do not pass over in the distillation process.
(b) To assure safe use of the additive, the label or labeling of the
food additive shall bear, in addition to the other information required
by the Act, the following:
(1) The name of the additive.
(2) Adequate directions for use.
(c) To assure safe use of the additive, the label or labeling of the
treated malt shall bear, in addition to other information required by
the Act, the statement, ''Brewer's Malt -- To be used in the production
of fermented malt beverages only'', or ''Distiller's Malt -- To be used
in the production of distilled spirits only'', whichever is the case.
21 CFR 172.735 Glycerol ester of wood rosin.
Glycerol ester of wood rosin may be safely used in food in accordance
with the following prescribed conditions:
(a) It has an acid number of 3 to 9, a drop-softening point of 88
C-96 C; and a color of N or paler as determined in accordance with
Official Naval Stores Standards of the United States. It is purified by
countercurrent steam distillation.
(b) It is used to adjust the density of citrus oils used in the
preparation of beverages whereby the amount of the additive does not
exceed 100 parts per million of the finished beverage.
21 CFR 172.755 Stearyl monoglyceridyl citrate.
The food additive stearyl monoglyceridyl citrate may be safely used
in food in accordance with the following provisions:
(a) The additive is prepared by controlled chemical reaction of the
following:
(b) The additive stearyl monoglyceridyl citrate, produced as
described under paragraph (a) of this section, meets the following
specifications:
Acid number 40 to 52.
Total citric acid 15 to 18 percent.
Saponification number 215-255.
(c) The additive is used or intended for use as an emulsion
stabilizer in or with shortenings containing emulsifiers.
21 CFR 172.765 Succistearin (stearoyl propylene glycol hydrogen
succinate).
The food additive succistearin (stearoyl propylene glycol hydrogen
succinate) may be safely used in food in accordance with the following
prescribed conditions:
(a) The additive is the reaction product of succinic anhydride, fully
hydrogenated vegetable oil (predominantly C16 or C18 fatty acid chain
length), and propylene glycol.
(b) The additive meets the following specifications:
Acid number 50-150.
Hydroxyl number 15-50.
Succinated ester content 45-75 percent.
(c) The additive is used or intended for use as an emulsifier in or
with shortenings and edible oils intended for use in cakes, cake mixes,
fillings, icings, pastries, and toppings, in accordance with good
manufacturing practice.
21 CFR 172.770 Ethylene oxide polymer.
The polymer of ethylene oxide may be safely used as a foam stabilizer
in fermented malt beverages in accordance with the following conditions.
(a) It is the polymer of ethylene oxide having a minimum viscosity of
1,500 centipoises in a 1 percent aqueous solution at 25 C.
(b) It is used at a level not to exceed 300 parts per million by
weight of the fermented malt beverage.
(c) The label of the additive bears directions for use to insure
compliance with paragraph (b) of this section.
21 CFR 172.775 Methacrylic acid-divinylbenzene copolymer.
Methacrylic acid-divinylbenzene copolymer may be safely used in food
in accordance with the following prescribed conditions:
(a) The additive is produced by the polymerization of methacrylic
acid and divinylbenzene. The divinylbenzene functions as a
cross-linking agent and constitutes a minimum of 4 percent of the
polymer.
(b) Aqueous extractives from the additive do not exceed 2 percent
(dry basis) after 24 hours at 25 C.
(c) The additive is used as a carrier of vitamin B12 in foods for
special dietary use.
21 CFR 172.775 Subpart I -- Multipurpose Additives
21 CFR 172.800 Acesulfame potassium.
Acesulfame potassium (CAS Reg. No. 55589-62-3), also known as
acesulfame K, may be safely used as a sweetening agent in food in
accordance with the following prescribed conditions:
(a) Acesulfame potassium is the potassium salt of
6-methyl-1,2,3-oxathiazine-4(3H)-one-2,2-dioxide.
(b) The additive meets the following specifications:
(1) Purity is not less than 99 percent on a dry basis. The purity
shall be determined by a method titled ''Acesulfame Potassium Assay,''
which is incorporated by reference. Copies are available from the
Division of Food and Color Additives, Center for Food Safety and Applied
Nutrition (HFF-330), 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.
(2) Fluoride content is not more than 30 parts per million, as
determined by method III of the Fluoride Limit Test of the Food
Chemicals Codex, 3d Ed. (1981), p. 511, which is incorporated by
reference. Copies are available from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418, or available for
inspection at the Office of the Federal Register, 1100 L St. NW.,
Washington, DC 20408.
(c) The additive may be used in the following foods when standards of
identity established under section 401 of the Federal Food, Drug, and
Cosmetic Act do not preclude such use:
(1) Dry, free-flowing sugar substitutes in package units not to
exceed the sweetening equivalent of 2 teaspoonsful of sugar.
(2) Sugar substitute tablets.
(3) Chewing gum.
(4) Dry bases for beverages, instant coffee, and instant tea.
(5) Dry bases for gelatins, puddings, and pudding desserts.
(6) Dry bases for dairy product analogs.
(d) If the food containing the additive is represented to be for
special dietary uses, it shall be labeled in compliance with part 105 of
this chapter.
(e) The additive shall be used in accordance with current good
manufacturing practice in an amount not to exceed that reasonably
required to accomplish the intended effect.
(53 FR 28382, July 28, 1988)
21 CFR 172.802 Acetone peroxides.
The food additive acetone peroxides may be safely used in flour, and
in bread and rolls where standards of identity do not preclude its use,
in accordance with the following prescribed conditions:
(a) The additive is a mixture of monomeric and linear dimeric acetone
peroxide, with minor proportions of higher polymers, manufactured by
reaction of hydrogen peroxide and acetone.
(b) The additive may be mixed with an edible carrier to give a
concentration of: (1) 3 grams to 10 grams of hydrogen peroxide
equivalent per 100 grams of the additive, plus carrier, for use in flour
maturing and bleaching; or (2) approximately 0.75 gram of hydrogen
peroxide equivalent per 100 grams of the additive, plus carrier, for use
in dough conditioning.
(c) It is used or intended for use: (1) In maturing and bleaching of
flour in a quantity not more than sufficient for such effect; and (2)
as a dough-conditioning agent in bread and roll production at not to
exceed the quantity of hydrogen peroxide equivalent necessary for the
artificial maturing effect.
(d) To insure safe use of the additive, the label of the food
additive container and any intermediate premix thereof shall bear, in
addition to the other information required by the act:
(1) The name of the additive, ''acetone peroxides''.
(2) The concentration of the additive expressed in hydrogen peroxide
equivalents per 100 grams.
(3) Adequate use directions to provide a final product that complies
with the limitations prescribed in paragraph (c) of this section.
21 CFR 172.804 Aspartame.
The food additive aspartame may be safely used in food in accordance
with good manufacturing practice as a sweetening agent or for an
authorized technological purpose in foods for which standards of
identity established under section 401 of the Act do not preclude such
use under the following conditions:
(a) Aspartame is the chemical
(b) The additive meets the specifications of the ''Food Chemicals
Codex,'' 3d Ed. (1981) pp. 28-29 and First Supplement p. 5, which is
incorporated by reference in accordance with 5 U.S.C. 552(a). Copies
are available from the National Academy Press, 2101 Constitution Avenue
NW., Washington, DC 20418, or for inspection at the Office of the
Federal Register, 1100 L Street NW., Washington, DC 20408.
(c) The additive may be used as a sweetener in the following foods:
(1) Dry, free-flowing sugar substitutes for table use (not to include
use in cooking) in package units not exceeding the sweetening equivalent
of 1 pound of sugar.
(2) Sugar substitute tablets for sweetening hot beverages, including
coffee and tea. L-leucine may be used as a lubricant in the manufacture
of such tablets at a level not to exceed 3.5 percent of the weight of
the tablet.
(3) Breakfast cereals.
(4) Chewing gum.
(5) Dry bases for:
(i) Beverages.
(ii) Instant coffee.
(iii) Gelatins, puddings, and fillings.
(iv) Dairy product analog toppings.
(6) Carbonated beverages and carbonated beverage syrup bases.
(7) Chewable multivitamin food supplements.
(8) Noncarbonated, refrigerated single-strength and frozen
concentrates of the following beverages:
(i) Fruit juice based drinks (where food standards do not preclude
such use).
(ii) Fruit flavored drinks and ades.
(iii) Imitation fruit flavored drinks and ades.
(9) Frozen stick-type confections and novelties.
(10) Breath mints.
(11) Tea beverages to include ready-to-serve, liquid concentrates,
and dry bases.
(12) Ready-to-serve nonrefrigerated, pasteurized, aseptically
packaged diluted fruit juice beverages. For beverages whose pH is above
4.5, aspartame may be added only subsequent to pasteurization.
(13) Refrigerated ready-to-serve gelatins, puddings, and fillings.
(14) Fruit (including grape) wine beverages with ethanol contents
below 7 percent volume per volume.
(15) Yogurt-type products where aspartame is added after
pasteurization and culturing.
(16) Refrigerated flavored milk beverages.
(17) Frozen desserts.
(18) The fillings of prebaked cookies.
(19) Frozen, ready-to-thaw-and-eat cheesecakes, fruit, and fruit
toppings.
(20) Frozen dairy and nondairy frostings, toppings, and fillings.
(21) Fruit spreads, fruit toppings, and fruit syrups.
(22) Malt beverages of less than 7 percent ethanol by volume and
containing fruit juice.
(d) The additive may be used as a flavor enhancer in chewing gum.
(e) To assure safe use of the additive, in addition to the other
information required by the Act:
(1) The principal display panel of any intermediate mix of the
additive for manufacturing purposes shall bear a statement of the
concentration of the additive contained therein;
(2) The label of any food containing the additive shall bear, either
on the principal display panel or on the information panel, the
following statement:
PHENYLKETONURICS: CONTAINS PHENYLALANINE
The statement shall appear in the labeling prominently and
conspicuously as compared to other words, statements, designs or devices
and in bold type and on clear contrasting background in order to render
it likely to be read and understood by the ordinary individual under
customary conditions of purchase and use.
(3) When the additive is used in a sugar substitute for table use,
its label shall bear instructions not to use in cooking or baking.
(4) Packages of the dry, free-flowing additive shall prominently
display the sweetening equivalence in teaspoons of sugar.
(f) If the food containing the additive purports to be or is
represented for special dietary uses, it shall be labeled in compliance
with part 105 of this chapter.
(42 FR 14491, Mar. 15, 1977, as amended at 48 FR 31382, July 8, 1983;
49 FR 22468, May 30, 1984; 51 FR 43000-43002, Nov. 28, 1986; 53 FR
20837 -- 20842, June 7, 1988; 53 FR 40879, Oct. 19, 1988; 53 FR 51273,
Dec. 21, 1988; 54 FR 23647, June 2, 1989; 54 FR 31333, July 28, 1989;
57 FR 3702, 3703, 3704, Jan. 30, 1992)
21 CFR 172.806 Azodicarbonamide.
The food additive azodicarbonamide may be safely used in food in
accordance with the following prescribed conditions:
(a) It is used or intended for use:
(1) As an aging and bleaching ingredient in cereal flour in an amount
not to exceed 2.05 grams per 100 pounds of flour (0.0045 percent; 45
parts per million).
(2) As a dough conditioner in bread baking in a total amount not to
exceed 0.0045 percent (45 parts per million) by weight of the flour
used, including any quantity of azodicarbonamide added to flour in
accordance with paragraph (a)(1) of this section.
(b) To assure safe use of the additive:
(1) The label and labeling of the additive and any intermediate
premix prepared therefrom shall bear, in addition to the other
information required by the Act, the following:
(i) The name of the additive.
(ii) A statement of the concentration or the strength of the additive
in any intermediate premixes.
(2) The label or labeling of the food additive shall also bear
adequate directions for use.
21 CFR 172.808 Copolymer condensates of ethylene oxide and propylene
oxide.
Copolymer condensates of ethylene oxide and propylene oxide may be
safely used in food under the following prescribed conditions:
(a) The additive consists of one of the following:
(1) -Hydro-omega-hydroxy-poly (oxyethylene)
poly(oxypropylene)-(55-61 moles)poly(oxyethylene) block copolymer,
having a molecular weight range of 9,760-13,200 and a cloud point above
100 C in 1 percent aqueous solution.
(2) -Hydro-omega-hydroxy-poly (oxyethylene)poly(oxypropylene)-(53-59
moles)poly(oxyethylene)(14-16 moles) block copolymer, having a molecular
weight range of 3,500-4,125 and a cloud point of 9 C-12 C in 10
percent aqueous solution.
(3) -Hydro-omega-hydroxy-poly(ox-yethylene)/poly(oxypropylene)
(minimum 15 moles)/poly(oxyethylene) block copolymer, having a minimum
average molecular weight of 1900 and a minimum cloud point of 9 C-12 C
in 10 percent aqueous solution.
(4) -Hydro-omega-hydroxy-poly(ox-yethylene) poly
(oxypropylene)-(51-57 moles) poly(oxyethylene) block copolymer, having
an average molecular weight of 14,000 and a cloud point above 100 C in
1 percent aqueous solution.
(b) The additive is used or intended for use as follows:
(1) The additive identified in paragraph (a)(1) of this section is
used in practice as a solubilizing and stabilizing agent in flavor
concentrates (containing authorized flavoring oils) for use in foods for
which standards of identity established under section 401 of the Act do
not preclude such use, provided that the weight of the additive does not
exceed the weight of the flavoring oils in the flavor concentrate.
(2) The additive identified in paragraph (a)(2) of this section is
used as a processing aid and wetting agent in combination with dioctyl
sodium sulfosuccinate for fumaric acid as prescribed in 172.810.
(3) The additive identified in paragraph (a)(3) of this section is
used:
(i) As a surfactant and defoaming agent, at levels not to exceed 0.05
percent by weight, in scald baths for poultry defeathering, followed by
potable water rinse. The temperatures of the scald baths shall be not
less than 125 F.
(ii) As a foam control and rinse adjuvant in hog dehairing machines
at a use level of not more than 5 grams per hog.
(4) The additive identified in paragraph (a)(4) of this section is
used as a dough conditioner in yeast-leavened bakery products for which
standards of identity established under section 401 of the Act do not
preclude such use, provided that the amount of the additive dose not
exceed 0.5 percent by weight of the flour used.
(42 FR 14491, Mar. 15, 1977, as amended at 46 FR 57476, Nov. 24,
1981)
21 CFR 172.810 Dioctyl sodium sulfosuccinate.
The food additive dioctyl sodium sulfosuccinate, which meets the
specifications of the Food Chemicals Codex, 3d Ed. (1981), pp.
102-104, which is incorporated by reference (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), may be safely used in food in accordance
with the following prescribed conditions:
(a) As a wetting agent in the following fumaric acid-acidulated
foods: Dry gelatin dessert, dry beverage base, and fruit juice drinks,
when standards of identity do not preclude such use. The labeling of
the dry gelatin dessert and dry beverage base shall bear adequate
directions for use, and the additive shall be used in such an amount
that the finished gelatin dessert will contain not in excess of 15 parts
per million of the additive and the finished beverage or fruit juice
drink will contain not in excess of 10 parts per million of the
additive.
(b) As a processing aid in sugar factories in the production of
unrefined cane sugar, in an amount not in excess of 0.5 part per million
of the additive per percentage point of sucrose in the juice, syrup, or
massecuite being processed, and so used that the final molasses will
contain no more than 25 parts per million of the additive.
(c) As a solubilizing agent on gums and hydrophilic colloids to be
used in food as stabilizing and thickening agents, when standards of
identity do not preclude such use. The additive is used in an amount
not to exceed 0.5 percent by weight of the gums or hydrophilic colloids.
(d) As an emulsifying agent for cocoa fat in noncarbonated beverages
containing cocoa, whereby the amount of the additive does not exceed 25
parts per million of the finished beverage.
(e) As a dispersing agent in ''cocoa with dioctyl sodium
sulfosuccinate for manufacturing'' that conforms to the provisions of
163.117 of this chapter and the use limitations prescribed in 172.520,
in an amount not to exceed 0.4 percent by weight thereof.
(f) As a processing aid and wetting agent in combination with
-hydro-omega - hydroxy - poly(oxyethylene) - poly-(oxypropylene) (53-59
moles) poly(oxyethylene) (14-16 moles) block copolymer, having a
molecular weight range of 3,500-4,125 and a cloud point of 9 C-12 C in
10 percent aqueous solution, for fumaric acid used in fumaric
acid-acidulated dry beverage base and in fumaric acid-acidulated fruit
juice drinks, when standards of identity do not preclude such use. The
labeling of the dry beverage base shall bear adequate directions for
use, and the additives shall be used in such an amount that the finished
beverage or fruit juice drink will contain not in excess of a total of
10 parts per million of the dioctyl sodium sulfosuccinate-block
copolymer combination.
(42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10105, Mar. 19,
1984)
21 CFR 172.811 Glyceryl tristearate.
The food additive glyceryl tristearate may be safely used in food in
accordance with the following prescribed conditions:
(a) The food additive (CAS Reg. No. 555-43-1) is prepared by reacting
stearic acid with glycerol in the presence of a suitable catalyst.
(b) The food additive meets the following specifications:
(c) The additive is used or intended for use as follows when
standards of identity established under section 401 of the Act do not
preclude such use:
(d) To assure safe use of the additive:
(1) In addition to the other information required by the act, the
label or labeling of the additive shall bear the name of the additive.
(2) The label of the additive shall bear adequate directions to
provide a final product that complies with the limitations prescribed in
paragraph (c) of this section.
(53 FR 21632, June 9, 1988)
21 CFR 172.812 Glycine.
The food additive glycine may be safely used for technological
purposes in food in accordance with the following prescribed conditions:
(a) The additive complies with the specifications of the ''Food
Chemicals Codex,'' 3d Ed. (1981), p. 140, which is incorporated by
reference. 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.
(b) The additive is used or intended for use as follows:
(c) To assure safe use of the additive, in addition to the other
information required by the Act:
(1) The labeling of the additive shall bear adequate directions for
use of the additive in compliance with the provisions of this section.
(2) The labeling of beverage bases containing the additive shall bear
adequate directions for use to provide that beverages prepared therefrom
shall contain no more than 0.2 percent glycine.
(42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10105, Mar. 19,
1984)
21 CFR 172.814 Hydroxylated lecithin.
The food additive hydroxylated lecithin may be safely used as an
emulsifier in foods in accordance with the following conditions:
(a) The additive is obtained by the treatment of lecithin in one of
the following ways, under controlled conditions whereby the separated
fatty acid fraction of the resultant product has an acetyl value of 30
to 38:
(1) With hydrogen peroxide, benzoyl peroxide, lactic acid, and sodium
hydroxide.
(2) With hydrogen peroxide, acetic acid, and sodium hydroxide.
(b) It is used or intended for use, in accordance with good
manufacturing practice, as an emulsifier in foods, except for those
standardized foods that do not provide for such use.
(c) To assure safe use of the additive, the label of the food
additive container shall bear, in addition to the other information
required by the Act:
(1) The name of the additive, ''hydroxylated lecithin''.
(2) Adequate directions for its use.
21 CFR 172.816 Methyl glucoside-coconut oil ester.
Methyl glucoside-coconut oil ester may be safely used in food in
accordance with the following conditions:
(a) It is the methyl glucoside-coconut oil ester having the following
specifications:
(b) It is used or intended for use as follows:
(1) As an aid in crystallization of sucrose and dextrose at a level
not to exceed the minimum quantity required to produce its intended
effect.
(2) As a surfactant in molasses at a level not to exceed 320 parts
per million in the molasses.
21 CFR 172.818 Oxystearin.
The food additive oxystearin may be safely used in foods, when such
use is not precluded by standards of identity in accordance with the
following conditions:
(a) The additive is a mixture of the glycerides of partially oxidized
stearic and other fatty acids obtained by heating hydrogenated
cottonseed or soybean oil under controlled conditions, in the presence
of air and a suitable catalyst which is not a food additive as so
defined. The resultant product meets the following specifications:
(b) It is used or intended for use as a crystallization inhibitor in
vegetable oils and as a release agent in vegetable oils and vegetable
shortenings, whereby the additive does not exceed 0.125 percent of the
combined weight of the oil or shortening.
(c) To insure safe use of the additive, the label and labeling of the
additive container shall bear, in addition to the other information
required by the Act:
(1) The name of the additive.
(2) Adequate directions to provide an oil or shortening that complies
with the limitations prescribed in paragraph (b) of this section.
21 CFR 172.820 Polyethylene glycol (mean molecular weight 200-9,500).
Polyethylene glycol identified in this section may be safely used in
food in accordance with the following prescribed conditions:
(a) Identity. (1) The additive is an addition polymer of ethylene
oxide and water with a mean molecular weight of 200 to 9,500.
(2) It contains no more than 0.2 percent total by weight of ethylene
and diethylene glycols when tested by the analytical methods prescribed
in paragraph (b) of this section.
(b) Analytical method. (1) The analytical method prescribed in the
National Formulary XV (1980), page 1244, for polyethylene glycol 400
shall be used to determine the total ethylene and diethylene glycol
content of polyethylene glycols having mean molecular weights of 450 or
higher.
(2) The following analytical method shall be used to determine the
total ethylene and diethylene glycol content of polyethylene glycols
having mean molecular weights below 450.
The analytical method for determining ethylene glycol and diethylene
glycol is as follows:
Gas chromatograph with hydrogen flame ionization detector (Varian
Aerograph 600 D or equivalent). The following conditions shall be
employed with the Varian Aerograph 600 D gas chromatograph:
Column temperature: 165 C.
Inlet temperature: 260 C.
Carrier gas (nitrogen) flow rate: 70 milliliters per minute.
Hydrogen and air flow to burner: Optimize to give maximum
sensitivity.
Sample size: 2 microliters.
Elution time: Ethylene glycol: 2.0 minutes. Diethylene glycol: 6.5
minutes.
Recorder: ^0.5 to +1.05 millivolt, full span, 1 second full response
time.
Syringe: 10-microliter (Hamilton 710 N or equivalent).
Chromatograph column: 5 feet 1/8 inch. I.D. stainless steel tube
packed with sorbitol (Mathieson-Coleman-Bell 2768 Sorbitol SX850, or
equivalent) 12 percent in H2O by weight on 60-80 mesh nonacid washed
diatomaceous earth (Chromosorb W. Johns-Manville, or equivalent).
Carrier gas, nitrogen: Commercial grade in cylinder equipped with
reducing regulator to provide 50 p.s.i.g. to the gas chromatograph.
Ethylene glycol: Commercial grade. Purify if necessary, by
distillation.
Diethylene glycol: Commercial grade. Purify, if necessary, by
distillation.
Glycol standards: Prepare chromatographic standards by dissolving
known amounts of ethylene glycol and diethylene glycol in water.
Suitable concentrations for standardization range from 1 to 6 milligrams
of each component per milliliter (for example 10 milligrams diluted to
volume in a 10-milliliter volumetric flask is equivalent to 1 milligram
per milliliter).
Inject a 2-microliter aliquot of the glycol standard into the gas
chromatograph employing the conditions described above. Measure the net
peak heights for the ethylene glycol and for the diethylene glycol.
Record the values as follows:
A=Peak height in millimeters of the ethylene glycol peak.
B=milligrams of ethylene glycol per milliliter of standard solution.
C=Peak height in millimeters of the diethylene glycol peak.
D=Milligrams of diethylene glycol per milliliter of standard
solution.
Weigh approximately 4 grams of polyethylene glycol sample accurately
into a 10-milliliter volumetric flask. Dilute to volume with water.
Mix the solution thoroughly and inject a 2-microliter aliquot into the
gas chromatograph. Measure the heights, in millimeters, of the ethylene
glycol peak and of the diethylene glycol peak and record as E and F,
respectively.
(c) Uses. It may be used, except in milk or preparations intended
for addition to milk, as follows:
(1) As a coating, binder, plasticizing agent, and/or lubricant in
tablets used for food.
(2) As an adjuvant to improve flavor and as a bodying agent in
nonnutritive sweeteners identified in 180.37 of this chapter.
(3) As an adjuvant in dispersing vitamin and/or mineral preparations.
(4) As a coating on sodium nitrite to inhibit hygroscopic properties.
(d) Limitations. (1) It is used in an amount not greater than that
required to produce the intended physical or technical effect.
(2) A tolerance of zero is established for residues of polyethylene
glycol in milk.
(42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10105, Mar. 19,
1984)
21 CFR 172.822 Sodium lauryl sulfate.
The food additive sodium lauryl sulfate may be safely used in food in
accordance with the following conditions:
(a) The additive meets the following specifications:
(1) It is a mixture of sodium alkyl sulfates consisting chiefly of
sodium lauryl sulfate (CH2(CH2)10CH2OSO2Na).
(2) It has a minimum content of 90 percent sodium alkyl sulfates.
(b) It is used or intended for use:
(1) As an emulsifier in or with egg whites whereby the additive does
not exceed the following limits:
Egg white solids, 1,000 parts per million.
Frozen egg whites, 125 parts per million.
Liquid egg whites, 125 parts per million.
(2) As a whipping agent at a level not to exceed 0.5 percent by
weight of gelatine used in the preparation of marshmallows.
(3) As a surfactant in:
(i) Fumaric acid-acidulated dry beverage base whereby the additive
does not exceed 25 parts per million of the finished beverage and such
beverage base is not for use in a food for which a standard of identity
established under section 401 of the Act precludes such use.
(ii) Fumaric acid-acidulated fruit juice drinks whereby the additive
does not exceed 25 parts per million of the finished fruit juice drink
and it is not used in a fruit juice drink for which a standard of
identity established under section 401 of the Act precludes such use.
(4) As a wetting agent at a level not to exceed 10 parts per million
in the partition of high and low melting fractions of crude vegetable
oils and animal fats, provided that the partition step is followed by a
conventional refining process that includes alkali neutralization and
deodorization of the fats and oils.
(c) To insure the safe use of the additive, the label of the food
additive container shall bear, in addition to the other information
required by the Act:
(1) The name of the additive, sodium lauryl sulfate.
(2) Adequate use directions to provide a final product that complies
with the limitations prescribed in paragraph (b) of this section.
(42 FR 14491, Mar. 15, 1977, as amended at 43 FR 18668, May 2, 1978)
21 CFR 172.824 Sodium mono- and dimethyl naphthalene sulfonates.
The food additive sodium mono- and dimethyl naphthalene sulfonates
may be safely used in accordance with the following prescribed
conditions:
(a) The additive has a molecular weight range of 245-260.
(b) The additive is used or intended for use:
(1) In the crystallization of sodium carbonate in an amount not to
exceed 250 parts per million of the sodium carbonate. Such sodium
carbonate is used or intended for use in potable water systems to reduce
hardness and aid in sedimentation and coagulation by raising the pH for
the efficient utilization of other coagulation materials.
(2) As an anticaking agent in sodium nitrite at a level not in excess
of 0.1 percent by weight thereof for authorized uses in cured fish and
meat.
(3) In the washing or to assist in the lye peeling of fruits and
vegetables as prescribed in 173.315 of this chapter.
(c) In addition to the general labeling requirements of the Act:
(1) Sodium carbonate produced in accordance with paragraph (b)(1) of
this section shall be labeled to show the presence of the additive and
its label or labeling shall bear adequate directions for use.
(2) Sodium nitrite produced in accordance with paragraph (b)(2) of
this section shall bear the labeling required by 172.175 and a
statement declaring the presence of sodium mono- and dimethyl
naphthalene sulfonates.
21 CFR 172.826 Sodium stearyl fumarate.
Sodium stearyl fumarate may be safely used in food in accordance with
the following conditions:
(a) It contains not less than 99 percent sodium stearyl fumarate
calculated on the anhydrous basis, and not more than 0.25 percent sodium
stearyl maleate.
(b) The additive is used or intended for use:
(1) As a dough conditioner in yeast-leavened bakery products in an
amount not to exceed 0.5 percent by weight of the flour used.
(2) As a conditioning agent in dehydrated potatoes in an amount not
to exceed 1 percent by weight thereof.
(3) As a stabilizing agent in nonyeast-leavened bakery products in an
amount not to exceed 1 percent by weight of the flour used.
(4) As a conditioning agent in processed cereals for cooking in an
amount not to exceed 1 percent by weight of the dry cereal, except for
foods for which standards of identity preclude such use.
(5) As a conditioning agent in starch-thickened or flour-thickened
foods in an amount not to exceed 0.2 percent by weight of the food.
21 CFR 172.828 Acetylated monoglycerides.
The food additive acetylated monoglycerides may be safely used in or
on food in accordance with the following prescribed conditions:
(a) The additive is manufactured by:
(1) The interesterification of edible fats with triacetin and in the
presence of catalytic agents that are not food additives or are
authorized by regulation, followed by a molecular distillation or by
steam stripping; or
(2) The direct acetylation of edible monoglycerides with acetic
anhydride without the use of catalyst or molecular distillation, and
with the removal by vacuum distillation, if necessary, of the acetic
acid, acetic anhydride, and triacetin.
(b) The food additive has a Reichert-Meissl value of 75-200 and an
acid value of less than 6.
(c) The food additive is used at a level not in excess of the amount
reasonably required to produce its intended effect in food, or in
food-processing, food-packing, or food-storage equipment.
(42 FR 14491, Mar. 15, 1977, as amended at 50 FR 3508, Jan. 25, 1985)
21 CFR 172.830 Succinylated monoglycerides.
The food additive succinylated monoglycerides may be safely used in
food in accordance with the following prescribed conditions:
(a) The additive is a mixture of semi-and neutral succinic acid
esters of mono- and diglycerides produced by the succinylation of a
product obtained by the glycerolysis of edible fats and oils, or by the
direct esterification of glycerol with edible fat-forming fatty acids.
(b) The additive meets the following specifications:
(c) The additive is used or intended for use in the following foods:
(1) As an emulsifier in liquid and plastic shortenings at a level not
to exceed 3 percent by weight of the shortening.
(2) As a dough conditioner in bread baking, when such use is
permitted by an appropriate food standard, at a level not to exceed 0.5
percent by weight of the flour used.
21 CFR 172.832 Monoglyceride citrate.
A food additive that is a mixture of glyceryl monooleate and its
citric acid monoester manufactured by the reaction of glyceryl
monooleate with citric acid under controlled conditions may be safely
used as a synergist and solubilizer for antioxidants in oils and fats,
when used in accordance with the conditions prescribed in this section.
(a) The food additive meets the following specifications:
Acid number, 70-100.
Total citric acid (free and combined), 14 percent-17 percent.
(b) It is used, or intended for use, in antioxidant formulations for
addition to oils and fats whereby the additive does not exceed 200 parts
per million of the combined weight of the oil or fat and the additive.
(c) To assure safe use of the additive:
(1) The container label shall bear, in addition to the other
information required by the Act, the name of the additive.
(2) The label or accompanying labeling shall bear adequate directions
for the use of the additive which, if followed, will result in a food
that complies with the requirements of this section.
21 CFR 172.834 Ethoxylated mono- and diglycerides.
The food additive ethoxylated mono-and diglycerides (polyoxyethylene
(20) mono- and diglycerides of fatty acids) (polyglycerate 60) may be
safely used in food in accordance with the following prescribed
conditions:
(a) The food additive is manufactured by:
(1) Glycerolysis of edible fats primarily composed of stearic,
palmitic, and myristic acids; or
(2) Direct esterification of glycerol with a mixture of primarily
stearic, palmitic, and myristic acids;
to yield a product with less than 0.3 acid number and less than 0.2
percent water, which is then reacted with ethylene oxide.
(b) The additive meets the following specifications:
Saponification number, 65-75.
Acid number, 0-2.
Hydroxyl number, 65-80.
Oxyethylene content, 60.5-65.0 percent.
(c) The additive is used or intended for use in the following foods
when standards of identity established under section 401 of the Act do
not preclude such use:
(d) When the name ''polyglycerate 60'' is used in labeling it shall
be followed by either ''polyoxyethylene (20) mono-and diglycerides of
fatty acids'' or ''ethoxylated mono- and diglycerides'' in parentheses.
(42 FR 14491, Mar. 15, 1977, as amended at 42 FR 37973, July 26,
1977; 50 FR 49536, Dec. 3, 1985)
21 CFR 172.836 Polysorbate 60.
The food additive polysorbate 60 (polyoxyethylene (20) sorbitan
monostearate) which is a mixture of polyoxyethylene ethers of mixed
partial stearic and palmitic acid esters of sorbitol anhydrides and
related compounds, may be safely used in food in accordance with the
following prescribed conditions:
(a) The food additive is manufactured by reacting stearic acid
(usually containing associated fatty acids, chiefly palmitic) with
sorbitol to yield a product with a maximum acid number of 10 and a
maximum water content of 0.2 percent, which is then reacted with
ethylene oxide.
(b) The food additive meets the following specifications:
Saponification number 45-55.
Acid number 0-2.
Hydroxyl number 81-96.
Oxyethylene content 65 percent-69.5 percent.
(c) It is used or intended for use as follows:
(1) As an emulsifier in whipped edible oil topping with or without
one or a combination of the following:
(i) Sorbitan monostearate;
(ii) Polysorbate 65;
(iii) Polysorbate 80;
whereby the maximum amount of the additive or additives used does not
exceed 0.4 percent of the weight of the finished whipped edible oil
topping; except that a combination of the additive with sorbitan
monostearate may be used in excess of 0.4 percent, provided that the
amount of the additive does not exceed 0.77 percent and the amount of
sorbitan monostearate does not exceed 0.27 percent of the weight of the
finished whipped edible oil topping.
(2) As an emulsifier in cakes and cake mixes, with or without one or
a combination of the following:
(i) Polysorbate 65.
(ii) Sorbitan monostearate.
When used alone, the maximum amount of polysorbate 60 shall not
exceed 0.46 percent of the cake or cake mix, on a dry-weight basis.
When used with polysorbate 65 and/or sorbitan monostearate, it shall not
exceed 0.46 percent, nor shall the polysorbate 65 exceed 0.32 percent or
the sorbitan monostearate exceed 0.61 percent, and no combination of
these emulsifiers shall exceed 0.66 percent of the cake or cake mix, all
calculated on a dry-weight basis.
(3) As an emulsifier, alone or in combination with sorbitan
monostearate, in nonstandardized confectionery coatings and standardized
cacao products specified in 163.123, 163.130, 163.135, 163.140,
163.145, and 163.150 of this chapter, as follows:
(i) It is used alone in an amount not to exceed 0.5 percent of the
weight of the finished nonstandardized confectionery coating or
standardized cacao product.
(ii) It is used with sorbitan monostearate in any combination of up
to 0.5 percent of polysorbate 60 and up to 1 percent of sorbitan
monostearate: Provided, That the total combination does not exceed 1
percent of the weight of the finished nonstandardized confectionery
coating or standardized cacao product.
(4) (Reserved)
(5) As an emulsifier in cake icings and cake fillings, with or
without one or a combination of the following:
(i) Polysorbate 65.
(ii) Sorbitan monostearate.
When used alone, the maximum amount of polysorbate 60 shall not
exceed 0.46 percent of the weight of the cake icings and cake fillings.
When used with polysorbate 65 and/or sorbitan monostearate, it shall not
exceed 0.46 percent, nor shall the polysorbate 65 exceed 0.32 percent or
the sorbitan monostearate exceed 0.7 percent, and no combination of
these emulsifiers shall exceed 1 percent of the weight of the cake icing
or cake filling.
(6) To impart greater opacity to sugar-type confection coatings
whereby the maximum amount of the additive does not exceed 0.2 percent
of the weight of the finished sugar coating.
(7) As an emulsifier in nonstandardized dressings whereby the maximum
amount of the additive does not exceed 0.3 percent of the weight of the
finished dressings.
(8) As an emulsifier, alone or in combination with polysorbate 80, in
shortenings and edible oils intended for use in foods as follows, when
standards of identity established under section 401 of the act do not
preclude such use:
(i) It is used alone in an amount not to exceed 1 percent of the
weight of the finished shortening or oil.
(ii) It is used with polysorbate 80 in any combination providing no
more than 1 percent of polysorbate 60 and no more than 1 percent of
polysorbate 80, provided that the total combination does not exceed 1
percent of the finished shortening or oil.
(iii) The 1-percent limitation specified in paragraph (c)(8) (i) and
(ii) of this section may be exceeded in premix concentrates of
shortening or edible oil if the labeling complies with the requirements
of paragraph (d) of this section.
(9) As an emulsifier in solid-state, edible vegetable fat-water
emulsions intended for use as substitutes for milk or cream in beverage
coffee, with or without one or a combination of the following:
(i) Polysorbate 65.
(ii) Sorbitan monostearate.
The maximum amount of the additive or additives shall not exceed 0.4
percent by weight of the finished edible vegetable fat-water emulsion.
(10) As a foaming agent in nonalcoholic mixes, to be added to
alcoholic beverages in the preparation of mixed alcoholic drinks, at a
level not to exceed 4.5 percent by weight of the nonalcoholic mix.
(11) As a dough conditioner in yeast-leavened bakery products in an
amount not to exceed 0.5 percent by weight of the flour used.
(12) As an emulsifier, alone or in combination with sorbitan
monostearate, in the minimum quantity required to accomplish the
intended effect, in formulations of white mineral oil conforming with
172.878 and/or petroleum wax conforming with 172.886 for use as
protective coatings on raw fruits and vegetables.
(13) As a dispersing agent in artificially sweetened gelatin desserts
and in artificially sweetened gelatin dessert mixes, whereby the amount
of the additive does not exceed 0.5 percent on a dry-weight basis.
(14) As an emulsifier in chocolate flavored syrups, whereby the
maximum amount of the additive does not exceed 0.05 percent in the
finished product.
(15) As a surfactant and wetting agent for natural and artificial
colors in food as follows:
(i) In powdered soft drink mixes in an amount not to exceed 4.5
percent by weight of the mix.
(ii) In sugar-based gelatin dessert mixes in an amount not to exceed
0.5 percent by weight of the mix.
(iii) In artificially sweetened gelatin dessert mixes in an amount
not to exceed 3.6 percent by weight of the mix.
(iv) In sugar-based pudding mixes in an amount not to exceed 0.5
percent by weight of the mix.
(v) In artificially sweetened pudding mixes in an amount not to
exceed 0.5 percent by weight of the mix.
(d) To assure safe use of the additive, in addition to the other
information required by the Act:
(1) The label of the additive and any intermediate premixes shall
bear:
(i) The name of the additive.
(ii) A statement of the concentration or strength of the additive in
any intermediate premixes.
(2) The label or labeling shall bear adequate directions to provide a
final product that complies with the limitations prescribed in paragraph
(c) of this section.
(42 FR 14491, Mar. 15, 1977, as amended at 43 FR 2871, Jan. 25, 1978;
45 FR 58836, Sept. 5, 1980; 46 FR 8466, Jan. 27, 1981)
21 CFR 172.838 Polysorbate 65.
The food additive polysorbate 65 (polyoxyethylene (20) sorbitan
tristearate), which is a mixture of polyoxyethylene ethers of mixed
stearic acid esters of sorbitol anhydrides and related compounds, may be
safely used in food in accordance with the following prescribed
conditions:
(a) The food additive is manufactured by reacting stearic acid
(usually containing associated fatty acids, chiefly palmitic) with
sorbitol to yield a product with a maximum acid number of 15 and a
maximum water content of 0.2 percent, which is then reacted with
ethylene oxide.
(b) The food additive meets the following specifications:
Saponification number 88-98.
Acid number 0-2.
Hydroxyl number 44-60.
Oxyethylene content 46 percent-50 percent.
(c) The additive is used, or intended for use, as follows:
(1) As an emulsifier in ice cream, frozen custard, ice milk, fruit
sherbet and nonstandardized frozen desserts when used alone or in
combination with polysorbate 80, whereby the maximum amount of the
additives, alone or in combination, does not exceed 0.1 percent of the
finished frozen dessert.
(2) As an emulsifier in cakes and cake mixes, with or without one or
a combination of the following:
(i) Sorbitan monostearate.
(ii) Polysorbate 60.
When used alone, the maximum amount of polysorbate 65 shall not
exceed 0.32 percent of the cake or cake mix, on a dry-weight basis.
When used with sorbitan monostearate and/or polysorbate 60, it shall not
exceed 0.32 percent, nor shall the sorbitan monostearate exceed 0.61
percent or the polysorbate 60 exceed 0.46 percent, and no combination of
these emulsifiers shall exceed 0.66 percent of the cake or cake mix, all
calculated on a dry-weight basis.
(3) As an emulsifier in whipped edible oil topping with or without
one or a combination of the following:
(i) Sorbitan monostearate;
(ii) Polysorbate 60;
(iii) Polysorbate 80;
whereby the maximum amount of the additive or additives used does not
exceed 0.4 percent of the weight of the finished whipped edible oil
topping.
(4) As an emulsifier in solid-state, edible vegetable fat-water
emulsions intended for use as substitutes for milk or cream in beverage
coffee, with or without one or a combination of the following:
(i) Sorbitan monostearate.
(ii) Polysorbate 60.
The maximum amount of the additive or additives shall not exceed 0.4
percent by weight of the finished edible vegetable fat-water emulsion.
(5) As an emulsifier in cake icings and cake fillings, with or
without one or a combination of the following:
(i) Sorbitan monostearate.
(ii) Polysorbate 60.
When used alone, the maximum amount of polysorbate 65 shall not
exceed 0.32 percent of the weight of the cake icing or cake filling.
When used with sorbitan monostearate and/or polysorbate 60, it shall not
exceed 0.32 percent, nor shall the sorbitan monostearate exceed 0.7
percent or the polysorbate 60 exceed 0.46 percent, and no combination of
these emulsifiers shall exceed 1 percent of the weight of the cake icing
or cake filling.
(d) To assure safe use of the additive, in addition to the other
information required by the Act:
(1) The label of the additive and any intermediate premixes shall
bear:
(i) The name of the additive.
(ii) A statement of the concentration or strength of the additive in
any intermediate premixes.
(2) The label or labeling shall bear adequate directions to provide a
final product that complies with the limitations prescribed in paragraph
(c) of this section.
(42 FR 14491, Mar. 15, 1977, as amended at 43 FR 2871, Jan. 20, 1978)
21 CFR 172.840 Polysorbate 80.
The food additive polysorbate 80 (polyoxyethylene (20) sorbitan
monooleate), which is a mixture of polyoxyethylene ethers of mixed
partial oleic acid esters of sorbitol anhydrides and related compounds,
may be safely used in food in accordance with the following prescribed
conditions:
(a) The food additive is manufactured by reacting oleic acid (usually
containing associated fatty acids) with sorbitol to yield a product with
a maximum acid number of 7.5 and a maximum water content of 0.5 percent,
which is then reacted with ethylene oxide.
(b) The food additive meets the following specifications:
Saponification number 45-55.
Acid number 0-2.
Hydroxyl number 65-80.
Oxyethylene content 65 percent-69.5 percent.
(c) The additive is used or intended for use as follows:
(1) An emulsifier in ice cream, frozen custard, ice milk, fruit
sherbet, and nonstandardized frozen desserts, when used alone or in
combination with polysorbate 65 whereby the maximum amount of the
additives, alone or in combination, does not exceed 0.1 percent of the
finished frozen dessert.
(2) In yeast-defoamer formulations whereby the maximum amount of the
additive does not exceed 4 percent of the finished yeast defoamer and
the maximum amount of the additive in the yeast from such use does not
exceed 4 parts per million.
(3) As a solubilizing and dispersing agent in pickles and pickle
products, whereby the maximum amount of the additive does not exceed 500
parts per million.
(4) As a solubilizing and dispersing agent in:
(i) Vitamin-mineral preparations containing calcium caseinate in the
absence of fat-soluble vitamins, whereby the maximum intake of
polysorbate 80 shall not exceed 175 milligrams from the recommended
daily dose of the preparations.
(ii) Fat-soluble vitamins in vitamin and vitamin-mineral preparations
containing no calcium caseinate, whereby the maximum intake of
polysorbate 80 shall not exceed 300 milligrams from the recommended
daily dose of the preparations.
(iii) In vitamin-mineral preparations containing both calcium
caseinate and fat-soluble vitamins, whereby the maximum intake of
polysorbate 80 shall not exceed 475 milligrams from the recommended
daily dose of the preparations.
(5) As a surfactant in the production of coarse crystal sodium
chloride whereby the maximum amount of the additive in the finished
sodium chloride does not exceed 10 parts per million.
(6) In special dietary foods, as an emulsifier for edible fats and
oils, with directions for use which provide for the ingestion of not
more than 360 milligrams of polysorbate 80 per day.
(7) As a solubilizing and dispersing agent for dill oil in canned
spiced green beans, not to exceed 30 parts per million.
(8) As an emulsifier, alone or in combination with polysorbate 60, in
shortenings and edible oils intended for use in foods as follows, when
standards of identity established under section 401 of the act do not
preclude such use:
(i) It is used alone in an amount not to exceed 1 percent of the
weight of the finished shortening or oil.
(ii) It is used with polysorbate 60 in any combination providing no
more than 1 percent of polysorbate 80 and no more than 1 percent of
polysorbate 60, provided that the total combination does not exceed 1
percent of the finished shortening or oil.
(iii) The 1-percent limitation specified in paragraph (c)(8) (i) and
(ii) of this section may be exceeded in premix concentrates of
shortening or edible oil if the labeling complies with the requirements
of paragraph (d) of this section.
(9) As an emulsifier in whipped edible oil topping with or without
one or a combination of the following:
(i) Sorbitan monostearate;
(ii) Polysorbate 60;
(iii) Polysorbate 65;
whereby the maximum amount of the additive or additives used does not
exceed 0.4 percent of the weight of the finished whipped edible oil
topping.
(10) It is used as a wetting agent in scald water for poultry
defeathering, followed by potable water rinse. The concentration of the
additive in the scald water does not exceed 0.0175 percent.
(11) As a dispersing agent in gelatin desserts and in gelatin dessert
mixes, whereby the amount of the additive does not exceed 0.082 percent
on a dry-weight basis.
(12) As an adjuvant added to herbicide use and plant-growth regulator
use dilutions by a grower or applicator prior to application of such
dilutions to the growing crop. Residues resulting from such use are
exempt from the requirement of a tolerance. When so used or intended
for use, the additive shall be exempt from the requirements of paragraph
(d)(1) of this section.
(13) As a defoaming agent in the preparation of the creaming mixture
for cottage cheese and lowfat cottage cheese, as identified in 133.128
and 133.131 of this chapter, respectively, whereby the amount of the
additive does not exceed .008 percent by weight of the finished
products.
(14) As a surfactant and wetting agent for natural and artificial
colors for use in barbecue sauce where the level of the additive does
not exceed 0.005 percent by weight of the barbecue sauce.
(d) To assure safe use of the additive, in addition to the other
information required by the Act:
(1) The label of the additive and any intermediate premixes shall
bear:
(i) The name of the additive.
(ii) A statement of the concentration or strength of the additive in
any intermediate premixes.
(2) The label or labeling shall bear adequate directions to provide a
final product that complies with the limitations prescribed in paragraph
(c) of this section.
(42 FR 14491, Mar. 15, 1977, as amended at 43 FR 2871, Jan. 20, 1978;
45 FR 58835, Sept. 5, 1980; 46 FR 8466, Jan. 27, 1981)
21 CFR 172.841 Polydextrose.
Polydextrose as identified in this section may be safely used in food
in accordance with the following prescribed conditions:
(a)(1) Polydextrose (CAS Reg. No. 68424-04-4) is a partially
metabolizable water-soluble polymer prepared by the condensation of a
melt which consists of approximately 89 percent d-glucose, 10 percent
sorbitol and 1 percent citric acid, on a weight basis.
(2) Polydextrose may be partially neutralized with potassium
hydroxide.
(b) It is used in accordance with good manufacturing practices as a
bulking agent, formulation aid, humectant, and texturizer in the
following foods when standards of identity established under section 401
of the act do not preclude such use: baked goods and baking mixes
(restricted to fruit, custard, and pudding-filled pies; cakes;
cookies; and similar baked products); chewing gum; confections and
frostings; dressings for salads; frozen dairy desserts and mixes;
gelatins, puddings, and fillings; and hard and soft candy.
(c) If the food containing the additive purports to be or is
represented for special dietary uses, it shall be labeled in compliance
with part 105 of this chapter.
(d) The label and labeling of food a single serving of which would be
expected to exceed 15 grams of the additive shall bear the statement:
''Sensitive individuals may experience a laxative effect from excessive
consumption of this product''.
(46 FR 30081, June 5, 1981)
21 CFR 172.842 Sorbitan monostearate.
The food additive sorbitan monostearate, which is a mixture of
partial stearic and palmitic acid esters of sorbitol anhydrides, may be
safely used in or on food in accordance with the following prescribed
conditions:
(a) The food additive is manufactured by reacting stearic acid
(usually containing associated fatty acids, chiefly palmitic) with
sorbitol to yield essentially a mixture of esters.
(b) The food additive meets the following specifications:
(c) It is used or intended for use, alone or in combination with
polysorbate 60 as follows:
(1) As an emulsifier in whipped edible oil topping with or without
one or a combination of the following:
(i) Polysorbate 60;
(ii) Polysorbate 65;
(iii) Polysorbate 80;
whereby the maximum amount of the additive or additives used does not
exceed 0.4 percent of the weight of the finished whipped edible oil
topping; except that a combination of the additive with polysorbate 60
may be used in excess of 0.4 percent: Provided, That the amount of the
additive does not exceed 0.27 percent and the amount of polysorbate 60
does not exceed 0.77 percent of the weight of the finished whipped
edible oil topping.
(2) As an emulsifier in cakes and cake mixes, with or without one or
a combination of the following:
(i) Polysorbate 65.
(ii) Polysorbate 60.
When used alone, the maximum amount of sorbitan monostearate shall
not exceed 0.61 percent of the cake or cake mix, on a dry-weight basis.
When used with polysorbate 65 and/or polysorbate 60, it shall not exceed
0.61 percent, nor shall the polysorbate 65 exceed 0.32 percent or the
polysorbate 60 exceed 0.46 percent, and no combination of the
emulsifiers shall exceed 0.66 percent of the weight of the cake or cake
mix, calculated on a dry-weight basis.
(3) As an emulsifier, alone or in combination with polysorbate 60 in
nonstandardized confectionery coatings and standardized cacao products
specified in 163.123, 163.130, 163.135, 163.140, 163.145, and 163.150
of this chapter, as follows:
(i) It is used alone in an amount not to exceed 1 percent of the
weight of the finished nonstandardized confectionery coating or
standardized cacao product.
(ii) It is used with polysorbate 60 in any combination of up to 1
percent sorbitan monostearate and up to 0.5 percent polysorbate 60
provided that the total combination does not exceed 1 percent of the
weight of the finished nonstandardized confectionery coating or
standardized cacao product.
(4) As an emulsifier in cake icings and cake fillings, with or
without one or a combination of the following:
(i) Polysorbate 65.
(ii) Polysorbate 60.
When used alone, the maximum amount of sorbitan monostearate shall
not exceed 0.7 percent of the weight of the cake icing or cake filling.
When used with polysorbate 65 and/or polysorbate 60, it shall not exceed
0.7 percent, nor shall the polysorbate 65 exceed 0.32 percent or the
polysorbate 60 exceed 0.46 percent, and no combination of these
emulsifiers shall exceed 1 percent of the weight of the cake icing or
cake filling.
(5) As an emulsifier in solid-state, edible vegetable fat-water
emulsions intended for use as substitutes for milk or cream in beverage
coffee, with or without one or a combination of the following:
(i) Polysorbate 60.
(ii) Polysorbate 65.
The maximum amount of the additive or additives shall not exceed 0.4
percent by weight of the finished edible vegetable fat-water emulsion.
(6) It is used alone as a rehydration aid in the production of active
dry yeast in an amount not to exceed 1 percent by weight of the dry
yeast.
(7) As an emulsifier, alone or in combination with polysorbate 60, in
the minimum quantity required to accomplish the intended effect, in
formulations of white mineral oil conforming with 172.878 and/or
petroleum wax conforming with 172.886 for use as protective coatings on
raw fruits and vegetables.
(d) To assure safe use of the additive, in addition to the other
information required by the Act:
(1) The label of the additive and any intermediate premixes shall
bear:
(i) The name of the additive.
(ii) A statement of the concentration or strength of the additive in
any intermediate premixes.
(2) The label or labeling shall bear adequate directions to provide a
final product that complies with the limitations prescribed in paragraph
(c) of this section.
(42 FR 14491, Mar. 15, 1977, as amended at 43 FR 2871, Jan. 20, 1978)
21 CFR 172.844 Calcium stearoyl-2-lactylate.
The food additive calcium stearoyl-2-lactylate may be safely used in
or on food in accordance with the following prescribed conditions:
(a) The additive, which is a mixture of calcium salts of stearoyl
lactylic acids and minor proportions of other calcium salts of related
acids, is manufactured by the reaction of stearic acid and lactic acid
and conversion to the calcium salts.
(b) The additive meets the following specifications:
Acid number, 50-86.
Calcium content, 4.2-5.2 percent.
Lactic acid content, 32-38 percent.
Ester number, 125-164.
(c) It is used or intended for use as follows:
(1) As a dough conditioner in yeast-leavened bakery products and
prepared mixes for yeast-leavened bakery products in an amount not to
exceed 0.5 part for each 100 parts by weight of flour used.
(2) As a whipping agent in:
(i) Liquid and frozen egg white at a level not to exceed 0.05
percent.
(ii) Dried egg white at a level not to exceed 0.5 percent.
(iii) Whipped vegetable oil topping at a level not to exceed 0.3
percent of the weight of the finished whipped vegetable oil topping.
(3) As a conditioning agent in dehydrated potatoes in an amount not
to exceed 0.5 percent by weight thereof.
(d) To assure safe use of the additive:
(1) The label and labeling of the food additive and any intermediate
premix prepared therefrom shall bear, in addition to the other
information required by the act, the following:
(i) The name of the additive.
(ii) A statement of the concentration or strength of the additive in
any intermediate premixes.
(2) The label or labeling of the food additive shall also bear
adequate directions of use to provide a finished food that complies with
the limitations prescribed in paragraph (c) of this section.
21 CFR 172.846 Sodium stearoyl lactylate.
The food additive sodium stearoyl lactylate (CAS Reg. No.
25-383-997) may be safely used in food in accordance with the following
prescribed conditions:
(a) The additive, which is a mixture of sodium salts of stearoyl
lactylic acids and minor proportions of sodium salts of related acids,
is manufactured by the reaction of stearic acid and lactic acid and
conversion to the sodium salts.
(b) The additive meets the specifications of the ''Food Chemicals
Codex,'' 3d Ed. (1981), pp. 300-301, which is incorporated by
reference. 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.
(c) It is used or intended for use as follows when standards of
identity established under section 401 of the Act do not preclude such
use:
(1) As a dough strengthener, emulsifier, or processing aid in baked
products, pancakes, and waffles, in an amount not to exceed 0.5 part for
each 100 parts by weight of flour used.
(2) As a surface-active agent, emulsifier, or stabilizer in icings,
fillings, puddings, and toppings, at a level not to exceed 0.2 percent
by weight of the finished food.
(3) As an emulsifier or stabilizer in liquid and solid edible
fat-water emulsions intended for use as substitutes for milk or cream in
beverage coffee, at a level not to exceed 0.3 percent by weight of the
finished edible fat-water emulsion.
(4) As a formulation aid, processing aid, or surface-active agent in
dehydrated potatoes, in an amount not to exceed 0.5 percent of the dry
weight of the food.
(5) As an emulsifier, stabilizer, or texturizer in snack dips, at a
level not to exceed 0.2 percent by weight of the finished product.
(6) As an emulsifier, stabilizer, or texturizer in cheese substitutes
and imitations and cheese product substitutes and imitations, at a level
not to exceed 0.2 percent by weight of the finished food.
(7) As an emulsifier, stabilizer, or texturizer in sauces or gravies,
and the products containing the same, in an amount not to exceed 0.25
percent by weight of the finished food.
(8) In prepared mixes for each of the foods listed in paragraphs (c)
(1) through (7) of this section, provided the additive is used only as
specified in each of those paragraphs.
(45 FR 51767, Aug. 5, 1980, as amended at 49 FR 10105, Mar. 19, 1984;
50 FR 49536, Dec. 3, 1985; 51 FR 1495, Jan. 14, 1986; 51 FR 3333,
Jan. 27, 1986)
21 CFR 172.848 Lactylic esters of fatty acids.
Lactylic esters of fatty acids may be safely used in food in
accordance with the following prescribed conditions:
(a) They are prepared from lactic acid and fatty acids meeting the
requirements of 172.860(b) and/or oleic acid derived from tall oil
fatty acids meeting the requirements of 172.862.
(b) They are used as emulsifiers, plasticizers, or surface-active
agents in the following foods, when standards of identity do not
preclude their use:
(c) They are used in an amount not greater than required to produce
the intended physical or technical effect, and they may be used with
shortening and edible fats and oils when such are required in the foods
identified in paragraph (b) of this section.
21 CFR 172.850 Lactylated fatty acid esters of glycerol and propylene
glycol.
The food additive lactylated fatty acid esters of glycerol and
propylene glycol may be safely used in food in accordance with the
following prescribed conditions:
(a) The additive is a mixture of esters produced by the lactylation
of a product obtained by reacting edible fats or oils with propylene
glycol.
(b) The additive meets the following specifications: Water insoluble
combined lactic acid, 14-18 percent; and acid number, 12 maximum.
(c) It is used in amounts not in excess of that reasonably required
to produce the intended physical effect as an emulsifier, plasticizer,
or surface-active agent in food.
21 CFR 172.852 Glyceryl-lacto esters of fatty acids.
Glyceryl-lacto esters of fatty acids (the lactic acid esters of mono-
and diglycerides) may be safely used in food in accordance with the
following prescribed conditions:
(a) They are manufactured from glycerin, lactic acid, and fatty acids
conforming with 172.860 and/or oleic acid derived from tall oil fatty
acids conforming with 172.862 and/or edible fats and oils.
(b) They are used in amounts not in excess of those reasonably
required to accomplish their intended physical or technical effect as
emulsifiers and plasticizers in food.
21 CFR 172.854 Polyglycerol esters of fatty acids.
Polyglycerol esters of fatty acids, up to and including the
decaglycerol esters, may be safely used in food in accordance with the
following prescribed conditions:
(a) They are prepared from corn oil, cottonseed oil, lard, palm oil
from fruit, peanut oil, safflower oil, sesame oil, soybean oil, and
tallow and the fatty acids derived from these substances (hydrogenated
and nonhydrogenated) meeting the requirements of 172.860(b) and/or
oleic acid derived from tall oil fatty acids meeting the requirements of
172.862.
(b) They are used as emulsifiers in food, in amounts not greater than
that required to produce the intended physical or technical effect.
(c) Polyglycerol esters of a mixture of stearic, oleic, and coconut
fatty acids are used as a cloud inhibitor in vegetable and salad oils
when use is not precluded by standards of identity. The fatty acids
used in the production of the polyglycerol esters meet the requirements
of 172.860(b), and the polyglycerol esters are used at a level not in
excess of the amount required to perform its cloud-inhibiting effect.
Oleic acid derived from tall oil fatty acids conforming with 172.862
may be used as a substitute for or together with the oleic acid
permitted by this paragraph.
(d) Polyglycerol esters of butter oil fatty acids are used as
emulsifiers in combination with other approved emulsifiers in dry,
whipped topping base. The fatty acids used in the production of the
polyglycerol esters meet the requirements of 172.860(b), and the
polyglycerol esters are used at a level not in excess of the amount
required to perform their emulsifying effect.
21 CFR 172.856 Propylene glycol mono- and diesters of fats and fatty
acids.
Propylene glycol mono- and diesters of fats and fatty acids may be
safely used in food, subject to the following prescribed conditions:
(a) They are produced from edible fats and/or fatty acids in
compliance with 172.860 and/or oleic acid derived from tall oil fatty
acids in compliance with 172.862.
(b) They are used in food in amounts not in excess of that reasonably
required to produce their intended effect.
21 CFR 172.858 Propylene glycol alginate.
The food additive propylene glycol alginate (CAS Reg. No. 9005-37-2)
may be used as an emulsifier, flavoring adjuvant, formulation aid,
stabilizer, surfactant, or thickener in foods in accordance with the
following prescribed conditions:
(a) The additive meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 256, which is incorporated by reference
(copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408),
and the additional specification that it shall have up to 85 percent of
the carboxylic acid groups esterified with the remaining groups either
free or neutralized.
(b) The additive is used or intended for use in the following foods
as defined in 170.3(n) of this chapter, when standards of identity
established under section 401 of the act do not preclude such use:
(1) As a stabilizer in frozen dairy desserts, in fruit and water
ices, and in confections and frostings at a level not to exceed 0.5
percent by weight of the finished product.
(2) As an emulsifier, flavoring adjuvant, stabilizer, or thickener in
baked goods at a level not to exceed 0.5 percent by weight of the
finished product.
(3) As an emulsifier, stabilizer, or thickener in cheeses at a level
not to exceed 0.9 percent by weight of the finished product.
(4) As an emulsifier, stabilizer, or thickener in fats and oils at a
level not to exceed 1.1 percent by weight of the finished product.
(5) As an emulsifier, stabilizer, or thickener in gelatins and
puddings at a level not to exceed 0.6 percent by weight of the finished
product.
(6) As a stabilizer or thickener in gravies and in sweet sauces at a
level not to exceed 0.5 percent by weight of the finished product.
(7) As a stabilizer in jams and jellies at a level not to exceed 0.4
percent by weight of the finished product.
(8) As an emulsifier, stabilizer, or thickener in condiments and
relishes at a level not to exceed 0.6 percent by weight of the finished
product.
(9) As a flavoring adjunct or adjuvant in seasonings and flavors at a
level not to exceed 1.7 percent by weight of the finished product.
(10) As an emulsifier, flavoring adjuvant, formulation aid,
stabilizer or thickener, or surface active agent in other foods, where
applicable, at a level not to exceed 0.3 percent by weight of the
finished product.
(c) To ensure safe use of the additive, the label of the food
additive container shall bear, in addition to the other information
required by the act:
(1) The name of the additive, ''propylene glycol alginate'' or
''propylene glycol ester of alginic acid''.
(2) Adequate directions for use.
(47 FR 29950, July 9, 1982)
21 CFR 172.859 Sucrose fatty acid esters.
Sucrose fatty acid esters identified in this section may be safely
used in accordance with the following prescribed conditions:
(a) Sucrose fatty acid esters are the mono-, di-, and tri-esters of
sucrose with fatty acids and are derived from sucrose and edible tallow
or hydrogenated edible tallow or edible vegetable oils. The only
solvents which may be used in the preparation of sucrose fatty acid
esters are those generally recognized as safe in food or regulated for
such use by an appropriate section in this part. Ethyl acetate or
methyl ethyl ketone or dimethyl sulfoxide and isobutyl alcohol
(2-methyl-1-propanol) may be used in the preparation of sucrose fatty
acid esters.
(b) Sucrose fatty acid esters meet the following specifications:
(1) The total content of mono-, di-, and tri-esters is not less than
80 percent as determined by a method title ''Sucrose Fatty Acid Esters,
Method of Assay,'' which is incorporated by reference. Copies are
available from the Division of Food and Color Additives, Center for Food
Safety and Applied Nutrition (HFF-330), 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.
(2) The free sucrose content is not more than 5 percent as determined
by Test S.2 in the method titled ''Sucrose Fatty Acid Esters, Method of
Assay,'' which is incorporated by reference. The availability of this
incorporation by reference is given in paragraph (b)(1) of this section.
(3) The acid value is not more than 6.
(4) The residue on ignition (sulfated ash) is not more than 2
percent.
(5) The total ethyl acetate content is not more than 350 parts per
million as determined by a method titled ''Determination of Ethyl
Acetate,'' which is incorporated by reference. Copies are available
from the Division of Food and Color Additives, Center for Food Safety
and Applied Nutrition (HFF-330), 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) Arsenic is not more than 3 parts per million.
(7) Total heavy metal content (as Pb) is not more than 50 parts per
million.
(8) Lead is not more than 10 parts per million.
(9) The total content of methyl ethyl ketone or of methanol shall not
be more than 10 parts per million as determined by a method titled
''Methyl Ethyl Ketone Test; Methyl Alcohol Test,'' which is
incorporated by reference. Copies are available from the Division of
Food and Color Additives, Center for Food Safety and Applied Nutrition
(HFF-330), 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.
(10) The total dimethyl sulfoxide content is not more than 2 parts
per million as determined by a method entitled ''Determination of
Dimethyl Sulfoxide,'' which is incorporated by reference. Copies are
available from the Division of Food and Color Additives, Center for Food
Safety and Applied Nutrition (HFF-330), 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.
(11) The total isobuytl alcohol (2-methyl-1-propanol) content is not
more than 10 parts per million as determined by a method entitled
''Determination of Isobutyl Alcohol,'' which is incorporated by
reference. Copies are available from the Division of Food and Color
Additives, Center for Food Safety and Applied Nutrition (HFF-330), 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. SW., Washington, DC 20408.
(c) Sucrose fatty acid esters may be used as follows when standards
of identity established under section 401 of the Federal Food, Drug, and
Cosmetic Act do not preclude such use:
(1) As emulsifiers as defined in 170.3(o)(8) of this chapter or as
stabilizers as defined in 170.3(o)(28) of this chapter in baked goods
and baking mixes as defined in 170.3(n)(1) of this chapter, in dairy
product analogs as defined in 170.3(n)(10) of this chapter, in frozen
dairy desserts and mixes as defined in 170.3(n)(20) of this chapter,
and in whipped milk products.
(2) As texturizers as defined in 170.3(o)(32) of this chapter in
biscuit mixes.
(3) As components of protective coatings applied to fresh apples,
avocados, bananas, banana plantains, limes, melons (honeydew and
cantaloupe), papaya, peaches, pears, pineapples, and plums to retard
ripening and spoiling.
(d) Sucrose fatty acid esters are used in accordance with current
good manufacturing practice and in an amount not to exceed that
reasonably required to accomplish the intended effect.
(47 FR 55475, Dec. 10, 1982, as amended at 48 FR 38226, Aug. 23,
1983; 52 FR 10883, Apr. 6, 1987; 53 FR 22294, 22297, June 15, 1988;
54 FR 24897, June 12, 1989)
21 CFR 172.860 Fatty acids.
The food additive fatty acids may be safely used in food and in the
manufacture of food components in accordance with the following
prescribed conditions:
(a) The food additive consists of one or any mixture of the following
straight-chain monobasic carboxylic acids and their associated fatty
acids manufactured from fats and oils derived from edible sources:
Capric acid, caprylic acid, lauric acid, myristic acid, oleic acid,
palmitic acid, and stearic acid.
(b) The food additive meets the following specifications:
(1) Unsaponifiable matter does not exceed 2 percent.
(2) It is free of chick-edema factor:
(i) As evidenced during the bioassay method for determining the
chick-edema factor as prescribed in paragraph (c)(2) of this section;
or
(ii) As evidenced by the absence of chromatographic peaks with a
retention time relative to aldrin (RA) between 10 and 25, using the gas
chromatographic-electron capture method prescribed in paragraph (c)(3)
of this section. If chromatographic peaks are found with RA values
between 10 and 25, the food additive shall meet the requirements of the
bioassay method prescribed in paragraph (c)(2) of this section for
determining chick-edema factor.
(c) For the purposes of this section:
(1) Unsaponifiable matter shall be determined by the method described
in the 13th Ed. (1980) of the ''Official Methods of Analysis of the
Association of Official Analytical Chemists,'' 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.
(2) Chick-edema factor shall be determined by the bioassay method
described in ''Official Methods of Analysis of the Association of
Official Analytical Chemists,'' 13th Ed. (1980), sections
28.127-28.130, 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.
(3) The gas chromatographic-electron capture method for testing fatty
acids for chick-edema shall be the method described in the ''Journal of
the Association of Official Analytical Chemists,'' Volume 50 (No. 1),
pages 216-218 (1967), or the modified method using a sulfuric acid
clean-up procedure, as described in the ''Journal of the Association of
the Offical Analytical Chemists,'' Volume 51 (No. 2), pages 489-490
(1968), which are incorporated by reference. See paragraph (c)(2) of
this section for availability of these references.
(d) It is used or intended for use as follows:
(1) In foods as a lubricant, binder, and as a defoaming agent in
accordance with good manufacturing practice.
(2) As a component in the manufacture of other food-grade additives.
(e) To assure safe use of the additive, the label and labeling of the
additive and any premix thereof shall bear, in addition to the other
information required by the act, the following:
(1) The common or usual name of the acid or acids contained therein.
(2) The words ''food grade'', in juxtaposition with and equally as
prominent as the name of the acid.
(42 FR 14491, Mar. 15, 1977, as amended at 47 FR 11837, Mar. 19,
1982; 49 FR 10105, Mar. 19, 1984; 54 FR 24897, June 12, 1989)
21 CFR 172.861 Cocoa butter substitute from coconut oil, palm kernel
oil, or both oils.
The food additive, cocoa butter substitute from coconut oil, palm
kernel oil, or both oils, may be safely used in food in accordance with
the following conditions:
(a) Cocoa butter substitute from coconut oil, palm kernel oil (CAS
Reg. No. 85665-33-4), or both oils is a mixture of triglycerides. It is
manufactured by esterification of glycerol with food-grade fatty acids
(complying with 172.860) derived from edible coconut oil, edible palm
kernel oil, or both oils.
(b) The ingredient meets the following specifications:
(c) The ingredient is used or intended for use as follows:
(1) As coating material for sugar, table salt, vitamins, citric acid,
succinic acid, and spices; and
(2) In compound coatings, cocoa creams, cocoa-based sweets, toffees,
caramel masses, and chewing sweets as defined in 170.3 (n)(9) and
(n)(38) of this chapter, except that the ingredient may not be used in a
standardized food unless permitted by the standard of identity.
(d) The ingredient is used in accordance with current good
manufacturing practice and in an amount not to exceed that reasonably
required to accomplish the intended effect.
(56 FR 66970, Dec. 27, 1991; 57 FR 2814, Jan. 23, 1992)
21 CFR 172.862 Oleic acid derived from tall oil fatty acids.
The food additive oleic acid derived from tall oil fatty acids may be
safely used in food and as a component in the manufacture of food-grade
additives in accordance with the following prescribed conditions:
(a) The additive consists of purified oleic acid separated from
refined tall oil fatty acids.
(b) The additive meets the following specifications:
(1) Specifications for oleic acid prescribed in the ''Food Chemicals
Codex.'' 3d Ed. (1981), pp. 207-208, which is incorporated by
reference, except that titer (solidification point) shall not exceed
13.5 C and unsaponifiable matter shall not exceed 0.5 percent. Copies
of the material incorporated by reference 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) The resin acid content does not exceed 0.01 as determined by ASTM
method D1240-82, ''Standard Test Method for Rosin Acids in Fatty
Acids,'' which is incorporated by reference. Copies may be obtained
from the American Society for Testing Materials, 1916 Race St.,
Philadelphia, PA 19103, or may be examined at the Office of the Federal
Register, 1100 L St. NW., Washington, DC 20408.
(3) The requirements for absence of chick-edema factor as prescribed
in 172.860.
(c) It is used or intended for use as follows:
(1) In foods as a lubricant, binder, and defoaming agent in
accordance with good manufacturing practice.
(2) As a component in the manufacture of other food-grade additives.
(d) To assure safe use of the additive, the label and labeling of the
additive and any premix thereof shall bear, in addition to the other
information required by the Act, the following:
(1) The common or usual name of the acid.
(2) The words ''food grade'' in juxtaposition with and equally as
prominent as the name of the acid.
(42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10105, Mar. 19,
1984)
21 CFR 172.863 Salts of fatty acids.
The food additive salts of fatty acids may be safely used in food and
in the manufacture of food components in accordance with the following
prescribed conditions:
(a) The additive consists of one or any mixture of two or more of the
aluminum, calcium, magnesium, potassium, and sodium salts of the fatty
acids conforming with 172.860 and/or oleic acid derived from tall oil
fatty acids conforming with 172.862.
(b) The food additive is used or intended for use as a binder,
emulsifier, and anticaking agent in food in accordance with good
manufacturing practice.
(c) To assure safe use of the additive, the label and labeling of the
additive and any premix thereof shall bear, in addition to the other
information required by the Act, the following:
(1) The common or usual name of the fatty acid salt or salts
contained therein.
(2) The words ''food grade'', in juxtaposition with and equally as
prominent as the name of the salt.
21 CFR 172.864 Synthetic fatty alcohols.
Synthetic fatty alcohols may be safely used in food and in the
synthesis of food components in accordance with the following prescribed
conditions:
(a) The food additive consists of any one of the following fatty
alcohols:
(1) Hexyl, octyl, decyl, lauryl, myristyl, cetyl, and stearyl;
manufactured by fractional distillation of alcohols obtained by a
sequence of oxidation and hydrolysis of organo-aluminums generated by
the controlled reaction of low molecular weight trialkylaluminum with
purified ethylene (minimum 99 percent by volume C2H4), and utilizing the
hydrocarbon solvent as defined in paragraph (b) of this section, such
that:
(i) Hexyl, octyl, decyl, lauryl, and myristyl alcohols contain not
less than 99 percent of total alcohols and not less than 96 percent of
straight chain alcohols. Any nonalcoholic impurities are primarily
paraffins.
(ii) Cetyl and stearyl alcohols contain not less than 98 percent of
total alcohols and not less than 94 percent of straight chain alcohols.
Any nonalcoholic impurities are primarily paraffins.
(iii) The synthetic fatty alcohols contain no more than 0.1 weight
percent of total diols as determined by a method available upon request
from the Commissioner of Food and Drugs.
(2) Hexyl, octyl, and decyl; manufactured by fractional distillation
of alcohols obtained by a sequence of oxidation, hydrolysis, and
catalytic hydrogenation (catalyst consists of copper, chromium, and
nickel) of organo-aluminums generated by the controlled reaction of low
molecular weight trialkylaluminum with purified ethylene (minimum 99
percent by volume C2H4), and utilizing an external coolant such that
these alcohols meet the specifications prescribed in paragraph (a)(1)
(i) and (iii) of this section.
(b) The hydrocarbon solvent used in the process described in
paragraph (a)(1) of this section is a mixture of liquid hydrocarbons
essentially paraffinic in nature, derived from petroleum and refined to
meet the specifications described in paragraph (b)(1) of this section
when subjected to the procedures described in paragraph (b) (2) and (3)
of this section.
(1) The hydrocarbon solvent meets the following specifications:
(i) Boiling-point range: 175 C-275 C.
(ii) Ultraviolet absorbance limits as follows:
(2) Use ASTM method D86-82, ''Standard Method for Distillation of
Petroleum Products,'' which is incorporated by reference, to determine
boiling point range. Copies of the material incorporated by reference
may be obtained from the American Society for Testing Materials, 1916
Race St., Philadelphia, PA 19103, or may be examined at the Office of
the Federal Register, 1100 L St. NW., Washington, DC 20408.
(3) The analytical method for determining ultraviolet absorbance
limits is as follows:
All glassware should be scrupulously cleaned to remove all organic
matter such as oil, grease, detergent residues, etc. Examine all
glassware, including stoppers and stopcocks, under ultraviolet light to
detect any residual fluorescent contamination. As a precautionary
measure, it is recommended practice to rinse all glassware with purified
isooctane immediately before use. No grease is to be used on stopcocks
or joints. Great care to avoid contamination of hydrocarbon solvent
samples in handling and to assure absence of any extraneous material
arising from inadequate packaging is essential. Because some of the
polynuclear hydrocarbons sought in this test are very susceptible to
photo-oxidation, the entire procedure is to be carried out under subdued
light.
Chromatographic tube. 450 millimeters in length (packing section),
inside diameter 19 millimeters 1 millimeter, equipped with a wad of
clean Pyrex brand filtering wool (Corning Glass Works Catalog No. 3950
or equivalent). The tube shall contain a 250-milliliter reservoir and a
2-millimeter tetrafluoroethylene polymer stopcock at the opposite end.
Overall length of the tube is 670 millimeters.
Stainless steel rod. 2 feet in length, 2 to 4 millimeters in
diameter.
Vacuum oven. Similar to Labline No. 3610 but modified as follows:
A copper tube one-fourth inch in diameter and 13 inches in length is
bent to a right angle at the 4-inch point and plugged at the opposite
end; eight copper tubes one-eighth inch in diameter and 5 inches in
length are silver soldered in drilled holes (one-eighth inch in
diameter) to the one-fourth-inch tube, one on each side at the 5-, 7.5-,
10- and 12.5-inch points; the one-eighth-inch copper tubes are bent to
conform with the inner periphery of the oven.
Beakers. 250-milliliter and 500-milliliter capacity.
Graduated cylinders. 25-milliliter, 50-milliliter, and
150-milliliter capacity.
Tuberculin syringe. 1-milliliter capacity, with 3-inch, 22-gauge
needle.
Volumetric flask. 5-milliliter capacity.
Spectrophotometric cells. Fused quartz ground glass stoppered cells,
optical path length in the range of 1.000 centimeter 0.005 centimeter.
With distilled water in the cells, determine any absorbance difference.
Spectrophotometer. Spectral range 250 millimicrons -- 400
millimicrons with spectral slit width of 2 millimicrons or less: under
instrument operating conditions for these absorbance measurements, the
spectrophotometer shall also meet the following performance
requirements:
Absorbance repeatability, 0.01 at 0.4 absorbance.
Absorbance accuracy,1050 0.05 at 0.4 absorbance.
Wavelength repeatability, 0.2 millimicron.
Wavelength accuracy, 1.0 millimicron.
Nitrogen cylinder. Water-pumped or equivalent purity nitrogen in
cylinder equipped with regulator and valve to control flow at 5 p.s.i.g.
Organic solvents. All solvents used throughout the procedure shall
meet the specifications and tests described in this specification. The
isooctane, benzene, hexane, and 1,2-dichloroethane designated in the
list following this paragraph shall pass the following test:
To the specified quantity of solvent in a 250-milliliter beaker, add
1 milliliter of purified n-hexadecane and evaporate in the vacuum oven
under a stream of nitrogen. Discontinue evaporation when not over 1
milliliter of residue remains. (To the residue from benzene add a
5-milliliter portion of purified isooctane, reevaporate, and repeat once
to insure complete removal of benzene.)
Dissolve the 1 milliliter of hexadecane residue in isooctane and make
to 5 milliliters volume. Determine the absorbance in the 1-centimeter
path length cells compared to isooctane as reference. The absorbance of
the solution of the solvent residue shall not exceed 0.02 per centimeter
path length between 280 and 300 m and shall not exceed 0.01 per
centimeter path length between 300 and 400 m .
Isooctane (2,2,4-trimethylpentane). Use 10 milliliters for the test
described in the preceding paragraph. If necessary, isooctane may be
purified by passage through a column of activated silica gel (Grade 12,
Davison Chemical Co., Baltimore, Md., or equivalent).
Benzene, spectro grade (Burdick and Jackson Laboratories, Inc.,
Muskegon, Mich., or equivalent). Use 80 milliliters for the test. If
necessary, benzene may be purified by distillation or otherwise.
Hexane, spectro grade (Burdick and Jackson Laboratories, Inc.,
Muskegon, Mich., or equivalent). Use 650 milliliters for the test. If
necessary, hexane may be purified by distillation or otherwise.
1,2-Dichloroethane, spectro grade (Matheson, Coleman, and Bell, East
Rutherford, N.J., or equivalent). Use 20 milliliters for test. If
necessary, 1,2-dichloroethane may be purified by distillation.
Eluting mixtures:
1. 10 percent 1,2-dichloroethane in hexane. Pipet 100 milliliters of
1,2-dichloroethane into a 1-liter glass-stoppered volumetric flask and
adjust to volume with hexane, with mixing.
2. 40 percent benzene in hexane. Pipet 400 milliliters of benzene
into a 1-liter glass-stoppered volumetric flask and adjust to volume
with hexane, with mixing.
n-Hexadecane, 99 percent olefin-free. Dilute 1.0 milliliter of
n-hexadecane to 5 milliliters with isooctane and determine the
absorbance in a 1-centimeter cell compared to isooctane as reference
between 280 m -400m . The absorbance per centimeter path length shall
not exceed 0.00 in this range. If necessary, n-hexadecane may be
purified by percolation through activated silica gel or by distillation.
Silica gel, 28-200 mesh (Grade 12, Davison Chemical Co., Baltimore,
Md., or equivalent). Activate as follows: Weigh about 900 grams into a
1-gallon bottle, add 100 milliliters of de-ionized water, seal the
bottle and shake and roll at intervals for 1 hour. Allow to equilibrate
overnight in the sealed bottle. Activate the gel at 150 C for 16
hours, in a 2-inch 7-inch 12-inch porcelain pan loosely covered with
aluminum foil, cool in a dessicator, transfer to a bottle and seal.
Determination of ultraviolet absorbance. Before proceeding with the
analysis of a sample determine the absorbance in a 1-centimeter path
cell for the reagent blank by carrying out the procedure without a
sample. Record the absorbance in the wavelength range of 280 to 400
millimicrons. Typical reagent blank absorbance in this range should not
exceed 0.04 in the 280 to 299 millimicron range, 0.02 in the 300 to 359
millimicron range, and 0.01 in the 360 to 400 millimicron range. If the
characteristic benzene peaks in the 250 to 260 millimicron region are
present, remove the benzene by the procedure described above under
''Reagents and Materials,'' ''Organic Solvents,'' and record absorbance
again.
Transfer 50 grams of silica gel to the chromatographic tube for
sample analysis. Raise and drop the column on a semisoft, clean surface
for about 1 minute to settle the gel. Pour 100 milliliters of hexane
into the column with the stopcock open and allow to drain to about
one-half inch above the gel. Turn off the stopcock and allow the column
to cool for 30 minutes. After cooling, vibrate the column to eliminate
air and stir the top 1 to 2 inches with a small diameter stainless steel
rod. Take care not to get the gel above the liquid and onto the sides
of the column.
Weigh out 40 grams 0.1 gram of the hydrocarbon solvent sample into a
250-milliliter beaker, add 50 milliliters of hexane, and pour the
solution into the column. Rinse the beaker with 50 milliliters of
hexane and add this to the column. Allow the hexane sample solution to
elute into a 500-milliliter beaker until the solution is about one-half
inch above the gel. Rinse the column three times with 50-milliliter
portions of hexane. Allow each hexane rinse to separately elute to
about one-half inch above the gel. Replace the eluate beaker (discard
the hexane eluate) with a 250-milliliter beaker. Add two separate
25-milliliter portions of 10 percent 1,2-dichloroethane and allow each
to separately elute as before. Finally, add 150 milliliters of 10
percent 1,2-dichloroethane for a total of 200 milliliters. When the
final 10 percent 1,2-dichloroethane fraction is about one-half inch
above the top of the gel bed, replace the receiving beaker (discard the
1,2-dichloroethane eluate) with a 250-milliliter beaker containing 1
milliliter of hexadecane. Adjust the elution rate to 2 to 3 milliliters
per minute, add two 25-milliliter portions of 40 percent benzene and
allow each to separately elute as before to within about one-half inch
of the gel bed. Finally, add 150 milliliters of 40 percent benzene for
a total of 200 milliliters. Evaporate the benzene in the oven with
vacuum and sufficient nitrogen flow to just ripple the top of the
benzene solution. When the benzene is removed (as determined by a
constant volume of hexadecane) add 5 milliliters of isooctane and
evaporate. Repeat once to insure complete removal of benzene. Remove
the beaker and cover with aluminum foil (previously rinsed with hexane)
until cool.
Quantitatively transfer the hexadecane residue to a 5-milliliter
volumetric flask and dilute to volume with isooctane. Determine the
absorbance of the solution in 1-centimeter path length cells between 280
and 400 millimicrons using isooctane as a reference. Correct the
absorbance values for any absorbance derived from reagents as determined
by carrying out the procedure without a sample. If the corrected
absorbance does not exceed the limits prescribed in paragraph (b)(1)(ii)
of this section, the sample meets the ultraviolet absorbance
specifications for hydrocarbon solvent.
(c) Synthetic fatty alcohols may be used as follows:
(1) As substitutes for the corresponding naturally derived fatty
alcohols permitted in food by existing regulations in this part or part
173 of this chapter provided that the use is in compliance with any
prescribed limitations.
(2) As substitutes for the corresponding naturally derived fatty
alcohols used as intermediates in the synthesis of food additives and
other substances permitted in food.
(42 FR 14491, Mar. 15, 1977, as amended at 47 FR 11837, Mar. 19,
1982; 49 FR 10105, Mar. 19, 1984; 54 FR 24897, June 12, 1989)
0501As determined by using potassium chromate for reference standard
and described in National Bureau of Standards Circular 484,
Spectrophotometry, U.S. Department of Commerce, (1949). The accuracy is
to be determined by comparison with the standard values at 290, 345, and
400 millimicrons. Circular 484 is incorporated by reference. Copies
are available from the Division of Food and Color Additives, Center for
Food Safety and Applied Nutrition (HFF-330), 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.
21 CFR 172.866 Synthetic glycerin produced by the hydrogenolysis of
carbohydrates.
Synthetic glycerin produced by the hydrogenolysis of carbohydrates
may be safely used in food, subject to the provisions of this section:
(a) It shall contain not in excess of 0.2 percent by weight of a
mixture of butanetriols.
(b) It is used or intended for use in an amount not to exceed that
reasonably required to produce its intended effect.
21 CFR 172.868 Ethyl cellulose.
The food additive ethyl cellulose may be safely used in food in
accordance with the following prescribed conditions:
(a) The food additive is a cellulose ether containing ethoxy (OC2H5)
groups attached by an ether linkage and containing on an anhydrous basis
not more than 2.6 ethoxy groups per anhydroglucose unit.
(b) It is used or intended for use as follows:
(1) As a binder and filler in dry vitamin preparations.
(2) As a component of protective coatings for vitamin and mineral
tablets.
(3) As a fixative in flavoring compounds.
21 CFR 172.870 Hydroxypropyl cellulose.
The food additive hydroxypropyl cellulose may be safely used in food,
except standardized foods that do not provide for such use, in
accordance with the following prescribed conditions:
(a) The additive consists of one of the following:
(1) A cellulose ether containing propylene glycol groups attached by
an ether linkage which contains, on an anhydrous basis, not more than
4.6 hydroxypropyl groups per anhydroglucose unit. The additive has a
minimum viscosity of 145 centipoises for 10 percent by weight aqueous
solution at 25 C.
(2) A cellulose ether containing propylene glycol groups attached by
an ether linkage having a hydroxypropoxy (OC3H6OH) content of 5 to 16
percent weight in weight (w/w) on an anhydrous basis, i.e., 0.1 to 0.4
hydroxypropyl groups per anhydroglucose unit. The common name for this
form of the additive is low substituted hydroxypropyl cellulose.
(b) The additive is used or intended for use as follows:
(1) The additive identified in paragraph (a)(1) of this section is
used or intended for use as an emulsifier, film former, protective
colloid, stabilizer, suspending agent, or thickener, in accordance with
good manufacturing practice.
(2) The additive identified in paragraph (a)(2) of this section is
used or intended for use as a binder and disintegrator in tablets or
wafers containing dietary supplements of vitamins and/or minerals. The
additive is used in accordance with good manufacturing practice.
(46 FR 50065, Oct. 9, 1981)
21 CFR 172.872 Methyl ethyl cellulose.
The food additive methyl ethyl cellulose may be safely used in food
in accordance with the following prescribed conditions.
(a) The additive is a cellulose ether having the general formula
(C6H(10-x-y)O5(CH3)x(C2H5)y)n, where x is the number of methyl groups
and y is the number of ethyl groups. The average value of x is 0.3 and
the average value of y is 0.7.
(b) The additive meets the following specifications:
(1) The methoxy content shall be not less than 3.5 percent and not
more than 6.5 percent, calculated as OCH3, and the ethoxy content shall
be not less than 14.5 percent and not more than 19 percent, calculated
as OC2H5, both measured on the dry sample.
(2) The viscosity of an aqueous solution, 2.5 grams of the material
in 100 milliliters of water, at 20 C, is 20 to 60 centipoises.
(3) The ash content on a dry basis has a maximum of 0.6 percent.
(c) The food additive is used as an aerating, emulsifying, and
foaming agent, in an amount not in excess of that reasonably required to
produce its intended effect.
21 CFR 172.874 Hydroxypropyl methylcellulose.
The food additive hydroxypropyl methylcellulose (CAS Reg. No.
9004-65-3) may be safely used in food, except in standardized foods
which do not provide for such use if:
(a) The additive complies with the definition and specifications
prescribed in the National Formulary, 12th edition.
(b) It is used or intended for use as an emulsifier, film former,
protective colloid, stabilizer, suspending agent, or thickener, in
accordance with good manufacturing practice.
(c) To insure safe use of the additive, the container of the
additive, in addition to being labeled as required by the general
provisions of the act, shall be accompanied by labeling which contains
adequate directions for use to provide a final product that complies
with the limitations prescribed in paragraph (b) of this section.
(42 FR 14491, Mar. 15, 1977, as amended at 47 FR 38273, Aug. 31,
1982)
21 CFR 172.876 Castor oil.
The food additive castor oil may be safely used in accordance with
the following conditions:
(a) The additive meets the specifications of the United States
Pharmacopeia XX (1980).
(b) The additive is used or intended for use as follows:
Hard candy production -- As a release agent and antisticking agent,
not to exceed 500 parts per million in hard candy.
Vitamin and mineral tablets -- As a component of protective coatings.
(42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10105, Mar. 19,
1984)
21 CFR 172.878 White mineral oil.
White mineral oil may be safely used in food in accordance with the
following conditions:
(a) White mineral oil is a mixture of liquid hydrocarbons,
essentially paraffinic and naphthenic in nature obtained from petroleum.
It is refined to meet the following specifications:
(1) It meets the test requirements of the United States Pharmacopeia
XX (1980) for readily carbonizable substances (page 532).
(2) It meets the test requirements of U.S.P. XVII for sulfur
compounds (page 400).
(3) It meets the specifications prescribed in the ''Journal of the
Association of Official Analytical Chemists,'' Volume 45, page 66
(1962), which is incorporated by reference, after correction of the
ultraviolet absorbance for any absorbance due to added antioxidants.
Copies of the material incorporated by reference are available from the
Division of Food and Color Additives, Center for Food Safety and Applied
Nutrition (HFF-330), 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.
(b) White mineral oil may contain any antioxidant permitted in food
by regulations issued in accordance with section 409 of the Act, in an
amount not greater than that required to produce its intended effect.
(c) White mineral oil is used or intended for use as follows:
(42 FR 14491, Mar. 15, 1977, as amended at 47 FR 8764, Mar. 2, 1982;
47 FR 11838, Mar. 19, 1982; 48 FR 55728, Dec. 15, 1983; 49 FR 10105,
Mar. 19, 1984; 54 FR 24897, June 12, 1989)
21 CFR 172.880 Petrolatum.
Petrolatum may be safely used in food, subject to the provisions of
this section.
(a) Petrolatum complies with the specifications set forth in the
United States Pharmacopeia XX (1980) for white petrolatum or in the
National Formulary XV (1980) for petrolatum.
(b) Petrolatum meets the following ultraviolet absorbance limits when
subjected to the analytical procedure described in 172.886(b):
Ultraviolet absorbance per centimeter path length:
(c) Petrolatum is used or intended for use as follows:
(d) Petrolatum may contain any antioxidant permitted in food by
regulations issued in accordance with section 409 of the Act, in an
amount not greater than that required to produce its intended effect.
(42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10105, Mar. 19,
1984)
21 CFR 172.882 Synthetic isoparaffinic petroleum hydrocarbons.
Synthetic isoparaffinic petroleum hydrocarbons may be safely used in
food, in accordance with the following conditions:
(a) They are produced by synthesis from petroleum gases and consist
of a mixture of liquid hydrocarbons meeting the following
specifications:
Boiling point 93-260 C as determined by ASTM method D86-82,
''Standard Method for Distillation of Petroleum Products,'' which is
incorporated by reference. Copies may be obtained from the American
Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or
may be examined at the Office of the Federal Register, 1100 L St. NW.,
Washington, DC 20408.
Ultraviolet absorbance:
260-319 millimicrons -- 1.5 maximum.
320-329 millimicrons -- 0.08 maximum.
330-350 millimicrons -- 0.05 maximum.
Nonvolatile residual: 0.002 gram per 100 milliliters maximum.
Synthetic isoparaffinic petroleum hydrocarbons containing
antioxidants shall meet the specified ultraviolet absorbance limits
after correction for any absorbance due to the antioxidants. The
ultraviolet absorbance shall be determined by the procedure described
for application of mineral oil, disregarding the last sentence of the
procedure, under ''Specifications'' on page 66 of the Journal of the
Association of Official Analytical Chemists, Volume 45 (February 1962),
which is incorporated by reference. Copies are available from the
Division of Food and Color Additives, Center for Food Safety and Applied
Nutrition (HFF-330), 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. For
hydrocarbons boiling below 250 F, the nonvolatile residue shall be
determined by ASTM method D1353-78, ''Standard Test Method for
Nonvolatile Matter in Volatile Solvents for Use in Paint, Varnish,
Lacquer, and Related Products;'' for those boiling above 121 C, ASTM
method D381-80, ''Standard Test Method for Existent Gum in Fuels by Jet
Evaporation'' shall be used. These methods are incorporated by
reference. Copies may be obtained from the American Society for Testing
Materials, 1916 Race St., Philadelphia, PA 19103, or may be examined at
the Office of the Federal Register, 1100 L St. NW., Washington, DC
20408.
(b) Isoparaffinic petroleum hydrocarbons may contain antioxidants
authorized for use in food in an amount not to exceed that reasonably
required to accomplish the intended technical effect nor to exceed any
prescribed limitations.
(c) Synthetic isoparaffinic petroleum hydrocarbons are used or
intended for use as follows:
(42 FR 14491, Mar. 15, 1977, as amended at 47 FR 11838, Mar. 19,
1982; 49 FR 10106, Mar. 19, 1984; 54 FR 24897, June 12, 1989)
21 CFR 172.884 Odorless light petroleum hydrocarbons.
Odorless light petroleum hydrocarbons may be safely used in food, in
accordance with the following prescribed conditions:
(a) The additive is a mixture of liquid hydrocarbons derived from
petroleum or synthesized from petroleum gases. The additive is chiefly
paraffinic, isoparaffinic, or naphthenic in nature.
(b) The additive meets the following specifications:
(1) Odor is faint and not kerosenic.
(2) Initial boiling point is 300 F minimum.
(3) Final boiling point is 650 F maximum.
(4) Ultraviolet absorbance limits determined by method specified in
178.3620(b)(1)(ii) of this chapter, as follows:
(c) The additive is used as follows:
21 CFR 172.886 Petroleum wax.
Petroleum wax may be safely used in or on food, in accordance with
the following conditions:
(a) Petroleum wax is a mixture of solid hydrocarbons, paraffinic in
nature, derived from petroleum, and refined to meet the specifications
prescribed by this section.
(b) Petroleum wax meets the following ultraviolet absorbance limits
when subjected to the analytical procedure described in this paragraph.
Because of the sensitivity of the test, the possibility of errors
arising from contamination is great. It is of the greatest importance
that all glassware be scrupulously cleaned to remove all organic matter
such as oil, grease, detergent residues, etc. Examine all glassware,
including stoppers and stopcocks, under ultraviolet light to detect any
residual fluorescent contamination. As a precautionary measure it is
recommended practice to rinse all glassware with purified isooctane
immediately before use. No grease is to be used on stopcocks or joints.
Great care to avoid contamination of wax samples in handling and to
assure absence of any extraneous material arising from inadequate
packaging is essential. Because some of the polynuclear hydrocarbons
sought in this test are very susceptible to photo-oxidation, the entire
procedure is to be carried out under subdued light.
Separatory funnels. 250-milliliter, 500-milliliter,
1,000-milliliter, and preferably 2,000-milliliter capacity, equipped
with tetrafluoroethylene polymer stopcocks.
Reservoir. 500-milliliter capacity, equipped with a 24/40 standard
taper male fitting at the bottom and a suitable ball-joint at the top
for connecting to the nitrogen supply. The male fitting should be
equipped with glass hooks.
Chromatographic tube. 180 millimeters in length, inside diameter to
be 15.7 millimeters 0.1 millimeter, equipped with a coarse,
fritted-glass disc, a tetrafluoroethylene polymer stopcock, and a female
24/40 standard tapered fitting at the opposite end. (Overall length of
the column with the female joint is 235 millimeters.) The female fitting
should be equipped with glass hooks.
Disc. Tetrafluoroethylene polymer 2-inch diameter disc approximately
3/16-inch thick with a hole bored in the center to closely fit the stem
of the chromatographic tube.
Heating jacket. Conical, for 500-milliliter separatory funnel.
(Used with variable transformer heat control.)
Suction flask. 250-milliliter or 500-milliliter filter flask.
Condenser. 24/40 joints, fitted with a drying tube, length optional.
Evaporation flask (optional). 250-milliliter or 500-milliliter
capacity all-glass flask equipped with standard taper stopper having
inlet and outlet tubes to permit passage of nitrogen across the surface
of contained liquid to be evaporated.
Vacuum distillation assembly. All glass (for purification of
dimethyl sulfoxide); 2-liter distillation flask with heating mantle;
Vigreaux vacuum-jacketed condenser (or equivalent) about 45 centimeters
in length and distilling head with separable cold finger condenser. Use
of tetrafluoroethylene polymer sleeves on the glass joints will prevent
freezing. Do not use grease on stopcocks or joints.
Spectrophotometric cells. Fused quartz cells, optical path length in
the range of 5.000 centimeters 0.005 centimeter; also for checking
spectrophotometer performance only, optical path length in the range
1.000 centimeter 0.005 centimeter. With distilled water in the cells,
determine any absorbance differences.
Spectrophotometer. Spectral range 250 millimicrons-400 millimicrons
with spectral slit width of 2 millimicrons or less, under instrument
operating conditions for these absorbance measurements, the
spectrophotometer shall also meet the following performance
requirements:
Absorbance repeatability, 0.01 at 0.4 absorbance.
Absorbance accuracy,1052 0.05 at 0.4 absorbance.
Wavelength repeatability, 0.2 millimicron.
Wavelength accuracy, 1.0 millimicron.
Nitrogen cylinder. Water-pumped or equivalent purity nitrogen in
cylinder equipped with regulator and valve to control flow at 5 p.s.i.g.
Organic solvents. All solvents used throughout the procedure shall
meet the specifications and tests described in this specification. The
isooctane, benzene, acetone, and methyl alcohol designated in the list
following this paragraph shall pass the following test:
To the specified quantity of solvent in a 250-milliliter Erlenmeyer
flask, add 1 milliliter of purified n-hexadecane and evaporate on the
steam bath under a stream of nitrogen (a) loose aluminum foil jacket
around the flask will speed evaporation). Discontinue evaporation when
not over 1 milliliter of residue remains. (To the residue from benzene
add a 10-milliliter portion of purified isooctane, reevaporate, and
repeat once to insure complete removal of benzene.)
Alternatively, the evaporation time can be reduced by using the
optional evaporation flask. In this case the solvent and n-hexadecane
are placed in the flask on the steam bath, the tube assembly is
inserted, and a stream of nitrogen is fed through the inlet tube while
the outlet tube is connected to a solvent trap and vacuum line in such a
way as to prevent any flow-back of condensate into the flask.
Dissolve the 1 milliliter of hexadecane residue in isooctane and make
to 25 milliliters volume. Determine the absorbance in the 5-centimeter
path length cells compared to isooctane as reference. The absorbance of
the solution of the solvent residue (except for methyl alcohol) shall
not exceed 0.01 per centimeter path length between 280 and 400 m . For
methyl alcohol this absorbance value shall be 0.00.
Isooctane (2,2,4-trimethylpentane). Use 180 milliliters for the test
described in the preceding paragraph. Purify, if necessary, by passage
through a column of activated silica gel (Grade 12, Davison Chemical
Company, Baltimore, Maryland, or equivalent) about 90 centimeters in
length and 5 centimeters to 8 centimeters in diameter.
Benzene, A.C.S. reagent grade. Use 150 milliliters for the test.
Purify, if necessary, by distillation or otherwise.
Acetone, A.C.S. reagent grade. Use 200 milliliters for the test.
Purify, if necessary, by distillation.
Eluting mixtures:
1. 10 percent benzene in isooctane. Pipet 50 milliliters of benzene
into a 500-milliliter glass-stoppered volumetric flask and adjust to
volume with isooctane, with mixing.
2. 20 percent benzene in isooctane. Pipet 50 milliliters of benzene
into a 250-milliliter glass-stoppered volumetric flask, and adjust to
volume with isooctane, with mixing.
3. Acetone-benzene-water mixture. Add 20 milliliters of water to 380
milliliters of acetone and 200 milliliters of benzene, and mix.
n-Hexadecane, 99 percent olefin-free. Dilute 1.0 milliliter of
n-hexadecane to 25 milliliters with isooctane and determine the
absorbance in a 5-centimeter cell compared to isooctane as reference
point between 280 m -400 m . The absorbance per centimeter path length
shall not exceed 0.00 in this range. Purify, if necessary, by
percolation through activated silica gel or by distillation.
Methyl alcohol, A.C.S. reagent grade. Use 10.0 milliliters of methyl
alcohol. Purify, if necessary, by distillation.
Dimethyl sulfoxide. Pure grade, clear, water-white, m.p. 18
minimum. Dilute 120 milliliters of dimethyl sulfoxide with 240
milliliters of distilled water in a 500-milliliter separatory funnel,
mix and allow to cool for 5-10 minutes. Add 40 milliliters of isooctane
to the solution and extract by shaking the funnel vigorously for 2
minutes. Draw off the lower aqueous layer into a second 500-milliliter
separatory funnel and repeat the extraction with 40 milliliters of
isooctane. Draw off and discard the aqueous layer. Wash each of the
40-milliliter extractives three times with 50-milliliter portions of
distilled water. Shaking time for each wash is 1 minute. Discard the
aqueous layers. Filter the first extractive through anhydrous sodium
sulfate prewashed with isooctane (see Sodium sulfate under ''Reagents
and Materials'' for preparation of filter), into a 250-milliliter
Erlenmeyer flask, or optionally into the evaporating flask. Wash the
first separatory funnel with the second 40-milliliter isooctane
extractive, and pass through the sodium sulfate into the flask. Then
wash the second and first separatory funnels successively with a
10-milliliter portion of isooctane, and pass the solvent through the
sodium sulfate into the flask. Add 1 milliliter of n-hexadecane and
evaporate the isooctane on the steam bath under nitrogen. Discontinue
evaporation when not over 1 milliliter of residue remains. To the
residue, add a 10-milliliter portion of isooctane and reevaporate to 1
milliliter of hexadecane. Again, add 10 milliliters of isooctane to the
residue and evaporate to 1 milliliter of hexadecane to insure complete
removal of all volatile materials. Dissolve the 1 milliliter of
hexadecane in isooctane and make to 25-milliliter volume. Determine the
absorbance in 5-centimeter path length cells compared to isooctane as
reference. The absorbance of the solution should not exceed 0.02 per
centimeter path length in the 280 m -400 m range. (Note. -- Difficulty
in meeting this absorbance specification may be due to organic
impurities in the distilled water. Repetition of the test omitting the
dimethyl sulfoxide will disclose their presence. If necessary to meet
the specification, purify the water by redistillation, passage through
an ion-exchange resin, or otherwise.)
Purify, if necessary, by the following procedure: To 1,500
milliliters of dimethyl sulfoxide in a 2-liter glass-stoppered flask,
add 6.0 milliliters of phosphoric acid and 50 grams of Norit A
(decolorizing carbon, alkaline) or equivalent. Stopper the flask, and
with the use of a magnetic stirrer (tetrafluoroethylene polymer coated
bar) stir the solvent for 15 minutes. Filter the dimethyl sulfoxide
through four thicknesses of fluted paper (18.5 centimeters, Schleicher &
Schuell, No. 597, or equivalent). If the initial filtrate contains
carbon fines, refilter through the same filter until a clear filtrate is
obtained. Protect the sulfoxide from air and moisture during this
operation by covering the solvent in the funnel and collection flask
with a layer of isooctane. Transfer the filtrate to a 2-liter
separatory funnel and draw off the dimethyl sulfoxide into the 2-liter
distillation flask of the vacuum distillation assembly and distill at
approximately 3-millimeter Hg pressure or less. Discard the first
200-milliliter fraction of the distillate and replace the distillate
collection flask with a clean one. Continue the distillation until
approximately 1 liter of the sulfoxide has been collected.
At completion of the distillation, the reagent should be stored in
glass-stoppered bottles since it is very hygroscopic and will react with
some metal containers in the presence of air.
Phosphoric acid. 85 percent A.C.S. reagent grade.
Sodium borohydride. 98 percent.
Magnesium oxide (Sea Sorb 43, Food Machinery Company, Westvaco
Division, distributed by chemical supply firms, or equivalent). Place
100 grams of the magnesium oxide in a large beaker, add 700 milliliters
of distilled water to make a thin slurry, and heat on a steam bath for
30 minutes with intermittent stirring. Stir well initially to insure
that all the absorbent is completely wetted. Using a Buchner funnel and
a filter paper (Schleicher & Schuell No. 597, or equivalent) of
suitable diameter, filter with suction. Continue suction until water no
longer drips from the funnel. Transfer the absorbent to a glass trough
lined with aluminum foil (free from rolling oil). Break up the magnesia
with a clean spatula and spread out the absorbent on the aluminum foil
in a layer about 1 centimeter to 2 centimeters thick. Dry for 24 hours
at 160 C 1 C. Pulverize the magnesia with mortar and pestle. Sieve
the pulverized absorbent between 60-180 mesh. Use the magnesia retained
on the 180-mesh sieve.
Celite 545. Johns-Manville Company, diatomaceous earth, or
equivalent.
Magnesium oxide-Celite 545 mixture (2+ 1) by weight. Place the
magnesium oxide (60-180 mesh) and the Celite 545 in 2 to 1 proportions,
respectively, by weight in a glass-stoppered flask large enough for
adequate mixing. Shake vigorously for 10 minutes. Transfer the mixture
to a glass trough lined with aluminum foil (free from rolling oil) and
spread it out on a layer about 1 centimeter to 2 centimeters thick.
Reheat the mixture at 160 C 1 C for 2 hours, and store in a tightly
closed flask.
Sodium sulfate, anhydrous, A.C.S. reagent grade, preferably in
granular form. For each bottle of sodium sulfate reagent used,
establish as follows the necessary sodium sulfate prewash to provide
such filters required in the method: Place approximately 35 grams of
anhydrous sodium sulfate in a 30-milliliter coarse, fritted-glass funnel
or in a 65-millimeter filter funnel with glass wool plug; wash with
successive 15-milliliter portions of the indicated solvent until a
15-milliliter portion of the wash shows 0.00 absorbance per centimeter
path length between 280 m and 400 m when tested as prescribed under
''Organic solvents.'' Usually three portions of wash solvent are
sufficient.
Before proceeding with analysis of a sample, determine the absorbance
in a 5-centimeter path cell between 250 m and 400 m for the reagent
blank by carrying out the procedure, without a wax sample, at room
temperature, recording the spectra after the extraction stage and after
the complete procedure as prescribed. The absorbance per centimeter
path length following the extraction stage should not exceed 0.040 in
the wavelength range from 280 m to 400 m ; the absorbance per
centimeter path length following the complete procedure should not
exceed 0.070 in the wavelength range from 280 m to 299 m , inclusive,
nor 0.045 in the wavelength range from 300 m to 400 m . If in either
spectrum the characteristic benzene peaks in the 250 m -260 m region
are present, remove the benzene by the procedure under ''Organic
solvents'' and record absorbance again.
Place 300 milliliters of dimethyl sulfoxide in a 1-liter separatory
funnel and add 75 milliliters of phosphoric acid. Mix the contents of
the funnel and allow to stand for 10 minutes. (The reaction between the
sulfoxide and the acid is exothermic. Release pressure after mixing,
then keep funnel stoppered.) Add 150 milliliters of isooctane and shake
to preequilibrate the solvents. Draw off the individual layers and
store in glass-stoppered flasks.
Place a representative 1-kilogram sample of wax, or if this amount is
not available, the entire sample, in a beaker of a capacity about three
times the volume of the sample and heat with occasional stirring on a
steam bath until the wax is completely melted and homogeneous. Weigh
four 25-gram 0.2 gram portions of the melted wax in separate
100-milliliter beakers. Reserve three of the portions for later
replicate analyses as necessary. Pour one weighed portion immediately
after remelting (on the steam bath) into a 500-milliliter separatory
funnel containing 100 milliliters of the preequilibrated
sulfoxide-phosphoric acid mixture that has been heated in the heating
jacket at a temperature just high enough to keep the wax melted. (Note:
In preheating the sulfoxide-acid mixture, remove the stopper of the
separatory funnel at intervals to release the pressure.)
Promptly complete the transfer of the sample to the funnel in the
jacket with portions of the preequilibrated isooctane, warming the
beaker, if necessary, and using a total volume of just 50 milliliters of
the solvent. If the wax comes out of solution during these operations,
let the stoppered funnel remain in the jacket until the wax redissolves.
(Remove stopper from the funnel at intervals to release pressure.) When
the wax is in solution, remove the funnel from the jacket and shake it
vigorously for 2 minutes. Set up three 250-milliliter separatory
funnels with each containing 30 milliliters of preequilibrated
isooctane. After separation of the liquid phases, allow to cool until
the main portion of the wax-isooctane solution begins to show a
precipitate. Gently swirl the funnel when precipitation first occurs on
the inside surface of the funnel to accelerate this process. Carefully
draw off the lower layer, filter it slowly through a thin layer of glass
wool fitted loosely in a filter funnel into the first 250-milliliter
separatory funnel, and wash in tandem with the 30-milliliter portions of
isooctane contained in the 250-milliliter separatory funnels. Shaking
time for each wash is 1 minute. Repeat the extraction operation with
two additional portions of the sulfoxide-acid mixture, replacing the
funnel in the jacket after each extraction to keep the wax in solution
and washing each extractive in tandem through the same three portions of
isooctane.
Collect the successive extractives (300 milliliters total) in a
separatory funnel (preferably 2-liter), containing 480 milliliters of
distilled water, mix, and allow to cool for a few minutes after the last
extractive has been added. Add 80 milliliters of isooctane to the
solution and extract by shaking the funnel vigorously for 2 minutes.
Draw off the lower aqueous layer into a second separatory funnel
(preferably 2-liter) and repeat the extraction with 80 milliliters of
isooctane. Draw off and discard the aqueous layer. Wash each of the
80-milliliter extractives three times with 100-milliliter portions of
distilled water. Shaking time for each wash is 1 minute. Discard the
aqueous layers. Filter the first extractive through anhydrous sodium
sulfate prewashed with isooctane (see Sodium Sulfate under ''Reagents
and Materials'' for preparation of filter) into a 250-milliliter
Erlenmeyer flask (or optionally into the evaporation flask). Wash the
first separatory funnel with the second 80-milliliter isooctane
extractive and pass through the sodium sulfate. Then wash the second
and first separatory funnels successively with a 20-milliliter portion
of isooctane and pass the solvent through the sodium sulfate into the
flask. Add 1 milliliter of n-hexadecane and evaporate the isooctane on
the steam bath under nitrogen. Discontinue evaporation when not over 1
milliliter of residue remains. To the residue, add a 10-milliliter
portion of isooctane, reevaporate to 1 milliliter of hexadecane, and
repeat this operation once.
Quantitatively transfer the residue with isooctane to a 25-milliliter
volumetric flask, make to volume, and mix. Determine the absorbance of
the solution in the 5-centimeter path length cells compared to isooctane
as reference between 280 m -400 m (take care to lose none of the
solution in filling the sample cell). Correct the absorbance values for
any absorbance derived from reagents as determined by carrying out the
procedure without a wax sample. If the corrected absorbance does not
exceed the limits prescribed in this paragraph (b), the wax meets the
ultraviolet absorbance specifications. If the corrected absorbance per
centimeter path length exceeds the limits prescribed in this paragraph
(b), proceed as follows:
Quantitatively transfer the isooctane solution to a 125-milliliter
flask equipped with 24/40 joint and evaporate the isooctane on the steam
bath under a stream of nitrogen to a volume of 1 milliliter of
hexadecane. Add 10 milliliters of methyl alcohol and approximately 0.3
gram of sodium borohydride. (Minimize exposure of the borohydride to
the atmosphere. A measuring dipper may be used.) Immediately fit a
water-cooled condenser equipped with a 24/40 joint and with a drying
tube into the flask, mix until the borohydride is dissolved, and allow
to stand for 30 minutes at room temperature, with intermittent swirling.
At the end of this period, disconnect the flask and evaporate the
methyl alcohol on the steam bath under nitrogen until the sodium
borohydride begins to come out of the solution. Then add 10 milliliters
of isooctane and evaporate to a volume of about 2-3 milliliters. Again,
add 10 milliliters of isooctane and concentrate to a volume of
approximately 5 milliliters. Swirl the flask repeatedly to assure
adequate washing of the sodium borohydride residues.
Fit the tetrafluoroethylene polymer disc on the upper part of the
stem of the chromatographic tube, then place the tube with the disc on
the suction flask and apply the vacuum (approximately 135 millimeters Hg
pressure). Weight out 14 grams of the 2:1 magnesium oxide-Celite 545
mixture and pour the adsorbent mixture into the chromatographic tube in
approximately 3-centimeter layers. After the addition of each layer,
level off the top of the adsorbent with a flat glass rod or metal
plunger by pressing down firmly until the adsorbent is well packed.
Loosen the topmost few millimeters of each adsorbent layer with the end
of a metal rod before the addition of the next layer. Continue packing
in this manner until all the 14 grams of the adsorbent is added to the
tube. Level off the top of the adsorbent by pressing down firmly with a
flat glass rod or metal plunger to make the depth of the adsorbent bed
approximately 12.5 centimeters in depth. Turn off the vacuum and remove
the suction flask. Fit the 500-milliliter reservoir onto the top of the
chromatographic column and prewet the column by passing 100 milliliters
of isooctane through the column. Adjust the nitrogen pressure so that
the rate of descent of the isooctane coming off of the column is between
2-3 milliliters per minute. Discontinue pressure just before the last
of the isooctane reaches the level of the adsorbent. (Caution: Do not
allow the liquid level to recede below the adsorbent level at any time.)
Remove the reservoir and decant the 5-milliliter isooctane concentrate
solution onto the column and with slight pressure again allow the liquid
level to recede to barely above the adsorbent level. Rapidly complete
the transfer similarly with two 5-milliliter portions of isooctane,
swirling the flask repeatedly each time to assure adequate washing of
the residue. Just before the final 5-milliliter wash reaches the top of
the adsorbent, add 100 milliliters of isooctane to the reservoir and
continue the percolation at the 2-3 milliliter per minute rate. Just
before the last of the isooctane reaches the adsorbent level, add 100
milliliters of 10 percent benzene in isooctane to the reservoir and
continue the percolation at the aforementioned rate. Just before the
solvent mixture reaches adsorbent level, add 25 milliliters of 20
percent benzene in isooctane to the reservoir and continue the
percolation at 2-3 milliliters per minute until all this solvent mixture
has been removed from the column. Discard all the elution solvents
collected up to this point. Add 300 milliliters of the
acetone-benzene-water mixture to the reservoir and percolate through the
column to elute the polynuclear compounds. Collect the eluate in a
clean 1-liter separatory funnel. Allow the column to drain until most
of the solvent mixture is removed. Wash the eluate three times with
300-milliliter portions of distilled water, shaking well for each wash.
(The addition of small amounts of sodium chloride facilitates
separation.) Discard the aqueous layer after each wash. After the final
separation, filter the residual benzene through anhydrous sodium sulfate
prewashed with benzene (see Sodium sulfate under ''Reagents and
Materials'' for preparation of filter) into a 250-milliliter Erlenmeyer
flask (or optionally into the evaporation flask). Wash the separatory
funnel with two additional 20-milliliter portions of benzene which are
also filtered through the sodium sulfate. Add 1 milliliter of
n-hexadecane and completely remove the benzene by evaporation under
nitrogen, using the special procedure to eliminate benzene as previously
described under ''Organic Solvents.'' Quantitatively transfer the
residue with isooctane to a 25-milliliter volumetric flask and adjust to
volume. Determine the absorbance of the solution in the 5-centimeter
path length cells compared to isooctane as reference between 250 m -400
m . Correct for any absorbance derived from the reagents as determined
by carrying out the procedure without a wax sample. If either spectrum
shows the characteristic benzene peaks in the 250 m -260m region,
evaporate the solution to remove benzene by the procedure under
''Organic Solvents.'' Dissolve the residue, transfer quantitatively, and
adjust to volume in isooctane in a 25-milliliter volumetric flask.
Record the absorbance again. If the corrected absorbance does not
exceed the limits prescribed in this paragraph (b), the wax meets the
ultraviolet absorbance specifications.
(c) Petroleum wax may contain one or more of the following adjuvants
in amounts not greater than that required to produce their intended
effect:
(1) Antioxidants permitted in food by regulations issued in
accordance with section 409 of the act.
(2) Poly(alkylacrylate) (CAS Reg. No. 27029-57-8), made from long
chain (C16-C22) alcohols and acrylic acid, having: (i) A number average
molecular weight between 40,000 and 100,000; (ii) a weight average
molecular weight (MWw) to number average molecular weight (MWn) ratio
(MWw/MWn) of not less than 3; and (iii) unreacted alkylacrylate monomer
content not in excess of 14 percent, as determined by a method entitled,
''Method for Determining Weight-Average and Number-Average Molecular
Weight and for Determining Alkylacrylate Monomer Content of
Poly(alkylacrylate) used as Processing Aid in Manufacture of Petroleum
Wax,'' which is incorporated by reference (copies are available from the
Division of Food and Color Additives, Center for Food Safety and Applied
Nutrition (HFF-330), 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). Petroleum wax shall contain not more than 1,050
parts per million of poly(alkylacrylate) residues as determined by a
method entitled, ''Method for Determining Residual Level of
Poly(alkylacrylate) in Petroleum Wax,'' which is incorporated by
reference. Copies are available from the address cited in this
paragraph (c)(2).
(d) Petroleum wax is used or intended for use as follows:
(42 FR 14491, Mar. 15, 1977, as amended at 45 FR 48123, July 18,
1980; 47 FR 11838, Mar. 19, 1982; 50 FR 32561, Aug. 13, 1985; 51 FR
19544, May 30, 1986; 54 FR 24897, June 12, 1989)
0521As determined by using potassium chromate for reference standard
and described in National Bureau of Standards Circular 484,
Spectrophotometry, U.S. Department of Commerce, (1949). The accuracy is
to be determined by comparison with the standard values at 290, 345, and
400 millimicrons. Circular 484 is incorporated by reference. Copies
are available from the Division of Food and Color Additives, Center for
Food Safety and Applied Nutrition (HFF-330), 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.
21 CFR 172.888 Synthetic petroleum wax.
Synthetic petroleum wax may be safely used in or on foods in
accordance with the following conditions:
(a) Synthetic petroleum wax is a mixture of solid hydrocarbons,
paraffinic in nature, prepared by catalytic polymerization of ethylene,
and refined to meet the specifications prescribed by this section.
(b) Synthetic petroleum wax meets the ultraviolet absorbance limits
of 172.886(b) when subjected to the analytical procedure described
therein.
(c) Synthetic petroleum wax has a number average molecular weight of
not less than 500 nor greater than 1,200 as determined by vapor pressure
osmometry.
(d) Synthetic petroleum wax may contain any antioxidant permitted in
food by regulations issued in accordance with section 409 of the act, in
an amount not greater than that required to produce its intended effect.
(e) Synthetic petroleum wax is used or intended for use as follows:
21 CFR 172.890 Rice bran wax.
Rice bran wax may be safely used in food in accordance with the
following conditions:
(a) It is the refined wax obtained from rice bran and meets the
following specifications:
Melting point 75 C to 80 C.
Free fatty acids, maximum 10 percent.
Iodine number, maximum 20.
Saponification number 75 to 120.
(b) It is used or intended for use as follows:
21 CFR 172.892 Food starch-modified.
Food starch-modified as described in this section may be safely used
in food. The quantity of any substance employed to effect such
modification shall not exceed the amount reasonably required to
accomplish the intended physical or technical effect, nor exceed any
limitation prescribed. To insure safe use of the food starch-modified,
the label of the food additive container shall bear the name of the
additive ''food starch-modified'' in addition to other information
required by the Act. Food starch may be modified by treatment
prescribed as follows:
(a) Food starch may be acid-modified by treatment with hydrochloric
acid or sulfuric acid or both.
(b) Food starch may be bleached by treatment with one or more of the
following:
(c) Food starch may be oxidized by treatment with chlorine, as sodium
hypochlorite, not to exceed 0.055 pound of chlorine per pound of dry
starch.
(d) Food starch may be esterified by treatment with one of the
following:
(e) Food starch may be etherified by treatment with one of the
following:
(f) Food starch may be esterified and etherified by treatment with
one of the following:
(g) Food starch may be modified by treatment with one of the
following:
(h) Food starch may be modified by a combination of the treatments
prescribed by paragraphs (a) and/or (b) of this section and any one of
the treatments prescribed by paragraph (c), (d), (e), (f), or (g) of
this section, subject to any limitations prescribed by the paragraphs
named.
(42 FR 14491, Mar. 15, 1977, as amended at 43 FR 11697, Mar. 21,
1978; 46 FR 32015, June 19, 1981)
21 CFR 172.894 Modified cottonseed products intended for human
consumption.
The food additive modified cottonseed products may be used for human
consumption in accordance with the following prescribed conditions:
(a) The additive is derived from:
(1) Decorticated, partially defatted, cooked, ground cottonseed
kernels; or
(2) Decorticated, ground cottonseed kernels, in a process that
utilizes n-hexane as an extracting solvent in such a way that no more
than 60 parts per million of n-hexane residues and less than 1 percent
fat by weight remain in the finished product; or
(3) Glandless cottonseed kernels roasted to attain a temperature of
not less than 250 F in the kernel for not less than 5 minutes for use
as a snack food, or in baked goods, or in soft candy; or
(4) Raw glandless cottonseed kernels may be used in hard candy where
the kernel temperature during cooking will exceed 250 F for not less
than 5 minutes.
(b) The additive is prepared to meet the following specifications:
(1) Free gossypol content not to exceed 450 parts per million.
(2) It contains no added arsenic compound and therefore may not
exceed a maximum natural background level of 0.2 part per million total
arsenic, calculated as As.
(c) To assure safe use of the additive, the label of the food
additive container shall bear, in addition to other information required
by the act, the name of the additive as follows:
(1) The additive identified in paragraph (a)(1) of this section as
''partially defatted, cooked cottonseed flour''.
(2) The additive identified in paragraph (a)(2) of this section as
''defatted cottonseed flour''.
(3) The additive identified in paragraph (a)(3) of this section as
''roasted glandless cottonseed kernels''.
(4) The additive identified in paragraph (a)(4) of this section as
''raw glandless cottonseed kernels for use in cooked hard candy''.
(d) The Food and Drug Administration and the Environmental Protection
Agency have determined that glandless cottonseed kernels permitted for
use by this section are a distinct commodity from glanded cottonseed.
21 CFR 172.896 Dried yeasts.
Dried yeast (Saccharomyces cerevisiae and Saccharomyces fragilis) and
dried torula yeast (Candida utilis) may be safely used in food provided
the total folic acid content of the yeast does not exceed 0.04 milligram
per gram of yeast (approximately 0.008 milligram of pteroyglutamic acid
per gram of yeast).
21 CFR 172.898 Bakers yeast glycan.
Bakers yeast glycan may be safely used in food in accordance with the
following conditions:
(a) Bakers yeast glycan is the comminuted, washed, pasteurized, and
dried cell walls of the yeast, Saccharomyces cerevisiae. It is composed
principally of long chain carbohydrates, not less than 85 percent on a
dry solids basis. The carbohydrate is composed of glycan and mannan
units in approximately a 2:1 ratio.
(b) The additive meets the following specifications on a dry weight
basis: Less than 0.4 part per million (ppm) arsenic, 0.13 ppm cadmium,
0.2 ppm lead, 0.05 ppm mercury, 0.09 ppm selenium, and 10 ppm zinc.
(c) The viable microbial content of the finished ingredient is:
(1) Less than 10,000 organisms/gram by aerobic plate count.
(2) Less than 10 yeasts and molds/gram.
(3) Negative for Salmonella, E. coli, coagulase positive
Staphylococci, Clostridium perfringens, Clostridium botulinum, or any
other recognized microbial pathogen or any harmful microbial toxin.
(d) The additive is used or intended for use in the following foods
when standards of identity established under section 401 of the Act do
not preclude such use:
(e) The label and labeling of the ingredient shall bear adequate
directions to assure that use of the ingredient complies with this
regulation.
(42 FR 14491, Mar. 15, 1977, as amended at 45 FR 58836, Sept. 5,
1980)
21 CFR 172.898 PART 173 -- SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION
21 CFR 172.898 Subpart A -- Polymer Substances and Polymer Adjuvants
for Food Treatment
Sec.
173.5 Acrylate-acrylamide resins.
173.10 Modified polyacrylamide resin.
173.20 Ion-exchange membranes.
173.25 Ion-exchange resins.
173.40 Molecular sieve resins.
173.45 Polymaleic acid and its sodium salt.
173.50 Polyvinylpolypyrrolidone.
173.55 Polyvinylpyrrolidone.
173.60 Dimethylamine-epichlorohydrin copolymer.
173.65 Divinylbenzene copolymer.
173.70 Chloromethylated aminated styrene-divinylbenzene resin.
173.73 Sodium polyacrylate.
173.75 Sorbitan monooleate.
21 CFR 172.898 Subpart B -- Enzyme Preparations and Microorganisms
173.110 Amyloglucosidase derived from Rhizopus niveus.
173.120 Carbohydrase and cellulase derived from Aspergillus niger.
173.130 Carbohydrase derived from Rhizopus oryzae.
173.135 Catalase derived from Microccocus lysodeikticus.
173.140 Esterase-lipase derived fron Mucor miehei.
173.145 Alpha-Galactosidase derived from Morteirella vinaceae var.
raffinoseutilizer.
173.150 Milk-clotting enzymes, microbial.
173.160 Candida guilliermondii.
173.165 Candida lipolytica.
21 CFR 172.898 Subpart C -- Solvents, Lubricants, Release Agents and
Related Substances
173.210 Acetone.
173.220 1,3-Butylene glycol.
173.228 Ethyl acetate.
173.230 Ethylene dichloride.
173.240 Isopropyl alcohol.
173.250 Methyl alcohol residues.
173.255 Methylene chloride.
173.270 Hexane.
173.275 Hydrogenated sperm oil.
173.280 Solvent extraction process for citric acid.
173.290 Trichloroethylene.
21 CFR 172.898 Subpart D -- Specific Usage Additives
173.310 Boiler water additives.
173.315 Chemicals used in washing or to assist in the lye peeling of
fruits and vegetables.
173.320 Chemicals for controlling microorganisms in cane-sugar and
beet-sugar mills.
173.322 Chemicals used in delinting cottonseed.
173.340 Defoaming agents.
173.342 Chlorofluorocarbon 113 and perfluorohexane.
173.345 Chloropentafluoroethane.
173.350 Combustion product gas.
173.355 Dichlorodifluoromethane.
173.357 Materials used as fixing agents in the immobilization of
enzyme preparations.
173.360 Octafluorocyclobutane.
173.385 Sodium methyl sulfate.
173.395 Trifluoromethane sulfonic acid.
173.400 Dimethyldialkylammonium chloride.
Authority: Secs. 201, 402, 409 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321, 342, 348).
Source: 42 FR 14526, Mar. 15, 1977, unless otherwise noted.
21 CFR 172.898 Subpart A -- Polymer Substances and Polymer Adjuvants for Food Treatment
21 CFR 173.5 Acrylate-acrylamide resins.
Acrylate-acrylamide resins may be safely used in food under the
following prescribed conditions:
(a) The additive consists of one of the following:
(1) Acrylamide-acrylic acid resin (hydrolyzed polyacrylamide) is
produced by the polymerization of acrylamide with partial hydrolysis, or
by copolymerization of acrylamide and acrylic acid, with the greater
part of the polymer being composed of acrylamide units.
(2) Sodium polyacrylate-acrylamide resin is produced by the
polymerization and subsequent hydrolysis of acrylonitrile in a sodium
silicate-sodium hydroxide aqueous solution, with the greater part of the
polymer being composed of acrylate units.
(b) The additive contains not more than 0.05 percent of residual
monomer calculated as acrylamide.
(c) The additive is used or intended for use as follows:
(1) The additive identified in paragraph (a) (1) of this section is
used as a flocculent in the clarification of beet sugar juice and liquor
or cane sugar juice and liquor or corn starch hydrolyzate in an amount
not to exceed 5 parts per million by weight of the juice or 10 parts per
million by weight of the liquor or the corn starch hydrolyzate.
(2) The additive identified in paragraph (a)(2) of this section is
used to control organic and mineral scale in beet sugar juice and liquor
or cane sugar juice and liquor in an amount not to exceed 2.5 parts per
million by weight of the juice or liquor.
(42 FR 14526, Mar. 15, 1977, as amended at 46 FR 30494, June 9, 1981)
21 CFR 173.10 Modified polyacrylamide resin.
Modified polyacrylamide resin may be safely used in food in
accordance with the following prescribed conditions:
(a) The modified polyacrylamide resin is produced by the
copolymerization of acrylamide with not more than 5-mole percent
-methacrylyloxyethy-ltrimethylammonium methyl sulfate.
(b) The modified polyacrylamide resin contains not more than 0.05
percent residual acrylamide.
(c) The modified polyacrylamide resin is used as a flocculent in the
clarification of beet or cane sugar juice in an amount not exceeding 5
parts per million by weight of the juice.
(d) To assure safe use of the additive, the label and labeling of the
additive shall bear, in addition to the other information required by
the act, adequate directions to assure use in compliance with paragraph
(c) of this section.
21 CFR 173.20 Ion-exchange membranes.
Ion-exchange membranes may be safely used in the processing of food
under the following prescribed conditions:
(a) The ion-exchange membrane is prepared by subjecting a
polyethylene base conforming to 177.1520 of this chapter to
polymerization with styrene until the polystyrene phase of the base is
not less than 16 percent nor more than 30 percent by weight. The base
is then modified by reaction with chloromethyl methyl ether, and by
subsequent amination with trimethylamine, dimethylamine,
diethylenetriamine, or dimethylethanolamine.
(b) The ion-exchange membrane is manufactured so as to comply with
the following extraction limitations when subjected to the described
procedure: Separate square-foot samples of membrane weighing
approximately 14 grams each are cut into small pieces and refluxed for 4
hours in 150 cubic centimeters of the following solvents: Distilled
water, 5 percent acetic acid, and 50 percent alcohol. Extraction from
each sample will not exceed 0.4 percent by weight of sample.
(c) The ion-exchange membrane will be used in the production of
grapefruit juice to adjust the ratio of citric acid to total solids of
the grapefruit juice produced.
21 CFR 173.25 Ion-exchange resins.
Ion-exchange resins may be safely used in the treatment of food under
the following prescribed conditions:
(a) The ion-exchange resins are prepared in appropriate physical
form, and consist of one or more of the following:
(1) Sulfonated copolymer of styrene and divinylbenzene.
(2) Sulfonated anthracite coal meeting the requirements of ASTM
method D388-38, Class I, Group 2, ''Standard Specifications for
Classification of Coal by Rank,'' which is incorporated by reference.
Copies are available from University Microfilms International, 300 N.
Zeeb Rd., Ann Arbor, MI 48106, or available for inspection at the Office
of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(3) Sulfite-modified cross-linked phenol-formaldehyde, with
modification resulting in sulfonic acid groups on side chains.
(4) Methacrylic acid-divinylbenzene copolymer.
(5) Cross-linked polystyrene, first chloromethylated then aminated
with trimethylamine, dimethylamine, di-ethylenetriamine, or
dimethylethanol-amine.
(6) Diethylenetriamine, triethylene-tetramine, or
tetraethylenepentamine cross-linked with epichlorohydrin.
(7) Cross-linked phenol-formaldehyde activated with one or both of
the following: Triethylene tetramine and tetraethylenepentamine.
(8) Reaction resin of formaldehyde, acetone, and
tetraethylenepentamine.
(9) Completely hydrolyzed copolymers of methyl acrylate and
divinylbenzene.
(10) Completely hydrolyzed terpolymers of methyl acrylate,
divinylbenzene, and acrylonitrile.
(11) Sulfonated terpolymers of styrene, divinylbenzene, and
acrylonitrile or methyl acrylate.
(12) Methyl acrylate-divinylbenzene copolymer containing not less
than 2 percent by weight of divinylbenzene, aminolyzed with
dimethylaminopro-pylamine.
(13) Methyl acrylate-divinylbenzene copolymer containing not less
than 3.5 percent by weight of divinylbenzene, aminolyzed with
dimethylaminopro-pylamine.
(14) Epichlorohydrin cross-linked with ammonia.
(15) Sulfonated tetrapolymer of styrene, divinylbenzene,
acrylonitrile, and methyl acrylate derived from a mixture of monomers
containing not more than a total of 2 percent by weight of acrylonitrile
and methyl acrylate.
(16) Methyl acrylate-divinylbenzenediethylene glycol divinyl ether
terpolymer containing not less than 3.5 percent by weight of
divinylbenzene and not more than 0.6 percent by weight of diethylene
glycol divinyl ether, aminolyzed with dimethylaminopropylamine.
(17) Styrene-divinylbenzene cross-linked copolymer, first
chloromethylated then aminated with dimethylamine and oxidized with
hydrogen peroxide whereby the resin contains not more than 15 percent by
weight of vinyl N,N-dimethylbenzylamine-N-oxide and not more than 6.5
percent by weight of nitrogen.
(18) Methyl acrylate-divinylbenzene-diethylene glycol divinyl ether
terpolymer containing not less than 7 percent by weight of
divinylbenzene and not more than 2.3 percent by weight of diethylene
glycol divinyl ether, aminolyzed with dimethylaminopropylamine and
quaternized with methyl chloride.
(19) Epichlorohydrin cross-linked with ammonia and then quaternized
with methyl chloride to contain not more than 18 percent strong base
capacity by weight of total exchange capacity (Chemical Abstracts
Service name: Oxirane (chloromethyl)-, polymer with ammonia, reaction
product with chloromethane; CAS Reg. No. 68036-99-7).
(20) Regenerated cellulose, cross-linked and alkylated with
epichlorohydrin and propylene oxide, then sulfonated whereby the amount
of epichlorohydrin plus propylene oxide employed does not exceed 61
percent by weight of the starting quantity of cellulose.
(b) Ion-exchange resins are used in the purification of foods,
including potable water, to remove undesirable ions or to replace less
desirable ions with one or more of the following: bicarbonate, calcium,
carbonate, chloride, hydrogen, hydroxyl, magnesium, potassium, sodium,
and sulfate except that: The ion-exchange resin identified in paragraph
(a)(12) of this section is used only in accordance with paragraph (b)(1)
of this section, the ion-exchange resin identified in paragraph (a)(13)
of this section is used only in accordance with paragraph (b)(2) of this
section, the resin identified in paragraph (a)(16) of this section is
used only in accordance with paragraph (b)(1) or (b)(2) of this section,
the ion-exchange resin identified in paragraph (a)(17) of this section
is used only in accordance with paragraph (b)(3) of this section, the
ion-exchange resin identified in paragraph (a)(18) of this section is
used only in accordance with paragraph (b)(4) of this section, and the
ion-exchange resin identified in paragraph (a)(20) of this section is
used only in accordance with paragraphs (b)(5) and (d) of this section.
(1) The ion-exchange resins identified in paragraphs (a) (12) and
(16) of this section are used to treat water for use in the manufacture
of distilled alcoholic beverages, subject to the following conditions:
(i) The water is subjected to treatment through a mixed bed
consisting of one of the resins identified in paragraph (a) (12) or (16)
of this section and one of the strongly acidic cation-exchange resins in
the hydrogen form identified in paragraphs (a) (1), (2), and (11) of
this section; or
(ii) The water is first subjected to one of the resins identified in
paragraph (a) (12) or (16) of this section and is subsequently subjected
to treatment through a bed of activated carbon or one of the strongly
acidic cation-exchange resins in the hydrogen form identified in
paragraphs (a) (1), (2), and (11) of this section.
(iii) The temperature of the water passing through the resin beds
identified in paragraphs (b)(1) (i) and (ii) of this section is
maintained at 30 C or less, and the flow rate of the water passing
through the beds is not less than 2 gallons per cubic foot per minute.
(iv) The ion-exchange resins identified in paragraph (a) (12) or (16)
of this section are exempted from the requirements of paragraph (c)(4)
of this section, but the strongly acidic cation-exchange resins referred
to in paragraphs (b)(1) (i) and (ii) of this section used in the process
meet the requirements of paragraph (c)(4) of this section, except for
the exemption described in paragraph (d) of this section.
(2) The ion-exchange resins identified in paragraphs (a) (13) and
(16) of this section are used to treat water and aqueous food only of
the types identified under Categories I, II, and VI-B in Table 1 of
176.170(c) of this chapter: Provided, That the temperature of the water
or food passing through the resin beds is maintained at 50 C or less
and the flow rate of the water or food passing through the beds is not
less than 0.5 gallon per cubic foot per minute.
(3) The ion-exchange resin identified in paragraph (a)(17) of this
section is used only for industrial application to treat bulk quantities
of aqueous food, including potable water, or for treatment of municipal
water supplies, subject to the condition that the temperature of the
food or water passing through the resin bed is maintained at 25 C or
less and the flow rate of the food or water passing through the bed is
not less than 2 gallons per cubic foot per minute.
(4) The ion-exchange resin identified in paragraph (a)(18) of this
section is used to treat aqueous sugar solutions subject to the
condition that the temperature of the sugar solution passing through the
resin bed is maintained at 82 C (179.6 F) or less and the flow rate of
the sugar solution passing through the bed is not less than 46.8 liters
per cubic meter (0.35 gallon per cubic foot) of resin bed volume per
minute.
(5) The ion-exchange resin identified in paragraph (a)(20) of this
section is limited to use in aqueous process streams for the isolation
and purification of protein concentrates and isolates. The pH range for
the resin shall be no less than 3.5 and no more than 9, and the
temperatures of water and food passing through the resin bed shall not
exceed 25 C.
(c) To insure safe use of ion-exchange resins, each ion-exchange
resin will be:
(1) Subjected to pre-use treatment by the manufacturer and/or the
user in accordance with the manufacturer's directions prescribed on the
label or labeling accompanying the resins, to guarantee a food-grade
purity of ion-exchange resins, in accordance with good manufacturing
practice.
(2) Accompanied by label or labeling to include directions for use
consistent with the intended functional purpose of the resin.
(3) Used in compliance with the label or labeling required by
paragraph (c)(2) of this section.
(4) Found to result in no more than 1 part per million of organic
extractives obtained with each of the named solvents, distilled water,
15 percent alcohol, and 5 percent acetic acid when, having been washed
and otherwise treated in accordance with the manufacturer's directions
for preparing them for use with food, the ion-exchange resin is
subjected to the following test: Using a separate ion-exchange column
for each solvent, prepare columns using 50 milliliters of the ready to
use ion-exchange resin that is to be tested. While maintaining the
highest temperature that will be encountered in use pass through these
beds at the rate of 350-450 milliliters per hour the three test solvents
distilled water, 15 percent (by volume) ethyl alcohol, and 5 percent (by
weight) acetic acid. The first liter of effluent from each solvent is
discarded, then the next 2 liters are used to determine organic
extractives. The 2-liter sample is carefully evaporated to constant
weight at 105 C; this is total extractives. This residue is fired in
a muffle furnace at 850 C to constant weight; this is ash. Total
extractives, minus ash equals the organic extractives. If the organic
extractives are greater than 1 part per million of the solvent used, a
blank should be run on the solvent and a correction should be made by
subtracting the total extractives obtained with the blank from the total
extractives obtained in the resin test. The solvents used are to be
made as follows:
Distilled water (de-ionized water is distilled).
15 percent ethyl alcohol made by mixing 15 volumes of absolute ethyl
alcohol A.C.S. reagent grade, with 85 volumes of distilled de-ionized
water.
5 percent acetic acid made by mixing 5 parts by weight of A.C.S.
reagent grade glacial acetic acid with 95 parts by weight of distilled
de-ionized water.
In addition to the organic extractives limitation prescribed in this
paragraph, the ion-exchange resin identified in paragraph (a)(17) of
this section, when extracted with each of the named solvents, distilled
water, 50 percent alcohol, and 5 percent acetic acid, will be found to
result in not more than 7 parts per million of nitrogen extractives
(calculated as nitrogen) when the resin in the free-base form is
subjected to the following test immediately before each use: Using a
separate 1-inch diameter glass ion-exchange column for each solvent,
prepare each column using 100 milliliters of ready to use ion-exchange
resin that is to be tested. With the bottom outlet closed, fill each
ion-exchange column with one of the three solvents at a temperature of
25 C until the solvent level is even with the top of the resin bed.
Seal each column at the top and bottom and store in a vertical position
at a temperature of 25 C. After 96 hours, open the top of each column,
drain the solvent into a collection vessel, and analyze each drained
solvent and a solvent blank for nitrogen by a standard micro-Kjeldahl
method.
(d)(1) The ion-exchange resins identified in paragraphs (a)(1),
(a)(2), (a)(11), and (a)(15) of this section are exempted from the
acetic acid extraction requirement of paragraph (c)(4) of this section.
(2) The ion-exchange resin identified in paragraph (a)(20) of this
section shall comply with the extraction requirement in paragraph (c)(4)
of this section by using dilute sulfuric acid, pH 3.5, as a substitute
for acetic acid.
(e) Acrylonitrile copolymers identified in this section shall comply
with the provisions of 180.22 of this chapter.
(42 FR 14526, Mar. 15, 1977, as amended at 46 FR 40181, Aug. 7, 1981;
46 FR 57033, Nov. 20, 1981; 49 FR 28830, July 17, 1984; 56 FR 16268,
Apr. 22, 1991)
21 CFR 173.40 Molecular sieve resins.
Molecular sieve resins may be safely used in the processing of food
under the following prescribed conditions:
(a) The molecular sieve resins consist of purified dextran having an
average molecular weight of 40,000, cross-linked with epichlorohydrin in
a ratio of 1 part of dextran to 10 parts of epichlorohydrin, to give a
stable three dimensional structure. The resins have a pore size of 2.0
to 3.0 milliliters per gram of dry resin (expressed in terms of water
regain), and a particle size of 10 to 300 microns.
(b) The molecular sieve resins are thoroughly washed with potable
water prior to their first use in contact with food.
(c) Molecular sieve resins are used as the gel filtration media in
the final purification of partially delactosed whey. The gel bed shall
be maintained in a sanitary manner in accordance with good manufacturing
practice so as to prevent microbial build-up on the bed and adulteration
of the product.
21 CFR 173.45 Polymaleic acid and its sodium salt.
Polymaleic acid (CAS Reg. No. 26099-09-2) and its sodium salt (CAS
Reg. No. 70247-90-4) may be safely used in food in accordance with the
following prescribed conditions:
(a) The additives have a minimum average molecular weight of 550-650
and a weight-average molecular weight of 650-850, calculated as the
acid. Molecular weight shall be determined by a method entitled
''Determination of Molecular Weight Distribution of Poly(Maleic Acid),''
which is incorporated by reference. Copies are available from the
Division of Food and Color Additives, Center for Food Safety and Applied
Nutrition (HFF-330), 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.
(b) The additives may be used, individually or together, in the
processing of beet sugar juice and liquor or of cane sugar juice and
liquor to control mineral scale.
(c) The additives are to be used so that the amount of either or both
additives does not exceed 0.4 part per million (calculated as the acid)
by weight of the beet or cane sugar juice or liquor process stream.
(51 FR 5315, Feb. 13, 1986)
21 CFR 173.50 Polyvinylpolypyrrolidone.
The food additive polyvinylpolypyrrolidone may be safely used in
accordance with the following prescribed conditions:
(a) The additive is a homopolymer of purified vinylpyrrolidone
catalytically produced under conditions producing polymerization and
cross-linking such that an insoluble polymer is produced.
(b) The food additive is so processed that when the finished polymer
is refluxed for 3 hours with water, 5 percent acetic acid, and 50
percent alcohol, no more than 50 parts per million of extractables is
obtained with each solvent.
(c) It is used or intended for use as a clarifying agent in beverages
and vinegar, followed by removal with filtration.
21 CFR 173.55 Polyvinylpyrrolidone.
The food additive polyvinylpyrroli-done may be safely used in
accordance with the following prescribed conditions:
(a) The additive is a polymer of purified vinylpyrrolidone
catalytically produced, having an average molecular weight of 40,000 and
a maximum unsaturation of 1 percent, calculated as the monomer, except
that the polyvinylpyrrolidone used in beer is that having an average
molecular weight of 360,000 and a maximum unsaturation of 1 percent,
calculated as the monomer.
(b) The additive is used or intended for use in foods as follows:
21 CFR 173.60 Dimethylamine-epichlorohydrin copolymer.
Dimethylamine-epichlorohydrin copolymer (CAS Reg. No. 25988-97-0) may
be safely used in food in accordance with the following prescribed
conditions:
(a) The food additive is produced by copolymerization of
dimethylamine and epichlorohydrin in which not more than 5 mole-percent
of dimethylamine may be replaced by an equimolar amount of
ethylenediamine, and in which the mole ratio of total amine to
epichlorohydrin is approximately 1:1.
(b) The additive meets the following specifications:
(1) The nitrogen content of the copolymer is 9.4 to 10.8 weight
percent on a dry basis.
(2) A 50-percent-by-weight aqueous solution of the copolymer has a
minimum viscosity of 175 centipoises at 25 C as determined by
LVT-series Brookfield viscometer using a No. 2 spindle at 60 RPM (or by
another equivalent method).
(3) The additive contains not more than 1,000 parts per million of
1,3-dichloro-2-propanol and not more than 10 parts per million
epichlorohydrin. The epichlorohydrin and 1,3-dichloro-2-propanol
content is determined by an analytical method entitled ''The
Determination of Epichlorohydrin and 1,3-Dichloro-2-Propanol in
Dimethylamine-Epichlorohydrin Copolymer,'' which is incorporated by
reference. Copies are available from the Division of Food and Color
Additives, Center for Food Safety and Applied Nutrition (HFF-330), 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.
(4) Heavy metals (as Pb), 2 parts per million maximum.
(5) Arsenic (as As), 2 parts per million maximum.
(c) The food additive is used as a decolorizing agent and/or
flocculant in the clarification of refinery sugar liquors and juices.
It is added only at the defecation/clarification stage of sugar liquor
refining at a concentration not to exceed 150 parts per million of
copolymer by weight of sugar solids.
(d) To assure safe use of the additive, the label and labeling of the
additive shall bear, in addition to other information required by the
Act, adequate directions to assure use in compliance with paragraph (c)
of this section.
(48 FR 37614, Aug. 19, 1983, as amended at 54 FR 24897, June 12,
1989)
21 CFR 173.65 Divinylbenzene copolymer.
Divinylbenzene copolymer may be used for the removal of organic
substances from aqueous foods under the following prescribed conditions:
(a) The copolymer is prepared in appropriate physical form and is
derived by the polymerization of a grade of divinylbenzene which
comprises at least 79 weight-percent divinylbenzene, 15 to 20
weight-percent ethylvinylbenzene, and no more than 4 weight-percent
nonpolymerizable impurities.
(b) In accordance with the manufacturer's directions, the copolymer
described in paragraph (a) of this section is subjected to pre-use
extraction with a water soluble alcohol until the level of
divinylbenzene in the extract is less than 50 parts per billion as
determined by a method titled, ''The Determination of Divinylbenzene in
Alcohol Extracts of Amberlite XAD-4,'' which is incorporated by
reference. Copies of this method are available from the Division of
Food and Color Additives, Center for Food Safety and Applied Nutrition
(HFF-330), 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. The copolymer is then
treated with water according to the manufacturer's recommendation to
remove the extraction solvent to guarantee a food-grade purity of the
resin at the time of use, in accordance with current good manufacturing
practice.
(c) The temperature of the aqueous food stream contacting the polymer
is maintained at 79.4 C (175 F) or less.
(d) The copolymer may be used in contact with food only of Types I,
II, and VI-B (excluding carbonated beverages) described in Table 1 of
paragraph (c) of 176.170 of this chapter.
(50 FR 61, Jan. 2, 1985)
21 CFR 173.70 Chloromethylated aminated styrene-divinylbenzene resin.
Chloromethylated aminated styrene-divinylbenzene copolymer (CAS Reg.
No. 60177-39-1) may be safely used in food in accordance with the
following prescribed conditions:
(a) The additive is an aqueous dispersion of styrene-divinylbenzene
copolymers, first chloromethylated then aminated with trimethylamine,
having an average particle size of not more than 2.0 microns.
(b) The additive shall contain no more than 3.0 percent nonvolatile,
soluble extractives when tested as follows: One hundred grams of the
additive is centrifuged at 17,000 r/min for 2 hours. The resulting
clear supernatant is removed from the compacted solids and concentrated
to approximately 10 grams on a steam bath. The 10-gram sample is again
centrifuged at 17,000 r/min for 2 hours to remove any residual insoluble
material. The supernatant from the second centrifugation is then
removed from any compacted solids and dried to constant residual weight
using a steam bath. The percent nonvolatile solubles is obtained by
dividing the weight of the dried residue by the weight of the solids in
the original resin dispersion.
(c) The additive is used as a decolorizing and clarification agent
for treatment of refinery sugar liquors and juices at levels not to
exceed 500 parts of additive solids per million parts of sugar solids.
(50 FR 29209, July 18, 1985)
21 CFR 173.73 Sodium polyacrylate.
Sodium polyacrylate (CAS Reg. No. 9003-04-7) may be safely used in
food in accordance with the following prescribed conditions:
(a) The additive is produced by the polymerization of acrylic acid
and subsequent hydrolysis of the polyacrylic acid with an aqueous sodium
hydroxide solution. As determined by a method entitled ''Determination
of Weight Average and Number Average Molecular Weight of Sodium
Polyacrylate'', which is incorporated by reference in accordance with 5
U.S.C. 552(a), the additive has --
(1) A weight average molecular weight of 2,000 to 2,300; and
(2) A weight average molecular weight to number average molecular
weight ratio of not more than 1.3. Copies of the method are available
from the Division of Food and Color Additives, Center for Food Safety
and Applied Nutrition (HFF-330), Food and Drug Administration, 200 C
Street SW., Washington, DC 20204, or available for inspection at the
Office of the Federal Register, 1100 L Street NW., Washington, DC 20408.
(b) The additive is used to control mineral scale during the
evaporation of beet sugar juice or cane sugar juice in the production of
sugar in an amount not to exceed 3.6 parts per million by weight of the
raw juice.
(53 FR 39456, Oct. 7, 1988; 53 FR 49823, Dec. 9, 1988)
21 CFR 173.75 Sorbitan monooleate.
Sorbitan monooleate may be safely used in accordance with the
following prescribed conditions:
(a) The additive is produced by the esterification of sorbitol with
commercial oleic acid.
(b) It meets the following specifications:
(1) Saponification number, 145-160.
(2) Hydroxyl number, 193-210.
(c) The additive is used or intended for use as follows:
(1) As an emulsifier in polymer dispersions that are used in the
clarification of cane or beet sugar juice or liquor in an amount not to
exceed 7.5 percent by weight in the final polymer dispersion.
(2) The additive is used in an amount not to exceed 0.70 part per
million in sugar juice and 1.4 parts per million in sugar liquor.
(51 FR 11720, Apr. 7, 1986)
21 CFR 173.75 Subpart B -- Enzyme Preparations and Microorganisms
21 CFR 173.110 Amyloglucosidase derived from Rhizopus niveus.
Amyloglucosidase enzyme product, consisting of enzyme derived from
Rhizopus niveus, and diatomaceous silica as a carrier, may be safely
used in food in accordance with the following conditions:
(a) Rhizopus niveus is classified as follows: Class, Phycomycetes;
order, Mucorales; family, Mucoraceae; genus, Rhizopus; species,
niveus.
(b) The strain of Rhizopus niveus is nonpathogenic and nontoxic in
man or other animals.
(c) The enzyme is produced by a process which completely removes the
organism Rhizopus niveus from the amyloglucosidase.
(d) The additive is used or intended for use for degrading
gelatinized starch into constituent sugars, in the production of
distilled spirits and vinegar.
(e) The additive is used at a level not to exceed 0.1 percent by
weight of the gelatinized starch.
21 CFR 173.120 Carbohydrase and cellulase derived from Aspergillus
niger.
Carbohydrase and cellulase enzyme preparation derived from
Aspergillus niger may be safely used in food in accordance with the
following prescribed conditions:
(a) Aspergillus niger is classified as follows: Class,
Deuteromycetes; order, Moniliales; family, Moniliaceae; genus,
Aspergillus; species, niger.
(b) The strain of Aspergillus niger is nonpathogenic and nontoxic in
man or other animals.
(c) The additive is produced by a process that completely removes the
organism Aspergillus niger from the carbohydrase and cellulase enzyme
product.
(d) The additive is used or intended for use as follows:
(1) For removal of visceral mass (bellies) in clam processing.
(2) As an aid in the removal of the shell from the edible tissue in
shrimp processing.
(e) The additive is used in an amount not in excess of the minimum
required to produce its intended effect.
21 CFR 173.130 Carbohydrase derived from Rhizopus oryzae.
Carbohydrase from Rhizopus oryzae may be safely used in the
production of dextrose from starch in accordance with the following
prescribed conditions:
(a) Rhizopus oryzae is classified as follows: Class, Phycomycetes;
order, Mucorales; family, Mucoraceae; genus, Rhizopus; species,
Rhizopus oryzae.
(b) The strain of Rhizopus oryzae is nonpathogenic and nontoxic.
(c) The carbohydrase is produced under controlled conditions to
maintain nonpathogenicity and nontoxicity, including the absence of
aflatoxin.
(d) The carbohydrase is produced by a process which completely
removes the organism Rhizopus oryzae from the carbohydrase product.
(e) The carbohydrase is maintained under refrigeration from
production to use and is labeled to include the necessity of
refrigerated storage.
21 CFR 173.135 Catalase derived from Micrococcus lysodeikticus.
Bacterial catalase derived from Micrococcus lysodeikticus by a pure
culture fermentation process may be safely used in destroying and
removing hydrogen peroxide used in the manufacture of cheese, in
accordance with the following conditions.
(a) The organism Micrococcus lysodeikticus from which the bacterial
catalase is to be derived is demonstrated to be nontoxic and
nonpathogenic.
(b) The organism Micrococcus lysodeikticus is removed from the
bacterial catalase prior to use of the bacterial catalase.
(c) The bacterial catalase is used in an amount not in excess of the
minimum required to produce its intended effect.
21 CFR 173.140 Esterase-lipase derived from Mucor miehei.
Esterase-lipase enzyme, consisting of enzyme derived from Mucor
miehei var. Cooney et Emerson by a pure culture fermentation process,
with maltodextrin or sweet whey as a carrier, may be safely used in food
in accordance with the following conditions:
(a) Mucor miehei var. Cooney et Emerson is classified as follows:
Class, Phycomycetes; subclass, Zygomycetes; order, Mucorales; family,
Mucoraceae; genus, Mucor; species, miehei; variety Cooney et Emerson.
(b) The strain of Mucor miehei var. Cooney et Emerson is
nonpathogenic and nontoxic in man or other animals.
(c) The enzyme is produced by a process which completely removes the
organism Mucor miehei var. Cooney et Emerson from the esterase-lipase.
(d) The enzyme is used as a flavor enhancer as defined in
170.3(o)(12).
(e) The enzyme is used at levels not to exceed current good
manufacturing practice in the following food categories: cheeses as
defined in 170.3(n)(5) of this chapter; fat and oils as defined in
170.(3)(n)(12) of this chapter; and milk products as defined in
170.(3)(n)(31) of this chapter. Use of this food ingredient is limited
to nonstandarized foods and those foods for which the relevant standards
of identity permit such use.
(f) The enzyme is used in the minimum amount required to produce its
limited technical effect.
(47 FR 28090, June 29, 1982; 48 FR 2748, Jan. 21, 1983)
21 CFR 173.145 Alpha-Galactosidase derived from Mortierella vinaceae
var. raffinoseutilizer.
The food additive alpha-galactosidase and parent mycelial
microorganism Mortierella vinaceae var. raffinoseutilizer may be safely
used in food in accordance with the following conditions:
(a) The food additive is the enzyme alpha-galactosidase and the
mycelia of the microorganism Mortierella vinaceae var.
raffinoseutilizer which produces the enzyme.
(b) The nonpathogenic microorganism matches American Type Culture
Collection (ATCC) No. 20034,1 and is classified as follows:
Class: Phycomycetes.
Order: Mucorales.
Family: Mortierellaceae.
Genus: Mortierella.
Species: vinaceae.
Variety: raffinoseutilizer.
(c) The additive is used or intended for use in the production of
sugar (sucrose) from sugar beets by addition as mycelial pellets to the
molasses to increase the yield of sucrose, followed by removal of the
spent mycelial pellets by filtration.
(d) The enzyme removal is such that there are no enzyme or mycelial
residues remaining in the finished sucrose.
(42 FR 14526, Mar. 15, 1977, as amended at 54 FR 24897, June 12,
1989)
1Available from: American Type Culture Collection, 12301 Parklawn
Drive, Rockville, MD 20852.
21 CFR 173.150 Milk-clotting enzymes, microbial.
Milk-clotting enzyme produced by pure-culture fermentation process
may be safely used in the production of cheese in accordance with the
following prescribed conditions:
(a) Milk-clotting enzyme is derived from one of the following
organisms by a pure-culture fermentation process:
(1) Endothia parasitica classified as follows: Class, Ascomycetes;
order, Sphaeriales; family, Diaporthacesae; genus, Endothia; species,
parasitica.
(2) Bacillus cereus classified as follows: Class, Schizomycetes;
order, Eubacteriales; family, Bacillaceae; genus, Bacillus; species,
cereus (Frankland and Frankland).
(3) Mucor pusillus Lindt classified as follows: Class, Phycomycetes;
subclass, Zygomycetes; order, Mucorales; family, Mucoraceae; genus,
Mucor; species, pusillus; variety, Lindt.
(4) Mucor miehei Cooney et Emerson classified as follows: Class,
Phycomycetes; subclass, Zygomycetes; order, Mucorales; family,
Mucoraceae; genus, Mucor; species, miehei; variety, Cooney et
Emerson.
(b) The strains of organism identified in paragraph (a) of this
section are nonpathogenic and nontoxic in man or other animals.
(c) The additive is produced by a process that completely removes the
generating organism from the milk-clotting enzyme product.
(d) The additive is used in an amount not in excess of the minimum
required to produce its intended effect in the production of those
cheeses for which it is permitted by standards of identity established
pursuant to section 401 of the Act.
(42 FR 14526, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977)
21 CFR 173.160 Candida guilliermondii.
The food additive Candida guilliermondii may be safely used as the
organism for fermentation production of citric acid in accordance with
the following conditions:
(a) The food additive is the enzyme system of the viable organism
Candida guilliermondii and its concomitant metabolites produced during
the fermentation process.
(b)(1) The nonpathogenic and nontoxicogenic organism descending from
strain, American Type Culture Collection (ATCC) No. 20474,1 is
classified as follows:
Class: Deuteromycetes.
Order: Moniliales.
Family: Cryptococcaceae.
Genus: Candida.
Species: guilliermondii.
Variety: guilliermondii.
(2) The toxonomic characteristics of the reference culture strain
ATCC No. 20474 agree in the essentials with the standard description
for Candida guilliermondii variety guilliermondii listed in ''The Yeasts
-- A Toxonomic Study;'' 2d Ed. (1970), by Jacomina Lodder, which is
incorporated by reference. Copies are available from the Division of
Food and Color Additives, Center for Food Safety and Applied Nutrition
(HFF-330), 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.
(c)(1) The additive is used or intended for use as a pure culture in
the fermentation process for the production of citric acid using an
acceptable aqueous carbohydrate substrate.
(2) The organism Candida quilliermondii is made nonviable and is
completely removed from the citric acid during the recovery and
purification process.
(d) The additive is so used that the citric acid produced conforms to
the specifications of the ''Food Chemicals Codex,'' 3d Ed. (1981),
under ''Citric acid,'' pp. 86-87, which is incorporated by reference.
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.
(42 FR 14526, Mar. 15, 1977, as amended at 47 FR 11838, Mar. 19,
1982; 49 FR 10106, Mar. 19, 1984; 54 FR 24897, June 12, 1989)
1Available from: American Type Culture Collection, 12301 Parklawn
Drive, Rockville, MD 20852.
21 CFR 173.165 Candida lipolytica.
The food additive Candida lipolytica may be safely used as the
organism for fermentation production of citric acid in accordance with
the following conditions:
(a) The food additive is the enzyme system of the organism Candida
lipolytica and its concimitant metabolites produced during the
fermentation process.
(b)(1) The nonpathogenic organism is classified as follows:
Class: Deuteromycetes.
Order: Moniliales.
Family: Cryptococcaceae.
Genus: Candida.
Species: lipolytica.
(2) The taxonomic characteristics of the culture agree in essential
with the standard description for Candida lipolytica variety lipolytica
listed in ''The Yeasts -- A Toxonomic Study,'' 2d Ed. (1970), by
Jacomina Lodder, which is incorporated by reference. Copies are
available from the Division of Food and Color Additives, Center for Food
Safety and Applied Nutrition (HFF-330), 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.
(c) The additive is used or intended for use as a pure culture in the
fermentation process for the production of citric acid from purified
normal alkanes.
(d) The additive is so used that the citric acid produced conforms to
the specifications of the ''Food Chemicals Codex,'' 3d Ed. (1981), pp.
86-87, which is incorporated by reference. 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., Wasington, DC 20408. The additive meets the following
ultraviolet absorbance limits when subjected to the analytical procedure
described in this paragraph:
Because of the sensitivity of the test, the possibility of errors
arising from contamination is great. It is of the greatest importance
that all glassware be scrupulously cleaned to remove all organic matter
such as oil, grease, detergent residues, etc. Examine all glassware
including stoppers and stopcocks, under ultraviolet light to detect any
residual fluorescent contamination. As a precautionary measure it is
recommended practice to rinse all glassware with purified isooctane
immediately before use. No grease is to be used on stopcocks or joints.
Great care to avoid contamination of citric acid samples in handling is
essential to assure absence of any extraneous material arising from
inadequate packaging. Because some of the polynuclear hydrocarbons
sought in this test are very susceptible to photo-oxidation, the entire
procedure is to be carried out under subdued light.
1. Aluminum foil, oil free.
2. Separatory funnels, 500-milliliter capacity, equipped with
tetrafluoroethylene polymer stopcocks.
3. Chromatographic tubes: (a) 80-millimeter ID x 900-millimeter
length equipped with tetrafluoroethylene polymer stopcock and course
fritted disk; (b) 18-millimeter ID x 300-millimeter length equipped
with tetrafluoroethylene polymer stopcock.
4. Rotary vacuum evaporator, Buchi or equivalent.
5. Spectrophotometer -- Spectral range 250-400 nanometers with
spectral slit width of 2 nanometers or less; under instrument operating
conditions for these absorbance measurements, the spectrophotometer
shall also meet the following performance requirements:
Absorbance repeatability, 0.01 at 0.4 absorbance.
Wavelength repeatability, 0.2 nanometer.
Wavelength accuracy, 1.0 nanometer.
The spectrophotometer is equipped with matched 1 centimeter path
length quartz microcuvettes with 0.5-milliliter volume capacity.
6. Vacuum oven, minimum inside dimensions: 200 mm 200 mm 300 mm
deep.
Organic solvents. All solvents used throughout the procedure shall
meet the specifications and tests described in this specification. The
methyl alcohol, isooctane, benzene, hexane and 1,2-dichloroethane
designated in the list following this paragraph shall pass the following
test:
The specified quantity of solvent is added to a 250-milliliter round
bottom flask containing 0.5 milliliter of purified n-hexadecane and
evaporated on the rotary evaporator at 45 C to constant volume. Six
milliliters of purified isooctane are added to this residue and
evaporated under the same conditions as above for 5 minutes. Determine
the absorbance of the residue compared to purified n-hexadecane as
reference. The absorbance of the solution of the solvent residue shall
not exceed 0.03 per centimeter path length between 280 and 299
nanometers and 0.01 per centimeter path length between 300 and 400
nanometers.
Methyl alcohol, A.C.S. reagent grade. Use 100 milliliters for the
test described in the preceding paragraph. If necessary, methyl alcohol
may be purified by distillation through a Virgreaux column discarding
the first and last ten percent of the distillate or otherwise.
Benzene, spectrograde (Burdick and Jackson Laboratories, Inc.,
Muskegon, Mich., or equivalent). Use 80 milliliters for the test. If
necessary, benzene may be purified by distillation or otherwise.
Isooctane (2,2,4-trimethylpentane). Use 100 milliliters for the
test. If necessary, isooctane may be purified by passage through a
column of activated silica gel, distillation or otherwise.
Hexane, spectrograde (Burdick and Jackson Laboratories, Inc.,
Muskegon, Mich., or equivalent). Use 100 milliliters for the test. If
necessary, hexane may be purified by distillation or otherwise.
1,2-Dichloroethane, spectrograde (Matheson, Coleman and Bell, East
Rutherford, N.J., or equivalent). Use 100 milliliters for the test. If
necessary, 1,2-dichloroethane may be purified by distillation or
otherwise.
1. 10 percent 1,2-dichloroethane in hexane. Prepare by mixing the
purified solvents in the volume ratio of 1 part of 1,2-dichloroethane to
9 parts of hexane.
2. 40 percent benzene in hexane. Prepare by mixing the purified
solvents in the volume ratio of 4 parts of benzene to 6 parts of hexane.
n-Hexadecane, 99 percent olefin-free. Determine the absorbance
compared to isooctane as reference. The absorbance per centimeter path
length shall not exceed 0.00 in the range of 280-400 nanometers. If
necessary, n-hexadecane may be purified by percolation through activated
silica gel, distillation or otherwise.
Silica gel, 28-200 mesh (Grade 12, Davison Chemical Co., Baltimore,
MD, or equivalent). Activate as follows: Slurry 900 grams of silica
gel reagent with 2 liters of purified water in a 3-liter beaker. Cool
the mixture and pour into a 80 900 chromatographic column with coarse
fritted disc. Drain the water, wash with an additional 6 liters of
purified water and wash with 3,600 milliliters of purified methyl
alcohol at a relatively slow rate. Drain all of the solvents and
transfer the silica gel to an aluminum foil-lined drying dish. Place
foil over the top of the dish. Activate in a vacuum oven at low vacuum
(approximately 750 millimeters Mercury or 27 inches of Mercury below
atmospheric pressure) at 173 to 177 C for at least 20 hours. Cool
under vacuum and store in an amber bottle.
Sodium sulfate, anhydrous, A.C.S. reagent grade. This reagent should
be washed with purified isooctane. Check the purity of this reagent as
described in 172.886 of this chapter.
Water, purified. All water used must meet the specifications of the
following test:
Extract 600 milliliters of water with 50 milliliters of purified
isooctane. Add 1 milliliter of purified n-hexadecane to the isooctane
extract and evaporate the resulting solution to 1 milliliter. The
absorbance of this residue shall not exceed 0.02 per centimeter path
length between 300-400 nanometers and 0.03 per centimeter path length
between 280-299 nanometers. If necessary, water may be purified by
distillation, extraction with purified organic solvents, treatment with
an absorbent (e.g., activated carbon) followed by filtration of the
absorbent or otherwise.
Separate portions of 200 milliliters of purified water are taken
through the procedure for use as control blanks. Each citric acid
sample is processed as follows: Weigh 200 grams of anhydrous citric
acid into a 500 milliliter flask and dissolve in 200 milliliters of pure
water. Heat the solution to 60 C and transfer to a 500 milliliter
separatory funnel. Rinse the flask with 50 milliliters of isooctane and
add the isooctane to the separatory funnel. Gently shake the mixture 90
times (caution: vigorous shaking will cause emulsions) with periodic
release of the pressure caused by shaking.
Allow the phases to separate for at least 5 minutes. Draw off the
lower aqueous layer into a second 500-milliliter separatory funnel and
repeat the extraction with a second aliquot of 50 milliliters of
isooctane. After separation of the layers, draw off and discard the
water layer. Combine both isooctane extracts in the funnel containing
the first extract. Rinse the funnel which contained the second extract
with 10 milliliters of isooctane and add this portion to the combined
isooctane extract.
A chromatographic column containing 5.5 grams of silica gel and 3
grams of anhydrous sodium sulfate is prepared for each citric acid
sample as follows: Fit 18 300 column with a small glass wool plug.
Rinse the inside of the column with 10 milliliters of purified
isooctane. Drain the isooctane from the column. Pour 5.5 grams of
activated silica gel into the column. Tap the column approximately 20
times on a semisoft, clean surface to settle the silica gel. Carefully
pour 3 grams of anhydrous sodium sulfate onto the top of the silica gel
in the column.
Carefully drain the isooctane extract of the citric acid solution
into the column in a series of additions while the isooctane is draining
from the column at an elution rate of approximately 3 milliliters per
minute. Rinse the separatory funnel with 10 milliliters of isooctane
after the last portion of the extract has been applied to the column and
add this rinse to the column. After all of the extract has been applied
to the column and the solvent layer reaches the top of the sulfate bed,
rinse the column with 25 milliliters of isooctane followed by 10
milliliters of a 10-percent dichloroethane in hexane solution. For each
rinse solution, drain the column until the solvent layer reaches the top
of the sodium sulfate bed. Discard the rinse solvents. Place a
250-milliliter round bottom flask containing 0.5 milliliter of purified
n-hexadecane under the column. Elute the polynuclear aromatic
hydrocarbons from the column with 30 milliliters of 40-percent benzene
in hexane solution. Drain the eluate until the 40-percent benzene in
the hexane solvent reaches the top of the sodium sulfate bed.
Evaporate the 40-percent benzene in hexane eluate on the rotary
vacuum evaporator at 45 C until only the n-hexadecane residue of 0.5
milliliter remains. Treat the n-hexadecane residue twice with the
following wash step: Add 6 milliliters of purified isooctane and remove
the solvents by vacuum evaporation at 45 C to constant volume, i.e.,
0.5 milliliter. Cool the n-hexadecane residue and transfer the solution
to an 0.5-milliliter microcuvette. Determine the absorbance of this
solution compared to purified n-hexadecane as reference. Correct the
absorbance values for any absorbance derived from the control reagent
blank. If the corrected absorbance does not exceed the limits
prescribed, the samples meet the ultraviolet absorbance specifications.
The reagent blank is prepared by using 200 milliliters of purified
water in place of the citric acid solution and carrying the water sample
through the procedure. The typical control reagent blank should not
exceed 0.03 absorbance per centimeter path length between 280 and 299
nanometers, 0.02 absorbance per centimeter path length between 300 and
359 nanometers, and 0.01 absorbance per centimeter path length between
360 and 400 nanometers.
(42 FR 14491, Mar. 15, 1977, as amended at 47 FR 11838, Mar. 19,
1982; 49 FR 10106, Mar. 19, 1984; 54 FR 24897, June 12, 1989)
21 CFR 173.165 Subpart C -- Solvents, Lubricants, Release Agents and Related Substances
21 CFR 173.210 Acetone.
A tolerance of 30 parts per million is established for acetone in
spice oleoresins when present therein as a residue from the extraction
of spice.
21 CFR 173.220 1,3-Butylene glycol.
1,3-Butylene glycol (1,3-butanediol) may be safely used in food in
accordance with the following prescribed conditions:
(a) The substance meets the following specifications:
(1) 1,3-Butylene glycol content: Not less than 99 percent.
(2) Specific gravity at 20/20 C: 1.004 to 1.006.
(3) Distillation range: 200 -215 C.
(b) It is used in the minimum amount required to perform its intended
effect.
(c) It is used as a solvent for natural and synthetic flavoring
substances except where standards of identity issued under section 401
of the act preclude such use.
21 CFR 173.228 Ethyl acetate.
Ethyl acetate (CAS Reg. No. 141-78-6) may be safely used in food in
accordance with the following conditions:
(a) The additive meets the specifications of the Food Chemicals
Codex,1 (Ethyl Acetate; p. 372, 3d Ed., 1981), which are incorporated
by reference.
(b) The additive is used in accordance with current good
manufacturing practice as a solvent in the decaffeination of coffee and
tea.
(47 FR 146, Jan. 5, 1982, as amended at 49 FR 28548, July 13, 1984)
1Copies may be obtained from: National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418 or examined at the Office
of the Federal Register, 1100 L St. NW., Washington, DC 20408.
21 CFR 173.230 Ethylene dichloride.
A tolerance of 30 parts per million is established for ethylene
dichloride in spice oleoresins when present therein as a residue from
the extraction of spice; Provided, however, That if residues of other
chlorinated solvents are also present the total of all residues of such
solvents shall not exceed 30 parts per million.
21 CFR 173.240 Isopropyl alcohol.
Isopropyl alcohol may be present in the following foods under the
conditions specified:
(a) In spice oleoresins as a residue from the extraction of spice, at
a level not to exceed 50 parts per million.
(b) In lemon oil as a residue in production of the oil, at a level
not to exceed 6 parts per million.
(c) In hops extract as a residue from the extraction of hops at a
level not to exceed 2.0 percent by weight: Provided, That,
(1) The hops extract is added to the wort before or during cooking in
the manufacture of beer.
(2) The label of the hops extract specifies the presence of the
isopropyl alcohol and provides for the use of the hops extract only as
prescribed by paragraph (c)(1) of this section.
21 CFR 173.250 Methyl alcohol residues.
Methyl alcohol may be present in the following foods under the
conditions specified:
(a) In spice oleoresins as a residue from the extraction of spice, at
a level not to exceed 50 parts per million.
(b) In hops extract as a residue from the extraction of hops, at a
level not to exceed 2.2 percent by weight; Provided, That:
(1) The hops extract is added to the wort before or during cooking in
the manufacture of beer.
(2) The label of the hops extract specifies the presence of methyl
alcohol and provides for the use of the hops extract only as prescribed
by paragraph (b)(1) of this section.
21 CFR 173.255 Methylene chloride.
Methylene chloride may be present in food under the following
conditions:
(a) In spice oleoresins as a residue from the extraction of spice, at
a level not to exceed 30 parts per million; Provided, That, if residues
of other chlorinated solvents are also present, the total of all
residues of such solvents shall not exceed 30 parts per million.
(b) In hops extract as a residue from the extraction of hops, at a
level not to exceed 2.2 percent, Provided, That:
(1) The hops extract is added to the wort before or during cooking in
the manufacture of beer.
(2) The label of the hops extract identifies the presence of the
methylene chloride and provides for the use of the hops extract only as
prescribed by paragraph (b)(1) of this section.
(c) In coffee as a residue from its use as a solvent in the
extraction of caffeine from green coffee beans, at a level not to exceed
10 parts per million (0.001 percent) in decaffeinated roasted coffee and
in decaffeinated soluble coffee extract (instant coffee).
21 CFR 173.270 Hexane.
Hexane may be present in the following foods under the conditions
specified:
(a) In spice oleoresins as a residue from the extraction of spice, at
a level not to exceed 25 parts per million.
(b) In hops extract as a residue from the extraction of hops, at a
level not to exceed 2.2 percent by weight; Provided, That:
(1) The hops extract is added to the wort before or during cooking in
the manufacture of beer.
(2) The label of the hops extract specifies the presence of the
hexane and provides for the use of the hops extract only as prescribed
by paragraph (b)(1) of this section.
21 CFR 173.275 Hydrogenated sperm oil.
The food additive hydrogenated sperm oil may be safely used in
accordance with the following prescribed conditions:
(a) The sperm oil is derived from rendering the fatty tissue of the
sperm whale or is prepared by synthesis of fatty acids and fatty
alcohols derived from the sperm whale. The sperm oil obtained by
rendering is refined. The oil is hydrogenated.
(b) It is used alone or as a component of a release agent or
lubricant in bakery pans.
(c) The amount used does not exceed that reasonably required to
accomplish the intended lubricating effect.
21 CFR 173.280 Solvent extraction process for citric acid.
A solvent extraction process for recovery of citric acid from
conventional Aspergillus niger fermentation liquor may be safely used to
produce food-grade citric acid in accordance with the following
conditions:
(a) The solvent used in the process consists of a mixture of n-octyl
alcohol meeting the requirements of 172.864 of this chapter, synthetic
isoparaffinic petroleum hydrocarbons meeting the requirements of
172.882 of this chapter, and tridodecyl amine.
(b) The component substances are used solely as a solvent mixture and
in a manner that does not result in formation of products not present in
conventionally produced citric acid.
(c) The citric acid so produced meets the specifications of the
''Food Chemicals Codex,'' 3d Ed. (1981), pp. 86-87, which is
incorporated by reference (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), and the polynuclear aromatic hydrocarbon
specifications of 173.165.
(d) Residues of n-octyl alcohol and synthetic isoparaffinic petroleum
hydrocarbons are removed in accordance with good manufacturing practice.
Current good manufacturing practice results in residues not exceeding
16 parts per million (ppm) n-octyl alcohol and 0.47 ppm synthetic
isoparaffinic petroleum hydrocarbons in citric acid.
(e) Tridodecyl amine may be present as a residue in citric acid at a
level not to exceed 100 parts per billion.
(42 FR 14491, Mar. 15, 1977, as amended at 49 FR 10106, Mar. 19,
1984)
21 CFR 173.290 Trichloroethylene.
Tolerances are established for residues of trichloroethylene
resulting from its use as a solvent in the manufacture of foods as
follows:
21 CFR 173.290 Subpart D -- Specific Usage Additives
21 CFR 173.310 Boiler water additives.
Boiler water additives may be safely used in the preparation of steam
that will contact food, under the following conditions:
(a) The amount of additive is not in excess of that required for its
functional purpose, and the amount of steam in contact with food does
not exceed that required to produce the intended effect in or on the
food.
(b) The compounds are prepared from substances identified in
paragraphs (c) and (d) of this section, and are subject to the
limitations, if any, prescribed:
(c) List of substances:
(d) Substances used alone or in combination with substances in
paragraph (c) of this section:
(e) To assure safe use of the additive, in addition to the other
information required by the Act, the label or labeling shall bear:
(1) The common or chemical name or names of the additive or
additives.
(2) Adequate directions for use to assure compliance with all the
provisions of this section.
(42 FR 14526, Mar. 15, 1977, as amended at 45 FR 73922, Nov. 7, 1980;
45 FR 85726, Dec. 30, 1980; 48 FR 7439, Feb. 22, 1983; 49 FR 5748,
Feb. 15, 1984; 49 FR 10106, Mar. 19, 1984; 50 FR 49536, Dec. 3, 1985;
53 FR 15199, Apr. 28, 1988; 54 FR 31012, July 26, 1989; 55 FR 12172,
Apr. 2, 1990)
21 CFR 173.315 Chemicals used in washing or to assist in the lye
peeling of fruits and vegetables.
Chemicals may be safely used to wash or to assist in the lye peeling
of fruits and vegetables in accordance with the following conditions:
(a) The chemicals consist of one or more of the following:
(1) Substances generally recognized as safe in food or covered by
prior sanctions for use in washing fruits and vegetables.
(2) Substances identified in this subparagraph and subject to such
limitations as are provided:
(3) Substances identified in this paragraph (a)(3) for use in flume
water for washing sugar beets prior to the slicing operation and subject
to the limitations as are provided for the level of the substances in
the flume water:
(b) The chemicals are used in amounts not in excess of the minimum
required to accomplish their intended effect.
(c) The use of the chemicals is followed by rinsing with potable
water to remove, to the extent possible, residues of the chemicals.
(d) To assure safe use of the additive:
(1) The label and labeling of the additive container shall bear, in
addition to the other information required by the act, the name of the
additive or a statement of its composition.
(2) The label or labeling of the additive container shall bear
adequate use directions to assure use in compliance with all provisions
of this section.
(42 FR 14526, Mar. 15, 1977, as amended at 42 FR 29856, June 10,
1977; 42 FR 32229, June 24, 1977; 43 FR 54926, Nov. 24, 1978)
21 CFR 173.320 Chemicals for controlling microorganisms in cane-sugar
and beet-sugar mills.
Agents for controlling microorganisms in cane-sugar and beet-sugar
mills may be safely used in accordance with the following conditions:
(a) They are used in the control of microorganisms in cane-sugar
and/or beet-sugar mills as specified in paragraph (b) of this section.
(b) They are applied to the sugar mill grinding, crusher, and/or
diffuser systems in one of the combinations listed in paragraph (b) (1),
(2), (3), or (5) of this section or as a single agent listed in
paragraph (b)(4) or (6) of this section. Quantities of the individual
additives in parts per million are expressed in terms of the weight of
the raw cane or raw beets.
(1) Combination for cane-sugar mills:
(2) Combination for cane-sugar mills:
(3) Combinations for cane-sugar mills and beet-sugar mills:
(4) Single additive for cane-sugar mills and beet-sugar mills.
(5) Combination for cane-sugar mills:
Limitations. Byproduct molasses, bagasse, and pulp containing
residues of these quaternary ammonium salts are not authorized for use
in animal feed.
(6) Single additive for beet-sugar mills:
(c) To assure safe use of the additives, their label and labeling
shall conform to that registered with the Environmental Protection
Agency.
(42 FR 14526, Mar. 15, 1977, as amended at 47 FR 35756, Aug. 17,
1982; 50 FR 3891, Jan. 29, 1985; 57 FR 8065, Mar. 6, 1992)
21 CFR 173.322 Chemicals used in delinting cottonseed.
Chemicals may be safely used to assist in the delinting of cottonseed
in accordance with the following conditions:
(a) The chemicals consist of one or more of the following:
(1) Substances generally recognized as safe for direct addition to
food.
(2) Substances identified in this paragraph and subject to such
limitations as are provided:
(47 FR 8346, Feb. 26, 1982)
21 CFR 173.340 Defoaming agents.
Defoaming agents may be safely used in processing foods, in
accordance with the following conditions:
(a) They consist of one or more of the following:
(1) Substances generally recognized by qualified experts as safe in
food or covered by prior sanctions for the use prescribed by this
section.
(2) Substances listed in this paragraph (a)(2) of this section,
subject to any limitations imposed:
(3) Substances listed in this paragraph (a)(3), provided they are
components of defoaming agents limited to use in processing beet sugar
and yeast, and subject to any limitations imposed:
(4) The substance listed in this paragraph (a)(4), provided it is a
component of defoaming agents limited to use in processing beet sugar
only, and subject to the limitations imposed:
(b) They are added in an amount not in excess of that reasonably
required to inhibit foaming.
(42 FR 14526, Mar. 15, 1977, as amended at 43 FR 2872, Jan. 20, 1978;
46 FR 30493, June 9, 1981; 46 FR 57476, Nov. 24, 1981)
21 CFR 173.342 Chlorofluorocarbon 113 and perfluorohexane.
A mixture of 99 percent chlorofluorocarbon 113
(1,1,2-trichloro-1,2,2-trifluoroethane) (CAS Reg. No. 76-13-1, also
known as fluorocarbon 113, CFC 113 and FC 113) and 1 percent
perfluorohexane (CAS Reg. No. 355-42-0) may be safely used in accordance
with the following prescribed conditions:
(a) The additive chlorofluorocarbon 113 has a purity of not less than
99.99 percent.
(b) The additive mixture is intended for use to quickly cool or
crust-freeze chickens sealed in intact bags composed of substances
regulated in parts 174, 175, 177, 178, and 179.45 of this chapter and
conforming to any limitations or specifications in such regulations.
(55 FR 8913, Mar. 9, 1990)
21 CFR 173.345 Chloropentafluoroethane.
The food additive chloropentafluoroethane may be safely used in food
in accordance with the following prescribed conditions:
(a) The food additive has a purity of not less than 99.97 percent,
and contains not more than 200 parts per million saturated fluoro
compounds and 10 parts per million unsaturated fluoro compounds as
impurities.
(b) The additive is used or intended for use alone or with one or
more of the following substances: Carbon dioxide, nitrous oxide,
propane, and octafluorocyclobutane complying with 173.360, as an
aerating agent for foamed or sprayed food products, with any propellant
effect being incidental and no more than is minimally necessary to
achieve the aerating function, except that use is not permitted for
those standardized foods that do not provide for such use.
(c) To assure safe use of the additive
(1) The label of the food additive container shall bear, in addition
to the other information required by the act, the following:
(i) The name of the additive, chloropentafluoroethane.
(ii) The percentage of the additive present in the case of a mixture.
(iii) The designation ''food grade''.
(2) The label or labeling of the food additive container shall bear
adequate directions for use.
(42 FR 14526, Mar. 15, 1977, as amended at 43 FR 11317, Mar. 17,
1978; 43 FR 14644, Apr. 7, 1978)
21 CFR 173.350 Combustion product gas.
The food additive combustion product gas may be safely used in the
processing and packaging of the foods designated in paragraph (c) of
this section for the purpose of removing and displacing oxygen in
accordance with the following prescribed conditions:
(a) The food additive is manufactured by the controlled combustion in
air of butane, propane, or natural gas. The combustion equipment shall
be provided with an absorption-type filter capable of removing possible
toxic impurities, through which all gas used in the treatment of food
shall pass; and with suitable controls to insure that any combustion
products failing to meet the specifications provided in this section
will be prevented from reaching the food being treated.
(b) The food additive meets the following specifications:
(1) Carbon monoxide content not to exceed 4.5 percent by volume.
(2) The ultraviolet absorbance in isooctane solution in the range 255
millimicrons to 310 millimicrons not to exceed one-third of the standard
reference absorbance when tested as described in paragraph (e) of this
section.
(c) It is used or intended for use to displace or remove oxygen in
the processing, storage, or packaging of beverage products and other
food, except fresh meats.
(d) To assure safe use of the additive in addition to the other
information required by the act, the label or labeling of the combustion
device shall bear adequate directions for use to provide a combustion
product gas that complies with the limitations prescribed in paragraph
(b) of this section, including instructions to assure proper filtration.
(e) The food additive is tested for compliance with paragraph (b)(2)
by the following empirical method:
Spectrophotometric measurements. All measurements are made in an
ultraviolet spectrophotometer in optical cells of 5 centimeters in
length, and in the range of 255 millimicrons to 310 millimicrons, under
the same instrumental conditions. The standard reference absorbance is
the absorbance at 275 millimicrons of a standard reference solution of
naphthalene (National Bureau of Standards Material No. 577 or equivalent
in purity) containing a concentration of 1.4 milligrams per liter in
purified isooctane, measured against isooctane of the same spectral
purity in 5-centimeter cells. (This absorbance will be approximately
0.30.)
Solvent. The solvent used is pure grade isooctane having an
ultraviolet absorbance not to exceed 0.05 measured against distilled
water as a reference. Upon passage of purified inert gas through some
isooctane under the identical conditions of the test, a lowering of the
absorbance value has been observed. The absorbance of isooctane to be
used in this procedure shall not be more than 0.02 lower in the range
255 millimicrons to 310 millimicrons, inclusive, than that of the
untreated solvent as measured in a 5-centimeter cell. If necessary to
obtain the prescribed purities, the isooctane may be passed through
activated silica gel.
Apparatus. To assure reproducible results, the additive is passed
into the isooctane solution through a gas-absorption train consisting of
the following components and necessary connections:
1. A gas flow meter with a range up to 30 liters per hour provided
with a constant differential relay or other device to maintain a
constant flow rate independent of the input pressure.
2. An absorption apparatus consisting of an inlet gas dispersion tube
inserted to the bottom of a covered cylindrical vessel with a suitable
outlet on the vessel for effluent gas. The dimensions and arrangement
of tube and vessel are such that the inlet tube introduces the gas at a
point not above 5 1/4 inches below the surface of the solvent through a
sintered glass outlet. The dimensions of the vessel are such, and both
inlet and vessel are so designed, that the gas can be bubbled through 60
milliliters of isooctane solvent at a rate up to 30 liters per hour
without mechanical loss of solvent. The level corresponding to 60
milliliters should be marked on the vessel.
3. A cooling bath containing crushed ice and water to permit
immersion of the absorption vessel at least to the solvent level mark.
Caution. The various parts of the absorption train must be connected
by gas-tight tubing and joints composed of materials which will neither
remove components from nor add components to the gas stream. The gas
source is connected in series to the flow-rate device, the flow meter,
and the absorption apparatus in that order. Ventilation should be
provided for the effluent gases which may contain carbon monoxide.
Sampling procedure. Immerse the gas-absorption apparatus containing
60 milliliters of isooctane in the coolant bath so that the solvent is
completely immersed. Cool for at least 15 minutes and then pass 120
liters of the test gas through the absorption train at a rate of 30
liters per hour or less. Maintain the coolant bath at 0 C throughout.
Remove the absorption vessel from the bath, disconnect, and warm to room
temperature. Add isooctane to bring the contents of the absorption
vessel to 60 milliliters, and mix. Determine the absorbance of the
solution in the 5-centimeter cell in the range 255 millimicrons to 310
millimicrons, inclusive, compared to isooctane. The absorbance of the
solution of combustion product gas shall not exceed that of the
isooctane solvent at any wavelength in the specified range by more than
one-third of the standard reference absorbance.
21 CFR 173.355 Dichlorodifluoromethane.
The food additive dichlorodifluoromethane may be safely used in food
in accordance with the following prescribed conditions:
(a) The additive has a purity of not less than 99.97 percent.
(b) It is used or intended for use, in accordance with good
manufacturing practice, as a direct-contact freezing agent for foods.
(c) To assure safe use of the additive:
(1) The label of its container shall bear, in addition to the other
information required by the act, the following:
(i) The name of the additive, dichlorodifluoromethane, with or
without the parenthetical name ''Food Freezant 12''.
(ii) The designation ''food grade''.
(2) The label or labeling of the food additive container shall bear
adequate directions for use.
21 CFR 173.357 Materials used as fixing agents in the immobilization of
enzyme preparations.
Fixing agents may be safely used in the immobilization of enzyme
preparations in accordance with the following conditions:
(a) The materials consist of one or more of the following:
(1) Substances generally recognized as safe in food.
(2) Substances identified in this subparagraph and subject to such
limitations as are provided:
(b) The fixed enzyme preparation is washed to remove residues of the
fixing materials.
(48 FR 5716, Feb. 8, 1983, as amended at 52 FR 39512, Oct. 22, 1987;
55 FR 12172, Apr. 2, 1990)
21 CFR 173.360 Octafluorocyclobutane.
The food additive octafluorocyclo-butane may be safely used as a
propellant and aerating agent in foamed or sprayed food products in
accordance with the following conditions:
(a) The food additive meets the following specifications:
99.99 percent octafluorocyclobutane.
Less than 0.1 part per million fluoroolefins, calculated as
perfluoroisobutylene.
(b) The additive is used or intended for use alone or with one or
more of the following substances: Carbon dioxide, nitrous oxide, and
propane, as a propellant and aerating agent for foamed or sprayed food
products, except for those standardized foods that do not provide for
such use.
(c) To assure safe use of the additive:
(1) The label of the food additive container shall bear, in addition
to the other information required by the act, the following:
(i) The name of the additive, octafluorocyclobutane.
(ii) The percentage of the additive present in the case of a mixture.
(iii) The designation ''food grade''.
(2) The label or labeling of the food additive container shall bear
adequate directions for use.
21 CFR 173.385 Sodium methyl sulfate.
Sodium methyl sulfate may be present in pectin in accordance with the
following conditions.
(a) It is present as the result of methylation of pectin by sulfuric
acid and methyl alcohol and subsequent treatment with sodium
bicarbonate.
(b) It does not exceed 0.1 percent by weight of the pectin.
21 CFR 173.395 Trifluoromethane sulfonic acid.
Trifluoromethane sulfonic acid has the empirical formula CF3SO3H (CAS
Reg. No. 1493-13-6). The catalyst (Trifluoromethane sulfonic acid) may
safely be used in the production of cocoa butter substitute from palm
oil (1-palmitoyl-2-oleoyl-3-stearin) (see 184.1259 of this chapter) in
accordance with the following conditions:
(a) The catalyst meets the following specifications:
Appearance, Clear liquid.
Color, Colorless to amber.
Neutralization equivalent, 147-151.
Water, 1 percent maximum.
Fluoride ion, 0.03 percent maximum.
Heavy metals (as Pb), 30 parts per million maximum.
Arsenic (as As), 3 parts per million maximum.
(b) It is used at levels not to exceed 0.2 percent of the reaction
mixture to catalyze the directed esterification.
(c) The esterification reaction is quenched with steam and water and
the catalyst is removed with the aqueous phase. Final traces of
catalyst are removed by washing batches of the product three times with
an aqueous solution of 0.5 percent sodium bicarbonate.
(d) No residual catalyst may remain in the product at a detection
limit of 0.2 part per million fluoride as determined by the method
described in ''Official Methods of Analysis of the Association of
Official Analytical Chemists,'' sections 25.049-25.055, 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.
(43 FR 54237, Nov. 11, 1978, as amended at 49 FR 10106, Mar. 19,
1984; 54 FR 24897, June 12, 1989)
21 CFR 173.400 Dimethyldialkylammonium chloride.
Dimethyldialkylammonium chloride may be safely used in food in
accordance with the following prescribed conditions:
(a) The food additive is produced by one of the following methods:
(1) Ammonolysis of natural tallow fatty acids to form amines that are
subsequently reacted with methyl chloride to form the quaternary
ammonium compounds consisting primarily of dimethyldioctadecylammonium
chloride and dimethyldihexadecylammonium chloride. The additive may
contain residues of isopropyl alcohol not in excess of 18 percent by
weight when used as a processing solvent.
(2) Ammonolysis of natural tallow fatty acids to form amines that are
then reacted with 2-ethylhexanal, reduced, methylated, and subsequently
reacted with methyl chloride to form the quaternary ammonium compound
known as dimethyl(2-ethylhexyl) hydrogenated tallow ammonium chloride
and consisting primarily of dimethyl(2-ethylhexyl)octadecylammonium
chloride and dimethyl(2-ethylhexyl)hexadecylammonium chloride.
(b) The food additive described in paragraph (a)(1) of this section
contains not more than a total of 2 percent by weight of free amine and
amine hydrochloride. The food additive described in paragraph (a)(2) of
this section contains not more than 3 percent by weight, each, of free
amine and amine hydrochloride as determined by A.O.C.S. method Te 3a-64,
''Acid Value and Free Amine Value of Fatty Quaternary Ammonium
Chlorides,'' 2d printing including additions and revisions 1990, which
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1
CFR part 51. Copies are available from the Division of Food and Color
Additives, Center for Food Safety and Applied Nutrition (HFF-330), Food
and Drug Administration, 200 C St. SW., Washington, DC 20204, and from
the American Oil Chemists' Society, P.O. Box 5037, Station A, Champaign,
IL 61820, or available for inspection at the Office of the Federal
Register, 1100 L St. NW., Washington, DC.
(c) The food additive is used as a decolorizing agent in the
clarification of refinery sugar liquors under the following limitations:
(1) The food additive described in paragraph (a)(1) of this section
is added only at the defecation/clarification stage of sugar liquor
refining in an amount not to exceed 700 parts per million by weight of
sugar solids.
(2) The food additive described in paragraph (a)(2) of this section
is used under the following conditions:
(i) The additive is adsorbed onto a support column composed of
suitable polymers that are regulated for contact with aqueous food.
Excess nonadsorbed additive shall be rinsed away with potable water
prior to passage of sugar liquor through the column.
(ii) The residue of the additive in the decolorized sugar liquor
prior to crystallization shall not exceed 1 part per million of sugar as
determined by a method entitled ''Colorimetric Determination of Residual
Quaternary Ammonium Compounds (Arquad HTL8) in Sugar and Sugar
Solutions,'' June 13, 1990, which is incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available
from the Division of Food and Color Additives, Center for Food Safety
and Applied Nutrition (HFF-330), 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.
(d) To assure safe use of the additive, the label and labeling of the
additive shall bear, in addition to other information required by the
Federal Food, Drug, and Cosmetic Act, adequate directions to assure use
in compliance with paragraph (c) of this section.
(56 FR 42686, Aug. 29, 1991)
21 CFR 173.400 PART 174 -- INDIRECT FOOD ADDITIVES: GENERAL
Authority: Secs. 201, 402, 409, 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321, 342, 348, 371).
21 CFR 174.5 General provisions applicable to indirect food additives.
(a) Regulations prescribing conditions under which food additive
substances may be safely used predicate usage under conditions of good
manufacturing practice. For the purpose of this part and parts 175,
176, and 177 of this chapter, good manufacturing practice shall be
defined to include the following restrictions:
(1) The quantity of any food additive substance that may be added to
food as a result of use in articles that contact food shall not exceed,
where no limits are specified, that which results from use of the
substance in an amount not more than reasonably required to accomplish
the intended physical or technical effect in the food-contact article;
shall not exceed any prescribed limitations; and shall not be intended
to accomplish any physical or technical effect in the food itself,
except as such may be permitted by regulations in parts 170 through 189
of this chapter.
(2) Any substance used as a component of articles that contact food
shall be of a purity suitable for its intended use.
(b) The existence in the subchapter B of a regulation prescribing
safe conditions for the use of a substance as an article or component of
articles that contact food shall not be construed to relieve such use of
the substance or article from compliance with any other provision of the
Federal Food, Drug, and Cosmetic Act. For example, if a regulated
food-packaging material were found on appropriate test to impart odor or
taste to a specific food product such as to render it unfit within the
meaning of section 402(a)(3) of the Act, the regulation would not be
construed to relieve such use from compliance with section 402(a)(3).
(c) The existence in this subchapter B of a regulation prescribing
safe conditions for the use of a substance as an article or component of
articles that contact food shall not be construed as implying that such
substance may be safely used as a direct additive in food.
(d) Substances that under conditions of good manufacturing practice
may be safely used as components of articles that contact food include
the following, subject to any prescribed limitations:
(1) Substances generally recognized as safe in or on food.
(2) Substances generally recognized as safe for their intended use in
food packaging.
(3) Substances used in accordance with a prior sanction or approval.
(4) Substances permitted for use by regulations in this part and
parts 175, 176, 177, 178 and 179.45 of this chapter.
(42 FR 14534, Mar. 15, 1977)
21 CFR 174.5 PART 175 -- INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF COATINGS
21 CFR 174.5 Subpart A -- (Reserved)
21 CFR 174.5 Subpart B -- Substances for Use Only as Components of
Adhesives
Sec.
175.105 Adhesives.
175.125 Pressure-sensitive adhesives.
21 CFR 174.5 Subpart C -- Substances for Use as Components of Coatings
175.210 Acrylate ester copolymer coatings.
175.230 Hot-melt strippable food coatings.
175.250 Paraffin (synthetic).
175.260 Partial phosphoric acid esters of polyester resins.
175.270 Poly(vinyl fluoride) resins.
175.300 Resinous and polymeric coatings.
175.320 Resinous and polymeric coatings for polyolefin films.
175.350 Vinyl acetate/crotonic acid copolymer.
175.360 Vinylidene chloride copolymer coatings for nylon film.
175.365 Vinylidene chloride copolymer coatings for polycarbonate
film.
175.380 Xylene-formaldehyde resins condensed with
4,4'-isopropylidenediphenol-epichlorohydrin epoxy resins.
175.390 Zinc-silicon dioxide matrix coatings.
Authority: Secs. 201, 402, 409, 706 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321, 342, 348, 376).
Source: 42 FR 14534, Mar. 15, 1977, unless otherwise noted.
21 CFR 174.5 Subpart A -- (Reserved)
21 CFR 174.5 Subpart B -- Substances for Use Only as Components of Adhesives
21 CFR 175.105 Adhesives.
(a) Adhesives may be safely used as components of articles intended
for use in packaging, transporting, or holding food in accordance with
the following prescribed conditions:
(1) The adhesive is prepared from one or more of the optional
substances named in paragraph (c) of this section, subject to any
prescribed limitations.
(2) The adhesive is either separated from the food by a functional
barrier or used subject to the following additional limitations:
(i) In dry foods. The quantity of adhesive that contacts packaged
dry food shall not exceed the limits of good manufacturing practice.
(ii) In fatty and aqueous foods. (a) The quantity of adhesive that
contacts packaged fatty and aqueous foods shall not exceed the trace
amount at seams and at the edge exposure between packaging laminates
that may occur within the limits of good manufacturing practice.
(b) Under normal conditions of use the packaging seams or laminates
will remain firmly bonded without visible separation.
(b) To assure safe usage of adhesives, the label of the finished
adhesive container shall bear the statement ''food-packaging adhesive''.
(c) Subject to any limitation prescribed in this section and in any
other regulation promulgated under section 409 of the Act which
prescribes safe conditions of use for substances that may be employed as
constituents of adhesives, the optional substances used in the
formulation of adhesives may include the following:
(1) Substances generally recognized as safe for use in food or food
packaging.
(2) Substances permitted for use in adhesives by prior sanction or
approval and employed under the specific conditions of use prescribed by
such sanction or approval.
(3) Flavoring substances permitted for use in food by regulations in
this part, provided that such flavoring substances are volatilized from
the adhesives during the packaging fabrication process.
(4) Color additives approved for use in food.
(5) Substances permitted for use in adhesives by other regulations in
this subchapter and substances named in this subparagraph: Provided,
however, That any substance named in this paragraph and covered by a
specific regulation in this subchapter, must meet any specifications in
such regulation.
(42 FR 14534, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977)
Editorial Note: For Federal Register citations affecting 175.105,
see the List of CFR Sections Affected in the Finding Aids section of
this volume.
21 CFR 175.125 Pressure-sensitive adhesives.
Pressure-sensitive adhesives may be safely used as the food-contact
surface of labels and/or tapes applied to food, in accordance with the
following prescribed conditions:
(a) Pressure-sensitive adhesives prepared from one or a mixture of
two or more of the substances listed in this paragraph may be used as
the food-contact surface of labels and/or tapes applied to poultry, dry
food, and processed, frozen, dried, or partially dehydrated fruits or
vegetables.
(1) Substances generally recognized as safe in food.
(2) Substances used in accordance with a prior sanction or approval.
(3) Color additives listed for use in or on food in parts 73 and 74
of this chapter.
(4) Substances identified in 172.615 of this chapter other than
substances used in accordance with paragraph (a)(2) of this section.
(5) Polyethylene, oxidized; complying with the identity prescribed
in 177.1620(a) of this chapter.
(6) 4-((4, 6-Bis(octylthio)-s-triazin-2-yl)amino)-2phenol (CAS Reg.
No. 991-84-4) as an antioxidant/stabilizer at a level not to exceed 1.5
percent by weight of the finished pressure-sensitive adhesive.
(b) Pressure-sensitive adhesives prepared from one or a mixture of
two or more of the substances listed in this paragraph may be used as
the food-contact surface of labels and/or tapes applied to raw fruit and
raw vegetables.
(1) Substances listed in paragraphs (a)(1), (2), (3), (5), and (6) of
this section, and those substances prescribed by paragraph (a)(4) of
this section that are not identified in paragraph (b)(2) of this
section.
(2) Substances identified in this subparagraph and subject to the
limitations provided:
BHA.
BHT.
Butadiene-acrylonitrile copolymer.
Butadiene-acrylonitrile-styrene copolymer.
Butadiene-styrene copolymer.
Butyl rubber.
Chlorinated natural rubber.
Isobutylene-styrene copolymer.
Petrolatum.
Polybutene-1.
Polybutene, hydrogenated; complying with the identity prescribed
under 178.3740(b) of this chapter.
Polyisobutylene.
cis-1,4-Polyisoprene.
Polystyrene.
Propyl gallate.
Rapeseed oil, vulcanized.
Rosins and rosin derivatives as provided in 178.3870 of this
chapter.
Rubber hydrochloride.
Rubber (natural latex solids or crepe, smoked or unsmoked).
Terpene resins ( - and -pinene), homopolymers, copolymers, and
condensates with phenol, formaldehyde, coumarone, and/or indene.
Tetrasodium ethylenediaminetetraacetate.
Tri(mixed mono- and dinonylphenyl) phosphite (which may contain not
more than 1 percent by weight of triisopropanolamine).
(c) Acrylonitrile copolymers identified in this section shall comply
with the provisions of 180.22 of this chapter.
(42 FR 14534, Mar. 15, 1977, as amended at 42 FR 15674, Mar. 22,
1977; 48 FR 15617, Apr. 12, 1983)
21 CFR 175.125 Subpart C -- Substances for Use as Components of Coatings
21 CFR 175.210 Acrylate ester copolymer coating.
Acrylate ester copolymer coating may safely be used as a food-contact
surface of articles intended for packaging and holding food, including
heating of prepared food, subject to the provisions of this section:
(a) The acrylate ester copolymer is a fully polymerized copolymer of
ethyl acrylate, methyl methacrylate, and methacrylic acid applied in
emulsion form to molded virgin fiber and heat-cured to an insoluble
resin.
(b) Optional substances used in the preparation of the polymer and in
the preparation and application of the emulsion may include substances
named in this paragraph, in an amount not to exceed that required to
accomplish the desired technical effect and subject to any limitation
prescribed: Provided, however, That any substance named in this
paragraph and covered by a specific regulation in subchapter B of this
chapter must meet any specifications in such regulation.
(c) The coating in the form in which it contacts food meets the
following tests:
(1) An appropriate sample when exposed to distilled water at 212 F
for 30 minutes shall yield total chloroform-soluble extractables not to
exceed 0.5 milligram per square inch.
(2) An appropriate sample when exposed to n-heptane at 120 F for 30
minutes shall yield total chloroform-soluble extractables not to exceed
0.5 milligram per square inch.
21 CFR 175.230 Hot-melt strippable food coatings.
Hot-melt strippable food coatings may be safely applied to food,
subject to the provisions of this section.
(a) The coatings are applied to and used as removable coatings for
food.
(b) The coatings may be prepared, as mixtures, from the following
substances:
(1) Substances generally recognized as safe in food.
(2) Substances identified in this subparagraph.
21 CFR 175.250 Paraffin (synthetic).
Synthetic paraffin may be safely used as an impregnant in, coating
on, or component of coatings on articles used in producing,
manufacturing, packing, processing, preparing, treating, packaging,
transporting, or holding food in accordance with the following
prescribed conditions:
(a) The additive is synthesized by the Fischer-Tropsch process from
carbon monoxide and hydrogen, which are catalytically converted to a
mixture of paraffin hydrocarbons. Lower molecular-weight fractions are
removed by distillation. The residue is hydrogenated and further
treated by percolation through activated charcoal. This mixture can be
fractionated into its components by a solvent separation method, using
synthetic isoparaffinic petroleum hydrocarbons complying with 178.3530
of this chapter.
(b) Synthetic paraffin shall conform to the following specifications:
(1) Congealing point. There is no specification for the congealing
point of synthetic paraffin components, except those components that
have a congealing point below 93 C when used in contact with food Types
III, IVA, V, VIIA, and IX identified in Table 1 of 176.170(c) of this
chapter and under conditions of use E, F, and G described in Table 2 of
176.170(c) of this chapter shall be limited to a concentration not
exceeding 15 percent by weight of the finished coating. The congealing
point shall be determined by ASTM method D938-71 (Reapproved 1981),
''Standard Test Method for Congealing Point of Petroleum Waxes,
Including Petrolatum,'' which is incorporated by reference. Copies may
be obtained from the American Society for Testing Materials, 1916 Race
St., Philadelphia, PA 19103, or may be examined at the Office of the
Federal Register, 1100 L St. NW., Washington, DC 20408.
(2) Oil content. The substance has an oil content not exceeding 0.5
percent as determined by ASTM method D721-56T, ''Tentative Method of
Test for Oil Content of Petroleum Waxes'' (Revised 1956), which is
incorporated by reference. See paragraph (b)(1) of this section for
availability of the incorporation by reference.
(3) Absorptivity. The substance has an absorptivity at 290
millimicrons in decahydronaphthalene at 88 C not exceeding 0.01 as
determined by ASTM method E131-81a, ''Standard Definitions of Terms and
Symbols Relating to Molecular-Spectroscopy,'' which is incorporated by
reference. See paragraph (b)(1) of this section for availability of the
incorporation by reference.
(c) The provisions of this section are not applicable to synthetic
paraffin used in food-packaging adhesives complying with 175.105.
(42 FR 14534, Mar. 15, 1977, as amended at 47 FR 11839, Mar. 19,
1982; 49 FR 10106, Mar. 19, 1984; 51 FR 47010, Dec. 30, 1986)
21 CFR 175.260 Partial phosphoric acid esters of polyester resins.
Partial phosphoric acid esters of polyester resins identified in this
section and applied on aluminum may be safely used as food-contact
coatings, in accordance with the following prescribed conditions:
(a) For the purpose of this section, partial phosphoric acid esters
of polyester resins are prepared by the reaction of trimellitic
anhydride with 2,2-dimethyl-1,3-propanediol followed by reaction of the
resin thus produced with phosphoric acid anhydride to produce a resin
having an acid number of 81 to 98 and a phosphorus content of 4.05 to
4.65 percent by weight.
(b) The coating is chemically bonded to the metal and cured at
temperatures exceeding 450 F.
(c) The finished food-contact coating, when extracted with the
solvent or solvents characterizing the type of food and under the
conditions of time and temperature characterizing the conditions of its
intended use, as determined from tables 1 and 2 of 175.300(d), yields
total extractives in each extracting solvent not to exceed 0.3
milligrams per square inch of food-contact surface, as determined by the
methods described in 175.300(e), and the coating yields
2,2-dimethyl-1,3-propanediol in each extracting solvent not to exceed
0.3 micrograms per square inch of food-contact surface. In testing the
finished food-contact articles, a separate test sample is to be used for
each required extracting solvent.
21 CFR 175.270 Poly(vinyl fluoride) resins.
Poly(vinyl fluoride) resins identified in this section may be safely
used as components of food-contact coatings for containers having a
capacity of not less than 5 gallons, subject to the provisions of this
section.
(a) For the purpose of this section, poly(vinyl fluoride) resins
consist of basic resins produced by the polymerization of vinyl
fluoride.
(b) The poly(vinyl fluoride) basic resins have an intrinsic viscosity
of not less than 0.75 deciliter per gram as determined by ASTM method
D1243-79, ''Standard Test Method for Dilute Solution Viscosity of Vinyl
Chloride Polymers,'' which is incorporated by reference. Copies may be
obtained from the American Society for Testing Materials, 1916 Race St.,
Philadelphia, PA 19103, or may be examined at the Office of the Federal
Register, 1100 L St. NW., Washington, DC 20408.
(1) Solvent. N,N-Dimethylacetamide, technical grade.
(2) Solution. Powdered resin and solvent are heated at 120 C until
the resin is dissolved.
(3) Temperature. Flow times of the solvent and solution are
determined at 110 C.
(4) Viscometer. Cannon-Ubbelohde size 50 semimicro dilution
viscometer (or equivalent).
(5) Calculation. The calculation method used is that described in
appendix X 1.3 (ASTM method D1243-79, ''Standard Test Method for Dilute
Solution Viscosity of Vinyl Chloride Polymers,'' which is incorporated
by reference; see paragraph (b) of this section for availability of the
incorporation by reference) with the reduced viscosity determined for
three concentration levels not greater than 0.5 gram per deciliter and
extrapolated to zero concentration for intrinsic viscosity. The
following formula is used for determining reduced viscosity:
Reduced viscosity in terms of deciliters per gram=
Where:
t=Solution efflux time.
to=Solvent efflux time.
c=Concentration of solution in terms of grams per deciliter.
(42 FR 14534, Mar. 15, 1977, as amended at 47 FR 11839, Mar. 19,
1982; 49 FR 10107, Mar. 19, 1984)
21 CFR 175.300 Resinous and polymeric coatings.
Resinous and polymeric coatings may be safely used as the
food-contact surface of articles intended for use in producing,
manufacturing, packing, processing, preparing, treating, packaging,
transporting, or holding food, in accordance with the following
prescribed conditions:
(a) The coating is applied as a continuous film or enamel over a
metal substrate, or the coating is intended for repeated food-contact
use and is applied to any suitable substrate as a continuous film or
enamel that serves as a functional barrier between the food and the
substrate. The coating is characterized by one or more of the following
descriptions:
(1) Coatings cured by oxidation.
(2) Coatings cured by polymerization, condensation, and/or
cross-linking without oxidation.
(3) Coatings prepared from prepolymerized substances.
(b) The coatings are formulated from optional substances that may
include:
(1) Substances generally recognized as safe in food.
(2) Substances the use of which is permitted by regulations in this
part or which are permitted by prior sanction or approval and employed
under the specific conditions, if any, of the prior sanction or
approval.
(3) Any substance employed in the production of resinous and
polymeric coatings that is the subject of a regulation in Subchapter B
of this chapter and conforms with any specification in such regulation.
Substances named in this paragraph (b)(3) and further identified as
required:
(i) Drying oils, including the triglycerides or fatty acids derived
therefrom:
Beechnut.
Candlenut.
Castor (including dehydrated).
Chinawood (tung).
Coconut.
Corn.
Cottonseed.
Fish (refined).
Hempseed.
Linseed.
Oiticica.
Perilla.
Poppyseed.
Pumpkinseed.
Safflower.
Sesame.
Soybean.
Sunflower.
Tall oil.
Walnut.
The oils may be raw, heat-bodied, or blown. They may be refined by
filtration, degumming, acid or alkali washing, bleaching, distillation,
partial dehydration, partial polymerization, or solvent extraction, or
modified by combination with maleic anhydride.
(ii) Reconstituted oils from triglycerides or fatty acids derived
from the oils listed in paragraph (b)(3)(i) of this section to form
esters with:
Butylene glycol.
Ethylene glycol.
Pentaerythritol.
Polyethylene glycol.
Polypropylene glycol.
Propylene glycol.
Sorbitol.
Trimethylol ethane.
Trimethylol propane.
(iii) Synthetic drying oils, as the basic polymer:
Butadiene and methylstyrene copolymer.
Butadiene and styrene copolymer, blown or unblown.
Maleic anhydride adduct of butadiene styrene.
Polybutadiene.
(iv) Natural fossil resins, as the basic resin:
Copal.
Damar.
Elemi.
Gilsonite.
Glycerol ester of damar, copal, elemi, and sandarac.
Sandarac.
Shellac.
Utah coal resin.
(v) Rosins and rosin derivatives, with or without modification by
polymerization, isomerization, incidental decarboxylation, and/or
hydrogenation, as follows:
(a) Rosins, refined to color grade of K or paler:
Gum rosin.
Tall oil rosin.
Wood rosin.
(b) Rosin esters formed by reacting rosin (paragraph (b)(3) (v)(a) of
this section) with:
4,4'-sec-Butylidenediphenol-epichlorohydrin (epoxy).
Diethylene glycol.
Ethylene glycol.
Glycerol.
4,4'-Isopropylidenediphenol-epichlorohydrin (epoxy).
Methyl alcohol.
Pentaerythritol.
(c) Rosin esters (paragraph (b)(3) (v)(b) of this section) modified
by reaction with:
Maleic anhydride.
o-, m-, and p-substituted phenol-formaldehydes listed in paragraph
(b)(3)(vi) of this section.
Phenol-formaldehyde.
(d) Rosin salts:
Calcium resinate (limed rosin).
Zinc resinate.
(vi) Phenolic resins as the basic polymer formed by reaction of
phenols with formaldehyde:
(a) Phenolic resins formed by reaction of formaldehyde with:
Alkylated (methyl, ethyl, propyl, isopropyl, butyl) phenols.
p-tert-Amylphenol.
4,4'-sec-Butylidenediphenol.
p-tert-Butylphenol.
o-, m-, and p-Cresol.
p-Cyclohexylphenol.
4,4'-Isopropylidenediphenol.
p-Nonylphenol.
p-Octylphenol.
3-Pentadecyl phenol mixture obtained from cashew nut shell liquid.
Phenol.
Phenyl o-cresol.
p-Phenylphenol.
Xylenol.
(b) Adjunct for phenolic resins: Aluminum butylate.
(vii) Polyester resins (including alkyd-type), as the basic polymers,
formed as esters of acids listed in paragraph (b)(3)(vii) (a) and (b) of
this section by reaction with alcohols in paragraph (b)(3) (vii) (c) and
(d) of this section.
(a) Polybasic acids:
Adipic.
Dimerized fatty acids derived from oils listed in paragraph (b)(3)(i)
of this section.
Fumaric.
Isophthalic.
Maleic.
Orthophthalic.
Sebacic.
Terephthalic.
Terpene-maleic acid adduct.
Trimellitic.
(b) Monobasic acids:
Benzoic acid.
4,4-Bis(4'-hydroxyphenyl)-pentanoic acid.
tert-Butyl benzoic acid.
Fatty acids derived from oils listed in paragraph (b)(3)(i) of this
section.
Rosins listed in paragraph (b)(3)(v)(a) of this section, for use only
as reactants in oil-based or fatty acid-based alkyd resins.
(c) Polyhydric alcohols:
Butylene glycol.
Diethylene glycol.
2,2-Dimethyl-1,3-propanediol for use only in forming polyester resins
for coatings intended for use in contact with non-alcoholic foods.
Ethylene glycol.
Glycerol.
Mannitol.
-Methyl glucoside.
Pentaerythritol.
Propylene glycol.
Sorbitol.
Triethylene glycol, for use as a component in polyester resins for
coatings not exceeding a coating weight of 4 milligrams per square inch
and that are intended for contact under conditions of use D, E, F or G
described in table 2 of paragraph (d) of this section with alcoholic
beverages containing less than 8 percent alcohol.
Trimethylol ethane.
Trimethylol propane.
(d) Monohydric alcohols:
Cetyl alcohol.
Decyl alcohol.
Lauryl alcohol.
Myristyl alcohol.
Octyl alcohol.
Stearyl alcohol.
(e) Catalysts:
Dibutyltin oxide (CAS Reg. No. 818-08-6), not to exceed 0.2 percent
of the polyester resin.
Hydroxybutyltin oxide (CAS Reg. No. 2273-43-0), not to exceed 0.2
percent of the polyester resin.
Monobutyltin tris(2-ethylhexoate) (CAS Reg. No. 23850-94-4), not to
exceed 0.2 percent of the polyester resin.
(viii) Epoxy resins, catalysts, and adjuncts:
(a) Epoxy resins, as the basic polymer:
(Alkoxy C10-C16)-2,3-epoxypropane, in which the alkyl groups are even
numbered and consist of a maximum of 1 percent C10 carbon atoms and a
minimum of 48 percent C12 carbon atoms and a minimum of 18 percent C14
carbon atoms, for use only in coatings that are intended for contact
with dry bulk foods at room temperature.
4,4'-sec-Butylidenediphenol-epichlorohydrin.
4,4'-sec-Butylidenediphenol-epichlorohydrin reacted with one or more
of the drying oils or fatty acids listed in paragraph (b)(3)(i) of this
section.
4,4'-sec-Butylidenediphenol-epichlorohydrin chemically treated with
one or more of the following substances:
Allyl ether of mono-, di-, or trimethylol phenol.
4,4'-sec-Butylidenediphenol-formaldehyde.
4,4'-Isopropylidenediphenol-formaldehyde.
Melamine-formaldehyde.
Phenol-formaldehyde.
Urea-formaldehyde.
Epoxidized polybutadiene.
Glycidyl ethers formed by reacting phenolnovolak resins with
epichlorohydrin.
4,4'-Isopropylidenediphenol-epichlorohydrin.
4,4'-Isopropylidenediphenol-epichlorohydrin reacted with one or more
of the drying oils or fatty acids listed in paragraph (b)(3)(i) of this
section.
4,4'-Isopropylidenediphenol-epichlorohydrin chemically treated with
one or more of the following substances:
Allyl ether of mono-, di-, or trimethylol phenol.
4,4'-sec-Butylidenediphenol-formaldehyde.
4,4'-Isopropylidenediphenol-formaldehyde.
Melamine-formaldehyde.
Phenol-formaldehyde.
Urea-formaldehyde.
(b) Catalysts and cross-linking agents for epoxy resins:
3-(Aminomethyl)-3,5,5-trimethylcyclohexylamine reacted with phenol
and formaldehyde in a ratio of 2.6:1.0:2.0, for use only in coatings
intended for repeated use in contact with foods only of the types
identified in paragraph (d) of this section, Table 1, under Category I
and Category VIII, at temperatures not exceeding 88 C (190 F).
Cyanoguanidine.
Dibutyl phthalate, for use only in coatings for containers having a
capacity of 1,000 gallons or more when such containers are intended for
repeated use in contact with alcoholic beverages containing up to 8
percent of alcohol by volume.
Diethylenetriamine.
Diphenylamine.
Ethylenediamine.
Isophthalyl dihydrazide for use only in coatings subject to the
provisions of paragraph (c) (3) or (4) of this section.
4,4'-Methylenedianiline, for use only in coatings for containers
having a capacity of 1,000 gallons or more when such containers are
intended for repeated use in contact with alcoholic beverages containing
up to 8 percent of alcohol by volume.
N-Oleyl-1,3-propanediamine with not more than 10 percent by weight of
diethylaminoethanol.
Polyamine produced when 1 mole of the chlorohydrin diether of
polyethylene glycol 400 is made to react under dehydrohalogenating
conditions with 2 moles of N-octadecyltrimethylenediamine for use only
in coatings that are subject to the provisions of paragraph (c) (3) or
(4) of this section and that contact food at temperatures not to exceed
room temperature.
Salicylic acid, for use only in coatings for containers having a
capacity of 1,000 gallons or more when such containers are intended for
repeated use in contact with alcoholic beverages containing up to 8
percent of alcohol by volume.
Stannous 2-ethylhexanoate for use only as a catalyst at a level not
to exceed 1 percent by weight of the resin used in coatings that are
intended for contact with food under conditions of use D, E, F, and G
described in Table 2 of paragraph (d) of this section.
Styrene oxide, for use only in coatings for containers having a
capacity of 1,000 gallons or more when such containers are intended for
repeated use in contact with alcoholic beverages containing up to 8
percent of alcohol by volume.
Tetraethylenepentamine.
Tetraethylenepentamine reacted with equimolar quantities of fatty
acids.
Tri(dimethylaminomethyl) phenol and its salts prepared from the fatty
acid moieties of the salts listed in paragraph (b)(3)(xxii)(b) of this
section, for use only in coatings subject to the provisions of paragraph
(c) (3) or (4) of this section.
Triethylenetetramine.
Trimellitic anhydride (CAS Reg. No. 552-30-7) for use only as a
cross-linking agent at a level not to exceed 15 percent by weight of the
resin in contact with food under all conditions of use, except that
resins intended for use with foods containing more than 8 percent
alcohol must contact such food only under conditions of use D, E, F, and
G described in Table 2 of paragraph (d) of this section.
Trimellitic anhydride adducts of ethylene glycol and glycerol,
prepared by the reaction of 1 mole of trimellitic anhydride with 0.4-0.6
mole of ethylene glycol and 0.04-0.12 mole of glycerol, for use only as
a cross-linking agent at a level not to exceed 10 percent by weight of
the cured coating, provided that the cured coating only contacts food
containing not more than 8 percent alcohol.
(c) Adjuncts for epoxy resins:
Aluminum butylate.
Benzoic acid, for use as a component in epoxy resins for coatings not
exceeding a coating weight of 4 milligrams per square inch and that are
intended for contact under conditions of use D, E, F or G described in
Table 2 of paragraph (d) of this section with alcoholic beverages
containing less than 8 percent alcohol.
Polyamides from dimerized vegetable oils and the amine catalysts
listed in paragraph (b)(3)(viii)(b) of this section, as the basic
polymer.
Silane coupled silica, prepared from the reaction of microcrystalline
quartz with N-beta-(N-vinylbenzylamino)
ethyl-gamma-aminopropyltrimethoxy silane, monohydrogen chloride, for use
only in coatings intended for repeated use in contact with foods only of
the types identified in paragraph (d) of this section, Table 1, under
Category I and Category VIII, at temperatures not exceeding 88 C (190
F).
Succinic anhydride, for use as a component in epoxy resins for
coatings not exceeding a coating weight of 4 milligrams per square inch,
and that are intended for contact under conditions of use D, E, F or G
described in Table 2 of paragraph (d) of this section with alcoholic
beverages containing less than 8 percent alcohol.
(ix) Coumarone-indene resin, as the basic polymer.
(x) Petroleum hydrocarbon resin (cyclopentadiene type), as the basic
polymer.
(xi) Terpene resins, as the basic polymer, from one or more of the
following:
Dipentene.
-Pinene.
-Pinene.
(xii) Urea-formaldehyde, resins and their curing catalyst:
(a) Urea-formaldehyde resins, as the basic polymer:
Urea-formaldehyde.
Urea-formaldehyde chemically modified with methyl, ethyl, propyl,
isopropyl, butyl, or isobutyl alcohol.
Urea-formaldehyde chemically modified with one or more of the amine
catalysts listed in paragraph (b)(3)(viii)(b) of this section.
(b) Curing (cross-linking) catalyst for urea-formaldehyde resins:
Dodecyl benzenesulfonic acid (C.A. Registry No. 27176-87-0).
(xiii) Triazine-formaldehyde resins and their curing catalyst:
(a) Triazine-formaldehyde resins, as the basic polymer:
Benzoguanamine-formaldehyde.
Melamine-formaldehyde.
Melamine-formaldehyde chemically modified with one or more of the
following amine catalysts:
Amine catalysts listed in paragraph (b)(3)(viii)(b) of this section.
Dimethylamine-2-methyl-1-propanol.
Methylpropanolamine.
Triethanolamine.
Melamine-formaldehyde chemically modified with methyl, ethyl, propyl,
isopropyl, butyl, or isobutyl alcohol.
(b) Curing (cross-linking) catalyst for triazine-formaldehyde resins:
Dodecyl benzenesulfonic acid (C.A. Registry No. 27176-87-0).
(xiv) Modifiers (for oils and alkyds, including polyesters), as the
basic polymer:
Butyl methacrylate.
Cyclopentadiene.
Methyl, ethyl, butyl, or octyl esters of acrylic acid.
Methyl methacrylate.
Styrene.
Vinyl toluene.
(xv) Vinyl resinous substance, as the basic polymers:
Polyvinyl acetate.
Polyvinyl alcohol.
Polyvinyl butyral.
Polyvinyl chloride.
Polyvinyl formal.
Polyvinylidene chloride.
Polyvinyl pyrrolidone.
Polyvinyl stearate.
Vinyl chloride-acetate-2,3-epoxypropyl methacrylate copolymers
containing not more than 10 weight percent of total polymer units
derived from 2,3-epoxypropyl methacrylate and not more than 0.1 weight
percent of unreacted 2,3-epoxypropyl methacrylate monomer for use in
coatings for containers.
Vinyl chloride-acetate, hydroxyl-modified copolymer.
Vinyl chloride-acetate, hydroxyl-modified copolymer, reacted with
trimellitic anhydride.
Vinyl chloride copolymerized with acrylamide and ethylene in such a
manner that the finished copolymers have a minimum weight average
molecular weight of 30,000 and contain not more than 3.5 weight percent
of total polymer units derived from acrylamide; the acrylamide portion
may or may not be subsequently partially hydrolyzed.
Vinyl chloride copolymerized with one or more of the following
substances:
Acrylonitrile.
Fumaric acid and/or its methyl, ethyl, propyl, butyl, amyl, hexyl,
heptyl, or octyl esters.
Maleic acid and/or its methyl, ethyl, propyl, butyl, amyl, hexyl,
heptyl, or octyl esters.
5-Norbornene-2,3-dicarboxylic acid, mono-n-butyl ester; for use such
that the finished vinyl chloride copolymers contain not more than 4
weight percent of total polymer units derived from this comonomer.
Vinyl acetate.
Vinylidene chloride.
Vinyl chloride-vinylidene chloride-2,3-epoxypropyl methacrylate
copolymers containing not more than 10 weight percent of total polymer
units derived from 2,3-epoxypropyl methacrylate and not more than 0.05
weight percent of unreacted 2,3-epoxypropyl methacrylate monomer based
on polymer solids for use only in coatings for containers intended for
contact with foods under conditions B, C, D, E, F, G, or H described in
Table 2 of paragraph (d) of this section.
(xvi) Cellulosics, as the basic polymer:
Carboxymethylcellulose.
Cellulose acetate.
Cellulose acetate-butyrate.
Cellulose acetate-propionate.
Ethylcellulose.
Ethyl hydroxyethylcellulose.
Hydroxyethylcellulose.
Hydroxypropyl methylcellulose.
Methylcellulose.
Nitrocellulose.
(xvii) Styrene polymers, as the basic polymer:
Polystyrene.
-Methyl styrene polymer.
Styrene copolymerized with one or more of the following:
Acrylonitrile.
-Methylstyrene.
(xviii) Polyethylene and its copolymers as the basic polymer:
Ethylene-ethyl acrylate copolymer.
Ethylene-isobutyl acrylate copolymers containing no more than 35
weight percent of total polymer units derived from isobutyl acrylate.
Ethylene-vinyl acetate copolymer.
Polyethylene.
(xix) Polypropylene as the basic polymer:
Polypropylene.
Maleic anhydride adduct of polypropylene The polypropylene used in
the manufacture of the adduct complies with 177.1520(c), item 1.1; and
the adduct has a maximum combined maleic anhydride content of 0.8
percent and a minimum intrinsic viscosity of 0.9, determined at 135 C
on a 0.1 percent solution of the modified polypropylene in
decahydronaphthalene as determined by a method titled ''Method for
Determination of Intrinsic Viscosity of Maleic Anhydride Adduct of
Polypropylene,'' which is incorporated by reference. Copies are
available from the Division of Food and Color Additives, Center for Food
Safety and Applied Nutrition (HFF-330), 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.
(xx) Acrylics and their copolymers, as the basic polymer:
Acrylamide with ethylacrylate and/or styrene and/or methacrylic acid,
subsequently reacted with formaldehyde and butanol.
Acrylic acid and the following esters thereof:
Ethyl. Methyl.
Butyl acrylate-styrene-methacrylic acid-hydroxyethyl methacrylate
copolymers containing no more than 20 weight percent of total polymer
units derived from methacrylic acid and containing no more than 7 weight
percent of total polymer units derived from hydroxyethyl methacrylate;
for use only in coatings that are applied by electrodeposition to metal
substrates.
Butyl acrylate-styrene-methacrylic acid-hydroxypropyl methacrylate
copolymers containing no more than 20 weight percent of total polymer
units derived from methacrylic acid and containing no more than 7 weight
percent of total polymer units derived from hydroxypropyl methacrylate;
for use only in coatings that are applied by electrodeposition to metal
substrates and that are intended for contact, under condition of use D,
E, F, or G described in Table 2 of paragraph (d) of this section, with
food containing no more than 8 percent of alcohol.
Ethyl acrylate-styrene-methacrylic acid copolymers for use only as
modifiers for epoxy resins listed in paragraph (b)(3)(viii)(a) of this
section.
Ethyl acrylate-methyl methacrylate-styrene-methacrylic acid
copolymers for use only as modifiers for epoxy resins listed in
paragraph (b)(3)(viii)(a) of this section.
2-Ethylhexyl acrylate-ethyl acrylate copolymers prepared by
copolymerization of 2-ethylhexyl acrylate and ethyl acrylate in a 7/3
weight ratio and having a number average molecular weight range of 5,800
to 6,500 and a refractive index, nD25 (40 percent in 2,2,4-trimethyl
pentane) of 1.4130-1.4190; for use as a modifier for nylon resins
complying with 177.1500 of this chapter and for phenolic and epoxy
resins listed in paragraph (b)(3) (vi) and (viii) of this section,
respectively, at a level not to exceed 1.5 percent of the coating.
2-Ethylhexyl acrylate-methyl methacrylate-acrylic acid copolymers for
use only as modifiers for epoxy resins listed in paragraph (b)(3)(viii)
of this section.
Methacrylic acid and the following esters thereof:
Butyl.
Ethyl.
Methyl.
Methacrylic acid or its ethyl and methyl esters copolymerized with
one or more of the following:
Acrylic acid.
Ethyl acrylate.
Methyl acrylate.
n-Butyl acrylate-styrene-methacrylic acid-hydroxyethyl methacrylate
copolymers containing no more than 2 weight percent of total polymer
units derived from methacrylic acid and containing no more than 9.5
weight percent of total polymer units derived from hydroxyethyl
methacrylate; for use only in coatings in contact with dry food (food
type VIII in Table 1 of paragraph (d) of this section).
2-(Dimethylamino) ethanol (C.A.S. Registry No. 108-01-0) may be employed
as an optional adjuvant substance limited to no more than 2 weight
percent based on polymer solids in the coating emulsion.
Styrene polymers made by the polymerization of any combination of
styrene or alpha methyl styrene with acrylic acid, methacrylic acid,
2-ethyl hexyl acrylate, methyl methacrylate, and butyl acrylate. The
styrene and alpha methyl styrene, individually, may constitute from 0 to
80 weight percent of the polymer. The other monomers, individually, may
be from 0 to 40 weight percent of the polymer. The polymer number
average molecular weight (Mn) shall be at least 2,000 (as determined by
gel permeation chromatography). The acid number of the polymer shall be
less than 250. The monomer content shall be less than 0.5 percent. The
polymers are for use only in contact with food of Types IV-A, V, VII in
table 1 of paragraph (d) of this section, under use conditions E through
G in table 2 of paragraph (d), and with food of Type VIII without use
temperature restriction.
(xxi) Elastomers, as the basic polymer:
Butadiene-acrylonitrile copolymer.
Butadiene-acrylonitrile-styrene copolymer.
Butadiene-styrene copolymer.
Butyl rubber.
Chlorinated rubber.
2-Chloro-1,3-butadiene (neoprene).
Natural rubber (natural latex or natural latex solids, smoked or
unsmoked).
Polyisobutylene.
Rubber hydrochloride.
Styrene-isobutylene copolymer.
(xxii) Driers made by reaction of a metal from paragraph
(b)(3)(xxii)(a) of this section with acid, to form the salt listed in
paragraph (b)(3)(xxii)(b) of this section:
(a) Metals:
Aluminum.
Calcium.
Cerium.
Cobalt.
Iron.
Lithium.
Magnesium.
Manganese.
Zinc.
Zirconium.
(b) Salts:
Caprate.
Caprylate.
Isodecanoate.
Linoleate.
Naphthenate.
Neodecanoate.
Octoate (2-ethylhexoate).
Oleate.
Palmitate.
Resinate.
Ricinoleate.
Soyate.
Stearate.
Tallate.
(xxiii) Waxes:
Paraffin, Type I.
Paraffin, Type II.
Polyethylene.
Sperm oil.
Spermaceti.
(xxiv) Plasticizers:
Acetyl tributyl citrate.
Acetyl triethyl citrate.
Butyl phthalyl butyl glycolate.
Butyl stearate.
p-tert-Butyl phenyl salicylate.
Dibutyl sebacate.
Diethyl phthalate.
Diisobutyl adipate.
Diisooctyl phthalate.
Epoxidized soybean oil (iodine number maximum 14; oxirane oxygen
content 6% minimum), as the basic polymer.
Ethyl phthalyl ethyl glycolate.
2-Ethylhexyl diphenyl phosphate.
di-2-Ethylhexyl phthalate.
Glycerol.
Glyceryl monooleate.
Glyceryl triacetate.
Monoisopropyl citrate.
Propylene glycol.
Sorbitol.
Mono-, di-, and tristearyl citrate.
Triethyl citrate.
Triethylene glycol.
3-(2-Xenolyl)-1,2-epoxypropane.
(xxv) Release agents, as the basic polymer, when applicable:
N, N'-Dioleoylethylenediamine (CAS Reg. No. 110-31-6) for use only in
ionomeric resins complying with 177.1330 of this chapter and in
ethylene vinyl acetate copolymers complying with 177.1350 of this
chapter at a level not to exceed 0.0085 milligram per square centimeter
(0.055 milligram per square inch) in the finished food-contact article.
N,N'-Distearoyl ethylenediamine.
Linoleic acid amide.
Oleic acid amide.
Palmitic acid amide.
Petrolatum.
Polyethylene wax.
Polyoxyethylene glycol monooleate (mol. wt. of the polyoxyethylene
glycol moiety greater than 300).
Polytetrafluoroethylene.
Silicones (not less than 300 centistokes viscosity):
Dimethylpolysiloxanes and/or methylphenylpolysiloxanes. The
methyl-phenylpolysiloxanes contain not more than 2.0 percent by weight
of cyclosiloxanes having up to and including 4 siloxy units.
Silicones (not less than 100 centistokes viscosity):
Dimethylpolysiloxanes and/or methylphenylpolysiloxanes limited to use
only on metal substrates. The methylphenylpolysiloxanes contain not
more than 2.0 percent by weight of cyclosiloxanes having up to and
including 4 siloxy units.
(xxvi) Colorants used in accordance with 178.3297 of this chapter.
(xxvii) Surface lubricants:
Cottonseed oil and other edible oils.
Dibutyl sebacate.
Dioctyl sebacate.
Glyceryl monostearate.
Lanolin.
Mineral oil, white.
Palm oil.
Paraffin, Type I.
Paraffin, Type II.
Petrolatum.
Stearic acid.
(xxviii) Silicones and their curing catalysts:
(a) Silicones as the basic polymer:
Siloxane resins originating from methyl hydrogen polysiloxane,
dimethyl polysiloxane, and methylphenyl polysiloxane.
(b) Curing (cross-linking) catalysts for silicones (the maximum
amount of tin catalyst used shall be that required to effect optimum
cure but shall not exceed 1 part of tin per 100 parts of siloxane resins
solids):
Dibutyltin dilaurate.
Stannous oleate.
Tetrabutyl titanate.
(xxix) Surface active agents:
Ethylene oxide adduct of 2,4,7,9-tetramethyl-5-decyn-4,7-diol (CAS
Reg. No. 9014-85-1).
Poly(2-(diethylamino) ethyl methacrylate) phosphate (minimum
intrinsic viscosity in water at 25 C is not less than 9.0 deciliters
per gram as determined by ASTM method D1243-79, ''Standard Test Method
for Dilute Solution Viscosity of Vinyl Chloride Polymers,'' which is
incorporated by reference (copies may be obtained from the American
Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or
may be examined at the Office of the Federal Register, 1100 L St. NW.,
Washington, DC 20408), for use only as a suspending agent in the
manufacture of vinyl chloride copolymers and limited to use at levels
not to exceed 0.1 percent by weight of the copolymers.
Sodium dioctyl sulfosuccinate.
Sodium dodecylbenzenesulfonate
Sodium lauryl sulfate.
2,4,7,9-Tetramethyl-5-decyn-4,7-diol (C.A.S. Reg. No. 126-86-3), for
use only in can coatings which are subsequently dried and cured at
temperatures of at least 193 C (380 F) for 4 minutes.
(xxx) Antioxidants:
Butylated hydroxyanisole.
Butylated hydroxytoluene.
Gum guaiac.
Dilauryl thiodipropionate.
Nordihydroguaiaretic acid.
Propyl gallate.
Distearyl thiodipropionate.
Thiodipropionic acid.
2,4,5-Trihydroxybutyrophenone.
(xxxi) Can end cements (sealing compounds used for sealing can ends
only): In addition to the substances listed in paragraph (b) of this
section and those listed in 177.1210(b)(5) of this chapter, the
following may be used:
Butadiene-styrene-divinylbenzene copolymer (CAS Reg. No. 26471-45-4)
for use only at levels not to exceed 23.8 percent by weight of the
cement solids in can end cements.
Butadiene-styrene-fumaric acid copolymer.
4,4'-Butylidenebis (6-tert-butyl-m-cresol).
Dibenzamido phenyl disulfide.
Di- -naphthyl phenylenediamine.
Dipentamethylene thiuram tetrasulfide.
Isobutylene-isoprene-divinylbenzene copolymers for use only at levels
not to exceed 15 percent by weight of the dry cement composition.
Naphthalene sulfonic acid-formaldehyde condensate, sodium salt, for
use only at levels not to exceed 0.6 percent by weight of the cement
solids in can end cements for containers having a capacity of not less
than 5 gallons.
Sodium decylbenzene sulfonate.
Sodium nitrite for use only at levels not to exceed 0.3 percent by
weight of the cement solids in can end cements for containers having a
capacity of not less than 5 gallons.
Sodium pentachlorophenate for use as a preservative at 0.1 percent by
weight in can-sealing compounds on containers having a capacity of 5
gallons or more.
Sodium phenylphenate.
Styrene-maleic anhydride resin, partial methyl and butyl (sec- or
iso-) esters, for use only at levels not in excess of 3 percent of the
cement solids in can end cement formulations.
Tetrasodium EDTA (tetrasodium ethylene-diaminetetraacetate).
Tri (mixed mono- and dinonylphenyl) phosphite.
Zinc dibutyldithiocarbamate.
(xxxii) Side seam cements: In addition to the substances listed in
paragraph (b)(3) (i) to (xxx), inclusive, of this section, the following
may be used.
p-tert-Butyl perbenzoate as a catalyst for epoxy resin.
epsilon-Caprolactam-(ethylene-ethyl acrylate) graft polymer.
Dicumyl peroxide for use only as polymerization catalyst.
4-(Diiodomethysulfonyl) toluene (CAS Reg. No. 20018-09-1) for use as
a preservative at a level not to exceed 0.3 percent by weight in
can-sealing cements.
Diisodecyl phthalate for use only as plasticizer in side seam cements
for containers intended for use in contact with food only of the types
identified in paragraph (d) of this section, Table 1, under Categories
I, II, and VI.
4,4'-Bis(alpha,alpha-dimethylbenzyl)diphenylamine, CAS Reg. No.
10081-67-1.
Ethyl toluene sulfonamide.
N,N'-Hexamethylenebis(3,5-di-tert-butyl-4-hydroxyhydrocinnamide), CAS
Reg. No. 23128-74-7.
Polyamides consisting of the following:
Copolymer of omega-laurolactam and espilon-caprolactam, CAS Reg. No.
25191-04-2 (Nylon 12/6).
Homopolymer of omega-aminododecanoic acid, CAS Reg. No. 24937-16-4.
Homopolymer of omega-laurolactam, CAS Reg. No. 25038-74-8 (Nylon
12).
Polyamides derived from the following acids and amines:
Acids:
Adipic.
Azelaic.
Sebacic.
Vegetable oil acids (with or without dimerization).
Amines:
Diethylenetriamine.
Diphenylamine.
Ethylenediamine.
Hexamethylenediamine.
Tetraethylenepentamine.
Triethylenetetramine.
Polypropylene glycol CAS Reg. No. 25322-69-4.
Sodium pentachlorophenate for use as a preservative at 0.1 percent by
weight in can-sealing compounds on containers having a capacity of 5
gallons or more.
Tetrakis (methylene(3,5-di-tert-butyl-4-hydroxyhyane, CAS Reg. No.
6683-19-8.
Toluene sulfonamide formaldehyde resin (basic polymer).
Triethylene glycol methacrylate for use only as polymerization
cross-linking agent in side seam cements for containers intended for use
in contact with food only of the types identified in paragraph (d) of
this section, Table 1, under Categories I, II, and VI.
Urea.
(xxxiii) Miscellaneous materials:
Ammonium citrate.
Ammonium potassium phosphate.
Bentonite, modified by reaction with benzyl dimethyl alkyl ammonium
chloride, where the alkyl groups are derived from hydrogenated tallow
(CAS Reg. No. 71011-24-0). For use only as a rheological agent in
coatings intended to contact food under repeated use conditions.
Bentonite, modified by reaction with sodium stearate and benzyl
dimethyl alkyl ammonium chloride, where the alkyl groups are derived
from hydrogenated tallow (CAS Reg. No. 121888-68-4). For use as a
rheological agent only in coatings intended to contact dry food under
repeated-use conditions.
Calcium acetate.
Calcium ethyl acetoacetate.
Calcium glycerophosphate.
Calcium, sodium, and potassium oleates.
Calcium, sodium, and potassium ricinoleates.
Calcium, sodium, and potassium stearates.
Castor oil, hydrogenated.
Castor oil, sulfated, sodium salt (CAS Reg. No. 68187-76-8), for use
only in coatings for containers intended for repeated use.
Cetyl alcohol.
Cyclohexanone-formaldehyde resin produced when 1 mole of
cyclohexanone is made to react with 1.65 moles of formaldehyde such that
the finished resin has an average molecular weight of 600-610 as
determined by ASTM method D2503-82, ''Standard Test Method for Molecular
Weight (Relative Molecular Mass) of Hydrocarbons by Thermoelectric
Measurement of Vapor Pressure,'' which is incorporated by reference.
Copies may be obtained from the American Society for Testing Materials,
1916 Race St., Philadelphia, PA 19103, or may be examined at the Office
of the Federal Register, 1100 L St. NW., Washington, DC 20408. For use
only in contact with nonalcoholic and nonfatty foods under conditions of
use E, F, and G, described in Table 2 of paragraph (d) this section.
Decyl alcohol.
Disodium hydrogen phosphate.
Ethyl acetoacetate.
Hectorite, modified by reaction with a mixture of benzyl methyl
dialkyl ammonium chloride and dimethyl dialkyl ammonium chloride, where
the alkyl groups are derived from hydrogenated tallow (CAS Reg. No.
121888-67-3). For use as a rheological agent only in coatings intended
to contact dry food under repeated-use conditions.
Lauryl alcohol.
Lecithin.
Magnesium, sodium, and potassium citrate.
Magnesium glycerophosphate.
Magnesium stearate.
Mono-, di-, and tricalcium phosphate.
Monodibutylamine pyrophosphate as sequestrant for iron.
Mono-, di-, and trimagnesium phosphate.
Myristyl alcohol.
Octyl alcohol.
Phosphoric acid.
Polybutene, hydrogenated; complying with the identity and
limitations prescribed by 178.3740 of this chapter.
Poly(ethylene oxide).
Siloxanes and silicones, dimethyl, 3-hydroxypropyl group-terminated,
diesters with poly(2-oxepanone), diacetates (CAS Reg. No. 116810-47-0)
at a level not to exceed 0.025 weight percent of the finished coating
having no greater than a 0.5 mil thickness for use as a component of
polyester, epoxy, and acrylic coatings complying with paragraphs
(b)(3)(vii), (viii), and (xx) of this section, respectively.
Sodium pyrophosphate.
Stannous chloride.
Stannous stearate.
Stannous sulfate.
Stearyl alcohol.
2-Sulfoethyl methacrylate, sodium salt (CAS Reg. No. 1804-87-1). For
use only in copolymer coatings on metal under conditions of use E, F,
and G described in Table 2 of paragraph (d) of this section, and limited
to use at a level not to exceed 2.0 percent by weight of the dry
copolymer coating.
Tetrasodium pyrophosphate.
Tridecyl alcohol produced from tetrapropylene by the oxo process, for
use only as a processing aid in polyvinyl chloride resins.
Vinyl acetate-dibutyl maleate copolymers produced when vinyl acetate
and dibutyl maleate are copolymerized with or without one of the
monomers: Acrylic acid or glycidyl methacrylate. For use only in
coatings for metal foil used in contact with foods that are dry solids
with the surface containing no free fat or oil. The finished copolymers
shall contain at least 50 weight-percent of polymer units derived from
vinyl acetate and shall contain no more than 5 weight-percent of total
polymer units derived from acrylic acid or glycidyl methacrylate.
(xxxiv) Polyamide resins derived from dimerized vegetable oil acids
(containing not more than 20 percent of monomer acids) and
ethylenediamine, as the basic resin, for use only in coatings that
contact food at temperatures not to exceed room temperature.
(xxxv) Polyamide resins having a maximum acid value of 5 and a
maximum amine value of 8.5 derived from dimerized vegetable oil acids
(containing not more than 10 percent of monomer acids), ethylenediamine,
and 4,4-bis (4-hydroxyphenyl) pentanoic acid (in an amount not to exceed
10 percent by weight of said polyamide resins); as the basic resin, for
use only in coatings that contact food at temperatures not to exceed
room temperature provided that the concentration of the polyamide resins
in the finished food-contact coating does not exceed 5 milligrams per
square inch of food-contact surface.
(xxxvi) Methacrylonitrile grafted polybutadiene copolymers containing
no more than 41 weight percent of total polymer units derived from
methacrylonitrile; for use only in coatings that are intended for
contact, under conditions of use D, E, F, or G described in Table 2 of
paragraph (d) of this section, with food containing no more than 8
percent of alcohol.
(c) The coating in the finished form in which it is to contact food,
when extracted with the solvent or solvents characterizing the type of
food, and under conditions of time and temperature characterizing the
conditions of its intended use as determined from Tables 1 and 2 of
paragraph (d) of this section, shall yield chloroform-soluble
extractives, corrected for zinc extractives as zinc oleate, not to
exceed the following:
(1) From a coating intended for or employed as a component of a
container not to exceed 1 gallon and intended for one-time use, not to
exceed 0.5 milligram per square inch nor to exceed that amount as
milligrams per square inch that would equal 0.005 percent of the water
capacity of the container, in milligrams, divided by the area of the
food-contact surface of the container in square inches. From a
fabricated container conforming with the description in this paragraph
(c)(1), the extractives shall not exceed 0.5 milligram per square inch
of food-contact surface nor exceed 50 parts per million of the water
capacity of the container as determined by the methods provided in
paragraph (e) of this section.
(2) From a coating intended for or employed as a component of a
container having a capacity in excess of 1 gallon and intended for
one-time use, not to exceed 1.8 milligrams per square inch nor to exceed
that amount as milligrams per square inch that would equal 0.005 percent
of the water capacity of the container in milligrams, divided by the
area of the food-contact surface of the container in square inches.
(3) From a coating intended for or employed as a component of a
container for repeated use, not to exceed 18 milligrams per square inch
nor to exceed that amount as milligrams per square inch that would equal
0.005 percent of the water capacity of the container in milligrams,
divided by the area of the food-contact surface of the container in
square inches.
(4) From coating intended for repeated use, and employed other than
as a component of a container, not to exceed 18 milligrams per square
inch of coated surface.
(d) Tables:
(e) Analytical methods -- (1) Selection of extractability conditions.
First ascertain the type of food product (Table 1, paragraph (d) of
this section) that is being packed commercially in the test container
and the normal conditions of thermal treatment used in packaging the
type of food involved. Using Table 2 (paragraph (d) of this section),
select the food-simulating solvent or solvents (demineralized distilled
water, heptane, and/or 8 percent ethyl alcohol) and the time-temperature
exaggerations of the container-use conditions. Aqueous products (Types
I, II, IV-B, and VI-B) require only a water-extractability test at the
temperature and time conditions shown for the most severe ''conditions
of use.'' Aqueous products with free oil or fat, and water-oil emulsions
(types III, IV-A, and VII) will require determinations of both water
extractability and heptane extractability. Low-moisture fats and oils
(type V with no free water) require only the heptane extractability.
Alcoholic beverages (type VI-A) require only the 8 percent alcohol
extractant. Having selected the appropriate extractant or extractants
simulating various types of foods and beverages and the time-temperature
exaggerations over normal use, follow the applicable extraction
procedure. Adapt the procedure, when necessary, for containers having a
capacity of over 1 gallon.
(2) Selection of coated-container samples. For consumer-sized
containers up to 1 gallon, quadruplicate samples of representative
containers (using for each replicate sample the number of containers
nearest to an area of 180 square inches) should be selected from the lot
to be examined.
(3) Cleaning procedure preliminary to determining the amount of
extractables from coated containers. Quadruplicate samples of
representative containers should be selected from the lot to be examined
and must be carefully rinsed to remove extraneous material prior to the
actual extraction procedure. Soda fountain pressure-type hot water
rinsing equipment, consisting in its simplest form of a 1/8-inch-
1/4-inch internal diameter metal tube attached to a hot water line and
bent so as to direct a stream of water upward, may be used. Be sure hot
water has reached a temperature of 190 F-200 F before starting to
rinse the container. Invert the container over the top of the fountain
and direct a strong stream of hot water against the bottom and all sides
for 1 minute, drain, and allow to dry.
(4) Exposure conditions -- (i) Water (250 F for 2 hours), simulating
high-temperature heat sterilization. Fill the container within 1/4-inch
of the top with a measured volume of demineralized distilled water.
Cover the container with clean aluminum foil and place the container on
a rack in a pressure cooker. Add a small amount of demineralized
distilled water to the pressure cooker, but do not allow the water to
touch the bottom of the container. Close the cooker securely and start
to heat over a suitable burner. When a steady stream of steam emerges
from the vent, close the vent and allow the pressure to rise to 15
pounds per square inch (250 F) and continue to maintain this pressure
for 2 hours. Slowly release the pressure, open the pressure cooker when
the pressure reads zero, and composite the water of each replicate
immediately in a clean Pyrex flask or beaker. Proceed with the
determination of the amount of extractives by the method described in
paragraph (e)(5) of this section.
(ii) Water (212 F for 30 minutes), simulating boiling water
sterilization. Fill the container within 1/4-inch of the top with a
measured volume of boiling, demineralized distilled water. Cover the
container with clean aluminum foil and place the container on a rack in
a pressure cooker in which a small amount of demineralized distilled
water is boiling. Do not close the pressure vent, but operate at
atmospheric pressure so that there is a continuous escape of a small
amount of steam. Continue to heat for 30 minutes, then remove the test
container and composite the contents of each replicate immediately in a
clean Pyrex flask or beaker. Proceed with the determination of the
amount of extractives by the method described in paragraph (e)(5) of
this section.
(iii) Water (from boiling to 100 F), simulating hot fill or
pasteurization above 150 F. Fill the container within 1/4-inch of the
top with a measured volume of boiling, demineralized distilled water.
Insert a thermometer in the water and allow the uncovered container to
stand in a room at 70 F-85 F. When the temperature reads 100 F,
composite the water from each replicate immediately in a clean Pyrex
flask or beaker. Proceed with the determination of the amount of
extractives by the method described in paragraph (e)(5) of this section.
(iv) Water (150 F for 2 hours), simulating hot fill or
pasteurization below 150 F. Preheat demineralized distilled water to
150 F in a clean Pyrex flask. Fill the container within 1/4-inch of
the top with a measured volume of the 150 F water and cover with clean
aluminum foil. Place the test container in an oven maintained at 150
F. After 2 hours, remove the test container from the oven and
immediately composite the water of each replicate in a clean Pyrex flask
or beaker. Proceed with the determination of the amount of extractives
by the method described in paragraph (e)(5) of this section.
(v) Water (120 F for 24 hours), simulating room temperature filling
and storage. Preheat demineralized distilled water to 120 F in a clean
Pyrex flask. Fill the container within 1/4-inch of the top with a
measured volume of the 120 F water and cover with clean aluminum foil.
Place the test container in an incubator or oven maintained at 120 F.
After 24 hours, remove the test container from the incubator and
immediately composite the water of each replicate in a clean Pyrex flask
or beaker. Proceed with the determination of the amount of extractives
by the method described in paragraph (e)(5) of this section.
(vi) Water (70 F for 48 hours), simulating refrigerated storage.
Bring demineralized distilled water to 70 F in a clean Pyrex flask.
Fill the container within 1/4-inch of the top with a measured volume of
the 70 F water, and cover with clean aluminum foil. Place the test
container in a suitable room maintained at 70 F. After 48 hours,
immediately composite the water of each replicate in a clean Pyrex flask
or beaker. Proceed with the determination of the amount of extractives
by the method described in paragraph (e)(5) of this section.
(vii) Water (70 F for 24 hours), simulating frozen storage. Bring
demineralized distilled water to 70 F in a clean Pyrex flask. Fill the
container within 1/4-inch of the top with a measured volume of the 70 F
water and cover with clean aluminum foil. Place the container in a
suitable room maintained at 70 F. After 24 hours, immediately
composite the water of each replicate in a clean Pyrex flask or beaker.
Proceed with the determination of the amount of extractives by the
method described in paragraph (e)(5) of this section.
(viii) Water (212 F for 30 minutes), simulating frozen foods
reheated in the container. Fill the container to within 1/4-inch of the
top with a measured volume of boiling, demineralized distilled water.
Cover the container with clean aluminum foil and place the container on
a rack in a pressure cooker in which a small amount of demineralized
distilled water is boiling. Do not close the pressure vent, but operate
at atmospheric pressure so that there is a continuous escape of a small
amount of steam. Continue to heat for 30 minutes, then remove the test
container and composite the contents of each replicate immediately in a
clean Pyrex flask or beaker. Proceed with the determination of the
amount of extractives by the method described in paragraph (e)(5) of
this section.
(ix) Heptane (150 F for 2 hours) simulating high-temperature heat
sterilization for fatty foods only. Preheat redistilled reagent-grade
heptane (boiling point 208 F) carefully in a clean Pyrex flask on a
water bath or nonsparking hot plate in a well-ventilated hood to 150 F.
At the same time preheat a pressure cooker or equivalent to 150 F in
an incubator. This pressure cooker is to serve only as a container for
the heptane-containing test package inside the incubator in order to
minimize the danger of explosion. Fill the test container within
1/4-inch of the top with a measured volume of the 150 F heptane and
cover with clean aluminum foil. Place the test container in the
preheated pressure cooker and then put the assembly into a 150 F
incubator. After 2 hours, remove the pressure cooker from the
incubator, open the assembly, and immediately composite the heptane of
each replicate in a clean Pyrex flask or beaker. Proceed with the
determination of the amount of extractives by the method described in
paragraph (e)(5) of this section.
(x) Heptane (120 F for 30 minutes), simulating boiling water
sterilization of fatty foods only. Preheat redistilled reagent-grade
heptane (boiling point 208 F) carefully in a clean Pyrex flask on a
water bath or nonsparking hot plate in a well-ventilated hood to 120 F.
At the same time, preheat a pressure cooker or equivalent to 120 F in
an incubator. This pressure cooker is to serve only as a vented
container for the heptane-containing test package inside the incubator
in order to minimize the danger of explosion. Fill the test container
within 1/4-inch of the top with a measured volume of the 120 F heptane
and cover with clean aluminum foil. Place the test container in the
preheated pressure cooker and then put the assembly into a 120 F
incubator. After 30 minutes, remove the pressure cooker from the
incubator, open the assembly, and immediately composite the heptane of
each replicate in a clean Pyrex flask or beaker. Proceed with the
determination of the amount of extractives by the method described in
paragraph (e)(5) of this section.
(xi) Heptane (120 F for 15 minutes), simulating hot fill or
pasteurization above 150 F for fatty foods only. Preheat redistilled
reagent-grade heptane (boiling point 208 F) carefully in a clean Pyrex
flask on a water bath or nonsparking hot plate in a well-ventilated hood
to 120 F. At the same time, preheat a pressure cooker or equivalent to
120 F in an incubator. This pressure cooker is to serve only as a
container for the heptane-containing test package inside the incubator
in order to minimize the danger of explosion. Fill the test container
within 1/4-inch of the top with a measured volume of the 120 F heptane
and cover with clean aluminum foil. Place the test container in the
preheated pressure cooker and then put the assembly into a 120 F
incubator. After 15 minutes, remove the pressure cooker from the
incubator, open the assembly, and immediately composite the heptane of
each replicate in a clean Pyrex flask or beaker. Proceed with the
determination of the amount of extractives by the method described in
paragraph (e)(5) of this section.
(xii) Heptane (100 F for 30 minutes), simulating hot fill or
pasteurization below 150 F for fatty foods only. Preheat redistilled
reagent-grade heptane (boiling point 208 F) carefully in a clean Pyrex
flask on a water bath or nonsparking hot plate in a well-ventilated hood
to 100 F. At the same time, preheat a pressure cooker or equivalent to
100 F in an incubator. This pressure cooker is to serve only as a
container for the heptane-containing test package inside the incubator
in order to minimize the danger of explosion. Fill the test container
within 1/4-inch of the top with a measured volume of the 100 F heptane
and cover with clean aluminum foil. Place the test container in the
preheated pressure cooker and then put the assembly into a 100 F
incubator. After 30 minutes, remove the pressure cooker from the
incubator, open the assembly and immediately composite the heptane of
each replicate in a clean Pyrex flask or beaker. Proceed with the
determination of the amount of extractives by the method described in
paragraph (e)(5) of this section.
(xiii) Heptane (70 F for 30 minutes), simulating room temperature
filling and storage of fatty foods only. Fill the test container within
1/4-inch of the top with a measured volume of the 70 F heptane and
cover with clean aluminum foil. Place the test container in a suitable
room maintained at 70 F. After 30 minutes, composite the heptane of
each replicate in a clean Pyrex flask or beaker. Proceed with the
determination of the amount of extractives by the method described in
paragraph (e)(5) of this section.
(xiv) Heptane (120 F for 30 minutes), simulating frozen fatty foods
reheated in the container. Preheat redistilled reagent-grade heptane
(boiling point 208 F) carefully in a clean Pyrex flask on a water bath
or hot plate in a well-ventilated hood to 120 F. At the same time,
preheat a pressure cooker to 120 F in an incubator. This pressure
cooker is to serve only as a container for the heptane-containing test
package inside the incubator in order to minimize the danger of
explosion. Fill the test container within 1/4-inch of the top with a
measured volume of the 120 F heptane and cover with clean aluminum
foil. Place the test container in the preheated pressure cooker and
then put the assembly into a 120 F incubator. After 30 minutes, remove
the pressure cooker from the incubator, open the assembly and
immediately composite the heptane from each replicate into a clean Pyrex
flask. Proceed with the determination of the amount of extractives by
the method described in paragraph (e)(5) of this section.
(xv) Alcohol -- 8 percent (150 F for 2 hours), simulating alcoholic
beverages hot filled or pasteurized below 150 F. Preheat 8 percent (by
volume) ethyl alcohol in demineralized distilled water to 150 F in a
clean Pyrex flask. Fill the test container with within 1/4-inch of the
top with a measured volume of the 8 percent alcohol. Cover the
container with clean aluminum foil and place in an oven maintained at
150 F. After 2 hours, remove the container from the oven and
immediately composite the alcohol from each replicate in a clean Pyrex
flask. Proceed with the determination of the amount of extractives by
the method described in paragraph (e)(5) of this section.
(xvi) Alcohol -- 8 percent (120 F for 24 hours), simulating
alcoholic beverages room-temperature filled and stored. Preheat 8
percent (by volume) ethyl alcohol in demineralized distilled water to
120 F in a clean Pyrex flask. Fill the test container within 1/4-inch
of the top with a measured volume of the 8 percent alcohol, cover the
container with clean aluminum foil and place in an oven or incubator
maintained at 120 F. After 24 hours, remove the container from the
oven or incubator and immediately composite the alcohol from each
replicate into a clean Pyrex flask. Proceed with the determination of
the amount of extractives by the method described in paragraph (e)(5) of
this section.
(xvii) Alcohol -- 8 percent (70 F for 48 hours), simulating
alcoholic beverages in refrigerated storage. Bring 8 percent (by
volume) ethyl alcohol in demineralized distilled water to 70 F in a
clean Pyrex flask. Fill the test container within 1/4-inch of the top
with a measured volume of the 8 percent alcohol. Cover the container
with clean aluminum foil. Place the test container in a suitable room
maintained at 70 F. After 48 hours, immediately composite the alcohol
from each replicate into a clean Pyrex flask. Proceed with the
determination of the amount of extractives by the method described in
paragraph (e)(5) of this section.
Note: The tests specified in paragraph (e)(4) (i) through (xvii) of
this section are applicable to flexible packages consisting of coated
metal contacting food, in which case the closure end is double-folded
and clamped with metal spring clips by which the package can be
suspended.
(5) Determination of amount of extractives -- (i) Total residues.
Evaporate the food-simulating solvents from paragraph (e)(4) (i) to
(xvii), inclusive, of this section to about 100 milliliters in the Pyrex
flask and transfer to a clean, tared platinum dish, washing the flask
three times with the solvent used in the extraction procedure, and
evaporate to a few milliliters on a nonsparking low-temperature
hotplate. The last few milliliters should be evaporated in an oven
maintained at a temperature of 212 F. Cool the platinum dish in a
desiccator for 30 minutes and weigh the residue to the nearest 0.1
milligram (e). Calculate the extractives in milligrams per square inch
and in parts per million for the particular size of container being
tested and for the specific food-simulating solvent used.
(a) Water and 8-percent alcohol.
Milligrams extractives per square inch=
Extractives residue=Ex=
(b) Heptane.
Milligrams extractives per square inch=
Extractives residue=Ex=
Where:
Ex=Extractives residue in ppm for any container size.
e=Milligrams extractives per sample tested.
a=Total coated area, including closure in square inches.
c=Water capacity of container, in grams.
s=Surface of coated area tested, in square inches.
F=Five, the ratio of the amount of extractives removed from a coated
container by heptane under exaggerated time-temperature test conditions
compared to the amount extracted by a fat or oil from a container tested
under exaggerated conditions of thermal sterilization and use.
e'=Chloroform-soluble extractives residue.
ee'=Zinc corrected chloroform-soluble extractive residue.
e' or ee' is substituted for e in the above equations when necessary.
If when calculated by the equations in paragraph (e)(5)(i) (a) and
(b) of this section, the concentration of extractives residue (Ex)
exceeds 50 parts per million or the extractives in milligrams per square
inch exceed the limitations prescribed in paragraph (c) of this section
for the particular container size, proceed to paragraph (e)(5)(ii) of
this section (method for determining the amount of chloroform-soluble
extractives residue).
(ii) Chloroform-soluble extractives residue. Add 50 milliliters of
chloroform (freshly distilled reagent grade or a grade having an
established consistently low blank) to the dried and weighed residue,
(e), in the platinum dish, obtained in paragraph (e)(5)(i) of this
section. Warm carefully, and filter through Whatman No. 41 filter
paper in a Pyrex funnel, collecting the filtrate in a clean, tared
platinum dish. Repeat the chloroform extraction, washing the filter
paper with this second portion of chloroform. Add this filtrate to the
original filtrate and evaporate the total down to a few milliliters on a
low-temperature hotplate. The last few milliliters should be evaporated
in an oven maintained at 212 F. Cool the platinum dish in a desiccator
for 30 minutes and weigh to the nearest 0.1 milligram to get the
chloroform-soluble extractives residue (e'). This e' is substituted for
e in the equations in paragraph (e)(5)(i) (a) and (b) of this section.
If the concentration of extractives (Ex) still exceeds 50 parts per
million or the extractives in milligrams per square inch exceed the
limitations prescribed in paragraph (c) of this section for the
particular container size, proceed as follows to correct for zinc
extractives (''C'' enamels only): Ash the residue in the platinum dish
by heating gently over a Meeker-type burner to destroy organic matter
and hold at red heat for about 1 minute. Cool in the air for 3 minutes,
and place the platinum dish in the desiccator for 30 minutes and weigh
to the nearest 0.1 milligram. Analyze this ash for zinc by standard
Association of Official Agricultural Chemists methods or equivalent.
Calculate the zinc in the ash as zinc oleate, and subtract from the
weight of chloroform-soluble extractives residue (e') to obtain the
zinc-corrected chloroform-soluble extractives residue (ee'). This ee'
is substituted for e in the formulas in paragraph (e)(5)(i) (a) and (b)
of this section. To comply with the limitations in paragraph (c) of
this section, the chloroform-soluble extractives residue (but after
correction for the zinc extractives in case of ''C'' enamels) must not
exceed 50 parts per million and must not exceed in milligrams per square
inch the limitations for the particular article as prescribed in
paragraph (c) of this section.
(f) Equipment and reagent requirements -- (1) Equipment.
Rinsing equipment, soda fountain pressure-type hot water, consisting
in simplest form of a 1/8-inch- 1/4-inch inside diameter metal tube
attached to a hot water line delivering 190 F-200 F water and bent so
as to direct a stream of water upward.
Pressure cooker, 21-quart capacity with pressure gage, safety
release, and removable rack, 12.5 inches inside diameter 11 inches
inside height, 20 pounds per square inch safe operating pressure.
Oven, mechanical convection, range to include 120 F-212 F
explosion-proof, inside dimensions (minimum), 19'' 19'' 19'',
constant temperature to 2 F (water bath may be substituted).
Incubator, inside dimensions (minimum) 19'' 19'' 19'' for use at
100 F 2 F explosion proof (water bath may be substituted).
Constant-temperature room or chamber 70 F 2 F minimum inside
dimensions 19'' 19'' 19''.
Hot plate, nonsparking (explosion proof), top 12'' 20'', 2,500
watts, with temperature control.
Platinum dish, 100-milliliter capacity minimum.
All glass, Pyrex or equivalent.
(2) Reagents.
Water, all water used in extraction procedure should be freshly
demineralized (deionized) distilled water.
Heptane, reagent grade, freshly redistilled before use, using only
material boiling at 208 F.
Alcohol, 8 percent (by volume), prepared from undenatured 95 percent
ethyl alcohol diluted with demineralized or distilled water.
Chloroform, reagent grade, freshly redistilled before use, or a grade
having an established, consistently low blank.
Filter paper, Whatman No. 41 or equivalent.
(g) In accordance with good manufacturing practice, finished coatings
intended for repeated food-contact use shall be thoroughly cleansed
prior to their first use in contact with food.
(h) Acrylonitrile copolymers identified in this section shall comply
with the provisions of 180.22 of this chapter.
(42 FR 14534, Mar. 15, 1977)
Editorial Note: For Federal Register citations affecting 175.300,
see the List of CFR Sections Affected in the Finding Aids section of
this volume.
21 CFR 175.320 Resinous and polymeric coatings for polyolefin films.
Resinous and polymeric coatings may be safely used as the
food-contact surface of articles intended for use in producing,
manufacturing, packing, processing, preparing, treating, packaging,
transporting, or holding food, in accordance with the following
prescribed conditions:
(a) The coating is applied as a continuous film over one or both
sides of a base film produced from one or more of the basic olefin
polymers complying with 177.1520 of this chapter. The base polyolefin
film may contain optional adjuvant substances permitted for use in
polyolefin film by applicable regulations in parts 170 through 189 of
this chapter.
(b) The coatings are formulated from optional substances which are:
(1) Substances generally recognized as safe for use in or on food.
(2) Substances the use of which is permitted under applicable
regulations in parts 170 through 189 of this chapter, by prior
sanctions, or approvals.
(3) Substances identified in this paragraph (b)(3) and subject to
such limitations as are provided:
(c) The coating in the finished form in which it is to contact food,
when extracted with the solvent or solvents characterizing the type of
food, and under conditions of time and temperature characterizing the
conditions of its intended use as determined from Tables 1 and 2 of
176.17(c) of this chapter, shall yield net chloroform-soluble
extractives not to exceed 0.5 milligram per square inch of coated
surface.
(d) Acrylonitrile copolymers identified in this section shall comply
with the provisions of 180.22 of this chapter.
(42 FR 14534, Mar. 15, 1977, as amended at 43 FR 7206, Feb. 21, 1978;
45 FR 6541, Jan. 29, 1980; 47 FR 22512, May 25, 1982; 49 FR 36497,
Sept. 18, 1984; 50 FR 47209, Nov. 15, 1985; 56 FR 49674, Oct. 1,
1991)
21 CFR 175.350 Vinyl acetate/crotonic acid copolymer.
A copolymer of vinyl acetate and crotonic acid may be safely used as
a coating or as a component of a coating which is the food-contact
surface of polyolefin films intended for packaging food, subject to the
provisions of this section.
(a) The copolymer may contain added optional substances to impart
desired properties.
(b) The quantity of any optional substance does not exceed the amount
reasonably required to accomplish the intended physical or technical
effect nor any limitations further provided.
(c) Any optional substance that is the subject of a regulation in
parts 174, 175, 176, 177, 178, and 179.45 of this chapter conforms with
any specifications in such regulation.
(d) Optional substances as provided in paragraph (a) of this section
include:
(1) Substances generally recognized as safe in food.
(2) Substances subject to prior sanction or approval for uses with a
copolymer of vinyl acetate and crotonic acid and used in accordance with
such sanction or approval.
(3) Substances identified in this subparagraph and subject to such
limitations as are provided:
(e) Copolymer of vinyl acetate and crotonic acid used as a coating or
as a component of a coating conforming with the specifications of
paragraph (e)(1) of this section are used as provided in paragraph
(e)(2) of this section.
(1) Specifications. (i) The chloroform-soluble portion of the water
extractives of the coated film obtained with distilled water at 120 F
for 24 hours does not exceed 0.5 milligram per square inch of coated
surface.
(ii) The chloroform-soluble portion of the n-heptane extractives of
the coated film obtained with n-heptane at 70 F for 30 minutes does not
exceed 0.5 milligram per square inch of coated surface.
(2) Conditions of use. The copolymer of vinyl acetate and crotonic
acid is used as a coating or as a component of a coating for polyolefin
films for packaging bakery products and confectionery.
21 CFR 175.360 Vinylidene chloride copolymer coatings for nylon film.
Vinylidene chloride copolymer coatings identified in this section and
applied on nylon film may be safely used as food-contact surfaces, in
accordance with the following prescribed conditions:
(a) The coating is applied as a continuous film over one or both
sides of a base film produced from nylon resins complying with 177.1500
of this chapter.
(b) The coatings are prepared from vinylidene chloride copolymers
produced by copolymerizing vinylidene chloride with one or more of the
monomers acrylic acid, acrylonitrile, ethyl acrylate, methacrylic acid,
methyl acrylate, methyl methacrylate (CAS Reg. No. 80-62-6; maximum use
level 6 weight percent) and 2-sulfoethyl methacrylate (CAS Reg. No.
10595-80-9; maximum use level 1 weight percent). The finished
copolymers contain at least 50 weight percent of polymer units derived
from vinylidene chloride. The finished coating produced from vinylidene
chloride copolymers produced by copolymerizing vinylidene chloride with
methyl methacrylate and/or 2-sulfoethyl methacrylate, or with methyl
methacrylate and/or 2-sulfoethyl methacrylate together with one or more
of the other monomers from this section, is restricted to use at or
below room temperature.
(c) Optional adjuvant substances employed in the production of the
coatings or added thereto to impart desired properties may include
sodium dodecylbenzenesulfonate.
(d) The coating in the finished form in which it is to contact food,
when extracted with the solvent or solvents characterizing the type of
food, and under conditions of time and temperature characterizing the
conditions of its intended use as determined from Tables 1 and 2 of
176.170(c) of this chapter, shall yield net chloroform-soluble
extractives not to exceed 0.5 milligram per square inch of coated
surface when tested by the methods described in 176.170(d) of this
chapter.
(e) Acrylonitrile copolymers identified in this section shall comply
with the provisions of 180.22 of this chapter.
(42 FR 14534, Mar. 15, 1977, as amended at 43 FR 7206, Feb. 21, 1978;
45 FR 76998, Nov. 21, 1980; 47 FR 54430, Dec. 3, 1982)
21 CFR 175.365 Vinylidene chloride copolymer coatings for polycarbonate
film.
Vinylidene chloride copolymer coatings identified in this section and
applied on polycarbonate film may be safely used as food-contact
surfaces, in accordance with the following prescribed conditions:
(a) The coating is applied as a continuous film over one or both
sides of a base film produced from polycarbonate resins complying with
177.1580 of this chapter.
(b) The coatings are prepared from vinylidene chloride copolymers
produced by copolymerizing vinylidene chloride with acrylonitrile,
methyl acrylate, and acrylic acid. The finished copolymers contain at
least 50 weight-percent of polymer units derived from vinyldene
chloride.
(c) Optional adjuvant substances employed in the production of the
coatings or added thereto to impart desired properties may include
sodium dodecylbenzenesulfonate in addition to substances described in
174.5(d) of this chapter.
(d) The coating in the finished form in which it is to contact food,
when extracted with the solvent or solvents characterizing the type of
food, and under the conditions of time and temperature characterizing
the conditions of its intended use as determined from Tables 1 and 2 of
176.170(c) of this chapter, shall yield net chloroform-soluble
extractives in each extracting solvent not to exceed 0.5 milligram per
square inch of coated surface as determined by the methods described in
176.170(d) of this chapter. In testing the finished food-contact
articles, a separate test sample is to be used for each required
extracting solvent.
(e) Acrylonitrile copolymers identified in this section shall comply
with the provisons of 180.22 of this chapter.
21 CFR 175.380 Xylene-formaldehyde resins condensed with
4,4'-isopropylidenediphenol-epichlorohydrin epoxy resins.
The resins identified in paragraph (a) of this section may be safely
used as a food-contact coating for articles intended for use in contact
with food, in accordance with the following prescribed conditions.
(a) The resins are produced by the condensation of
xylene-formaldehyde resin and 4,4'-isopropylidenediphenol-epichlorohydin
epoxy resins, to which may have been added certain optional adjuvant
substances required in the production of the resins or added to impart
desired physical and technical properties. The optional adjuvant
substances may include resins produced by the condensation of allyl
ether of mono-, di-, or trimethylol phenol and capryl alcohol and also
may include substances identified in 175.300(b)(3), with the exception
of paragraph (b)(3)(xxxi) and (xxxii) of that section.
(b) The resins identified in paragraph (a) of this section may be
used as a food-contact coating for articles intended for contact at
temperatures not to exceed 160 F with food of Types I, II, VI-A and B,
and VIII described in Table 1 of 176.170(c) of this chapter provided
that the coating in the finished form in which it is to contact food
meets the following extractives limitations when tested by the methods
provided in 175.300(e):
(1) The coating when extracted with distilled water at 180 F for 24
hours yields total extractives not to exceed 0.05 milligram per square
inch of food-contact surface.
(2) The coating when extracted with 8 percent (by volume) ethyl
alcohol in distilled water at 160 F for 4 hours yields total
extractives not to exceed 0.05 milligram per square inch of food-contact
surface.
(c) The resins identified in paragraph (a) of this section may be
used as a food-contact coating for articles intended for contact at
temperatures not to exceed room temperature with food of Type VI-C
described in Table 1 of 176.170(c) of this chapter provided the coating
in the finished form in which it is to contact food meets the following
extractives limitations when tested by the methods provided in
175.300(e):
(1) The coating when extracted with distilled water at 180 F for 24
hours yields total extractives not to exceed 0.05 milligram per square
inch of food-contact surface.
(2) The coating when extracted with 50 percent (by volume) ethyl
alcohol in distilled water at 180 F for 24 hours yields total
extractives not to exceed 0.05 milligram per square inch.
21 CFR 175.390 Zinc-silicon dioxide matrix coatings.
Zinc-silicon dioxide matrix coatings may be safely used as the
food-contact surface of articles intended for use in producing,
manufacturing, packing, processing, preparing, treating, packaging,
transporting, or holding food, subject to the provisions of this
section;
(a) The coating is applied to a metal surface, cured, and washed with
water to remove soluble substances.
(b) The coatings are formulated from optional substances which
include:
(1) Substances generally recognized as safe.
(2) Substances for which safe conditions of use have been prescribed
in 175.300.
(3) Substances identified in paragraph (c) of this section, subject
to the limitations prescribed.
(c) The optional substances permitted are as follows:
(d) The coating in the finished form in which it is to contact food,
when extracted with the solvent or solvents characterizing the type of
food, and under the conditions of its intended use as shown in Tables 1
and 2 of 175.300(d) (using 20 percent alcohol as the solvent when the
type of food contains approximately 20 percent alcohol) shall yield
total extractives not to exceed those prescribed in 175.300(c)(3);
lithium extractives not to exceed 0.025 milligram per square inch of
surface; and chromium extractives not to exceed 0.05 microgram per
square inch of surface.
(e) The coatings are used as food-contact surfaces for bulk reusable
containers intended for storing, handling, and transporting food.
21 CFR 175.390 PART 176 -- INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS
21 CFR 175.390 Subpart A -- (Reserved)
21 CFR 175.390 Subpart B -- Substances for Use Only as Components of
Paper and Paperboard
Sec.
176.110 Acrylamide-acrylic acid resins.
176.120 Alkyl ketene dimers.
176.130 Anti-offset substances.
176.150 Chelating agents used in the manufacture of paper and
paperboard.
176.160 Chromium (Cr III) complex of
N-ethyl-N-heptadecylfluoro-octane sulfonyl glycine.
176.170 Components of paper and paperboard in contact with aqueous
and fatty foods.
176.180 Components of paper and paperboard in contact with dry food.
176.200 Defoaming agents used in coatings.
176.210 Defoaming agents used in the manufacture of paper and
paperboard.
176.230 3,5-Dimethyl-1,3,5,2H-tetrahydrothiadiazine-2-thione.
176.250 Poly-1,4,7,10,13-pentaaza-15-hydroxyhexadecane.
176.260 Pulp from reclaimed fiber.
176.300 Slimicides.
176.320 Sodium nitrate-urea complex.
176.350 Tamarind seed kernel powder.
Authority: Secs. 201, 402, 406, 409, 706 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321, 342, 346, 348, 376).
Source: 42 FR 14554, Mar. 15, 1977, unless otherwise noted.
21 CFR 175.390 Subpart A -- (Reserved)
21 CFR 175.390 Subpart B -- Substances for Use Only as Components of Paper and Paperboard
21 CFR 176.110 Acrylamide-acrylic acid resins.
Acrylamide-acrylic acid resins may be safely used as components of
articles intended for use in producing, manufacturing, packing,
processing, preparing, treating, packaging, transporting, or holding
food, subject to the provisions of this section.
(a) Acrylamide-acrylic acid resins are produced by the polymerization
of acrylamide with partial hydrolysis or by the copolymerization of
acrylamide and acrylic acid.
(b) The acrylamide-acrylic acid resins contain less than 0.2 percent
residual monomer.
(c) The resins are used as adjuvants in the manufacture of paper and
paperboard in amounts not to exceed that necessary to accomplish the
technical effect and not to exceed 2 percent by weight of the paper or
paperboard.
21 CFR 176.120 Alkyl ketene dimers.
Alkyl ketene dimers may be safely used as a component of articles
intended for use in producing, manufacturing, packing, processing,
preparing, treating, packaging, transporting, or holding food, subject
to the provisions of this section.
(a) The alkyl ketene dimers are manufactured by the
dehydrohalogenation of the acyl halides derived from the fatty acids of
animal or vegetable fats and oils.
(b) The alkyl ketene dimers are used as an adjuvant in the
manufacture of paper and paperboard under such conditions that the alkyl
ketene dimers and their hydrolysis products dialkyl ketones do not
exceed 0.4 percent by weight of the paper or paperboard.
(c) The alkyl ketene dimers may be used in the form of an aqueous
emulsion which may contain sodium lignosulfonate as a dispersant.
21 CFR 176.130 Anti-offset substances.
Substances named in paragraphs (b) and (c) of this section may be
safely used to prevent the transfer of inks employed in printing and
decorating paper and paperboard used for food packaging in accordance
with the provisions of this section:
(a) The substances are applied to the nonfood contact, printed side
of the paper or paperboard in an amount not greater than that required
to accomplish the technical effect nor greater than any specific
limitations, where such are provided.
(b) Anti-offset powders are prepared from substances that are
generally recognized as safe in food, substances for which prior
sanctions or approvals were granted and which are used in accordance
with the specific provisions of such sanction or approval, and
substances named in paragraph (c) of this section.
(c) The substances permitted are as follows:
21 CFR 176.150 Chelating agents used in the manufacture of paper and
paperboard.
The substances named in paragraph (a) of this section may be safely
used in the manufacture of paper and paperboard, in accordance with the
conditions prescribed in paragraphs (b) and (c) of this section:
(a) Chelating agents: 04
(b) Any one or any combination of the substances named is used or
intended for use as chelating agents.
(c) The substances are added in an amount not greater than that
required to accomplish the intended technical effect nor greater than
any specific limitation, where such is provided.
21 CFR 176.160 Chromium (Cr III) complex of
N-ethyl-N-heptadecylfluoro-octane sulfonyl glycine.
The chromium (Cr III) complex of N-ethyl - N -
heptadecylfluoro-octane sulfonyl glycine containing up to 20 percent by
weight of the chromium (Cr III) complex of heptadecylfluoro-octane
sulfonic acid may be safely used as a component of paper for packaging
dry food when used in accordance with the following prescribed
conditions.
(a) The food additive is used as a component of paper in an amount
not to exceed 0.5 percent by weight of the paper.
(b)(1) The food-contact surface of the paper is overcoated with a
polymeric or resinous coating at least 1/3-mil in thickness, that meets
the provision of 176.170; or
(2) The treated paper forms one or more plies of a paper in a
multiwall bag and is separated from the food by at least one ply of
packaging films or grease-resistant papers which serves as a functional
barrier between the food additive and the food. Such packaging films or
grease-resistant papers conform with appropriate food additive
regulations.
(c) The labeling of the food additive shall contain adequate
directions for its use to insure compliance with the requirements of
paragraphs (a) and (b) of this section.
21 CFR 176.170 Components of paper and paperboard in contact with
aqueous and fatty foods.
Substances identified in this section may be safely used as
components of the uncoated or coated food-contact surface of paper and
paperboard intended for use in producing, manufacturing, packaging,
processing, preparing, treating, packing, transporting, or holding
aqueous and fatty foods, subject to the provisions of this section.
Components of paper and paperboard in contact with dry food of the type
identified under Type VIII of Table 1 in paragraph (c) of this section
are subject to the provisions of 176.180.
(a) Substances identified in paragraph (a)(1) through (5) of this
section may be used as components of the food-contact surface of paper
and paperboard. Paper and paperboard products shall be exempted from
compliance with the extractives limitations prescribed in paragraph (c)
of this section: Provided, That the components of the food-contact
surface consist entirely of one or more of the substances identified in
this paragraph: And provided further, That if the paper or paperboard
when extracted under the conditions prescribed in paragraph (c) of this
section exceeds the limitations on extractives contained in paragraph
(c) of this section, information shall be available from manufacturing
records from which it is possible to determine that only substances
identified in this paragraph (a) are present in the food-contact surface
of such paper or paperboard.
(1) Substances generally recognized as safe in food.
(2) Substances generally recognized as safe for their intended use in
paper and paperboard products used in food packaging.
(3) Substances used in accordance with a prior sanction or approval.
(4) Substances that by regulation in parts 170 through 189 of this
chapter may be safely used without extractives limitations as components
of the uncoated or coated food-contact surface of paper and paperboard
in contact with aqueous or fatty food, subject to the provisions of such
regulation.
(5) Substances identified in this paragraph, as follows:
(b) Substances identified in paragraphs (b) (1) and (2) of this
section may be used as components of the food-contact surface of paper
and paperboard, provided that the food-contact surface of the paper or
paperboard complies with the extractives limitations prescribed in
paragraph (c) of this section.
(1) Substances identified in 175.300(b)(3) of this chapter with the
exception of those identified in paragraphs (b)(3) (v), (xv), (xx),
(xxvi), (xxxi), and (xxxii) of that section and paragraph (a) of this
section.
(2) Substances identified in this paragraph (b)(2) follow:
(c) The food-contact surface of the paper and paperboard in the
finished form in which it is to contact food, when extracted with the
solvent or solvents characterizing the type of food, and under
conditions of time and temperature characterizing the conditions of its
intended use as determined from Tables 1 and 2 of this paragraph, shall
yield net chloroform-soluble extractives (corrected for wax, petrolatum,
mineral oil and zinc extractives as zinc oleate) not to exceed 0.5
milligram per square inch of food-contact surface as determined by the
methods described in paragraph (d) of this section.
I. Nonacid, aqueous products; may contain salt or sugar or both (pH
above 5.0).
II. Acid, aqueous products; may contain salt or sugar or both, and
including oil-in-water emulsions of low- or high-fat content.
III. Aqueous, acid or nonacid products containing free oil or fat;
may contain salt, and including water-in-oil emulsions of low- or
high-fat content.
IV. Dairy products and modifications:
A. Water-in-oil emulsions, high- or low-fat.
B. Oil-in-water emulsions, high- or low-fat.
V. Low-moisture fats and oil.
VI. Beverages:
A. Containing up to 8 percent of alcohol.
B. Nonalcoholic.
C. Containing more than 8 percent alcohol.
VII. Bakery products other than those included under Types VIII or IX
of this table:
A. Moist bakery products with surface containing free fat or oil.
B. Moist bakery products with surface containing no free fat or oil.
VIII. Dry solids with the surface containing no free fat or oil (no
end test required).
IX. Dry solids with the surface containing free fat or oil.
(d) Analytical methods -- (1) Selection of extractability conditions.
First ascertain the type of food product (Table 1, paragraph (c) of
this section) that is being packed commercially in the paper or
paperboard and the normal conditions of thermal treatment used in
packaging the type of food involved. Using Table 2, paragraph (c) of
this section, select the food-simulating solvent or solvents and the
time-temperature exaggerations of the paper or paperboard use
conditions. Having selected the appropriate food-simulating solvent or
solvents and the time-temperature exaggeration over normal use, follow
the applicable extraction procedure.
(2) Reagents -- (i) Water. All water used in extraction procedures
should be freshly demineralized (deionized) distilled water.
(ii) n-Heptane. Reagent grade, freshly redistilled before use, using
only material boiling at 208 F.
(iii) Alcohol. 8 or 50 percent (by volume), prepared from
undenatured 95 percent ethyl alcohol diluted with demineralized
(deionized) distilled water.
(iv) Chloroform. Reagent grade, freshly redistilled before use, or a
grade having an established consistently low blank.
(3) Selection of test method. Paper or paperboard ready for use in
packaging shall be tested by use of the extraction cell described in
''Official Methods of Analysis of the Association of Official Analytical
Chemists,'' 13th Ed. (1980), sections 21.010-21.015, under ''Exposing
Flexible Barrier Materials for Extraction,'' 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); also described in ASTM method
F34-76 (Reapproved 1980), ''Standard Test Method for Liquid Extraction
of Flexible Barrier Materials,'' which is incorporated by reference
(copies may be obtained from the American Society for Testing Materials,
1916 Race St., Philadelphia, PA 19103, or may be examined at the Office
of the Federal Register, 1100 L St. NW., Washington, DC 20408), except
that formed paper and paperboard products may be tested in the container
by adapting the in-container methods described in 175.300(e) of this
chapter. Formed paper and paperboard products such as containers and
lids, that cannot be tested satisfactorily by any of the above methods
may be tested in specially designed extraction equipment, usually
consisting of clamping devices that fit the closure or container so that
the food-contact surface can be tested, or, if flat samples can be cut
from the formed paper or paperboard products without destroying the
integrity of the food-contact surface, they may be tested by adapting
the following ''sandwich'' method:
(i) Apparatus. (a) Thermostated ( 1.0 F) water bath, variable
between 70 F and 120 F water bath cover capable of holding at least
one 800-milliliter beaker partially submersed in bath.
(b) Analytical balance sensitive to 0.1 milligram with an approximate
capacity of 100 grams.
(c) Tongs.
(d) Hood and hot-plate facilities.
(e) Forced draft oven.
For each extraction, the following additional apparatus is necessary:
(f) One No. 2 paper clip.
(g) One 800-milliliter beaker with watch-glass cover.
(h) One 250-milliliter beaker.
(i) Five 2 1/2-inch-square aluminum screens (standard aluminum window
screening is acceptable).
(j) One wire capable of supporting sample stack.
(ii) Procedure. (a) For each extraction, accurately cut eight 2
1/2-inch-square samples from the formed paper or paperboard product to
be tested.
(b) Carefully stack the eight 2 1/2-inch-square samples and the five
2 1/2-inch-square aluminum screens in sandwich form such that the
food-contact side of each sample is always next to an aluminum screen,
as follows: Screen, sample, sample, screen, sample, sample, screen,
etc. Clip the sandwich together carefully with a No. 2 paper clip,
leaving just enough space at the top to slip a wire through.
(c) Place an 800-milliliter beaker containing 100-milliliters of the
appropriate food-simulating solvent into the constant temperature bath,
cover with a watch glass and condition at the desired temperature.
(d) After conditioning, carefully lower the sample sandwich with
tongs into the beaker.
(e) At the end of the extraction period, using the tongs, carefully
lift out the sample sandwich and hang it over the beaker with the wire.
(f) After draining, pour the food-simulating solvent solution into a
tared 250-milliliter beaker. Rinse the 800-milliliter beaker three
times, using a total of not more than 50 milliliters of the required
solvent.
(g) Determine total nonvolatile extractives in accordance with
paragraph (d)(5) of this section.
(4) Selection of samples. Quadruplicate samples should be tested,
using for each replicate sample the number of cups, containers, or
preformed or converted products nearest to an area of 100 square inches.
(5) Determination of amount of extractives -- (i) Total residues. At
the end of the exposure period, remove the test container or test cell
from the oven and combine the solvent for each replicate in a clean
Pyrex (or equivalent) flask or beaker being sure to rinse the test
container or cell with a small quantity of clean solvent. Evaporate the
food-simulating solvents to about 100 milliliters in the flask or
beaker, and transfer to a clean, tared evaporating dish (platinum or
Pyrex), washing the flask three times with small portions of solvent
used in the extraction procedure, and evaporate to a few milliliters on
a nonsparking, low-temperature hotplate. The last few milliliters
should be evaporated in an oven maintained at a temperature of
approximately 221 F. Cool the evaporating dish in a desiccator for 30
minutes and weigh the residue to the nearest 0.1 milligram, (e).
Calculate the extractives in milligrams per square inch of the container
or sheeted paper or paperboard surface.
(a) Water and 8- and 50-percent alcohol. Milligrams extractives per
square inch=(e)/(s).
(b) Heptane. Milligrams extractives per square inch=(e)/(s)(F)
Where:
e=Milligrams extractives per sample tested.
s=Surface area tested, in square inches.
F=Five, the ratio of the amount of extractives removed by heptane
under exaggerated time-temperature test conditions compared to the
amount extracted by a fat or oil under exaggerated conditions of thermal
sterilization and use.
e'=Chloroform-soluble extractives residue.
ee'=Corrected chloroform-soluble extractives residue.
e' or ee' is substituted for e in the above equations when necessary.
If when calculated by the equations in paragraph (d)(5)(i) (a) and
(b) of this section, the extractives in milligrams per square inch
exceeds the limitations prescribed in paragraph (c) of this section,
proceed to paragraph (d)(5)(ii) of this section (method for determining
the amount of chloroform-soluble extractives residues).
(ii) Chloroform-soluble extractives residue. Add 50 milliliters of
chloroform (freshly distilled reagent grade or a grade having an
established consistently low blank) to the dried and weighed residue,
(e), in the evaporating dish obtained in paragraph (d)(5)(i) of this
section. Warm carefully, and filter through Whatman No. 41 filter
paper (or equivalent) in a Pyrex (or equivalent) funnel, collecting the
filtrate in a clean, tared evaporating dish (platinum or Pyrex). Repeat
the chloroform extraction, washing the filter paper with this second
portion of chloroform. Add this filtrate to the original filtrate and
evaporate the total down to a few milliliters on a low-temperature
hotplate. The last few milliliters should be evaporated in an oven
maintained at approximately 221 F. Cool the evaporating dish in a
desiccator for 30 minutes and weigh to the nearest 0.1 milligram to get
the chloroform-soluble extractives residue (e'). This e' is substituted
for e in the equations in paragraph (d)(5)(i) (a) and (b) of this
section. If the chloroform-soluble extractives in milligrams per square
inch still exceeds the limitation prescribed in paragraph (c) of this
section, proceed to paragraph (d)(5)(iii) of this section (method for
determining corrected chloroform-soluble extractives residue).
(iii) Corrected chloroform-soluble extractives residue -- (a)
Correction for zinc extractives. Ash the residue in the evaporating
dish by heating gently over a Meker-type burner to destroy organic
matter and hold at red heat for about 1 minute. Cool in the air for 3
minutes, and place the evaporating dish in the desiccator for 30 minutes
and weigh to the nearest 0.1 milligram. Analyze this ash for zinc by
standard Association of Official Agricultural Chemists methods or
equivalent. Calculate the zinc in the ash as zinc oleate, and subtract
from the weight of chloroform-soluble extractives residue (e') to obtain
the zinc-corrected chloroform-soluble extractives residue (ee'). This
ee' is substituted for e in the equations in paragraph (d)(5)(i) (a) and
(b) of this section.
(b) Correction for wax, petrolatum, and mineral oil -- (1) Apparatus.
Standard 10 millimeter inside diameter x 60 centimeter chromatographic
column (or standard 50-milliliter buret with an inside diameter of 10-11
millimeters) with a stopcock of glass, perfluorocarbon resin, or
equivalent material. The column (or buret) may be optionally equipped
with an integral coarse, fritted glass disc and the top of the column
(or buret) may be optionally fitted with a 100-millimeter solvent
reservoir.
(2) Preparation of column. Place a snug pledget of fine glass wool
in the bottom of the column (or buret) if the column (or buret) is not
equipped with integral coarse, fritted glass disc. Overlay the glass
wool pledget (or fritted glass disc) with a 15-20 millimeter deep layer
of fine sand. Measure in a graduated cylinder 15 milliliters of
chromatographic grade aluminum oxide (80-200 mesh) that has been tightly
settled by tapping the cylinder. Transfer the aluminum oxide to the
chromatographic tube, tapping the tube during and after the transfer so
as to tightly settle the aluminum oxide. Overlay the layer of aluminum
oxide with a 1.0-1.5 centimeter deep layer of anhydrous sodium sulfate
and on top of this place an 8-10 millimeter thick plug of fine glass
wool. Next carefully add about 25 milliliters of heptane to the column
with stopcock open, and allow the heptane to pass through the column
until the top level of the liquid just passes into the top glass wool
plug in the column, and close stopcock.
(3) Chromatographing of sample extract -- (i) For chloroform residues
weighing 0.5 gram or less. To the dried and weighed chloroform-soluble
extract residue in the evaporating dish, obtained in paragraph
(d)(5)(ii) of this section, add 20 milliliters of heptane and stir. If
necessary, heat carefully to dissolve the residue. Additional heptane
not to exceed a total volume of 50 milliliters may be used if necessary
to complete dissolving. Cool to room temperature. (If solution becomes
cloudy, use the procedure in paragraph (d)(5)(iii)(b)(3)(ii) of this
section to obtain an aliquot of heptane solution calculated to contain
0.1-0.5 gram of chloroform-soluble extract residue.) Transfer the clear
liquid solution to the column (or buret). Rinse the dish with 10
millimeters of additional heptane and add to column. Allow the liquid
to pass through the column into a clean, tared evaporating dish
(platinum or Pyrex) at a dropwise rate of about 2 milliliters per minute
until the liquid surface reaches the top glass wool plug; then close
the stopcock temporarily. Rinse the Pyrex flask which contained the
filtrate with an additional 10-15 milliliters of heptane and add to the
column. Wash (elute) the column with more heptane collecting about 100
milliliters of total eluate including that already collected in the
evaporating dish. Evaporate the combined eluate in the evaporating dish
to dryness on a steam bath. Dry the residue for 15 minutes in an oven
maintained at a temperature of approximately 221 F. Cool the
evaporating dish in a desiccator for 30 minutes and weigh the residue to
the nearest 0.1 milligram. Subtract the weight of the residue from the
weight of chloroform-soluble extractives residue (e') to obtain the
wax-, petrolatum-, and mineral oil-corrected chloroform-soluble
extractives residue (ee'). This ee' is substituted for e in the
equations in paragraph (d)(5)(i) (a) and (b) of this section.
(ii) For chloroform residues weighing more than 0.5 gram. Redissolve
the dried and weighed chloroform-soluble extract residue as described in
paragraph (d)(5)(iii)(b)(3)(i) of this section using proportionately
larger quantities of heptane. Transfer the heptane solution to an
appropriate-sized volumetric flask (i.e., a 250-milliliter flask for
about 2.5 grams of residue) and adjust to volume with additional
heptane. Pipette out an aliquot (about 50 milliliters) calculated to
contain 0.1-0.5 gram of the chloroform-soluble extract residue and
analyze chromatographically as described in paragraph
(d)(5)(iii)(b)(3)(i) of this section. In this case the weight of the
dried residue from the heptane eluate must be multiplied by the dilution
factor to obtain the weight of wax, petrolatum, and mineral oil residue
to be subtracted from the weight of chloroform-soluble extractives
residue (e') to obtain the wax-, petrolatum-, and mineral oil-corrected
chloroform-soluble extractives residue (ee'). This ee' is substituted
for e in the equations in paragraph (d)(5)(i) (a) and (b) of this
section. (Note: In the case of chloroform-soluble extracts which
contain high melting waxes (melting point greater than 170 F), it may
be necessary to dilute the heptane solution further so that a
50-milliliter aliquot will contain only 0.1-0.2 gram of the
chloroform-soluble extract residue.)
(e) Acrylonitrile copolymers identified in this section shall comply
with the provisions of 180.22 of this chapter, except where the
copolymers are restricted to use in contact with food only of the type
identified in paragraph (c), Table 1 under Category VIII.
(42 FR 14554, Mar. 15, 1977)
Editorial Note: For Federal Register citations affecting 176.170,
see the List of CFR Sections Affected in the Finding Aids section of
this volume.
21 CFR 176.180 Components of paper and paperboard in contact with dry
food.
The substances listed in this section may be safely used as
components of the uncoated or coated food-contact surface of paper and
paperboard intended for use in producing, manufacturing, packing,
processing, preparing, treating, packaging, transporting, or holding dry
food of the type identified in 176.170(c), Table 1, under Type VIII,
subject to the provisions of this section.
(a) The substances are used in amounts not to exceed that required to
accomplish their intended physical or technical effect, and are so used
as to accomplish no effect in food other than that ordinarily
accomplished by packaging.
(b) The substances permitted to be used include the following:
(1) Substances that by 176.170 and other applicable regulations in
parts 170 through 189 of this chapter may be safely used as components
of the uncoated or coated food-contact surface of paper and paperboard,
subject to the provisions of such regulation.
(2) Substances identified in the following list:
(42 FR 14554, Mar. 15, 1977)
Editorial Note: For additional Federal Register citations affecting
176.180, see the List of CFR Sections Affected in the Finding Aids
section of this volume.
21 CFR 176.200 Defoaming agents used in coatings.
The defoaming agents described in this section may be safely used as
components of articles intended for use in producing, manufacturing,
packing, processing, preparing, treating, packaging, transporting, or
holding food, subject to the provisions of this section.
(a) The defoaming agents are prepared as mixtures of substances
described in paragraph (d) of this section.
(b) The quantity of any substance employed in the formulation of
defoaming agents does not exceed the amount reasonably required to
accomplish the intended physical or technical effect in the defoaming
agents or any limitation further provided.
(c) Any substance employed in the production of defoaming agents and
which is the subject of a regulation in parts 174, 175, 176, 177, 178
and 179.45 of this chapter conforms with any specification in such
regulation.
(d) Substances employed in the formulation of defoaming agents
include:
(1) Substances generally recognized as safe in food.
(2) Substances subject to prior sanction or approval for use in
defoaming agents and used in accordance with such sanction or approval.
(3) Substances identified in this paragraph (d)(3) and subject to
such limitations as are provided:
(e) The defoaming agents are used as follows:
(1) The quantity of defoaming agent or agents used shall not exceed
the amount reasonably required to accomplish the intended effect, which
is to prevent or control the formation of foam.
(2) The defoaming agents are used in the preparation and application
of coatings for paper and paperboard.
21 CFR 176.210 Defoaming agents used in the manufacture of paper and
paperboard.
Defoaming agents may be safely used in the manufacture of paper and
paperboard intended for use in packaging, transporting, or holding food
in accordance with the following prescribed conditions:
(a) The defoaming agents are prepared from one or more of the
substances named in paragraph (d) of this section, subject to any
prescribed limitations.
(b) The defoaming agents are used to prevent or control the formation
of foam during the manufacture of paper and paperboard prior to and
during the sheet-forming process.
(c) The quantity of defoaming agent or agents added during the
manufacturing process shall not exceed the amount necessary to
accomplish the intended technical effect.
(d) Substances permitted to be used in the formulation of defoaming
agents include substances subject to prior sanctions or approval for
such use and employed subject to the conditions of such sanctions or
approvals, substances generally recognized as safe for use in food,
substances generally recognized as safe for use in paper and paperboard,
and substances listed in this paragraph, subject to the limitations, if
any, prescribed.
(1) Fatty triglycerides, and the fatty acids, alcohols, and dimers
derived therefrom:
Beef tallow.
Castor oil.
Coconut oil.
Corn oil.
Cottonseed oil.
Fish oil.
Lard oil.
Linseed oil.
Mustardseed oil.
Palm oil.
Peanut oil.
Rapeseed oil.
Ricebran oil.
Soybean oil.
Sperm oil.
Tall oil.
(2) Fatty triglycerides, and marine oils, and the fatty acids and
alcohols derived therefrom (paragraph (d)(1) of this section) reacted
with one or more of the following, with or without dehydration, to form
chemicals of the category indicated in parentheses:
Aluminum hydroxide (soaps).
Ammonia (amides).
Butanol (esters).
Butoxy-polyoxypropylene, molecular weight 1,000-2,500 (esters).
Butylene glycol (esters).
Calcium hydroxide (soaps).
Diethanolamine (amides).
Diethylene glycol (esters).
Ethylene glycol (esters).
Ethylene oxide (esters and ethers).
Glycerin (mono- and diglycerides).
Hydrogen (hydrogenated compounds).
Hydrogen (amines).
Isobutanol (esters).
Isopropanol (esters).
Magnesium hydroxide (soaps).
Methanol (esters).
Morpholine (soaps).
Oxygen (air-blown oils).
Pentaerythritol (esters).
Polyoxyethylene, molecular weights 200, 300, 400, 600, 700, 1,000,
1,540, 1,580, 1,760, 4,600 (esters).
Polyoxypropylene, molecular weight 200-2,000 (esters).
Potassium hydroxide (soaps).
Propanol (esters).
Propylene glycol (esters).
Propylene oxide (esters).
Sodium hydroxide (soaps).
Sorbitol (esters).
Sulfuric acid (sulfated and sulfonated compounds).
Triethanolamine (amides and soaps).
Triisopropanolamine (amides and soaps).
Trimethylolethane (esters).
Zinc hydroxide (soaps).
(3) Miscellaneous:
Alcohols and ketone alcohols mixture (still-bottom product from
C12-C18 alcohol manufacturing process).
Amyl alcohol.
Butoxy polyethylene polypropylene glycol molecular weight 900-4,200.
Butoxy-polyoxypropylene molecular weight 1,000-2,500.
Butylated hydroxyanisole.
Butylated hydroxytoluene.
Calcium lignin sulfonate.
Capryl alcohol.
p-Chlorometacresol.
Cyclohexanol.
Diacetyltartaric acid ester of tallow mono-glyceride.
Diethanolamine.
Diethylene triamine.
Di-(2-ethylhexyl) phthalate.
2,6-Dimethyl heptanol-4 (nonyl alcohol).
Dimethylpolysiloxane.
Di-tert-butyl hydroquinone.
Dodecylbenzene sulfonic acids.
Ethanol.
2-Ethylhexanol.
Ethylenediamine tetraacetic acid tetrasodium salt.
Formaldehyde.
Heavy oxo-fraction (a still-bottom product of iso-octyl alcohol
manufacture, of approximate composition: Octyl alcohol 5 percent nonyl
alcohol 10 percent, decyl and higher alcohols 35 percent, esters 45
percent, and soaps 5 percent).
2-Heptadecenyl-4-methyl-4-hydroxymethyl-2-oxazoline.
Hexylene glycol (2-methyl-2-4-pentanediol).
12-Hydroxystearic acid.
Isobutanol.
Isopropanol.
Isopropylamine salt of dodecylbenzene suffonic acid.
Kerosine.
Lanolin.
Methanol.
Methyl 12-hydroxystearate.
Methyl taurine-oleic acid condensate, molecular weight 486.
o
a,a'-(Methylenebis(4-(1,1,3,3-tetramethymega-hydroxypoly (oxyethylene))
having 6-7.5 moles of ethylene oxide per hydroxyl group.
Mineral oil.
Mono-, di-, and triisopropanolamine.
Mono- and diisopropanolamine stearate.
Monobutyl ether of ethylene glycol.
Monoethanolamine.
Morpholine.
Myristyl alcohol.
Naphtha.
-Naphthol.
Nonylphenol.
Odorless light petroleum hydrocarbons.
Oleyl alcohol.
Petrolatum.
o-Phenylphenol.
Pine oil.
Polybutene, hydrogenated; complying with the identity prescribed
under 178.3740(b) of this chapter.
Polyethylene.
Polyethylene, oxidized (air-blown).
Polymer derived from N-vinyl pyrrolidone and copolymers derived from
the mixed alkyl (C12-C15, C16, C18, C20, and C22) methacrylate esters,
butyl methacrylate (CAS Reg. No. 97-88-1), isobutyl methacrylate (CAS
Reg. No. 97-86-9) and methyl methacrylate (CAS Reg. No. 80-62-6); the
combined polymer contains no more than 5 weight percent of polymer units
derived from N-vinyl pyrrolidone and is present at a level not to exceed
7 parts per million by weight of the finished dry paper and paperboard
fibers.
Polyoxyethylene (4 mols) decyl phosphate.
Polyoxyethylene (4 mols) di(2-ethyl hexanoate).
Polyoxyethylene (15 mols) ester of rosin.
Polyoxyethylene (3-15 mols) tridecyl alcohol.
Polyoxypropylene, molecular weight 200-2,000.
Polyoxypropylene-polyoxethylene condensate, minimum molecular weight
950.
Polyoxypropylene-ethylene oxide condensate of ethylene diamine,
molecular weight 1,700-3,800.
Polyvinyl pyrrolidone, molecular weight 40,000.
Potassium distearyl phosphate.
Potassium pentachlorophenate.
Potassium trichlorophenate.
Rosins and rosin derivatives identified in 175.105(c)(5) of this
chapter.
Silica.
Siloxanes and silicones, dimethyl, methylhydrogen, reaction products
with polyethylene-polypropylene glycol monoallyl ether (CAS Reg. No.
71965-38-3).
Sodium alkyl (C9-C15) benzene-sulfonate.
Sodium dioctyl sulfosuccinate.
Sodium distearyl phosphate.
Sodium lauryl sulfate.
Sodium lignin sulfonate.
Sodium 2-mercaptobenzothiazole.
Sodium naphthalenesulfonic acid (3 mols) condensed with formaldehyde
(2 mols).
Sodium orthophenylphenate.
Sodium pentachlorophenate.
Sodium petroleum sulfonate, molecular weight 440-450.
Sodium trichlorophenate.
Stearyl alcohol.
-(p-(1,1,3,3-Tetramethylbutyl) phenyl-, p-nonylphenyl-, or
p-dodecylphenyl)-omega-hydroxypoly(oxyethylene) produced by the
condensation of 1 mole of p-alkylphenol (alkyl group is
1,1,3,3-tetramethylbutyl, a propylene trimer isomer, or a propylene
tetramer isomer) with an average of 1.5-15 moles of ethylene oxide.
Tetrahydrofurfuryl alcohol.
Tributoxyethyl phosphate.
Tributyl phosphate.
Tridecyl alcohol.
Triethanolamine.
Triethylene glycol di(2-ethyl hexanoate).
Tri-(2-ethylhexyl) phosphate.
Tristearyl phosphate.
Wax, petroleum, Type I and Type II.
Wax, petroleum (oxidized).
Wax (montan).
(42 FR 14554, Mar. 15, 1977, as amended at 47 FR 17986, Apr. 27,
1982; 47 FR 46495, Oct. 19, 1982; 47 FR 56845, Dec. 21, 1982; 54 FR
24897, June 12, 1989)
21 CFR 176.230 3,5-Dimethyl-1,3,5,2H-tetrahydrothiadiazine-2-thione.
3,5-Dimethyl-1,3,5,2H-tetrahydrothi-adiazine-2-thione may safely be
used as a preservative in the manufacture and coating of paper and
paperboard intended for use in contact with food in accordance with the
following prescribed conditions:
(a) It is used as follows:
(1) In the manufacture of paper and paperboard as a preservative for
substances added to the pulp suspension prior to the sheet-forming
operation provided that the preservative is volatilized by heat in the
drying and finishing of the paper and paperboard.
(2) As a preservative for coatings for paper and paperboard,
Provided, That the preservative is volatilized by heat in the drying and
finishing of the coated paper or paperboard.
(b) The quantity used shall not exceed the least amount reasonably
required to accomplish the intended technical effect and shall not be
intended to nor, in fact, accomplish any physical or technical effect in
the food itself.
(c) The use of a preservative in any substance or article subject to
any regulation in parts 174, 175, 176, 177, 178 and 179.45 of this
chapter must comply with any specifications and limitations prescribed
by such regulation for the substance or article.
21 CFR 176.250 Poly-1,4,7,10,13-pentaaza-15-hydroxyhexadecane.
Poly-1,4,7,10,13-pentaaza-15-hydrox-yhexadecane may be safely used as
a retention aid employed prior to the sheet-forming operation in the
manufacture of paper and paperboard intended for use in contact with
food in an amount not to exceed that necessary to accomplish the
intended physical or technical effect and not to exceed 6 pounds per ton
of finished paper or paperboard.
21 CFR 176.260 Pulp from reclaimed fiber.
(a) Pulp from reclaimed fiber may be safely used as a component of
articles used in producing, manufacturing, packing, processing,
preparing, treating, packaging, transporting, or holding food, subject
to the provisions of paragraph (b) of this section.
(b) Pulp from reclaimed fiber is prepared from the paper and
paperboard products described in paragraphs (b) (1) and (2) of this
section, by repulping with water to recover the fiber with the least
possible amount of nonfibrous substances.
(1) Industrial waste from the manufacture of paper and paperboard
products excluding that which bears or contains any poisonous or
deleterious substance which is retained in the recovered pulp and that
migrates to the food, except as provided in regulations promulgated
under sections 406 and 409 of the Federal Food, Drug, and Cosmetic Act.
(2) Salvage from used paper and paperboard excluding that which (i)
bears or contains any poisonous or deleterious substance which is
retained in the recovered pulp and that migrates to the food, except as
provided in regulations promulgated under sections 406 and 409 of the
act or (ii) has been used for shipping or handling any such substance.
21 CFR 176.300 Slimicides.
(a) Slimicides may be safely used in the manufacture of paper and
paperboard that contact food, in accordance with the following
prescribed conditions:
(1) Slimicides are used as antimicrobial agents to control slime in
the manufacture of paper and paperboard.
(2) Subject to any prescribed limitations, slimicides are prepared
from one or more of the slime-control substances named in paragraph (c)
of this section to which may be added optional adjuvant substances as
provided for under paragraph (d) of this section.
(3) Slimicides are added to the process water used in the production
of paper or paperboard, and the quantity added shall not exceed the
amount necessary to accomplish the intended technical effect.
(b) To insure safe usage, the label or labeling of slimicides shall
bear adequate directions for use.
(c) Slime-control substances permitted for use in the preparation of
slimicides include substances subject to prior sanction or approval for
such use and the following:
(d) Adjuvant substances permitted to be used in the preparation of
slimicides include substances generally recognized as safe for use in
food, substances generally recognized as safe for use in paper and
paperboard, substances permitted to be used in paper and paperboard by
other regulations in this chapter, and the following:
Acetone.
Butlylene oxide.
Dibutyl phthalate.
Didecyl phthalate.
N,N-Dimethylformamide.
Dodecyl phthalate.
Ethanolamine.
Ethylene glycol.
Ethylenediamine.
N-methyl-2-pyrrolidone (CAS Reg. No. 872-50-4).
a,a'-(Methylenebis(4-(1,1,3,3-tetramethylbutyl)-o-phenylene))
bis(omega-hydroxypoly (oxyethylene)) having 6-7.5 moles of ethylene
oxide per hydroxyl group.
Monomethyl ethers of mono-, di-, and tripropylene glycol.
Nonylphenol reaction product with 9 to 12 molecules of ethylene
oxide.
Octylphenol reaction product with 25 molecules of propylene oxide and
40 molecules of ethylene oxide.
(42 FR 14554, Mar. 15, 1977, as amended at 42 FR 41854, Aug. 19,
1977; 44 FR 75627, Dec. 21, 1979; 46 FR 36129, July 14, 1981; 49 FR
5748, Feb. 15, 1984; 51 FR 19059, May 27, 1986; 51 FR 43734, Dec. 4,
1986; 54 FR 18103, Apr. 27, 1989; 55 FR 31825, Aug. 6, 1990)
21 CFR 176.320 Sodium nitrate-urea complex.
Sodium nitrate-urea complex may be safely used as a component of
articles intended for use in producing, manufacturing, packing,
processing, preparing, treating, packaging, transporting, or holding
food, subject to the provisions of this section.
(a) Sodium nitrate-urea complex is a clathrate of approximately two
parts urea and one part sodium nitrate.
(b) Sodium nitrate-urea complex conforming to the limitations
prescribed in paragraph (b)(1) of this section is used as provided in
paragraph (b)(2) of this section.
(1) Limitations. (i) It is used as a plasticizer in glassine and
greaseproof paper.
(ii) The amount used does not exceed that required to accomplish its
intended technical effect or exceed 15 percent by weight of the finished
paper.
(2) Conditions of use. The glassine and greaseproof papers are used
for packaging dry food or as the food-contact surface for dry food.
21 CFR 176.350 Tamarind seed kernel powder.
Tamarind seed kernel powder may be safely used as a component of
articles intended for use in producing, manufacturing, packing,
processing, preparing, treating, packaging, transporting, or holding
food, subject to the provisions of this section.
(a) Tamarind seed kernel powder is the ground kernel of tamarind seed
(Tamarindus indica L.) after removal of the seed coat.
(b) It is used in the manufacture of paper and paperboard.
21 CFR 176.350 Pt. 177
21 CFR 176.350 PART 177 -- INDIRECT FOOD ADDITIVES: POLYMERS
21 CFR 176.350 Subpart A -- (Reserved)
21 CFR 176.350 Subpart B -- Substances for Use as Basic Components of
Single and Repeated Use Food Contact Surfaces
Sec.
177.1010 Acrylic and modified acrylic plastics, semirigid and rigid.
177.1020 Acrylonitrile/butadiene/styrene co-polymer.
177.1030 Acrylonitrile/butadiene/styrene/methyl methacrylate
copolymer.
177.1040 Acrylonitrile/styrene copolymer.
177.1050 Acrylonitrile/styrene copolymer modified with
butadiene/styrene elastomer.
177.1060 n-Alkylglutarimide/acrylic copolymers.
177.1200 Cellophane.
177.1210 Closures with sealing gaskets for food containers.
177.1240 1,4-Cyclohexylene dimethylene terephthalate and
1,4-cyclohexylene dimethylene isophthalate copolymer.
177.1310 Ethylene-acrylic acid copolymers.
177.1315 Ethylene-1,4-cyclohexylene dimethylene terephthalate
copolymers.
177.1320 Ethylene-ethyl acrylate copolymers.
177.1330 Ionomeric resins.
177.1340 Ethylene-methyl acrylate copolymer resins.
177.1350 Ethylene-vinyl acetate copolymers.
177.1360 Ethylene-vinyl acetate-vinyl alcohol copolymers.
177.1380 Fluorocarbon resins.
177.1390 Laminate structures for use at temperatures of 250 F and
above.
177.1395 Laminate structures for use at temperatures between 120 F
and 250 F.
177.1400 Hydroxyethyl cellulose film, water-insoluble.
177.1420 Isobutylene polymers.
177.1430 Isobutylene-butene copolymers.
177.1440 4,4'-Isopropylidenediphenol-epichlorohydrin resins minimum
molecular weight 10,000.
177.1460 Melamine-formaldehyde resins in molded articles.
177.1480 Nitrile rubber modified acrylonitrile-methyl acrylate
copolymers.
177.1500 Nylon resins.
177.1520 Olefin polymers.
177.1550 Perfluorocarbon resins.
177.1555 Polyarylate resins.
177.1560 Polyarylsulfone resins.
177.1570 Poly-1-butene resins and butene/ethylene copolymers.
177.1580 Polycarbonate resins.
177.1585 Polyestercarbonate resins.
177.1590 Polyester elastomers.
177.1595 Polyetherimide resin.
177.1600 Polyethylene resins, carboxyl modified.
177.1610 Polyethylene, chlorinated.
177.1615 Polyethylene, fluorinated.
177.1620 Polyethylene, oxidized.
177.1630 Polyethylene phthalate polymers.
177.1632 Poly (phenyleneterephthalamide) resins.
177.1635 Poly(p-methylstyrene) and rubber-modified
poly(p-methylstyrene).
177.1640 Polystyrene and rubber-modified polystyrene.
177.1650 Polysulfide polymer-polyepoxy resins.
177.1655 Polysulfone resins.
177.1660 Poly (tetramethylene terephthalate).
177.1670 Polyvinyl alcohol film.
177.1680 Polyurethane resins.
177.1810 Styrene block polymers.
177.1820 Styrene-maleic anhydride copolymers.
177.1830 Styrene-methyl methacrylate copolymers.
177.1850 Textryls.
177.1900 Urea-formaldehyde resins in molded articles.
177.1950 Vinyl chloride-ethylene copolymers.
177.1960 Vinyl chloride-hexene-1 copolymers.
177.1970 Vinyl chloride-lauryl vinyl ether copolymers.
177.1980 Vinyl chloride-propylene copolymers.
177.1990 Vinylidene chloride/methyl acrylate copolymers.
177.2000 Vinylidene chloride/methyl acrylate/methyl methacrylate
polymers.
21 CFR 176.350 Subpart C -- Substances for Use Only as Components of
Articles Intended for Repeated Use
177.2210 Ethylene polymer, chlorosulfonated.
177.2250 Filters, microporous polymeric.
177.2260 Filters, resin-bonded.
177.2280 4,4'-Isopropylidenediphenol-epichlorohydrin thermosetting
epoxy resins.
177.2355 Mineral reinforced nylon resins.
177.2400 Perfluorocarbon cured elastomers.
177.2410 Phenolic resins in molded articles.
177.2420 Polyester resins, cross-linked.
177.2430 Polyether resins, chlorinated.
177.2440 Polyethersulfone resins.
177.2450 Polyamide-imide resins.
177.2460 Poly(2,6-dimethyl-1,4-phenylene) oxide resins.
177.2470 Polyoxymethylene copolymer.
177.2480 Polyoxymethylene homopolymer.
177.2490 Polyphenylene sulfide resins.
177.2510 Polyvinylidene fluoride resins.
177.2550 Reverse osmosis membranes.
177.2600 Rubber articles intended for repeated use.
177.2710 Styrene-divinylbenzene resins, cross-linked.
177.2800 Textiles and textile fibers.
177.2910 Ultra-filtration membranes.
Authority: Secs. 201, 402, 409, 706 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321, 342, 348, 376).
Source: 42 FR 14572, Mar. 15, 1977, unless otherwise noted.
21 CFR 176.350 Subpart A -- (Reserved)
21 CFR 176.350 Subpart B -- Substances for Use as Basic Components of Single and Repeated Use Food Contact Surfaces
21 CFR 177.1010 Acrylic and modified acrylic plastics, semirigid and
rigid.
Semirigid and rigid acrylic and modified acrylic plastics may be
safely used as articles intended for use in contact with food, in
accordance with the following prescribed conditions. The acrylic and
modified acrylic polymers or plastics described in this section also may
be safely used as components of articles intended for use in contact
with food.
(a) The optional substances that may be used in the formulation of
the semirigid and rigid acrylic and modified acrylic plastics, or in the
formulation of acrylic and modified acrylic components of articles,
include substances generally recognized as safe in food, substances used
in accordance with a prior sanction or approval, substances permitted
for use in such plastics by regulations in parts 170 through 189 of this
chapter, and substances identified in this paragraph. At least 50
weight-percent of the polymer content of the acrylic and modified
acrylic materials used as finished articles or as components of articles
shall consist of polymer units derived from one or more of the acrylic
or methacrylic monomers listed in paragraph (a)(1) of this section.
(1) Homopolymers and copolymers of the following monomers:
n-Butyl acrylate.
n-Butyl methacrylate.
Ethyl acrylate.
2-Ethylhexyl acrylate.
Ethyl methacrylate.
Methyl acrylate.
Methyl methacrylate.
(2) Copolymers produced by copolymerizing one or more of the monomers
listed in paragraph (a)(1) of this section with one or more of the
following monomers:
Acrylonitrile.
Methacrylonitrile.
-Methylstyrene.
Styrene.
Vinyl chloride.
Vinylidene chloride.
(3) Polymers identified in paragraphs (a)(1) and (2) of this section
containing no more than 5 weight-percent of total polymer units derived
by copolymerization with one or more of the monomers listed in paragraph
(a)(3)(i) and (ii) of this section. Monomers listed in paragraph
(a)(3)(ii) of this section are limited to use only in plastic articles
intended for repeated use in contact with food.
(i) List of minor monomers:
Acrylamide.
Acrylic acid
1,3-Butylene glycol dimethacrylate.
1,4-Butylene glycol dimethacrylate.
Diethylene glycol dimethacrylate.
Diproplylene glycol dimethacrylate.
Divinylbenzene.
Ethylene glycol dimethacrylate.
Itaconic acid.
Methacrylic acid.
N-Methylolacrylamide.
N-Methylolmethacrylamide.
4-Methyl-1,4-pentanediol dimethacrylate.
Propylene glycol dimethacrylate.
Trivinylbenzene.
(ii) List of minor monomers limited to use only in plastic articles
intended for repeated use in contact with food:
Allyl methacrylate (Chemical Abstracts Service Registry No. 96-05-9)
tert-Butyl acrylate.
tert-Butylaminoethyl methacrylate.
sec-Butyl methacrylate.
tert-Butyl methacrylate.
Cyclohexyl methacrylate.
Dimethylaminoethyl methacrylate.
2-Ethylhexyl methacrylate.
Hydroxyethyl methacrylate.
Hydroxyethyl vinyl sulfide.
Hydroxypropyl methacrylate.
Isobornyl methacrylate.
Isobutyl methacrylate.
Isopropyl acrylate.
Isopropyl methacrylate.
Methacrylamide.
Methacrylamidoethylene urea.
Methacryloxyacetamidoethylethylene urea.
Methacryloxyacetic acid.
n-Propyl methacrylate.
3,5,5-Trimethylcyclohexyl methacrylate.
(4) Polymers identified in paragraphs (a)(1), (2), and (3) of this
section are mixed together and/or with the following polymers, provided
that no chemical reactions, other than addition reactions, occur when
they are mixed:
Butadiene-acrylonitrile copolymers.
Butadiene-acrylonitrile-styrene copolymers.
Butadiene-acrylonitrile-styrene-methyl methacrylic copolymers.
Butadiene-styrene copolymers.
Butyl rubber.
Natural rubber.
Polybutadiene.
Poly (3-chloro-1,3-butadiene).
Polyester identified in 175.300(b)(3)(vii) of this chapter.
Polyvinyl chloride.
Vinyl chloride copolymers complying with 177.1980.
Vinyl chloride-vinyl acetate copolymers.
(5) Antioxidants and stabilizers identified in 175.300(b)(3)(xxx) of
this chapter and the following:
Di-tert-butyl-p-cresol.
2-Hydroxy-4-methoxybenzophenone.
2-Hydroxy-4-methoxy-2-carboxybenzophenone.
3-Hydroxyphenyl benzoate.
p-Methoxyphenol.
Methyl salicylate.
Octadecyl 3,5-di-tert-butyl-4-hydroxyhydrocinnamate (CAS Reg. No.
2082-79-3): For use only: (1) At levels not exceeding 0.2 percent by
weight in semirigid and rigid acrylic and modified acrylic plastics,
where the finished articles contact foods containing not more than 15
percent alcohol; and (2) at levels not exceeding 0.01 percent by weight
in semirigid and rigid acrylic and modified acrylic plastics intended
for repeated food-contact use where the finished article may be used for
foods containing more than 15 percent alcohol.
Phenyl salicylate.
(6) Release agents: Fatty acids derived from animal and vegetable
fats and oils, and fatty alcohols derived from such acids.
(7) Surface active agent: Sodium dodecylbenzenesulfonate.
(8) Miscellaneous materials:
Di(2-ethylhexyl) phthalate, for use only as a flow promoter at a
level not to exceed 3 weight-percent based on the monomers.
Dimethyl phthalate.
Oxalic acid, for use only as a polymerization catalyst aid.
Tetraethylenepentamine, for use only as a catalyst activator at a
level not to exceed 0.5 weight-percent based on the monomers.
Toluene.
Xylene.
(b) The semirigid and rigid acrylic and modified acrylic plastics, in
the finished form in which they are to contact food, when extracted with
the solvent or solvents characterizing the type of food and under the
conditions of time and temperature as determined from Tables 1 and 2 of
176.170(c) of this chapter, shall yield extractives not to exceed the
following, when tested by the methods prescribed in paragraph (c) of
this section. The acrylic and modified acrylic polymers or plastics
intended to be used as components of articles also shall yield
extractives not to exceed the following limitations when prepared as
strips as described in paragraph (c)(2) of this section:
(1) Total nonvolatile extractives not to exceed 0.3 milligram per
square inch of surface tested.
(2) Potassium permanganate oxidizable distilled water and 8 and 50
percent alcohol extractives not to exceed an absorbance of 0.15.
(3) Ultraviolet-absorbing distilled water and 8 and 50 percent
alcohol extractives not to exceed an absorbance of 0.30.
(4) Ultraviolet-absorbing n-heptane extractives not to exceed an
absorbance of 0.10.
(c) Analytical methods -- (1) Selection of extractability conditions.
These are to be chosen as provided in 176.170(c) of this chapter.
(2) Preparation of samples. Sufficient samples to allow duplicates
of all applicable tests shall be cut from the articles or formed from
the plastic composition under tests, as strips about 2.5 inches by about
0.85-inch wide by about 0.125-inch thick. The total exposed surface
should be 5 square inches 0.5-square inch. The samples, after
preparation, shall be washed with a clean brush under hot tapwater,
rinsed under running hot tapwater (140 F minimum), rinsed with
distilled water, and air-dried in a dust-free area or in a desiccator.
(3) Preparation of solvents. The water used shall be
double-distilled water, prepared in a still using a block tin condenser.
The 8 and 50 percent (by volume) alcohol solvents shall be prepared
from ethyl alcohol meeting the specifications of the United States
Pharmacopeia XX and diluted with double-distilled water that has been
prepared in a still using a tin block condenser. The n-heptane shall be
spectrophotometric grade. Adequate precautions must be taken to keep
all solvents dust-free.
(4) Blank values on solvents. (i) Duplicate determinations of
residual solids shall be run on samples of each solvent that have been
exposed to the temperature-time conditions of the extraction test
without the plastic sample. Sixty milliliters of exposed solvent is
pipetted into a clean, weighed platinum dish, evaporated to 2-5
milliliters on a nonsparking, low-temperature hot plate and dried in 212
F oven for 30 minutes. The residue for each solvent shall be
determined by weight and the average residue weight used as the blank
value in the total solids determination set out in paragraph (c)(6) of
this section. The residue for an acceptable solvent sample shall not
exceed 0.5 milligram per 60 milliliters.
(ii) For acceptability in the ultraviolet absorbers test, a sample of
each solvent shall be scanned in an ultraviolet spectrophotometer in
5-centimeter silica spectrophotometric absorption cells. The absorbance
of the distilled water when measured versus air in the reference cell
shall not exceed 0.03 at any point in the wavelength region of 245 to
310 m . The absorbance of the 8 percent alcohol when measured versus
distilled water in the reference cell shall not exceed 0.01 at any point
in the wavelength region of 245 to 310 m . The absorbance of the 50
percent alcohol when measured versus distilled water in the reference
cell shall not exceed 0.05 at any point in the wavelength region of 245
to 310 m . The absorbance of the heptane when measured versus distilled
water in the reference cell shall not exceed 0.15 at 245, 0.09 at 260,
0.04 at 270, and 0.02 at any point in the wavelength region of 280 to
310 m .
(iii) Duplicate ultraviolet blank determinations shall be run on
samples of each solvent that has been exposed to the temperature-time
conditions of the extraction test without the plastic sample. An
aliquot of the exposed solvent shall be measured versus the unexposed
solvent in the reference cell. The average difference in the
absorbances at any wavelength in the region of 245 to 310 m shall be
used as a blank correction for the ultraviolet absorbers measured at the
same wavelength according to paragraph (c)(8)(ii) of this section.
(iv) The acceptability of the solvents for use in the permanganate
test shall be determined by preparing duplicate permanganate test blanks
according to paragraph (c)(7)(iv) of this section. For this test, the
directions referring to the sample extract shall be disregarded. The
blanks shall be scanned in 5-centimeter silica spectrophotometric cells
in the spectrophotometer versus the appropriate solvent as reference.
The absorbance in distilled water in the wavelength region of 544 to 552
m should be 1.16 but must not be less than 1.05 nor more than 1.25. The
absorbance in the 8 and 50 percent alcohol must not be less than 0.85
nor more than 1.15.
(v) Duplicate permanganate test determinations shall be run on
samples of distilled water and 8 and 50 percent alcohol solvents that
have been exposed to the temperature-time conditions of the extraction
test without the plastic sample. The procedure shall be as described in
paragraph (c)(7)(iv) of this section, except that the appropriate
exposed solvent shall be substituted where the directions call for
sample extract. The average difference in the absorbances in the region
of 544 to 552 m shall be used as a blank correction for the
determination of permanganate oxidizable extractives according to
paragraph (c)(7)(iv) of this section.
(5) Extraction procedure. For each extraction, place a plastic
sample in a clean 25 millimeters 200 millimeters hard-glass test tube
and add solvent equal to 10 milliliters of solvent per square inch of
plastic surface. This amount will be between 45 milliliters and 55
milliliters. The solvent must be preequilibrated to the temperature of
the extraction test. Close the test tube with a ground-glass stopper
and expose to the specified temperature for the specified time. Cool
the tube and contents to room temperature if necessary.
(6) Determination of total nonvolatile extractives. Remove the
plastic strip from the solvent with a pair of clean forceps and wash the
strip with 5 milliliters of the appropriate solvent, adding the washings
to the contents of the test tube. Pour the contents of the test tube
into a clean, weighed platinum dish. Wash the tube with 5 milliliters
of the appropriate solvent and add the solvent to the platinum dish.
Evaporate the solvent to 2-5 milliliters on a nonsparking,
low-temperature hotplate. Complete the evaporation in a 212 F oven for
30 minutes. Cool the dish in a desiccator for 30 minutes and weigh to
the nearest 0.1 milligram. Calculate the total nonvolatile extractives
as follows:
Milligrams extractives per square inch=
Extractives in parts per million=
where:
e=Total increase in weight of the dish, in milligrams.
b=Blank value of the solvent in milligrams, as determined in
paragraph (c)(4)(i) of this section.
s=Total surface of the plastic sample in square inches.
(7) Determination of potassium permanganate oxidizable extractives.
(i) Pipette 25 milliliters of distilled water into a clean
125-milliliter Erlenmeyer flask that has been rinsed several times with
aliquots of distilled water. This is the blank. Prepare a distilled
water solution containing 1.0 part per million of p-methoxyphenol
(melting point 54-56 C, Eastman grade or equivalent). Pipette 25
milliliters of this p-methoxyphenol solution into a rinsed Erlenmeyer
flask. Pipette exactly 3.0 milliliters of 154 parts per million aqueous
potassium permanganate solution into the p-methoxyphenol and exactly 3.0
milliliters into the blank, in that order. Swirl both flasks to mix the
contents and then transfer aliquots from each flask into matched
5-centimeter spectrophotometric absorption cells. The cells are placed
in the spectrophotometer cell compartment with the p-methoxyphenol
solution in the reference beam. Spectrophotometric measurement is
conducted as in paragraph (c)(7)(iv) of this section. The absorbance
reading in the region 544-552 m should be 0.24 but must be not less
than 0.12 nor more than 0.36. This test shall be run in duplicate. For
the purpose of ascertaining compliance with the limitations in paragraph
(b)(2) of this section, the absorbance measurements obtained on the
distilled water extracts according to paragraph (c)(7)(iv) of this
section shall be multiplied by a correction factor, calculated as
follows:
=Correction factor for water extracts.
(ii) The procedure in paragraph (c)(7)(i) of this section is repeated
except that, in this instance, the solvent shall be 8 percent alcohol.
The absorbance in the region 544-552 m should be 0.26 but must be not
less than 0.13 nor more than 0.39. This test shall be run in duplicate.
For the purpose of ascertaining compliance with the limitations
prescribed in paragraph (b)(2) of this section, the absorbance
measurements obtained on the 8 percent alcohol extracts according to
paragraph (c)(7)(iv) of this section shall be multiplied by a correction
factor, calculated as follows:
=Correction factor for aqueous 8 percent alcohol extracts.
(iii) The procedure in paragraph (c)(7)(i) of this section is
repeated except that, in this instance, the solvent shall be 50 percent
alcohol. The absorbance in the region 544-552 m should be 0.25 but
must be not less than 0.12 nor more than 0.38. This test shall be run in
duplicate. For the purpose of ascertaining compliance with the
limitations prescribed in paragraph (b)(2) of this section, the
absorbance measurements obtained on the 50 percent alcohol extracts
according to paragraph (c)(7)(iv) of this section shall be multiplied by
a correction factor, calculated as follows:
=Correction factor for 50 percent aqueous alcohol extracts.
(iv) Water and 8 and 50 percent alcohol extracts. Pipette 25
milliliters of the appropriate solvent into a clean, 125-milliliter
Erlenmeyer flask that has been rinsed several times with aliquots of the
same solvent. This is the blank. Into another similarly rinsed flask,
pipette 25 milliliters of the sample extract that has been exposed under
the conditions specified in paragraph (c)(5) of this section. Pipette
exactly 3.0 milliliters of 154 parts per million aqueous potassium
permanganate solution into the sample and exactly 3.0 milliliters into
the blank, in that order. Before use, the potassium permanganate
solution shall be checked as in paragraph (c)(7)(i) of this section.
Both flasks are swirled to mix the contents, and then aliquots from each
flask are transferred to matched 5-centimeter spectrophotometric
absorption cells. Both cells are placed in the spectrophotometer cell
compartment with the sample solution in the reference beam. The
spectrophotometer is adjusted for 0 and 100 percent transmittance at 700
m . The spectrum is scanned on the absorbance scale from 700 m to 500
m in such a way that the region 544 m to 552 m is scanned within 5
minutes to 10 minutes of the time that permanganate was added to the
solutions. The height of the absorbance peak shall be measured,
corrected for the blank as determined in paragraph (c)(4)(v) of this
section, and multiplied by the appropriate correction factor determined
according to paragraph (c)(7) (i), (ii), and (iii) of this section.
This test shall be run in duplicate and the two results averaged.
(8) Determination of ultraviolet-absorbing extractives. (i) A
distilled water solution containing 1.0 part per million of
p-methoxyphenol (melting point 54 C-56 C. Eastman grade or equivalent)
shall be scanned in the region 360 to 220 m in 5-centimeter silica
spectrophotometric absorption cells versus a distilled water reference.
The absorbance at the wavelength of maximum absorbance (should be about
285 m ) is about 0.11 but must be not less than 0.08 nor more than 0.14.
This test shall be run in duplicate. For the purpose of ascertaining
compliance with the limitations prescribed in paragraph (b) (3) and (4)
of this section, the absorbance obtained on the extracts according to
paragraph (c)(8)(ii) of this section shall be multiplied by a correction
factor, calculated as follows:
=Correction factor for ultraviolet absorbers test.
(ii) An aliquot of the extract that has been exposed under the
conditions specified in paragraph (c)(5) of this section is scanned in
the wavelength region 360 to 220 m versus the appropriate solvent
reference in matched 5-centimeter silica spectrophotometric absorption
cells. The height of any absorption peak shall be measured, corrected
for the blank as determined in paragraph (c)(4)(iii) of this section,
and multiplied by the correction factor determined according to
paragraph (c)(8)(i) of this section.
(d) In accordance with current good manufacturing practice, finished
semirigid and rigid acrylic and modified acrylic plastics, and articles
containing these polymers, intended for repeated use in contact with
food shall be thoroughly cleansed prior to their first use in contact
with food.
(e) Acrylonitrile copolymers identified in this section shall comply
with the provisions of 180.22 of this chapter.
(f) The acrylic and modified acrylic polymers identified in and
complying with this section, when used as components of the food-contact
surface of an article that is the subject of a regulation in this part
and in parts 174, 175, 176, and 178 of this chapter, shall comply with
any specifications and limitations prescribed by such regulation for the
article in the finished form in which it is to contact food.
(42 FR 14572, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977, as amended
at 43 FR 54927, Nov. 24, 1978; 45 FR 67320, Oct. 10, 1980; 46 FR
46796, Sept. 22, 1981; 49 FR 10108, Mar. 19, 1984; 49 FR 13139, Apr.
3, 1984; 50 FR 31045, July 24, 1985)
21 CFR 177.1020 Acrylonitrile/butadiene/styrene co-polymer.
Acrylonitrile/butadiene/styrene copolymer identified in this section
may be safely used as an article or component of articles intended for
use with all foods, except those containing alcohol, under conditions of
use E, F, and G described in Table 2 of 176.170(c) of this chapter.
(a) Identity. For the purpose of this section, the
acrylonitrile/butadiene/styrene copolymer consists of:
(1) Eighty-four to eighty-nine parts by weight of a matrix polymer
containing 73 to 78 parts by weight of acrylonitrile and 22 to 27 parts
by weight of styrene; and
(2) Eleven to sixteen parts by weight of a grafted rubber consisting
of (i) 8 to 13 parts of butadiene/styrene elastomer containing 72 to 77
parts by weight of butadiene and 23 to 28 parts by weight of styrene and
(ii) 3 to 8 parts by weight of a graft polymer having the same
composition range as the matrix polymer.
(b) Adjuvants. The copolymer identified in paragraph (a) of this
section may contain adjuvant substances required in its production.
Such adjuvants may include substances generally recognized as safe in
food, substances used in accordance with prior sanction, substances
permitted in this part, and the following:
(c) Specifications. (1) Nitrogen content of the copolymer is in the
range of 16 to 18.5 percent as determined by Micro-Kjeldahl analysis.
(2) Residual acrylonitrile monomer content of the finished copolymer
articles is not more than 11 parts per million as determined by a gas
chromatographic method titled ''Determination of Residual Acrylonitrile
and Styrene Monomers-Gas Chromatographic Internal Standard Method,''
which is incorporated by reference. Copies are available from the
Division of Food and Color Additives, Center for Food Safety and Applied
Nutrition (HFF-330), 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.
(d) Extractive limitations. (1) Total nonvolatile extractives not to
exceed 0.0005 milligram per square inch surface area when the finished
food contact article is exposed to distilled water, 3 percent acetic
acid, or n-heptane for 8 days at 120 F.
(2) The finished food-contact article shall yield not more than
0.0015 milligram per square inch of acrylonitrile monomer when exposed
to distilled water and 3 percent acetic acid at 150 F for 15 days when
analyzed by a polarographic method titled ''Extracted Acrylonitrile by
Differential Pulse Polarography,'' which is incorporated by reference.
Copies are available from the Division of Food and Color Additives,
Center for Food Safety and Applied Nutrition (HFF-330), 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.
(e) Acrylonitrile copolymers identified in this section shall comply
with the provisions of 180.22 of this chapter.
(f) Acrylonitrile copolymers identified in this section are not
authorized to be used to fabricate beverage containers.
(42 FR 14572, Mar. 15, 1977, as amended at 42 FR 48543, Sept. 23,
1977; 47 FR 11841, Mar. 19, 1982; 54 FR 24897, June 12, 1989)
21 CFR 177.1030 Acrylonitrile/butadiene/styrene/methyl methacrylate
copolymer.
Acrylonitrile/butadiene/styrene/methyl methacrylate copolymer
identified in this section may be safely used as an article or component
of articles intended for use with food identified in Table 1 of
176.170(c) of this chapter as Type I, II, III, IVA, IVB, V, VIB, (except
bottles intended to hold carbonated beverages), VIIA, VIIB, VIII and IX,
under conditions of use C, D, E, F, and G described in Table 2 of
176.170(c) of this chapter with a high temperature limitation of 190 F.
(a) Identity. For the purpose of this section,
acrylonitrile/butadiene/styrene/methyl methacrylate copolymer consists
of: (1) 73 to 79 parts by weight of a matrix polymer containing 64 to
69 parts by weight of acrylonitrile, 25 to 30 parts by weight of styrene
and 4 to 6 parts by weight of methyl methacrylate; and (2) 21 to 27
parts by weight of a grafted rubber consisting of (i) 16 to 20 parts of
butadiene/styrene/elastomer containing 72 to 77 parts by weight of
butadiene and 23 to 28 parts by weight of styrene and (ii) 5 to 10 parts
by weight of a graft polymer having the same composition range as the
matrix polymer.
(b) Adjuvants. The copolymer identified in paragraph (a) of this
section may contain adjuvant substances required in its production.
Such adjuvants may include substances generally recognized as safe in
food, substances used in accordance with prior sanction, substances
permitted under applicable regulations in this part, and the following:
(c) Specifications. (1) Nitrogen content of the copolymer is in the
range of 13.0 to 16.0 percent as determined by Micro-Kjeldahl analysis.
(2) Residual acrylonitrile monomer content of the finished copolymer
articles is not more than 11 parts per million as determined by a gas
chromatographic method titled ''Determination of Residual Acrylonitrile
and Styrene Monomers-Gas Chromatographic Internal Standard Method,''
which is incorporated by reference. Copies are available from the
Division of Food and Color Additives, Center for Food Safety and Applied
Nutrition (HFF-330), 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.
(d) Extractive limitations. (1) Total nonvolatile extractives not to
exceed 0.0005 milligram per square inch surface area of the food-contact
article when exposed to distilled water, 3 percent acetic acid, 50
percent ethanol, and n-heptane for 10 days at 120 F.
(2) The finished food-contact article shall yield not more than
0.0025 milligram per square inch of acrylonitrile monomer when exposed
to distilled water, 3 percent acetic acid and n-heptane at 190 F for 2
hours, cooled to 120 F (80 to 90 minutes) and maintained at 120 F for
10 days when analyzed by a polarographic method titled ''Extracted
Acrylonitrile by Differential Pulse Polarography,'' which is
incorporated by reference. Copies are available from the Division of
Food and Color Additives, Center for Food Safety and Applied Nutrition
(HFF-330), 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.
(e) Acrylonitrile copolymers identified in this section shall comply
with the provisions of 180.22 of this chapter.
(f) Acrylonitrile copolymers identified in this section are not
authorized to be used to fabricate beverage containers.
(42 FR 14572, Mar. 15, 1977, as amended at 42 FR 48543, Sept. 23,
1977; 47 FR 11841, Mar. 19, 1982; 54 FR 24898, June 12, 1989)
21 CFR 177.1040 Acrylonitrile/styrene copoly-mer.
Acrylonitrile/styrene copolymers identified in this section may be
safely used as a component of packaging materials subject to the
provisions of this section.
(a) Identity. For the purposes of this section acrylonitrile/styrene
copoly-mers are basic copolymers meeting the specifications prescribed
in paragraph (c) of this section.
(b) Adjuvants. (1) The copolymers identified in paragraph (c) of
this section may contain adjuvant substances required in their
production, with the exception that they shall not contain mercaptans or
other substances which form reversible complexes with acryl-onitrile
monomer. Permissible adjuvants may include substances generally
recognized as safe in food, substances used in accordance with prior
sanction, substances permitted under applicable regulations in this
part, and those authorized in paragraph (b)(2) of this section.
(2) The optional adjuvants for the acrylonitrile/styrene copolymer
identified in paragraphs (c) (1) and (3) of this section are as follows:
(c) Specifications.
(d) Interim listing. Acrylonitrile copolymers identified in this
section shall comply with the provisions of 180.22 of this chapter.
(e) Acrylonitrile copolymer identified in this section may be used to
fabricate beverage containers only if they comply with the
specifications of item 3 in paragraph (c) of this section.
(42 FR 14572, Mar. 15, 1977, as amended at 42 FR 48543, Sept. 23,
1977; 47 FR 11841, Mar. 19, 1982; 49 FR 36643, Sept. 19, 1984; 52 FR
33803, Sept. 8, 1987)
21 CFR 177.1050 Acrylonitrile/styrene copoly-mer modified with
butadiene/styrene elastomer.
Acrylonitrile/styrene copolymer modified with butadiene/styrene
elastomer identified in this section may be safely used as a component
of bottles intended for use with foods identified in Table I of
176.170(c) of this chapter as Type VI-B under conditions for use E, F,
or G described in Table 2 of 176.170(c) of this chapter.
(a) Identity. For the purpose of this section, acrylonitrile/styrene
copoly- mer modified with butadiene/styrene elastomer consists of a
blend of:
(1) 82-88 parts by weight of a matrix copolymer produced by
polymerization of 77-82 parts by weight of acrylonitrile and 18-23 parts
of styrene; and
(2) 12-18 parts by weight of a grafted rubber consisting of (i) 8-12
parts of butadiene/styrene elastomer containing 77-82 parts by weight of
butadiene and 18-23 parts by weight of styrene and (ii) 4-6 parts by
weight of a graft copolymer consisting of 70-77 parts by weight of
acrylonitrile and 23-30 parts by weight of styrene.
(b) Adjuvants. The modified copoly-mer identified in paragraph (a)
of this section may contain adjuvant substances required in its
production. Such adjuvants may include substances generally recognized
as safe in food, substances used in accordance with prior sanction,
substances permitted under applicable regulations in this part, and the
following:
(c) Specifications. (1) Nitrogen content of the modified copolymer
is in the range of 17.7-19.8 percent.
(2) Intrinsic viscosity of the matrix copolymer in butyrolactone is
not less than 0.5 deciliter/gram at 35 C, as determined by the method
titled ''Molecular Weight of Matrix Copolymer by Solution Viscosity,''
which is incorporated by reference. Copies are available from the
Division of Food and Color Additives, Center for Food Safety and Applied
Nutrition (HFF-330), 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.
(3) Residual acrylonitrile monomer content of the modified copolymer
articles is not more than 11 ppm as determined by a gas chromatographic
method titled ''Determination of Residual Acrylonitrile and Styrene
Monomers-Gas Chromatographic Internal Standard Method,'' which is
incorporated by reference. Copies are available from the Division of
Food and Color Additives, Center for Food Safety and Applied Nutrition
(HFF-330), 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.
(d) Extractives limitations. The following extractives limitations
are determined by an infrared spectrophotometric method titled
''Infrared Spectrophotometric Determination of Polymer Extracted from
Borex# 210 Resin Pellets,'' which is incorporated by reference. Copies
are available from the Division of Food and Color Additives, Center for
Food Safety and Applied Nutrition (HFF-330), 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, and are applicable to the modified copolymers in
the form of particles of a size that will pass through a U.S. Standard
Sieve No. 6 and that will be held on a U.S. Standard Sieve No. 10:
(1) The extracted copolymer shall not exceed 2.0 ppm in aqueous
extract obtained when a 100-gram sample of copolymer is extracted with
250 milliliters of freshly distilled water at reflux temperature for 2
hours.
(2) The extracted copolymer shall not exceed 0.5 ppm in n-heptane
when a 100-gram sample of the basic copol-ymer is extracted with 250
milliliters spectral grade n-heptane at reflux temperature for 2 hours.
(e) Accelerated extraction end test. The modified copolymer shall
yield acrylonitrile monomer not in excess of 0.4 ppm when tested as
follows:
(1) The modified copolymer shall be in the form of eight strips 1/2
inch by 4 inches by .03 inch.
(2) The modified copolymer strips shall be immersed in 225
milliliters of 3 percent acetic acid in a Pyrex glass pressure bottle.
(3) The pyrex glass pressure bottle is then sealed and heated to 150
F in either a circulating air oven or a thermostat controlled bath for a
period of 8 days.
(4) The Pyrex glass pressure bottle is then removed from the oven or
bath and cooled to room temperature. A sample of the extracting solvent
is then withdrawn and analyzed for acrylonitrile monomer by a gas
chromatographic method titled ''Gas-Solid Chromatographic Procedure for
Determining Acrylonitrile Monomer in Acrylonitrile-Containing Polymers
and Food Simulating Solvents,'' which is incorporated by reference.
Copies, are available from the Division of Food and Color Additives,
Center for Food Safety and Applied Nutrition (HFF-330), 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.
(f) Acrylonitrile copolymers identified in this section shall comply
with the provisions of 180.22 of this chapter.
(g) Acrylonitrile copolymers identified in this section are not
authorized to be used to fabricate beverage containers.
(42 FR 14572, Mar. 15, 1977, as amended at 42 FR 48544, Sept. 23,
1977; 47 FR 11841, Mar. 19, 1982; 47 FR 16775, Apr. 20, 1982; 54 FR
24898, June 12, 1989)
21 CFR 177.1060 n-Alkylglutarimide/acrylic copolymers.
n-Alkylglutarimide/acrylic copolymers identified in this section may
be safely used as articles or components of articles intended for use in
contact with food subject to provisions of this section and part 174 of
this chapter.
(a) Identity. For the purpose of this section,
n-alkylglutarimide/acrylic copolymers are copolymers obtained by
reaction of substances permitted by 177.1010(a) (1), (2), and (3) with
the following substance: Monomethylamine (CAS Reg. No. 74-89-5), to
form n-methylglutarimide/acrylic copolymers.
(b) Adjuvants. The copolymers identified in paragraph (a) of this
section may contain adjuvant substances required in their production.
The optional adjuvant substances required in the production of the basic
polymer may include substances permitted for such use by applicable
regulations, as set forth in part 174 of this chapter.
(c) Specifications. Maximum nitrogen content of the copolymer
determined by micro-Kjeldahl analysis, shall not exceed 8 percent.
(d) Limitations. (1) The n-alkylglutarimide/acrylic copolymers in
the finished form in which they shall contact food, when extracted with
the solvent or solvents characterizing the type of food and under the
conditions of time and temperature described in Tables 1 and 2 of
176.170(c) of this chapter, shall yield extractives not to exceed the
limitations of 177.1010(b) of this chapter, when prepared as strips, as
described in 177.1010(c)(2) of this chapter.
(2) The n-alkylglutarimide/acrylic copolymers shall not be used as
polymer modifiers in vinyl chloride homo- or copolymers.
(e) Conditions of use. The n-alkylglutarimide/acrylic copolymers are
used as articles or components of articles (other than articles composed
of vinyl chloride homo- or copolymers) intended for use in contact with
all foods except beverages containing more than 8 percent alcohol under
conditions of use D, E, F, and G as described in Table 1 of 176.170(c)
of this chapter.
(54 FR 20382, May 11, 1989)
21 CFR 177.1200 Cellophane.
Cellophane may be safely used for packaging food in accordance with
the following prescribed conditions:
(a) Cellophane consists of a base sheet made from regenerated
cellulose to which have been added certain optional substances of a
grade of purity suitable for use in food packaging as constituents of
the base sheet or as coatings applied to impart desired technological
properties.
(b) Subject to any limitations prescribed in this part, the optional
substances used in the base sheet and coating may include:
(1) Substances generally recognized as safe in food.
(2) Substances for which prior approval or sanctions permit their use
in cellophane, under conditions specified in such sanctions and
substances listed in 181.22 of this chapter.
(3) Substances that by any regulation promulgated under section 409
of the act may be safely used as components of cellophane.
(4) Substances named in this section and further identified as
required.
(c) List of substances:
(d) Any optional component listed in this section covered by a
specific food additive regulation must meet any specifications in that
regulation.
(e) Acrylonitrile copolymers identified in this section shall comply
with the provisions of 180.22 of this chapter.
(42 FR 14572, Mar. 15, 1977, as amended at 47 FR 11842, Mar. 19,
1982)
21 CFR 177.1210 Closures with sealing gaskets for food containers.
Closures with sealing gaskets may be safely used on containers
intended for use in producing, manufacturing, packing, processing,
preparing, treating, packaging, transporting, or holding food in
accordance with the following prescribed conditions:
(a) Closures for food containers are manufactured from substances
generally recognized as safe for contact with food; substances that are
subject to the provisions of prior sanctions; substances authorized by
regulations in parts 174, 175, 176, 177, 178 and 179.45 of this
chapter; and closure-sealing gaskets, as further prescribed in this
section.
(b) Closure-sealing gaskets and overall discs are formulated from
substances identified in 175.300(b) of this chapter, with the exception
of paragraph (b)(3) (v), (xxxi), and (xxxii) of that section, and from
other optional substances, including the following:
(1) Substances generally recognized as safe in food.
(2) Substances used in accordance with the provisions of a prior
sanction or approval within the meaning of section 201(s) of the act.
(3) Substances that are the subject of regulations in parts 174, 175,
176, 177, 178 and 179.45 of this chapter and used in accordance with
the conditions prescribed.
(4) Substances identified in paragraph (b)(5) of this section, used
in amounts not to exceed those required to accomplish the intended
physical or technical effect and in conformance with any limitation
provided; and further provided that any substance employed in the
production of closure-sealing gasket compositions that is the subject of
a regulation in parts 174, 175, 176, 177, 178 and 179.45 of this
chapter conforms with the identity or specifications prescribed.
(5) Substances that may be employed in the manufacture of
closure-sealing gaskets include:
(c) The closure assembly to include the sealing gasket or sealing
compound, together with any polymeric or resinous coating, film, foil,
natural cork, or glass that forms a part of the food-contact surface of
the assembly, when extracted on a suitable glass container with a
solvent or solvents characterizing the type of foods, and under
conditions of time and temperature characterizing the conditions of its
use as determined from Tables 3 and 4 shall yield net chloroform-soluble
extractives (corrected for zinc as zinc oleate) not to exceed the
tolerances specified in Table 2, calculated on the basis of the water
capacity of the container on which the closure is to be used. Employ
the analytical method described in 175.300 of this chapter, adapting
the procedural details to make the method applicable to closures; such
as, for example, placing the closed glass container on its side to
assure contact of the closure's food-contacting surface with the
solvent.
(42 FR 14572, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977, as amended
at 47 FR 22090, May 21, 1982; 49 FR 5748, Feb. 15, 1984; 55 FR 34555,
Aug. 23, 1990)
21 CFR 177.1240 1,4-Cyclohexylene dimethylene terephthalate and
1,4-cyclohexylene dimethylene isophthalate copolymer.
Copolymer of 1,4-cyclohexylene dimethylene terephthalate and
1,4-cyclohexylene dimethylene isophthalate may be safely used as an
article or component of articles used in producing, manufacturing,
packing, processing, preparing, treating, packaging, transporting, or
holding food, subject to the provisions of this section:
(a) The copolymer is a basic polyester produced by the catalytic
condensation of dimethyl terephthalate and dimethyl isophthalate with
1,4-cyclohexanedimethanol, to which may have been added certain optional
substances required in its production or added to impart desired
physical and technical properties.
(b) The quantity of any optional substance employed in the production
of the copolymer does not exceed the amount reasonably required to
accomplish the intended physical or technical effect or any limitation
further provided.
(c) Any substance employed in the production of the copolymer that is
the subject of a regulation in parts 174, 175, 176, 177, 178 and 179.45
of this chapter conforms with any specification in such regulation.
(d) Substances employed in the production of the copolymer include:
(1) Substances generally recognized as safe in food.
(2) Substances subject to prior sanction or approval for use in the
copoly-mer and used in accordance with such sanction or approval.
(3) Substances which by regulation in parts 174, 175, 176, 177, 178
and 179.45 of this chapter may be safely used as components of resinous
or polymeric coatings and film used as food-contact surfaces, subject to
the provisions of such regulation.
(e) The copolymer conforms with the following specifications:
(1) The copolymer, when extracted with distilled water at reflux
temperature for 2 hours, yields total extractives not to exceed 0.05
percent.
(2) The copolymer, when extracted with ethyl acetate at reflux
temperature for 2 hours, yields total extractives not to exceed 0.7
percent.
(3) The copolymer, when extracted with n-hexane at reflux temperature
for 2 hours, yields total extractives not to exceed 0.05 percent.
(42 FR 14572, Mar. 15, 1977; 49 FR 5748, Feb. 15, 1984, as amended
at 55 FR 34555, Aug. 23, 1990)
21 CFR 177.1310 Ethylene-acrylic acid copolymers.
The ethylene-acrylic acid copolymers identified in paragraph (a) of
this section may be safely used as components of articles intended for
use in contact with food subject to the provisions of this section.
(a) The ethylene-acrylic acid copolymers consist of basic copolymers
produced by the copolymerization of ethylene and acrylic acid such that
the finished basic copolymers contain no more than:
(1) 10 weight-percent of total polymer units derived from acrylic
acid when used in accordance with paragraph (b) of this section; and
(2) 25 weight-percent of total polymer units derived from acrylic
acid when used in accordance with paragraph (c) of this section.
(b) The finished food-contact articles made with no more than 10
percent total polymer units derived from acrylic acid, when extracted
with the solvent or solvents characterizing the type of food and under
the conditions of its intended use as determined from tables 1 and 2 of
176.170(c) of this chapter, yield net acidified chloroform-soluble
extractives not to exceed 0.5 milligram per square inch of food-contact
surface when tested by the methods prescribed in 177.1330(e)(1), (3)(i)
through (iv), (4), (5), and (6), except that
(1) The total residue method using 3 percent acetic acid, as
prescribed in 177.1330(e)(6)(i)(a), does not apply, and
(2) The net acidified chloroform-soluble extractives from paper and
paperboard complying with 176.170 of this chapter may be corrected for
wax, petrolatum, and mineral oil as provided in 176.170(d)(5)(iii)(b)
of this chapter.
If the finished food-contact article is itself the subject of a
regulation in parts 174, 175, 176, 177, 178, and 179.45 of this
chapter, it shall also comply with any specifications and limitations
prescribed for it by that regulation.
(c) The finished food-contact layer made with basic copolymers
containing more than 10 weight-percent but no more than 25
weight-percent of total polymer units derived from acrylic acid and with
a maximum thickness of 0.0025 inch (2.5 mils) may be used in contact
with food types I, II, IVB, VIA, VIB, VIIB, and VIII identified in table
1 of 176.170(c) of the chapter under conditions of use B through H as
described in table 2 of 176.170(c) of this chapter, and in contact with
food types III, IVA, V, VIIA, and IX identified in table 1 of
176.170(c) of this chapter under conditions of use E through G as
described in table 2 of 176.170(c) of this chapter.
(d) The provisions of this section are not applicable to
ethylene-acrylic acid copolymers used in food-packaging adhesives
complying with 175.105 of this chapter.
(42 FR 14572, Mar. 15, 1977, as amended at 51 FR 19060, May 27, 1986;
53 FR 44009, Nov. 1, 1988)
21 CFR 177.1315 Ethylene-1, 4-cyclohexylene dimethylene terephthalate
copolymers.
Ethylene-1, 4-cyclohexylene dimethylene terephthalate copolymer may
be safely used as articles or components of articles intended for use in
contact with food subject to provisions of this section and of part 174
of this chapter.
(a) Identity. For the purposes of this section,
ethylene-1,4-cyclohexylene dimethylene terephthalate copolymers
(1,4-benzene dicarboxylic acid, dimethyl ester, polymerized with
1,4-cyclohexanedimethanol and 1,2-ethanediol) (CAS Reg. No. 25640-14-6)
or (1,4-benzenedicarboxylic acid, polymerized with
1,4-cyclohexanedimethanol and 1,2-ethanediol) (CAS Reg. No. 25038-91-9)
are basic copolymers meeting the specifications prescribed in paragraph
(b) of this section, to which may have been added certain optional
substances required in their production or added to impart desired
physical or technical properties.
(b) Specifications:
(c) Analytical method for determination of extractability. The total
extracted terephthaloyl moieties can be determined in the extracts,
without evaporation of the solvent, by measuring the ultraviolet (UV)
absorbance at 240 nanometers. The spectrophotometer (Varian 635-D, or
equivalent) is zeroed with a sample of the solvent taken from the same
lot used in the extraction tests. The concentration of the total
terephthaloyl moieties in water, 3 percent acetic acid, and in 8 percent
aqueous alcohol is calculated as bis(2-hydroxyethyl terephthalate) by
reference to standards prepared in the appropriate solvent.
Concentration of the terephthaloyl moieties in heptane is calculated as
cyclic trimer (C6H4CO2C2H4CO2)3, by reference to standards prepared in
95:5 percent (v/v) heptane: tetrahydrofuran.
(45 FR 39252, June 10, 1980, as amended at 47 FR 24288, June 4, 1982;
49 FR 25629, June 22, 1984; 51 FR 22929, June 24, 1986)
21 CFR 177.1320 Ethylene-ethyl acrylate copolymers.
Ethylene-ethyl acrylate copolymers may be safely used to produce
packaging materials, containers, and equipment intended for use in
producing, manufacturing, packing, processing, preparing, treating,
packaging, transporting, or holding food, in accordance with the
following prescribed conditions:
(a) Ethylene-ethyl acrylate copolymers consist of basic resins
produced by the catalytic copolymerization of ethylene and ethyl
acrylate, to which may have been added certain optional substances to
impart desired technological properties to the resin. Subject to any
limitations prescribed in this section, the optional substances may
include:
(1) Substances generally recognized as safe in food and food
packaging.
(2) Substances the use of which is permitted under applicable
regulations in parts 170 through 189 of this chapter, prior sanction, or
approvals.
(b) The ethyl acrylate content of the copolymer does not exceed 8
percent by weight unless it is blended with polyethylene or with one or
more olefin copolymers complying with 177.1520 or with a mixture of
polyethylene and one or more olefin copolymers, in such proportions that
the ethyl acrylate content of the blend does not exceed 8 percent by
weight, or unless it is used in a coating complying with 175.300 or
176.170 of this chapter, in such proportions that the ethyl acrylate
content does not exceed 8 percent by weight of the finished coating.
(c) Ethylene-ethyl acrylate copolymers or the blend shall conform to
the specifications prescribed in paragraph (c)(1) of this section and
shall meet the ethyl acrylate content limits prescribed in paragraph (b)
of this section, and the extractability limits prescribed in paragraph
(c)(2) of this section, when tested by the methods prescribed for
polyethylene in 177.1520.
(1) Specifications -- (i) Infrared identification. Ethylene-ethyl
acrylate copolymers can be identified by their characteristic infrared
spectra.
(ii) Quantitative determination of ethyl acrylate content. The ethyl
acrylate can be determined by the infrared spectra. Prepare a scan from
10.5 microns to 12.5 microns. Obtain a baseline absorbance at 11.6
microns and divide by the plaque thickness to obtain absorbance per mil.
From a previously prepared calibration curve, obtain the amount of
ethyl acrylate present.
(iii) Specific gravity. Ethylene-ethyl acrylate copolymers have a
specific gravity of not less than 0.920 nor more than 0.935, as
determined by ASTM method D1505-68 (Reapproved 1979), ''Standard Test
Method for Density of Plastics by the Density-Gradient Technique,''
which is incorporated by reference. Copies may be obtained from the
American Society for Testing Materials, 1916 Race St., Philadelphia, PA
19103, or may be examined at the Office of the Federal Register, 1100 L
St. NW., Washington, DC 20408.
(2) Limitations. Ethylene-ethyl acrylate copolymers or the blend may
be used in contact with food except as a component of articles used for
packaging or holding food during cooking provided they meet the
following extractability limits:
(i) Maximum soluble fraction of 11.3 percent in xylene after
refluxing and subsequent cooling to 25 C.
(ii) Maximum extractable fraction of 5.5 percent when extracted with
n-hexane at 50 C.
(d) The provisions of paragraphs (b) and (c)(2) of this section are
not applicable to ethylene-ethyl acrylate copolymers used in the
formulation of adhesives complying with 175.105 of this chapter.
(42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10108, Mar. 19,
1984)
21 CFR 177.1330 Ionomeric resins.
Ionomeric resins manufactured from either ethylene-methacrylic acid
copolymers (and/or their ammonium, calcium, magnesium, potassium,
sodium, and/or zinc partial salts), ethylene-methacrylic acid-vinyl
acetate copolymers (and/or their ammonium, calcium, magnesium,
potassium, sodium, and/or zinc partial salts,), or methacrylic acid
polymers with ethylene and isobutyl acrylate (and/or their potassium,
sodium and/or zinc partial salts) may be safely used as articles or
components of articles intended for use in contact with food, in
accordance with the following prescribed conditions:
(a) For the purpose of this section, the ethylene-methacrylic acid
copolymers consist of basic copolymers produced by the copolymerization
of ethylene and methacrylic acid such that the copolymers contain no
more than 20 weight percent of polymer units derived from methacrylic
acid, and the ethylene-methacrylic acid-vinyl acetate copolymers consist
of basic copolymers produced by the copolymerization of ethylene,
methacrylic acid, and vinyl acetate such that the copolymers contain no
more than 15 weight percent of polymer units derived from methacrylic
acid.
(b) For the purpose of this section, the methacrylic acid copolymers
with ethylene and isobutyl acrylate consist of basic copolymers produced
by the copolymerization of methacrylic acid, ethylene, and isobutyl
acrylate such that the copolymers contain no less than 70 weight percent
of polymer units derived from ethylene, no more than 15 weight percent
of polymer units derived from methacrylic acid, and no more than 20
weight percent of polymer units derived from isobutyl acrylate. From 20
percent to 70 percent of the carboxylic acid groups may optionally be
neutralized to form sodium or zinc salts.
(c) The finished food-contact article described in paragraph (a) of
this section, when extracted with the solvent or solvents characterizing
the type of food and under the conditions of time and temperature
characterizing the conditions of its intended use as determined from
Tables 1 and 2 of 176.170(c) of this chapter, yields net acidified
chloroform-soluble extractives in each extracting solvent not to exceed
0.5 milligram per square inch of food-contact surface when tested by the
methods described in paragraph (e)(1) of this section, and if the
finished food-contact article is itself the subject of a regulation in
parts 174, 175, 176, 177, 178 and 179.45 of this chapter, it shall also
comply with any specifications and limitations prescribed for it by that
regulation.
Note: In testing the finished food-contact article, use a separate
test sample for each required extracting solvent.
(d) The finished food-contact article described in paragraph (b) of
this section, when extracted according to the methods listed in
paragraph (e)(2) of this section and referenced in this paragraph (d),
using the solvent or solvents characterizing the type of food as
determined from Table I of paragraph (f) of this section, shall yield
net acidified chloroform-soluble extractives as follows:
(1) For fatty food use. (i) For films of 2 mil (0.002 inches)
thickness or less, extractives shall not exceed 0.70 milligram/square
inch1 (0.109 milligram/square centimeter) of food-contact surface
(n-heptane extractions) when extracted by the abbreviated method cited
in paragraph (e)(2)(i) of this section.
(ii) For films of greater than 2 mils (0.002 inch) thickness,
extractives shall not exceed 0.40 milligram/square inch1 (0.062
milligram/square centimeter) of food-contact surface (n-heptane
extractions) when extracted by the abbreviated method cited in paragraph
(e)(2)(i) of this section, or
(iii) Alternatively, for films of greater than 2 mils thickness,
extractives shall not exceed 0.70 milligram/square inch1 (0.109
milligram/square centimeter) of food-contact surface (n-heptane
extractions) when extracted by the equilibrium method cited in paragraph
(e)(2)(ii) of this section.
(2) For aqueous foods. (i) The net acidified chloroform-soluble
extractives shall not exceed 0.02 milligram/square inch2 (0.003
milligram/square centimeter) of food-contact surface (water, acetic
acid, or ethanol/water extractions) when extracted by the abbreviated
method cited in paragraph (e)(2)(i) of this section.
(ii) Alternatively, the net acidified chloroform-soluble extractives
shall not exceed 0.05 milligram/square inch2 (0.078 mg/square
centimeter) of food-contact surface (water, acetic acid, or
ethanol/water extractions) when extracted by the equilibrium method
cited in paragraph (e)(2)(ii) of this section. If when exposed to
n-heptane, a particular film splits along die lines, thus permitting
exposure of both sides of the film to the extracting solvent, the
results for that film sample are invalid and the test must be repeated
for that sample until no splitting by the solvent occurs. If the
finished food-contact article is itself the subject of a regulation in
parts 174, 175, 176, 177, 178 and 179.45 of this chapter, it shall also
comply with any specifications and limitations prescribed for it by that
regulation.
Note: In testing the finished food-contact article, use a separate
test sample for each required extracting solvent.
(e) Analytical methods -- (1) Selection of extractability conditions
for ionomeric resins. First ascertain the type of food (Table 1 of
176.170(c) of this chapter) that is being packed or used in contact with
the finished food-contact article described in paragraph (a) of this
section, and also ascertain the normal conditions of thermal treatment
used in packaging or contacting the type of food involved. Using Table
2 of 176.170 (c) of this chapter, select the food-simulating solvent or
solvents and the time-temperature test conditions that correspond to the
intended use of the finished food-contact article. Having selected the
appropriate food-simulating solvent or solvents and time-temperature
exaggeration over normal use, follow the applicable extraction
procedure.
(2) Selection of extractability conditions for ionomeric resins.
Using Table I of paragraph (f) of this section ascertain the type of
food that is being packed or used in contact with the finished
food-contact article described in paragraph (b) of this section, and
also ascertain the food-simulating solvent or solvents that correspond
to the intended use of the finished food-contact article.
(i) Abbreviated test. For intended use involving food contact at or
below 120 F (49 C), the appropriate food-simulating solvent is to
contact the food-contact film for the time and temperatures as follows:
(ii) Equilibrium test. For intended use involving food contact at or
below 120 F (49 C), the appropriate food-simulating solvent is to
contact the food-contact film at a temperature of 120 F until
equilibrium is demonstrated.
The results from a series of extraction times demonstrate equilibrium
when the net chloroform-soluble extractives are unchanging within
experimental error appropriate to the method as described in paragraphs
(d) (1)(i) and (2)(i) of this section. Should equilibrium not be
demonstrated over the above time series, extraction times must be
extended until three successive unchanging values for extractives are
obtained. In the case where intended uses involve temporary food
contact above 120 F, the food-simulating solvent is to be contacted
with the food-contact article under conditions of time and temperature
that duplicate the actual conditions in the intended use. Subsequently
the extraction is to be continued for the time period and under the
conditions specified in the above table.
(3) Reagents -- (i) Water. All water used in extraction procedures
should be freshly demineralized (deionized) distilled water.
(ii) n-Heptane. Reagent grade, freshly redistilled before use, using
only material boiling at 208 F (97.8 C).
(iii) Alcohol. 8 or 50 percent (by volume), prepared from
undenatured 95 percent ethyl alcohol diluted with demineralized
(deionized), distilled water.
(iv) Chloroform. Reagent grade, freshly redistilled before use, or a
grade having an established, consistently low blank.
(v) Acetic acid. 3 percent (by weight), prepared from glacial acetic
acid diluted with demineralized (deionized), distilled water.
(4) Selection of test method. The finished food-contact articles
shall be tested either by the extraction cell described in the Journal
of the Association of Official Agricultural Chemists, Vol. 47, No. 1,
p. 177-179 (February 1964), also described in ASTM method F34-76
(Reapproved 1980), ''Standard Test Method for Liquid Extraction of
Flexible Barrier Materials,'' which are incorporated by reference, or by
adapting the in-container methods described in 175.300(e) of this
chapter. Copies of the material incorporated by reference are available
from the Division of Food and Color Additives, Center for Food Safety
and Applied Nutrition (HFF-330), Food and Drug Administration, 200 C St.
SW., Washington, DC 20204, and the American Society for Testing
Materials, 1916 Race St., Philadelphia, PA 19103, respectively, or may
be examined at the Office of the Federal Register, 1100 L St. NW.,
Washington, DC 20408.
(5) Selection of samples. Quadruplicate samples should be tested,
using for each replicate sample the number of finished articles with a
food-contact surface nearest to 100 square inches.
(6) Determination of amount of extractives -- (i) Total residues. At
the end of the exposure period, remove the test container or test cell
from the oven, if any, and combine the solvent for each replicate in a
clean Pyrex (or equivalent) flask or beaker, being sure to rinse the
test container or cell with a small quantity of clean solvent.
Evaporate the food-simulating solvents to about 100 milliliters in the
flask, and transfer to a clean, tared evaporating dish (platinum or
Pyrex), washing the flask three times with small portions of solvent
used in the extraction procedure, and evaporate to a few milliliters on
a nonsparking, low-temperature hotplate. The last few milliliters
should be evaporated in an oven maintained at a temperature of 221 F
(105 C). Cool the evaporating dish in a desiccator for 30 minutes and
weigh the residues to the nearest 0.1 milligram, e. Calculate the
extractives in milligrams per square inch of the container or material
surface.
(a) Water, 3 percent acetic acid, and 8 percent and 50 percent
alcohol. Milligrams extractives per square inch=e/s.
(b) Heptane. Milligrams extractives per square inch=(e)/(s)(F)
Where:
e=Milligrams extractives per sample tested.
s=Surface area tested, in square inches.
F=Five, the ratio of the amount of extractives removed by heptane
under exaggerated time-temperature test conditions compared to the
amount extracted by a fat or oil under exaggerated conditions of thermal
sterilization and use.
e'=Acidified chloroform-soluble extractives residue. e' is
substituted for e in the above equations when necessary (See paragraph
(e)(6)(ii) of this section for method to obtain e').
If when calculated by the equations in paragraphs (e)(6)(i) (a) and
(b) of this section, the extractives in milligrams per square inch
exceed the limitations prescribed in paragraphs (c) or (d) of this
section, proceed to paragraph (e)(6)(ii) of this section (method for
determining the amount of acidified chloroform-soluble extractives
residue).
(ii) Acidified chloroform-soluble extractives residue. Add 3
milliliters of 37 percent ACS reagent grade hydrochloric acid and 3
milliliters of distilled water to the evaporating dish containing the
dried and weighed residue, e, obtained in paragraph (e)(6)(i) of this
section. Mix well so every portion of the residue is wetted with the
hydrochloric acid solution. Then add 50 milliliters of chloroform.
Warm carefully, and filter through Whatman No. 41 filter paper (or
equivalent) in a Pyrex (or equivalent) funnel, collecting the filtrate
in a clean separatory funnel. Shake for 1 minute, then draw off the
chloroform layer into a clean tared evaporating dish (platinum or
Pyrex). Repeat the chloroform extraction, washing the dish, the filter
paper, and the separatory funnel with this second portion of chloroform.
Add this filtrate to the original filtrate and evaporate the total down
to a few milliliters on a low-temperature hotplate. The last few
milliliters should be evaporated in an oven maintained at 221 F. Cool
the evaporating dish in a desiccator for 30 minutes and weigh to the
nearest 0.1 milligram to get the acidified chloroform-soluble
extractives residue, e'. This e' is substituted for e in the equations
in paragraphs (e)(6)(i) (a) and (b) of this section.
(f) The types of food and appropriate solvents are as follows:
(g) The provisions of paragraphs (c) and (d) of this section are not
applicable to the ionomeric resins that are used in food-packaging
adhesives complying with 175.105 of this chapter.
(45 FR 22916, Apr. 4, 1980, as amended at 49 FR 10108, Mar. 19, 1984;
49 FR 37747, Sept. 26, 1984; 53 FR 44009, Nov. 1, 1988; 54 FR 24898,
June 12, 1989)
1Average of four separate values, no single value of which differs
from the average of those values by more then 10 percent.
2Average of four separate values, no single value of which differs
from the average of those values by more than 50 percent.
/2/ See footnote 2 to paragraph (d)(2)(i) of this section.
21 CFR 177.1340 Ethylene-methyl acrylate copolymer resins.
Ethylene-methyl acrylate copolymer resins may be safely used as
articles or components of articles intended for use in contact with
food, in accordance with the following prescribed conditions:
(a) For the purpose of this section, the ethylene-methyl acrylate
copolymer resins consist of basic copolymers produced by the
copolymerization of ethylene and methyl acrylate such that the
copolymers contain no more than 25 weight percent of polymer units
derived from methyl acrylate.
(b) The finished food-contact article, when extracted with the
solvent or solvents characterizing the type of food and under the
conditions of time and temperature characterizing the conditions of its
intended use as determined from Tables 1 and 2 of 176.170(c) of this
chapter, yields net chloroform-soluble extractives (corrected for zinc
extractives as zinc oleate) in each extracting solvent not to exceed 0.5
milligram per square inch of food-contact surface when tested by the
methods described in 176.170(d) of this chapter. If the finished
food-contact article is itself the subject of a regulation in parts 174,
175, 176, 177, 178 and 179.45 of this chapter, it shall also comply
with any specifications and limitations prescribed for it by that
regulation.
Note: In testing the finished food-contact article, use a separate
test sample for each required extracting solvent.
(c) The provisions of this section are not applicable to
ethylene-methyl acrylate copolymer resins used in food-packaging
adhesives complying with 175.105 of this chapter.
21 CFR 177.1350 Ethylene-vinyl acetate copolymers.
Ethylene-vinyl acetate copolymers may be safely used as articles or
components of articles intended for use in producing, manufacturing,
packing, processing, preparing, treating, packaging, transporting, or
holding food in accordance with the following prescribed conditions:
(a) Ethylene-vinyl acetate copolymers consist of basic resins
produced by the catalytic copolymerization of ethylene and vinyl acetate
to which may have been added certain optional substances to impart
desired technological or physical properties to the resin. Subject to
any limitations prescribed in this section, the optional substances may
include:
(1) Substances generally recognized as safe in food and food
packaging.
(2) Substances the use of which is permitted under applicable
regulations in parts 170 through 189 of this chapter, prior sanction, or
approvals.
(3) Substances identified in 175.300(b)(3) (xxv), (xxvii), (xxx),
and (xxxiii) of this chapter, and colorants used in accordance with
178.3297 of this chapter.
(4) Erucamide as identified in 178.3860 of this chapter.
(5) Xanthan gum as identified in 172.695 for use as a thickening
agent at a level not to exceed 1 percent by weight of coating solids in
aqueous dispersions of ethylene-vinyl acetate copolymers, where such
copolymers are used only as coatings or a component of coatings.
(6) The copolymer of vinylidene fluoride and hexafluoropropene (CAS
Reg. No. 9011-17-0), containing 65 to 71 percent fluorine and having a
Mooney Viscosity of at least 28, for use as a processing aid at a level
not to exceed 0.2 percent by weight of ethylene-vinyl acetate
copolymers.
(b) Ethylene-vinyl acetate copolymers, with or without the optional
substances described in paragraph (a) of this section, when extracted
with the solvent or solvents characterizing the type of food, and under
conditions of time and temperature characterizing the conditions of
their intended use as determined from Tables 1 and 2 of 176.170(c) of
this chapter, shall yield net chloroform-soluble extractives corrected
for zinc as zinc oleate not to exceed 0.5 milligram per square inch of
an appropriate sample.
(c) The provisions of paragraph (b) of this section are not
applicable to ethylene-vinyl acetate copolymers used in food-packaging
adhesives complying with 175.105 of this chapter.
(d) Ethylene-vinyl acetate copolymers may be irradiated under the
following conditions to produce molecular crosslinking of the polymers
to impart desired properties such as increased strength and increased
ability to shrink when exposed to heat:
(1) Electron beam source of ionizing radiation at a maximum energy of
3 million electron volts: Maximum absorbed dose not to exceed 150
kiloGray (15 megarads).
(2) The finished food-contact film shall meet the extractives
limitations prescribed in paragraph (e)(2) of this section.
(3) The ethylene-vinyl acetate copolymer films may be further
irradiated in accordance with the provisions of paragraph (e)(1) of this
section: Provided, That the total accumulated radiation dose from both
electron beam and gamma ray radiation does not exceed 150 kiloGray (15
megarads).
(e) Ethylene-vinyl acetate copolymer films intended for contact with
food may be irradiated to control the growth of microorganisms under the
following conditions:
(1) Gamma photons emitted from a cobalt-60 sealed source in the dose
range of 5-50 kiloGray (0.5-5.0 megarads).
(2) The irradiated ethylene-vinyl acetate copolymer films, when
extracted with reagent grade n-heptane (freshly redistilled before use)
according to methods described under 176.170(d)(3) of this chapter, at
75 F for 30 minutes shall yield total extractives not to exceed 4.5
percent by weight of the film.
(42 FR 14572, Mar. 15, 1977, as amended at 43 FR 29287, July 7, 1978;
54 FR 35874, Aug. 30, 1989; 55 FR 18595, May 3, 1990; 56 FR 42932,
Aug. 30, 1991)
21 CFR 177.1360 Ethylene-vinyl acetate-vinyl alcohol copolymers.
Ethylene-vinyl acetate-vinyl alcohol copolymers (CAS Reg. No.
26221-27-2) may be safely used as articles or components of articles
intended for use in contact with food, in accordance with the following
prescribed conditions:
(a) Ethylene-vinyl acetate-vinyl alcohol copolymers are produced by
the partial or complete alcoholysis or hydrolysis of those
ethylene-vinyl acetate copolymers complying with 177.1350.
(1) Those copolymers containing a minimum of 55 percent ethylene and
a maximum of 30 percent vinyl alcohol units by weight may be used in
contact with foods as described in paragraph (b) of this section.
(2) Those copolymers containing a minimum of 55 percent ethylene and
a maximum of 15 percent vinyl alcohol units by weight may be used in
contact with foods as described in paragraph (c) of this section.
(3) Those copolymers containing 20 to 40 percent ethylene and 60 to
80 percent vinyl alcohol units by weight may be used in contact with
foods as described in paragraph (d) of this section.
(b) The finished food-contact article shall not exceed 0.013
centimeter (0.005 inch) thickness and shall contact foods only of the
types identified in Table 1 of 176.170(c) of this chapter in Categories
I, II, IV-B, VI, VII-B, and VIII under conditions of use D through G
described in Table 2 of 176.170(c) of this chapter. Film samples of
0.013 centimeter (0.005) inch thickness representing the finished
article shall meet the following extractive limitation when tested by
ASTM method F34-76 (Reapproved 1980), ''Standard Test Method for Liquid
Extraction of Flexible Barrier Materials,'' which is incorporated by
reference. Copies may be obtained from the American Society for Testing
Materials, 1916 Race St., Philadelphia, PA 19103, or may be examined at
the Office of the Federal Register, 1100 L St. NW., Washington, DC
20408.
(1) The film when extracted with distilled water at 21 C (70 F) for
48 hours yields total extractives not to exceed 0.0047 milligram per
square centimeter (0.03 milligram per square inch) of food-contact
surface.
(2) The film when extracted with 50 percent ethyl alcohol at 21 C
(70 F) for 48 hours yields total extractives not to exceed 0.0062
milligram per square centimeter (0.04 milligram per square inch) of
food-contact surface.
(c) The finished food-contact article shall not exceed 0.0076
centimeter (0.003 inch) thickness and shall contact foods only of the
types identified in Table 1 of 176.170(c) of this chapter in Categories
III, IV-A, VII-A, and IX under conditions of use F and G described in
Table 2 of 176.170(c) of this chapter. Film samples of 0.0076
centimeter (0.003 inch) thickness representing the finished articles
shall meet the following extractive limitation when tested by ASTM
method F34-76 (Reapproved 1980), ''Standard Test Method for Liquid
Extraction of Flexible Barrier Materials,'' which is incorporated by
reference. The availability of this incorporation by reference is given
in paragraph (b) of this section. The film when extracted with
n-heptane at 38 C (100 F) for 30 minutes yields total extractives not
to exceed 0.0078 milligram per square centimeter (0.05 milligram per
square inch) of food-contact surface, after correcting the total
extractives by dividing by a factor of five.
(d) The finished food-contact article shall not exceed 0.018
centimeter (0.007 inch) thickness and may contact all foods except those
containing more than 8 percent alcohol under conditions of use B through
H described in Table 2 of 176.170(c) of this chapter. Film samples of
0.018 centimeter (0.007 inch) thickness representing the finished
articles shall meet the following extractive limitation when tested by
ASTM method F34-76 (Reapproved 1980), ''Standard Test Method for Liquid
Extraction of Flexible Barrier Materials,'' which is incorporated by
reference. The availability of this incorporation by reference is given
in paragraph (b) of this section. The film when extracted with
distilled water at 100 C (212 F) for 30 minutes yields total
extractives not to exceed 0.023 milligram per square centimeter (0.15
milligram per square inch) of food-contact surface.
(e) The provisions of this section are not applicable to
ethylene-vinyl acetate-vinyl alcohol copolymers used in the
food-packaging adhesives complying with 175.105 of this chapter.
(47 FR 41531, Sept. 21, 1982, as amended at 49 FR 10108, Mar. 19,
1984)
21 CFR 177.1380 Fluorocarbon resins.
Fluorocarbon resins may be safely used as articles or components of
articles intended for use in contact with food, in accordance with the
following prescribed conditions:
(a) For the purpose of this section, fluorocarbon resins consist of
basic resins produced as follows:
(1) Chlorotrifluoroethylene resins produced by the homopolymerization
of chlorotrifluoroethylene.
(2) Chlorotrifluoroethylene-1,1-difluoroethylene copolymer resins
produced by copolymerization of chlorotrifluoroethylene and
1,1-difluoroethylene.
(3) Chlorotrifluoroethylene-1,1-difluoroethye co-polymer resins
produced by copolymerization of chlorotrifluoroethylene,
1,1-difluoroethylene, and tetrafluoroethylene.
(4) Ethylene-chlorotrifluoroethylene copolymer resins produced by
copolymerization of nominally 50 mole percent of ethylene and 50 mole
percent of chlorotrifluoroethylene. The copolymer shall have a melting
point of 239 to 243 C and a melt index of less than or equal to 20 as
determined by ASTM Method D 3275-89 ''Standard Specification for
E-CTFE-Fluoroplastic Molding, Extrusion, and Coating Materials,'' which
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1
CFR Part 51. Copies may be obtained from the American Society for
Testing and Materials, 1916 Race St., Philadelphia, PA 19013, or may be
examined at the Office of the Federal Register, 1100 L St. NW.,
Washington, DC.
(b) Fluorocarbon resins that are identified in paragraph (a) of this
section and that comply with extractive limitations prescribed in
paragraph (c) of this section may be used as articles or components of
articles intended for use in contact with food as follows:
(1) Fluorocarbon resins that are identified in paragraphs (a)(1),
(a)(2), and (a)(3) of this section and that comply only with the
extractive limitations prescribed in paragraphs (c)(1) and (c)(2) of
this section may be used when such use is limited to articles or
components of articles that are intended for repeated use in contact
with food or that are intended for one-time use in contact with foods
only of the types identified in 176.170(c) of this chapter, Table 1,
under Types I, II, VI, VII-B, and VIII.
(2) Fluorocarbon resins that are identified in paragraph (a)(4) of
this section and that comply with the extractive limitations prescribed
in paragraphs (c)(1) and (c)(2) of this section may be used only when
such use is limited to articles or components of articles that are
intended for repeated use in contact with food.
(3) In accordance with current good manufacturing practice, those
food-contact articles intended for repeated use shall be thoroughly
cleansed prior to their first use in contact with food.
(c) Extractives limitations are applicable to the basic resins in the
form of pellets that have been ground or cut into small particles that
will pass through a U.S. Standard Sieve No. 6 and that will be held on
a U.S. Standard Sieve No. 10.
(1) A 100-gram sample of the resin pellets, when extracted with 100
milliliters of distilled water at reflux temperature for 8 hours, shall
yield total extractives not to exceed 0.003 percent by weight of the
resins.
(2) A 100-gram sample of the resin pellets, when extracted with 100
milliliters of 50 percent (by volume) ethyl alcohol in distilled water
at reflux temperature for 8 hours, shall yield total extractives not to
exceed 0.003 percent by weight of the resins.
(3) A 100-gram sample of the resin pellets, when extracted with 100
milliliters of n-heptane at reflux temperature for 8 hours, shall yield
total extractives not to exceed 0.01 percent by weight of the resins.
(42 FR 14572, Mar. 15, 1977, as amended at 57 FR 185, Jan. 3, 1992)
21 CFR 177.1390 Laminate structures for use at temperatures of 250 F
and above.
(a) The high-temperature laminates identified in this section may be
safely used for food contact at temperatures not exceeding 135 C (275
F) unless otherwise specified. These articles are layered constructions
that are optionally bonded with adhesives. The interior (food-contact)
layer(s) may be separated from the exterior layer(s) by a functional
barrier, such as aluminum foil. Upon review of the physical properties
of a particular construction, the Food and Drug Administration may
consider other layers to serve as functional barriers. This regulation
is not intended to limit these constructions as to shape, degree of
flexibility, thickness, or number of layers. These layers may be
laminated, extruded, coextruded, or fused.
(b) When containers subject to this regulation undergo heat
sterilization to produce shelf-stable foods, certain control measures
(in addition to the food additive requirements in paragraphs (c) and (d)
of this section) are necessary to ensure proper food sterilization and
package integrity. Refer to parts 108, 110, 113, and 114 of this
chapter for details.
(c) Subject to the provisions of this paragraph, food-contact
articles produced from high-temperature laminates may be safely used to
package all food types except those containing more than 8 percent ethyl
alcohol.
(1) Polymeric films/layers. Films or layers not separated from food
by a functional barrier must meet the following requirements:
(i) Films/layers may consist of the following:
(a) Polyolefin resins complying with item 2.2 or 3.2 of the table in
177.1520(c).
(b) Polymeric resin blends formulated from a base polymer complying
with item 2.2 or 3.2 of the table in 177.1520(c) blended with no more
than 10 percent by weight of a copolymer of ethylene and vinyl acetate
complying with 177.1350.
(c) Polymeric resin blends formulated from a base polymer complying
with item 2.2 or 3.2 of the table in 177.1520(c) blended with no more
than 38 percent by weight of a homopolymer of isobutylene complying with
177.1420(a)(1).
(d) Polyethylene phthalate resins complying with 177.1630(e)(4) (i)
and (ii).
(e) Polymeric resins that comply with an applicable regulation in
this chapter which permits food type and time/temperature conditions to
which the container will be exposed, including sterilization processing.
(ii) Adjuvants used in these layers must comply with an applicable
regulation that permits food type and time/temperature conditions to
which the container will be exposed, including sterilization processing.
(2) Adhesives. The use of adhesives in these containers is optional.
Adhesives may be formulated from the following substances, subject to
the prescribed limitations:
(i) Any substance suitable for use in formulating adhesives that
complies with an applicable regulation of this chapter which permits
food type and time/temperature conditions to which the container will be
exposed, including sterilization processing.
(ii) Substances complying with 175.105 of this chapter may be used
in these constructions, provided they are separated from the interior
(food-contact) layer(s) by a functional barrier as discussed under
paragraph (a) of this section.
(iii) Maleic anhydride adduct of polypropylene complying with
175.300 of this chapter.
(iv) Polyester-urethane adhesive for use at temperatures not
exceeding 121 C (250 F) and formulated from the following:
(a) Polyester-urethanediol resin prepared by the reaction of a
mixture of polybasic acids and polyhydric alcohols listed in
175.300(b)(3)(vii) of this chapter,
3-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate (CAS Reg. No.
4098-71-9) and optional trimethoxysilane coupling agents containing
amino, epoxy, ether, and/or mercapto groups not to exceed 3 percent by
weight of the cured adhesive.
(b) Urethane cross-linking agent comprising not more than 25 percent
by weight of the cured adhesive and formulated from
3-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate (CAS Reg. No.
4098-71-9) adduct of trimethylol propane (Cas Reg. No. 77-99-6) and/or
1,3-bis(isocyanatomethyl) benzene (CAS Reg. No. 25854-16-4) adduct of
trimethylol propane.
(v) Polyester-epoxy-urethane adhesives formulated from the following:
(a) Polyester resin formed by the reaction of polybasic acids and
polyhydric alcohols listed in 175.300(b)(3)(vii) of this chapter.
Azelaic acid may also be used as a polybasic acid.
(b) Epoxy resin listed in 175.300(b)(3)(viii)(a) of this chapter and
comprising no more than 30 percent by weight of the cured adhesive.
(c) Urethane cross-linking agent comprising no more than 14 percent
weight of the cured adhesive and formulated from
3-isocyanatomethyl-3,5.5-trimethylcyclohexyl isocyanate cyanurate (CAS
Reg. No. 53880-05-0).
(vi) Polyurethane-polyester resin-epoxy adhesives formulated from the
following mixture:
(a)(1) Polyester-polyurethanediol resins prepared by the reaction of
a mixture of polybasic acids and polyhydric alcohols listed in
175.300(b)(3)(vii) of this chapter and
3-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate (CAS Reg. No.
4098-71-9).
(2) Polyester resin formed by the reaction of polybasic acids and
polyhydric alcohols listed in 175.300(b)(3)(vii) of this chapter.
Additionally, azelaic acid and 1,6-hexanediol may also be used as
reactants in lieu of a polyhydric alcohol.
(3) Epoxy resin listed in 175.300(b)(3)(viii)(a) of this chapter and
comprising not more than 5 percent by weight of the cured adhesive.
(4) Optional trimethoxy silane curing agents, containing amino,
epoxy, ether, or mercapto groups not in excess of 3 percent of the cured
adhesive.
(b) Urethane cross-linking agent, comprising not more than 20 percent
by weight of the cured adhesive, and formulated from trimethylol propane
(CAS Reg. No. 77-99-6) adducts of
3-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate (CAS Reg. No.
4098-71-9) or 1,3-bis(isocyanatomethyl)benzene (CAS Reg. No.
25854-16-4).
(3) Test specifications. These specifications apply only to
materials on the food-contact side of a functional barrier, if present.
All tests must be performed on containers made under production
conditions. Laminated structures submitted to extraction procedures
must maintain complete structural integrity (particularly with regard to
delamination) throughout the test.
(i) Nonvolatile extractives. (a) For use at temperatures not to
exceed 121 C (250 F): The container interior (food-contact side)
shall be extracted with deionized distilled water at 121 C (250 F) for
2 hours.
(1) The chloroform-soluble fraction of the total nonvolatile
extractives for containers using adhesives listed in paragraphs (c)(2)
(i), (ii), (iii), and (iv) of this section shall not exceed 0.0016
milligram per square centimeter (0.01 milligram per square inch) as
determined by a method titled ''Determination of Non-volatile Chloroform
Soluble Residues in Retort Pouch Water Extracts,'' which is incorporated
by reference. Copies are available from the Division of Food and Color
Additives, Center for Food Safety and Applied Nutrition (HFF-334), Food
and Drug Administration, 200 C St. SW., Washington, DC 20404, or
available for inspection at the Office of the Federal Register, 1100 L
St. NW., Washington, DC 20408.
(2) The chloroform-soluble fraction of the total nonvolatile
extractives for containers using adhesives listed in paragraph (c)(2)(v)
of this section shall not exceed 0.016 milligram per square centimeter
(0.10 milligram per square inch) as determined by a method titled
''Determination of Non-volatile Chloroform Soluble Residues in Retort
Pouch Water Extracts,'' which is incorporated by reference in paragraph
(c)(3)(i)(a)(1) of this section.
(b) For use at temperatures not to exceed 135 C (275 F): The
container interior (food-contact side) shall be extracted with deionized
distilled water at 135 C (275 F) for 1 hour.
(1) The chloroform-soluble fraction of the total nonvolatile
extractives for containers using no adhesive, or adhesives listed in
paragraphs (c)(2) (i), (ii), and (iii) of this section shall not exceed
0.0020 milligram per square centimeter (0.013 milligram per square inch)
as determined by a method titled ''Determination of Non-volatile
Chloroform Soluble Residues in Retort Pouch Water Extracts,'' which is
incorporated by reference. The availability of this incorporation by
reference is given in paragraph (c)(3)(i)(a)(1) of this section.
(2) The chloroform-soluble fraction of the total nonvolatile
extractives for containers using adhesives listed in paragraph (c)(2)(v)
of this section shall not exceed 0.016 milligram per square centimeter
(0.10 milligram per square inch) as determined by a method titled
''Determination of Non-volatile Chloroform Soluble Residues in Retort
Pouch Water Extracts,'' which is incorporated by reference. The
availability of this incorporation by reference is given in paragraph
(c)(3)(i)(a)(1) of this section.
(3) The chloroform-soluble fraction of the total nonvolatile
extractives for containers using adhesives listed in paragraph
(c)(2)(vi) of this section shall not exceed 0.008 milligram per square
centimeter (0.05 milligram per square inch) as determined by a method
entitled, ''Determination of Non-volatile Chloroform Soluble Residues in
Retort Pouch Water Extracts,'' which is incorporated by reference in
paragraph (c)(3)(i)(a)(1) of this section.
(ii) Volatiles. Volatile substances employed in the manufacture of
high-temperature laminates must be removed to the greatest extent
possible in keeping with good manufacturing practice prescribed in
174.5(a) of this chapter.
(d) Nylon 12/aluminum foil high-temperature laminates: Subject to
the provisions of this paragraph, containers constructed of nylon 12
laminated to aluminum foil may be safely used at temperatures no greater
than 250 F (121 C) in contact with all food types except those
containing more than 8 percent alcohol.
(1) The container is constructed of aluminum foil to which nylon 12
film is fused. Prior to fusing the nylon 12, the aluminum foil may be
optionally precoated with a coating complying with 175.300 of this
chapter.
(2) Nylon 12 resin complying with 177.1500 and having an average
thickness not to exceed 0.0016 inch (41 microns) may be used as the
food-contact surface of the container.
(3) Container test specifications. On exposure to distilled water at
250 F (121 C) for 2 hours, extractives from the food-contact side of
the nylon 12 multilayered construction shall not exceed 0.05 milligram
per square inch (0.0078 milligram per square centimeter) as total
nonvolatile extractives.
(45 FR 2843, Jan. 15, 1980, as amended at 47 FR 49639, Nov. 2, 1982;
48 FR 236, Jan. 4, 1983; 48 FR 15242, Apr. 8, 1983; 48 FR 17347, Apr.
22, 1983; 49 FR 7558, Mar. 1, 1984; 52 FR 33575, Sept. 4, 1987; 53
FR 39084, Oct. 5, 1988; 54 FR 24898, June 12, 1989)
21 CFR 177.1395 Laminate structures for use at temperatures between 120
F and 250 F.
(a) The laminates identified in this section may be safely used at
the specified temperatures. These articles are layered structures that
are optionally bonded with adhesives. In these articles, the
food-contact layer does not function as a barrier to migration of
components from non-food-contact layers. The layers may be laminated,
extruded, coextruded, or fused.
(b) Laminate structures may be manufactured from:
(1) Polymers and adjuvants complying with 177.1390 of this chapter.
(2) Any polymeric resin listed in these regulations so long as the
use of the resin in the structure complies with the conditions of use
(food type and time/temperature) specified in the regulation for that
resin.
(3) Optional adjuvant substances used in accordance with 174.5 of
this chapter.
(4) The following substances in non-food-contact layers only:
(52 FR 33575, Sept. 4, 1987, as amended at 53 FR 19772, May 31, 1988)
21 CFR 177.1400 Hydroxyethyl cellulose film, water-insoluble.
Water-insoluble hydroxyethyl cellulose film may be safely used for
packaging food in accordance with the following prescribed conditions:
(a) Water-insoluble hydroxyethyl cellulose film consists of a base
sheet manufactured by the ethoxylation of cellulose under controlled
conditions, to which may be added certain optional substances of a grade
of purity suitable for use in food packaging as constituents of the base
sheet or as coatings applied to impart desired technological properties.
(b) Subject to any limitations prescribed in parts 170 through 189 of
this chapter, the optional substances used in the base sheet and coating
may include:
(1) Substances generally recognized as safe in food.
(2) Substances permitted to be used in water-insoluble hydroxyethyl
cellulose film by prior sanction or approval and under conditions
specified in such sanctions or approval, and substances listed in part
181, Subpart B of this chapter.
(3) Substances that by any regulation promulgated under section 409
of the act may be safely used as components of water-insoluble
hydroxyethyl cellulose film.
(4) Substances identified in and used in compliance with
177.1200(c).
(c) Any substance employed in the production of the water-insoluble
hydroxyethyl cellulose film described in this section that is the
subject of a regulation in parts 174, 175, 176, 177, 178 and 179.45 of
this chapter conforms with any specification in such regulation.
21 CFR 177.1420 Isobutylene polymers.
Isobutylene polymers may be safely used as components of articles
intended for use in producing, manufacturing, packing, processing,
preparing, treating, packaging, transporting, or holding food, in
accordance with the following prescribed conditions:
(a) For the purpose of this section, isobutylene polymers are those
produced as follows:
(1) Polyisobutylene produced by the homopolymerization of isobutylene
such that the finished polymers have a molecular weight of 750,000
(Flory) or higher.
(2) Isobutylene-isoprene copolymers produced by the copolymerization
of isobutylene with not more than 3 molar percent of isoprene such that
the finished polymers have a molecular weight of 300,000 (Flory) or
higher.
(3) Chlorinated isobutylene-isoprene copolymers produced when
isobutylene-isoprene copolymers (molecular weight 300,000 (Flory) or
higher) are modified by chlorination with not more than 1.3
weight-percent of chlorine.
(b) The polymers identified in paragraph (a) of this section may
contain optional adjuvant substances required in the production of the
polymers. The optional adjuvant substances required in the production
of the polymers may include substances generally recognized as safe in
food, substances used in accordance with a prior sanction or approval,
and aluminum chloride.
(c) The provisions of this section are not applicable to
polyisobutylene used in food-packaging adhesives complying with 175.105
of this chapter.
21 CFR 177.1430 Isobutylene-butene copolymers.
Isobutylene-butene copolymers identified in paragraph (a) of this
section may be safely used as components of articles intended for use in
contact with food, subject to the provisions of this section.
(a) For the purpose of this section, isobutylene-butene copolymers
consist of basic copolymers produced by the copolymerization of
isobutylene with mixtures of n-butenes such that the finished basic
copolymers contain not less than 45 weight percent of polymer units
derived from isobutylene and meet the specifications prescribed in
paragraph (b) of this section when tested by the methods described in
paragraph (c) of this section.
(b) Specifications:
(c) The analytical methods for determining whether isobutylene-butene
copolymers conform to the specifications in paragraph (b) are as
follows:
(1) Molecular weight. Molecular weight shall be determined by
American Society for Testing and Materials (ASTM) method D2503-82,
''Standard Test Method for Molecular Weight (Relative Molecular Mass) of
Hydrocarbons by Thermoelectric Measurement of Vapor Pressure,'' which is
incorporated by reference. Copies may be obtained from the American
Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or
may be examined at the Office of the Federal Register, 1100 L St. NW.,
Washington, DC 20408.
(2) Viscosity. Viscosity shall be determined by ASTM method D445-74,
''Test for Kinematic Viscosity of Transparent and Opaque Liquids,''
which is incorporated by reference. The availability of this
incorporation by reference is given in paragraph (c)(1) of this section.
(3) Maximum bromine value. Maximum bromine value shall be determined
by ASTM method D1492-78, ''Standard Test Method for Bromine Index of
Aromatic Hydrocarbons by Coulometric Titration,'' which is incorporated
by reference. The availability of this incorporation by reference is
given in paragraph (c)(1) of this section.
(d) The provisions of this section are not applicable to
isobutylene-butene copolymers used as provided under 175.105 of this
chapter.
(52 FR 11641, Apr. 10, 1987)
21 CFR 177.1440 4,4'-Isopropylidenediphenol-ep-ichlorohydrin resins
minimum molecular weight 10,000.
4,4'-Isopropylidenediphenol-epichlo-rohydrin resins having a minimum
molecular weight of 10,000 may be safely used as articles or components
of articles intended for use in producing, manufacturing, packing,
processing, preparing, treating, packaging, transporting, or holding
food in accordance with the following prescribed conditions:
(a) 4,4'-Isopropylidenediphenol-ep-ichlorohydrin resins consist of
basic resins produced by the condensation of equimolar amounts of
4,4'-isopropylidenediphenol and epichlorohydrin terminated with phenol,
to which may have been added certain optional adjuvant substances
required in the production of the resins.
(b) The optional adjuvant substances required in the production of
the resins may include substances generally recognized as safe in food,
substances used in accordance with a prior sanction or approval, and the
following:
(c) 4,4'-Isopropylidenediphenol-ep-ichlorohydrin resins shall meet
the following nonvolatile extractives limitations:
(1) Maximum extractable nonvolatile fraction of 2 parts per million
when extracted with distilled water at 70 C for 2 hours, using a
volume-to-surface ratio of 2 milliliters per square inch.
(2) Maximum extractable nonvolatile fraction of 3 parts per million
when extracted with n-heptane at 70 C for 2 hours, using a
volume-to-surface ratio of 2 milliliters per square inch.
(3) Maximum extractable nonvolatile fraction of 6 parts per million
when extracted with 10 percent (by volume) ethyl alcohol in distilled
water at 70 C for 2 hours, using a volume-to-surface ratio of 2
milliliters per square inch.
(d) The provisions of this section are not applicable to
4,4'-isopropylidene-diphenol-epichlorohydrin resins listed in other
sections of Subchapter B of this chapter.
21 CFR 177.1460 Melamine-formaldehyde resins in molded articles.
Melamine-formaldehyde resins may be safely used as the food-contact
surface of molded articles intended for use in producing, manufacturing,
packing, processing, preparing, treating, packaging, transporting, or
holding food in accordance with the following prescribed conditions:
(a) For the purpose of this section, melamine-formaldehyde resins are
those produced when 1 mole of melamine is made to react with not more
than 3 moles of formaldehyde in water solution.
(b) The resins may be mixed with refined woodpulp and the mixture may
contain other optional adjuvant substances which may include the
following:
(c) The molded melamine-formaldehyde articles in the finished form in
which they are to contact food, when extracted with the solvent or
solvents characterizing the type of food and under the conditions of
time and temperature as determined from Tables 1 and 2 of 175.300(d) of
this chapter, shall yield net chloroform-soluble extractives not to
exceed 0.5 milligram per square inch of food-contact surface.
(42 FR 14572, Mar. 15, 1977, as amended at 56 FR 42933, Aug. 30,
1991)
21 CFR 177.1480 Nitrile rubber modified acrylonitrile-methyl acrylate
copolymers.
Nitrile rubber modified acrylonitrile-methyl acrylate copolymers
identified in this section may be safely used as components of articles
intended for food-contact use under conditions of use D, E, F, or G
described in table 2 of 176.170(c) of this chapter, subject to the
provisions of this section.
(a) For the purpose of this section, nitrile rubber modified
acrylonitrile-methyl acrylate copolymers consist of basic copolymers
produced by the graft copolymerization of 73-77 parts by weight of
acrylonitrile and 23-27 parts by weight of methyl acrylate in the
presence of 8-10 parts by weight of butadiene-acrylonitrile copolymers
containing approximately 70 percent by weight of polymer units derived
from butadiene.
(b) The nitrile rubber modified acrylonitrile-methyl acrylate basic
copolymers meet the following specifications and extractives
limitations:
(1) Specifications. (i) Nitrogen content is in the range 16.5-19
percent as determined by Kjeldahl analysis.
(ii) Intrinsic viscosity in acetonitrile at 25 C is not less than
0.29 deciliter per gram as determined by ASTM method D1243-79,
''Standard Test Method for Dilute Solution Viscosity of Vinyl Chloride
Polymers,'' which is incorporated by reference. Copies may be obtained
from the American Society for Testing Materials, 1916 Race St.,
Philadelphia, PA 19103, or may be examined at the Office of the Federal
Register, 1100 L St. NW., Washington, DC 20408.
(iii) Residual acrylonitrile monomer content is not more than 11
parts per million as determined by gas chromatography.
(iv) Acetonitrile-soluble fraction after refluxing the base polymer
in acetonitrile for 1 hour is not greater than 95 percent by weight of
the basic copolymers.
(2) Extractives limitations. The following extractive limitations
are determined by an infrared spectrophotometric method titled,
''Infrared Spectrophotometric Determination of Polymer Extracted from
Borex# 210 Resin Pellets,'' which is incorporated by reference. Copies
are available from the Division of Food and Color Additives, Center for
Food Safety and Applied Nutrition (HFF-334), 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, and are applicable to the basic copolymers in the
form of particles of a size that will pass through a U.S. standard sieve
No. 6 and that will be held on a U.S. standard sieve No. 10:
(i) Extracted copolymer not to exceed 2.0 parts per million in
aqueous extract obtained when a 100-gram sample of the basic copolymers
is extracted with 250 milliliters of demineralized (deionized) water at
reflux temperature for 2 hours.
(ii) Extracted copolymer not to exceed 0.5 part per million in
n-heptane extract obtained when a 100-gram sample of the basic
copolymers is extracted with 250 milliliters of reagent grade n-heptane
at reflux temperature for 2 hours.
(c) Acrylonitrile copolymers identified in this section shall comply
with the provisions of 180.22 of this chapter.
(d) Acrylonitrile copolymers identified in this section are not
authorized to be used to fabricate beverage containers.
(42 FR 14572, Mar. 15, 1977, as amended at 42 FR 48544, Sept. 23,
1977; 47 FR 11843, Mar. 19, 1982; 47 FR 16775, Apr. 20, 1982; 49 FR
10109, Mar. 19, 1984; 54 FR 24898, June 12, 1989)
21 CFR 177.1500 Nylon resins.
The nylon resins listed in paragraph (a) of this section may be
safely used to produce articles intended for use in processing,
handling, and packaging food, subject to the provisions of this section:
(a) The nylon resins are manufactured as described in this paragraph
so as to meet the specifications prescribed in paragraph (b) of this
section when tested by the methods described in paragraph (c) of this
section.
(1) Nylon 66 resins are manufactured by the condensation of
hexamethylene-diamine and adipic acid.
(2) Nylon 610 resins are manufactured by the condensation of
hexamethylene-diamine and sebacic acid.
(3) Nylon 66/610 resins are manufactured by the condensation of
equal-weight mixtures of nylon 66 salts and nylon 610 salts.
(4) Nylon 6/66 resins manufactured by the condensation and
polymerization of Nylon 66 salts and epsilon-caprolactam.
(5) Nylon 11 resins are manufactured by the condensation of
11-aminoundecanoic acid.
(6) Nylon 6 resins are manufactured by the polymerization of
epsilon-caprolactam.
(7) Nylon 66T resins are manufactured by the condensation of
hexamethyl-enediamine, adipic acid, and terephthalic acid such that
composition in terms of ingredients is 43.1 0.2 weight percent
hexamethyl-enediamine, 35.3 1.2 weight percent adipic acid, and 21.6 1.2
weight percent terephthalic acid.
(8) Nylon 612 resins are manufactured by the condensation of
hexamethylenediamine and dodecanedioic acid.
(9) Nylon 12 resins are manufactured by the condensation of
omega-laurolactam.
(10)(i) Impact modified Nylon MXD-6 resins (CAS Reg. No. 59655-05-9)
manufactured by the condensation of adipic acid,
1,3-benzenedimethanamine, and
T3alpha-(3-aminopropyl)-omega-(3-amino-popoxy)poly- oxyethylene under
such conditions that the alpha-(3-amino-propyl)-omega-(3-aminopropoxy)
polyoxyethylene monomer content does not exceed 7 percent by weight of
the finished resin.
(ii) Nylon MXD-6 resins (CAS Reg. No. 25718-70-1) manufactured by the
condensation of adipic acid and 1,3-benzenedimethanamine.
(11) Nylon 12T resins are manufactured by the condensation of
omega-laurolactam (CAS Reg. No. 0947-04-6), isophthalic acid (CAS Reg.
No. 0121-91-5), and bis(4-amino-3-methylcycl-ohexyl)methane (CAS Reg.
No. 6864-37-5) such that the composition in terms of ingredients is 34.4
1.5 weight percent omega-laurolactam, 26.8 0.4 weight percent
isophthalic acid, and 38.8 0.5 weight percent
bis(4-amino-3-methylcyclohexyl)-methane.
(12) Nylon 6I/6T resins (CAS Reg. No. 25750-23-6) are manufactured by
the condensation of hexamethylenediamine, terephthalic acid, and
isophthalic acid such that 65 to 80 percent of the polymer units are
derived from hexamethylene isophthalamide.
(13) Nylon 6/12 resins (CAS Reg. No. 25194-04-2) are manufactured by
the copolymerization of a 1 to 1 ratio by weight of epsilon-caprolactam
and omega-laurolactam.
(14) Nylon 6/69 resins (CAS Reg. No. 51995-62-1) are manufactured by
the condensation of 49.5+0.5 weight percent epsilon-caprolactam,
19.4+0.2 weight percent hexamethylenediamine and 31.2+0.3 weight percent
azelaic acid.
(b) Specifications:
(c) Analytical methods -- (1) Specific gravity. Specific gravity
shall be determined by weighing a 1-gram to 5-gram sample first in air
and then in freshly boiled distilled water at 23 C 2 C.
(2) Melting point. The melting point shall be determined as follows:
Use a hot-stage apparatus. The use of crossed nicol prisms with a
microscope hot stage and reading of the thermometer when the
birefringence disappears increases the accuracy. If the crossed nicol
apparatus is not available, use the lowest temperature at which the
sample becomes transparent or the sharp edges or corners of the sample
become rounded as the melting point. In case of doubt as to the onset
of melting, the sample is prodded with a sharp instrument. If it sticks
to the heating block, it is considered to have melted. If the melting
point is low, dry the sample in an oven at 85 C for 24 hours in a
nitrogen atmosphere then repeat the test.
(3) Solubility in boiling 4.2N HCl. The test shall be run on a sample
approximately the size of a 1/8-inch cube in at least 25 milliliters of
4.2 normal hydrochloric acid.
(4) Maximum extractable fraction in selected solvents. The procedure
for determining the maximum extractable fraction of the nylon resins in
selected solvents is as follows:
(i) Film should be cut with ordinary scissors into pieces of a
convenient size such as 1/4-inch squares, for the extraction tests
described in this section. The granules of nylon molding powders are in
the proper form for the extraction tests. Samples of fabricated
articles such as pipe, fittings, and other similar articles must be cut
to approximately the size of the molding powder. This can be done
conveniently by using a small-scale commercial plastics granulator and
cutting the sample through a screen having 1/4-inch mesh. Fine
particles should be separated from the cut resin by screening through a
20-mesh screen. The material retained on the screen is suitable for the
extraction tests.
(ii) The organic solvents must be of American Chemical Society
analytical reagent grade; distilled water is used. Approximately 30
grams of the prepared sample is weighed to the nearest milligram. The
weighed resin is transferred to a 500-milliliter round-bottom flask
equipped with a reflux condenser. Approximately 300-milliliters of
solvent is added to the flask and the contents refluxed gently for 8
hours with a heating mantle. The solvent is then filtered off
immediately while still hot, using a Buchner funnel approximately 5
inches in diameter, a suction flask, and a hardened filter paper
(Whatman No. 50 or equivalent). The paper is wet with the solvent and a
slight suction applied just before starting the filtration. The resin
is washed twice with approximately 100-milliliter portions of solvent
and the combined filtrate and washings are reduced to approximately 25
milliliters by evaporation at reduced pressure (50 millimeters to 100
millimeters of mercury, absolute), heating as necessary. The contents
of the flask are transferred to an evaporation dish (which has been held
in a vacuum desiccator over anhydrous calcium sulfate until constant
weight has been attained) and carefully evaporated to dryness. The
weight of the solid residue is determined by difference after holding in
a vacuum desiccator over anhydrous calcium sulfate until constant weight
has been attained. The percent of solids extracted is calculated by
dividing the weight of the solid residue by the weight of the sample and
multiplying by 100.
(5) Viscosity number (VN). (i) The viscosity number (VN) for Nylon
6/12 resin in a 96 percent sulfuric acid solution (5 milligrams resin
per milliliter) shall be determined at 25 C (77 F) by method ISO
307-1984(E), ''Plastics-Polyamides-Determination of Viscosity Number,''
which is incorporated by reference. Copies are available from the
Division of Food and Color Additives, Center for Food Safety and Applied
Nutrition (HFF-335), 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. DC 20408.
(ii) The viscosity number (VN) for Nylon 6/69 resin in a 99 percent
cresol solution (5 milligrams resin per milliliter) shall be determined
at 25 C (77 F) by method ISO 307-1984(E),
''Plastics-Polyamides-Determination of Viscosity Number,'' which is
incorporated by reference. The availability of this incorporation by
reference is given in paragraph (c)(5)(i) of this section.
(42 FR 14572, Mar. 15, 1977, as amended at 45 FR 2844, Jan. 15, 1980;
48 FR 30361, July 1, 1983; 48 FR 33478, July 22, 1983; 48 FR 36099,
Aug. 9, 1983; 51 FR 33250, Sept. 19, 1986; 52 FR 26667, July 16, 1987;
52 FR 33575, Sept. 4, 1987; 52 FR 39635, Oct. 23, 1987; 52 FR 42760,
Nov. 6, 1987; 53 FR 19773, May 31, 1988; 54 FR 29019, July 11, 1989)
21 CFR 177.1520 Olefin polymers.
The olefin polymers listed in paragraph (a) of this section may be
safely used as articles or components of articles intended for use in
contact with food, subject to the provisions of this section.
(a) For the purpose of this section, olefin polymers are basic
polymers manufactured as described in this paragraph, so as to meet the
specifications prescribed in paragraph (c) of this section, when tested
by the methods described in paragraph (d) of this section.
(1) Polypropylene consists of basic polymers manufactured by the
catalytic polymerization of propylene.
(2) Polyethylene consists of basic polymers manufactured by the
catalytic polymerization of ethylene.
(3) Olefin basic copolymers consist of basic copolymers manufactured
by the catalytic copolymerization of:
(i) Two or more of the 1-alkenes having 2 to 8 carbon atoms. Such
olefin basic copolymers contain not less than 96 weight-percent of
polymer units derived from ethylene and/or propylene, except that:
(a) Olefin basic copolymers manufactured by the catalytic
copolymerization of ethylene and hexene-1 or ethylene and octene-1 shall
contain not less than 90 weight-percent of polymer units derived from
ethylene;
(b) Olefin basic copolymers manufactured by the catalytic
copolymerization of ethylene and 4-methylpentene-1 shall contain not
less than 89 weight-percent of polymer units derived from ethylene;
(c)(1) Olefin basic copolymers manufactured by the catalytic
copolymerization of two or more of the monomers ethylene, propylene,
butene-1, 2-methylpropene-1, and 2,4,4-trimethylpentene-1 shall contain
not less than 85 weight-percent of polymer units derived from ethylene
and/or propylene;
(2) Olefin basic copolymers manufactured by the catalytic
copolymerization of propylene and butene-1 shall contain greater than 15
but not greater than 35 weight percent of polymer units derived from
butene-1 with the remainder being propylene.
(d) Olefin basic terpolymers manufactured by the catalytic
copolymerization of ethylene, hexene-1, and either propylene or
butene-1, shall contain not less than 85 weight percent polymer units
derived from ethylene.
(ii) 4-Methylpentene-1 and 1-alkenes having 6 to 10 carbon atoms.
Such olefin basic copolymers shall contain not less than 95 molar
percent of polymer units derived from 4-methylpentene-1; or
(iii) Ethylene and propylene that may contain as modifiers not more
than 5 weight-percent of total polymer units derived by copolymerization
with one or more of the following monomers:
5-Ethylidine-2-norbornene.
5-Methylene-2-norbornene.
(iv) Ethylene and propylene that may contain as a modifier not more
than 4.5 weight percent of total polymer units derived by
copolymerization with 1,4-hexadiene.
(v) Ethylene and butene-1 copolymers (CAS Reg. No. 25087-34-7) that
shall contain not less than 80 weight percent of polymer units derived
from ethylene.
(4) Poly(methylpentene) consists of basic polymers manufactured by
the catalytic polymerization of 4-methylpentene-1.
(5) Polyethylene graft copolymers consist of polyethylene complying
with item 2.2 of paragraph (c) of this section which subsequently has
3a,4,7,7a-tetrahydromethyl-4,7-methanois3-dione grafted onto it at a
level not to exceed 1.7 percent by weight of the finished copolymer.
(b) The basic olefin polymers identified in paragraph (a) of this
section may contain optional adjuvant substances required in the
production of such basic olefin polymers. The optional adjuvant
substances required in the production of the basic olefin polymers or
finished food-contact articles may include substances permitted for such
use by applicable regulations in parts 170 through 189 of this chapter,
substances generally recognized as safe in food and food packaging,
substances used in accordance with a prior sanction or approval, and the
following:
(c) Specifications:
(d) The analytical methods for determining whether olefin polymers
conform to the specifications prescribed in this section are as follows,
and are applicable to the basic polymer in film form not exceeding 4
mils in thickness. The film to be tested shall be cut into
approximately 1-inch squares by any convenient method that avoids
contamination by dust, dirt, or grease (Note: Do not touch samples with
bare fingers -- use forceps to hold or transfer samples).
(1) Density. Density shall be determined by ASTM method D1505-68
(Reapproved 1979), ''Standard Test Method for Density of Plastics by the
Density-Gradient Technique,'' which is incorporated by reference.
Copies may be obtained from the American Society for Testing Materials,
1916 Race St., Philadelphia, PA 19103, or may be examined at the Office
of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(2) Melting point or softening point -- (i) Melting point. The
melting point shall be determined by ASTM method D2117-82, ''Standard
Test Method for Melting Point of Semicrystalline Polymers by the Hot
Stage Microscopy Method,'' which is incorporated by reference. The
availability of this incorporation by reference is given in paragraph
(d)(1) of this section.
(ii) Softening point. The softening point shall be determined by
ASTM method E28-67 (Reapproved 1982), ''Standard Test Method for
Softening Point by Ring-and-Ball Apparatus,'' which is incorporated by
reference. The availability of this incorporation by reference is given
in paragraph (d)(1) of this section.
(3) Maximum extractable fraction in n-hexane -- (i) Olefin copolymers
described in paragraph (a)(3)(ii) of this section, polypropylene, and
poly(methylpentene). A sample is refluxed in the solvent for 2 hours
and filtered at the boiling point. The filtrate is evaporated and the
total residue weighed as a measure of the solvent extractable fraction.
(a) Apparatus. (1) Erlenmeyer flasks, 250-milliliter, with ground
joint.
(2) Condensers, Allihn, 400-millimeter jacket, with ground joint.
(3) Funnels, ribbed 75-millimeter diameter, stem cut to 40
millimeters.
(4) Funnels, Buchner type, with coarse-porosity fritted disc,
60-millimeter diameter.
(5) Bell jar for vacuum filtration into beaker.
(b) Reagent. n-Hexane, commercial grade, specific gravity
0.663-0.667 (20 C/20 C), boiling range 66 C-69 C, or equivalent.
(c) Procedure. Weigh 1 gram of sample accurately and place in a
250-milliliter Erlenmeyer flask containing two or three boiling stones.
Add 100 milliliters of solvent, attach the flask to the condenser (use
no grease), and reflux the mixture for 2 hours. Remove the flask from
the heat, disconnect the condenser, and filter rapidly, while still hot,
through a small wad of glass wool packed in a short-stem funnel into a
tared 150-millimeter beaker. Rinse the flask and filter with two
10-milliliter portions of the hot solvent, and add the rinsings to the
filtrate. Evaporate the filtrate on a stream bath with the aid of a
stream of nitrogen. Dry the residue in a vacuum oven at 110 C for 2
hours, cool in a desiccator, and weigh to the nearest 0.0001 gram.
Determine the blank on 120 milliliters of solvent evaporated in a tared
150-milliliter beaker. Correct the sample residue for this blank if
significant. Calculation:
Grams of residue/Grams of sample 100=Percent extractable with
n-hexane.
(ii) Olefin copolymers described in paragraph (a)(3)(i) of this
section and polyethylene. A sample is extracted at 50 C in the solvent
for 2 hours and filtered. The filtrate is evaporated and the total
residue weighed as a measure of the solvent extractable fraction.
(a) Extraction apparatus. Two-liter, straight-walled, Pyrex (or
equivalent) resin kettles, fitted with three-hole ground-glass covers
are most convenient for this purpose. The cover is fitted with a
thermometer, a gas-tight stirrer driven by an air motor or
explosion-proof electric motor, and a reflux condenser. The kettle is
fitted with an electric heating mantle of appropriate size and shape,
which is controlled by a variable-voltage transformer.
(b) Evaporating apparatus. Rapid evaporation of large volumes of
solvent requires special precautions to prevent contamination by dust.
This is facilitated by a special ''gas'' cover consisting of an inverted
flat Pyrex crystallizing dish of an appropriate size (190 millimeters x
100 millimeters) to fit a 1-liter beaker. Through the center of the
dish are sealed an inlet tube for preheated, oxygen-free nitrogen, and
an outlet tube located 1 inch off center. Nitrogen is fed from the
supply source through a coil of 1/4-inch stainless steel tubing immersed
in the same steam bath used to supply heat for solvent evaporation. All
connections are made with flexible tetrafluoroethylene tubing.
(c) Reagents -- (1) n-Hexane. Spectrograde n-hexane.
(2) Nitrogen. High-purity dry nitrogen containing less than 10 parts
per million of oxygen.
(d) Procedure. Transfer 2.5 grams (accurately weighed to nearest
0.001 gram) of the polymer to the resin kettle. Add 1 liter of solvent
and clamp top in position. Start water flowing through jacket of the
reflux condenser and apply air pressure to the stirring motor to produce
vigorous agitation. Turn on heating jacket with transformer set at a
predetermined voltage to bring the temperature of the contents to 50 C
within 20-25 minutes. As the thermometer reading approaches 45 C-47
C, reduce the voltage to the predetermined setting that will just
maintain the temperature at 50 C. Do not overshoot the prescribed
temperature. Should this occur discard the test and start afresh.
Exactly 2 hours after the solvent temperature has reached 50 C,
disconnect the heater, remove the resin kettle from the heating jacket,
and decant the solvent, while still warm, through a coarse filter paper
placed on top of a fritted-glass funnel, collecting the filtrate in a
tared, glass-stoppered Erlenmeyer flask of 1-liter capacity. Determine
the weight of the filtrate recovered to the nearest gram. Recovery
should be at least 90 percent of the original solvent. Losses due to
evaporation during heating and filtering have been found not to exceed
10 percent. Transfer about half of the solvent filtrate to a 1-liter
beaker placed on an opening in the steam bath and immediately cover with
the special ''gas'' cover, the inlet tube of which has been attached
with flexible tetrafluoroethylene tubing to a source of high-purity
nitrogen in series with a stainless steel heating coil immersed directly
in the body of the steam bath. Maintain a positive flow of warm
nitrogen gas throughout the evaporation of the solvent, adding the
remainder of the filtrate from the Erlenmeyer flask as the evaporation
proceeds. When the volume of the solvent has been reduced to about 50
milliliters, transfer the concentrated liquid to a previously tared
weighing dish of suitable size. Wash the beaker twice with 20-30
milliliter portions of warm solvent, adding the washings to the weighing
dish while continuing to evaporate the remainder of the solvent under
the gas cover with its flow of warm nitrogen directed toward the center
of the dish. In the event that an insoluble residue that cannot be
removed with warm solvent remains in the beaker, it may be necessary to
heat with a small amount of a higher boiling solvent such as benzene or
toluene, transferring these washings to the weighing dish before final
evaporation to dryness. Transfer the weighing dish with its residue to
a vacuum desiccator, and allow it to remain overnight (at least 12
hours), after which the net weight of the dry residue is determined to
the nearest 0.0001 gram. Correct the result for any solvent blank
equivalent to the nonvolatile matter determined to be contained in the
amount of solvents used in the test.
(4) Maximum soluble fraction in xylene -- (i) Olefin copolymers
described in paragraph (a)(3)(ii) of this section, polypropylene, and
poly(methylpen-tene). A sample is dissolved completely in xylene by
heating and stirring in a bottle with little free space. The solution
is allowed to cool without stirring, whereupon the insoluble portion
precipitates and is filtered off; the total solids content of the
filtrate is then determined as a measure of the soluble fraction.
(a) Apparatus. (1) Pyrex (or equivalent) reagent bottle,
125-milliliter, glass-stoppered.
(2) Heating mantle of size for 150-milliliter beaker (or suitable
aluminum block to fit the 125-milliter bottle described in paragraph
(d)(4)(i)(a)(1) of this section.
(3) Magnetic stirrer for use under the heating mantle (combination
magnetic stirrer and hotplate may be used if aluminum block is used in
place of heating mantle).
(4) Variable-voltage transformer, 7.5 amperes.
(5) Tetrafluoroethylene-resin-coated stirring bar, 1-inch long.
(6) Constant temperature water bath maintained at 25 C 0.5 C.
(7) Aluminum dishes, 18 millimeters x 60 millimeters, disposable.
(8) Funnel, Buchner type, with coarse-porosity fritted disc, 30-60
millimeter diameter.
(b) Reagent. Xylene with antioxidant. Dissolve 0.020 gram of
phenyl- - naphthylamine in 1 liter of industrial grade xylene having
specific gravity 0.856-0.867 (20 C/20 C) and boiling range 123 C-160
C.
(c) Procedure. Weigh 1 to 2 grams of sample to the nearest 0.001
gram and place in a 125-milliliter Pyrex reagent bottle containing a
1-inch long tetrafluoroethylene-resin-coated stirring bar. Add 100
milliliters of solvent, set the stopper in lightly, and place the bottle
in the heating mantle or aluminum block maintained at a temperature of
120 C, and stir with a magnetic stirrer until the sample is completely
dissolved. Remove the bottle from the heat and allow it to cool 1 hour
in the air, without stirring. Then place the bottle in a water bath
maintained at 25 C 0.5 C, and allow to stand 1 hour without stirring.
Next, remove the bottle from the water bath, shake, and pour part of the
contents into the coarse-porosity fritted-glass funnel. Apply suction,
and draw 30-40 milliliters of filtrate through, adding more slurry to
the funnel, and catching the filtrate in a large test tube. (If the
slurry is hard to filter, add 10 grams of diatomaceous earth filter aid
to the bottle and shake vigorously just prior to the filtration.) Pipet
a suitable aliquot (preferably 20 milliliters) of the filtrate into a
tared aluminum disposable dish. Place the dish on a steam bath covered
with a fresh sheet of aluminum foil and invert a short-stemmed 4-inch
funnel over the dish. Pass nitrogen (heated if desired) down through
the funnel at a rate sufficient to just ripple the surface of the
solvent. When the liquid has evaporated, place the dish in a vacuum
oven at 140 C and less than 50 millimeters mercury pressure for 2
hours. Cool in a desiccator and weigh. (Note: If the residue value
seems high, redry in the vacuum oven for one-half hour to ensure
complete removal of all xylene solvent.) Calculation:
Grams of residue/Grams of sample 100 milliliters/volume of aliquot
in milliliters 100=Percent soluble in xylene
(ii) Olefin copolymers described in paragraph (a)(3)(i) of this
section and polyethylene. A sample is extracted in xylene at reflux
temperature for 2 hours and filtered. The filtrate is evaporated and
the total residue weighed as a measure of soluble fraction.
(a) Apparatus -- (1) Extraction apparatus. Two-liter,
straight-walled Pyrex (or equivalent) resin kettles, fitted with
ground-glass covers, are most convenient for this purpose. The cover is
equipped with a thermometer and an efficient reflux condenser. The
kettle is fitted with an electric heating mantle of appropriate size and
shape which is controlled by a variable-voltage transformer.
(2) Constant temperature water bath. It must be large enough to
permit immersion of the extraction kettle and set to maintain 25 C 0.1
C.
(3) Evaporating apparatus. Gas cover consisting of a flat Pyrex
crystallizing dish (190 millimeters x 100 millimeters) inverted to fit
over a 1-liter beaker with 8-millimeter gas inlet tube sealed through
center and an outlet tube 1 inch off center. The beaker with gas cover
is inserted in an electric heating mantle equipped with a
variable-voltage transformer. The outlet tube is attached to an
efficient condenser mounted on a receiving flask for solvent recovery
and having an outlet for connection to an aspirator pump. The heating
mantle (with the beaker) is mounted on a magnetic stirring device. An
infrared heat lamp is mounted vertically 3-4 inches above the gas cover
to prevent condensation of the solvent inside the cover. Make all
connections with flexible tetrafluoroethylene tubing.
(b) Reagents -- (1) Xylene. American Chemical Society reagent grade
that has been redistilled through a fractionating column to reduce the
nonvolatile residue.
(2) Nitrogen. High-purity dry nitrogen containing less than 104
parts per million oxygen.
(c) Procedure. Transfer 5 grams 0.001 gram of sample to the resin
kettle, add 1,000 milliliters (840 grams) of xylene, and clamp top in
position after inserting a piece of glass rod to prevent bumping during
reflux. Start water flowing through the jacket of the reflux condenser
and apply full voltage (115 volts) to the heating mantle. When the
xylene starts to boil, reduce the voltage to a level just sufficient to
maintain reflux. After refluxing for at least 2 hours, disconnect the
power source to the mantle, remove the kettle, and allow to cool in air
until the temperature of the contents drops to 50 C, after which the
kettle may be rapidly cooled to 25 C-30 C by immersing in a cold water
bath. Transfer the kettle to a constant temperature bath set to
maintain 25 C 0.1 C, and allow to equilibrate for a least 1 hour (may
be left overnight if convenient). Break up any precipitated polymers
that may have formed, and decant the xylene solution successively
through a fast filter paper and then through a fritted-glass filter into
a tared 1-liter Erlenmeyer flask, collecting only the first 450
milliliters -- 500 milliliters of filtrate (any attempt to collect more
of the xylene solution usually results in clogging the filter and
risking losses). Reweigh the Erlenmeyer flask and calculate the weight
of the filtrate obtained to the nearest 0.1 gram. Transfer the filtrate,
quantitatively, from the Erlenmeyer flask to the 1-liter beaker, insert
the beaker in its heating mantle, add a glass-coated magnetic stirring
bar, and mount the gas cover in place, connecting the inlet tube to the
nitrogen source and the outlet to the condenser of the receiving flask.
Start a flow of nitrogen (2 to 3 liters per minute) into the gas cover
and connect an aspirator to the receiver using a free-flow rate
equivalent to 6-7 liters of air per minute. With the infrared lamp on,
adjust the voltage to the heating mantle to give a distillation rate of
12-13 milliliters per minute when the magnetic stirrer is revolving just
fast enough to promote good boiling. When the volume of solvent in the
beaker has been reduced to 30-50 milliliters, transfer the concentrated
extractive to a suitable weighing dish that has been previously tared
(dry). Rinse the beaker twice with 10-20 milliliter portions of fresh
xylene, adding the rinsings to the weighing dish. Evaporate the
remainder of the xylene on an electric hotplate set at low heat under
the gas cover with a stream of nitrogen directed toward the center of
the dish. Avoid any charring of the residue. Transfer the weighing
dish to a vacuum desiccator at room temperature and allow to remain
under reduced pressure for at least 12 hours (overnight), after which
determine the net weight of the residue to the nearest 0.0001 gram.
Correct the result for nonvolatile solvent blank obtained by evaporating
the equivalent amount of xylene under identical conditions. Calculate
the weight of residue originally present in the total weight of solvent
(840 grams), using the appropriate factor based on the weight of
filtrate evaporated.
(5) Viscosity average molecular weight olefin copolymers described in
paragraphs (a) (3) (iii) and (iv) of this section. The viscosity
average molecular weight shall be determined from the kinematic
viscosity (using ASTM method D445-74, ''Test for Kinematic Viscosity of
Transparent and Opaque Liquids'' (Revised 1974), which is incorporated
by reference; copies are available from American Society for Testing
and Materials (ASTM), 1916 Race Street, Philadelphia, PA 19103, or
available for inspection at the Office of the Federal Register, 1100 L
St. NW., Washington, DC 20408) of solutions of the copolymers in
solvents and at temperatures as follows:
(i) Olefin polymers described in paragraph (a)(3)(iii) of this
section in decahydronaphthalene at 135 C.
(ii) Olefin polymers described in paragraph (a)(3)(iv) of this
section in tetrachloroethylene at 30 C.
(6) Mooney viscosity -- olefin copolymers described in paragraph
(a)(3)(iii) of this section. Mooney viscosity is determined by ASTM
method D1646-81, ''Standard Test Method for Rubber -- Viscosity and
Vulcanization Characteristics (Mooney Viscometer),'' which is
incorporated by reference (the availability of this incorporation by
reference is given in paragraph (d)(1) of this section), using the large
rotor at a temperature of 100 C, except that a temperature of 127 C
shall be used for those copolymers whose Mooney viscosity cannot be
determined at 100 C. The apparatus containing the sample is warmed for
1 minute, run for 8 minutes, and viscosity measurements are then made.
(7) Melt flow index. The melt flow index of olefin polymers
described below shall be determined by ASTM method D-1238-82, ''Standard
Test Method for Flow Rates of Thermoplastics by Extrusion Plastometer,''
which is incorporated by reference in accordance with 5 U.S.C. 552(a).
The availability of this incorporation by reference is given in
paragraph (d)(1) of this section. The olefin polymers and test
conditions and procedures are as follows:
(8) Melting peak temperature. The melt temperature of the olefin
polymers described in paragraph (a)(3)(ii) of this section shall be
determined by ASTM method D 3418-82, ''Standard Test Method for
Transition Temperatures of Polymers by Thermal Analysis,'' which is
incorporated by reference in accordance with 5 U.S.C. 552(a). The
availability of this incorporation by reference is given in paragraph
(d)(1) of this section.
(9) Intrinsic viscosity. The intrinsic viscosity of the olefin
polymers described in paragraph (a)(3)(ii) of this section shall be
determined by ASTM method D 1601-78, ''Standard Test Method for Dilute
Solution Viscosity of Ethylene Polymers,'' which is incorporated by
reference in accordance with 5 U.S.C. 552(a). The availability of this
incorporation by reference is given in paragraph (d)(1) of this section.
(e) Olefin copolymers described in paragraph (a)(3) (i) of this
section and polyethylene, alone or in combination, may be subjected to
irradiation bombardment from a source not to exceed 2.3 million volts
intensity to cause molecular crosslinking of the polymers to impart
desired properties, such as increased strength and increased ability to
shrink when exposed to heat.
(f) The olefin polymers identified in and complying with this
section, when used as components of the food-contact surface of any
article that is the subject of a regulation in parts 174, 175, 176, 177,
178, and 179.45 of this chapter, shall comply with any specifications
and limitations prescribed by such regulation for the article in the
finished form in which it is to contact food.
(g) The provisions of this section are not applicable to olefin
polymers identified in 175.105(c) (5) of this chapter and used in
food-packaging adhesives complying with 175.105 of this chapter.
(42 FR 14572, Mar. 15, 1977)
Editorial Note: For Federal Register citations affecting 177.1520,
see the List of CFR Sections Affected in the Finding Aids section of
this volume.
21 CFR 177.1550 Perfluorocarbon resins.
Perfluorocarbon resins identified in this section may be safely used
as articles or components of articles intended to contact food, subject
to the provisions of this section:
(a) Identity. For the purpose of this section, perfluorocarbon
resins are those produced by: (1) The homopolymerization and/or
copolymerization of hexafluoropropylene and tetrafluoroethylene, and (2)
the copolymerization of perfluoropropylvinylether and
tetrafluoroethylene (CAS Reg. No. 26655-00-5). The resins shall meet the
extractives limitations in paragraph (d) of this section.
(b) Optional components. The perfluorocarbon resins identified in
paragraph (a) of this section as well as articles or coating made from
these resins may include the following optional components except that
the resin identified in paragraph (a)(2) of this section may not be used
with the optional component, lithium polysilicate, mentioned in
paragraph (b)(4) of this section.
(1) Substances generally recognized as safe (GRAS) in food or food
packaging subject to any limitations cited on their use.
(2) Substances used in accordance with a prior sanction or approval,
subject to any limitations cited in the prior sanction or approval.
(3) Substances authorized under applicable regulations in this part
and in parts 175 and 178 of this chapter and subject to any limitations
prescribed therein.
(4) The following substances, subject to any limitations prescribed:
(c) Optional processing. Poly- tetrafluoroethylene resins may be
irradiated by either a cobalt-60 sealed source, at a maximum dose of
gamma radiation not to exceed 7.5 megarads, or an electron beam at
energy levels not to exceed 2.5 million electron volts with a maximum
dosage of 7.5 megarads, to produce lubricant powders having a particle
diameter of not more than 20 microns for use only as components of
articles intended for repeated use in contact with food.
(d) Specifications -- (1) Infrared identification. Perfluorocarbon
resins can be identified by their characteristic infrared spectra.
(2) Melt-viscosity. (i) The perfluorocarbon resins identified in
paragraph (a)(1) of this section shall have a melt viscosity of not less
than 104 poises at 380 C (716 F) as determined by ASTM method
D1238-82, ''Standard Test Method for Flow Rates of Thermoplastics by
Extrusion Plastometer,'' which is incorporated by reference. Copies may
be obtained from the American Society for Testing Materials, 1916 Race
St., Philadelphia, PA 19103, or may be examined at the Office of the
Federal Register, 1100 L St. NW., Washington, DC 20408. The melt
viscosity of the perfluorocarbon resins identified in paragraph (a)(1)
of this section shall not vary more than 50 percent within one-half hour
at 380 C (716 F).
(ii) Perfluorocarbon resins identified in paragraph (a)(2) of this
section shall have a melt viscosity of not less than 104 poises at 372
C (702 F) as determined by a more detailed method titled
''Determination of Melt Viscosity, Molecular Weight Distribution Index
and Viscosity Stability,'' which is incorporated by reference. Copies
are available from the Division of Food and Color Additives (HFF-330),
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.
(3) Thermal instability index. The thermal instability index of the
tetrafluoroethylene homopolymer shall not exceed 50 as determined by
ASTM method D1457-56T, ''Test for Thermal Instablility index of
Tetrafluoroethylene Homopolymer'' (Revised 1956), which is incorporated
by reference. Copies are available from University Microfilms
International, 300 N. Zeeb Rd., Ann Arbor, MI 48106, or available for
inspection at the Office of the Federal Register, 1100 L St. NW.,
Washington, DC 20408. The requirements of this paragraph do not apply
to polytetrafluoroethylene resin lubricant powders described in
paragraph (c) of this section.
(e) Limitations. /1/ (1) Perfluorocarbon-molded articles having a
surface area of 6.45 square decimeters (100 square inches) or more and
at least 1.27 millimeters (0.05 inch) thick shall be extracted at reflux
temperatures for 2 hours separately with distilled water, 50 percent
ethanol, n-heptane, and ethyl acetate.
(2) Perfluorocarbon resins identified in paragraphs (a)(1) and (2) of
this section and intended for use as coatings or components of coatings
shall meet extractability limits prescribed in paragraph (e)(3) of this
section when the resins in the form of coatings described in paragraphs
(e)(2) (i) and (ii) of this section are extracted at reflux temperatures
for 2 hours separately with distilled water, 8 percent ethanol, and
n-heptane:
(i) Perfluorocarbon resin coatings based on resins identified in
paragraph (a)(1) of this section shall be applied to both sides of a
0.025-millimeter (0.001 inch) thick aluminum foil to a thickness of
0.025 millimeter (0.001 inch) after thermal curing at 399 C (750 F)
for 10 minutes. If a primer is used, the total thickness of the primer
plus topcoat shall equal 0.025 millimeter (0.001 inch) after heat
curing.
(ii) Perfluorocarbon resin coatings based on resins identified in
paragraph (a)(2) of this section shall be applied to both sides of a
0.025-millimeter (0.001 inch) thick aluminum foil to a thickness of 0.10
millimeter (0.004 inch) after thermal curing at 427 C (800 F) for 10
minutes. If a primer is used, the total thickness of the primer plus
topcoat shall equal 0.10 millimeter (0.004 inch) after heat curing.
(3) The extracted surfaces shall meet the following extractability
limits:
(i) Total extractives not to exceed 3.1 milligrams per square
decimeter (0.2 milligram per square inch).
(ii) Fluoride extractives calculated as fluorine not to exceed 0.46
milligram per square decimeter (0.03 milligram per square inch).
(f) Conditions of use. Perfluorocarbon resins identified in
paragraph (a)(2) of this section are limited to use as coatings or
components of coatings for articles intended for repeated food-contact
use.
(43 FR 44834, Sept. 29, 1978, as amended at 47 FR 11843, Mar. 19,
1982; 47 FR 14699, Apr. 6, 1982; 49 FR 10109, Mar. 19, 1984; 50 FR
1502, Jan. 11, 1985; 54 FR 24898, June 12, 1989)
/1/ A more detailed procedure of extraction conditions is entitled,
''Preparation of Extracts,'' which is incorporated by reference. Copies
are available from the Division of Food and Color Additives, Center for
Food Safety and Applied Nutrition (HFF-330), 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.
21 CFR 177.1555 Polyarylate resins.
Polyarylate resins (CAS Reg. No. 51706-10-6) may be safely used as
articles or components of articles intended for use in contact with food
in accordance with the following prescribed conditions:
(a) Identity. Polyarylate resins (1, 3-benzenedicarboxylic acid,
diphenyl ester, polymer with diphenyl 1,4-benzenedicarboxylate and 4-4
-(1-methylethylidine) bis(phenol)) are formed by melt polycondensation
of bisphenol-A with diphenylisophthalate and diphenylterephthalate.
(b) Specifications. (1) The finished copolymers shall contain from
70 to 80 weight percent of polymer units derived from
diphenylisophthalate and 20 to 30 weight percent of polymer units
derived from diphenylterephthalate.
(2) Polyarylate resins shall have a minimum weight average molecular
weight of 20,000.
(3) Polyarylate resins may be identified by their characteristic
infrared spectra.
(c) Extractive limitations. The finished polyarylate resins in sheet
form at least 0.5 millimeter (0.020 inch) thick, when extracted with
water at 121 C (250 F) for 2 hours, shall yield total nonvolatile
extractives not to exceed 2.33 micrograms per square centimeter (15
micrograms per square inch) of the exposed resin surface.
(d) Limitations. Polyarylate resin articles may be used in contact
with all foods except beverages containing more than 8 volume percent
ethanol under conditions of use A through H, described in Table 2 of
176.170(c) of this chapter.
(52 FR 35540, Sept. 22, 1987)
21 CFR 177.1560 Polyarylsulfone resins.
Polyarylsulfone resins (CAS Reg. No. 79293-56-4) may be safely used
as articles or components of articles intended for use in contact with
food, at temperatures up to and including normal baking temperatures, in
accordance with the following prescribed conditions:
(a) Identity. Polyarylsulfone resins are copolymers containing not
more than 25 percent of oxy-p-phenylene-oxy-p-phenylenesulfonyl-henylene
polymer units and not less than 75 percent of
oxy-p-phenylenesulfonyl-p-phenylene-oxy-lenesulfonyl-p-phenylene polymer
units. The copolymers have a minimum reduced viscosity of 0.40
deciliter per gram in 1-methyl-2-pyrrolidinone in accordance with ASTM
method D2857-70 (Reapproved 1977), ''Standard Test Method for Dilute
Solution Viscosity of Polymers,'' which is incorporated by reference.
Copies may be obtained from the American Society for Testing and
Materials, 1916 Race St., Philadelphia, PA 19103, or may be examined at
the Office of the Federal Register, 1100 L St., NW., Washington, DC
20408.
(b) Optional adjuvant substances. The basic polyarylsulfone resins
identified in paragraph (a) of this section may contain optional
adjuvant substances required in the production of such basic copolymers.
These optional adjuvant substances may include substances permitted for
such use by regulations in parts 170 through 179 of this chapter,
substances generally recognized as safe in food, substances used in
accordance with a prior sanction of approval, and substances named in
this paragraph and further identified as required:
(c) Extractive limitations. The finished polyarylsulfone resin when
extracted for 2 hours with the following solvents at the specified
temperatures yields total extractives in each extracting solvent not to
exceed 0.008 milligram per square centimeter of food-contact surface:
distilled water at 121 C (250 F), 50 percent (by volume) ethyl alcohol
in distilled water at 71.1 C (160 F), 3 percent acetic acid in
distilled water at 100 C (212 F), and n-heptane at 65.6 C (150 F).
Note: In testing the finished polyarylsulfone resin use a separate
test sample for each required extracting solvent.
(50 FR 31046, July 24, 1985)
21 CFR 177.1570 Poly-1-butene resins and butene/ethylene copolymers.
The poly-1-butene resins and butene/ethylene copolymers identified in
this section may be safely used as articles or components of articles
intended for use in contact with food subject to the provisions of this
section.
(a) Identity. Poly-1-butene resins are produced by the catalytic
polymerization of 1-butene liquid monomer. Butene/ethylene copolymers
are produced by the catalytic polymerization of 1-butene liquid monomer
in the presence of small amounts of ethylene monomer so as to yield no
higher than a 6-weight percent concentration of polymer units derived
from ethylene in the copolymer.
(b) Specifications and limitations. Poly-1-butene resins and
butene/ethylene copolymers shall conform to the specifications
prescribed in paragraph (b)(1) of this section, and shall meet the
extractability limits prescribed in paragraph (b)(2) of this section.
(1) Specifications -- (i) Infrared identification. Poly-1-butene
resins and butene/ethylene copolymers can be identified by their
characteristic infrared spectra.
(ii) Viscosity. Poly-1-butene resins and the butene/ethylene
copolymers have an intrinsic viscosity 1.0 to 3.2 as determined by ASTM
method D1601-78, ''Standard Test Method for Dilute Solution Viscosity of
Ethylene Polymers,'' which is incorporated by reference. Copies may be
obtained from the American Society for Testing Materials, 1916 Race St.,
Philadelphia, PA 19103, or may be examined at the Office of the Federal
Register, 1100 L St. NW., Washington, DC 20408.
(iii) Density. Poly-1-butene resins have a density of 0.904 to 0.920
gms/cm3, and butene/ethylene copolymers have a density of 0.890 to 0.916
gms/cm3 as determined by ASTM method D1505-68 (Reapproved 1979),
''Standard Test Method for Density of Plastics by the Density-Gradient
Technique,'' which is incorporated by reference. The availability of
this incorporation by reference is given in paragraph (b)(1)(ii) of this
section.
(iv) Melt index. Poly-1-butene resins have a melt index of 0.1 to 24
and the butene/ethylene copolymers have a melt index of 0.1 to 20 as
determined by ASTM method D1238-82, condition E, ''Standard Test Method
for Flow Rates of Thermoplastics by Extrusion Plastometer,'' which is
incorporated by reference. The availability of this incorporation by
reference is given in paragraph (b)(1)(ii) of this section.
(2) Limitations. Poly-1-butene resins and butene/ethylene copolymers
for use in articles that contact food, and for articles used for packing
or holding food during cooking shall yield no more than the following
extractables:
(i) Poly-1-butene resins may be used as articles or components of
articles intended for use in contact with food, provided that the
maximum extractables do not exceed 2.5 percent by weight of the polymer
when film or molded samples are tested for 2 hours at 50 C (122 F) in
n-heptane.
(ii) Butene/ethylene copolymers containing no more than 6 percent by
weight of polymer units derived from ethylene may be used as articles or
components of articles intended for contact with food under conditions
of use B, C, D, E, F, G, or H described in Table 2 of 176.170(c) of
this chapter, subject to the provisions of this section and provided
that the maximum extractables from test films 0.1 to 0.2 millimeter
(0.004 to 0.008 inch) in thickness do not exceed 0.80 percent by weight
of the polymer when extracted in a soxhlet extractor for 6 hours with
refluxing 95 percent ethanol.
(iii) Poly-1-butene resins may be used as articles or components of
articles intended for packaging or holding food during cooking, provided
that the thickness of such polymers in the form in which they contact
food shall not exceed 0.1 millimeter (0.004 inch) and yield maximum
extractables of not more than 2.5 percent by weight of the polymer when
films are extracted for 2 hours at 50 C (122 F) in n-heptane.
(42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10109, Mar. 19,
1984; 50 FR 31349, Aug. 2, 1985)
21 CFR 177.1580 Polycarbonate resins.
Polycarbonate resins may be safely used as articles or components of
articles intended for use in producing, manufacturing, packing,
processing, preparing, treating, packaging, transporting, or holding
food, in accordance with the following prescribed conditions:
(a) Polycarbonate resins are polyesters produced by:
(1) The condensation of 4,4'-iso-propylidenediphenol and carbonyl
chloride to which may have been added certain optional adjuvant
substances required in the production of the resins; or by
(2) The reaction of molten 4,4'-iso-propylidenediphenol with molten
diphenyl carbonate in the presence of the disodium salt of
4,4'-isopropylidenediphenol.
(3) The condensation of 4,4'-isopro- pylidenediphenol, carbonyl
chloride, and 0.5 percent weight maximum of a2,a6-bis
(6-hydroxy-m-tolyl) mesitol to which may have been added certain
optional adjuvant substances required in the production of branched
polycarbonate resins.
(b) The optional adjuvant substances required in the production of
resins produced by the methods described in paragraph (a)(1) and (3) of
this section may include substances generally recognized as safe in
food, substances used in accordance with a prior sanction or approval,
and the following:
(c) Polycarbonate resins shall conform to the specification
prescribed in paragraph (c)(1) of this section and shall meet the
extractives limitations prescribed in paragraph (c)(2) of this section.
(1) Specification. Polycarbonate resins can be identified by their
characteristic infrared spectrum.
(2) Extractives limitations. The polycarbonate resins to be tested
shall be ground or cut into small particles that will pass through a
U.S. standard sieve No. 6 and that will be held on a U.S. standard
sieve No. 10.
(i) Polycarbonate resins, when extracted with distilled water at
reflux temperature for 6 hours, shall yield total extractives not to
exceed 0.15 percent by weight of the resins.
(ii) Polycarbonate resins, when extracted with 50 percent (by volume)
ethyl alcohol in distilled water at reflux temperature for 6 hours,
shall yield total extractives not to exceed 0.15 percent by weight of
the resins.
(iii) Polycarbonate resins, when extracted with n-heptane at reflux
temperature for 6 hours, shall yield total extractives not to exceed
0.15 percent by weight of the resins.
(42 FR 14572, Mar. 15, 1977, as amended at 46 FR 23227, Apr. 24,
1981; 49 FR 4372, Feb. 6, 1984; 50 FR 14096, Apr. 10, 1985; 53 FR
29656, Aug. 8, 1988)
21 CFR 177.1585 Polyestercarbonate resins.
Polyestercarbonate resins may be safely used as articles or
components of articles intended for use in producing, manufacturing,
packing, processing, preparing, treating, packaging, or holding food, in
accordance with the following prescribed conditions:
(a) Polyestercarbonate resins (CAS Reg. No. 71519-80-7) are produced
by the condensation of 4,4'-isopropylidenediphenol, carbonyl chloride,
terephthaloyl chloride, and isophthaloyl chloride such that the resins
are composed of 70 to 85 percent ester, of which up to 10 percent is the
terephthaloyl isomer. The resins are manufactured using a phthaloyl
chloride/carbonyl chloride mole ratio of 2.3-4.0/1 and an isophthaloyl
chloride/terephthaloyl chloride mole ratio of 9.0/1 or greater.
(b) Optional adjuvants. The optional adjuvant substances required in
the production of resins identified in paragraph (a) of this section may
include:
(1) Substances used in accordance with 174.5 of this chapter.
(2) Substances identified in 177.1580(b).
(3) Substances regulated in 178.2010(b) of this chapter for use in
polycarbonate resins complying with 177.1580:
Provided, That the substances are used in accordance with any
limitation on concentration, conditions of use, and food types specified
in 178.2010(b) of this chapter.
(c) Polyestercarbonate resins shall conform to the specifications
prescribed in paragraph (c)(1) of this section and shall meet the
extractive limitations prescribed in paragraph (c)(2) of this section.
(1) Specifications. Polyestercarbonate resins identified in
paragraph (a) of this section can be identified by their characteristic
infrared spectrum. The solution intrinsic viscosity of the
polyestercarbonate resins shall have a range of 0.50 to 0.58 deciliter
per gram as determined by a method titled, ''Intrinsic Viscosity (IV) of
Lexan# Polycarbonate Resin by a Single Point Method Using
Dichloromethane as the Solvent,'' developed by the General Electric Co.,
September 20, 1985, which is incorporated by reference in accordance
with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the
Division of Food and Color Additives, Center for Food Safety and Applied
Nutrition (HFF-330), Food and Drug Administration, 200 C St. SW.,
Washington, DC 20204, or may be examined at the Office of the Federal
Register, 1100 L St. NW., Washington, DC.
(2) Extractives limitations. The polyestercarbonate resins to be
tested shall be ground or cut into small particles that will pass
through a U.S. standard sieve No. 6 and that will be held on U.S.
standard sieve No. 10.
(i) Polyestercarbonate resins, when extracted with distilled water at
reflux temperature for 6 hours, shall yield total nonvolatile
extractives not to exceed 0.005 percent by weight of the resins.
(ii) Polyestercarbonate resins, when extracted with 50 percent (by
volume) ethyl alcohol in distilled water at reflux temperature for 6
hours, shall yield total nonvolatile extractives not to exceed 0.005
percent by weight of the resins.
(iii) Polyestercarbonate resins, when extracted with n-heptane at
reflux temperature for 6 hours, shall yield total nonvolatile
extractives not to exceed 0.002 percent by weight of the resins.
(3) Residual methylene chloride levels in polyestercarbonate resins.
Polyestercarbonate resin articles in the finished form shall not contain
residual methylene chloride in excess of 5 parts per million as
determined by a method titled ''Analytical Method for Determination of
Residual Methylene Chloride in Polyestercarbonate Resin,'' developed by
the General Electric Co., July 23, 1991, which is incorporated by
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies
are available from the Division of Food and Color Additives, Center for
Food Safety and Applied Nutrition (HFF-330), Food and Drug
Administration, 200 C St. SW., Washington, DC 20204, or may be examined
at the Office of the Federal Register, 1100 L St. NW., Washington, DC.
(57 FR 3940, Feb. 3, 1992)
21 CFR 177.1590 Polyester elastomers.
The polyester elastomers identified in paragraph (a) of this section
may be safely used as the food-contact surface of articles intended for
use in contact with bulk quantities of dry food of the type identified
in 176.170(c) of this chapter, Table 1, under Type VIII, in accordance
with the following prescribed conditions:
(a) For the purpose of this section, polyester elastomers are those
produced by the ester exchange reaction when one or more of the
following phthalates -- dimethyl terephthalate, dimethyl orthophthalate,
and dimethyl isophthalate -- is made to react with
alpha-hydroomega-hydroxypoly (oxytetramethylene) and/or 1,4-butanediol
such that the finished elastomer has a number average molecular weight
between 20,000 and 30,000.
(b) Optional adjuvant substances employed in the production of the
polyester elastomers or added thereto to impart desired technical or
physical properties may include the following substances:
(c) An appropriate sample of the finished polyester elastomer in the
form in which it contacts food when subjected to ASTM method D968-81,
''Standard Test Methods for Abrasion Resistance of Organic Coatings by
the Falling Abrasive Tester,'' which is incorporated by reference
(copies may be obtained from the American Society for Testing Materials,
1916 Race St., Philadelphia, PA 19103, or may be examined at the Office
of the Federal Register, 1100 L St. NW., Washington, DC 20408), using
No. 50 emery abrasive in lieu of Ottawa sand, shall exhibit an abrasion
coefficient of not less than 100 liters per mil of thickness.
(42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10109, Mar. 19,
1984)
21 CFR 177.1595 Polyetherimide resin.
The polyetherimide resin identified in this section may be safely
used as an article or component of an article intended for use in
contact with food, subject to the provisions of this section.
(a) Identity. For the purpose of this section, the polyetherimide
resin is 1,3-isobenzofurandione, 5,5
((1-methyl-ethylidene)bis(4,1-phenyleneoxy)) bis-polymer with
1,3-benzenediamine (CAS Reg. No. 61128-46-9), and is derived from the
condensation reaction of m-phenylenediamine and bisphenol A-dianhydride.
(b) Optional adjuvants. The basic polymer identified in paragraph
(a) of this section may contain optional adjuvant substances required in
the production of basic resins or finished food-contact articles. The
optional adjuvant substances required in the production of the basic
polymer may include substances permitted for such use by applicable
regulations as set forth in part 174 of this chapter.
(c) Specifications and extractives limitations -- (1) Specifications.
Polyetherimide resin identified in paragraph (a) of this section shall
have an intrinsic viscosity in chloroform at 25 C (77 F) of not less
than 0.35 deciliter per gram as determined by a method titled
''Intrinsic Viscosity of ULTEM Polyetherimide Using Chloroform as the
Solvent,'' which is incorporated by reference. Copies are available
from the Division of Food and Color Additives, Center for Food Safety
and Applied Nutrition (HFF-330), 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.
(2) Extractive limitations. Extractive limitations are applicable to
the basic polyetherimide resin in the form of molded discs of thickness
0.16 centimeter (0.063 inch). The resin discs when extracted with
distilled water at 121 C (250 F) for 2 hours yield total nonvolatile
extractives of not more than 12.3 micrograms per square centimeter.
(50 FR 31351, Aug. 2, 1985; 50 FR 35535, Sept. 3, 1985)
21 CFR 177.1600 Polyethylene resins, carboxyl modified.
Carboxyl-modified polyethylene resins may be safely used as the
food-contact surface of articles intended for use in contact with food
in accordance with the following prescribed conditions:
(a) For the purpose of this section, carboxyl-modified polyethylene
resins consist of basic polymers produced when etylene-methyl acrylate
basic copolymers, containing no more than 25 weight percent of polymer
units derived from methyl acrylate, are made to react in an aqueous
medium with one or more of the following substances:
Ammonium hydroxide.
Calcium carbonate.
Potassium hydroxide.
Sodium hydroxide.
(b) The finished food-contact article, when extracted with the
solvent or solvents characterizing the type of food and under the
conditions of time and temperature characterizing the conditions of its
intended use as determined from Tables 1 and 2 of 176.170(c) of this
chapter, yields total extractives in each extracting solvent not to
exceed 0.5 milligram per square inch of food-contact surface as
determined by the methods described in 176.170(d) of this chapter; and
if the finished food-contact article is itself the subject of a
regulation in parts 174, 175, 176, 177, 178, and 179.45 of this
chapter, it shall also comply with any specifications and limitations
prescribed for it by that regulation. In testing the finished
food-contact articles, a separate test sample is to be used for each
required extracting solvent.
(c) The provisions of paragraph (b) of this section are not
applicable to carboxyl-modified polyethylene resins used in
food-packaging adhesives complying with 175.105 of this chapter.
21 CFR 177.1610 Polyethylene, chlorinated.
Chlorinated polyethylene identified in this section may be safely
used as articles or components of articles that contact food, except for
articles used for packing or holding food during cooking, subject to the
provisions of this section.
(a) For the purpose of this section, chlorinated polyethylene
consists of basic polymers produced by the direct chlorination of
polyethylene conforming to the density, maximum n-hexane extractable
fraction, and maximum xylene soluble fraction specifications prescribed
under item 2.1 of the table in 177.1520(c). Such chlorinated
polyethylene contains a maximum of 60 percent by weight of total
chlorine, as determined by ASTM method D1303-55 (Reapproved 1979),
''Standard Test Method for Total Chlorine in Vinyl Chloride Polymers and
Copolymers,'' which is incorporated by reference (copies may be obtained
from the American Society for Testing Materials, 1916 Race St.,
Philadelphia, PA 19103, or may be examined at the Office of the Federal
Register, 1100 L St. NW., Washington, DC 20408), and has a 7.0 percent
maximum extractable fraction in n-hexane at 50 C, as determined by the
method in contact with all types of food, except that when used in
contact with fatty food of Types III, IV-A, V, VII-A, and IX described
in Table 1 of 176.170(c) of this chapter, chlorinated polyethylene is
limited to use only as a modifier admixed at levels not exceeding 15
weight percent in plastic articles prepared from polyvinyl chloride
and/or from vinyl chloride copolymers complying with 177.1980.
(42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10109, Mar. 19,
1984)
21 CFR 177.1615 Polyethylene, fluorinated.
Fluorinated polyethylene, identified in paragraph (a) of this
section, may be safely used as food-contact articles in accordance with
the following prescribed conditions:
(a) Fluorinated polyethylene food-contact articles are produced by
modifying the surface of polyethylene articles through action of
fluorine gas in combination with gaseous nitrogen as an inert diluent.
Such modification affects only the surface of the polymer, leaving the
interior unchanged. Fluorinated polyethylene articles are manufactured
from basic resins containing not less than 85 weight-percent of polymer
units derived from ethylene and identified in 177.1520 (a)(2) and
(3)(i).
(b) Fluorinated polyethylene articles conform to the specifications
and use limitations of 177.1520(c), items 2.1 and 3.1.
(c) The finished food-contact article, when extracted with the
solvent or solvents characterizing the type of food and under conditions
of time and temperature characterizing the conditions of its intended
use as determined from Tables 1 and 2 of 176.170(c) of this chapter,
yields fluoride ion not to exceed 5 parts per million calculated on the
basis of the volume of food held by the food-contact article.
(48 FR 39057, Aug. 29, 1983)
21 CFR 177.1620 Polyethylene, oxidized.
Oxidized polyethylene identified in paragraph (a) of this section may
be safely used as a component of food-contact articles, in accordance
with the following prescribed conditions:
(a) Oxidized polyethylene is the basic resin produced by the mild air
oxidation of polyethylene conforming to the density, maximum n-hexane
extractable fraction, and maximum xylene soluble fraction specifications
prescribed under item 2.3 of the table in 177.1520(c). Such oxidized
polyethylene has a minimum number average molecular weight of 1,200, as
determined by high temperature vapor pressure osmometry, contains a
maximum of 5 percent by weight of total oxygen, and has an acid value of
9 to 19.
(b) The finished food-contact article, when extracted with the
solvent or solvents characterizing the type of food and under the
conditions of time and temperature characterizing the conditions of its
intended use as determined from Tables 1 and 2 of 176.170(c) of this
chapter, yields net acidified chloroform-soluble extractives not to
exceed 0.5 milligram per square inch of food-contact surface when tested
by the methods described in 177.1330(c), except that net acidified
chloroform-soluble extractives from paper and paperboard complying with
176.170 of this chapter may be corrected for wax, petrolatum, and
mineral oil as provided in 176.170(d) (5)(iii)(b) of this chapter. If
the finished food-contact article is itself the subject of a regulation
in parts 174, 175, 176, 177, 178 and 179.45 of this chapter, it shall
also comply with any specifications and limitations prescribed for it by
such regulations. (Note: In testing the finished food-contact article,
use a separate test sample for each extracting solvent.)
(c) The provisions of this section are not applicable to oxidized
polyethylene used as provided in 175.105 and 176.210 of this chapter,
and 177.2800. The provisions of paragraph (b) of this section are not
applicable to oxidized polyethylene used as provided in 175.125 and
176.170(a)(5) of this chapter and 177.1200.
21 CFR 177.1630 Polyethylene phthalate polymers.
Polyethylene phthalate polymers identified in this section may be
safely used as, or components of plastics (films, articles, or fabric)
intended for use in contact with food in accordance with the following
prescribed conditions:
(a) Polyethylene phthalate films consist of a base sheet of ethylene
terephthalate polymer or ethylene terephthalate-isophthalate copolymers,
to which have been added optional substances, either as constituents of
the base sheet or as constituents of coatings applied to the base sheet.
(b) Polyethylene phthalate articles consist of a base polymer of
ethylene terephthalate polymer to which have been added optional
substances, either as constituents of the base polymer or as
constituents of coatings applied to the base polymer.
(c)(1) Polyethylene phthalate spunbonded nonwoven fabric consist of
continuous filaments of ethylene terephthalate polymer and ethylene
terephthalate-isophthalate copolymer to which may have been added
optional adjuvant substances required in their preparation and
finishing.
(2) The ethylene terephthalate-isophthalate copolymer component of
the fabric shall not exceed 25 percent by weight. The filaments may be
blended with other fibers regulated for the specific use and the
spunbonded fabric may be further bonded by application of heat and/or
pressure.
(3) The fabric shall be used only in accordance with paragraph (i) of
this section.
(d) The quantity of any optional substance employed in the production
of polyethylene phthalate plastics does not exceed the amount reasonably
required to accomplish the intended physical or technical effect or any
limitations further provided. Any substance employed in the production
of polyethylene phthalate plastics that is the subject of a regulation
in parts 174, 175, 176, 177, 178 and 179 of this chapter conforms with
any specification in such regulation.
(e) Substances employed in the production of polyethylene phthalate
plastics include:
(1) Substances generally recognized as safe in food.
(2) Substances subject to prior sanction or approval for use in
polyethylene phthalate plastics and used in accordance with such
sanction or approval.
(3) Substances which by regulation in parts 174, 175, 176, 177, 178
and 179.45 of this chapter may be safely used as components of resinous
or polymeric food-contact surfaces subject to the provisions of such
regulation.
(4) Substances identified in this paragraph (e)(4) subject to the
limitations prescribed:
(i) Base sheet:
Ethylene terephthalate copolymers: Prepared by the condensation of
dimethyl terephthalate or terephthalic acid with ethylene glycol,
modified with one or more of the following: Azelaic acid, dimethyl
azelate, dimethyl sebacate, sebacic acid.
Ethylene terephthalate-isophthalate copolymers: Prepared by the
condensation of dimethyl terephthalate or terephthalic acid and dimethyl
isophthalate or isophthalic acid with ethylene glycol. The finished
copolymers contain either:
(a) 77 to 83 weight percent or
(b) At least 97 weight percent of polymer units derived from ethylene
terephthalate.
(ii) Base sheet and base polymer:
Ethylene terephthalate polymer: Prepared by the condensation of
dimethyl terephthalate and ethylene glycol.
Ethylene terephthalate polymer: Prepared by the condensation of
terephthalic acid and ethylene glycol.
(iii) Coatings:
Ethylene azelate-terephthalate copolymer: The copolymer, dissolved
in 1,1,2-trichloroethane and/or methylene chloride, may be used as a
heat-activated sealant on polyethylene terephthalate film intended for
sealing polyethylene terephthalate pouches that are used as containers
of either nonalcoholic beverages or alcoholic beverages containing not
more than 15 percent ethyl alcohol. The copolymer has a
terephthalate/azelate molecular ratio of 1.25/1.00 and a relative
viscosity of not less than 1.5 as determined by a method title ''General
Procedure of Determining the Relative Viscosity of Resin Polymers,''
which is incorporated by reference. Copies are available from the
Division of Food and Color Additives, Center for Food Safety and Applied
Nutrition (HFF-330), 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. Total residual
copolymer solvent (1,1,2-trichloroethane and/or methylene chloride)
shall not exceed 0.13 milligram per square inch of film, and food
contact of the film shall be limited to not more than 1 square inch per
250 grams of beverage.
2-Ethylhexyl acrylate copolymerized with one or more of the
following:
Acrylonitrile.
Methacrylonitrile.
Methyl acrylate.
Methyl methacrylate.
Itaconic acid.
Vinylidene chloride copolymerized with one or more of the following:
Methacrylic acid and its methyl, ethyl, propyl, butyl, or octyl
esters.
Acrylic acid and its methyl, ethyl, propyl, butyl, or octyl esters.
Acrylonitrile.
Methacrylonitrile.
Vinyl chloride.
Itaconic acid.
Styrene-maleic anhydride resin, partial 2-butoxyethyl ester, ammonium
salt (CAS Reg. No. 68890-80-2). For use only as a coating for
polyethylene phthalate films complying with paragraph (a) of this
section, at levels not to exceed 0.025 gram per square meter (0.016
milligram per square inch) of the film, in contact with food of types
VIII and IX in Table 1 of 176.170(c) of this chapter, under use
conditions E, F, and G in Table 2 of 176.170(c) of this chapter.
(iv) Emulsifiers:
Sodium dodecylbenzenesulfonate: As an adjuvant in the application of
coatings to the base sheet or base polymer.
Sodium lauryl sulfate: As an adjuvant in the application of coatings
to the base sheet or base polymer.
2-Sulfoethyl methacrylate, sodium salt (CAS Reg. No. 1804-87-1). For
use only in copolymer coatings on polyethylene phthalate film under
conditions of use E, F, and G described in table 2 of 175.300(d) of
this chapter, and limited to use at a level not to exceed 2.0 percent by
weight of the dry copolymer coating.
(v) Modifier:
1,4-Benzenedicarboxylic acid, dimethyl ester, polymer with
1,4-butanediol and a-hydro-omega-hydroxypoly(oxy-1,4-butanediyl) CAS
Reg. No. 9078-71-1) meeting the following specifications:
Melting point: 200 to 215 C as determined by ASTM method D2117-82,
''Standard Test Method for Melting Point of Semicrystalline Polymers by
the Hot Stage Microscopy Method,'' which is incorporated by reference.
Copies may be obtained from the American Society for Testing Materials,
1916 Race St., Philadelphia, PA 19103, or may be examined at the Office
of the Federal Register, 1100 L St. NW., Washington, DC 20408.
Density: 1.15 to 1.20 as determined by ASTM method D1505-68
(Reapproved 1979), ''Standard Test Method for Density of Plastics by the
Density-Gradient Technique,'' which is incorporated by reference.
Copies may be obtained from the American Society for Testing Materials,
1916 Race St., Philadelphia, PA 19103, or may be examined at the Office
of the Federal Register, 1100 L St. NW., Washington, DC 20408.
The modifier is used at a level not to exceed 5 percent by weight of
polyethylene terephthalate film. The average thickness of the finished
film shall not exceed 0.016 millimeter (0.0006 inch).
Hexanedioic acid polymer with 1,3-benzenedimethanamine (CAS Reg. No.
25718-70-1) meeting the specifications in 177.1500(b), item 10, when
tested by the methods given in 177.1500(c). The modifier is used in
polyethylene terephthalate at a level not to exceed 30 percent by weight
of the polyethylene terephthalate.
Chloroform-soluble extractives shall not exceed 0.08
milligram/centimeter2 (0.5 milligram/inch2) of food-contact surface of
the modified polyethylene terephthalate article when exposed to the
following solvents at temperatures and times indicated:
(a) Distilled water at 49 C (120 F) for 24 hours;
(b) n-Heptane at 49 C (120 F) for 24 hours;
(c) 8 percent ethyl alcohol at 49 C (120 F) for 24 hours.
For use in contact with all types of foods except (a) those
containing more than 8 percent alcohol, or (b) those at temperatures
over 49 C (120 F).
(f) Polyethylene phthalate plastics conforming with the
specifications prescribed in paragraph (f)(1) of this section are used
as provided in paragraph (f)(2) of this section:
(1) Specifications. (i) The food contact surface, when exposed to
distilled water at 250 F for 2 hours, yields chloroform-soluble
extractives not to exceed 0.5 mg/in2 of food contact surface exposed to
the solvent; and
(ii) The food contact surface, when exposed to n-heptane at 150 F for
2 hours, yields chloroform-soluble extractives not to exceed 0.5 mg/in2
of food contact surface exposed to the solvent.
(2) Conditions of use. The plastics are used for packaging,
transporting, or holding food, excluding alcoholic beverages, at
temperatures not to exceed 250 F.
(g) Polyethylene phthalate plastics conforming with the
specifications prescribed in paragraph (g)(1) of this section are used
as provided in paragraph (g)(2) of this section.
(1) Specifications. (i) The food contact surface meets the
specifications in paragraph (f)(1) of this section; and
(ii) The food contact surface when exposed to 50 percent ethyl
alcohol at 120 F for 24 hours, yields chloroform-soluble extractives
not to exceed 0.5 mg/in2 of food contact surface exposed to the solvent.
(2) Conditions of use. The plastics are used for packaging,
transporting, or holding alcoholic beverages that do not exceed 50
percent alcohol by volume.
(h) Uncoated polyethylene phthalate plastics consisting of a base
sheet or base polymer prepared as prescribed from substances identified
in paragraphs (e)(4)(i) and (ii) of this section and conforming with the
specifications prescribed in paragraph (h)(1) of this section are used
as provided in paragraph (h)(2) of this section:
(1) Specifications. (i) The food contact surface, when exposed to
distilled water at 250 F for 2 hours yields chloroform-soluble
extractives not to exceed 0.02 milligram/inch2 of food contact surface
exposed to the solvent; and
(ii) The food contact surface, when exposed to n-heptane at 150 F
for 2 hours, yields chloroform-soluble extractives not to exceed 0.02
milligram/inch2 of food contact surface exposed to the solvent.
(2) Conditions of use. The plastics are used to contain foods during
oven baking or oven cooking at temperatures above 250 F.
(i) Polyethylene phthalate fabric, identified in paragraph (c) of
this section and conforming with the specifications prescribed in
paragraph (i)(1) of this section, is used only as provided in paragraph
(i)(2) of this section.
(1) Specifications. Chloroform-soluble extractives shall not exceed
0.2 milligram/inch2 of food-contact surface when exposed to the
following solvents at temperatures and times indicated:
(i) Distilled water at 212 F for 2 hours.
(ii) n-Heptane at 150 F for 2 hours.
(iii) 50 percent ethyl alcohol at 120 F for 24 hours.
(2) Conditions of use. The plastics are intended for:
(i) Dry food contact.
(ii) Bulk food (excluding alcoholic beverages) repeated use
applications, including filtration, at temperatures not exceeding 212
F.
(iii) Filtration of bulk alcoholic beverages, not exceeding 50
percent alcohol by volume, at temperatures not exceeding 120 F.
(j) Polyethylene phthalate plastics, composed of ethylene
terephthalate-isophthalate containing a minimum of 98 weight percent of
polymer units derived from ethylene terephthalate, conforming with the
specifications prescribed in paragraph (j)(1) of this section are used
as provided in paragraph (j)(2) of this section.
(1) Specifications. (i) The food contact surface meets the
specifications in paragraph (f)(1) of this section and
(ii)(a) Containers with greater than 500 mL capacity. The
food-contact surface when exposed to 95 percent ethanol at 120 F for 24
hours should not yield chloroform-soluble extractives in excess of 0.005
mg/in2.
(b) Containers with less than or equal to 500 mL capacity. The food
contact surface when exposed to 95 percent ethanol at 120 F for 24 hours
should not yield chloroform-soluble extractives in excess of 0.05
mg/in2.
(2) Conditions of use. The plastics are used for packaging,
transporting, or holding alcoholic foods that do not exceed 95 percent
alcohol by volume.
(42 FR 14572, Mar. 15, 1977, as amended at 42 FR 18611, Apr. 8, 1977;
44 FR 40886, July 13, 1979; 45 FR 6541, Jan. 29, 1980; 47 FR 11844,
Mar. 19, 1982; 47 FR 53346, Nov. 26, 1982; 48 FR 30361, July 1, 1983;
49 FR 10110, Mar. 19, 1984; 50 FR 31047, July 24, 1985; 51 FR 3772,
Jan. 30, 1986; 52 FR 32917, Sept. 1, 1987; 54 FR 15750, Apr. 19, 1989;
54 FR 24898, June 12, 1989)
21 CFR 177.1632 Poly (phenyleneterephthalamide) resins.
Poly(phenyleneterephthalamide) resins identified in paragraph (a) of
this section may be safely used as articles or components of articles
intended for repeated contact with food.
(a) Identity. For the purpose of this section, the poly(phenylene-
terephthalamide) resins (CAS Reg. No. 26125-61-1) are produced by the
polymerization of terephthalolyl chloride with p-phenylenediamine. The
poly(phenyleneterephthalamide) resin fibers and yarns may contain
optional adjuvant substances required in their preparation and
finishing.
(b) Optional adjuvant substances. The poly(phenyleneterephthalamide)
resins identified in paragraph (a) of this section may contain the
following optional adjuvant substances, subject to any limitation on
their use:
(1) Optional adjuvant substances authorized for this use in
accordance with 174.5 of this chapter.
(2) Optional finish components, total weight not to exceed 1 percent
by weight of the base polymer, as follows:
(c) Specifications. (1) Poly(phenyleneterephthalamide) resins in the
form of continuous filament yarns or fibers that have been scoured in
accordance with paragraph (d)(1) of this section, when refluxed in a 50
percent ethanol/water mixture for 24 hours, yields total extractables
not exceeding 0.5 percent by weight of the sample.
(2) Poly(phenyleneterephthalamide) resins in the form of pulp, when
refluxed in a 50 percent ethanol/water mixture for 24 hours, yields
total extractables not exceeding 0.65 percent by weight of the sample.
(d) Conditions of use. (1) Poly(phenyleneterephthalamide) resins in
the form of continuous filament yarns and fibers may be used as
components of articles intended for repeated use in contact with food at
temperatures not to exceed 260 C (500 F). All items are scoured prior
to use by agitation in a water bath containing 0.5 gram/liter of
tetrasodium pyrophosphate and 0.5 percent detergent. The items are
agitated at 80 C (180 F) for 20 minutes, and then subjected to a cold
water rinse.
(2) Poly(phenyleneterephthalamide) resins in the form of pulp may be
used as gaskets and packing for food processing equipment at
temperatures not to exceed 260 C (500 F).
(57 FR 3125, Jan. 28, 1992)
21 CFR 177.1635 Poly(p-methylstyrene) and rubber-modified
poly(p-methylstyrene).
Poly(p-methylstyrene) and rubber-modified poly(p-methylstyrene)
identified in this section may be safely used as components of articles
intended for use in contact with food, subject to the provisions of this
section:
(a) Identity. For the purposes of this section,
poly(p-methylstyrene) and rubber-modified poly(p-methylstyrene) are
basic polymers, manufactured as described in this paragraph, meeting the
specifications prescribed in paragraph (c) of this section.
(1) Poly(p-methylstyrene) (CAS Reg. No. 24936-41-2) polymer produced
by the polymerization of p-methylstyrene.
(2) Rubber-modified poly(p-methylstyrene) (CAS Reg. No. 33520-88-6)
polymer produced by combining styrene-butadiene copolymer and/or
polybutadiene with poly(p-methylstyrene), either during or after
polymerization of the poly(p-methylstyrene), such that the finished
polymers contain not less than 75 weight percent of total polymer units
derived from p-methylstyrene) monomer.
(b) Optional adjuvants. The basic polymers identified in paragraph
(a) of this section may contain optional adjuvant substances required in
the production of such basic polymers. Such optional adjuvant
substances may include substances permitted for such use by applicable
regulations in this chapter, substances generally recognized as safe in
food, substances generally recognized as safe in indirect additives, and
substances used in accordance with prior sanction or approval.
(c) Specifications. (1) Poly(p-methylstyrene) basic polymers
identified in paragraph (a)(1) of this section shall contain not more
than 1 weight percent of total residual p-methystyrene monomer, as
determined by a gas chromatographic method titled, ''Gas Chromatographic
Determination of PMS and PET in PPMS Basic Polymers,'' which is
incorporated by reference. Copies are available from the Division of
Food and Color Additives, Center for Food Safety and Applied Nutrition
(HFF-330), 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.
(2) Rubber-modified poly(p-methylstyrene) basic polymers identified
in paragraph (a)(2) of this section shall contain not more than 0.5
weight percent of total residual p-methylstyrene monomer, as determined
by the method identified in paragraph (c)(1) of this section
(d) Other specifications and limitations. The poly(p-methylstyrene)
and rubber-modified poly(p-methylstyrene) identified in and complying
with this section, when used as components of the food-contact surface
of any article that is the subject of a regulation in parts 175, 176,
177, 178 and 179.45 of this chapter, shall comply with any
specifications and limitations prescribed by such regulation for the
article in the finished form in which it is to contact food.
(e) Conditions of use. Poly(p-methylstyrene) basic polymers and
rubber-modified poly(p-methylstyrene) basic polymers identified in
paragraphs (a)(1) and (a)(2), respectively, of this section shall be
used in contact with food only under conditions of use B through H set
forth in Table 2 of 176.170(c) of this chapter.
(48 FR 31384, July 8, 1983, as amended at 54 FR 24898, June 12, 1989;
55 FR 52989, Dec. 26, 1990)
21 CFR 177.1640 Polystyrene and rubber-modified polystyrene.
Polystyrene and rubber-modified polystyrene identified in this
section may be safely used as components of articles intended for use in
contact with food, subject to the provisions of this section.
(a) Identity. For the purposes of this section, polystyrene and
rubber-modified polystyrene are basic polymers manufactured as described
in this paragraph so as to meet the specifications prescribed in
paragraph (c) of this section when tested by the method described in
paragraph (d) of this section.
(1) Polystyrene consists of basic polymers produced by the
polymerization of styrene.
(2) Rubber-modified polystyrene consists of basic polymers produced
by combining styrene-butadiene copolymers and/or polybutadiene with
polystyrene, either during or after polymerization of the polystyrene,
such that the finished basic polymers contain not less than 75 weight
percent of total polymer units derived from styrene monomer.
(b) Optional adjuvants. The basic polymers identified in paragraph
(a) of this section may contain optional adjuvant substances required in
the production of such basic polymers. Such optional adjuvant
substances may include substances permitted for such use by regulations
in parts 170 through 189 of this chapter, substances generally
recognized as safe in food, and substances used in accordance with a
prior sanction or approval.
(c) Specifications. (1) Polystyrene basic polymers identified in
paragraph (a)(1) of this section shall contain not more than 1 weight
percent of total residual styrene monomer, as determined by the method
described in paragraph (d) of this section, except that when used in
contact with fatty foods of Types III, IV-A, V, VII-A, and IX described
in Table 1 of 176.170(c) of this chapter, such polystyrene basic
polymers shall contain not more than 0.5 weight percent of total
residual styrene monomer.
(2) Rubber-modified polystyrene basic polymers identified in
paragraph (a)(2) of this section shall contain not more than 0.5 weight
percent of total residual styrene monomer, as determined by the method
described in paragraph (d) of this section.
(d) Analytical method for determination of total residual styrene
monomer content -- (1) Scope. This method is suitable for the
determination of residual styrene monomer in all types of styrene
polymers.
(2) Principle. The sample is dissolved in methylene chloride. An
aliquot of the solution is injected into a gas chromatograph. The
amount of styrene monomer present is determined from the area of the
resulting peak.
(3) Apparatus -- (i) Gas chromatograph. Beckman GC-2A gas
chromatograph with hydrogen flame detector or apparatus of equivalent
sensitivity.
(ii) Chromatograph column. One-quarter inch outside diameter
stainless steel tubing (0.028 inch wall thickness), 4 feet in length,
packed with 20 percent polyethylene glycol (20,000 molecular weight) on
alkaline treated 60-80 mesh firebrick.
(iii) Recorder. Millivolt range of 0-1, chart speed of 30 inches per
hour.
(4) Reagents. Compressed air, purified; helium gas; hydrogen gas;
methylene chloride, redistilled; and styrene monomer, redistilled.
(5) Operating conditions for the gas chromatograph. (i) The column
is operated at a temperature of 100 C with a helium flow rate of 82
milliliters per minute.
(ii) The hydrogen burner is operated with 15 pounds per square inch
of air pressure and 7 pounds per square inch of hydrogen pressure.
(iii) The attenuation of the hydrogen flame detector is set at 2 102.
(6) Standardization. (i) Prepare a standard solution by weighing
accurately 15 to 20 milligrams of styrene monomer into a 2-ounce bottle
containing 25.0 milliliters of methylene chloride. Cap the bottle
tightly and shake to thoroughly mix the solution.
(ii) By means of a microliter syringe, inject 1 microliter of the
standard solution into the gas chromatograph. Measure the area of the
styrene monomer peak which emerges after approximately 12 minutes.
(7) Procedure. (i) Transfer 1 gram of sample (accurately weighed to
the nearest 0.001 gram to a 2-ounce bottle and add several glass beads.
Pipette 25.0 milliliters of methylene chloride into the bottle. Cap the
bottle tightly and place on a mechanical shaker. Shake until the polymer
is completely dissolved. If any insoluble residue remains, allow the
bottle to stand (or centrifuge at a low speed) until a clear supernatant
layer appears.
(ii) By means of a microliter syringe, inject 3 microliters of the
clear supernatant liquid into the gas chromatograph.
(iii) Measure the area of the resulting styrene monomer peak.
Compare the sample peak area with the area produced by the standard
styrene monomer solution. Calculation:
Percent residual styrene monomer=Milligrams monomer in standard peak
area of sample/Peak area of monomer standard sample weight in grams 30
(e) Other specifications and limitations. The polystyrene and
rubber-modified polystyrene identified in and complying with this
section, when used as components of the food-contact surface of any
article that is the subject of a regulation in parts 174, 175, 176, 177,
178 and 179.45 of this chapter, shall comply with any specifications
and limitations prescribed by such regulation for the article in the
finished form in which it is to contact food.
(f) Nonapplicability. The provisions of this section are not
applicable to polystyrene and rubber-modified polystyrene used in
food-packaging adhesives complying with 175.105 of this chapter.
21 CFR 177.1650 Polysulfide polymer-polyepoxy resins.
Polysulfide polymer-polyepoxy res- ins may be safely used as the
food-contact surface of articles intended for packaging, transporting,
holding, or otherwise contacting dry food, in accordance with the
following prescribed conditions:
(a) Polysulfide polymer-polyepoxy resins are the reaction products of
liquid polysulfide polymers and polyfunctional epoxide resins, cured
with the aid of tri(dimethylaminomethyl) phenol, to which have been
added certain optional substances to impart desired technological
properties to the resins. Subject to any limitations prescribed in this
section, the optional substances may include:
(1) Substances generally recognized as safe in food and food
packaging.
(2) Substances the use of which is permitted under applicable
regulations in this part, prior sanctions, or approvals.
(3) Substances named in this subparagraph and further identified as
required:
(b) The resins are used as the food-contact surface for dry food.
(c) An appropriate sample of the finished resin in the form in which
it contacts food, when subjected to ASTM method D968-81, ''Standard Test
Methods for Abrasion Resistance of Organic Coatings by the Falling
Abrasive Tester,'' which is incorporated by reference (copies may be
obtained from the American Society for Testing Materials, 1916 Race St.,
Philadelphia, PA 19103, or may be examined at the Office of the Federal
Register, 1100 L St. NW., Washington, DC 20408), using No. 50 Emery
abrasive in lieu of Ottawa sand, shall exhibit and abrasion coefficient
of not less than 20 liters per mil of film thickness.
(42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10110, Mar. 19,
1984)
21 CFR 177.1655 Polysulfone resins.
Polysulfone resins identified in paragraph (a) of this section may be
safely used as articles or components of articles intended for use in
contact with food, in accordance with the following prescribed
conditions:
(a) For the purpose of this section, polysulfone resins
(poly(oxy-p-phenylenesulfonyl-p-phenyleneoxy-p-phenyleneisopropylidene-
p-phenyl-ene)resins) (CAS Reg. No. 25154-01-2) consist of basic resins
produced when the disodium salt of 4,4 -isopropylidenediphenol is made
to react with 4,4 dichlorodiphenyl sulfone in such a way that the
finished resins have a minimum number average molecular weight of
15,000, as determined by osmotic pressure in monochlorobenzene.
(b) The basic polysulfone resins identified in paragraph (a) of this
section may contain optional adjuvant substances required in the
production of such basic resins. The optional adjuvant substances
required in the production of the basic polysulfone resins may include
substances described in 174.5(d) of this chapter and the following:
(c) Polysulfone resins, when extracted at reflux temperatures for 6
hours with the solvents -- distilled water, 50 percent (by volume) ethyl
alcohol in distilled water, 3 percent acetic acid in distilled water,
and n-heptane, yield total extractives in each extracting solvent not to
exceed 0.0078 milligram per square centimeter (0.05 milligram per square
inch) of resin surface. Note: In testing the finished polysulfone
resins, use a separate resin test sample for each required extracting
solvent.
(d) Polysulfone resins intended for repeated use in contact with food
may be used under conditions of use A through H in Table 2 of
176.170(c) of this chapter. The resins intended for single-service
food-contact use may be used only under condition of use H described in
Table 2 of 176.170(c) of this chapter.
(51 FR 882, Jan. 9, 1986; 51 FR 4165, Feb. 3, 1986)
21 CFR 177.1660 Poly (tetramethylene terephthalate).
Poly(tetramethylene terephthalate) (poly
(oxytetramethyleneoxyter-ephthaloyl)) (Chemical Abstracts Service
Registry No. 24968-12-5) identified in this section may be safely used
as articles or components of articles intended to contact food, in
accordance with the following prescribed conditions:
(a) Identity. For the purpose of this section, poly (tetramethylene
terephthalate) is the reaction product of dimethyl terephthalate with
1,4-butanediol to which may have been added certain optional substances
to impart desired technological properties to the polymer.
(b) Optional adjuvant substances. Poly(tetramethylene terephthalate)
identified in paragraph (a) of this section may contain optional
adjuvant substances. The quantity of any optional adjuvant substance
employed in the production of the polymer does not exceed the amount
reasonably required to accomplish the intended technical or physical
effect. Such adjuvants may include substances generally recognized as
safe in food, substances used in accordance with prior sanction, and
substances permitted under applicable regulations in this part.
(c) Specifications. (1) Inherent viscosity of a 0.50 percent
solution of the polymer in phenol/tetrachloroethane (60/40 weight ratio)
solvent is not less than 0.6 as determined using a Wagner viscometer (or
equivalent) and calculated from the following equation:
Inherent viscosity=(natural logarithm of Nr)/(c)
where:
Nr=Ratio of flow time of the polymer solution to that of the solvent
and c=polymer concentration of the test solution in grams per 100
milliliters.
(2) Poly(tetramethylene terephthalate) in the finished form in which
it is to contact food shall yield total extractives as follows:
(i) Not to exceed 0.08 milligram per square inch of food contact
surface when extracted for 2 hours at 250 F with distilled water.
(ii) Not to exceed 0.02 milligram per square inch of food contact
surface when extracted for 2 hours at 150 F with n-heptane.
(iii) Not to exceed 0.04 milligram per square inch of food contact
surface when extracted for 2 hours at 212 F with 3 percent aqueous
acetic acid.
(iv) Not to exceed 0.02 milligram per square inch of food contact
surface when extracted for 2 hours at 65.6 C (150 F) with 50 percent
ethanol.
(42 FR 14572, Mar. 15, 1977, as amended at 50 FR 20748, May 20, 1985;
52 FR 20069, May 29, 1987)
21 CFR 177.1670 Polyvinyl alcohol film.
Polyvinyl alcohol film may be safely used in contact with food of the
types identified in 176.170(c) of this chapter, Table 1, under Types V,
VIII, and IX, in accordance with the following prescribed conditions:
(a) The polyvinyl alcohol film is produced from polyvinyl alcohol
having a minimum viscosity of 4 centipoises when a 4-percent aqueous
solution is tested at 20 C.
(b) The finished food-contact film for use in contact with Food Types
V or IX, when extracted with the solvent characterizing the type of food
and under the conditions of time and temperature characterizing its
intended use as determined from Tables 1 and 2 of 176.170(c) of this
chapter, yields total extractives not to exceed 0.078 milligram per
square centimeter (0.5 milligram per square inch) of food-contact
surface when tested by ASTM method F34-76 (Reapproved 1980), ''Standard
Test Method for Liquid Extraction of Flexible Barrier Materials,'' which
is incorporated by reference. Copies may be obtained from the American
Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or
may be examined at the Office of the Federal Register, 1100 L St. NW.,
Washington, DC 20408.
(c) The finished food-contact film shall not be used as a component
of food containers intended for use in contact with water.
(42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10110, Mar. 19,
1984)
21 CFR 177.1680 Polyurethane resins.
The polyurethane resins identified in paragraph (a) of this section
may be safely used as the food-contact surface of articles intended for
use in contact with bulk quantities of dry food of the type identified
in 176.170(c) of this chapter, Table 1, under Type VIII, in accordance
with the following prescribed conditions:
(a) For the purpose of this section, polyurethane resins are those
produced when one or more of the isocyanates listed in paragraph (a)(1)
of this section is made to react with one or more of the substances
listed in paragraph (a) (2) of this section:
(1) Isocyanates:
Bis(isocyanatomethyl) benzene (CAS Reg. No. 25854-16-4).
Bis(isocyanatomethyl) cyclohexane (CAS Reg. No. 38661-72-2).
4,4'-Diisocyanato-3,3'-dimethylbiphenyl (bi-tolylene diisocyanate).
Diphenylmethane diisocyanate.
Hexamethylene diisocyanate.
3-Isocyanatomethyl - 3,5,5 - trimethylcyclohexyl isocyanate.
4,4-Methylenebis(cyclohexyl isocyanate).
Toluene diisocyanate.
(2) List of substances:
Adipic acid.
1,4-Butanediol.
1,3-Butylene glycol.
1,4-Cyclohexane dimethanol (CAS Reg. No. 105-08-8).
2,2-Dimethyl-1,3-propanediol.
Ethylene glycol.
1,6-Hexanediol (CAS Reg. No. 629-11-8).
-Hydro-v-hydroxypoly(oxy-1,4-butanediyl) (CAS Reg. No. 25190-06-1).
-Hydro-omega-hydroxypoly (oxytetramethylene).
, '- (Isopropylidenedi - p - phenylene)bis (omega -hydroxypoly
(oxypropylene)(3-4 moles)), average molecular weight 675.
Maleic anhydride.
Methyl oxirane polymer with oxirane (CAS Reg. No. 9003-11-6).
Methyl oxirane polymer with oxirane, ether with 1,2,3-propanetriol
(CAS Reg. No. 9082-00-2).
, ', '', '''-Neopentanetetrayltetrakis (omega- hydroxypoly
(oxypropylene) (1-2 moles)), average molecular weight 400.
Pentaerythritol-linseed oil alcoholysis product.
Phthalic anhydride.
Polybutylene glycol.
Polyethyleneadipate modified with ethanolamine with the molar ratio
of the amine to the adipic acid less than 0.1 to 1.
Poly(oxycarbonylpentamethylene).
Polyoxypropylene ethers of 4.4'-isopropyl-idenediphenol (containing
an average of 2-4 moles of propylene oxide).
Polypropylene glycol.
, ', ''-1,2,3-Propanetriyltris (omega-hydroxypoly (oxypropylene)
(15-18 moles)), average molecular weight 3,000.
Propylene glycol.
, ', ''-(Propylidynetris (methylene)) tris (omega-hydroxypoly
(oxypropylene) (minimum 1.5 moles)), minimum molecular weight 400.
-( (1,1,3,3-Tetramethylbutyl) - phenyl)-omega -
hydroxypoly(oxyethylene) (5 moles), average molecular weight 425.
Trimethylol propane.
(b) Optional adjuvant substances employed in the production of the
polyurethane resins or added thereto to impart desired technical or
physical properties may include the following substances:
(c) An appropriate sample of the finished resin in the form in which
it contacts food, when subjected to ASTM method D968-81, ''Standard Test
Methods for Abrasion Resistance of Organic Coatings by the Falling
Abrasive Tester,'' which is incorporated by reference (copies may be
obtained from the American Society for Testing Materials, 1916 Race St.,
Philadelphia, PA 19103, or may be examined at the Office of the Federal
Register, 1100 L St. NW., Washington, DC 20408), using No. 50 Emery
abrasive in lieu of Ottawa sand, shall exhibit an abrasion coefficient
of not less than 20 liters per mil of film thickness.
(42 FR 14572, Mar. 15, 1977, as amended at 46 FR 57033, Nov. 20,
1981; 49 FR 10110, Mar. 19, 1984; 50 FR 51847, Dec. 20, 1985; 56 FR
15278, Apr. 16, 1991; 56 FR 42933, Aug. 30, 1991)
21 CFR 177.1810 Styrene block polymers.
The styrene block polymers identified in paragraph (a) of this
section may be safely used as articles or as components of articles
intended for use in contact with food, subject to provisions of this
section.
(a) For the purpose of this section, styrene block polymers are basic
polymers manufactured as described in this paragraph, so that the
finished polymers meet the specifications prescribed in paragraph (b) of
this section, when tested by the methods described in paragraph (c) of
this section.
(1) Styrene block polymers with 1,3-butadiene are those produced by
the catalytic solution polymerization of styrene and 1,3-butadiene.
(2) Styrene block polymers with 2-methyl-1,3-butadiene are those
produced by the catalytic solution polymerization of styrene and
2-methyl-1,3-butadiene.
(3) Styrene block polymers with 1,3-butadiene, hydrogenated are those
produced by the catalytic solution polymerization of styrene and
1,3-butadiene, and subsequently hydrogenated.
(b) Specifications:
(c) The analytical methods for determining whether styrene block
polymers conform to the specifications prescribed in this section are as
follows and are applicable to the finished polymer.
(1) Molecular weight. Molecular weight shall be determined by
intrinsic viscosity (or other suitable method).
(2) Glass transition points. The glass transition points shall be
determined by either of the following methods:
(i) ASTM method D2236-70 (''Standard Method of Test for Dynamic
Mechanical Properties of Plastics by Means of Torsional Pendulum,''
which is incorporated by reference; copies are available from American
Society for Testing and Materials (ASTM), 1916 Race Street,
Philadelphia, PA 19103, or available for inspection at the Office of the
Federal Register, 1100 L St. NW., Washington, DC 20408) modified by
using a forced resonant vibration instead of a fixed vibration and by
using frequencies of 25 to 40 cycles per second instead of 0.1 to 10
cycles per second.
(ii) Direct reading viscoelastometric method titled ''Direct Reading
Viscoelastrometric Method for Determining Glass Transition Points of
Styrene Block Polymers'' (which is incorporated by reference; copies
are available from the Division of Food and Color Additives, Center for
Food Safety and Applied Nutrition (HFF-330), 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), by which the glass transition points are
determined in the tensile mode of deformation at a frequency of 35 hertz
using a Rheovibron Model DDV-II (or equivalent) Direct Reading
Viscoelastometer. Take maxima in the out-of-phase component of the
complex modulus as the glass transition points. For block polymers of
low styrene content or for simple block polymers, the polymer may be
treated with 0.3 part per hundred dicumyl peroxide and cured for 30
minutes at 153 C to accentuate the upper transition point.
(3) Maximum extractable fractions in distilled water and 50 percent
ethanol and the maximum net residue solubles in chloroform. The maximum
extractable fractions in distilled water and 50 percent ethanol, and the
maximum net residue solubles in chloroform, shall be determined in
accordance with 176.170(d)(3) of this chapter using a sandwich form of
the finished copolymer of the specified thickness and for the time and
temperature specified in paragraph (b) of this section.
(d) The provisions of this section are not applicable to
butadiene-styrene copolymers listed in other sections of this subpart.
(e) The provisions of this section are not applicable to styrene
block polymers with 1,3-butadiene listed in 175.105 of this chapter.
(42 FR 14572, Mar. 15, 1977, as amended at 42 FR 43621, Aug. 30,
1977; 47 FR 11844, Mar. 19, 1982; 51 FR 16828, May 7, 1986; 54 FR
24898, June 12, 1989)
21 CFR 177.1820 Styrene-maleic anhydride copolymers.
Styrene-maleic anhydride copolymers identified in paragraph (a) of
this section may be safely used as articles or components of articles
intended for use in contact with food, subject to provisions of this
section.
(a) For the purpose of this section, styrene-maleic anhydride
copolymers are those produced by the polymerization of styrene and
maleic anhydride so that the finished polymers meet the specifications
prescribed in paragraph (b) of this section, when tested by the methods
described in paragraph (c) of this section.
(b) Specifications:
(c) The analytical methods for determining conformance with
specifications for styrene-maleic anhydride copolymers prescribed in
this section are as follows:
(1) Molecular weight. Molecular weight shall be determined by
membrane osmometry.
(2) Residual styrene monomer content. Residual styrene monomer
content shall be determined by the method described in 177.1640(d).
(3) Residual maleic anhydride monomer content. Residual maleic
anhydride monomer content shall be determined by a gas chromatographic
method titled ''Determination of Residual Maleic Anhydride in Polymers
by Gas Chromatography,'' which is incorporated by reference. Copies are
available from the Division of Food and Color Additives, Center for Food
Safety and Applied Nutrition (HFF-330), 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.
(d) The provisions of this section are not applicable to
styrene-maleic anhydride copolymers listed in other sections of this
subpart.
(42 FR 14572, Mar. 15, 1977, as amended at 47 FR 11844, Mar. 19,
1982; 47 FR 14698, Apr. 6, 1982; 54 FR 24898, June 12, 1989)
21 CFR 177.1830 Styrene-methyl methacrylate copolymers.
Styrene-methyl methacrylate copolymers identified in this section may
be safely used as components of plastic articles intended for use in
contact with food, subject to the provisions of this section.
(a) For the purpose of this section, styrene-methyl methacrylate
copolymers consist of basic copolymers produced by the copolymerization
of styrene and methyl methacrylate such that the finished basic
copolymers contain more than 50 weight percent of polymer units derived
from styrene.
(b) The finished plastic food-contact article, when extracted with
the solvent or solvents characterizing the type of food and under the
conditions of time and temperature characterizing the conditions of
intended use as determined from Tables 1 and 2 of 176.170(c) of this
chapter, yields extractives not to exceed the following when tested by
the methods prescribed in 177.1010(c);
(1) Total nonvolatile extractives not to exceed 0.3 milligram per
square inch of surface tested.
(2) Potassium permanganate oxidizable distilled water and 8 and 50
percent alcohol extractives not to exceed an absorbance of 0.15.
(3) Ultraviolet-absorbing distilled water and 8 and 50 percent
alcohol extractives not to exceed an absorbance of 0.30.
(4) Ultraviolet-absorbing n-heptane extractives not to exceed an
absorbance of 0.40.
21 CFR 177.1850 Textryls.
Textryls identified in this section may be safely used as articles or
components of articles, intended for use in producing, manufacturing,
packing, processing, preparing, treating, packaging, transporting or
holding food, subject to the provisions of this section.
(a) Textryls are nonwoven sheets prepared from natural or synthetic
fibers, bonded with fibryl (Fibryl consists of a polymeric resin in
fibrous form commingled with fiber to facilitate sheet formation and
subsequently heat cured to fuse the fibryl and effect bonding).
(b) Textryls are prepared from the fibers, fibryls, and adjuvants
identified in paragraph (c) of this section, and subject to limitations
prescribed in that paragraph, provided that any substance that is the
subject of a regulation in parts 174, 175, 176, 177, 178 and 179.45 of
this chapter conforms with any specifications in such regulation for
that substance as a component of polymeric resins used as food contact
surfaces.
(c) The fibers, fibryls, and adjuvants permitted are as follows:
(d) Textryls meeting the conditions of test prescribed in paragraph
(d)(1) of this section are used as prescribed in paragraph (d)(2) of
this section.
(1) Conditions of test. Textryls, when extracted with distilled
water at reflux temperature for 1 hour, yield total extractives not to
exceed 1 percent.
(2) Uses. Textryls are used for packaging or holding food at
ordinary temperatures and in the brewing of hot beverages.
21 CFR 177.1900 Urea-formaldehyde resins in molded articles.
Urea-formaldehyde resins may be safely used as the food-contact
surface of molded articles intended for use in contact with food, in
accordance with the following prescribed conditions:
(a) For the purpose of this section, urea-formaldehyde resins are
those produced when 1 mole of urea is made to react with not more than 2
moles of formaldehyde in water solution.
(b) The resins may be mixed with refined wood pulp and the mixture
may contain other optional adjuvant substances which may include the
following:
(c) The finished food-contact article, when extracted with the
solvent or solvents characterizing the type of food and under the
conditions of time and temperature characterizing the conditions of its
intended use as determined from Tables 1 and 2 of 175.300(d) of this
chapter, yields total extractives in each extracting solvent not to
exceed 0.5 milligram per square inch of food-contact surface as
determined by the methods described in 175.300(e) of this chapter.
Note: In testing the finished food-contact article, use a separate
test sample for each required extracting solvent.
21 CFR 177.1950 Vinyl chloride-ethylene copolymers.
The vinyl chloride-ethylene copolymers identified in paragraph (a) of
this section may be safely used as components of articles intended for
contact with food, under conditions of use D, E, F, or G described in
Table 2 of 176.170 (c) of this chapter, subject to the provisions of
this section.
(a) For the purpose of this section, vinyl chloride-ethylene
copolymers consist of basic copolymers produced by the copolymerization
of vinyl chloride and ethylene such that the finished basic copolymers
meet the specifications and extractives limitations prescribed in
paragraph (c) of this section, when tested by the methods described in
paragraph (d) of this section.
(b) The basic vinyl chloride-ethylene copolymers identified in
paragraph (a) of this section may contain optional adjuvant substances
required in the production of such basic copolymers. The optional
adjuvant substances required in the production of the basic vinyl
chloride-ethylene copolymers may include substances permitted for such
use by regulations in parts 170 through 189 of this chapter, substances
generally recognized as safe in food, and substances used in accordance
with a prior sanction or approval.
(c) The vinyl chloride-ethylene basic copolymers meet the following
specifications and extractives limitations:
(1) Specifications. (i) Total chlorine content is in the range of 53
to 56 percent as determined by any suitable analytical procedure of
generally accepted applicability.
(ii) Intrinsic viscosity in cyclohexanone at 30 C is not less than
0.50 deciliter per gram as determined by ASTM method D1243-79,
''Standard Test Method for Dilute Solution Viscosity of Vinyl Chloride
Polymers,'' which is incorporated by reference. Copies may be obtained
from the American Society for Testing Materials, 1916 Race St.,
Philadelphia, PA 19103, or may be examined at the Office of the Federal
Register, 1100 L St. NW., Washington, DC 20408.
(2) Extractives limitations. The following extractives limitations
are determined by the methods described in paragraph (d) of this
section:
(i) Total extractives do not exceed 0.10 weight-percent when
extracted with n-heptane at 150 F for 2 hours.
(ii) Total extractives do not exceed 0.03 weight-percent when
extracted with water at 150 F for 2 hours.
(iii) Total extractives obtained by extracting with water at 150 F
for 2 hours contain no more than 0.5 milligram of vinyl
chloride-ethylene copol-ymer per 100 grams of sample tested as
determined from the organic chlorine content. The organic chlorine
content is determined as described in paragraph (d)(3) of this section.
(d) Analytical methods: The analytical methods for determining
whether vinyl chloride-ethylene basic copolymers conform to the
extractives limitations prescribed in paragraph (c) of this section are
as follows and are applicable to the basic copolymers in powder form
having a particle size such that 100 percent will pass through a U.S.
Standard Sieve No. 40 and 80 percent will pass through a U.S. Standard
Sieve No. 80:
(1) Reagents -- (i) Water. All water used in these procedures shall
be demineralized (deionized), freshly distilled water.
(ii) n-Heptane. Reagent grade, freshly distilled n-heptane shall be
used.
(2) Determination of total amount of extractives. All determinations
shall be done in duplicate using duplicate blanks. Approximately 400
grams of sample (accurately weighed) shall be placed in a 2-liter
Erlenmeyer flask. Add 1,200 milliliters of solvent and cover the flask
with aluminum foil. The covered flask and contents are suspended in a
thermostated bath and are kept, with continual shaking at 150 F for 2
hours. The solution is then filtered through a No. 42 Whatman filter
paper, and the filtrate is collected in a graduated cylinder. The total
amount of filtrate (without washing) is measured and called A
milliliters. The filtrate is transferred to a Pyrex (or equivalent)
beaker and evaporated on a steam bath under a stream of nitrogen to a
small volume (approximately 50-60 milliliters). The concentrated
filtrate is then quantitatively transferred to a tared 100-milliliter
Pyrex beaker using small, fresh portions of solvent and a rubber
policeman to effect the transfer. The concentrated filtrate is
evaporated almost to dryness on a hotplate under nitrogen, and is then
transferred to a drying oven at 230 F in the case of the aqueous
extract or to a vacuum oven at 150 F in the case of the heptane
extract. In the case of the aqueous extract, the evaporation to
constant weight is completed in 15 minutes at 230 F; and in the case
of heptane extract, it is overnight under vacuum at 150 F. The residue
is weighed and corrected for the solvent blank. Calculation:
=Total extractives expressed as percent by weight of sample.
(3) Vinyl chloride-ethylene copolymer content of aqueous extract --
(i) Principle. The vinyl chloride-ethylene copolymer content of the
aqueous extract can be determined by determining the organic chlorine
content and calculating the amount of copolymer equivalent to the
organic chlorine content.
(ii) Total organic chlorine content. A weighed sample of
approximately 400 grams is extracted with 1,200 milliliters of water at
150 F for 2 hours, filtered, and the volume of filtrate is measured (A
milliliters) as described in paragraph (d)(2) of this section.
(a) A slurry of Amberlite IRA-400, or equivalent, is made with
distilled water in a 150-milliliter beaker. The slurry is added to a
chromatographic column until it is filled to about half its length.
This should give a volume of resin of 15-25 milliliters. The liquid
must not be allowed to drain below the top of the packed column.
(b) The column is regenerated to the basic (OH) form by slowly
passing through it (10-15 milliliters per minute) 10 grams of sodium
hydroxide dissolved in 200 milliliters of water. The column is washed
with distilled water until the effluent is neutral to phenolphthalein.
One drop of methyl red indicator is added to the A milliliters of
filtered aqueous extract and, if on the basic side (yellow), nitric acid
is added drop by drop until the solution turns pink.
(c) The extract is deionized by passing it through the exchange
column at a rate of 10-15 milliliters per minute. The column is washed
with 200 milliliters of distilled water. The deionized extract and
washings are collected in a 1,500-milliliter beaker. The solution is
evaporated carefully on a steam plate to a volume of approximately 50
milliliters and then transferred quantitatively, a little at a time, to
a clean 22-milliliter Parr cup, also on the steam plate. The solution
is evaporated to dryness. Next 0.25 gram of sucrose and 0.5 gram of
benzoic acid are added to the cup. One scoop (approximately 15 grams)
of sodium peroxide is then added to the cup. The bomb is assembled and
ignition is conducted in the usual fashion.
(d) After the bomb has cooled, it is rinsed thoroughly with distilled
water and disassembled. The top of the bomb is rinsed into a
250-milliliter beaker with distilled water. The beaker is placed on the
steam plate. The bomb cup is placed in the beaker and carefully tipped
over to allow the water to leach out the combustion mixture. After the
bubbling has stopped, the cup is removed from the beaker and rinsed
thoroughly. The solution is cooled to room temperature and cautiously
neutralized with concentrated nitric acid by slowly pouring the acid
down a stirring rod until the bubbling ceases. The solution is cooled
and an equal volume of acetone is added.
(e) The solution is titrated with 0.005 N silver nitrate using
standard potentiometric titration techniques with a silver electrode as
indicator and a potassium nitrate modified calomel electrode as a
reference electrode. An expanded scale recording titrimeter. Metrohm
Potentiograph 2336 or equivalent, should be used; a complete blank must
be run in duplicate.
(iii) Calculations.
Milligrams of aqueous extracted copolymer per 100-gram sample=
where:
T=Milliliters of silver nitrate (sample minus blank) normality of
silver nitrate.
F=1,200/A (as defined above)
(e) The vinyl chloride-ethylene copolymers identified in and
complying with this section, when used as components of the food-contact
surface of any article that is the subject of a regulation in parts 174,
175, 176, 177, 178 and 179.45 of this chapter, shall comply with any
specifications and limitations prescribed by such regulation for the
article in the finished form in which it is to contact food.
(f) The provisions of this section are not applicable to vinyl
chloride-ethylene copolymers used as provided in 175.105 and 176.180
of this chapter.
(42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10110, Mar. 19,
1984)
21 CFR 177.1960 Vinyl chloride-hexene-1 copolymers.
The vinyl chloride-hexene-1 copolymers identified in paragraph (a) of
this section or as components of articles intended for use in contact
with food, under conditions of use D, E, F, or G described in Table 2 of
176.170(c) of this chapter, subject to the provisions of this section.
(a) Identity. For the purposes of this section vinyl
chloride-hexene-1 copolymers consist of basic copolymers produced by the
copolymerization of vinyl chloride and hexene-1 such that the finished
copolymers contain not more than 3 mole-percent of polymer units derived
from hexene-1 and meet the specifications and extractives limitations
prescribed in paragraph (b) of this section. The copolymers may
optionally contain hydroxypropyl methylcellulose and trichloroethylene
used as a suspending agent and chain transfer agent, respectively, in
their production.
(b) Specifications and limitations. The vinyl chloride-hexene-1
basic copolymers meet the following specifications and extractives
limitations:
(1) Specifications. (i) Total chlorine content is 53 to 56 percent
as determined by any suitable analytical procedure of generally accepted
applicability.
(ii) Inherent viscosity in cyclohexanone at 30 C is not less than
0.59 deciliters per gram as determined by ASTM method D1243-79,
''Standard Test Method for Dilute Solution Viscosity of Vinyl Chloride
Polymers,'' which is incorporated by reference. Copies may be obtained
from the American Society for Testing Materials, 1916 Race St.,
Philadelphia, PA 19103, or may be examined at the Office of the Federal
Register, 1100 L St. NW., Washington, DC 20408.
(2) Extractives limitations. The following extractives limitations
are determined by the methods prescribed in 177.1970(d).
(i) Total extractives do not exceed 0.01 weight percent when
extracted with water at 150 F for 2 hours.
(ii) Total extractives do not exceed 0.30 weight percent when
extracted with n-heptane at 150 F for 2 hours.
(c) Other specifications and limitations. The vinyl
chloride-hexene-1 copolymers identified in and complying with this
section, when used as components of the food-contact surface of any
article that is subject to a regulation in parts 174, 175, 176, 177, 178
and 179.45 of this chapter, shall comply with any specifications and
limitations prescribed by such regulation for the article in the
finished form in which it is to contact food.
(42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10110, Mar. 19,
1984)
21 CFR 177.1970 Vinyl chloride-lauryl vinyl ether copolymers.
The vinyl chloride-lauryl vinyl ether copolymers identified in
paragraph (a) of this section may be used as an article or as a
component of an article intended for use in contact with food subject to
the provisions of this section.
(a) Identity. For the purposes of this section vinyl chloride-lauryl
vinyl ether copolymers consist of basic copolymers produced by the
copolymerization of vinyl chloride and lauryl vinyl ether such that the
finished copolymers contain not more than 3 weight-percent of polymer
units derived from lauryl vinyl ether and meet the specifications and
extractives limitations prescribed in paragraph (c) of this section.
(b) Optional adjuvant substances. The basic vinyl chloride-lauryl
vinyl ether copolymers identified in paragraph (a) of this section may
contain optional adjuvant substances required in the production of such
basic copolymers. These optional adjuvant substances may include
substances permitted for such use by regulations in parts 170 through
189 of this chapter, substances generally recognized as safe in food,
and substances used in accordance with a prior sanction or approval.
(c) Specifications and limitations. The vinyl chloride-lauryl vinyl
ether basic copolymers meet the following specifications and extractives
limitations:
(1) Specifications. (i) Total chlorine content is 53 to 56 percent
as determined by any suitable analytical procedure of generally accepted
applicability.
(ii) Inherent viscosity in cylcohexanone at 30 C is not less than
0.60 deciliter per gram as determined by ASTM method D1243-79,
''Standard Test Method for Dilute Solution Viscosity of Vinyl Chloride
Polymers,'' which is incorporated by reference. Copies may be obtained
from the American Society for Testing Materials, 1916 Race St.,
Philadelphia, PA 19103, or may be examined at the Office of the Federal
Register, 1100 L St. NW., Washington, DC 20408.
(2) Extractives limitations. The following extractives limitations
are determined by the method described in paragraph (d) of this section:
(i) Total extractives do not exceed 0.03 weight-percent when
extracted with water at 150 F for 2 hours.
(ii) Total extractives do not exceed 0.60 weight-percent when
extracted with n-heptane at 150 F for 2 hours.
(d) Analytical methods. The analytical methods for determining total
extractives are applicable to the basic copolymers in powder form having
a particle size such that 100 percent will pass through a U.S. Standard
Sieve No. 40 and such that not more than 10 percent will pass through a
U.S. Standard Sieve No. 200.
(1) Reagents -- (i) Water. All water used in these procedures shall
be demineralized (deionized), freshly distilled water.
(ii) n-Heptane. Reagent grade, freshly distilled n-heptane shall be
used.
(2) Determination of total amount of extractives. Place an
accurately weighed sample of suitable size in a clean borosilicate
flask, and for each gram of sample add 3 milliliters of solvent
previously heated to 150 F. Maintain the temperature of the contents of
the flask at 150 F for 2 hours using a hot plate while also maintaining
gentle mechanical agitation. Filter the contents of the flask rapidly
through No. 42 Whatman filter paper with the aid of suction. Transfer
the filtrate to flat glass dishes that are warmed on a hot plate and
evaporate the solvent with the aid of a stream of filtered air. When
the volume of the filtrate has been reduced to 10 to 15 milliliters,
transfer the filtrate to tared 50-milliliter borosilicate glass beakers
and complete evaporation to a constant weight in a 140 F vacuum oven.
Carry out a corresponding blank determination with each solvent.
Determine the weight of the residue corrected for the solvent blank and
calculate the result as percent of the initial weight of the resin
sample taken for analysis.
(e) Other specifications and limitations. The vinyl chloride-lauryl
vinyl ether copolymers identified in and complying with this section,
when used as components of the food-contact surface of any article that
is subject to a regulation in parts 174, 175, 176, 177, 178 and 179.45
of this chapter, shall comply with any specifications and limitations
prescribed by such regulation for the article in the finished form in
which it is to contact food.
(42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10110, Mar. 19,
1984)
21 CFR 177.1980 Vinyl chloride-propylene copolymers.
The vinyl chloride-propylene copolymers identified in paragraph (a)
of this section may be safely used as components of articles intended
for contact with food, subject to the provisions of this section.
(a) For the purpose of this section, vinyl chloride-propylene
copolymers consist of basic copolymers produced by the copolymezation of
vinyl chloride and propylene such that the finished basic copolymers
meet the specifications and extractives limitations prescribed in
paragraph (c) of this section, when tested by the methods described in
paragraph (d) of this section.
(b) The basic vinyl chloride-propylene copolymers identified in
paragraph (a) of this section may contain optional adjuvant substances
required in the production of such basic copolymers. The optional
adjuvant substances required in the production of the basic vinyl
chloride-propylene copolymers may include substances permitted for such
use by regulations in parts 170 through 189 of this chapter, substances
generally recognized as safe in food, and substances used in accordance
with a prior sanction or approval.
(c) The vinyl chloride-propylene basic copolymers meet the following
specifications and extractives limitations:
(1) Specifications. (i) Total chlorine content is in the range of 53
to 56 percent as determined by any suitable analytical procedure of
generally accepted applicability.
(ii) Intrinsic viscosity in cyclohexanone at 30 C is not less than
0.50 deciliter per gram as determined by ASTM method D1243-79,
''Standard Test Method for Dilute Solution Viscosity of Vinyl Chloride
Polymers,'' which is incorporated by reference. Copies may be obtained
from the American Society for Testing Materials, 1916 Race St.,
Philadelphia, PA 19103, or may be examined at the Office of the Federal
Register, 1100 L St. NW., Washington, DC 20408.
(2) Extractives limitations. The following extractives limitations
are determined by the methods described in paragraph (d) of this
section:
(i) Total extractives do not exceed 0.10 weight-percent when
extracted with n-heptane at 150 F for 2 hours.
(ii) Total extractives do not exceed 0.03 weight-percent when
extracted with water at 150 F for 2 hours.
(iii) Total extractives obtained by extracting with water at 150 F
for 2 hours contain no more than 0.17 milligram of vinyl
chloride-propylene copolymer per 100 grams of sample tested as
determined from the organic chlorine content. For the purpose of this
section, the organic chlorine content is the difference between the
total chlorine and ionic chlorine contents determined as described in
paragraph (d) of this section.
(d) Analytical methods: The analytical methods for determining
whether vinyl chloride-propylene basic copolymers conform to the
extractives limitations prescribed in paragraph (c) of this section are
as follows and are applicable to the basic copolymers in powder form
having a particle size such that 100 percent will pass through a U.S.
Standard Sieve No. 40 and 80 percent will pass through a U.S. Standard
Sieve No. 80:
(1) Reagents -- (i) Water. All water used in these procedures shall
be demineralized (deionized), freshly distilled water.
(ii) n-Heptane. Reagent grade, freshly distilled n-heptane shall be
used.
(2) Determination of total amount of extractives. All determinations
shall be done in duplicate using duplicate blanks. Approximately 400
grams of sample (accurately weighed) shall be placed in a 2-liter
Erlenmeyer flask. Add 1,200 milliliters of solvent and cover the flask
with aluminum foil. The covered flask and contents are suspended in a
thermostated bath and are kept, with continual shaking, at 150 F for 2
hours. The solution is then filtered through a No. 42 Whatman filter
paper, and the filtrate is collected in a graduated cylinder. The total
amount of filtrate (without washing) is measured and called A
milliliters. The filtrate is transferred to a Pyrex (or equivalent)
beaker and evaporated on a steam bath under a stream of nitrogen to a
small volume (approximately 50-60 milliliters). The concentrated
filtrate is then quantitatively transferred to a tared 100-milliliter
Pyrex beaker using small, fresh portions of solvent and a rubber
policeman to effect the transfer. The concentrated filtrate is
evaporated almost to dryness on a hotplate under nitrogen, and is then
transferred to a drying oven at 230 F in the case of the aqueous
extract or to a vacuum oven at 150 F in the case of the heptane
extract. In the case of the aqueous extract the evaporation to constant
weight is completed in 15 minutes at 230 F; and in the case of heptane
extract, it is overnight under vacuum at 150 F. The residue is weighed
and corrected for the solvent blank. Calculation:
=Total extractives expressed as percent by weight of sample.
(3) Vinyl chloride-propylene copolymer content of aqueous extract --
(i) Principle. The vinyl chloride-propylene copolymer content of the
aqueous extract can be determined by determining the organic chlorine
content and calculating the amount of copolymer equivalent to the
organic chlorine content. The organic chlorine content is the
difference between the total chlorine content and the ionic chlorine
content.
(ii) Total chlorine content. A weighed sample is extracted with
water at 150 F for 2 hours, filtered, and the volume of filtrate is
measured (A milliliters) as described in paragraph (d)(2) of this
section. Two drops of 50 percent by weight sodium hydroxide solution
are added to prevent loss of chloride from ammonium chloride, if
present, and the solution is evaporated to approximately 15 milliliters.
The concentrated filtrate is quantitatively transferred to a
22-milliliter Parr bomb fusion cup and gently evaporated to dryness. To
the contents of the cup are added 3.5 grams of granular sodium peroxide,
0.1 gram of powdered starch, and 0.02 gram potassium nitrate; and the
contents are mixed thoroughly. The bomb is assembled, water is added to
the recess at the top of the bomb and ignition is conducted in the usual
fashion using a Meeker burner. The heating is continued for 1 minute
after the water at the top has evaporated. The bomb is quenched in
water, rinsed with distilled water, and placed in a 400-milliliter
beaker. The bomb cover is rinsed with water, catching the washings in
the same 400-milliliter beaker. The bomb is covered with distilled
water and a watch glass and heated until the melt has dissolved. The
bomb is removed, rinsed, catching the rinsings in the beaker, and the
solution is acidified with concentrated nitric acid using methyl purple
as an indicator. The beaker is covered with a watch glass, and the
contents are boiled gently for 10-15 minutes. After cooling to room
temperature the solution is made slightly alkaline with 50 percent by
weight sodium hydroxide solution, then acidified with dilute (1:5)
nitric acid. Then 1.5 milliliters of 2 N nitric acid per 100
milliliters of solution is added and the solution is titrated with 0.005
N silver nitrate to the equivalence potential end point using an
expanded scale pH meter (Beckman Model 76, or equivalent). A complete
blank must be run in duplicate. Calculation:
=Milliequivalents of total chlorine in aqueous extract of 100 grams
of sample.
where:
A=volume of filtrate obtained in extraction.
B=milliliters of silver nitrate solution used in sample titration
normality of silver nitrate solution.
C=milliliters of silver nitrate solution used in blank titration
normality of silver nitrate solution.
(iii) Ionic chlorine content. A weighed sample is extracted with
water at 150 F for 2 hours, filtered, and the volume of filtrate is
measured (A milliliters) as in paragraph (d)(2) of this section. Two
drops of 50 percent by weight sodium hydroxide solution are added and
the solution is evaporated to approximately 150 milliliters. The
solution is quantitatively transferred to a 250-milliliter beaker,
methyl purple indicator is added, and the solution is neutralized with
0.1 N nitric acid. For each 100 milliliters of solution is added 1.5
milliliters of 2 N nitric acid. The solution is titrated with 0.005 N
silver nitrate to the equivalence potential end point, using the
expanded scale pH meter described in paragraph (d)(3)(ii) of this
section. A complete blank must be run in duplicate. Calculation:
=Milliequivalents of ionic chlorine in aqueous extract of 100 grams
of sample.
where:
A=volume of filtrate obtained in extraction.
D=milliliters of silver nitrate solution used in sample titration
normality of silver nitrate solution.
E=milliliters of silver nitrate solution used in blank titration
normality of silver nitrate solution.
(iv) Organic chlorine content and vinyl chloride-propylene copolymer
content of aqueous extract. The organic chlorine content and the vinyl
chloride propylene copolymer content of the aqueous extract is
calculated as follows:
(a) Organic chlorine content. Milliequivalents of organic chlorine
in aqueous extract of 100 grams of sample equal milliequivalents of
total chlorine in aqueous extract of 100 grams of sample (as calculated
in paragraph (d)(3)(ii) of this section) minus milliequivalents of ionic
chlorine in aqueous extract of 100 grams of sample (as calculated in
paragraph (d)(3)(iii) of this section).
(b) Vinyl chloride-propylene copolymer content. Milligrams of vinyl
chloride-propylene copolymer in aqueous extract of 100 grams of sample
equal milliequivalents of organic chlorine in aqueous extract of 100
grams of sample (as calculated in paragraph (d)(3)(iv) (a) of this
section) multiplied by 84.5.
Note: The conversion factor, 84.5, is derived from the equivalent
weight of chlorine divided by the chlorine content of the heptane
extractable fraction.)
(e) The vinyl chloride-propylene copolymers identified in and
complying with this section, when used as components of the food-contact
surface of any article that is the subject of a regulation in parts 174,
175, 176, 177, 178 and 179.45 of this chapter, shall comply with any
specifications and limitations prescribed by such regulation for the
article in the finished form in which it is to contact food.
(f) The provisions of this section are not applicable to vinyl
chloride-propylene copolymers used in food-packaging adhesives complying
with 175.105 of this chapter.
(42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10111, Mar. 19,
1984)
21 CFR 177.1990 Vinylidene chloride/methyl acrylate copolymers.
The vinylidene chloride/methyl acrylate copolymers (CAS Reg. No.
25038-72-6) identified in paragraph (a) of this section may be safely
used as an article or as a component of an article intended for use in
contact with food subject to the provisions of this section.
(a) Identity. For the purposes of this section vinylidene
chloride/methyl acrylate copolymers consist of basic copolymers produced
by the copolymerization of vinylidene chloride and methyl acrylate such
that the copolymers contain not more than 15 weight-percent of polymer
units derived from methyl acrylate.
(b) Optional adjuvant substances. The basic vinylidene
chloride/methyl acrylate copolymers identified in paragraph (a) of this
section may contain optional adjuvant substances required in the
production of such basic copolymers. These optional adjuvant substances
may include substances permitted for such use by regulations in parts
170 through 179 of this chapter, substances generally recognized as safe
in food, and substances used in accordance with a prior sanction or
approval.
(c) Specifications. (1) The methyl acrylate content is determined by
an infrared spectrophotometric method titled ''Determination of
Copolymer Ratio in Vinylidene Chloride/Methyl Acrylate Copolymers,''
which is incorporated by reference. Copies are available from the
Division of Food and Color Additives, Center for Food Safety and Applied
Nutrition (HFF-330), 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.
(2) The weight average molecular weight of the copolymer is not less
than 50,000 when determined by gel permeation chromatography using
tetrahydrofuran as the solvent. The gel permeation chromatograph is
calibrated with polystyrene standards. The basic gel permeation
chromatographic method is described in ANSI/ASTM D3536-76, ''Standard
Test Method for Molecular Weight Averages and Molecular Weight
Distribution of Polystyrene by Liquid Exclusion Chromatography (Gel
Permeation Chromatography-GPC),'' which is incorporated by reference.
Copies are available from University Microfilms International, 300 North
Zeeb Rd., Ann Arbor, MI 48106, or available for inspection at the Office
of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(3) Residual vinylidene chloride and residual methyl acrylate in the
copolymer in the form in which it will contact food (unsupported film,
barrier layer, or as a copolymer for blending) will not exceed 10 parts
per million and 5 parts per million, respectively, as determined by
either a gas chromatographic method titled ''Determination of Residual
Vinylidene Chloride and Methyl Acrylate in Vinylidene Chloride/Methyl
Acrylate Copolymer Resins and Films,'' or, alternatively, ''Residual
Methyl Acrylate and Vinylidene Chloride Monomers in Saran MA/VDC Resins
and Pellets by Headspace Gas Chromatography,'' dated March 3, 1986,
which are incorporated by reference in accordance with 5 U.S.C. 552(a).
Copies are available from the Division of Food and Color Additives,
Center for Food Safety and Applied Nutrition (HFF-330), 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.
(d) Extractives limitations. The basic copolymer resin in the form
of granules that will pass through a U.S. Standard Sieve No. 45 (350
microns) shall meet the following extractives limitations:
(1) 10-gram samples of the resin, when extracted separately with 100
milliliters of distilled water at 121 C (250 F) for 2 hours, and 100
milliliters of n-heptane at 66 C (150 F) for 2 hours, shall yield
total nonvolatile extractives not to exceed 0.5 percent by weight of the
resin.
(2) The basic copolymer in the form of film when extracted separately
with distilled water at 121 C (250 F) for 2 hours shall yield total
nonvolatile extractives not to exceed 0.047 milligram per square
centimeter (0.3 milligram per square inch).
(e) Conditions of use. The copolymers may be safely used as articles
or components of articles intended for use in producing, manufacturing,
processing, preparing, treating, packaging, transporting, or holding
food, including processing of packaged food at temperatures not to
exceed 135 C (275 F).
(f) Other specifications and limitations. The vinylidene
chloride-methyl acrylate copolymers identified in and complying with
this section, when used as components of the food contact surface of any
article that is subject to a regulation in parts 174 through 178 and
179.45 of this chapter, shall comply with any specifications and
limitations prescribed by such regulation for the article in the
finished form in which it is to contact food.
(48 FR 38605, Aug. 25, 1983; 48 FR 50077, Oct. 31, 1983, as amended
at 53 FR 47185, Nov. 22, 1988; 54 FR 24898, June 12, 1989)
21 CFR 177.2000 Vinylidene chloride/methyl acrylate/methyl methacrylate
polymers.
The vinylidene chloride/methyl acrylate/methyl methacrylate polymers
(CAS Reg. No. 34364-83-5) identified in paragraph (a) of this section
may be safely used as articles or as a component of articles intended
for use in contact with food subject to the provisions of this section.
(a) Identity. For the purpose of this section, vinylidene
chloride/methyl acrylate/methyl methacrylate polymers consist of basic
polymers produced by the copolymerization of vinylidene chloride/methyl
acrylate/methyl methacrylate such that the basic polymers or the
finished food-contact articles meet the specifications prescribed in
paragraph (d) of this section.
(b) Optional adjuvant substances. The basic vinylidene
chloride/methyl acrylate/methyl methacrylate polymers identified in
paragraph (a) of this section may contain optional adjuvant substances
required in the production of such basic polymers. These optional
adjuvant substances may include substances permitted for such use by
regulations in parts 170 through 179 of this chapter, substances
generally recognized as safe in food, and substances used in accordance
with a prior sanction of approval.
(c) Conditions of use. The polymers may be safely used as articles
or as components of articles intended for use in producing,
manufacturing, processing, preparing, treating, packaging, transporting,
or holding food, including processing of packaged food at temperatures
up to 121 C (250 F).
(d) Specifications and limitations. The vinylidene chloride/methyl
acrylate/methyl methacrylate basic polymers and/or finished food-contact
articles meet the following specifications and limitations:
(1)(i) The basic vinylidene chloride/methyl acrylate/methyl
methacrylate polymers contain not more than 2 weight percent of polymer
units derived from methyl acrylate monomer and not more than 6 weight
percent of polymer units derived from methyl methacrylate monomer.
(ii) The basic polymers are limited to a thickness of not more than
0.005 centimeter (0.002 inches).
(2) The weight average molecular weight of the basic polymer is not
less than 100,000 when determined by gel permeation chromatography using
tetrahydrofuran as the solvent. The gel permeation chromatography is
calibrated with polystyrene standards. The basic gel permeation
chromatographic method is described in ANSI/ASTM D3536-76, which is
incorporated by reference. Copies are available from the American
Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or
available for inspection at the Office of the Federal Register, 1100 L
St. NW., Washington, DC 20408.
(3) The basic polymer or food-contact article described in paragraph
(a) of this section, when extracted with the solvent or solvents
characterizing the type of food and under the conditions of time and
temperature characterizing the conditions of its intended use as
determined from Tables 1 and 2 of 176.170(c) of this chapter, yields
net chloroform-soluble extractives in each extracting solvent not to
exceed .08 milligram per square centimeter (0.5 milligram per square
inch) of food-contact surface when tested by the methods described in
176.170(d). If the finished food-contact article is itself the subject
of a regulation in parts 174 through 178 and 179.45 of this chapter, it
shall also comply with any specifications and limitations prescribed for
it by the regulation.
(49 FR 29578, July 23, 1984)
21 CFR 177.2000 Subpart C -- Substances for Use Only as Components of Articles Intended for Repeated Use
21 CFR 177.2210 Ethylene polymer, chlorosulfonated.
Ethylene polymer, chlorosulfonated as identified in this section may
be safely used as an article or component of articles intended for use
in contact with food, subject to the provisions of this section.
(a) Ethylene polymer, chlorosulfonated is produced by
chlorosulfonation of a carbon tetrachloride solution of polyethylene
with chlorine and sulfuryl chloride.
(b) Ethylene polymer, chlorosulfonated shall meet the following
specifications:
(1) Chlorine not to exceed 25 percent by weight.
(2) Sulfur not to exceed 1.15 percent by weight.
(3) Molecular weight is in the range of 95,000 to 125,000.
Methods for the specifications in this paragraph (b), titled
''Chlorine and Bromine -- Coulometric Titration Method by Aminco
Chloridometer,'' ''Hypolon# Synthetic Rubber -- Determination of Sulfur
by Parr Bomb,'' and ASTM method D2857-70 (Reapproved 1977), ''Standard
Test Method for Dilute Solution Viscosity of Polymers,'' are
incorporated by reference. Copies of the ASTM method may be obtained
from the American Society for Testing Materials, 1916 Race St.,
Philadelphia, PA 19103. Copies of the other two methods are available
from the Division of Food and Color Additives, Center for Food Safety
and Applied Nutrition (HFF-330), Food and Drug Administration, 200 C St.
SW., Washington, DC 20204. Copies of all three methods may be examined
at the Office of the Federal Register, 1100 L St. NW., Washington, DC
20408.
(c) The additive is used as the article, or a component of articles,
intended for use as liners and covers for reservoirs intended for the
storage of water for drinking purposes.
(d) Substances permitted by 177.2600 may be employed in the
preparation of ethylene polymers, chlorosulfonated, subject to any
limitations prescribed therein.
(e) The finished ethylene copolymers, chlorosulfonated shall conform
to 177.2600(e) and (g).
(42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10111, Mar. 19,
1984; 54 FR 24898, June 12, 1989)
21 CFR 177.2250 Filters, microporous polymeric.
Microporous polymeric filters identified in paragraph (a) of this
section may be safely used, subject to the provisions of this section,
to remove particles of insoluble matter in producing, manufacturing,
processing, and preparing bulk quantities of liquid food.
(a) Microporous polymeric filters consist of a suitably permeable,
continuous, polymeric matrix of polyvinyl chloride, vinyl
chloride-propylene, or vinyl chloride-vinyl acetate, in which finely
divided silicon dioxide is embedded. Cyclohexanone may be used as a
solvent in the production of the filters.
(b) Any substance employed in the production of microporous polymeric
filters that is the subject of a regulation in parts 170 through 189 of
this chapter must conform with any specification in such regulation.
(c) Cyclohexanone when used as a solvent in the production of the
filters shall not exceed 0.35 percent by weight of the microporous
polymeric filters.
(d) The microporous polymeric filters may be colored with colorants
used in accordance with 178.3297 of this chapter.
(e) The temperature of food being processed through the microporous
polymeric filters shall not exceed 180 F.
(f) The microporous polymeric filters shall be maintained in a
sanitary manner in accordance with good manufacturing practice so as to
prevent potential microbial adulteration of the food.
(g) To assure safe use of the microporous polymeric filters, the
label or labeling shall include adequate directions for a pre-use
treatment, consisting of washing with a minimum of 2 gallons of potable
water at a temperature of 180 F for each square foot of filter, prior
to the filter's first use in contact with food.
(42 FR 14572, Mar. 15, 1977, as amended at 56 FR 42933, Aug. 30,
1991)
21 CFR 177.2260 Filters, resin-bonded.
Resin-bonded filters may be safely used in producing, manufacturing,
processing, and preparing food, subject to the provisions of this
section.
(a) Resin-bonded filters are prepared from natural or synthetic
fibers to which have been added substances required in their preparation
and finishing, and which are bonded with resins prepared by condensation
or polymerization of resin-forming materials, together with adjuvant
substances required in their preparation, application, and curing.
(b) The quantity of any substance employed in the production of the
resin-bonded filter does not exceed the amount reasonably required to
accomplish the intended physical or technical effect or any limitation
further provided.
(c) Any substance employed in the production of resin-bonded filters
that is the subject of a regulation in parts 174, 175, 176, 177, 178 and
179.45 of this chapter conforms with any specification in such
regulation.
(d) Substances employed in the production of resin-bonded filters
include the following, subject to any limitations provided:
(1) Fibers:
Cellulose pulp.
Cotton.
Nylon. (From nylon resins complying with the provisions of applicable
regulations in Subchapter B of this chapter.
Polyethylene terephthalate complying in composition with the
provisions of 177.1630; for use in inline filtration only as provided
for in paragraphs (e) and (f) of this section.
Rayon (viscose).
(2) Substances employed in fiber finishing:
BHT.
Butyl (or isobutyl) palmitate or stearate.
2,5-Di-tert-butyl hydroquinone for use only in lubricant formulations
for rayon fiber finishing and at a usage level not to exceed 0.1 percent
by weight of the lubricant formulations.
Dimethylpolysiloxane.
4-Ethyl-4-hexadecyl morpholinium ethyl sulfate for use only as a
lubricant in the manufacture of polyethylene terephthalate fibers
specified in paragraph (d)(1) of this section at a level not to exceed
0.03 percent by weight of the finished fibers.
Fatty acid (C10-C18) diethanolamide condensates.
Fatty acids derived from animal or vegetable fats and oils, and salts
of such acids, single or mixed, as follows:
Aluminum.
Ammonium.
Calcium.
Magnesium.
Potassium.
Sodium.
Triethanolamine.
Fatty acid (C10-C18) mono- and diesters of polyoxyethylene glycol
(molecular weight 400-3,000).
Methyl esters of fatty acids (C10-C18).
Mineral oil.
Polybutene, hydrogenated; complying with the identity prescribed
under 178.3740 (b) of this chapter.
Polyoxyethylene (4 mols) ethylenediamine monolauramide for use only
in lubricant formulations for rayon fiber finishing and at a usage level
not to exceed 10 percent by weight of the lubricant formulations.
Ricebran oil.
Titanium dioxide.
(3) Resins:
Acrylic polymers produced by polymerizing ethyl acrylate alone or
with one or more of the monomers: Acrylic acid, acrylonitrile,
N-methylolacrylamide, and styrene. The finished copolymers shall
contain at least 70 weight percent of polymer units derived from ethyl
acrylate, no more than 2 weight percent of total polymer units derived
from acrylic acid, no more than 10 weight percent of total polymer units
derived from acrylonitrile, no more than 2 weight percent of total
polymer units derived from N-methylolacrylamide, and no more than 25
weight percent of total polymer units derived from styrene. For use
only as provided in paragraph (m) of this section.
Melamine-formaldehyde.
Melamine-formaldehyde chemically modified with one or more of the
amine catalysts identified in 175.300(b)(3)(xiii) of this chapter.
Melamine-formaldehyde chemically modified with methyl alcohol.
Melamine-formaldehyde chemically modified with urea; for use only as
provided for in paragraphs (e), (f), (g), (h), and (i) of this section.
Phenol-formaldehyde resins.
Polyvinyl alcohol.
Polyvinyl alcohol with the copolymer of acrylic acid-allyl sucrose.
Polyvinyl alcohol with melamine formaldehyde.
Polyvinyl acetate with melamine formaldehyde.
p--Toluenesulfonamide-formaldehyde chemically modified with one or
more of the amine catalysts identified in 175.300 (b)(3)(xiii) of this
chapter.
(4) Adjuvant substances:
Dimethyl polysiloxane with methylcellulose and sorbic acid (as an
antifoaming agent).
Phosphoric acid.
(5) Colorants: Colorants used in accordance with 178.3297 of this
chapter.
(e) Resin-bonded filters conforming with the specifications of
paragraph (e) (1) of this section are used as provided in paragraph
(e)(2) of this section:
(1) Total extractives. The finished filter, when exposed to
distilled water at 100 F for 2 hours, yields total extractives not to
exceed 2.8 percent by weight of the filter.
(2) Conditions of use. It is used to filter milk or potable water at
operating temperatures not to exceed 100 F.
(f) Resin-bonded filters conforming with the specifications of
paragraph (f) (1) of this section are used as provided in paragraph
(e)(2) of this section:
(1) Total extractives. The finished filter, when exposed to
distilled water at 145 F for 2 hours, yields total extractives not to
exceed 4 percent by weight of the filter.
(2) Conditions of use. It is used to filter milk or potable water at
operating temperatures not to exceed 145 F.
(g) Resin-bonded filters conforming with the specifications of
paragraph (g) (1) of this section are used as provided in paragraph
(g)(2) of this section:
(1) Total extractives. The finished filter, when exposed to n-hexane
at reflux temperature for 2 hours, yields total extractives not to
exceed 0.5 percent by weight of the filter.
(2) Conditions of use. It is used to filter edible oils.
(h) Resin-bonded filters conforming with the specifications of
paragraph (h) (1) of this section are used as provided in paragraph
(h)(2) of this section:
(1) Total extractives. The finished filter, when exposed to
distilled water at 212 F for 2 hours, yields total extractives not to
exceed 4 percent by weight of the filter.
(2) Conditions of use. It is used to filter milk, coffee, tea, and
potable water at temperatures not to exceed 212 F.
(i) Resin-bonded filters conforming with the specifications of
paragraph (i) (1) of this section are used as provided in paragraph
(i)(2) of this section:
(1) Total extractives. The finished filter, when exposed to
distilled water for 2 hours at a temperature equivalent to, or higher
than, the filtration temperature of the aqueous food, yields total
extractives not to exceed 4 percent, by weight, of the filter.
(2) Conditions of use. It is used in commercial filtration of bulk
quantities of nonalcoholic, aqueous foods having a pH above 5.0.
(j) Resin-bonded filters conforming with the specifications of
paragraph (j) (1) of this section are used as provided in paragraph
(j)(2) of this section:
(1) Total extractives. The finished filter, when exposed to 5
percent (by weight) acetic acid for 2 hours at a temperature equivalent
to, or higher than, the filtration temperature of the aqueous food,
yields total extractives not to exceed 4 percent, by weight, of the
filter.
(2) Conditions of use. It is used in commercial filtration of bulk
quantities of nonalcoholic, aqueous foods having a pH of 5.0 or below.
(k) Resin-bonded filters conforming with the specifications of
paragraph (k) (1) of this section are used as provided in paragraph
(k)(2) of this section:
(1) Total extractives. The finished filter, when exposed to 8
percent (by volume) ethyl alcohol in distilled water for 2 hours at a
temperature equivalent to, or higher than, the filtration temperature of
the alcoholic beverage, yields total extractives not to exceed 4
percent, by weight, of the filter.
(2) Conditions of use. It is used in commercial filtration of bulk
quantities of alcoholic beverages containing not more than 8 percent
alcohol.
(l) Resin-bonded filters conforming with the specifications of
paragraph (l) (1) of this section are used as provided in paragraph
(l)(2) of this section:
(1) Total extractives. The finished filter, when exposed to 50
percent (by volume) ethyl alcohol in distilled water for 2 hours at a
temperature equivalent to, or higher than, the filtration temperature of
the alcoholic beverage, yields total extractives not to exceed 4
percent, by weight, of the filter.
(2) Conditions of use. It is used in commercial filtration of bulk
quantities of alcoholic beverages containing more than 8 percent
alcohol.
(m) Resin-bonded filters fabricated from acrylic polymers as provided
in paragraph (d)(3) of this section together with other substances as
provided in paragraph (d), (1), (2), and (4) of this section may be used
as follows:
(1) The finished filter may be used to filter milk or potable water
at operating temperatures not to exceed 100 F, provided that the
finished filter when exposed to distilled water at 100 F for 2 hours
yields total extractives not to exceed 1 percent by weight of the
filter.
(2) The finished filter may be used to filter milk or potable water
at operating temperatures not to exceed 145 F, provided that the
finished filter when exposed to distilled water at 145 F for 2 hours
yields total extractives not to exceed 1.2 percent by weight of the
filter.
(n) Acrylonitrile copolymers identified in this section shall comply
with the provisions of 180.22 of this chapter.
(42 FR 14572, Mar. 15, 1977, as amended at 56 FR 42933, Aug. 30,
1991)
21 CFR 177.2280 4,4'-Isopropylidenediphenolepi-chlorohydrin
thermosetting epoxy resins.
4,4'-Isopropylidenediphenol-epichlo-rohydrin thermosetting epoxy
resins may be safely used as articles or components of articles intended
for repeated use in producing, manufacturing, packing, processing,
preparing, treating, packaging, transporting, or holding food, in
accordance with the following prescribed conditions:
(a) The basic thermosetting epoxy resin is made by reacting
4,4'-isopropylidenediphenol with epichlorohydrin.
(b) The resin may contain one or more of the following optional
substances provided the quantity used does not exceed that reasonably
required to accomplish the intended effect:
(c) In accordance with good manufacturing practice, finished articles
containing the resins shall be thoroughly cleansed prior to their first
use in contact with food.
(d) The provisions of this section are not applicable to
4,4'-isopropylidenedi-phenol-epichlorohydrin resins listed in other
sections of parts 174, 175, 176, 177, 178 and 179 of this chapter.
(42 FR 14572, Mar. 15, 1977; 49 FR 5748, Feb. 15, 1984)
21 CFR 177.2355 Mineral reinforced nylon resins.
Mineral reinforced nylon resins identified in paragraph (a) of this
section may be safely used as articles or components of articles
intended for repeated use in contact with nonacidic food (pH above 5.0)
and at use temperatures not exceeding 212 F. in accordance with the
following prescribed conditions:
(a) For the purpose of this section the mineral reinforced nylon
resins consist of nylon 66, as identified in and complying with the
specifications of 177.1500, reinforced with up to 40 weight percent of
calcium silicate and up to 0.5 weight percent 3-(triethoxysilyl)
propylamine (Chemical Abstracts Service Registry No. 000919302) based on
the weight of the calcium silicate.
(b) The mineral reinforced nylon resins may contain up to 0.2 percent
by weight of titanium dioxide as an optional adjuvant substance.
(c) The mineral reinforced nylon resins with or without the optional
substance described in paragraph (b) of this section, and in the form of
1/8-inch molded test bars, when extracted with the solvents, i.e.,
distilled water and 50 percent (by volume) ethyl alcohol in distilled
water, at reflux temperature for 24 hours using a volume-to-surface
ratio of 2 milliliters of solvent per square inch of surface tested,
shall meet the following extractives limitations:
(1) Total extractives not to exceed 5.0 milligrams per square inch of
food-contact surface tested for each solvent.
(2) The ash after ignition of the extractives described in paragraph
(c)(1) of this section, not to exceed 0.5 milligram per square inch of
food-contact surface tested.
(d) In accordance with good manufacturing practice, finished articles
containing the mineral reinforced nylon resins shall be thoroughly
cleansed prior to their first use in contact with food.
(42 FR 54533, Oct. 7, 1977, as amended at 42 FR 61594, Dec. 6, 1977)
21 CFR 177.2400 Perfluorocarbon cured elastomers.
Perfluorocarbon cured elastomers identified in paragraph (a) of this
section may be safely used as articles or components of articles
intended for repeated use in contact with nonacid food (pH above 5.0),
subject to the provisions of this section.
(a) Identity. (1) For the purpose of this section, perfluorocarbon
cured elastomers are produced by terpolymerizing tetrafluorethylene (CAS
Reg. No. 116-14-3), perfluoromethyl vinyl ether (CAS Reg. No.
1187-93-5), and perfluoro-2-phenoxypropyl vinyl ether (CAS Reg. No.
24520-19-2) and subsequent curing of the terpolymer (CAS Reg. No.
26658-70-8) using the crosslinking agent, phenol,
4,4'-(2,2,2-trifluoro-1-(trifluoromethyl) ethylidene) bis-,dipotassium
salt (CAS Reg. No. 25088-69-1) and accelerator,
1,4,7,10,13,16-hexaoxacyclooctadecane (CAS Reg. No. 17455-13-9).
(2) The perfluorocarbon base polymer shall contain no less than 40
weight-percent of polymer units derived from tetrafluoroethylene, no
less than 40 weight-percent of polymer units derived from
perfluoromethyl vinyl ether and no more than 5 weight-percent polymer
units derived from perfluoro-2-phenoxy-propyl vinyl ether.
(3) The composition limitations of the cured elastomer, calculated as
parts per 100 parts of terpolymer, are as follows: Phenol,
4,4'-(2,2,2-trifluoro-1-(trifluoromethyl)-ethylidene) bis-,dipotassium
salt -- not to exceed 5 parts. 1,4,7,10,13,16-Hexaoxacyclo-octadecane
-- not to exceed 5 parts.
(b) Optional adjuvant substances. The perfluorocarbon cured
elastomer identified in paragraph (a) of this section may contain the
following optional adjuvant substances, subject to any limitations cited
on their use:
(1) Substances generally recognized as safe (GRAS) in food or food
packaging.
(2) Substances used in accordance with a prior sanction.
(3) Substances authorized under applicable regulations in this part
and in parts 175 and 178 of this chapter and subject to any limitations
prescribed therein.
(4) Substances identified in this paragraph (b)(4) subject to such
limitations as are provided:
(c) Specifications -- (1) Infrared identification. Perfluorocarbon
cured elastomers may be identified by the characteristic infrared
spectra of the pyrolysate breakdown product that is obtained by heating
and decomposing the elastomer using the method entitled ''Qualitative
Identification of Kalrez# by Infrared Examination of Pyrolysate.'' This
method is incorporated by reference. Copies of the method are available
from the Division of Food and Color Additives, Center for Food Safety
and Applied Nutrition (HFF-330), 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.
(2) Thermogravimetry. Perfluorocarbon cured elastomers have a major
decomposition peak occurring at 490 15 C (914 F). Less than 1.5
percent of the elastomers will volatilize below 400 C (752 F) when run
under nitrogen at a 10 C or 18 F per minute heating rate using a Du
Pont Thermal Analyzer Model 1099 with Model 951 TGA unit or the
equivalent.
(d) Extractive limitations. Articles fabricated from perfluorocarbon
cured elastomers having a thickness of at least 1.0 millimeter (0.039
inch) when extracted at reflux temperatures for 2 hours separately with
distilled water, 50 percent ethanol, and n-heptane, shall meet the
following extractability limits:
(1) Total extractives not to exceed 3.1 milligrams per square
decimeter (0.2 milligrams per square inch).
(2) Fluoride extractives calculated as fluorine not to exceed 0.47
milligram per square decimeter (0.03 milligram per square inch).
(e) Conditions of use. In accordance with current good manufacturing
practice, finished food contact articles containing the perfluorocarbon
cured elastomers shall be thoroughly cleaned prior to their first use in
contact with food.
(49 FR 43050, Oct. 26, 1984)
21 CFR 177.2410 Phenolic resins in molded articles.
Phenolic resins identified in this section may be safely used as the
food-contact surface of molded articles intended for repeated use in
contact with nonacid food (pH above 5.0), in accordance with the
following prescribed conditions:
(a) For the purpose of this section, the phenolic resins are those
produced when one or more of the phenols listed in paragraph (a)(1) of
this section are made to react with one or more of the aldehydes listed
in paragraph (a)(2) of this section, with or without aniline and/or
anhydro-formaldehyde aniline (hexahydro-1, 3,5-triphenyl-s-triazine):
(1) Phenols:
p-tert-Amylphenol.
p-tert-Butylphenol.
o-, m-, and p-Cresol.
p-Octylphenol.
Phenol.
o- and p-Phenylethylphenol mixture produced when phenol is made to
react with styrene in the presence of sulfuric acid catalyst.
(2) Aldehydes:
Acetaldehyde.
Formaldehyde.
Paraldehyde.
(b) Optional adjuvant substances employed in the production of the
phenolic resins or added thereto to impart desired technical or physical
properties include the following:
(c) The finished food-contact article, when extracted with distilled
water at reflux temperature for 2 hours, using a volume-to-surface ratio
of 2 milliliters of distilled water per square inch of surface tested,
shall meet the following extractives limitations:
(1) Total extractives not to exceed 0.15 milligram per square inch of
food-contact surface.
(2) Extracted phenol not to exceed 0.005 milligram per square inch of
food-contact surface.
(3) No extracted aniline when tested by a spectrophotometric method
sensitive to 0.006 milligram of aniline per-square inch of food-contact
surface.
(d) In accordance with good manufacturing practice, finished molded
articles containing the phenolic resins shall be thoroughly cleansed
prior to their first use in contact with food.
21 CFR 177.2420 Polyester resins, cross-linked.
Cross-linked polyester resins may be safely used as articles or
components of articles intended for repeated use in contact with food,
in accordance with the following prescribed conditions:
(a) The cross-linked polyester resins are produced by the
condensation of one or more of the acids listed in paragraph (a)(1) of
this section with one or more of the alcohols or epoxides listed in
paragraph (a)(2) of this section, followed by copolymerization with one
or more of the cross-linking agents listed in paragraph (a)(3) of this
section:
(1) Acids:
Adipic.
Fatty acids, and dimers thereof, from natural sources.
Fumaric.
Isophthalic.
Maleic.
Methacrylic.
Orthophthalic.
Sebacic.
Terephthalic.
Trimellitic.
(2) Polyols and polyepoxides:
Butylene glycol.
Diethylene glycol.
2,2-Dimethyl-1,3-propanediol.
Dipropylene glycol.
Ethylene glycol.
Glycerol.
4,4' - Isopropylidenediphenol - epichlorohydrin.
Mannitol.
a-Methyl glucoside.
Pentaerythritol.
Polyoxypropylene ethers of 4,4'-isopropylide-nediphenol (containing
an average of 2-7.5 moles of propylene oxide).
Propylene glycol.
Sorbitol.
Trimethylol ethane.
Trimethylol propane.
2,2,4-Trimethyl-1,3-pentanediol.
(3) Cross-linking agents:
Butyl acrylate.
Butyl methacrylate.
Ethyl acrylate.
Ethylhexyl acrylate.
Methyl acrylate.
Methyl methacrylate.
Styrene.
Triglycidyl isocyanurate (CAS Reg. No. 2451-62-9), for use only in
coatings contacting bulk quantities of dry food of the type identified
in 176.170(c) of this chapter, Table 1, under type VIII.
Vinyl toluene.
(b) Optional adjuvant substances employed to facilitate the
production of the resins or added thereto to impart desired technical or
physical properties include the following, provided that the quantity
used does not exceed that reasonably required to accomplish the intended
physical or technical effect and does not exceed any limitations
prescribed in this section:
(c) The cross-linked polyester resins, with or without the optional
substances described in paragraph (b) of this section, and in the
finished form in which they are to contact food, when extracted with the
solvent or solvents characterizing the type of food and under the
conditions of time and temperature characterizing the conditions of
their intended use, as determined from Tables 1 and 2 of 176.170(c) of
this chapter, shall meet the following extractives limitations:
(1) Net chloroform-soluble extractives not to exceed 0.1 milligram
per square inch of food-contact surface tested when the prescribed
food-simulating solvent is water or 8 or 50 percent alcohol.
(2) Total nonvolatile extractives not to exceed 0.1 milligram per
square inch of food-contact surface tested when the prescribed
food-simulating solvent is heptane.
(d) In accordance with good manufacturing practice, finished articles
containing the cross-linked polyester resins shall be thoroughly
cleansed prior to their first use in contact with food.
(42 FR 14572, Mar. 15, 1977, as amended at 48 FR 37618, Aug. 19,
1983; 54 FR 48858, Nov. 28, 1989)
21 CFR 177.2430 Polyether resins, chlorinated.
Chlorinated polyether resins may be safely used as articles or
components of articles intended for repeated use in producing,
manufacturing, packing, processing, preparing, treating, packaging,
transporting, or holding food, in accordance with the following
prescribed conditions:
(a) The chlorinated polyether resins are produced by the catalytic
polymerization of 3,3-bis(chloromethyl)-oxetane, and shall contain not
more than 2 percent residual monomer.
(b) In accordance with good manufacturing practice, finished articles
containing the chlorinated polyether resins shall be thoroughly cleansed
prior to their first use in contact with food.
21 CFR 177.2440 Polyethersulfone resins.
Polyethersulfone resins identified in paragraph (a) of this section
may be safely used as articles or components of articles intended for
repeated use in contact with food in accordance with the following
prescribed conditions:
(a) For the purpose of this section, polyethersulfone resins are
poly(oxy-p-phenylenesulfonyl-p-phenylene) resins (CAS Reg. No.
25667-42-9), which have a minimum number average molecular weight of
16,000, as determined by reduced viscosity in dimethyl formamide in
accordance with ASTM method D2857-70 (Reapproved 1977), ''Standard Test
Method for Dilute Solution Viscosity of Polymers,'' which is
incorporated by reference. Copies may be obtained from the American
Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or
may be examined at the Office of the Federal Register, 1100 L St. NW.,
Washington, DC 20408.
(b) The basic resins identified in paragraph (a) of this section may
contain optional adjuvant substances used in their production. These
adjuvants may include substances described in 174.5(d) of this chapter
and the following:
(c) The finished food-contact article, when extracted at reflux
temperatures for 2 hours with the following four solvents, yields net
chloroform-soluble extractives in each extracting solvent not to exceed
0.02 milligram per square inch of food-contact surface: distilled
water, 50 percent (by volume) ethyl alcohol in distilled water, 3
percent acetic acid in distilled water, and n-heptane. (Note: In
testing the finished food-contact article, use a separate test sample
for each required extracting solvent.)
(d) In accordance with good manufacturing practice, finished
food-contact articles containing the polyethersulfone resins shall be
thoroughly cleansed before their first use in contact with food.
(44 FR 34493, June 15, 1979, as amended at 47 FR 38885, Sept. 3,
1982; 49 FR 10111, Mar. 19, 1984; 50 FR 47211, Nov. 15, 1985)
21 CFR 177.2450 Polyamide-imide resins.
Polyamide-imide resins identified in paragraph (a) of this section
may be safely used as components of articles intended for repeated use
in contact with food, in accordance with the following prescribed
conditions:
(a) Identity. (1) For the purpose of this section the
polyamide-imide resins are derived from the condensation reaction of
substantially equimolar parts of trimellitic anhydride and p,p
-diphenylmethane diisocyanate.
(2) The polyamide-imide resins (CAS Reg. No. 31957-38-7) derived from
the condensation reaction of equimolar parts of benzoyl
chloride-3,4-dicarboxylic anhydride and 4,4 -diphenylmethanediamine.
(b) Specifications. (1) Polyamide-imide resins identified in
paragraph (a)(1) of this section shall have a nitrogen content of not
less than 7.8 weight percent and not more than 8.2 weight percent.
Polyamide-imide resins identified in paragraph (a)(2) of this section
shall have a nitrogen content of not less than 7.5 weight percent and
not more than 7.8 weight percent. Nitrogen content is determined by the
Dumas Nitrogen Determination as set forth in the ''Official Methods of
Analysis of the Association of Official Analytical Chemists,'' 13th Ed.
(1980), sections 7.016-7.020, which is incorporated by reference in
accordance with 5 U.S.C. 552(a). 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.
(2) Polyamide-imide resins identified in paragraph (a)(1) of this
section shall have a solution viscosity of not less than 1.200.
Polyamide-imide resins identified in paragraph (a)(2) of this section
shall have a solution viscosity of not less than 1.190. Solution
viscosity shall be determined by a method titled ''Solution Viscosity''
which is incorporated by reference in accordance with 5 U.S.C. 552(a).
Copies are available from the Division of Food and Color Additives
(HFF-330), 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.
(3) The polyamide-imide resins identified in paragraph (a)(1) of this
section are heat cured at 600 F for 15 minutes when prepared for
extraction tests and the residual monomers: p,p-diphenylmethane
diisocyanate should not be present at greater than 100 parts per million
and trimellitic anhydride should not be present at greater than 500
parts per million. Residual monomers are determined by gas
chromatography (the gas chromatography method titled ''Amide-Imide
Polymer Analysis -- Analysis of Monomer Content,'' is incorporated by
reference in accordance with 5 U.S.C. 552(a). Copies are available from
the Division of Food and Color Additives (HFF-330), 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).
(c) Extractive limitations are applicable to the polyamide-imide
resins identified in paragraphs (a) (1) and (2) of this section in the
form of films of 1 mil uniform thickness after coating and heat curing
at 600 F for 15 minutes on stainless steel plates, each having such
resin-coated surface area of 100 square inches. The cured-resin film
coatings shall be extracted in accordance with the method described in
176.170(d)(3) of this chapter, using a plurality of spaced, coated
stainless steel plates, exposed to the respective food simulating
solvents. The resin shall meet the following extractive limitations
under the corresponding extraction conditions:
(1) Distilled water at 250 F for 2 hours: Not to exceed 0.01
milligram per square inch.
(2) Three percent acetic acid at 212 F for 2 hours: Not to exceed
0.05 milligram per square inch.
(3) Fifty percent ethyl alcohol at 160 F for 2 hours: Not to exceed
0.03 milligram per square inch.
(4) n-Heptane at 150 F for 2 hours: Not to exceed 0.05 milligram
per square inch.
(d) In accordance with good manufacturing practice, those food
contact articles, having as components the polyamide-imide resins
identified in paragraph (a) of this section and intended for repeated
use shall be thoroughly cleansed prior to their first use in contact
with food.
(42 FR 14572, Mar. 15, 1977, as amended at 47 FR 11845, Mar. 19,
1982; 49 FR 10111, Mar. 19, 1984; 54 FR 24898, June 12, 1989; 54 FR
43170, Oct. 23, 1989)
21 CFR 177.2460 Poly(2,6-dimethyl-1,4-phenylene) oxide resins.
The poly(2,6-dimethyl-1,4-phenylene) oxide resins identified in
paragraph (a) of this section may be used as an article or as a
component of an article intended for use in contact with food subject to
the provisions of this section.
(a) Identity. For the purposes of this section,
poly(2,6-dimethyl-1,4-phenylene) oxide resins consist of basic resins
produced by the oxidative coupling of 2,6-xylenol such that the finished
basic resins meet the specifications and extractives limitations
prescribed in paragraph (c) of this section.
(b) Optional adjuvant substances. The basic
poly(2,6-dimethyl-1,4-phenylene) oxide resins identified in paragraph
(a) of this section may contain optional adjuvant substances required in
the production of such basic resins. The optional adjuvant substances
required in the production of the basic poly(2,6-dimethyl-1,4-phenylene)
oxide resins may include substances permitted for such use by
regulations in parts 170 through 189 of this chapter, substances
generally recognized as safe in food, substances used in accordance with
a prior sanction or approval, and the following:
(c) Specifications and extractives limitations. The
poly(2,6-dimethyl-1,4-phenylene) oxide basic resins meet the following:
(1) Specifications. Intrinsic viscosity is not less then 0.40
deciliter per gram as determined by ASTM method D1243-79, ''Standard
Test Method for Dilute Solution Viscosity of Vinyl Chloride Polymers,''
which is incorporated by reference, modified as follows. Copies of the
incorporation by reference may be obtained from the American Society for
Testing Materials, 1916 Race St., Philadelphia, PA 19103, or may be
examined at the Office of the Federal Register, 1100 L St. NW.,
Washington, DC 20408.
(i) Solvent: Chloroform, reagent grade containing 0.01 percent
tert-butylcatechol.
(ii) Resin sample: Powdered resin obtained from production prior to
molding or extrusion.
(iii) Viscometer: Cannno-Ubbelohde series 25 dilution viscometer (or
equivalent).
(iv) Calculation: The calculation method used is that described in
Appendix X.1.3 (ASTM method D1243-79, cited and incorporated by
reference in paragraph (c)(1) of this section) with the reduced
viscosity determined for three concentration levels (0.4, 0.2, and 0.1
gram per deciliter) and extrapolated to zero concentration for
intrinisic viscosity. The following formula is used for determining
reduced viscosity:
Reduced viscosity in terms of deciliters per gram=
Where:
t=Solution efflux time.
to=Solvent efflux time.
c=Concentration of solution in terms of grams per deciliter.
(2) Extractives limitations. Total resin extracted not to exceed
0.02 weight-percent when extracted with n-heptane at 160 F for 2 hours
as determined using 200 milliliters of reagent grade n-heptane which has
been freshly distilled before use and 25 grams of poly
(2,-6-dimethyl-1,4-phenylene) oxide resin. The resin as tested is in
pellet form having a particle size such that 100 percent of the pellets
will pass through a U.S. Standard Sieve No. 6 and 100 percent of the
pellets will be held on a U.S. Standard Sieve No. 10.
(d) Other limitations. The poly(2,6-dimethyl-1,4-phenylene) oxide
resins identified in and complying with this section, when used as
components of the food-contact surface of any article that is the
subject of a regulation in parts 174, 175, 176, 177, 178 and 179.45 of
this chapter, shall comply with any specifications and limitations
prescribed by such regulation for the article in the finished form in
which it is to contact food.
(e) Uses. The poly(2,6-dimethyl-1,4-phenylene) oxide resins
identified in and complying with the limitations in this section may be
used as articles or components of articles intended for repeated
food-contact use or as articles or components of articles intended for
single-service food-contact use only under the conditions described in
176.170(c) of this chapter, Table 2, conditions of use H.
(42 FR 14572, Mar. 15, 1977, as amended at 49 FR 10111, Mar. 19,
1984)
21 CFR 177.2470 Polyoxymethylene copolymer.
Polyoxymethylene copolymer identified in this section may be safely
used as an article or component of articles intended for food-contact
use in accordance with the following prescribed conditions:
(a) Identity. For the purpose of this section, polyoxymethylene
copolymers are identified as the following: The reaction product of
trioxane (cyclic trimer of formaldehyde) and ethylene oxide (CAS Reg.
No. 24969-25-3) or the reaction product of trioxane (cyclic trimer of
formaldehyde) and a maximum of 5 percent by weight of butanediol formal
(CAS Reg. No. 25214 85-1). Both copolymers may have certain optional
substances added to impart desired technological properties to the
copolymer.
(b) Optional adjuvant substances. The polyoxymethylene copolymer
identified in paragraph (a) of this section may contain optional
adjuvant substances required in its production. The quantity of any
optional adjuvant substance employed in the production of the copolymer
does not exceed the amount reasonably required to accomplish the
intended technical or physical effect. Such adjuvants may include
substances generally recognized as safe in food, substances used in
accordance with prior sanction, substances permitted under applicable
regulations in parts 170 through 189 of this chapter, and the following:
(1) Stabilizers (total amount of stabilizers not to exceed 2.0
percent and amount of any one stabilizer not to exceed 1.0 percent of
polymer by weight)
Calcium ricinoleate.
Cyanoguanidine.
Hexamethylene bis(3,5-di-tert-butyl-4-hydroxyhydrocinnamate) (CAS
Reg. No. 35074-77-2).
Melamine-formaldehyde resin.
2,2'-Methylenebis(4-methyl-6-tert- butylphenol).
Nylon 6/66, weight ratio 2/3.
Tetrakis (methylene (3,5-di-tert-butyl-4-hydroxyhydrocinnamate))
methane.
(2) Lubricant: N,N'Distearoylethyl-enediamine.
(c) Specifications. (1) Polyoxymethylene copolymer can be identified
by its characteristic infrared spectrum.
(2) Minimum number average molecular weight of the copolymer is
15,000 as determined by a method titled ''Number Average Molecular
Weight,'' which is incorporated by reference. Copies are available from
the Division of Food and Color Additives, Center for Food Safety and
Applied Nutrition (HFF-330), 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.
(d) Extractive limitations. (1) Polyoxymethylene copolymer in the
finished form in which it is to contact food, when extracted with the
solvent or solvents characterizing the type of food and under conditions
of time and temperature as determined from Tables 1 and 2 of 175.300(d)
of this chapter, shall yield net chloroform-soluble extractives not to
exceed 0.5 milligram per square inch of food-contact surface.
(2) Polyoxymethylene copolymer with or without the optional
substances described in paragraph (b) of this section, when ground or
cut into particles that pass through a U.S.A. Standard Sieve No. 6 and
that are retained on a U.S.A. Standard Sieve No. 10, shall yield total
extractives as follows:
(i) Not to exceed 0.20 percent by weight of the copolymer when
extracted for 6 hours with distilled water at reflux temperature.
(ii) Not to exceed 0.15 percent by weight of the copolymer when
extracted for 6 hours with n-heptane at reflux temperature.
(e) Conditions of use. (1) The polyoxymethylene copolymer is for use
as articles or components of articles intended for repeated use.
(2) Use temperature shall not exceed 250 F.
(3) In accordance with good manufacturing practice, finished articles
containing polyoxymethylene copolymer shall be thoroughly cleansed
before their first use in contact with food.
(42 FR 14572, Mar. 15, 1977, as amended at 48 FR 56204, Dec. 20,
1983; 49 FR 5748, Feb. 15, 1984; 50 FR 1842, Jan. 14, 1985; 50 FR
20560, May 17, 1985; 52 FR 4493, Feb. 12, 1987, 54 FR 24898, June 12,
1989)
21 CFR 177.2480 Polyoxymethylene homopoly-mer.
Polyoxymethylene homopolymer identified in this section may be safely
used as articles or components of articles intended for food-contact use
in accordance with the following prescribed conditions:
(a) Identity. For the purpose of this section, polyoxymethylene
homopolymer is polymerized formaldehyde (Chemical Abstracts Service
Registry No. 9002-81-7). Certain optional adjuvant substances, described
in paragraph (b) of this section, may be added to impart desired
technological properties to the homopolymer.
(b) Optional adjuvant substances. The polyoxymethylene homopolymer
identified in paragraph (a) of this section may contain optional
adjuvant substances in its production. The quantity of any optional
adjuvant substance employed in the production of the homopolymer does
not exceed the amount reasonably required to accomplish the intended
effect. Such adjuvants may include substances generally recognized as
safe in food, substances used in accordance with prior sanction,
substances permitted under applicable regulations in this part, and the
following:
(1) Stabilizers. The homopolymer may contain one or more of the
following stabilizers. The total amount of stabilizers shall not exceed
1.9 percent of homopolymer by weight, and the quantity of individual
stabilizer used shall not exceed the limitations set forth below:
(2) Lubricant. N,N'-Distearoylethyl-enediamine.
(3) Molding assistant. Polyethylene glycol 6,000.
(c) Specifications. (1) Polyoxymethylene homopolymer can be
identified by its characteristic infrared spectrum.
(2) Minimum number average molecular weight of the homopolymer is
25,000.
(3) Density of the homopolymer is between 1.39 and 1.44 as determined
by ASTM method D1505-68 (Reapproved 1979), ''Standard Test Method for
Density of Plastics by the Density-Gradient Technique,'' which is
incorporated by reference. Copies may be obtained from the American
Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or
may be examined at the Office of the Federal Register, 1100 L St. NW.,
Washington, DC 20408.
(4) Melting point is between 172 C and 184 C as determined by ASTM
method D2133-66, ''Specifications for Acetal Resin Injection Molding and
Extrusion Materials'' (Revised 1966), which is incorporated by
reference. Copies are available from American Society for Testing and
Materials (ASTM), 1916 Race Street, Philadelphia, PA 19103, or available
for inspection at the Office of the Federal Register, 1100 L St. NW.,
Washington, DC 20408.
(d) Extractive limitations. (1) Polyoxymethylene homopolymer, in the
finished form which is to contact food, when extracted with the solvent
or solvents characterizing the type of food and under conditions of time
and temperature characterizing the conditions of intended use under
paragraphs (c)(3) and (d) of 175.300 of this chapter and as limited by
paragraph (e) of this section, shall yield net chloroform-soluble
extractives not to exceed 0.5 milligram per square inch of food-contact
surface.
(2) Polyoxymethylene homopolymer, with or without the optional
adjuvant substances described in paragraph (b) of this section, when
ground or cut into particles that pass through a U.S.A. Standard Sieve
No. 6 and that are retained on a U.S.A. Standard Sieve No. 10, shall
yield extractives as follows:
(i) Formaldehyde not to exceed 0.0050 percent by weight of
homopolymer as determined by a method titled ''Formaldehyde Release and
Formaldehyde Analysis,'' which is incorporated by reference. Copies are
available from Division of Food and Color Additives, Center for Food
Safety and Applied Nutrition (HFF-330) 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.
(ii) Total extractives not to exceed 0.20 percent by weight of
homopolymer when extracted for 6 hours with distilled water at reflux
temperature and 0.15 percent by weight of homopolymer when extracted for
6 hours with n-heptane at reflux temperature.
(e) Conditions of use. (1) Polyoxymethylene homopolymer is for use
as articles or components of articles intended for repeated use.
(2) Use temperature shall not exceed 250 F.
(3) In accordance with good manufacturing practice, finished articles
containing polyoxymethylene homopolymer shall be thoroughly cleansed
prior to first use in contact with food.
(42 FR 14572, Mar. 15, 1977, as amended at 43 FR 44835, Sept. 29,
1978; 47 FR 11846, Mar. 19, 1982; 47 FR 51562, Nov. 16, 1982; 49 FR
10111, Mar. 19, 1984; 54 FR 24898, June 12, 1989)
21 CFR 177.2490 Polyphenylene sulfide resins.
Polyphenylene sulfide resins (poly(1,4-phenylene sulfide) resins) may
be safely used as coatings or components of coatings of articles
intended for repeated use in contact with food, in accordance with the
following prescribed conditions.
(a) Polyphenylene sulfide resins consist of basic resins produced by
the reaction of equimolar parts of p-dichlorobenzene and sodium sulfide,
such that the finished resins meet the following specifications as
determined by methods titled ''Oxygen Flask Combustion-Gravimetric
Method for Determination of Sulfur in Organic Compounds,''
''Determination of the Inherent Viscosity of Polyphenylene Sulfide,''
and ''Analysis for Dichlorobenzene in Ryton Polyphenylene Sulfide,''
which are incorporated by reference. Copies are available from the
Division of Food and Color Additives, Center for Food Safety and Applied
Nutrition (HFF-330), 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.
(1) Sulfur content: 28.2-29.1 percent by weight of finished resin.
(2) Minimum inherent viscosity: 0.13 deciliters per gram.
(3) Maximum residual p-dichlorobenzene: 0.8 ppm.
(b) Subject to any limitations prescribed in parts 170 through 189 of
this chapter, the following optional substances may be added to the
polyphenylene sulfide basic resins in an amount not to exceed that
reasonably required to accomplish the intended physical or technical
effect.
(1) Substances generally recognized as safe in food.
(2) Substances used in accordance with prior sanction or approval.
(3) Substances the use of which is permitted in coatings under
regulations in parts 170 through 189 of this chapter.
(c) The finished coatings are thermally cured at temperatures of 700
F and above.
(d) Polyphenylene sulfide resin coatings may be used in contact with
food at temperatures not to exceed the boiling point of water; provided
that the finished cured coating, when extracted at reflux temperatures
for 8 hours separately with distilled water, 50 percent ethanol in
water, and 3 percent acetic acid, yields total extractives in each
extracting solvent not to exceed 0.02 milligram per square inch of
surface and when extracted at reflux temperature for 8 hours with
heptane yields total extractives not to exceed 0.1 milligram per square
inch of surface.
(e) Polyphenylene sulfide resin coatings containing perfluorocarbon
resins complying with 177.1550 may be used in contact with food at
temperatures up to and including normal baking and frying temperatures;
provided that the finished cured coating, when extracted at reflux
temperatures for 2 hours separately with distilled water, 50 percent
ethanol in water, 3 percent acetic acid and heptane, yields total
extractives in each extracting solvent not to exceed 0.2 milligram per
square inch of surface and when extracted at reflux temperature for 1
hour with diphenyl ether yields total extractives not to exceed 4.5
milligrams per square inch of surface.
(42 FR 14572, Mar. 15, 1977, as amended at 47 FR 11846, Mar. 19,
1982; 54 FR 24898, June 12, 1989)
21 CFR 177.2510 Polyvinylidene fluoride resins.
Polyvinylidene fluoride resins may be safely used as articles or
components of articles intended for repeated use in contact with food,
in accordance with the following prescribed conditions:
(a) For the purpose of this section, the polyvinylidene fluoride
resins consist of basic resins produced by the polymerization of
vinylidene fluoride.
(b) The finished food-contact article, when extracted at reflux
temperatures for 2 hours with the solvents distilled water, 50 percent
(by volume) ethyl alcohol in distilled water, and n-heptane, yields
total extractives in each extracting solvent not to exceed 0.01
milligram per square inch of food-contact surface tested; and if the
finished food-contact article is itself the subject of a regulation in
parts 174, 175, 176, 177, 178 and 179.45 of this chapter, it shall also
comply with any specifications and limitations prescribed for it by that
regulation. (Note: In testing the finished food-contact article, use a
separate test sample for each required extracting solvent.)
(c) In accordance with good manufacturing practice, finished
food-contact articles containing the polyvinylidene fluoride resins
shall be thoroughly cleansed prior to their first use in contact with
food.
21 CFR 177.2550 Reverse osmosis membranes.
Substances identified in paragraph (a) of this section may be safely
used as reverse osmosis membranes intended for use in processing bulk
quantities of liquid food to separate permeate from food concentrate or
in purifying water for food manufacturing under the following prescribed
conditions:
(a) Identity. For the purpose of this section, reverse osmosis
membranes may consist of either of the following formulations:
(1) A cross-linked high molecular weight polyamide reaction product
of 1,3,5-benzenetricarbonyl trichloride with 1,3-benzenediamine (CAS
Reg. No. 83044-99-9) or piperazine (CAS Reg. No. 110-85-0). The
membrane is on the food-contact surface, and its maximum weight is 62
milligrams per square decimeter (4 milligrams per square inch) as a thin
film composite on a suitable support.
(2) A cross-linked polyetheramine (CAS Reg. No. 101747-84-6),
identified as the copolymer of epichlorohydrin, 1,2-ethanediamine and
1,2-dichloroethane, whose surface is the reaction product of this
copolymer with 2,4-toluenediisocyanate (CAS Reg. No. of the final
polymer is 99811-80-0) for use as the food-contact surface of reverse
osmosis membranes used in processing liquid food. The composite
membrane is on the food-contact surface and its maximum weight is 4.7
milligrams per square decimeter (0.3 milligrams per square inch) as a
thin film composite on a suitable support. The maximum weight of the
2,4-toluenediisocyanate component of the thin film composite is 0.47
milligrams per square decimeter (0.03 milligrams per square inch).
(3) For the purpose of this section, the reverse osmosis membrane
consists of a polyaramide identified as 2,4-diaminobenzenesulfonic acid,
calcium salt (2:1) polymer with 1,3-benzenediamine,
1,3-benzenedicarbonyl dichloride, and 1,4-benzenedicarbonyl dichloride
(CAS Reg. No. 39443-76-0). The membrane is the food contact surface and
may be applied as a film on a suitable support. Its maximum weight is
512 milligrams per square decimeter (33 milligrams per square inch).
(4) A cross-linked high molecular weight polyamide reaction product
of poly(N-vinyl-N-methylamine) (CAS Reg. No. 31245-56-4),
N,N'-bis(3-aminopropyl)ethylenediamine (CAS Reg. No. 10563-26-5),
1,3-benzenedicarbonyl dichloride (CAS Reg. No. 99-63-8) and
1,3,5-benzenetricarbonyl trichloride (CAS Reg. No. 4422-95-1). The
membrane is the food-contact surface. Its maximum weight is 20
milligrams per square decimeter (1.3 milligrams per square inch) as a
thin film composite on a suitable support.
(b) Optional adjuvant substances. The basic polymer identified in
paragraph (a) of this section may contain optional adjuvant substances
required in the production of such basic polymer. These optional
adjuvant substances may include substances permitted for such use by
regulations in parts 170 through 186 of this chapter, substances
generally recognized as safe in food, and substances used in accordance
with a prior sanction or approval.
(c) Supports. Suitable supports for reverse osmosis membranes are
materials permitted for such use by regulations in parts 170 through 186
of this chapter, substances generally recognized as safe in food, and
substances used in accordance with a prior sanction or approval.
(d) Conditions of use.
(1) Reverse osmosis membranes described in paragraphs (a)(1), (2),
and (3) of this section may be used in contact with all types of liquid
food at temperatures up to 80 C (176 F).
(2) Reverse osmosis membranes described in paragraph (a)(4) of this
section may be used in contact wit all types of liquid food, except food
containing more than 8 percent alcohol, at temperatures up to 80 C (176
F).
(3) Reverse osmosis membranes shall be maintained in a sanitary
manner in accordance with current good manufacturing practice so as to
prevent microbial adulteration of food.
(4) To assure their safe use, reverse osmosis membranes and their
supports shall be thoroughly cleaned prior to their first use in
accordance with current good manufacturing practice.
(49 FR 49448, Dec. 20, 1984, as amended at 52 FR 29668, Aug. 11,
1987; 53 FR 31835, Aug. 22, 1988; 53 FR 32215, Aug. 24, 1988; 55 FR
8139, Mar. 7, 1990)
21 CFR 177.2600 Rubber articles intended for repeated use.
Rubber articles intended for repeated use may be safely used in
producing, manufacturing, packing, processing, preparing, treating,
packaging, transporting, or holding food, subject to the provisions of
this section.
(a) The rubber articles are prepared from natural and/or synthetic
polymers and adjuvant substances as described in paragraph (c) of this
section.
(b) The quantity of any substance employed in the production of
rubber articles intended for repeated use shall not exceed the amount
reasonably required to accomplish the intended effect in the rubber
article and shall not be intended to accomplish any effect in food.
(c) Substances employed in the preparation of rubber articles include
the following, subject to any limitations prescribed:
(1) Substances generally recognized as safe for use in food or food
packaging.
(2) Substances used in accordance with the provisions of a prior
sanction or approval.
(3) Substances that by regulation in parts 170 through 189 of this
chapter may be safely used in rubber articles, subject to the provisions
of such regulation.
(4) Substances identified in this paragraph (c)(4), provided that any
substance that is the subject of a regulation in parts 174, 175, 176,
177, 178 and 179.45 of this chapter conforms with any specification in
such regulation.
(i) Elastomers.
Acrylonitrile-butadiene copolymer.
Brominated isobutylene-isoprene copolymers complying with 177.1210.
Butadiene-acrylonitrile-ethylene glycol dimethacrylate copolymers
containing not more than 5 weight percent of polymer units derived from
ethylene glycol dimethacrylate.
Butadiene-acrylonitrile-methacrylic acid copolymer.
Butadiene-styrene-methacrylic acid copolymer.
Chloroprene polymers.
Chlorotrifluoroethylene-vinylidene fluoride copolymer.
Ethylene-propylene copolymer elastomers which may contain not more
than 5 weight-percent of total polymer units derived from
5-methylene-2-norbornene and/or 5-ethylidine-2-norbornene.
Ethylene-propylene-dicyclopentadiene copolymer.
Ethylene-propylene-1,4-hexadiene copolymers containing no more than 8
weight percent of total polymer units derived from 1,4-hexadiene.
Isobutylene-isoprene copolymer.
Polybutadiene.
Polyester elastomers derived from the reaction of dimethyl
terephthalate, 1,4-butanediol, and a-hydro-V-hydroxypoly
(oxytetramethylene). Additionally, trimethyl trimellitate may be used
as a reactant. The polyester elastomers may be used only in contact
with foods containing not more than 8 percent alcohol and limited to use
in contact with food at temperatures not exceeding 150 F.
Polyisoprene.
Polyurethane resins (CAS Reg. Nos. 37383-28-1 or 9018-04-6) derived
from the reaction of diphenylmethane diisocyanate with 1,4-butanediol
and polytetramethylene ether glycol.
Polyurethane resins derived from reactions of diphenylmethane
diisocyanate with adipic acid and 1,4-butanediol.
Rubber, natural.
Silicone basic polymer as described in ASTM method D1418-81,
''Standard Practice for Rubber and Rubber Latices -- Nomenclature,''
which is incorporated by reference. Copies may be obtained from the
American Society for Testing Materials, 1916 Race St., Philadelphia, PA
19103, or may be examined at the Office of the Federal Register, 1100 L
St. NW., Washington, DC 20408.
Silicone (Si) elastomers containing methyl groups.
Silicone (Psi) elastomers containing methyl and phenyl groups.
Silicone (Vsi) elastomers containing methyl and vinyl groups.
Silicone (Fsi) elastomers containing methyl and fluorine groups.
Silicone (PVsi) elastomers containing phenyl, methyl, and vinyl
groups.
Styrene-butadiene copolymer.
Vinylidene fluoride-hexafluoropropylene copolymers (minimum number
average molecular weight 70,000 as determined by osmotic pressure in
methyl ethyl ketone).
Vinylidene fluoride-hexafluoropropylene-tetrafluoroethylene
copolymers (minimum number average molecular weight 100,000 as
determined by osmotic pressure in methyl ethyl ketone).
(ii) Vulcanization materials -- (a) Vulcanizing agents.
4,4'-Bis(aminocyclohexyl)methane carbamate for use only as
cross-linking agent in the vulcanization of vinylidene
fluoridehexafluoropropylene copolymer and vinylidene
fluoride-hexafluoropropylene-tetrafluoroethylene copolymer elastomers
identified under paragraph (c)(4)(i) of this section and limited to use
at levels not to exceed 2.4 percent by weight of such copolymers.
Hexamethylenediamine carbamate for use only as cross-linking agent in
the vulcanization of vinylidene fluoride-hexafluoropropylene copolymer
and vinylidene fluoride-hexafluoropropylene-tetrafluorone copolymer
elastomers identified under paragraph (c)(4)(i) of this section and
limited to use at levels not to exceed 1.5 percent by weight of such
copolymers.
Sulfur, ground.
(b) Accelerators (total not to exceed 1.5 percent by weight of rubber
product).
2-Benzothiazyl-N,N-diethylthiocarbamyl-sulfide.
Benzoyl peroxide.
1,3-Bis(2-benzothiazolylmercaptomethyl) urea.
N-tert-Butyl-2-benzothiazole sulfenamide.
Butyraldehyde-aniline resin (iodine number 670-705).
Carbon disulfide-1,1'-methylenedipiperidine reaction product.
Copper dimethyldithiocarbamate.
N-Cyclohexyl-2-benzothiazole sulfenamide.
Dibenzoyl-p-quinone dioxime.
Dibenzylamine.
Di-tert-butyl peroxide.
Dibutyl xanthogen disulfide.
2,4-Dichlorobenzoyl peroxide.
Dicumyl peroxide.
N,N-Dimethylcyclohexylamine salt of dibutyldithiocarbamic acid.
2,6-Dimethylmorpholine thiobenzothiazol.
Dipentamethylenethiuram tetrasulfide.
Diphenylguanidine.
Diphenylguanidine phthalate.
1,3-Diphenyl-2-thiourea.
2,2'-Dithiobis(benzothiazole).
4,4'-Dithiodimorpholine.
N,N'-Di-o-tolylguanidine.
Di-o-tolylguanidine salt of pyrocatecholborate.
Ethylenediamine carbamate.
Heptaldehyde-aniline resin (iodine number 430-445).
Hexamethylenetetramine.
2-Mercaptobenzothiazole.
2-Mercaptothiazoline.
N-Oxydiethylene-benzothiazole-2-sulfenamide.
Piperidinium pentamethylenedithiocarba-mate.
Potassium pentamethylenedithiocarbamate.
p-Quinone dioxime.
Sodium dibutyldithiocarbamate.
Sodium dimethyldithiocarbamate.
Stannous oleate for use only as an accelerator for silicone
elastomers.
Tetrabutylthiuram monosulfide.
Tetraethylthiuram disulfide.
(1,1,4,4-Tetramethyltetramethylene)bis (tert-butyl peroxide).
Tetramethylthiuram monosulfide.
Thiram (tetramethylthiuram disulfide).
Triallyl cyanurate.
Triethylenetetramine.
1,3,5-Triethyl-hexahydro-s-triaxine (triethyltrimethylenetriamine).
Triphenylguanidine.
Zinc butyl xanathate.
Zinc dibenzyl dithiocarbamate.
Zinc dibutyldithiocarbamate.
Zinc diethyldithiocarbamate.
Zinc 2-mercaptobenzothiazole.
Ziram (zinc dimethyldithiocarbamate).
(c) Retarders (total not to exceed 10 percent of weight of rubber
product).
Cyanoguanidine.
Phthalic anhydride.
Salicylic acid.
(d) Activators (total not to exceed 5 percent by weight of rubber
product except magnesium oxide may be used at higher levels).
Diethylamine.
Fatty acid amines, mixed.
Fatty acids.
Magnesium carbonate.
Magnesium oxide, light and heavy.
Oleic acid, dibutylamine salt (dibutylammonium oleate).
Stannous chloride.
Tall oil fatty acids.
Tetrachloro-p-benzoquinone.
Triethanolamine.
Zinc salts of fatty acids.
(iii) Antioxidants and antiozonants (total not to exceed 5 percent by
weight of rubber product).
Aldol-a-naphthylamine.
Alkylated (C4 and/or C8) phenols.
BHT (butylated hydroxytoluene).
o
4-((4,6-bis(octylthio)-s-triazin-2-yl)aml (CAS Reg. No. 991-84-4) for
use only as a stabilizer at levels not to exceed 0.5 percent by weight
of the finished rubber product.
Butylated reaction product of p-cresol and dicyclopentadiene as
identified in 178.2010(b) of this chapter.
Butylated, styrenated cresols identified in 178.2010(b) of this
chapter.
4,4'-Butylidinebis(6-tert-butyl-m-cresol).
N-Cyclohexyl-N'-phenylphenylenediamine.
p,p'-Diaminodiphenylmethane.
2,5-Di-tert-amylhydroquinone.
Diaryl-p-phenylenediamine, where the aryl group may be phenyl, tolyl,
or xylyl.
2,6-Di-tert-butyl-p-phenylphenol.
1,2-Dihydro-2,2,4-trimethyl-6-dodecylquinoline.
1,2-Dihydro-2,2,4-trimethyl-6-ethoxyquinoline.
1,2-Dihydro-2,2,4-trimethyl-6-phenylquinoline.
4,4'-Dimethoxydiphenylamine.
4,6-Dinonyl-o-cresol.
N,N'-Dioctyl-p-phenylenediamine.
Diphenylamine-acetone resin.
Diphenylamine-acetone-formaldehyde resin.
N,N'-Diphenylethylenediamine.
N,N'-Disalicylalpropylenediamine.
N,N'-Di-o-tolylethylenediamine.
Hydroquinone monobenzyl ether.
Isopropoxydiphenylamine.
N-Isopropyl-N'-phenyl-p-phenylenediamine.
2,2'-Methylenebis(6-tert-butyl-4-ethylphenol).
2,2'-Methylenebis(4-methyl-6-tert- butylphenol).
2,2'-Methylenebis(4-methyl-6-nonylphenol).
2,2'-Methylenebis(4-methyl-6-tert- octylphenol).
Monooctyl- and dioctyldiphenylamine.
N,N'-Di- -naphthyl-p-phenylenediamine.
Phenyl-a-naphthylamine.
Phenyl- -naphthylamine.
Phenyl- -naphthylamine-acetone aromatic amine resin (average
molecular weight 600; nitrogen content 5.3 percent).
o- and p-Phenylphenol.
Polybutylated (mixture) 4,4'-isopropylidenediphenol.
Sodium pentachlorophenate.
Styrenated cresols produced when 2 moles of styrene are made to react
with 1 mole of a mixture of phenol and o-, m-, and p- cresols so that
the final product has a Brookfield viscosity at 25 C of 1400 to 1700
centipoises.
Styrenated phenol.
4,4'-Thiobis (6-tert-butyl-m-cresol).
Toluene-2,4-diamine.
N-o-Tolyl-N'-phenyl-p-phenylenediamine.
p(p-Tolylsufanilamide) diphenylamine.
Tri(mixed mono- and dinonylphenyl) phosphite.
Tri(nonylphenyl) phosphite-formaldehyde resins produced when 1 mole
of tri(nonylphenyl) phosphite is made to react with 1.4 moles of
formaldehyde or produced when 1 mole of nonylphenol is made to react
with 0.36 mole of formaldehyde and the reaction product is then further
reacted with 0.33 mole of phosphorus trichloride. The finished resins
have a minimum viscosity of 20,000 centipoises at 25 C, as determined
by LV-series Brookfield viscometer (or equivalent) using a No. 4
spindle at 12 r.p.m., and have an organic phosphorus content of 4.05 to
4.15 percent by weight.
(iv) Plasticizers (total not to exceed 30 percent by weight of rubber
product unless otherwise specified).
n-Amyl n-decyl phthalate.
Butylacetyl ricinoleate.
n-Butyl ester of tall oil fatty acids.
Butyl laurate.
Butyl oleate.
Butyl stearate.
Calcium stearate.
Castor oil.
Coumarone-indene resins.
2,2'-Dibenzamidodiphenyl disulfide.
Dibenzyl adipate.
Dibutoxyethoxyethyl adipate.
Dibutyl phthalate.
Dibutyl sebacate.
Didecyl adipate.
Didecyl phthalate.
Diisodecyl adipate.
Diisodecyl phthalate.
Diisooctyl adipate.
Diisooctyl sebacate.
Dioctyl adipate.
Dioctyl phthalate.
Dioctyl sebacate.
Dipentene resin.
Diphenyl ketone.
Fatty acids.
Fatty acids, hydrogenated.
Isooctyl ester of tall oil fatty acids.
Lanolin.
a-Methylstyrene-vinyltoluene copolymer resins (molar ratio 1
a-methylstyrene to 3 vinyltoluene).
Mineral oil; (1) In rubber articles complying with this section, not
to exceed 30 percent by weight; (2) Alone or in combination with waxes,
petroleum, total not to exceed 45 percent by weight of rubber articles
that contain at least 20 percent by weight of ethylene-propylene
copolymer elastomer complying with paragraph (c)(4)(i) of this section,
in contact with foods of Types I, II, III, IV, VI, VII, VIII, and IX
idenified in Table 1 of 176.170(c) of this chapter.
Montan wax.
n-Octyl n-decyl adipate.
n-Octyl n-decyl phthalate.
Petrolatum.
Petroleum hydrocarbon resin (cyclopentadiene type), hydrogenated.
Petroleum hydrocarbon resin (produced by the homo- and
copolymerization of dienes and olefins of the aliphatic, alicyclic, and
monobenzenoid arylalkene types from distillates of cracked petroleum
stocks).
Petroleum hydrocarbon resin (produced by the catalytic polymerization
and subsequent hydrogenation of styrene, vinyltoluene, and indene types
from distillates of cracked petroleum stocks).
Petroleum oil, sulfonated.
Phenol-formaldehyde resin.
Pine tar.
Polybutene.
Polystyrene.
Propylene glycol.
n-Propyl ester of tall oil fatty acids.
Rapeseed oil vulcanized with rubber maker's sulfur.
Rosins and rosin derivatives identified in 175.105(c)(5) of this
chapter.
Soybean oil vulcanized with rubber maker's sulfur.
Styrene-acrylonitrile copolymer.
Terpene resins.
Triethylene glycol dicaprate.
Triethylene glycol dicaprylate.
Waxes, petroleum.
Xylene (or toluene) alkylated with dicyclopentadiene.
Zinc 2-benzamidothiophenate.
(v) Fillers.
Aluminum hydroxide.
Aluminum silicate.
Asbestos fiber, chrysotile or crocidolite.
Barium sulfate.
Carbon black (channel process or furnace combustion process; total
carbon black not to exceed 50 percent by weight of rubber product;
furnace combustion black content not to exceed 10 percent by weight of
rubber products intended for use in contact with milk or edible oils).
Cork.
Cotton (floc, fibers, fabric).
Mica.
Nylon (floc, fibers, fabric).
Silica.
Titanium dioxide.
Zinc carbonate.
Zinc sulfide.
(vi) Colorants. Colorants used in accordance with 178.3297 of this
chapter.
(vii) Lubricants (total not to exceed 2 percent by weight of rubber
product).
Polyethylene.
Sodium stearate.
(viii) Emulsifiers.
Fatty acid salts, sodium or potassium.
Naphthalene sulfonic acid-formaldehyde condensate, sodium salt.
Rosins and rosin-derivatives identified in 175.105(c)(5) of this
chapter.
Sodium decylbenzenesulfonate
Sodium dodecylbenzenesulfonate
Sodium lauryl sulfate.
Tall oil mixed soap (calcium, potassium, and sodium).
(ix) Miscellaneous (total not to exceed 5 percent by weight of rubber
product).
Animal glue as described in 178.3120 of this chapter.
Azodicarbonamide as chemical blowing agent.
2-Anthraquinone sulfonic acid sodium salt for use only as
polymerization inhibitor in chloroprene polymers and not to exceed 0.03
percent by weight of the chloroprene polymers.
n-Butyllithium for use only as polymerization catalyst for
polybutadiene.
4-tert-Butyl-o-thiocresol as peptizing agent.
tert-Butyl peracetate.
p-tert-Butylpyrocatechol.
Dialkyl (C8^C18) dimethylammonium chloride for use only as a
flocculating agent in the manufacture of silica.
Di- and triethanolamine.
Diethyl xanthogen disulfide.
4-(Diiodomethylsulfonyl) toluene, Chemical Abstracts Service Registry
No. 20018-09-01, for use as an antifungal preservative at levels not to
exceed 0.3 percent by weight of the sealants and caulking materials.
Dodecyl mercaptan isomers, single or mixed.
2-Ethoxyethanol.
Iodoform.
p-Menthane hydroperoxide.
a-(p-Nonylphenyl)-omega-hydroxypoly (oxyethylene) mixture of
dihydrogen phosphate and monohydrogen phosphate esters, barium salt;
the nonyl group is a propylene trimer isomer and the poly (oxyethylene)
content averages 9 moles; for use only as residual polymerization
emulsifier at levels not to exceed 0.7 percent by weight of
ethylene-propylene-1,4-hexadiene copolymers identified under paragraph
(c)(4)(i) of this section.
4,4'-Oxybis (benzenesulfonhydrazide) as chemical blowing agent.
Phenothiazine.
Potassium persulfate.
Sodium formaldehyde sulfoxylate.
Sodium polysulfide.
Sodium nitrite.
Sodium salt of ethylenediamine tetraacetic acid and glycine.
Sodium sulfide.
Styrene monomer.
Tall oil.
Thioxylenois as peptizing agents.
Tridecyl mercaptan.
Zinc 4-tert-butylthiophenate as peptizing agent.
(d) Rubber articles intended for use with dry food are so formulated
and cured under conditions of good manufacturing practice as to be
suitable for repeated use.
(e) Rubber articles intended for repeated use in contact with aqueous
food shall meet the following specifications: The food-contact surface
of the rubber article in the finished form in which it is to contact
food, when extracted with distilled water at reflux temperature, shall
yield total extractives not to exceed 20 milligrams per square inch
during the first 7 hours of extraction, nor to exceed 1 milligram per
square inch during the succeeding 2 hours of extraction.
(f) Rubber articles intended for repeated use in contact with fatty
foods shall meet the following specifications: The food-contact surface
of the rubber article in the finished form in which it is to contact
food, when extracted with n-hexane at reflux temperature, shall yield
total extractives not to exceed 175 milligrams per square inch during
the first 7 hours of extraction, nor to exceed 4 milligrams per square
inch during the succeeding 2 hours of extraction.
(g) In accordance with good manufacturing practice finished rubber
articles intended for repeated use in contact with food shall be
thoroughly cleansed prior to their first use in contact with food.
(h) The provisions of this section are not applicable to rubber
nursing-bottle nipples.
(i) Acrylonitrile copolymers identified in this section shall comply
with the provisions of 180.22 of this chapter.
(42 FR 14572, Mar. 15, 1977, as amended at 43 FR 16972, Apr. 21,
1978; 44 FR 52189, Sept. 7, 1979; 45 FR 67321, Oct. 10, 1980; 46 FR
46796, Sept. 22, 1981; 49 FR 4073, Feb. 2, 1984; 49 FR 10111, Mar.
19, 1984; 52 FR 35910, Sept. 24, 1987; 54 FR 35638, Aug. 29, 1989; 54
FR 38969, Sept. 22, 1989; 55 FR 34555, Aug. 23, 1990; 56 FR 42933,
Aug. 30, 1991; 57 FR 3128, Jan. 28, 1992)
21 CFR 177.2710 Styrene-divinylbenzene resins, cross-linked.
Styrene-divinylbenzene cross-linked copolymer resins may be safely
used as articles or components of articles intended for repeated use in
producing, manufacturing, packing, processing, preparing, treating,
packaging, transporting, or holding food, in accordance with the
following prescribed conditions:
(a) The resins are produced by the copolymerization of styrene with
divinylbenzene.
(b) The resins meet the extractives limitations prescribed in this
paragraph:
(1) The resins to be tested are ground or cut into small particles
that will pass through a U.S. standard sieve No. 3 and that will be
held on a U.S. standard sieve No. 20.
(2) A 100-gram sample of the resins, when extracted with 100
milliliters of ethyl acetate at reflux temperature for 1 hour, yields
total extractives not to exceed 1 percent by weight of the resins.
(c) In accordance with good manufacturing practice, finished articles
containing the resins shall be thoroughly cleansed prior to their first
use in contact with food.
21 CFR 177.2800 Textiles and textile fibers.
Textiles and textile fibers may safely be used as articles or
components of articles intended for use in producing, manufacturing,
packing, processing, preparing, treating, packaging, transporting, or
holding food, subject to the provisions of this section.
(a) The textiles and textile fibers are prepared from one or more of
the fibers identified in paragraph (d) of this section and from certain
other adjuvant substances required in the production of the textiles or
textile fibers or added to impart desired properties.
(b) The quantity of any adjuvant substance employed in the production
of textiles or textile fibers does not exceed the amount reasonably
required to accomplish the intended physical or technical effect or any
limitation further provided.
(c) Any substance employed in the production of textiles or textile
fibers that is the subject of a regulation in parts 174, 175, 176, 177,
178 and 179.45 of this chapter conforms with any specification in such
regulation.
(d) Substances employed in the production of or added to textiles and
textile fibers may include:
(1) Substances generally recognized as safe in food.
(2) Substances subject to prior sanction or approval for use in
textiles and textile fibers and used in accordance with such sanction or
approval.
(3) Substances generally recognized as safe for use in cotton and
cotton fabrics used in dry-food packaging.
(4) Substances that by regulation in this part may safely be used in
the production of or as a component of textiles or textile fibers and
subject to provisions of such regulation.
(5) Substances identified in this paragraph (d)(5), subject to such
limitations as are provided:
(e) Textile and textile fibers are used as articles or components of
articles that contact dry food only.
(f) The provisions of this section are not applicable to jute fibers
used as prescribed by 178.3620(d)(2) of this chapter.
(42 FR 14572, Mar. 15, 1977, as amended at 46 FR 37042, July 17,
1981; 49 FR 4372, Feb. 6, 1984; 49 FR 5748, Feb. 15, 1984; 56 FR
42933, Aug. 30, 1991)
21 CFR 177.2910 Ultra-filtration membranes.
Ultra-filtration membranes identified in paragraphs (a)(1) and (a)(2)
of this section may be safely used in the processing of food, under the
following prescribed conditions:
(a)(1) Ultra-filtration membranes that consist of paper impregnated
with cured phenol-formaldehyde resin, which is used as a support and is
coated with a vinyl chloride-acrylonitrile copolymer.
(2) Ultra-filtration membranes that consist of a sintered carbon
support that is coated with zirconium oxide (CAS Reg. No. 1314-23-4)
containing up to 12 percent yttrium oxide (CAS Reg. No. 1314-36-9).
(b) Any substance employed in the production of ultra-filtration
membranes that is the subject of a regulation in parts 174, 175, 176,
177, 178 and 179.45 of this chapter conforms with the specifications of
such regulation.
(c) Ultra-filtration membranes are used in the physical separation of
dissolved or colloidally suspended varying molecular size components of
liquids during the commercial processing of bulk quantities of food.
(d) Ultra-filtration membranes shall be maintained in a sanitary
manner in accordance with good manufacturing practice so as to prevent
potential microbial adulteration of the food.
(e) To assure safe use of the ultra-filtration membranes, the label
or labeling shall include adequate directions for a pre-use treatment,
consisting of conditioning and washing with a minimum of 8 gallons of
potable water prior to their first use in contact with food.
(f) Acrylonitrile copolymers identified in this section shall comply
with the provisions of 180.22 of this chapter.
(42 FR 14572, Mar. 15, 1977, as amended at 53 FR 17925, May 19, 1988)
21 CFR 177.2910 PART 178 -- INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS
21 CFR 177.2910 Subpart A -- (Reserved)
21 CFR 177.2910 Subpart B -- Substances Utilized To Control the Growth
of Microorganisms
Sec.
178.1005 Hydrogen peroxide solution.
178.1010 Sanitizing solutions.
21 CFR 177.2910 Subpart C -- Antioxidants and Stabilizers
178.2010 Antioxidants and/or stabilizers for polymers.
178.2550 4-Hydroxymethyl-2,6-di-tert- butylphenol.
178.2650 Organotin stabilizers in vinyl chloride plastics.
21 CFR 177.2910 Subpart D -- Certain Adjuvants and Production Aids
178.3010 Adjuvant substances used in the manufacture of foamed
plastics.
178.3120 Animal glue.
178.3125 Anticorrosive agents.
178.3130 Antistatic and/or antifogging agents in food-packaging
materials.
178.3280 Castor oil, hydrogenated.
178.3290 Chromic chloride complexes.
178.3295 Clarifying agents for polymers.
178.3297 Colorants for polymers.
178.3300 Corrosion inhibitors used for steel or tinplate.
178.3400 Emulsifiers and/or surface-active agents.
178.3450 Esters of stearic and palmitic acids.
178.3480 Fatty alcohols, synthetic.
178.3500 Glycerin, synthetic.
178.3505 Glyceryl tri-(12-acetoxystearate).
178.3520 Industrial starch-modified.
178.3530 Isoparaffinic petroleum hydrocarbons, synthetic.
178.3570 Lubricants with incidental food contact.
178.3600 Methyl glucoside-coconut oil ester.
178.3610 a-Methylstyrene-vinyltoluene resins, hydrogenated.
178.3620 Mineral oil.
178.3650 Odorless light petroleum hydrocarbons.
178.3690 Pentaerythritol adipate-stearate.
178.3700 Petrolatum.
178.3710 Petroleum wax.
178.3720 Petroleum wax, synthetic.
178.3730 Piperonyl butoxide and pyrethrins as components of bags.
178.3740 Plasticizers in polymeric substances.
178.3750 Polyethylene glycol (mean molecular weight 200-9,500).
178.3760 Polyethylene glycol (400) monolaurate.
178.3770 Polyhydric alcohol esters of oxidatively refined (Gersthofen
process) montan wax acids.
178.3780 Polyhydric alcohol esters of long chain monobasic acids.
178.3790 Polymer modifiers in semirigid and rigid vinyl chloride
plastics.
178.3800 Preservatives for wood.
178.3850 Reinforced wax.
178.3860 Release agents.
178.3870 Rosins and rosin derivatives.
178.3900 Sodium pentachlorophenate.
178.3910 Surface lubricants used in the manufacture of metallic
articles.
178.3930 Terpene resins.
178.3940 Tetraethylene glycol di-(2-ethyl-hexoate).
178.3950 Tetrahydrofuran.
Authority: Secs. 201, 402, 409, 706 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321, 342, 348, 376).
Source: 42 FR 14609, Mar. 15, 1977, unless otherwise noted.
21 CFR 177.2910 Subpart A -- (Reserved)
21 CFR 177.2910 Subpart B -- Substances Utilized To Control the Growth of Microorganisms
21 CFR 178.1005 Hydrogen peroxide solution.
Hydrogen peroxide solution identified in this section may be safely
used to sterilize polymeric food-contact surfaces identified in
paragraph (e)(1) of this section.
(a) Identity. For the purpose of this section, hydrogen peroxide
solution is an aqueous solution containing not more than 35 percent
hydrogen peroxide (CAS Reg. No. 7722-84-1) by weight, meeting the
specifications prescribed in paragraph (c) of this section.
(b) Optional adjuvant substances. Hydrogen peroxide solution
identified in paragraph (a) of this section may contain substances
generally recognized as safe in or on food, substances generally
recognized for their intended use in food packaging, substances used in
accordance with a prior sanction or approval, and substances permitted
by applicable regulations in parts 174 through 179 of this chapter.
(c) Specifications. Hydrogen peroxide solution shall meet the
specifications of the ''Food Chemicals Codex,'' 3d Ed. (1981), pp.
146-147, which is incorporated by reference (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), and the United States Pharmacopeia XX
(1980), except that hydrogen peroxide may exceed the concentration
specified therein.
(d) Limitations. No use of hydrogen peroxide solution in the
sterilization of food packaging material shall be considered to be in
compliance if more than 0.5 part per million of hydrogen peroxide can be
determined in distilled water packaged under production conditions
(assay to be performed immediately after packaging).
(e) Conditions of use. (1) Hydrogen peroxide solution identified in
and complying with the specifications in this section may be used by
itself or in combination with other processes to treat food-contact
surfaces to attain commercial sterility at least equivalent to that
attainable by thermal processing for metal containers as provided for in
part 113 of this chapter. Food-contact surfaces include the following:
(2) The packaging materials identified in paragraph (e)(1) of this
section may be used for packaging all commercially sterile foods except
that the olefin polymers may be used in articles for packaging foods
only of the types identified in 176.170(c) of this chapter, Table 1,
under Categories I, II, III, IV-B, V, and VI.
(3) Processed foods packaged in the materials identified in paragraph
(e)(1) of this section shall conform with parts 108, 110, 113, and 114
of this chapter as applicable.
(46 FR 2342, Jan. 9, 1981, as amended at 49 FR 10111, Mar. 19, 1984;
49 FR 32345, Aug. 14, 1984; 49 FR 37747, Sept. 26, 1984; 51 FR 45881,
Dec. 23, 1986; 52 FR 26146, July 13, 1987; 53 FR 47186, Nov. 22, 1988;
54 FR 5604, Feb. 6, 1989; 54 FR 13167, Mar. 31, 1989; 54 FR 6365 Feb.
9, 1989; 55 FR 47055, Nov. 9, 1990)
21 CFR 178.1010 Sanitizing solutions.
Sanitizing solutions may be safely used on food-processing equipment
and utensils, and on other food-contact articles as specified in this
section, within the following prescribed conditions:
(a) Such sanitizing solutions are used, followed by adequate
draining, before contact with food.
(b) The solutions consist of one of the following, to which may be
added components generally recognized as safe and components which are
permitted by prior sanction or approval.
(1) An aqueous solution containing potassium, sodium, or calcium
hypochlorite, with or without the bromides of potassium, sodium, or
calcium.
(2) An aqueous solution containing dichloroisocyanuric acid,
trichloroisocyanuric acid, or the sodium or potassium salts of these
acids, with or without the bromides of potassium, sodium, or calcium.
(3) An aqueous solution containing potassium iodide, sodium
p-toluenesulfonchloroamide, and sodium lauryl sulfate.
(4) An aqueous solution containing iodine, butoxy monoether of mixed
(ethylene-propylene) polyalkylene glycol having a cloudpoint of 90 -100
C in 0.5 percent aqueous solution and an average molecular weight of
3,300, and ethylene glycol monobutyl ether. Additionally, the aqueous
solution may contain diethylene glycol monoethyl ether as an optional
ingredient.
(5) An aqueous solution containing elemental iodine, hydriodic acid,
a-(p-nonylphenyl)-omega-hydroxypoly-(oxyethylene) (complying with the
identity prescribed in 178.3400(c) and having a maximum average
molecular weight of 748) and/or polyoxyethylene-polyoxypropylene block
polymers (having a minimum average molecular weight of 1,900).
Additionally, the aqueous solution may contain isopropyl alcohol as an
optional ingredient.
(6) An aqueous solution containing elemental iodine, sodium iodide,
sodium dioctylsulfosuccinate, and polyoxyethylene-polyoxypropylene block
polymers (having a minimum average molecular weight of 1,900).
(7) An aqueous solution containing dodecylbenzenesulfonic acid and
either isopropyl alcohol or polyoxyethylene-polyoxypropylene block
polymers (having a minimum average molecular weight of 2,800). In
addition to use on food-processing equipment and utensils, this solution
may be used on glass bottles and other glass containers intended for
holding milk.
(8) An aqueous solution containing elemental iodine, butoxy monoether
of mixed (ethylene-propylene) polyalkylene glycol having a minimum
average molecular weight of 2,400 and -lauroyl-omega-hydroxypoly
(oxyethylene) with an average 8-9 moles of ethylene oxide and an average
molecular weight of 400. In addition to use on food-processing
equipment and utensils, this solution may be used on beverage
containers, including milk containers or equipment. Rinse water treated
with this solution can be recirculated as a preliminary rinse. It is
not to be used as final rinse.
(9) An aqueous solution containing n-alkyl (C12-C18)
benzyldimethylam-monium chloride compounds having average molecular
weights of 351 to 380. The alkyl groups consist principally of groups
with 12 to 16 carbon atoms and contain not more than 1 percent each of
groups with 8 and 10 carbon atoms. Additionally, the aqueous solution
may contain either ethyl alcohol or isopropyl alcohol as an optional
ingredient.
(10) An aqueous solution containing trichloromelamine and either
sodium lauryl sulfate or dodecyl- benzenesulfonic acid. In addition to
use on food-processing equipment and utensils and other food-contact
articles, this solution may be used on beverage containers except milk
containers or equipment.
(11) An aqueous solution containing equal amounts of n-alkyl
(C12-C18) benzyl dimethyl ammonium chloride and n- alkyl (C12-C18)
dimethyl ethylbenzyl ammonium chloride (having an average molecular
weight of 384). In addition to use on food-processing equipment and
utensils, this solution may be used on food-contact surfaces in public
eating places.
(12) An aqueous solution containing the sodium salt of sulfonated
oleic acid, polyoxyethylene-polyoxypropylene block polymers (having an
average molecular weight of 2,000 and 27 to 31 moles of
polyoxypropylene). In addition to use on food-processing equipment and
utensils, this solution may be used on glass bottles and other glass
containers intended for holding milk. All equipment, utensils, glass
bottles, and other glass containers treated with this sanitizing
solution shall have a drainage period of 15 minutes prior to use in
contact with food.
(13) An aqueous solution containing elemental iodine and alkyl
(C12-C15) monoether of mixed (ethylene-propylene) polyalkylene glycol,
having a cloud-point of 70 -77 C in 1 percent aqueous solution and an
average molecular weight of 807.
(14) An aqueous solution containing iodine, butoxy monoether of mixed
(ethylene-propylene) polyalkylene glycol, having a cloud-point of 90
-100 C in 0.5 percent aqueous solution and an average molecular weight
of 3,300, and polyoxyethylene-polyoxypropylene block polymers (having a
minimum average molecular weight of 2,000).
(15) An aqueous solution containing lithium hypochlorite.
(16) An aqueous solution containing equal amounts of n-alkyl
(C12-C18) benzyl dimethyl ammonium chloride and n- alkyl (C12-C14)
dimethyl ethylbenzyl ammonium chloride (having average molecular weights
of 377 to 384), with the optional adjuvant substances tetrasodium
ethylenediaminetetraacetate and/or alpha-(p-nonylphenol)-omega-hydroxy
poly (oxyethylene) having an average poly- (oxyethylene) content of 11
moles.
Alpha-hydro-omega-hydroxypoly-(oxyethylene) poly(oxypropoylene) (15
to 18 mole minimum) poly (oxyethylene) block copolymer, having a minimum
molecular weight of 1,900 (CAS Registry No. 9003-11-6) may be used in
lieu of alpha- (p-nonylphenol)-omega-hydroxy- poly(oxyethylene) having
an average poly(oxyethylene) content of 11 moles. In addition to use on
food-processing equipment and utensils, this solution may be used on
food-contact surfaces in public eating places.
(17) An aqueous solution containing di-n-alkyl(C8-C10)dimethyl
ammonium chlorides having average molecular weights of 332-361 and
either ethyl alcohol or isopropyl alcohol. In addition to use on
food-processing equipment and utensils, this solution may be used on
food-contact surfaces in public eating places.
(18) An aqueous solution containing n-alkyl(C12-C18)
benzyldimethylammo-nium chloride, sodium metaborate, alpha-terpineol and
alpha(p-(1,1,3,3-tetramethylbutyl)phenyl) -omega-hydroxy-poly
(oxyethylene) produced with one mole of the phenol and 4 to 14 moles
ethylene oxide.
(19) An aqueous solution containing sodium dichloroisocyanurate and
tetrasodium ethylenediaminetetraace- tate. In addition to use on
food-processing equipment and utensils, this solution may be used on
food-contact surfaces in public eating places.
(20) An aqueous solution containing ortho-phenylphenol,
ortho-benzyl-para-chlorophenol, para-tertiaryamylphenol, sodium
-alpha-alkyl(C12-C15)-omega-hydroxypoly (oxyethylene) sulfate with the
poly(oxyethylene) content averaging one mole, potassium salts of coconut
oil fatty acids, and isopropyl alcohol or hexylene glycol.
(21) An aqueous solution containing sodium dodecylbenzenesulfonate.
In addition to use on food-processing equipment and utensils, this
solution may be used on glass bottles and other glass containers
intended for holding milk.
(22) An aqueous solution containing (1) di-n-alkyl(C8-C10)
dimethylammonium chloride compounds having average molecular weights of
332-361, (2) n-alkyl (C12-C18) benzyldimethylammonium chloride compounds
having average molecular weights of 351-380 and consisting principally
of alkyl groups with 12 to 16 carbon atoms with or without not over 1
percent each of groups with 8 and 10 carbon atoms, and (3) ethyl
alcohol. The ratio of compound (1) to compound (2) is 60 to 40.
(23) An aqueous solution containing n-alkyl (C12-C16)
benzyl-dimethylammonium chloride and didecyldimethylammonium chloride.
(24) An aqueous solution containing elemental iodine (CAS Reg. No.
7553-56-2), alpha-(p-(1,1,3,3-tetramethylbutyl)-phenly-(oxyethylene)
produced with one mole of the phenol and 4 to 14 moles ethylene oxide,
and alpha-alkyl(C12-C15)-omega-hydroxy(poly(oxyethylene)
poly(oxypropylene)) (having an average molecular weight of 965).
(25) An aqueous solution containing elemental iodine (CAS Reg. No.
7553-56-2), potassium iodide (CAS Reg. No. 7681-11-0), and isopropanol
(CAS Reg. No. 67-63-0). In addition to use on food processing equipment
and utensils, this solution may be used on beverage containers,
including milk containers and equipment and on food-contact surfaces in
public eating places.
(26) (Reserved)
(27) An aqueous solution containing decanoic acid (CAS Reg. No.
334-48-5), octanoic acid (CAS Reg. No. 124-07-2), and sodium
1-octanesulfonate (CAS Reg. No. 5324-84-5). Additionally, the aqueous
solution may contain isopropyl alcohol (CAS Reg. No. 67-63-0) as an
optional ingredient.
(28) An aqueous solution containing sulfonated 9-octadecenoic acid
(CAS Reg. No. 68988-76-1) and sodium xylenesulfonate (CAS Reg. No.
1300-72-7).
(29) An aqueous solution containing dodecyldiphenyloxidedisulfonic
acid (CAS Reg. No. 30260-73-2), sulfonated tall oil fatty acid (CAS Reg.
No. 68309-27-3), and neo-decanoic acid (CAS Reg. No. 26896-20-8). In
addition to use on food-processing equipment and utensils, this solution
may be used on glass bottles and other glass containers intended for
holding milk.
(30) An aqueous solution containing hydrogen peroxide (CAS Reg. No.
7722-84-1), peracetic acid (CAS Reg. No. 79-21-0), acetic acid (CAS Reg.
No. 64-19-7), and 1-hydroxyethylidene-1,1-diphosphonic acid (CAS Reg.
No. 2809-21-4).
(31) An aqueous solution containing elemental iodine,
alpha-alkyl(C10-C14)-omega-hydroxypoly(oxyethylene)poly-(oxypropylene)
of average molecular weight between 768 and 837, and
alpha-alkyl(C12-C18)-omega-hydroxypoly(oxyethylene) poly(oxypropylene)
of average molecular weight between 950 and 1,120. In addition to use
on food-processing equipment and utensils, this solution may be used on
food-contact surfaces in public eating places.
(32) An aqueous solution containing (i) di-n-alkyl(C8-C10)dimethyl-
ammonium chloride compounds having average molecular weights of 332 to
361, (ii) n-alkyl(C12-C18)benzyldimethyl- ammonium chloride compounds
having average molecular weights of 351 to 380 and consisting
principally of alkyl groups with 12 to 16 carbon atoms with no more than
1 percent of groups with 8 and 10, (iii) ethyl alcohol, and (iv)
alpha-(p-nonylphenyl)-omega-hydroxypoly(oxyethylene) produced by the
condensation of 1 mole of p-nonylphenol with 9 to 12 moles of ethylene
oxide. The ratio of compound (i) to compound (ii) is 3 to 2.
(33) An aqueous solution containing (i)
di-n-alkyl-(C8-C10)-dimethylammonium chloride compounds having average
molecular weights of 332 to 361; (ii) n-alkyl(C12-C18)
-benzyldimethylammonium chloride compounds having molecular weights of
351 to 380 and consisting principally of alkyl groups with 12 to 16
carbon atoms with no more than 1 percent of the groups with 8 to 10;
and (iii) tetrasodium ethylenediamine tetraacetate. Additionally, the
aqueous solution contains either
alpha-(p-nonylphenyl)-omega-hydroxypoly-(oxyethylene) or
alpha-alkyl(C11-C15)-omega-hydroxypoly-(oxyethylene), each produced with
9 to 13 moles of ethylene oxide. The ratio of compound (i) to compound
(ii) is 3 to 2.
(34) An aqueous solution of an equilibrium mixture of oxychloro
species (predominantly chlorite, chlorate, and chlorine dioxide)
generated either (i) by directly metering a concentrated chlorine
dioxide solution, prepared just prior to use, into potable water to
provide the concentration of available chlorine dioxide stated in
paragraph (c)(29) of this section, or (ii) by acidification of an
aqueous alkaline solution of oxychloro species (predominantly chlorite
and chlorate) followed by dilution with potable water to provide the
concentration of available chlorine dioxide described in paragraph
(c)(29) of this section.
(35) An aqueous solution containing decanoic acid (CAS Reg. No.
334-48-5), octanoic acid (CAS Reg. No. 124-07-2), lactic acid (CAS Reg.
No. 050-21-5), phosphoric acid (CAS Reg. No. 7664-38-2) and a mixture of
the sodium salt of naphthalenesulfonic acid (CAS Reg. No. 1321-69-3);
the methyl, dimethyl, and trimethyl dervatives of the sodium salt of
naphthalenesulfonic acid; and a mixture of the sodium salt of
naphthalenesulfonic acid, and the methyl, dimethyl, and trimethyl
derivatives of the sodium salt of naphthalenesulfonic acid alkylated at
3 percent by weight with C6-C9 linear olefins, as components of a
sanitizing solution to be used on food-processing equipment and
utensils. The methyl and dimethyl substituted derivatives (described
within this paragraph (b)(35)) constitute no less than 70 percent by
weight of the mixture of naphthalenesulfonates.
(36) The sanitizing solution contains decanoic acid (CAS Reg. No.
334-48-5); octanoic acid (CAS Reg. No. 124-07-2); lactic acid (CAS
Reg. No. 050-21-5); phosphoric acid (CAS Reg. No. 7664-38-2); a
mixture of 1-octanesulfonic acid (CAS Reg. No. 3944-72-7), and
1-octanesulfonic-2-sulfinic acid (CAS Reg. No. 113652-56-5) or
1,2-octanedisulfonic acid (CAS Reg. No. 1934210); the condensate of
four moles of poly(oxyethylene)poly(oxypropylene) block copolymers with
one mole of ethylenediamine (CAS Reg. No. 11111-34-5); and the optional
ingredient FD&C Yellow No. 5 (CAS Reg. No. 001934210). In addition to
use on food-processing equipment and utensils, this solution may be used
on dairy-processing equipment.
(37) The sanitizing solution contains sodium hypochlorite (CAS Reg.
No. 7681-52-9), trisodium phosphate (CAS Reg. No. 7601-54-9), sodium
lauryl sulfate (CAS Reg. No. 151-21-3), and potassium permanganate (CAS
Reg. No. 7722-64-7). Magnesium oxide (CAS Reg. No. 1309-48-4) and
potassium bromide (CAS Reg. No. 7758-02-3) may be added as optional
ingredients to this sanitizing solution. In addition to use on
food-processing equipment and utensils, this solution may be used on
food-contact surfaces in public eating places.
(38) An aqueous solution containing hydrogen peroxide (CAS Reg. No.
7722-84-1); peroxyacetic acid (CAS Reg. No. 79-21-0); acetic acid (CAS
Reg. No. 64-19-7); sulfuric acid (CAS Reg. No. 7664-93-9); and
2,6-pyridinedicarboxylic acid (CAS Reg. No. 499-83-2). In addition to
use on food-processing equipment and utensils, this solution may be used
on dairy-processing equipment.
(c) The solutions identified in paragraph (b) of this section will
not exceed the following concentrations:
(1) Solutions identified in paragraph (b)(1) of this section will
provide not more than 200 parts per million of available halogen
determined as available chlorine.
(2) Solutions identified in paragraph (b)(2) of this section will
provide not more than 100 parts per million of available halogen
determined as available chlorine.
(3) Solution identified in paragraph (b)(3) of this section will
provide not more than 25 parts per million of titratable iodine. The
solutions will contain the components potassium iodide, sodium
p-toluenesulfonchloramide and sodium lauryl sulfate at a level not in
excess of the minimum required to produce their intended functional
effect.
(4) Solutions identified in paragraph (b)(4), (5), (6), (8), (13),
and (14) of this section will contain iodine to provide not more than 25
parts per million of titratable iodine. The adjuvants used with the
iodine will not be in excess of the minimum amounts required to
accomplish the intended technical effect.
(5) Solutions identified in paragraph (b)(7) of this section will
provide not more than 400 parts per million dodecylbenzenesulfonic acid
and not more than 80 parts per million of
polyoxyethylene-polyoxypropylene block polymers (having a minimum
average molecular weight of 2,800) or not more than 40 parts per million
of isopropyl alcohol.
(6) Solutions identified in paragraph (b)(9) of this section shall
provide when ready to use no more than 200 parts per million of the
active quaternary compound.
(7) Solutions identified in paragraph (b)(10) of this section shall
provide not more than sufficient trichloromelamine to produce 200 parts
per million of available chlorine and either sodium lauryl sulfate at a
level not in excess of the minimum required to produce its intended
functional effect or not more than 400 parts per million of
dodecylbenzenesulfonic acid.
(8) Solutions identified in paragraph (b)(11) of this section shall
provide, when ready to use, not more than 200 parts per million of
active quaternary compound.
(9) The solution identified in paragraph (b)(12) of this section
shall provide not more than 200 parts per million of sulfonated oleic
acid, sodium salt.
(10) Solutions identified in paragraph (b)(15) of this section will
provide not more than 200 parts per million of available chlorine and
not more than 30 ppm lithium.
(11) Solutions identified in paragraph (b)(16) of this section shall
provide not more than 200 parts per million of active quaternary
compound.
(12) Solutions identified in paragraph (b)(17) of this section shall
provide, when ready to use, a level of 150 parts per million of the
active quaternary compound.
(13) Solutions identified in paragraph (b)(18) of this section shall
provide not more than 200 parts per million of active quaternary
compound and not more than 66 parts per million of
alpha(p-(1,1,3,3-tetramethylbutyl) phenyl)-omega-hydroxypoly
(oxyethylene).
(14) Solutions identified in paragraph (b)(19) of this section shall
provide, when ready to use, a level of 100 parts per million of
available chlorine.
(15) Solutions identified in paragraph (b)(20) of this section are
for single use applications only and shall provide, when ready to use, a
level of 800 parts per million of total active phenols consisting of 400
parts per million ortho-phenylphenol, 320 parts per million
ortho-benzyl-para-chlorophenol and 80 parts per million
para-tertiaryamylphenol.
(16) Solution identified in paragraph (b)(21) of this section shall
provide not more than 430 parts per million and not less than 25 parts
per million of sodium dodecylbenzenesulfonate.
(17) Solutions identified in paragraph (b)(22) of this section shall
provide, when ready to use, at least 150 parts per million and not more
than 400 parts per million of active quaternary compound.
(18) Solutions identified in paragraph (b)(23) of this section shall
provide at least 150 parts per million and not more than 200 parts per
million of the active quaternary compound.
(19) Solutions identified in paragraphs (b)(24) and (b)(25) of this
section shall provide at least 12.5 parts per million and not more than
25 parts per million of titratable iodine. The adjuvants used with the
iodine shall not be in excess of the minimum amounts required to
accomplish the intended technical effect.
(20)-(21) (Reserved)
(22) Solutions identified in paragraph (b)(27) of this section shall
provide, when ready to use, at least 109 parts per million and not more
than 218 parts per million of total active fatty acids and at least 156
parts per million and not more than 312 parts per million of the sodium
1-octanesulfonate.
(23) Solutions identified in paragraph (b)(28) of this section shall
provide, when ready to use, at least 156 parts per million and not more
than 312 parts per million of sulfonated 9-octadecenoic acid, at least
31 parts per million and not more then 62 parts per million of sodium
xylenesulfonate.
(24) Solutions identified in paragraph (b)(29) of this section will
provide at least 237 parts per million and not more than 474 parts per
million dodecyldiphenyloxidedisulfonic acid, at least 33 parts per
million and not more than 66 parts per million sulfonated tall oil fatty
acid, and at least 87 parts per million and not more than 174 parts per
million neo-decanoic acid.
(25) Solutions identified in paragraph (b)(30) of this section shall
provide, when ready to use, not less than 550 parts per million and not
more than 1,100 parts per million hydrogen peroxide, not less than 100
parts per million and not more than 200 parts per million peracetic
acid, not less than 150 parts per million and not more than 300 parts
per million acetic acid, and not less than 15 parts per million and not
more than 30 parts per million 1-hydroxyethylidene-1,1-diphosphonic
acid.
(26) The solution identified in paragraph (b)(31) of this section
shall provide, when ready to use, at least 12.5 parts per million and
not more than 25 parts per million of titratable iodine. The adjuvants
used with the iodine will not be in excess of the minimum amounts
required to accomplish the intended technical effect.
(27) Solutions identified in paragraph (b)(32) of this section shall
provide, when ready to use, at least 150 parts per million and no more
than 400 parts per million of active quarternary compounds in solutions
containing no more than 600 parts per million water hardness. The
adjuvants used with the quarternary compounds will not exceed the
amounts required to accomplish the intended technical effect.
(28) Solutions identified in paragraph (b)(33) of this section shall
provide, when ready to use, at least 150 parts per million and not more
than 400 parts per million of active quaternary compounds. The
adjuvants used with the quaternary compounds shall not exceed the
amounts required to accomplish the intended technical effect.
Tetrasodium ethylenediamine tetraacetate shall be added at a minimum
level of 60 parts per million. Use of these sanitizing solutions shall
be limited to conditions of water hardness not in excess of 300 parts
per million.
(29) Solutions identified in paragraph (b)(34) of this section should
provide, when ready to use, at least 100 parts per million and not more
than 200 parts per million available chlorine dioxide as determined by
the method titled ''Iodometric Method for the Determination of Available
Chlorine Dioxide (50-250 ppm available ClO2),'' which is incorporated by
reference. Copies are available from the Division of Food and Color
Additives, Center for Food Safety and Applied Nutrition (HFF-330), 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.
(30) Solutions identified in paragraph (b)(35) of this section shall
provide, when ready for use, at least 117 parts per million and not more
than 234 parts per million of total fatty acids and at least 166 parts
per million and not more than 332 parts per million of a mixture of
naphthalenesulfonates. The adjuvants phosphoric acid and lactic acid,
used with decanoic acid, octanoic acid, and sodium naphthalenesulfonate
and its alkylated derivatives, will not be in excess of the minimum
amounts required to accomplish the intended technical effects.
(31) Solutions identified in paragraph (b)(36) of this section shall
provide, when ready for use, at least 29 parts per million and not more
than 58 parts per million decanoic acid; at least 88 parts per million
and not more than 176 parts per million of octanoic acid; at least 69
parts per million and not more than 138 parts per million of lactic
acid; at least 256 parts per million and not more than 512 parts per
million of phosphoric acid; at least 86 parts per million and not more
than 172 parts per million of 1-octanesulfonic acid; at least 51 parts
per million and not more than 102 parts per million of
1-octanesulfonic-2-sulfinic acid or 1,2-octanedisulfonic acid; and at
least 10 parts per million and not more than 20 parts per million of the
condensate of four moles of poly(oxyethylene)poly(oxypropylene) block
copolymers with one mole of ethylenediamine. The colorant adjuvant FD&C
Yellow No. 5 shall not be used in excess of the minimum amount required
to accomplish the intended technical effect.
(32)(i) The solution identified in paragraph (b)(37) of this section
without potassium bromide shall provide, when ready to use, at least 100
parts per million and not more than 200 parts per million of available
halogen determined as available chlorine; at least 2,958 parts per
million and not more than 5,916 parts per million of trisodium
phosphate; at least 1 part per million and not more than 3 parts per
million of sodium lauryl sulfate; and at least 0.3 part per million and
not more than 0.7 part per million on potassium permanganate.
(ii) The solution identified in paragraph (b)(37) of this section
with potassium bromide shall provide, when ready to use, at least 25
parts per million and not more than 200 parts per million of available
halogen determined as available chlorine; at least 15 parts per million
and not more than 46 parts per million of potassium bromide; at least
690 parts per million and not more than 2,072 parts per million of
trisodium phosphate; at least 0.3 part per million and not more than 1
part per million of sodium lauryl sulfate; and at least 0.1 part per
million and not more than 0.3 part per million of potassium
permanganate.
(iii) Magnesium oxide when used in paragraph (c)(32) (i) or (ii) of
this section shall not be used in excess of the minimum amount required
to accomplish its intended technical effect.
(33) Solutions identified in paragraph (b)(38) of this section shall
provide when ready for use not less than 300 parts per million and not
more than 465 parts per million of hydrogen peroxide; not less than 200
parts per million and not more than 315 parts per million of
peroxyacetic acid; not less than 200 parts per million and not more
than 340 parts per million of acetic acid; not less than 10 parts per
million and not more than 20 parts per million of sulfuric acid; and
not less than 0.75 parts per million and not more than 1.2 parts per
million of 2,6-pyridinedicarboxylic acid.
(d) Sanitizing agents for use in accordance with this section will
bear labeling meeting the requirements of the Federal Insecticide,
Fungicide, and Rodenticide Act.
(42 FR 14609, Mar. 16, 1977)
Editorial Note: For Federal Register citations affecting 178.1010,
see the List of CFR Sections Affected in the Finding Aids section of
this volume.
21 CFR 178.1010 Subpart C -- Antioxidants and Stabilizers
21 CFR 178.2010 Antioxidants and/or stabilizers for polymers.
The substances listed in paragraph (b) of this section may be safely
used as antioxidants and/or stabilizers in polymers used in the
manufacture of articles or components of articles intended for use in
producing, manufacturing, packing, processing, preparing, treating,
packaging, transporting, or holding food, subject to the provisions of
this section:
(a) The quantity used shall not exceed the amount reasonably required
to accomplish the intended technical effect.
(b) List of substances:
(42 FR 14609, Mar. 15, 1977)
Editorial Note: For Federal Register citations affecting 178.2010,
see the List of CFR Sections Affected in the Finding Aids section of
this volume.
21 CFR 178.2550 4-Hydroxymethyl-2,6-di-tert-butylphenol.
4-Hydroxymethyl-2,6-di-tert-butyl-phenol may be safely used as an
antioxidant in articles intended for use in contact with food, in
accordance with the following prescribed conditions:
(a) The additive has a solidification point of 140 -141 C.
(b) The concentration of the additive and any other permitted
antioxidants in the finished food-contact article does not exceed a
total of 0.5 milligram per square inch of food-contact surface.
21 CFR 178.2650 Organotin stabilizers in vinyl chloride plastics.
The organotin chemicals identified in paragraph (a) of this section
may be safety used alone or in combination, at levels not to exceed a
total of 3 parts per hundred of resin, as stabilizers in vinyl chloride
homopolymers and copolymers complying with the provisions of 177.1950
or 177.1980 of this chapter and that are identified for use in contact
with food of types I, II, III, IV (except liquid milk), V, VI (except
malt beverages and carbonated nonalcoholic beverages), VII, VIII, and IX
described in table 1 of 176.170(c) of this chapter, except for the
organotin chemical identified in paragraph (a)(3) of this section, which
may be used in contact with food of types I through IX at temperatures
not exceeding 75 C (167 F), and further that the organotin chemicals
identified in paragraphs (a) (5) and (6) of this section may be used in
contact with food of types I through IX at temperatures not exceeding 66
C (150 F), conditions of use D through G described in table 2 of
176.170(c) of this chapter, and further that dodecyltin chemicals
identified in paragraph (a)(7) of this section which may be used in
contact with food of types I, II, III, IV (except liquid milk), V, VI
(except malt beverages and carbonated nonalcoholic beverages), VII,
VIII, and IX described in table 1 of 176.170(c) of this chapter at
temperatures not exceeding 71 C (160 F), in accordance with the
following prescribed conditions:
(a) For the purpose of this section, the organotin chemicals are
those listed in paragraphs (a) (1), (2), (3), (4), (5), (6), and (7) of
this section.
(1) Di(n-octyl)tin S,S -bis(isooctylmercaptoacetate) is an octyltin
chemical having 15.1 to 16.4 percent by weight of tin (Sn) and having
8.1 to 8.9 percent by weight of mercapto sulfur. It is made from
di(n-octyl)tin dichloride or di(n-octyl)tin oxide. The isooctyl radical
in the mercaptoacetate is derived from oxo process isooctyl alcohol.
Di(n-octyl)tin dichloride has an organotin composition that is not less
than 95 percent by weight of di(n-octyl)tin dichloride and not more than
5 percent by weight of tri(n-octyl)tin chloride. Di(n-octyl)tin oxide
has an organotin composition that is not less than 95 percent by weight
of di(n-octyl)tin oxide and not more than 5 percent by weight of
bis(tri(n-octyl)tin) oxide, and/or mono n-octyltin oxide.
(2) Di(n-octyl) tin maleate polymer is an octyltin chemical having
the formula ((C8H17)2SnC4H2O4)n (where n is between 2 and 4 inclusive),
having 25.2 to 26.6 percent by weight of tin (Sn) and having a
saponification number of 225 to 255. It is made from di(n-octyl)tin
dichloride or di(n-octyl)tin oxide meeting the specifications prescribed
for di(n- octyl) tin dichloride or di(n-octyl) tin oxide in paragraph
(a)(1) of this section.
(3) C10-16-Alkyl mercaptoacetates reaction products with
dichlorodioctylstannane and trichlorooctylstannane (CAS Reg. No.
83447-69-2) is an organotin chemical mixture having 10.8 to 11.8 percent
by weight of tin (Sn) and having 8.0 to 8.6 percent by weight of
mercapto sulfur. It is made from a mixture of di(n-octyl)tin dichloride
and (n-octyl)tin trichloride which has an organotin composition that is
not less than 95 percent by weight di(n-octyl)tin
dichloride/(n-octyl)tin trichloride, and not more than 1.5 percent by
weight of tri(n-octyl)tin chloride. The alkyl radical in the
mercaptoacetate is derived from a mixture of saturated n-alcohols which
has a composition that is not less than 50 percent by weight tetradecyl
alcohol, and that is not more than 50 percent by weight total of decyl
alcohol and/or dodecyl alcohol, and/or hexadecyl alcohol.
(4) (n-Octyl)tin S,S S" tris(isooctyl-mercaptoacetate) is an octyltin
chemical having the formula n-C8H17Sn(SCH2CO2C8H17)3 (CAS Reg. No.
26401-86-5) having 13.4 to 14.8 percent by weight of tin (Sn) and having
10.9 to 11.9 percent by weight of mercapto sulfur. It is made from
(n-octyl)tin trichloride. The isooctyl radical in the mercaptoacetate
is derived from oxo process isooctyl alcohol. The (n-octyl)tin
trichloride has an organotin composition that is not less than 95
percent by weight of (n-octyl)tin trichloride and not more than 5
percent by weight of tri(n-octyl)tin chloride.
(5) Bis(beta-carbobutoxyethyl)tin bis(isooctylmercaptoacetate) (CAS
Reg. No. 63397-60-4) is an estertin chemical having 14.0 to 15.0 percent
by weight of tin (Sn) and having 7.5 to 8.5 percent by weight of
mercapto sulfur. It is made from bis(beta-carbobutoxyethyl)tin
dichloride. The isooctyl radical in the mercaptoacetate is derived from
oxo process primary octyl alcohols. The bis(beta-carbobutoxyethyl)tin
dichloride has an organotin composition that is not less than 95 percent
by weight of bis(beta-carbobutoxyethyl)tin dichloride and not more than
5 percent by weight of bis(beta-carbobutoxyethyltin trichloride. The
triestertin chloride content of bis(beta-carbobutoxyethyltin) dichloride
shall not exceed 0.02 percent.
(6) Beta-carbobutoxyethyltin tris(isooctylmercaptoacetate) (CAS Reg.
No. 63438-80-2) is an estertin chemical having 13.0 to 14.0 percent by
weight of tin (Sn) and having 10.5 to 11.5 percent by weight of mercapto
sulfur. It is made from beta-carbobutoxyethyltin trichloride. The
isooctyl radical in the mercaptoacetate is derived from oxo process
primary octyl alcohol. The beta-carbobutoxyethyltin trichloride has an
organotin composition that is not less than 95 percent by weight of
beta-carbobutoxyethyltin trichloride and not more than 5 percent total
of triestertin chloride and diestertin chloride.
(7) The dodecyltin stabilizer is a mixture of 50 to 60 percent by
weight of n-dodecyltin S,S',S''-tris(isooctylmercaptoacetate) (CAS Reg.
No. 67649-65-4) and 40 to 50 percent by weight of di(n-dodecyl)tin
S,S'-di(isooctylmercaptoacetate) (CAS Reg. No. 84030-61-5) having 13 to
14 percent by weight of tin (Sn) and having 8 to 9 percent by weight of
mercapto sulfur. It is made from a mixture of dodecyltin trichloride
and di(dodecyl)tin dichloride which has not more than 0.2 percent by
weight of dodecyltin trichloride, not more than 2 percent by weight of
dodecylbutyltin dichloride and not more than 3 percent by weight of
tri(dodecyl)tin chloride. The isooctyl radical in the mercaptoacetate
is derived from oxo process primary octyl alcohols.
(b) The vinyl chloride plastic containers, film or panels in the
finished form in which they are to contact food, shall meet the
following limitations:
(1) The finished plastics intended for contact with foods of the
types listed in this section shall be extracted with the solvent or
solvents characterizing those types of foods as determined from Table 2
of 176.170(c) of this chapter at the temperature reflecting the
conditions of intended use as determined therein. Additionally,
extraction tests for acidic foods shall be included and simulated by
3-percent acetic acid at temperatures specified for water in Table 2 of
176.170(c) of this chapter. The extraction tests shall cover at least
three equilibrium periodic determinations, as follows:
(i) The exposure time for the first determination shall be at least
72 hours for aqueous solvents, and at least 6 hours for heptane.
(ii) Subsequent determinations shall be at a minimum of 24-hour
intervals for aqueous solvents, and 2-hour intervals for heptane. These
tests shall yield total octylin stabilizers not to exceed 0.5 parts per
million as determined by analytical method entitled ''Atomic Absorption
Spectrometric Determination of Sub-part-per-Million Quantities of Tin in
Extracts and Biological Materials with Graphite Furnace,'' Analytical
Chemistry, Vol. 49, p. 1090-1093 (1977), which is incorporated by
reference.Copies are available from the Division of Food and Color
Additives, Center for Food Safety and Applied Nutrition (HFF-330), 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.
(iii) Subsequent determinations for the dodecyltin mixture described
in paragraph (a)(7) of this section shall be at a minimum of 24-hour
intervals for aqueous solvents and 2-hour intervals for heptane. These
tests shall yield di(n-octyl)tin S,S'-bis(isooctylmercaptoacetate), or
di(n-octyl)tin maleate polymer, or (C10-C16)-alkylmercaptoacetate
reaction products with dichlorodioctylstannane and
trichlorooctylstannane, or n-octyltin
S,S',S''-tris(isooctylmercaptoacetate), tris(isooctylmercaptoacetate)
and di(n-dodecyl)tin bis(isooctylmercaptoacetate) or any combination
thereof, not to exceed 0.5 parts per million as determined by an
analytical method entitled ''Atomic Absorption Spectrophotometric
Determination of Sub-part-per-Million Quantities of Tin in Extracts and
Biological Materials with Graphite Furnace,'' Analytical Chemistry, Vol.
49, pp. 1090-1093 (1977), which is incorporated by reference in
accordance with 5 U.S.C. 552(a). The availability of this incorporation
by reference is given in paragraph (b)(1)(ii) of this section.
(2) In lieu of the tests prescribed in paragraph (b) (1) of this
section, the finished plastics intended for contact with foods only of
Types II, V, VI-A (except malt beverages), and VI-C may be end-tested
with food-simulating solvents, under conditions of time and temperature,
as specified below, whereby such tests shall yield the octyltin residues
cited in paragraph (b)(1) of this section not in excess of 0.5 ppm:
(42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11847, Mar. 19,
1982; 48 FR 7170, Feb. 18, 1983; 48 FR 42972, Sept. 21, 1983; 48 FR
51612, Nov. 10, 1983; 49 FR 8432, Mar. 7, 1984; 50 FR 62, Jan. 2,
1985; 50 FR 3510, Jan. 25, 1985; 50 FR 37998, Sept. 19, 1985; 50 FR
47212, Nov. 15, 1985; 54 FR 24898, June 12, 1989)
21 CFR 178.2650 Subpart D -- Certain Adjuvants and Production Aids
21 CFR 178.3010 Adjuvant substances used in the manufacture of foamed
plastics.
The following substances may be safely used as adjuvants in the
manufacture of foamed plastics intended for use in contact with food,
subject to any prescribed limitations:
(47 FR 22090, May 21, 1982)
21 CFR 178.3120 Animal glue.
Animal glue may be safely used as a component of articles intended
for use in producing, manufacturing, packing, processing, preparing,
treating, packaging, transporting, or holding food, subject to the
provisions of this section.
(a) Animal glue consists of the proteinaceous extractives obtained
from hides, bones, and other collagen-rich substances of animal origin
(excluding diseased or rotted animals), to which may be added other
optional adjuvant substances required in its production or added to
impart desired properties.
(b) The quantity of any substance employed in the production of
animal glue does not exceed the amount reasonably required to accomplish
the intended physical or technical effect nor any limitation further
provided.
(c) Any substance employed in the production of animal glue and which
is the subject of a regulation in parts 174, 175, 176, 177, 178 and
179.45 of this chapter conforms with any specification in such
regulation.
(d) Optional adjuvant substances employed in the production of animal
glue include:
(1) Substances generally recognized as safe in food.
(2) Substances subject to prior sanction or approval for use in
animal glue and used in accordance with such sanction or approval.
(3) Substances identified in this paragraph (d)(3) and subject to
such limitations as are provided:
(e) The conditions of use are as follows:
(1) The use of animal glue in any substance or article that is the
subject of a regulation in this subpart conforms with any specifications
or limitations prescribed by such regulation for the finished form of
the substance or article.
(2) It is used as an adhesive or component of an adhesive in
accordance with the provisions of 175.105 of this chapter.
(3) It is used as a colloidal flocculant added to the pulp suspension
prior to the sheet-forming operation in the manufacture of paper and
paperboard.
(4) It is used as a protective colloid in resinous and polymeric
emulsion coatings.
21 CFR 178.3125 Anticorrosive agents.
The substances listed in this section may be used as anticorrosive
agents in food-contact materials subject to the provisions of this
section:
(50 FR 21835, May 29, 1985)
21 CFR 178.3130 Antistatic and/or antifogging agents in food-packaging
materials.
The substances listed in paragraph (b) of this section may be safely
used as antistatic and/or antifogging agents in food-packaging
materials, subject to the provisions of this section:
(a) The quantity used shall not exceed the amount reasonably required
to accomplish the intended technical effect.
(b) List of substances:
(42 FR 14609, Mar. 15, 1977, as amended at 45 FR 56797, Aug. 26,
1980; 45 FR 85727, Dec. 30, 1980; 46 FR 13688, Feb. 24, 1981; 47 FR
26824, June 22, 1982; 51 FR 28932, Aug. 13, 1986; 56 FR 41457, Aug.
21, 1991)
21 CFR 178.3280 Castor oil, hydrogenated.
Hydrogenated castor oil may be safely used in the manufacture of
articles or components of articles intended for use in contact with food
subject to the provisions of this section.
(a) The quantity used shall not exceed the amount reasonably required
to accomplish the intended technical effect.
(b) The additive is used as follows:
(42 FR 14609, Mar. 15, 1977, as amended at 55 FR 8914, Mar. 9, 1990)
21 CFR 178.3290 Chromic chloride complexes.
Myristo chromic chloride complex and stearato chromic chloride
complex may be safely used as release agents in the closure area of
packaging containers intended for use in producing, manufacturing,
packing, processing, preparing, treating, packaging, transporting, or
holding food, subject to the provisions of this section:
(a) The quantity used shall not exceed that reasonably required to
accomplish the intended technical effect nor exceed 7 micrograms of
chromium per square inch of closure area.
(b) The packaging container which has its closure area treated with
the release agent shall have a capacity of not less than 120 grams of
food per square inch of such treated closure area.
21 CFR 178.3295 Clarifying agents for polymers.
Clarifying agents may be safely used in polymers that are articles or
components of articles intended for use in contact with food, subject to
the provisions of this section:
(46 FR 59236, Dec. 4, 1981, as amended at 52 FR 30920, Aug. 18, 1987;
53 FR 30049, Aug. 10, 1988; 54 FR 12432, Mar. 27, 1989; 54 FR 14734,
Apr. 12, 1989; 55 FR 52990, Dec. 26, 1990; 56 FR 1085, Jan. 11, 1991)
21 CFR 178.3297 Colorants for polymers.
The substances listed in paragraph (e) of this section may be safely
used as colorants in the manufacture of articles or components of
articles intended for use in producing, manufacturing, packing,
processing, preparing, treating, packaging, transporting, or holding
food, subject to the provisions and definitions set forth in this
section:
(a) The term colorant means a dye, pigment, or other substance that
is used to impart color to or to alter the color of a food-contact
material, but that does not migrate to food in amounts that will
contribute to that food any color apparent to the naked eye. For the
purpose of this section, the term ''colorant'' includes substances such
as optical brighteners and fluorescent whiteners, which may not
themselves be colored, but whose use is intended to affect the color of
a food-contact material.
(b) The colorant must be used in accordance with current good
manufacturing practice, including use levels which are not in excess of
those reasonably required to accomplish the intended coloring effect.
(c) Colorants in this section must conform to the description and
specifications indicated. If a polymer described in this section is
itself the subject of a regulation promulgated under section 409 of the
Federal Food, Drug, and Cosmetic Act, it shall also comply with any
specifications and limitations prescribed by that regulation.
Extraction testing guidelines to conduct studies for additional uses of
colorants under this section are available from the Food and Drug
Administration free of charge from the Center for Food Safety and
Applied Nutrition, Division of Food and Color Additives (HFF-335), Food
and Drug Administration, 200 C St. SW., Washington, DC 20204.
(d) Color additives and their lakes permanently listed for direct use
in foods, under the provisions of the color additive regulations in
parts 73 and 74 of this chapter, may also be used as colorants for
food-contact polymers.
(e) List of substances:
(48 FR 46774, 46775, Oct. 14, 1983, as amended at 51 FR 7551, Mar.
5, 1986; 51 FR 19168, May 28, 1986; 51 FR 23535, June 30, 1986; 53 FR
52132, Dec. 27, 1988; 54 FR 21053, May 16, 1989; 54 FR 24898, June 12,
1989; 54 FR 35875, Aug. 30, 1989; 55 FR 3585, Feb. 2, 1990; 55 FR
12344, Apr. 3, 1990; 55 FR 18721, May 4, 1990; 55 FR 31827, Aug. 6,
1990; 56 FR 42933, Aug. 30, 1991; 56 FR 65782, Dec. 18, 1991)
21 CFR 178.3300 Corrosion inhibitors used for steel or tinplate.
Corrosion inhibitors may be safely used for steel or tinplate
intended for use in, or to be fabricated as, food containers or
food-processing or handling equipment, subject to the provisions of this
section.
(a) The corrosion inhibitors are prepared from substances identified
in this section and used subject to the limitations prescribed.
(b) The following corrosion inhibitors or adjuvants are used in
amounts not to exceed those reasonably required to accomplish the
intended physical or technical effect:
(1) Corrosion inhibitors (active ingredients) used in packaging
materials for the packaging of steel or tinplate or articles fabricated
therefrom:
(2) Adjuvants employed in the application and use of corrosion
inhibitors:
21 CFR 178.3400 Emulsifiers and/or surface-active agents.
The substances listed in paragraph (c) of this section may be safely
used as emulsifiers and/or surface-active agents in the manufacture of
articles or components of articles intended for use in producing,
manufacturing, packing, processing, preparing, treating, packaging,
transporting, or holding food, subject to the provisions of this
section.
(a) The quantity used shall not exceed the amount reasonably required
to accomplish the intended technical effect; and the quantity that may
become a component of food as a result of such use shall not be intended
to, nor in fact, accomplish any physical or technical effect in the food
itself.
(b) The use as an emulsifier and/or surface-active agent in any
substance or article that is the subject of a regulation in parts 174,
175, 176, 177, 178 and 179.45 of this chapter conforms with any
specifications and limitations prescribed by such regulation for the
finished form of the substance or article.
(c) List of substances:
(d) The provisions of this section are not applicable to emulsifiers
and/or surface-active agents listed in 175.105(c)(5) of this chapter
and used in food-packaging adhesives complying with 175.105 of this
chapter.
(42 FR 14609, Mar. 15, 1977, as amended at 43 FR 58557, Dec. 15,
1978; 44 FR 42679, July 20, 1979; 45 FR 67321, Oct. 10, 1980; 48 FR
24870, June 3, 1983; 49 FR 5748, Feb. 15, 1984; 51 FR 31763, Sept. 5,
1986; 56 FR 41457, Aug. 21, 1991)
21 CFR 178.3450 Esters of stearic and palmitic acids.
The ester stearyl palmitate or palmityl stearate or mixtures thereof
may be safely used as adjuvants in food-packaging materials when used in
accordance with the following prescribed conditions:
(a) They are used or intended for use as plasticizers or lubricants
in polystyrene intended for use in contact with food.
(b) They are added to the formulated polymer prior to extrusion.
(c) The quantity used shall not exceed that required to accomplish
the intended technical effect.
21 CFR 178.3480 Fatty alcohols, synthetic.
Synthetic fatty alcohols may be safely used as components of articles
intended for use in contact with food, and in synthesizing food
additives and other substances permitted for use as components of
articles intended for use in contact with food in accordance with the
following prescribed conditions:
(a) The food additive consists of fatty alcohols meeting the
specifications and definition prescribed in 172.864 of this chapter,
except as provided in paragraph (c) of this section.
(b) It is used or intended for use as follows:
(1) As substitutes for the corresponding naturally derived fatty
alcohols permitted for use as components of articles intended for use in
contact with food by existing regulations in parts 174, 175, 176, 177,
178 and 179.45 of this chapter: Provided, That the use is in
compliance with any prescribed limitations.
(2) As substitutes for the corresponding naturally derived fatty
alcohols used as intermediates in the synthesis of food additives and
other substances permitted for use as components of food-contact
articles.
(c) Synthetic fatty alcohols identified in paragraph (c)(1) of this
section may contain not more than 0.8 weight percent of total diols as
determined by a method titled ''Diols in Monohydroxy Alcohol by
Miniature Thin Layer Chromatography (MTLC),'' which is incorporated by
reference. Copies are available from the Division of Food and Color
Additives, Center for Food Safety and Applied Nutrition (HFF-330), 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.
(1) Synthetic fatty alcohols. (i) Hexyl, octyl, decyl, lauryl,
myristyl, cetyl, and stearyl alcohols meeting the specifications and
definition prescribed in 172.864 of this chapter, except that they may
contain not more than 0.8 weight percent total diols.
(ii) Lauryl, myristyl, cetyl, and stearyl alcohols manufactured by
the process described in 172.864(a)(2) of this chapter such that lauryl
and myristyl alcohols meet the specifications in 172.864(a)(1)(i) of
this chapter, and cetyl and stearyl alcohols meet the specifications in
172.864(a)(1)(ii) of this chapter.
(2) Conditions of use. (i) Synthetic fatty alcohols as substitutes
for the corresponding naturally derived fatty alcohols permitted for use
in compliance with 178.3910.
(ii) Synthetic lauryl alcohol as a substitute for the naturally
derived lauryl alcohol permitted as an intermediate in the synthesis of
sodium lauryl sulfate used in compliance with 178.3400.
(42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11847, Mar. 19,
1982; 54 FR 24898, June 12, 1989)
21 CFR 178.3500 Glycerin, synthetic.
Synthetic glycerin may be safely used as a component of articles
intended for use in packaging materials for food, subject to the
provisions of this section:
(a) It is produced by the hydrogenolysis of carbohydrates, and shall
contain not in excess of 0.2 percent by weight of a mixture of
butanetriols.
(b) It is used in a quantity not to exceed that amount reasonably
required to produce its intended physical or technical effect, and in
accordance with any limitations prescribed by applicable regulations in
parts 174, 175, 176, 177, 178 and 179 of this chapter. It shall not be
intended to, nor in fact accomplish, any direct physical or technical
effect in the food itself.
21 CFR 178.3505 Glyceryl tri-(12-acetoxystearate).
Glyceryl tri-(12-acetoxystearate) (CAS Reg. No. 139-43-5) may be
safely used as a component of articles intended for use in producing,
manufacturing, packing, processing, preparing, treating, packaging,
transporting, or holding food, subject to the provisions of this
section.
(a) The additive is applied to the surface of calcium carbonate at a
level not to exceed 1 weight-percent of the total mixture.
(b) The calcium carbonate/glyceryl tri-(12-acetoxystearate) mixture
is used as an adjuvant in polymers in contact with nonfatty foods at a
level not to exceed 20 weight-percent of the polymer.
(50 FR 1503, Jan. 11, 1985)
21 CFR 178.3520 Industrial starch-modified.
Industrial starch-modified may be safely used as a component of
articles intended for use in producing, manufacturing, packing,
processing, preparing, treating, packaging, transporting, or holding
food, subject to the provisions of this section.
(a) Industrial starch-modified is identified as follows:
(1) A food starch-modified or starch or any combination thereof that
has been modified by treatment with one of the reactants hereinafter
specified, in an amount reasonably required to achieve the desired
functional effect but in no event in excess of any limitation
prescribed, with or without subsequent treatment as authorized in
172.892 of this chapter.
(2) A starch irradiated under one of the following conditions to
produce free radicals for subsequent graft polymerization with the
reactants listed in this paragraph (a)(2):
(i) Radiation from a sealed cobalt 60 source, maximum absorbed dose
not to exceed 5.0 megarads.
(ii) An electron beam source at a maximum energy of 7 million
electron volts of ionizing radiation, maximum absorbed dose not to
exceed 5.0 megarads.
(b) The following adjuvants may be used as surface-active agents in
the processing of industrial starch-modified:
Polyethylene glycol (400) dilaurate.
Polyethylene glycol (400) monolaurate.
Polyoxyethylene (4) lauryl ether.
(c) To insure safe use of the industrial starch-modified, the label
of the food additive container shall bear the name of the additive
''industrial starch-modified,'' and in the instance of an industrial
starch-modified which is limited with respect to conditions of use, the
label of the food additive container shall contain a statement of such
limited use.
(42 FR 14609, Mar. 15, 1977, as amended at 42 FR 49453, Sept. 27,
1977)
21 CFR 178.3530 Isoparaffinic petroleum hydrocarbons, synthetic.
Isoparaffinic petroleum hydrocarbons, synthetic, may be safely used
in the production of nonfood articles intended for use in producing,
manufacturing, packing, processing, preparing, treating, packaging,
transporting, or holding food, subject to the provisions of this
section.
(a) The isoparaffinic petroleum hydrocarbons, produced by synthesis
from petroleum gases consist of a mixture of liquid hydrocarbons meeting
the following specifications:
Boiling point 63 -260 C, as determined by ASTM method D86-82,
''Standard Method for Distillation of Petroleum Products,'' which is
incorporated by reference. Copies may be obtained from the American
Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or
may be examined at the Office of the Federal Register, 1100 L St. NW.,
Washington, DC 20408.
Ultraviolet absorbance:
260-319 millimicrons -- 1.5 maximum.
320-329 millimicrons -- 0.08 maximum.
330-350 millimicrons -- 0.05 maximum.
Nonvolatile residue 0.002 gram per 100 milliliters maximum.
Synthetic isoparaffinic petroleum hydrocarbons containing
antioxidants shall meet the specified ultraviolet absorbance limits
after correction for any absorbance due to the antioxidants. The
ultraviolet absorbance shall be determined by the procedure described
for application to mineral oil under ''Specifications'' on page 66 of
the Journal of the Association of Official Agricultural Chemists, Vol.
45 (February 1962), which is incorporated by reference, disregarding the
last sentence of that procedure. For hydrocarbons boiling below 121 C,
the nonvolatile residue shall be determined by ASTM method D1353-78,
''Standard Test Method for Nonvolatile Matter in Volatile Solvents for
Use in Paint, Varnish, Lacquer, and Related Products;'' for those
boiling above 121 C, ASTM procedure D381-80, ''Standard Test Method for
Existent Gum in Fuels by Jet Evaporation,'' which are incorporated by
reference. Copies may be obtained from the American Society for Testing
Materials, 1916 Race St., Philadelphia, PA 19103, or may be examined at
the Office of the Federal Register, 1100 L St. NW., Washington, DC
20408.
(b) Isoparaffinic petroleum hydrocarbons may contain antioxidants
authorized for use in food in an amount not to exceed that reasonably
required to accomplish the intended technical effect.
(c) Isoparaffinic petroleum hydrocarbons are used in the production
of nonfood articles. The quantity used shall not exceed the amount
reasonably required to accomplish the intended technical effect, and the
residual remaining in the finished article shall be the minimum amount
reasonably attainable.
(42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11847, Mar. 19,
1982; 49 FR 10112, Mar. 19, 1984)
21 CFR 178.3570 Lubricants with incidental food contact.
Lubricants with incidental food contact may be safely used on
machinery used for producing, manufacturing, packing, processing,
preparing, treating, packaging, transporting, or holding food, subject
to the provisions of this section:
(a) The lubricants are prepared from one or more of the following
substances:
(1) Substances generally recognized as safe for use in food.
(2) Substances used in accordance with the provisions of a prior
sanction or approval.
(3) Substances identified in this paragraph (a)(3).
(b) The lubricants are used on food-processing equipment as a
protective antirust film, as a release agent on gaskets or seals of tank
closures, and as a lubricant for machine parts and equipment in
locations in which there is exposure of the lubricated part to food.
The amount used is the minimum required to accomplish the desired
technical effect on the equipment, and the addition to food of any
constituent identified in this section does not exceed the limitations
prescribed.
(c) Any substance employed in the production of the lubricants
described in this section that is the subject of a regulation in parts
174, 175, 176, 177, 178 and 179.45 of this chapter conforms with any
specification in such regulation.
(42 FR 14609, Mar. 15, 1977)
Editorial Note: For Federal Register citations affecting 178.3570,
see the List of CFR Sections Affected in the Finding Aids section of
this volume.
21 CFR 178.3600 Methyl glucoside-coconut oil ester.
Methyl glucoside-coconut oil ester identified in 172.816(a) of this
chapter may be safely used as a processing aid (filter aid) in the
manufacture of starch, including industrial starch-modified complying
with 178.3520, intended for use as a component of articles that contact
food.
21 CFR 178.3610 a-Methylstyrene-vinyltoluene resins, hydrogenated.
Hydrogenated -methylstyrene-vinyltoluene copolymer resins having a
molar ratio of 1 -methylstyrene to 3 vinyltoluene may be safely used as
components of polyolefin film intended for use in contact with food,
subject to the following provisions:
(a) Hydrogenated -methylstyrene-vinyltoluene copolymer resins have a
drop-softening point of 125 to 165 C and a maximum absorptivity of
0.17 liter per gram centimeter at 266 nanometers, as determined by
methods titled ''Determination of Softening Point (Drop Method)'' and
''Determination of Unsaturation of Resin 1977,'' which are incorporated
by reference. Copies are available from the Division of Food and Color
Additives, Center for Food Safety and Applied Nutrition (HFF-330), 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.
(b) The polyolefin film is produced from olefin polymers complying
with 177.1520 of this chapter, and the average thickness of the film in
the form in which it contacts food does not exceed 0.002 inch.
(42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11847, Mar. 19,
1982; 54 FR 24898, June 12, 1989)
21 CFR 178.3620 Mineral oil.
Mineral oil may be safely used as a component of nonfood articles
intended for use in contact with food, subject to the provisions of this
section:
(a) White mineral oil meeting the specifications prescribed in
172.878 of this chapter may be used as a component of nonfood articles
provided such use complies with any applicable limitations in parts 170
through 189 of this chapter. The use of white mineral oil in or on food
itself, including the use of white mineral oil as a protective coating
or release agent for food, is subject to the provisions of 172.878 of
this chapter.
(b) Technical white mineral oil identified in paragraph (b)(1) of
this section may be used as provided in paragraph (b)(2) of this
section.
(1) Technical white mineral oil consists of specially refined
distillates of virgin petroleum or of specially refined distillates that
are produced synthetically from petroleum gases. Technical white
mineral oil meets the following specifications:
(i) Saybolt color 20 minimum as determined by ASTM method D156-82,
''Standard Test Method for Saybolt Color of Petroleum Products (Saybolt
Chromometer Method),'' which is incorporated by reference. Copies may
be obtained from the American Society for Testing Materials, 1916 Race
St., Philadelphia, PA 19103, or may be examined at the Office of the
Federal Register, 1100 L St. NW., Washington, DC 20408.
(ii) Ultraviolet absorbance limits as follows:
Technical white mineral oil containing antioxidants shall meet the
specified ultraviolet absorbance limits after correction for any
absorbance due to the antioxidants. The ultraviolet absorbance shall be
determined by the procedure described for application to mineral oil
under ''Specification'' on page 66 of the Journal of the Association of
Official Agricultural Chemists, Volume 45 (February 1962) (which is
incorporated by reference; copies are available from the Division of
Food and Color Additives, Center for Food Safety and Applied Nutrition
(HFF-330), 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), disregarding the last
two sentences of that procedure and substituting therefor the following:
Determine the absorbance of the mineral oil extract in a 10-millimeter
cell in the range from 260-350 m , inclusive, compared to the solvent
control. If the absorbance so measured exceeds 2.0 at any point in
range 280-350 m , inclusive, dilute the extract and the solvent control,
respectively, to twice their volume with dimethyl sulfoxide and
remeasure the absorbance. Multiply the remeasured absorbance values by
2 to determine the absorbance of the mineral oil extract per centimeter
optical pathlength.
(2) Technical white mineral oil may be used wherever mineral oil is
permitted for use as a component of nonfood articles complying with
175.105, 176.200, 176.210, 177.2260, 177.2600, and 177.2800 of this
chapter and 178.3570 and 178.3910.
(3) Technical white mineral oil may contain any antioxidant permitted
in food by regulations issued in accordance with section 409 of the Act,
in an amount not greater than that required to produce its intended
effect.
(c) Mineral oil identified in paragraph (c)(1) of this section may be
used as provided in paragraph (c)(2) of this section.
(1) The mineral oil consists of virgin petroleum distillates refined
to meet the following specifications:
(i) Initial boiling point of 450 F minimum.
(ii) Color 5.5 maximum as determined by ASTM method D1500-82,
''Standard Test Method for ASTM Color of Petroleum Products (ASTM Color
Scale),'' which is incorporated by reference. The availability of this
incorporation by reference is given in paragraph (b)(1)(i) of this
section.
(iii) Ultraviolet absorbance limits as follows as determined by the
analytical method described in paragraph (c)(3) of this section:
(2) The mineral oil may be used wherever mineral oil is permitted for
use as a component of nonfood articles complying with 175.105 and
176.210 of this chapter and 178.3910 (for use only in rolling of
metallic foil and sheet stock), 176.200, 177.2260, 177.2600, and
177.2800 of this chapter.
(3) The analytical method for determining ultraviolet absorbance
limit is as follows:
Because of the sensitivity of the test, the possibility of errors
arising from contamination is great. It is of the greatest importance
that all glassware be scrupulously cleaned to remove all organic matter
such as oil, grease, detergent residues, etc. Examine all glassware,
including stoppers and stopcocks, under ultraviolet light to detect any
residual fluorescent contamination. As a precautionary measure it is
recommended practice to rinse all glassware with purified isooctane
immediately before use. No grease is to be used on stopcocks or joints.
Great care to avoid contamination of oil samples in handling and to
assure absence of any extraneous material arising from inadequate
packaging is essential. Because some of the polynuclear hydrocarbons
sought in this test are very susceptible to photo-oxidation, the entire
procedure is to be carried out under subdued light.
Separatory funnels. 250-milliliter, 500-milliliter,
1,000-milliliter, and preferably 2,000-milliliter capacity, equipped
with tetrafluoroethylene polymer stopcocks.
Reservoir. 500-milliliter capacity, equipped with a 24/40 standard
taper male fitting at the bottom and a suitable ball-joint at the top
for connecting to the nitrogen supply. The male fitting should be
equipped with glass hooks.
Chromatographic tube. 180 millimeters in length, inside diameter to
be 15.7 millimeters 0.1 millimeter, equipped with a coarse,
fritted-glass disc, a tetrafluoroethylene polymer stopcock, and a female
24/40 standard tapered fitting at the opposite end. (Overall length of
the column with the female joint is 235 millimeters.) The female fitting
should be equipped with glass hooks.
Disc. Tetrafluoroethylene polymer 2-inch diameter disk approximately
3/16-inch thick with a hole bored in the center to closely fit the stem
of the chromatographic tube.
Suction flask. 250-milliliter or 500-milliliter filter flask.
Condenser. 24/40 joints, fitted with a drying tube, length optional.
Evaporation flask (optional). 250-milliliter or 500-milliliter
capacity all-glass flask equipped with standard taper stopper having
inlet and outlet tubes to permit passage of nitrogen across the surface
of contained liquid to be evaporated.
Spectrophotometric cells. Fused quartz cells, optical path length in
the range of 5,000 centimeter 0.005 centimeter; also for checking
spectrophotometer performance only, optical path length in the range
1,000 centimeter 0.005 centimeter. With distilled water in the cells,
determine any absorbance differences.
Spectrophotometer. Spectral range 250 millimicrons -- 400
millimicrons with spectral slit width of 2 millimicrons or less; under
instrument operating conditions for these absorbance measurements, the
spectrophotometer shall also meet the following performance
requirements:
Absorbance repeatability, 0.01 at 0.4 absorbance.
Absorbance accuracy1062 0.05 at 0.4 absorbance.
Wavelength accuracy, 1.0 millimicron.
Nitrogen cylinder. Water-pumped or equivalent purity nitrogen in
cylinder equipped with regulator and valve to control flow at 5 p.s.i.g.
Organic solvents. All solvents used throughout the procedure shall
meet the specifications and tests described in this specification. The
isooctane, benzene, acetone, and methyl alcohol designated in the list
following this paragraph shall pass the following test:
To the specified quantity of solvent in a 250-milliliter Erlenmeyer
flask, add 1 milliliter of purified n-hexadecane and evaporate on the
steam bath under a stream of nitrogen (a loose aluminum foil jacket
around the flask will speed evaporation). Discontinue evaporation when
not over 1 milliliter of residue remains. (To the residue from benzene
add a 10-milliliter portion of purified isooctane, reevaporate, and
repeat once to insure complete removal of benzene.)
Alternatively, the evaporation time can be reduced by using the
optional evaporation flask. In this case the solvent and n-hexadecane
are placed in the flask on the steam bath, the tube assembly is
inserted, and a stream of nitrogen is fed through the inlet tube while
the outlet tube is connected to a solvent trap and vacuum line in such a
way as to prevent any flow-back of condensate into the flask.
Dissolve the 1 milliliter of hexadecane residue in isooctane and make
to 25 milliliters volume. Determine the absorbance in the 5-centimeter
path length cells compared to isooctane as reference. The absorbance of
the solution of the solvent residue (except for methyl alcohol) shall
not exceed 0.01 per centimeter path length between 280 and 400 m . For
methyl alcohol this absorbance value shall be 0.00.
Isooctane (2,2,4-trimethylpentane). Use 180 milliliters for the test
described in the preceding paragraph. Purify, if necessary, by passage
through a column of activated silica gel (Grade 12, Davison Chemical
Company, Baltimore, Maryland, or equivalent) about 90 centimeters in
length and 5 centimeters to 8 centimeters in diameter.
Benzene, A.C.S. reagent grade. Use 150 milliliters for the test.
Purify, if necessary, by distillation or otherwise.
Acetone, A.C.S. reagent grade. Use 200 milliliters for the test.
Purify, if necessary, by distillation.
Eluting mixtures:
1. 10 percent benzene in isooctane. Pipet 50 milliliters of benzene
into a 250-milliliter glass-stoppered volumetric flask and adjust to
volume with isooctane, with mixing.
2. 20 percent benzene in isooctane. Pipet 50 milliliters of benzene
into a 250-milliliter glass-stoppered volumetric flask and adjust to
volume with isooctane, with mixing.
3. Acetone-benzene-water mixture. Add 20 milliliters of water to 380
milliliters of acetone and 200 milliliters of benzene, and mix.
n-Hexadecane, 99-percent olefin-free. Dilute 1.0 milliliter of
n-hexadecane to 25 milliliters with isooctane and determine the
absorbance in a 5-centimeter cell compared to isooctane as reference
point between 280 m -400 m . The absorbance per centimeter path length
shall not exceed 0.00 in this range. Purify, if necessary, by
percolation through activated silica gel or by distillation.
Methyl alcohol, A.C.S. reagent grade. Use 10.0 milliliters of methyl
alcohol. Purify, if necessary, by distillation.
Dimethyl sulfoxide. Spectrophotometric grade (Crown Zellerbach
Corporation, Camas, Washington, or equivalent). Absorbance
(1-centimeter cell, distilled water reference, sample completely
saturated with nitrogen).
There shall be no irregularities in the absorbance curve within these
wavelengths.
Phosphoric acid. 85 percent A.C.S. reagent grade.
Sodium borohydride. 98 percent.
Magnesium oxide (Sea Sorb 43, Food Machinery Company, Westvaco
Division, distributed by chemical supply firms, or equivalent). Place
100 grams of the magnesium oxide in a large beaker, add 700 milliliters
of distilled water to make a thin slurry, and heat on a steam bath for
30 minutes with intermittent stirring. Stir well initially to insure
that all the adsorbent is completely wetted. Using a Buchner funnel and
a filter paper (Schleicher & Schuell No. 597, or equivalent) of
suitable diameter, filter with suction. Continue suction until water no
longer drips from the funnel. Transfer the adsorbent to a glass trough
lined with aluminum foil (free from rolling oil). Break up the magnesia
with a clean spatula and spread out the adsorbent on the aluminum foil
in a layer about 1 centimeter to 2 centimeters thick. Dry for 24 hours
at 160 C 1 C. Pulverize the magnesia with mortar and pestle. Sieve
the pulverized adsorbent between 60-180 mesh. Use the magnesia retained
on the 180-mesh sieve.
Celite 545. Johns Mansville Company, diatomaceous earth, or
equivalent.
Magnesium oxide-Celite 545 mixture (2+1) by weight. Place the
magnesium oxide (60-180 mesh) and the Celite 545 in 2 to 1 proportions,
respectively, by weight in a glass-stoppered flask large enough for
adequate mixing. Shake vigorously for 10 minutes. Transfer the mixture
to a glass trough lined with aluminum foil (free from rolling oil) and
spread it out on a layer about 1 centimeter to 2 centimeters thick.
Reheat the mixture at 160 C 1 C for 2 hours, and store in a tightly
closed flask.
Sodium sulfate, anhydrous, A.C.S. reagent grade, preferably in
granular form. For each bottle of sodium sulfate reagent used,
establish as follows the necessary sodium sulfate prewash to provide
such filters required in the method: Place approximately 35 grams of
anhydrous sodium sulfate in a 30-milliliter course, fritted-glass funnel
or in a 65-millimeter filter funnel with glass wool plug; wash with
successive 15-milliliter portions of the indicated solvent until a
15-milliliter portion of the wash shows 0.00 absorbance per centimeter
path length between 280 m and 400 m when tested as prescribed under
''Organic solvents.'' Usually three portions of wash solvent are
sufficient.
Before proceeding with analysis of a sample, determine the absorbance
in a 5-centimeter path cell between 250 millimicrons and 400
millimicrons for the reagent blank by carrying out the procedure,
without an oil sample, recording the spectra after the extraction stage
and after the complete procedure as prescribed. The absorbance per
centimeter pathlength following the extraction stage should not exceed
0.02 in the wavelength range from 280 m to 400 m ; the absorbance per
centimeter pathlength following the complete procedure should not exceed
0.02 in the wavelength range from 280 m to 400 m . If in either
spectrum the characteristic benzene peaks in the 250 m -260 m region
are present, remove the benzene by the procedure under ''Organic
solvents'' and record absorbance again.
Place 300 milliliters of dimethyl sulfoxide in a 1-liter separatory
funnel and add 75 milliliters of phosphoric acid. Mix the contents of
the funnel and allow to stand for 10 minutes. (The reaction between the
sulfoxide and the acid is exothermic. Release pressure after mixing,
then keep funnel stoppered.) Add 150 milliliters of isooctane and shake
to pre-equilibrate the solvents. Draw off the individual layers and
store in glass-stoppered flasks.
Weigh a 20-gram sample of the oil and transfer to a 500-milliliter
separatory funnel containing 100 milliliters of pre-equilibrated
sulfoxide-phosphoric acid mixture. Complete the transfer of the sample
with small portions of preequilibrated isooctane to give a total volume
of the oil and solvent of 75 milliliters. Shake the funnel vigorously
for 2 minutes. Set up three 250-milliliter separatory funnels with each
containing 30 milliliters of pre-equilibrated isooctane. After
separation of liquid phases, carefully draw off lower layer into the
first 250-milliliter separatory funnel and wash in tandem with the
30-milliliter portions of isooctane contained in the 250-milliliter
separatory funnels. Shaking time for each wash is 1 minute. Repeat the
extraction operation with two additional portions of the sulfoxide-acid
mixture and wash each extractive in tandem through the same three
portions of isooctane.
Collect the successive extractives (300 milliliters total) in a
separatory funnel (preferably 2-liter) containing 480 milliliters of
distilled water; mix, and allow to cool for a few minutes after the
last extractive has been added. Add 80 milliliters of isooctane to the
solution and extract by shaking the funnel vigorously for 2 minutes.
Draw off the lower aqueous layer into a second separatory funnel
(preferably 2-liter) and repeat the extraction with 80 milliliters of
isooctane. Draw off and discard the aqueous layer. Wash each of the
80-milliliter extractives three times with 100-milliliter portions of
distilled water. Shaking time for each wash is 1 minute. Discard the
aqueous layers. Filter the first extractive through anhydrous sodium
sulfate prewashed with isooctane (see Sodium sulfate under ''Reagents
and Materials'' for preparation of filter) into a 250-milliliter
Erlenmeyer flask (or optionally into the evaporation flask). Wash the
first separatory funnel with the second 80-milliliter isooctane
extractive and pass through the sodium sulfate. Then wash the second
and first separatory funnels successively with a 20-milliliter portion
of isooctane and pass the solvent through the sodium sulfate into the
flask. Add 1 milliliter of n-hexadecane and evaporate the isooctane on
the steam bath under nitrogen. Discontinue evaporation when not over 1
milliliter of residue remains. To the residue, add a 10-milliliter
portion of isooctane, reevaporate to 1 milliliter of hexadecane, and
repeat this operation once.
Quantitatively transfer the residue with isooctane to a
200-milliliter volumetric flask, make to volume, and mix. Determine the
absorbance of the solution in the 1-centimeter pathlength cells compared
to isooctane as reference between 280 m -400 m (take care to lose none
of the solution in filling the sample cell). Correct the absorbance
values for any absorbance derived from reagents as determined by
carrying out the procedure without an oil sample. If the corrected
absorbance does not exceed the limits prescribed in this paragraph, the
oil meets the ultraviolet absorbance specifications. If the corrected
absorbance per centimeter pathlength exceeds the limits prescribed in
this paragraph, proceed as follows: Quantitatively transfer the
isooctane solution to a 125-milliliter flask equipped with 24/40 joint,
and evaporate the isooctane on the steam bath under a stream of nitrogen
to a volume of 1 milliliter of hexadecane. Add 10 milliliters of methyl
alcohol and approximately 0.3 gram of sodium borohydride. (Minimize
exposure of the borohydride to the atmosphere. A measuring dipper may be
used.) Immediately fit a water-cooled condenser equipped with a 24/40
joint and with a drying tube into the flask, mix until the borohydride
is dissolved, and allow to stand for 30 minutes at room temperature,
with intermittent swirling. At the end of this period, disconnect the
flask and evaporate the methyl alcohol on the steam bath under nitrogen
until the sodium borohydride begins to come out of the solution. Then
add 10 milliliters of isooctane and evaporate to a volume of about 2-3
milliliters. Again, add 10 milliliters of isooctane and concentrate to
a volume of approximately 5 milliliters. Swirl the flask repeatedly to
assure adequate washing of the sodium borohydride residues.
Fit the tetrafluoroethylene polymer disc on the upper part of the
stem of the chromatographic tube, then place the tube with the disc on
the suction flask and apply the vacuum (approximately 135 millimeters Hg
pressure). Weigh out 14 grams of the 2:1 magnesium oxide-Celite 545
mixture and pour the adsorbent mixture into the chromatographic tube in
approximately 3-centimeter layers. After the addition of each layer,
level off the top of the adsorbent with a flat glass rod or metal
plunger by pressing down firmly until the adsorbent is well packed.
Loosen the topmost few millimeters of each adsorbent layer with the end
of a metal rod before the addition of the next layer. Continue packing
in this manner until all the 14 grams of the adsorbent is added to the
tube. Level off the top of the adsorbent by pressing down firmly with a
flat glass rod or metal plunger to make the depth of the adsorbent bed
approximately 12.5 centimeters in depth. Turn off the vacuum and remove
the suction flask. Fit the 500-milliliter reservoir onto the top of the
chromatographic column and prewet the column by passing 100 milliliters
of isooctane through the column. Adjust the nitrogen pressure so that
the rate of descent of the isooctane coming off the column is between
2-3 milliliters per minute. Discontinue pressure just before the last
of the isooctane reaches the level of the adsorbent. (Caution: Do not
allow the liquid level to recede below the adsorbent level at any time.)
Remove the reservoir and decant the 5-milliliter isooctane concentrate
solution onto the column and with slight pressure again allow the liquid
level to recede to barely above the adsorbent level. Rapidly complete
the transfer similarly with two 5-milliliter portions of isooctane,
swirling the flask repeatedly each time to assure adequate washing of
the residue. Just before the final 5-milliliter wash reaches the top of
the adsorbent, add 100 milliliters of isooctane to the reservoir and
continue the percolation at the 2-3 milliliters per minute rate. Just
before the last of the isooctane reaches the adsorbent level, add 100
milliliters of 10 percent benzene in isooctane to the reservoir and
continue the percolation at the aforementioned rate. Just before the
solvent mixture reaches adsorbent level, add 25 milliliters of 20
percent benzene in isooctane to the reservoir and continue the
percolation at 2-3 milliliters per minute until all this solvent mixture
has been removed from the column. Discard all the elution solvents
collected up to this point. Add 300 milliliters of the
acetone-benzene-water mixture to the reservoir and percolate through the
column to eluate the polynuclear compounds. Collect the eluate in a
clean 1-liter separatory funnel. Allow the column to drain until most
of the solvent mixture is removed. Wash the eluate three times with
300-milliliter portions of distilled water, shaking well for each wash.
(The addition of small amounts of sodium chloride facilitates
separation.) Discard the aqueous layer after each wash. After the final
separation, filter the residual benzene through anhydrous sodium sulfate
pre-washed with benzene (see Sodium sulfate under ''Reagents and
Materials'' for preparation of filter) into a 250-milliliter Erlenmeyer
flask (or optionally into the evaporation flask). Wash the separatory
funnel with two additional 20-milliliter portions of benzene which are
also filtered through the sodium sulfate. Add 1 milliliter of
n-hexadecane and completely remove the benzene by evaporation under
nitrogen, using the special procedure to eliminate benzene as previously
described under ''Organic solvents.'' Quantitatively transfer the
residue with isooctane to a 200-milliliter volumetric flask and adjust
to volume. Determine the absorbance of the solution in the 1-centimeter
pathlength cells compared to isooctane as reference between 250 m -400 m
. Correct for any absorbance derived from the reagents as determined by
carrying out the procedure without an oil sample. If either spectrum
shows the characteristic benzene peaks in the 250 m -260 m region,
evaporate the solution to remove benzene by the procedure under
''Organic solvents.'' Dissolve the residue, transfer quantitatively, and
adjust to volume in isooctane in a 200-milliliter volumetric flask.
Record the absorbance again. If the corrected absorbance does not
exceed the limits proposed in this paragraph, the oil meets the proposed
ultraviolet absorbance specifications.
(d) Mineral oil identified in paragraph (d)(1) of this section may be
used as provided in paragraph (d)(2) of this section.
(1) The mineral oil consists of virgin petroleum distillates refined
to meet the following specifications:
(i) Distillation endpoint at 760 millimeters pressure not to exceed
371 C, with a maximum residue not to exceed 2 percent, as determined by
ASTM method D86-82, ''Standard Method for Distillation of Petroleum
Products,'' which is incorporated by reference. The availability of
this incorporation by reference is given in paragraph (b)(1)(i) of this
section.
(ii) Ultraviolet absorbance limits as follows as determined by the
method described in paragraph (d)(3) of this section.
(iii) Pyrene content not to exceed a maximum of 25 parts per million
as determined by the method described in paragraph (d)(3) of this
section.
(2) The mineral oil may be used only in the processing of jute fiber
employed in the production of textile bags intended for use in contact
with the following types of food: Dry grains and dry seeds (for
example, beans, peas, rice, and lentils); whole root crop vegetables of
the types identified in 40 CFR 180.34(f); unshelled and shelled nuts
(including peanuts); and dry animal feed. The finished processed jute
fiber shall contain no more than 6 percent by weight of residual mineral
oil.
(3) The analytical method for determining ultraviolet absorbance
limits and pyrene content is as follows:
I. Apparatus. A. Assorted beakers, separatory funnels fitted with
tetrafluoroethylene polymer stopcocks, and graduated cylinders.
B. Volumetric flasks, 200-milliliter.
C. A chromatographic column made from nominal 1.3 centimeters outside
diameter x 75 centimeters glass tubing tapered at one end and joined to
a 2-millimeter-bore tetrafluoroethylene polymer stopcock. The opposite
end is flanged and joined to a female 24/40 standard taper fitting.
This provides for accommodating the 500-milliliter reservoir described
in item I.E below.
D. A chromatographic column made from nominal 1.7 centimeters outside
diameter x 115 centimeters glass tubing tapered at one end and joined to
a 2-millimeter-bore tetrafluoroethylene polymer stopcock. The opposite
end is flanged and joined to a 2.5 centimeters outside diameter x 9.0
centimeters glass tube having a female 24/40 standard taper fitting.
This provides for accommodating the 500-milliliter reservoir described
in item I. E below.
E. A 500-milliliter reservoir having a 24/40 standard taper male
fitting at bottom and a suitable ball joint at the top for connecting to
the nitrogen supply. The female fitting of the chromatographic columns
described in items I. C and D above and the male fitting of the
reservoir described in this item E should both be equipped with glass
hooks.
(Note: Rubber stoppers are not to be used. Stopcock grease is not to
be used on ground-glass joints in this method.)
F. A spectrophotometer equipped to automatically record absorbance of
liquid samples in 1-centimeter pathlength cells in the spectral region
of 280-400 m with a spectral slit width of 2 m or less. At an
absorbance level of about 0.4, absorbance measurements shall be
repeatable within 0.01 and accurate within 0.05. Wavelength
measurements shall be repeatable with 0.2 m and accurate within 1.0 m
. Instrument operating conditions are selected to realize this
performance under dynamic (automatic) recording operations. Accuracy of
absorbance measurements are determined at 290, 345, and 400 m , using
potassium chromate as the reference standard. (National Bureau of
Standards Circular 484, Spectrophotometry, U.S. Department of Commerce,
1949.)
G. Two fused quartz cells having pathlengths of 1.00 0.005 centimeter
or better.
II. Purity of reagents and materials. Reagent-grade chemicals shall
be used in all tests. It is further specified that each chemical shall
be tested for purity in accordance with the instruction given under
''Reagents and Materials'' in III below. In addition, a blank run by
the procedure shall be made on each purified lot of reagents and
materials. Unless otherwise indicated, references to water shall be
understood to mean distilled water.
III. Reagents and materials -- A. Organic solvents. All solvents
used throughout the procedure shall meet the specifications and tests
described in this section III. The isooctane, benzene, cyclohexane,
nitromethane, and n-hexadecane designated shall pass the following test:
To the specified quantity of solvent in a 150-milliliter beaker, add 1
milliliter of purified n-hexadecane and evaporate on the steam bath
under a stream of nitrogen. Discontinue evaporation when not over 1
milliliter of residue remains (to the residue from benzene and
nitromethane add a 10-milliliter portion of purified isooctane,
re-evaporate, and repeat once to insure complete removal of solvent).
Dissolve the 1 milliliter of n-hexadecane residue in isooctane and make
to 10-milliliter volume. Determine the absorbance in 1.0-centimeter
pathlength cells compared to water as reference. The absorbance of the
solution of solvent residue shall not exceed 0.05 between 280 and 400 m
.
1. Isooctane (2,2,4-trimethylpentane). Use 240 milliliters for the
above test. Purify, if necessary, by passage through a column of
activated silica gel.
2. Benzene. Use 200 milliliters for the above test. Purify, if
necessary, by distillation or otherwise.
3. Cyclohexane. Use 70 milliliters for the above test. Purify, if
necessary, by distillation, silica gel percolation, or otherwise.
4. Nitromethane. Use 125 milliliters for the above test. Purify, if
necessary, by distillation or otherwise.
5. n-Hexadecane. Determine the absorbance on this solvent directly.
Purify, if necessary, by silica gel percolation or otherwise.
B. Other materials -- 1. Pyrene standard reference. Pyrene, reagent
grade, melting point range 150-152 C. (Organic Chemical 3627, Eastman
Kodak Co., Rochester, N.Y., or equivalent). The standard reference
absorbance is the absorbance at 334 millimicrons of a standard reference
solution of pyrene containing a concentration of 1.0 milligram per liter
in purified isooctane measured against isooctane of the same spectral
purity in 1.0-centimeter cells. (This absorbance will be approximately
0.28.)
2. Chrysene solution. Prepare a solution at a concentration of 5.0
milligrams per liter by dissolving 5.0 milligrams of chrysene in
purified isooctane in a 1-liter volumetric flask. Adjust to volume with
isooctane.
3. Nitrogen gas. Water pumped or equivalent purity, cylinder with
regulator, and valve control flow at 5 p.s.i.
4. Silica gel. 100-200 mesh (Davison Chemical, Baltimore, Md., Grade
923, or equivalent), purified and activated by the following procedure:
Place about 1 kilogram of silica gel in a large column and wash with
contaminant-free benzene until a 200-milliliter sample of the benzene
coming off the column will pass the ultraviolet absorption test for
benzene. This test is performed as stipulated under ''Organic
solvents'' in A under III above. When the silica gel has been
sufficiently cleaned, activate the gel before use by placing the
1-kilogram batch in a shallow container in a layer no greater than 1
inch in depth and heating in an oven (Caution! Explosion Hazard) at 130
C. for 16 hours, and store in a vacuum desiccator. Reheating about
once a week is necessary if the silica gel is repeatedly removed from
the desiccator.
5. Aluminum oxide (Aluminum Co. of America, Grade F-20, or equivalent
grade). 80-200 mesh, purified and activated by the following procedure:
Place about 1 kilogram of aluminum oxide in a large column and wash
with contaminant-free benzene until a 200-milliliter sample of the
benzene coming off the column will pass the ultraviolet absorption test
for benzene. This test is performed as stipulated under ''Organic
solvents'' in A under III above. (Caution! Remove Benzene From
Adsorbent Under Vacuum To Minimize Explosion Hazard in Subsequent
Heating!) When the aluminum oxide has been sufficiently cleaned and
freed of solvent, activate it before use by placing the 1-kilogram batch
in a shallow container in a layer no greater than 1 inch in depth. Heat
in an oven at 130 C for 16 hours. Upon removal from heat, store at
atmospheric pressure over 80 percent (by weight) sulfuric acid in a
desiccator for at least 36 hours before use. This gives aluminum oxide
with between 6 to 9.5 percent volatiles. This is determined by heating
a weighed sample of the prepared aluminum oxide at 2,000 F for 2 hours
and then quickly reweighing. To insure the proper adsorptive properties
of the aluminum oxide, perform the following test:
a. Weigh 50 grams 1 gram of the activated aluminum oxide and pack
into the chromatographic column (1.3 centimeters x 75 centimeters)
described under ''Apparatus'' in C under I above. Use glass wool at the
column exit to prevent the aluminum oxide from passing through the
column.
b. Place a 250-milliliter graduated cylinder under the column to
measure the amount of eluate coming from the column.
c. Prewet the aluminum oxide by passing 40 milliliters of isooctane
through the column. Adjust the nitrogen pressure so that the rate of
descent of the isooctane coming off the column is between 1.5 to 2.5
milliliters per minute.
d. Just prior to the last of the isooctane reaching the top of the
aluminum oxide bed, add 10 milliliters of the isooctane solution
containing 5.0 milligrams of chrysene per liter.
e. Continue percolation until the isooctane is just above the
aluminum oxide. Then add 200 milliliters of a mixture of benzene and
isooctane (33 1/3 percent benzene and 66 2/3 percent isooctane by
volume) to the reservoir and continue percolation.
f. Continue percolation, collecting the eluates (40 milliliters of
the prewet solution, 10 milliliters of the sample solution, and 200
milliliters of the gradient solution) in the 250-milliliter graduated
cylinder until the level of the gradient solution is just above the
aluminum oxide. Add 200 milliliters of the eluting solution of benzene
and isooctane (90 percent benzene and 10 percent isooctane by volume) to
the column and continue collecting until a total of 250 milliliters of
solution has been obtained. This may be discarded. Now begin to
collect the final eluate.
g. Place a 100-milliliter graduated cylinder under the column and
continue the percolation until a 100-milliliter eluate has been
obtained.
h. Measure the amount of chrysene in this 100-milliliter fraction by
ultraviolet analysis. If the aluminum oxide is satisfactory, more than
80 percent of the original amount of chrysene should be found in this
fraction. (Note: If the amount of chrysene recovered is less than 80
percent, the original batch of aluminum oxide should be sieved between
100-160 mesh. Activation and testing of this sieved batch should
indicate a satisfactory aluminum oxide for use.)
IV. Sampling. Precautions must be taken to insure that an
uncontaminated sample of the mineral oil is obtained since ultraviolet
absorption is very sensitive to small amounts of extraneous material
contaminating the sample through careless handling.
V. Procedure. A. Blank. Before proceeding with the analysis of a
sample, determine the absorbance of the solvent residues by carrying out
the procedure without a sample.
B. Sample. 1. Weigh out 20.0 grams 0.1 gram of the mineral oil into
a beaker and transfer to a 250-milliliter separatory funnel fitted with
a tetrafluoroethylene polymer stopcock, using enough cyclohexane (25
milliliters) to give a final total volume of 50 milliliters (mineral oil
plus cyclohexane).
2. Add 25 milliliters of nitromethane saturated with cyclohexane and
shake by hand vigorously for 3 minutes. Recover the lower nitromethane
layer in a 150-milliliter beaker containing 1 milliliter of n-hexadecane
and evaporate on the steam bath under nitrogen. Repeat the extraction
four more times, recovering each extract in the 150-milliliter beaker.
Exercise care not to fill the beaker to such a capacity that solvent
losses may occur. Evaporate the combined nitromethane extracts to 1
milliliter of n-hexadecane residue containing the nitromethane-soluble
mineral oil extractives. (Note: Complete removal of the nitromethane
is essential. This can be assured by two successive additions of 5
milliliters of isooctane and reevaporation.)
3. Remove the beaker from the steam bath and allow to cool.
4. Weigh 50 grams 1 gram of activated aluminum oxide and pack into
the chromatographic column (1.3 centimeters x 75 centimeters) described
under ''Apparatus'' in C under I above. (Note: A small plug of glass
wool is placed at the column exit to prevent the aluminum oxide from
passing through the column. After adding aluminum oxide, tap the column
lightly to remove air voids. All percolations using aluminum oxide are
performed under nitrogen pressure. The 500-milliliter reservoir
described under ''Apparatus'' in E under I above is to be used to hold
the elution solvents.)
5. Prewet the column by adding 40 milliliters of isooctane to the
column. Adjust nitrogen pressure so that rate of descent of the
isooctane coming off the column is 2.0 to 3.0 milliliters per minute.
Be careful to maintain the level of solvent in the reservoir to prevent
air from entering the aluminum oxide bed. New or additional solvent is
added just before the last portion of the previous solvent enters the
bed. To minimize possible photo-oxidation effects, the following
procedures (steps 6 through 18) shall be carried out in subdued light.
6. Before the last of the isooctane reaches the top of the aluminum
oxide bed, release the nitrogen pressure and turn off the stopcock on
the column. Transfer the n-hexadecane residue from the 150-milliliter
beaker from procedure step 3 above onto the column, using several washes
of isooctane (total volume of washes should be no greater than 10-15
milliliters).
7. Open the stopcock and continue percolation until the isooctane is
about 1 centimeter above the top of the aluminum oxide bed. Add 200
milliliters of isooctane to the reservoir, and continue the percolation
at the specified rate.
8. Just before the isooctane surface reaches the top of the aluminum
oxide bed, add 200 milliliters of a mixture of benzene and isooctane (33
1/3 percent benzene and 66 2/3 percent isooctane by volume) to the
reservoir, and continue the percolation.
9. Just before the surface of this mixture reaches the top of the
aluminum oxide bed, release the nitrogen pressure, turn off the
stopcock, and discard all the elution solvents collected up to this
point.
10. Add to the reservoir 300 milliliters of a mixture of benzene and
isooctane (90 percent benzene and 10 percent isooctane by volume), place
a 25-milliliter graduated cylinder under the column, continue the
percolation until 20 milliliters of eluate has been collected, and then
discard the eluate.
11. At this point, place a clean 250-milliliter Erlenmeyer flask
under the column. Continue the percolation and collect all the
remaining eluate.
(Note: Allow the column to drain completely. An increase in the
nitrogen pressure may be necessary as the last of the solvent comes off
the column.)
12. Place 1 milliliter of n-hexadecane into a 150-milliliter beaker.
Place this onto a steam bath under a nitrogen stream and transfer in
small portions the eluate from step 11 above. Wash out the Erlenmeyer
flask with small amounts of benzene and transfer to the evaporation
beaker. Evaporate until only 1 milliliter of hexadecane residue
remains. (Note: Complete removal of the benzene is essential. This can
be assured by two successive additions of 5 milliliters of isooctane and
reevaporation.)
13. Remove the beaker from the steam bath and cool.
14. Place a sample of 113.5 grams activated 100- 200-mesh silica gel
in a 500-milliliter glass-stoppered Erlenmeyer flask. Add to the silica
gel 46.2 grams (41 milliliters) of nitromethane. Stopper and shake the
flask vigorously until no lumps of silica gel are observed and then
shake occasionally during a period of 1 hour. The resultant
nitromethane-treated silica gel is 29 weight-percent nitro-methane and
71 weight-percent silica gel.
15. Place a small plug of glass wool in the tapered end of the 1.7
centimeters outside diameter x 115 centimeters column, described under
''Apparatus'' in D of I above, adjacent to the stopcock to prevent
silica gel from passing through the stopcock. Pack the
nitromethane-treated silica gel into the column, tapping lightly. The
resultant silica gel bed should be about 95 centimeters in depth. Place
into a flask 170 milliliters of isooctane saturated with nitromethane.
16. Place a 100-milliliter graduated cylinder under the column and
transfer the residue from the beaker in procedure step 13 above with
several washes of the 170 milliliters of isooctane, saturated with
nitromethane, onto the top of the column. (Total volume of washes
should be no greater than 10 to 15 milliliters.) Permit isooctane
solution to enter the silica gel bed until the liquid level is at the
top bed level. Place the remaining amount of the 170 milliliters of
isooctane, saturated with nitromethane, in the reservoir above the bed
for percolation through the silica gel. Apply nitrogen pressure to the
top of the column, adjusting the pressure so that the isooctane is
collected at the rate of 2.5 to 3.5 milliliters per minute, and
percolate isooctane through the bed until a quantity of 75.0 milliliters
of eluate is collected. Discard the 75 milliliters of eluate. Turn off
the stopcock and add 250 milliliters of benzene to the reservoir above
the bed. Use a 400-milliliter beaker to collect the remaining eluate.
17. Open the stopcock, renew the pressure, and percolate the
remaining isooctane and benzene through the column eluting the remaining
aromatics. Transfer the eluate in small portions from the 400
milliliter beaker to a 150-milliliter beaker containing 1 milliliter of
n-hexadecane and evaporate on the steam bath under nitrogen. Rinse the
400-milliliter beaker well with small portions of isooctane to obtain a
complete transfer.
(Note: Complete removal of the nitromethane and benzene is
essential. This can be assured by successive additions of 5 milliliters
of isooctane and reevaporation.)
18. Transfer the residue with several washes of isooctane into a
200-milliliter volumetric flask. Add isooctane to mark.
19. Record the spectrum of the sample solution in a 1-centimeter cell
compared to isooctane from 270 to 400 m . After making necessary
corrections in the spectrum for cell differences and for the blank
absorbance, record the maximum absorbance in each of the wavelength
intervals (m ), 280-299, 300-319, 320-359, 360-400.
a. If the spectrum then shows no discernible peak corresponding to
the absorbance maximum of the pyrene reference standard solution at 334
m , the maximum absorbances in the respective wavelength intervals
recorded shall not exceed those prescribed in paragraph (d)(1)(ii) of
this section.
b. If such a peak is evident in the spectrum of the sample solution,
and the spectrum as a whole is not incompatible with that of a pyrene
contaminant yielding such a peak of the observed absorbance, calculate
the concentration of pyrene that would yield this peak (334 m) by the
base-line technique described in ASTM method E169-63 (Reapproved 1981),
''Standard Recommended Practices for General Techniques of Ultraviolet
Quantitative Analysis,'' which is incorporated by reference. The
availability of this incorporation by reference is given in paragraph
(b)(1)(i) of this section. Correct each of the maximum absorbances in
the respective specified wavelength intervals by subtracting the
absorbance due to pyrene, determined as follows:
Absorbance due to pyrene=
Where:
Cp=Calculated concentration of pyrene in sample solution;
Sp=Concentration of pyrene reference standard solution in same units
of concentration;
Sa=Absorbance of pyrene reference standard solution at wavelength of
maximum absorbance of sample solution in the respective specified
wavelength intervals.
Also calculate the pyrene content of the oil sample in parts per
million as follows:
Pyrene content (p.p.m.)=
Where:
C=Calculated concentration of pyrene in milligrams per liter of
sample solution.
c. The pyrene content so determined shall not exceed 25 p.p.m. The
maximum absorbances corrected for pyrene content as described in this
step 19 for each of the specified wavelength intervals shall not exceed
the limits prescribed in paragraph (d)(1)(ii) of this section.
d. If the spectrum as a whole of the sample solution is in any
respect clearly incompatible with the presence of pyrene as the source
of the peak at 334 m , then the maximum absorbances in the respective
wavelength intervals without correction for any assumed pyrene content
shall not exceed the limits prescribed in paragraph (d)(1)(ii) of this
section.
(42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11847, Mar. 19,
1982; 49 FR 10112, Mar. 19, 1984; 54 FR 24898, June 12, 1989)
0621As determined by procedure using potassium chromate for reference
standard and described in National Bureau of Standards Circular 484,
Spectrophotometry, U.S. Department of Commerce (1949). The accuracy is
to be determined by comparison with the standard values at 290, 345, and
400 millimicrons. Circular 484 is incorporated by reference. Copies
are available from the Division of Food and Color Additives, Center for
Food Safety and Applied Nutrition (HFF-330), 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.
21 CFR 178.3650 Odorless light petroleum hydrocarbons.
Odorless light petroleum hydrocarbons may be safely used, as a
component of nonfood articles intended for use in contact with food, in
accordance with the following prescribed conditions:
(a) The additive is a mixture of liquid hydrocarbons derived from
petroleum or synthesized from petroleum gases. The additive is chiefly
paraffinic, isoparaffinic, or naphthenic in nature.
(b) The additive meets the following specifications:
(1) Odor is faint and not kerosenic.
(2) Initial boiling point is 300 F minimum.
(3) Final boiling point is 650 F maximum.
(4) Ultraviolet absorbance limits determined by method specified in
178.3620(b)(1)(ii), as follows:
(c) The additive is used as follows:
21 CFR 178.3690 Pentaerythritol adipate-stearate.
Pentaerythritol adipate-stearate identified in paragraph (a) of this
section may be safely used as a lubricant in the fabrication of rigid
and semi-rigid polyvinyl chloride and/or vinyl chloride-propylene
copolymers complying with 177.1980 of this chapter used as articles or
components of articles that contact food, excluding food with alcohol
content greater than 8 percent under conditions of use of E, F, and G
described in Table 2 in 175.300(d) of this chapter, subject to the
provisions of this section.
(a) Identity. For the purpose of this section, pentaerythritol
adipate-stearate is an ester of pentaerythritol with stearic and adipic
acids, having 71 percent stearic acid and 14 percent adipic acid.
(b) Specifications. Pentaerythritol adipate-stearate has the
following specifications:
(1) Melting point (dropping) of 49 -52 C as determined by ASTM
method D566-76 (Reapproved 1982), ''Standard Test Method for Dropping
Point of Lubricating Grease,'' which is incorporated by reference.
Copies may be obtained from the American Society for Testing Materials,
1916 Race St., Philadelphia, PA 19103, or may be examined at the Office
of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(2) Acid value not to exceed 15 as determined by ASTM method
D1386-78, ''Standard Test Method for Saponification Number (Empirical)
of Synthetic and Natural Waxes'' (Revised 1978), which is incorporated
by reference. Copies are available from American Society for Testing
and Materials (ASTM), 1916 Race Street, Philadelphia, PA 19103, or
available for inspection at the Office of the Federal Register, 1100 L
St. NW., Washington, DC 20408.
(3) Saponification number of 270-280 as determined by ASTM method
D1387-78, ''Standard Test Method for Acid Number (Empirical) of
Synthetic and Natural Waxes'' (Revised 1978), which is incorporated by
reference. Copies are available from American Society for Testing and
Materials (ASTM), 1916 Race Street, Philadelphia, PA 19103, or available
for inspection at the Office of the Federal Register, 1100 L St. NW.,
Washington, DC 20408.
(4) Iodine number not to exceed 2 as determined by Iodine Absorption
Number, Hanus Method, of the ''Official Methods of Analysis of the
Association of Official Analytical Chemists,'' sections 28.018-28.019,
13th Ed. (1980), which is incorporated by reference. Copies may be
obtained from the Association of Official Analytical Chemists, 2200
Wilson Boulevard., Suite 400, Arlington VA 22201-3301, or may be
examined at the Office of the Federal Register, 1100 L St. NW.,
Washington, D.C. 20408.
(c) The total amount of ester (calculated as free pentaerythritol)
shall not exceed 0.4 percent by weight of the polyvinyl chloride and/or
the vinyl chloride-propylene copolymers complying with 177.1980.
(45 FR 1018, Jan. 4, 1980, as amended at 47 FR 11848, Mar. 19, 1982;
49 FR 10112, Mar. 19, 1984; 54 FR 24898, June 12, 1989)
21 CFR 178.3700 Petrolatum.
Petrolatum may be safety used as a component of nonfood articles in
contact with food, in accordance with the following conditions:
(a) Petrolatum complies with the specifications set forth in the
United States Pharmacopeia XX (1980) for white petrolatum or in the
National Formulary XV (1980) for yellow petrolatum.
(b) Petrolatum meets the following ultraviolet absorbance limits when
subjected to the analytical procedure described in 172.886(b) of this
chapter:
Ultraviolet absorbance per centimeter pathlength:
(c) It is used or intended for use as a protective coating of the
surfaces of metal or wood tanks used in fermentation process, in an
amount not in excess of that required to produce its intended effect.
(d) Petrolatum as defined by this section may be used for the
functions described and within the limitations prescribed by specific
regulations in parts 175, 176, 177, and 178 of this chapter which
prescribe uses of petrolatum. For the purpose of cross-reference, such
specific regulations include: 175.105, 175.125, 175.300, 176.170,
176.200, 176.210, 177.2600, 177.2800, and 178.3570 of this chapter.
(e) Petrolatum may contain any antioxidant permitted in food by
regulations issued pursuant to section 409 of the act, in an amount not
greater than that required to produce its intended effect.
(42 FR 14609, Mar. 15, 1977, as amended at 49 FR 10113, Mar. 19,
1984; 55 FR 12172, Apr. 2, 1990)
21 CFR 178.3710 Petroleum wax.
Petroleum wax may be safely used as a component of nonfood articles
in contact with food, in accordance with the following conditions:
(a) Petroleum wax is a mixture of solid hydrocarbons, paraffinic in
nature, derived from petroleum, and refined to meet the specifications
prescribed in this section.
(b) The petroleum wax meets the following ultraviolet absorbance
limits when subjected to the analytical procedure described in
172.886(b) of this chapter.
Ultraviolet absorbance per centimeter pathlength:
(c) Petroleum wax may contain any antioxidant permitted in food by
regulations issued in accordance with section 409 of the act, in an
amount not greater than that required to produce its intended effect.
(d) Petroleum wax may contain a total of not more than 1 weight
percent of residues of the following polymers when such residues result
from use of the polymers as processing aids (filter aids) in the
production of the petroleum wax: Homopolymers and/or copolymers derived
from one or more of the mixed n-alkyl (C12, C14, C16, and C18)
methacrylate esters where the C12 and C14 alkyl groups are derived from
coconut oil and the C16 and C18 groups are derived from tallow.
(e) Petroleum wax may contain 2-hydroxy-4-n-octoxybenzophenone as a
stabilizer at a level not to exceed 0.01 weight percent of the petroleum
wax.
(f) Petroleum wax may contain poly(alkylacrylate) (CAS Reg. No.
27029-57-8), as described in 172.886(c)(2) of this chapter, as a
processing aid in the manufacture of petroleum wax.
(42 FR 14609, Mar. 15, 1977, as amended at 51 FR 19545, May 30, 1986)
21 CFR 178.3720 Petroleum wax, synthetic.
Synthetic petroleum wax may be safely used in applications and under
the same conditions where naturally derived petroleum wax is permitted
in Subchapter B of this chapter as a component of articles intended to
contact food, provided that the synthetic petroleum wax meets the
definition and specifications prescribed in 172.888 of this chapter.
21 CFR 178.3730 Piperonyl butoxide and pyrethrins as components of
bags.
Piperonyl butoxide in combination with pyrethrins may be safely used
for insect control on bags that are intended for use in contact with
dried feed in compliance with 561.310 and 561.340 of this chapter, or
that are intended for use in contact with dried food in compliance with
193.60 and 193.390 of this chapter.
21 CFR 178.3740 Plasticizers in polymeric substances.
Subject to the provisions of this regulation, the substances listed
in paragraph (b) of this section may be safely used as plasticizers in
polymeric substances used in the manufacture of articles or components
of articles intended for use in producing, manufacturing, packing,
processing, preparing, treating, packaging, transporting, or holding
food.
(a) The quantity used shall not exceed the amount reasonably required
to accomplish the intended technical effect.
(b) List of substances:
(c) The use of the plasticizers in any polymeric substance or article
subject to any regulation in parts 174, 175, 176, 177, 178 and 179 of
this chapter must comply with any specifications and limitations
prescribed by such regulation for the finished form of the substance or
article.
(42 FR 14609, Mar. 15, 1977, as amended at 42 FR 44223, Sept. 2,
1977; 45 FR 56052, Aug. 22, 1980; 48 FR 5748, Feb. 15, 1984; 49 FR
10113, Mar. 19, 1984; 51 FR 47011, Dec. 30, 1986)
21 CFR 178.3750 Polyethylene glycol (mean molecular weight 200-9,500).
Polyethylene glycol identified in this section may be safely used as
a component of articles intended for use in contact with food, in
accordance with the following prescribed conditions:
(a) The additive is an addition polymer of ethylene oxide and water
with a mean molecular weight of 200 to 9,500.
(b) It contains no more than 0.2 percent total by weight of ethylene
and diethylene glycols if its mean molecular weight is 350 or higher and
no more than 0.5 percent total by weight of ethylene and diethylene
glycols if its mean molecular weight is below 350, when tested by the
analytical methods prescribed in 172.820(b) of this chapter.
(c) The provisions of paragraph (b) of this section are not
applicable to polyethylene glycols used in food-packaging adhesives
complying with 175.105 of this chapter.
21 CFR 178.3760 Polyethylene glycol (400) monolaurate.
Polyethylene glycol (400) monolaurate containing not more than 0.1
percent by weight of ethylene and/or diethylene glycol may be used at a
level not to exceed 0.3 percent by weight of twine as a finish on twine
to be used for tying meat provided the twine fibers are produced from
nylon resins complying with 177.1500 of this chapter.
21 CFR 178.3770 Polyhydric alcohol esters of oxidatively refined
(Gersthofen process) montan wax acids.
Polyhydric alcohol esters of oxidatively refined (Gersthofen process)
montan wax acids identified in this section may be safely used as
components of articles intended for use in contact with food in
accordance with the following prescribed conditions:
(a) The polyhydric alcohol esters identified in this paragraph may be
used as lubricants in the fabrication of vinyl chloride plastic
food-contact articles prepared from polyvinyl chloride and/or from vinyl
chloride copolymers complying with 177.1980 of this chapter. Such
esters meet the following specifications and are produced by partial
esterification of oxidatively refined (Gersthofen process) montan wax
acids by either ethylene glycol or 1,3-butanediol with or without
neutralization of unreacted carboxylic groups with calcium hydroxide:
(1) Dropping point 76 -105 C, as determined by ASTM method D566-76
(Reapproved 1982), ''Standard Test Method for Dropping Point of
Lubricating Grease,'' which is incorporated by reference. Copies may be
obtained from the American Society for Testing Materials, 1916 Race St.,
Philadelphia, PA 19103, or may be examined at the Office of the Federal
Register, 1100 L St. NW., Washington, DC 20408.
(2) Acid value 10-20, as determined by ASTM method D1386-78
(''Standard Test Method for Saponification Number (Empirical) of
Synthetic and Natural Waxes'' (Revised 1978), which is incorporated by
reference; copies are available from American Society for Testing and
Materials (ASTM), 1916 Race Street, Philadelphia, PA 19103, or available
for inspection at the Office of the Federal Register, 1100, L St. NW.,
Washington, DC 20408) using as solvent xylene-ethyl alcohol in a 2:1
ratio instead of toluene-ethyl alcohol in a 2:1 ratio.
(3) Saponification value 100-160, as determined by ASTM method
D1387-78 (''Standard Test Method for Acid Number (Empirical) of
Synthetic and Natural Waxes'' (Revised 1978), which is incorporated by
reference; copies are available from American Society for Testing and
Materials (ASTM), 1916 Race Street, Philadelphia, PA 19103, or available
for inspection at the Office of the Federal Register, 1100 L St. NW.,
Washington, DC 20408) using xylene-ethyl alcohol in a 2:1 ratio instead
of ethyl alcohol in preparation of potassium hydroxide solution.
(4) Ultraviolet absorbance limits as follows, as determined by the
analytical method described in this subparagraph:
Ultraviolet absorbance per centimeter pathlength.
Because of the sensitivity of the test, the possibility of errors
arising from contamination is great. It is of the greatest importance
that all glassware be scrupulously cleaned to remove all organic matter
such as oil, grease, detergent residues, etc. Examine all glassware,
including stoppers and stopcocks, under ultraviolet light to detect any
residual fluorescent contamination. As a precautionary measure it is
recommended practice to rinse all glassware with purified isooctane
immediately before use. No grease is to be used on stopcocks or joints.
Great care to avoid contamination of wax samples in handling and to
assure absence of any extraneous material arising from inadequate
packaging is essential. Because some of the polynuclear hydrocarbons
sought in this test are very susceptible to photo-oxidation, the entire
procedure is to be carried out under subdued light.
Separatory funnels. 250-milliliter, 500-milliliter,
1,000-milliliter, and preferably 2,000-milliliter capacity, equipped
with tetrafluoroethylene polymer stopcocks.
Reservoir. 1,000-milliliter capacity, equipped with a 24/40 standard
taper male fitting at the bottom and a suitable balljoint at the top.
Chromatographic tube. 1,200 millimeters in length, inside diameter
to be 16.5 millimeters 0.5 millimeter, equipped with a coarse,
fritted-glass disc, a tetrafluoroethylene polymer stopcock, and a female
24/40 standard tapered fitting at the opposite end. (Overall length of
the column with the female joint is 1,255 millimeters.) The female
fitting should be equipped with glass hooks.
Disc. Tetrafluoroethylene polymer 2-inch diameter disc approximately
3/16-inch thick with a hole bored in the center to closely fit the stem
of the chromatographic tube.
Heating jackets. Conical, for 500-milliliter and 1,000-milliliter
separatory funnels. (Used with variable transformer heat control.)
Suction flask. 250-milliliter or 500-milliliter filter flask.
Condenser. 24/40 joints, fitted with a drying tube, length optional.
Evaporation flasks (optional). A 250-milliliter or 500-milliliter
capacity and a 1-liter capacity all-glass flask equipped with standard
taper stopper having inlet and outlet tubes to permit passage of
nitrogen across the surface of contained liquid to be evaporated.
Vacuum distillation assembly. All glass (for purification of
dimethyl sulfoxide) 2-liter distillation flask with heating mantle;
Vigreaux vacuum-jacketed condenser (or equivalent) about 45 centimeters
in length and distilling head with separable cold finger condenser. Use
of tetrafluoroethylene polymer sleeves on the glass joints will prevent
freezing. Do not use grease on stopcocks or joints.
Oil bath. Capable of heating to 90 C.
Spectrophotometric cells. Fused quartz cells, optical pathlength in
the range 1.000 centimeter 0.005 centimeter. With distilled water in
the cells, determine any absorbance differences.
Spectrophotometer. Spectral range 250 millimicrons-400 millimicrons
with spectral slit width of 0.2 millimicron or less; under instrument
operating conditions for these absorbance measurements. The
spectrophotometer shall also meet the following performance
requirements:
Absorbance repeatability, 0.01 at 0.4 absorbance.
Absorbance accuracy,1063 0.05 at 0.4 absorbance.
Wavelength repeatability, 0.2 millimicron.
Wavelength accuracy, 1.0 millimicron.
Recording time, 50 seconds.
Time constant, 0.6 second.
Sensitivity, 30.
Ordinate scale, 90-100 percent transmission through scale.
Abscissa scale, 8X.
Nitrogen cylinder. Water-pumped or equivalent purity nitrogen in
cylinder equipped with regulator and valve to control flow at 5 p.s.i.g.
Organic solvents. All solvents used throughout the procedure shall
meet the specifications and tests described in this specification. The
isooctane and benzene designated in the list following this paragraph
shall pass the following test:
To be specified quantity of solvent in a 250-milliliter Erlenmeyer
flask, add 1 milliliter of purified n-hexadecane and evaporate on the
steam bath under a stream of nitrogen (a loose aluminum foil jacket
around the flask will speed evaporation). Discontinue evaporation when
not over 1 milliliter of residue remains. (To the residue from benzene
add a 10-milliliter portion of purified isooctane, reevaporate, and
repeat once to insure complete removal of benzene.)
Alternatively, the evaporation time can be reduced by using the
optional evaporation flask. In this case the solvent and n-hexadecane
are placed in the flask on the steam bath, the tube assembly is
inserted, and a stream of nitrogen is fed through the inlet tube while
the outlet tube is connected to a solvent trap and vacuum line in such a
way as to prevent any flow-back of condensate into the flask.
Dissolve the 1 milliliter of hexadecane residue in isooctane and make
up to 25 milliliters volume. Determine the absorbance in the
1-centimeter pathlength cells compared to isooctane as reference. The
absorbance of the solution of the solvent residue (except for methyl
alcohol) shall not exceed 0.01 per centimeter pathlength between 280 m
and 400 m .
Isooctane (2,2,4-trimethylpentane). Use 180 milliliters for the test
described in the preceding paragraph. Purify, if necessary, by passage
through a column of activated silica gel (Grade 12, Davison Chemical
Co., Baltimore, Md., or equivalent) about 90 centimeters in length and 5
centimeters to 8 centimeters in diameter.
Benzene, A.C.S. reagent grade. Use 150 milliliters for the test.
Purify, if necessary, by distillation or otherwise.
n-Hexadecane, 99 percent olefin-free. Dilute 1.0 milliliter of
n-hexadecane to 25 milliliters with isooctane and determine the
absorbance in a 1-centimeter cell compared to isooctane as reference
point between 280 m -400 m . The absorbance per centimeter pathlength
shall not exceed 0.00 in this range. If necessary, purify by filtering
through a column containing 100 grams of aluminum oxide (use same grade
as described below) in the lower half and 100 grams of activated silica
gel in the upper half keeping the column at 150 C., for a period of 15
hours or overnight. The first 100 milliliters of eluate are used.
Purification can also be accomplished by distillation.
Dimethyl sulfoxide. Pure grade, clear, water-white, m.p. 18
minimum. Dilute 120 milliliters of dimethyl sulfoxide with 240
milliliters of distilled water in a 500-milliliter separatory funnel,
mix and allow to cool for 5-10 minutes. Add 40 milliliters of isooctane
to the solution and extract by shaking the funnel vigorously for 2
minutes. Draw off the lower aqueous layer into a second 500-milliliter
separatory funnel and repeat the extraction with 40 milliliters of
isooctane. Draw off and discard the aqueous layer. Wash each of the
40-milliliter extractives three times with 50-milliliter portions of
distilled water. Shaking time for each wash is 1 minute. Discard the
aqueous layers. Filter the first extractive through anhydrous sodium
sulfate prewashed with isooctane (see Sodium sulfate under ''Reagents
and materials'' for preparation of filter), into a 250-milliliter
Erlenmeyer flask, or optionally into the evaporating flask. Wash the
first separatory funnel with the second 40-milliliter isooctane
extractive, and pass through the sodium sulfate into the flask. Then
wash the second and first separatory funnels successively with a
10-milliliter portion of isooctane, and pass the solvent through the
sodium sulfate into the flask. Add 1 milliliter of n-hexadecane and
evaporate the isooctane on the steam bath under nitrogen. Discontinue
evaporation when not over 1 milliliter of residue remains. To the
residue, add a 10-milliliter portion of isooctane and reevaporate to 1
milliliter of hexadecane. Again, add 10 milliliters of isooctane to the
residue and evaporate to 1 milliliter of hexadecane to insure complete
removal of all volatile materials. Dissolve the 1 milliliter of
hexadecane in isooctane and make to 25-milliliter volume. Determine the
absorbance in 1-centimeter pathlength cells compared to isooctane as
reference. The absorbance of the solution should not exceed 0.02 per
centimeter pathlength in the 280 m -400 m range. (Note: Difficulty in
meeting this absorbance specification may be due to organic impurities
in the distilled water. Repetition of the test omitting the dimethyl
sulfoxide will disclose their presence. If necessary to meet the
specification, purify the water by redistillation, passage through an
ion-exchange resin, or otherwise.)
Purify, if necessary, by the following procedure: To 1,500
milliliters of dimethyl sulfoxide in a 2-liter glass-stoppered flask,
add 6.0 milliliters of phosphoric acid and 50 grams of Norit A
(decolorizing carbon, alkaline) or equivalent. Stopper the flask, and
with the use of a magnetic stirrer (tetrafluoroethylene polymer coated
bar) stir the solvent for 15 minutes. Filter the dimethyl sulfoxide
through four thicknesses of fluted paper (18.5 centimeters, Schleicher &
Schuell, No. 597, or equivalent). If the initial filtrate contains
carbon fines, refilter through the same filter until a clear filtrate is
obtained. Protect the sulfoxide from air and moisture during this
operation by covering the solvent in the funnel and collection flask
with a layer of isooctane. Transfer the filtrate to a 2-liter
separatory funnel and draw off the dimethyl sulfoxide into the 2-liter
distillation flask of the vacuum distillation assembly and distill at
approximately 3-millimeter Hg pressure or less. Discard the first
200-milliliter fraction of the distillate and replace the distillate
collection flask with a clean one. Continue the distillation until
approximately 1 liter of the sulfoxide has been collected.
At completion of the distillation, the reagent should be stored in
glass-stoppered bottles since it is very hygroscopic and will react with
some metal containers in the presence of air.
Phosphoric acid. 85 percent A.C.S. reagent grade.
Aluminum oxide (80-200 mesh Woelm neutral activity grade 1
(Brockmann), Alupharm Chemicals, New Orleans, La., or equivalent).
Pipette 1 milliliter of distilled water into a dry 250-milliliter
Erlenmeyer flask equipped with a ground-glass stopper. Stopper the
flask and rotate it in such a manner as to completely wet out the inside
surfaces. When this has been done add 180 grams of the aluminum oxide
and shake until no lumps or wet spots remain. Allow to stand at room
temperature for a period of 2 hours. At the end of this time the water
should be evenly distributed throughout the aluminum oxide powder, and
it should have the same free flowing properties as the original material
(flow velocity with water 0.2 milliliter per minute). At this point the
aluminum oxide has an activity of 1 as expressed in Brockmann degrees,
and the amount of added water is 0.5 percent by volume. This product is
used in toto and as is, without further screening.
Sodium sulfate, anhydrous, A.C.S. reagent grade, preferably in
granular form. For each bottle of sodium sulfate reagent used,
establish as follows the necessary sodium sulfate prewash to provide
such filters required in the method: Place approximately 35 grams of
anhydrous sodium sulfate in a 30-milliliter coarse, fritted-glass funnel
or in a 65-millimeter filter funnel with glass wool plug; wash with
successive 15-milliliter portions of the indicated solvent until a
15-milliliter portion of the wash shows 0.00 absorbance per centimeter
pathlength between 280 m and 400 m when tested as prescribed under
''Organic solvents.'' Usually three portions of wash solvent are
sufficient.
Before proceeding with analysis of a sample, determine the absorbance
in a 1-centimeter path cell between 250 m and 400 m for the reagent
blank by carrying out the procedure, without a wax sample, at room
temperature, recording the spectrum after the complete procedure as
prescribed. The absorbance per centimeter pathlength following the
complete procedure should not exceed 0.04 in the wavelength range from
280 m to 299 m , inclusive, nor 0.02 in the wavelength range from 300 m
to 400 m . If in either spectrum the characteristic benzene peaks in
the 250 m -260 m region are present, remove the benzene by the
procedure under ''Organic solvents'' and record absorbance again. Place
300 milliliters of dimethyl sulfoxide in a 1-liter separatory funnel and
add 75 milliliters of phosphoric acid. Mix the contents of the funnel
and allow to stand for 10 minutes. (The reaction between the sulfoxide
and the acid is exothermic. Release pressure after mixing, then keep
funnel stoppered.) Add 150 milliliters of isooctane and shake to
preequilibrate the solvents. Draw off the individual layers and store
in glass-stoppered flasks.
In a 1-liter separatory funnel place a representative 25-gram sample
of wax, add 50 milliliters of isooctane, heat gently, stir until the wax
is in solution; add 100 milliliters of preequilibrated
sulfoxide-phosphoric acid mixture and shake, making sure it remains in
solution. If the wax comes out of solution during these operations, let
the stoppered funnel remain in the jacket until the wax redissolves.
(Remove stopper from the funnel at intervals to release pressure.) When
the wax is in solution, remove the funnel from the jacket and shake it
vigorously for 2 minutes. Set up three 250-milliliter separatory
funnels with each containing 30 milliliters of preequilibrated
isooctane. After separation of the liquid phases, allow to cool until
the main portion of the wax-isooctane solution begins to show a
precipitate. Gently swirl the funnel when precipitation first occurs on
the inside surface of the funnel to accelerate this process. Carefully
draw off the lower layer, filter it slowly through a thin layer of glass
wool fitted loosely in a filter funnel into the first 250-milliliter
separatory funnel, and wash in tandem with the 30-milliliter portions of
isooctane contained in the 250-milliliter separatory funnels. Shaking
time for each wash is 1 minute. Repeat the extraction operation with
two additional portions of the sulfoxide-acid mixture, replacing the
funnel in the jacket after each extraction to keep the wax in solution
and washing each extractive in tandem through the same three portions of
isooctane.
Collect the successive extractives (300 milliliters total) in a
separatory funnel (preferably 2-liter), containing 480 milliliters of
distilled water, mix, and allow to cool for a few minutes after the last
extractive has been added. Add 80 milliliters of isooctane to the
solution and extract by shaking the funnel vigorously for 2 minutes.
Draw off the lower aqueous layer into a second separatory funnel
(preferably 2-liter) and repeat the extraction with 80 milliliters of
isooctane. Draw off and discard the aqueous layer. Wash each of the
80-milliliter extractives three times with 100-milliliter portions of
distilled water. Shaking time for each wash is 1 minute. Discard the
aqueous layers. Filter the first extractive through anhydrous sodium
sulfate prewashed with isooctane (see Sodium sulfate under ''Reagents
and Materials'' for preparation of filter) into a 250-milliliter
Erlenmeyer flask (or optionally into the evaporation flask). Wash the
first separatory funnel with the second 80-milliliter isooctane
extractive and pass through the sodium sulfate. Then wash the second
and first separatory funnels successively with a 20-milliliter portion
of isooctane and pass the solvent through the sodium sulfate into the
flask. Add 1 milliliter of n-hexadecane and evaporate the isooctane
using an aspirator vacuum under nitrogen and in an oil bath temperature
of approximately 90 C. Discontinue evaporation when not over 1
milliliter of residue remains. To the residue, add a 10-milliliter
portion of isooctane, reevaporate to 1 milliliter of hexadecane, and
repeat this operation once.
Reserve the residue for column chromatography on the aluminum oxide.
Fit the tetrafluoroethylene polymer disc on the upper part of the stem
of the chromatographic tube, then place the tube with the disc on the
suction flask and apply the vacuum (approximately 135 millimeters Hg
pressure). Weigh out 180 grams of the aluminum oxide and pour the
adsorbent mixture into the chromatographic tube in approximately
30-centimeter layers. After the addition of each layer, level off the
top of the adsorbent with a flat glass rod or metal plunger by pressing
down firmly until the adsorbent is well packed. Loosen the topmost few
millimeters of each adsorbent layer with the end of a metal rod before
the addition of the next layer. Continue packing in this manner until
all the 180 grams of the adsorbent is added to the tube. Level off the
top of the adsorbent by pressing down firmly with a flat glass rod or
metal plunger to make the depth of the adsorbent bed approximately 80
centimeters in depth. Turn off the vacuum and remove the suction flask.
Dissolve the hexadecane residue in 10 milliliters of warm benzene and
decant the solution onto the column and allow the liquid level to recede
to barely above the adsorbent level. Rapidly complete the transfer
similarly with two 10-milliliter portions of benzene swirling the flask
repeatedly each time to assure adequate washing of the residue. Fix the
1,000-milliliter reservoir onto the top of the chromatographic column.
Just before the final 10-milliliter wash reaches the top of the
adsorbent, add 670 milliliters of benzene to the reservoir and continue
the percolation at the 2-3 milliliter per minute rate until a total of
670 milliliters of benzene has been utilized. Collect the eluate in a
clean 1-liter Erlenmeyer flask (or optionally into a 1-liter evaporation
flask). Allow the column to drain until most of the solvent mixture is
removed. Add 1 milliliter of n-hexadecane and completely remove the
benzene by evaporation under nitrogen, using the special procedure to
eliminate benzene as previously described under ''Organic Solvents.''
Quantitatively transfer the residue with isooctane to a 25-milliliter
volumetric flask and adjust to volume. Determine the absorbance of the
solution in the 1-centimeter pathlength cells compared to isooctane as
reference between 250 m -400 m . Correct for any absorbance derived
from the reagents as determined by carrying out the procedure without a
wax sample. If either spectrum shows the characteristic benzene peaks
in the 250 m -260 m region, evaporate the solution to remove benzene by
the procedure under ''Organic Solvents.'' Dissolve the residue, transfer
quantitatively, and adjust to volume in isooctane in a 25-milliliter
volumetric flask. Record the absorbance again. If the corrected
absorbance does not exceed the limits prescribed in paragraph (a) of
this section, the wax meets the ultraviolet absorbance specifications.
(b) The polyhydric alcohol esters identified in this paragraph may be
used as release agents in resinous and polymeric coatings for polyolefin
films complying with 175.320 of this chapter. Such esters meet the
following specifications and are produced by partial esterification of
oxidatively refined (Gersthofen process) montan wax acids with equimolar
proportions of ethylene glycol and 1,3-butanediol:
(1) Dropping point 77 -82 C, as determined by ASTM method D566-76
(Reapproved 1982), ''Standard Test Method for Dropping Point of
Lubricating Grease,'' which is incorporated by reference. The
availability of this incorporation by reference is given in paragraph
(a)(1) of this section.
(2) Acid value 25-35, as determined by ASTM method D1386-78
(''Standard Test Method for Saponification Number (Empirical) of
Synthetic and Natural Waxes'' (Revised 1978), which is incorporated by
reference; copies are available from American Society for Testing and
Materials (ASTM), 1916 Race Street, Philadelphia, PA 19103, or available
for inspection at the Office of the Federal Register, 1100 L St. NW.,
Washington, DC 20408) using as solvent xylene-ethyl alcohol in a 2:1
ratio instead of toluene-ethyl alcohol in a 1:2 ratio.
(3) Saponification value 135-150, as determined by ASTM method
D1387-78 (''Standard Test Method for Acid Number (Empirical) of
Synthetic and Natural Waxes'' (Revised 1978), which is incorporated by
reference; copies are available from American Society for Testing and
Materials (ASTM), 1916 Race Street, Philadelphia, PA 19103, or available
for inspection at the Office of the Federal Register, 1100 L St. NW.,
Washington, DC 20408) using xylene-ethyl alcohol in a 2:1 ratio instead
of ethyl alcohol in preparation of potassium hydroxide solution.
(4) Ultraviolet absorbance limits specified in paragraph (a)(4) of
this section, as determined by the analytical method described therein.
(c) The polyhydric alcohol esters of oxidatively refined (Gersthofen
process) montan wax acids, identified in paragraph (a) or (b) of this
section, may also be used as a component of an aqueous dispersion of
vinylidene chloride copolymers, subject to the conditions described in
paragraphs (c) (1) and (2) of this section.
(1) The aqueous dispersion of the additive contains not more that 18
percent polyhydric alcohol esters of oxidatively refined (Gersthofen
process) montan wax acids, not more than 2 percent poly(oxyethylene)
(minimum 20 moles of ethylene oxide) oleyl ether (CAS Reg. No.
9005-98-2), and not more than 1 percent poly(oxyethylene) (minimum 3
moles ethylene oxide) cetyl alcohols (CAS Reg. No. 9004-95-9).
(2) The aqueous dispersion described in paragraph (c)(1) of this
section is used as an additive to aqueous dispersions of vinylidene
chloride copolymers, regulated in 175.300, 175.320, 175.360, 176.170,
176,180, and 177.1630 of this chapter, at levels not to exceed 1.5
percent (solids basis) in the finished coating.
(d) The polyhydric alcohol esters identified in this paragraph may be
used as lubricants in the fabrication of vinyl chloride plastic food
contact articles prepared from vinyl chloride polymers. Such esters
meet the following specifications and are produced by partial
esterification of oxidatively refined (Gersthofen process) montan wax
acids with glycerol followed by neutralization:
(1) Dropping point 79 to 85 C, as determined by the American Society
for Testing and Materials (ASTM), Method D-566-76 (Reapproved 1982),
''Standard Test Method for Dropping Point of Lubricating Grease,'' which
is incorporated by reference in accordance with 5 U.S.C. 552(a). The
availability of this incorporation by reference is given in paragraph
(a)(1) of this section.
(2) Acid value 20 to 30, as determined by ASTM Method D-1386-78
''Standard Test Method for Saponification Number (Empirical) of
Synthetic and Natural Waxes'' (Revised 1978) (which is incorporated by
reference in accordance with 5 U.S.C. 552(a); the availability of this
incorporation by reference is given in paragraph (a)(2) of this
section), using as a solvent xylene-ethyl alcohol in a 2:1 ratio instead
of toluene-ethyl alcohol in a 2:1 ratio.
(3) Saponification value 130-160, as determined by ASTM Method
D-1387-78 ''Standard Test Method for Acid Number (Empirical) of
Synthetic and Natural Waxes'' (Revised 1978), (which is incorporated by
reference in accordance with 5 U.S.C. 552(a); the availability of this
incorporation by reference is given in paragraph (a)(3) of this
section), using xylene-ethyl alcohol in a 2:1 ratio instead of ethyl
alcohol in the preparation of potassium hydroxide solution.
(4) Ultraviolet absorbance limits specified in paragraph (a)(4) of
this section, as determined by the analytical method described therein.
(42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11848, Mar. 19,
1982; 49 FR 10113, Mar. 19, 1984; 51 FR 33895, Sept. 24, 1986; 54 FR
24898, June 12, 1989; 55 FR 28020, July 9, 1990)
0631As determined by procedure using potassium chromate for reference
standard and described in National Bureau of Standards Circular 484,
Spectrometry, U.S. Department of Commerce (1949). The accuracy is to be
determined by comparison with the standard values at 290, 345, and 400
millimicrons. Circular 484 is incorporated by reference. Copies are
available from the Division of Food and Color Additives, Center for Food
Safety and Applied Nutrition (HFF-330), 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.
21 CFR 178.3780 Polyhydric alcohol esters of long chain monobasic
acids.
Polyhydric alcohol esters of long chain monobasic acids identified in
this section may be safely used as lubricants in the fabrication of
polyvinyl chloride and/or polyvinyl chloride copolymer articles
complying with 177.1980 of this chapter that contact food of Types I,
II, IV-B, VI-B, VII-B, and VIII identified in Table 1 in 176.170(c) of
this chapter under conditions of use E, F, and G described in Table 2 in
176.170(c) of this chapter, subject to the provisions of this section.
(a) Identity. For the purpose of this section, polyhydric alcohol
esters of long chain monobasic acids consist of polyhydric alcohol
esters having number average molecular weights in the range of 1,050 to
1,700. The esters are produced by the reaction of either ethylene
glycol or glycerol with long chain monobasic acids containing from 9 to
49 carbon atoms obtained by the ozonization of long chain alpha-olefins,
the unreacted carboxylic acids in the formation of the glycerol esters
being neutralized with calcium hydroxide to produce a composition having
up to 2 percent by weight calcium. The alpha-olefins, obtained from the
polymerization of ethylene, have 20 to 50 carbon atoms and contain a
minimum of 75 percent by weight straight chain alpha-olefins and not
more than 25 percent vinylidene compounds.
(b) Specifications. The polyhydric alcohol esters have the following
specifications:
(1) Melting point of 60-80 C for the ethylene glycol ester and
90-105 C for the glycerol ester as determined by the Fisher Johns
method as described in ''Semimicro Qualitative Organic Analysis -- The
Systematic Identification of Organic Compounds,'' by Cheronis and
Entrikin, 2d Ed., Interscience Publishers, NY, which is incorporated by
reference. Copies are available from the Division of Food and Color
Additives, Center for Food Safety and Applied Nutrition (HFF-334), 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.
(2) Acid value 15-25 for each ester as determined by the A.O.C.S.
method Trla-64T ''Titer Test,'' which is incorporated by reference.
Copies are available from American Association of Oil Chemists, 36 East
Wacker Drive, Chicago, IL 60601, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
The method is modified to use as the acid solvent a 1:1 volume mixture
of anhydrous isopropyl alcohol and toluene. The solution is titrated
with 0.1N methanolic sodium hydroxide.
(3) Saponification value 120-160 for the ethylene glycol ester and
90-130 for the glycerol ester as determined the A.O.C.S. method Trla-64T
''Saponification Value,'' which is incorporated by reference. Copies
are available from American Association of Oil Chemists, 36 East Wacker
Drive, Chicago, IL 60601, or available for inspection at the Office of
the Federal Register, 1100 L St. NW., Washington, DC 20408.
(4) Ultraviolet absorbance as specified in 178.3770(a)(4) of this
chapter when tested by the analytical method described therein.
(42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11849, Mar. 19,
1982; 54 FR 24899, June 12, 1989)
21 CFR 178.3790 Polymer modifiers in semirigid and rigid vinyl chloride
plastics.
The polymers identified in paragraph (a) of this section may be
safely admixed, alone or in mixture with other permitted polymers, as
modifiers in semirigid and rigid vinyl chloride plastic food-contact
articles prepared from vinyl chloride homopolymers and/or from vinyl
chloride copolymers complying with 177.1950, 177.1970, and/or
177.1980 of this chapter, in accordance with the following prescribed
conditions:
(a) For the purpose of this section, the polymer modifiers are
identified as follows:
(1) Acrylic polymers identified in this subparagraph provided that
such polymers contain at least 50 weight-percent of polymer units
derived from one or more of the monomers listed in paragraph (a)(1)(i)
of this section.
(i) Homopolymers and copolymers of the following monomers:
n-Butyl acrylate.
n-Butyl methacrylate.
Ethyl acrylate.
Methyl methacrylate.
(ii) Copolymers produced by copolymerizing one or more of the
monomers listed in paragraph (a)(1)(i) of this section with one or more
of the following monomers:
Acrylonitrile.
Butadiene.
a-Methylstyrene.
Styrene.
Vinylidene chloride.
(iii) Polymers identified in paragraphs (a)(1) (i) and (ii) of this
section containing no more than 5 weight-percent of total polymer units
derived by copolymerization with one or more of the following monomers:
Acrylic acid.
1,3-Butylene glycol dimethacrylate.
Divinylbenzene.
Methacrylic acid.
(iv) Mixtures of polymers identified in paragraph (a)(1) (i), (ii),
and (iii) of this section; provided that no chemical reactions, other
than addition reactions, occur when they are mixed.
(2) Polymers identified in paragraph (a)(1) of this section combined
during their polymerization with butadiene-styrene copolymers; provided
that no chemical reactions, other than addition reactions, occur when
they are combined. Such combined polymers may contain 50 weight-percent
or more of total polymer units derived from the butadiene-styrene
copolymers.
(b) The polymer content of the finished plastic food-contact article
consists of:
(1) Not less than 80 weight-percent of polymer units derived from the
vinyl chloride polymers identified in the introduction to this section
and not more than 5 weight-percent of polymer units derived from
polymers identified in paragraph (a)(1) of this section and may
optionally contain up to 15 weight-percent of polymer units derived from
butadiene-styrene copolymers; or
(2) Not less than 50 weight-percent of polymer units derived from the
vinyl chloride polymers identified in the introduction to this section,
not more than 50 weight-percent of polymer units derived from
homopolymers and/or copolymers of ethyl acrylate and methyl
methacrylate, and not more than 30 weight-percent of polymer units
derived from copolymers of methyl methacrylate, a-methylstyrene and
acrylonitrile and may optionally contain up to 15 weight-percent of
polymer units derived from butadiene-styrene copolymers.
(c) No chemical reactions, other than addition reactions, occur among
the vinyl chloride polymers and the modifying polymers present in the
polymer mixture used in the manufacture of the finished plastic
food-contact article.
(d) The finished plastic food-contact article, when extracted with
the solvent or solvents characterizing the type of food and under the
conditions of time and temperature characterizing the conditions of its
intended use as determined from Tables 1 and 2 of 176.170(c) of this
chapter, yields extractives not to exceed the limits prescribed in
177.1010 (b) (1), (2), (3), and (4) of this chapter when tested by the
methods prescribed in 177.1010 (c) of this chapter.
(e) Acrylonitrile copolymers identified in this section shall comply
with the provisions of 180.22 of this chapter.
21 CFR 178.3800 Preservatives for wood.
Preservatives may be safely used on wooden articles that are used or
intended for use in packaging, transporting, or holding raw agricultural
products subject to the provisions of this section:
(a) The preservatives are prepared from substances identified in
paragraph (b) of this section and applied in amounts not to exceed those
necessary to accomplish the technical effect of protecting the wood from
decay, mildew, and water absorption.
(b) The substances permitted are as follows:
21 CFR 178.3850 Reinforced wax.
Reinforced wax may be safely used as an article or component of
articles intended for use in producing, manufacturing, packing,
processing, transporting, or holding food subject to the provisions of
this section.
(a) Reinforced wax consists of petroleum wax to which have been added
certain optional substances required in its production, or added to
impart desired physical or technical properties.
(b) The quantity of any optional adjuvant substance employed in the
production of or added to reinforced wax does not exceed the amount
reasonably required to accomplish the intended physical or technical
effect or any limitation provided in this section.
(c) Any substance employed in the production of reinforced wax,
including any optional substance, that is the subject of a regulation in
parts 174, 175, 176, 177, 178 and 179.45 of this chapter, conforms with
any specification in such regulation.
(d) The substances and optional adjuvant substances employed in the
production of or added to reinforced wax include:
(1) Substances generally recognized as safe in food.
(2) Substances subject to prior sanction for use in reinforced wax
and used in accordance with such sanction or approval.
(3) Substances identified in this subparagraph and subject to any
limitations provided therein:
(e) Reinforced wax conforming with the specifications in this
paragraph is used as provided in paragraph (e)(2) of this section.
(1) The chloroform-soluble portion of the water extract obtained by
exposing reinforced wax to demineralized water at 70 F for 48 hours
shall not exceed 0.5 milligram per square inch of food-contact surface.
(2) It is used as a packaging material or component of packaging
materials for cheese and cheese products.
(42 FR 14609, Mar. 15, 1977, as amended at 47 FR 1288, Jan. 12, 1982)
21 CFR 178.3860 Release agents.
Substances listed in paragraph (b) of this section may be safely used
as release agents in petroleum wax complying with 178.3710 and in
polymeric resins that contact food, subject to the provisions of this
section.
(a) The quantity used shall not exceed the amount reasonably required
to accomplish the intended technical effect or any limitations
prescribed in this section.
(b) Release agents:
(42 FR 14609, Mar. 15, 1977, as amended at 44 FR 69649, Dec. 4, 1979;
46 FR 51902, Oct. 23, 1981)
21 CFR 178.3870 Rosins and rosin derivatives.
The rosins and rosin derivatives identified in paragraph (a) of this
section may safely be used in the manufacture of articles or components
of articles intended for use in producing, manufacturing, packing,
processing, preparing, treating, packaging, transporting, or holding
food, subject to the provisions of this section.
(a) The rosins and rosin derivatives are identified as follows:
(1) Rosins:
(i) Gum rosin, refined to color grade of K or paler.
(ii) Wood rosin, refined to color grade of K or paler.
(iii) Tall oil rosin, refined to color grade of K or paler.
(iv) Dark tall oil rosin, a fraction resulting from the refining of
tall oil rosin produced by multicolumnar distillation of crude tall oil
to effect removal of fatty acids and pitch components and having a
saponification number of from 110-135 and 32 percent-44 percent rosin
acids.
(v) Dark wood rosin, all or part of the residue after the volatile
terpene oils are distilled from the oleoresin extracted from pine wood.
(2) Modified rosins manufactured from rosins identified in paragraph
(a)(1) of this section:
(i) Partially hydrogenated rosin, catalytically hydrogenated to a
maximum refractive index of 1.5012 at 100 C, and a color of WG or
paler.
(ii) Fully hydrogenated rosin, catalytically hydrogenated to a
maximum dehydroabietic acid content of 2 percent, a minimum
drop-softening point of 79 C, and a color of X or paler.
(iii) Partially dimerized rosin, dimerized by sulfuric acid catalyst
to a drop-softening point of 95 -105 C and a color of WG or paler.
(iv) Fully dimerized rosin, dimerized by sulfuric acid catalyst, and
from which sufficient nondimerized rosin has been removed by
distillation to achieve a minimum drop-softening point of 143 C, and a
color of H or paler.
(v) Disproportionated rosin, catalytically disproportionated to a
minimum dehydroabietic acid content of 35 percent, a maximum abietic
acid content of 1 percent, a maximum content of substituted
phenanthrenes (as retene) of 0.25 percent, and a color of WG or paler.
(3) Rosin esters manufactured from rosins and modified rosins
identified in paragraphs (a)(1) and (2) of this section:
(i) Glycerol ester of wood rosin purified by steam stripping to have
an acid number of 3 to 9, a drop-softening point of 88 -96 C, and a
color of N or paler.
(ii) Glycerol ester of partially hydrogenated wood rosin, having an
acid number of 3 to 10, a drop-softening point of 79 -88 C, and a color
of N or paler.
(iii) Glycerol ester of partially dimerized rosin, having an acid
number of 3 to 8, a drop-softening point of 109 -119 C, and a color of
M or paler.
(iv) Glycerol ester of fully dimerized rosin, having an acid number
of 5 to 16, a drop-softening point of 165 -175 C, and a color of H or
paler.
(v) Glycerol ester of maleic anhydride-modified wood rosin, having an
acid number of 30 to 40, a drop-softening point of 138 -146 C, a color
of M or paler, and a saponification number less than 280.
(vi) Methyl ester of rosin, partially hydrogenated, purified by steam
stripping to have an acid number of 4 to 8, a refractive index of 1.5170
to 1.5205 at 20 C, and a viscosity of 23 to 66 poises at 25 C.
(vii) Pentaerythritol ester of wood rosin, having an acid number of 6
to 16, a drop-softening point of 109 -116 C, and a color of M or paler.
(viii) Pentaerythritol ester of partially hydrogenated wood rosin,
having an acid number of 7 to 18, a drop-softening point of 102 -110 C,
and a color of K or paler.
(ix) Pentaerythritol ester of maleic anhydride-modified wood rosin,
having an acid number of 8 to 16, a drop-softening point of 154 -162 C,
a color of M or paler, and having a saponification number less than 280.
(x) Pentaerythritol ester of maleic anhydride-modified wood rosin,
having an acid number of 9 to 16, a drop-softening point of 130 -140 C,
a color of N or paler, and having a saponification number less than 280.
(xi) Pentaerythritol ester of maleic anhydride-modified wood rosin,
having an acid number of 134 to 145, a drop-softening point of 127 -137
C, a color of M or paler, and having a saponification number less than
280.
(xii) Pentaerythritol ester of maleic anhydride-modified wood rosin,
having an acid number of 30 to 40, a drop-softening point of 131 -137
C, a color of N or paler, and having a saponification number less than
280.
(xiii) Pentaerythritol ester of maleic anhydride-modified wood rosin,
further modified by reaction with
4,4'-isopropyl-idenediphenol-formaldehyde condensate, having an acid
number of 10 to 22, a drop-softening point of 162 -172 C, a color of K
or paler, a saponification number less than 280, and a maximum
ultraviolet absorbance of 0.14 at 296 m (using a 1-centimeter cell and
200 milligrams of the rosin ester per liter of solvent consisting of
ethyl alcohol made alkaline by addition of 0.1 percent of potassium
hydroxide).
(xiv) Mixed methyl and pentaerythritol ester of maleic
anhydride-modified wood rosin, having an acid number of 73 to 83, a
drop-softening point of 113 -123 C, a color of M or paler, and a
saponification number less than 280.
(xv) Triethylene glycol ester of partially hydrogenated wood rosin,
having an acid number of 2 to 10, a color of K or paler, and a viscosity
of 350 to 425 seconds Saybolt at 100 C.
(xvi) Glycerol ester of maleic anhydride-modified wood rosin, having
an acid number of 17 to 23, a drop-softening point of 136 -140 C, a
color of M or paler, and a saponification number less than 280. For use
only in cellophane complying with 177.1200 of this chapter.
(xvii) Citric acid-modified glycerol ester of rosin, having an acid
number less than 20, a drop-softening point of 105 -115 C, and a color
of K or paler. For use only as a blending agent in coatings for
cellophane complying with 177.1200 of this chapter.
(xviii) Glycerol ester of tall oil rosin, purified by steam stripping
to have an acid number of 5-12, a softening point of 80 -88 C, and a
color of N or paler.
(xix) Glycerol ester of maleic anhydride-modified tall oil rosin,
having an acid number of 30 to 40, a drop-softening point of 141 -146
C, a color of N or paler, and a saponification number less than 280.
(xx) Glycerol ester of disproportionated tall oil rosin, having an
acid number of 5 to 10, a drop-softening point of 84 -93 C, a color of
WG or paler, and a saponification number less than 180.
(4) Rosin salts and sizes -- Ammonium, calcium, potassium, sodium, or
zinc salts of rosin manufactured by the partial or complete
saponification of any one of the rosins or modified rosins identified in
paragraph (a)(1) and (2) of this section, or blends thereof, and with or
without modification by reaction with one or more of the following:
(i) Formaldehyde.
(ii) Fumaric acid.
(iii) Maleic anhydride.
(iv) Saligenin.
(b) The quantity used shall not exceed the amount reasonably required
to accomplish the intended technical effect.
(c) The use in any substance or article that is the subject of a
regulation in parts 174, 175, 176, 177, 178 and 179.45 of this chapter
shall conform with any specifications and limitations prescribed by such
regulation for the finished form of the substance or article.
(d) The provisions of this section are not applicable to rosins and
rosin derivatives identified in 175.300(b)(3)(v) of this chapter and
used in resinous and polymeric coatings complying with 175.300 of this
chapter.
(e) The provisions of this section are not applicable to rosins and
rosin derivatives identified in 175.105(c)(5) of this chapter and used
in defoaming agents complying with 176.210 of this chapter,
food-packaging adhesives complying with 175.105 of this chapter, and
rubber articles complying with 177.2600 of this chapter.
(f) The analytical methods for determining whether rosins and rosin
derivatives conform to the specifications prescribed in paragraph (a) of
this section are as follows:
(1) Color: Color shall be as determined by ASTM method D509-70
(Reapproved 1981), ''Standard Methods of Sampling and Grading Rosin,''
which is incorporated by reference. Copies may be obtained from the
American Society for Testing Materials, 1916 Race St., Philadelphia, PA
19103, or may be examined at the Office of the Federal Register, 1100 L
St. NW., Washington, D.C. 20408.
(2) Refractive index: Refractive index shall be as determined by
ASTM method D1747-62 (Reapproved 1978), ''Standard Test Method for
Refractive Index of Viscous Materials,'' which is incorporated by
reference. The availability of this incorporation by reference is given
in paragraph (f)(1) of this section.
(3) Acid number: Acid number shall be as determined by ASTM method
D465-82, ''Standard Test Methods for Acid Number of Rosin,'' which is
incorporated by reference. The availability of this incorporation by
reference is given in paragraph (f)(1) of this section.
(4) Viscosity: Viscosity in poises shall be as determined by ASTM
method D1824-66 (Reapproved 1980), ''Standard Test Method for Apparent
Viscosity of Plastisols and Organosols at Low Shear Rates by Brookfield
Viscometer,'' and in Saybolt seconds by ASTM method D88-81, ''Standard
Test Method for Saybolt Viscosity,'' which are incorporated by
reference. The availability of this incorporation by reference is given
in paragraph (f)(1) of this section.
(5) Softening point: Softening point shall be as determined by ASTM
method E28-67, ''Standard Test Method for Softening Point by Ring and
Ball Apparatus'' (Reapproved 1977), which is incorporated by reference.
Copies are available from American Society for Testing and Materials
(ASTM), 1916 Race St., Philadelphia, PA 19103, or available for
inspection at the Office of the Federal Register, 1100 L St. NW.,
Washington, DC 20408.
(6) Analytical methods for determining drop-softening point,
saponification number, and any other specifications not listed under
paragraphs (f)(1) through (5) of this section, titled: (i)
''Determination of Abeitic Acid and Dehydroabietic Acid in Rosins'';
(ii) ''Determination of Softening Point of Solid Resins''; (iii)
''Determination of Saponification Number of Rosin Esters,'' and (iv)
''Determination of Phenolic Modification of Rosin Derivatives,'' which
are incorporated by reference. Copies are available from the Division
of Food and Color Additives, Center for Food Safety and Applied
Nutrition (HFF-330), 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.
(42 FR 14609, Mar. 15, 1977, as amended at 47 FR 11849, Mar. 19,
1982; 49 FR 10113, Mar. 19, 1984; 54 FR 24899, June 12, 1989)
21 CFR 178.3900 Sodium pentachlorophenate.
Sodium pentachlorophenate may be safely used as a preservative for
ammonium alginate employed as a processing aid in the manufacture of
polyvinyl chloride emulsion polymers intended for use as articles or
components of articles that contact food at temperatures not to exceed
room temperature. The quantity of sodium pentachlorophenate used shall
not exceed 0.5 percent by weight of ammonium alginate solids.
21 CFR 178.3910 Surface lubricants used in the manufacture of metallic
articles.
The substances listed in this section may be safely used in surface
lubricants employed in the manufacture of metallic articles that contact
food, subject to the provisions of this section.
(a) The following substances may be used in surface lubricants used
in the rolling of metallic foil or sheet stock provided that total
residual lubricant remaining on the metallic article in the form in
which it contacts food does not exceed 0.015 milligram per square inch
of metallic food-contact surface:
(1) Substances identified in paragraphs (b)(1) and (2) of this
section.
(2) Substances identified in this paragraph.
(3) Mineral oil conforming to the identity prescribed in
178.3620(c).
(4) Light petroleum hydrocarbons identified in paragraph (a)(4) (i)
of this section: Provided, That the total residual lubricant on the
metallic article in the form in which it contacts food meets the
ultraviolet absorbance limits prescribed in paragraph (a) (4) (ii) of
this section as determined by the analytical method described in
paragraph (a) (4) (iii) of this section.
(i) Light petroleum hydrocarbons are derived by distillation from
virgin petroleum stocks or are synthesized from petroleum gases. They
are chiefly paraffinic, isoparaffinic, napthenic, or aromatic in nature,
and meet the following specifications:
(a) Initial boiling point is 24 C minimum and final boiling point is
288 C maximum, as determined by ASTM method D86-82, ''Standard Method
for Distillation of Petroleum Products,'' which is incorporated by
reference. Copies may be obtained from the American Society for Testing
Materials, 1916 Race St., Philadelphia, PA 19103, or may be examined at
the Office of the Federal Register, 1100 L St. NW., Washington, D.C.
20408.
(b) Nonvolatile residue is 0.005 gram per 100 milliliters, maximum,
as determined by ASTM method D381-80, ''Standard Test Method for
Existent Gum in Fuels by Jet Evaporation,'' when the final boiling point
is 121 C or above and by ASTM method D1353-78, ''Standard Test Method
for Nonvolatile Matter in Volatile Solvents for Use in Paint, Varnish,
Lacquer, and Related Products,'' when the final boiling point is below
121 C. These ASTM methods are incorporated by reference. The
availability of these incorporations by reference is given in paragraph
(a)(4)(i)(a) of this section.
(c) Saybolt color 20 minimum as determined by ASTM method D156-82,
''Standard Test Method for Saybolt Color of Petroleum Products (Saybolt
Chromometer Method),'' which is incorporated by reference. The
availability of this incorporation by reference is given in paragraph
(a)(4)(i)(a) of this section.
(d) Aromatic component content shall not exceed 32 percent.
(e) Conforms with ultraviolet absorbance limits prescribed in
178.3620(c) as determined by the analytical method described therein.
(ii) Ultraviolet absorbance limits on residual lubricants are as
follows:
(iii) The analytical method for determining ultraviolet absorbance
limits on residual lubricants is as follows:
Because of the sensitivity of the test, the possibility of errors
arising from contamination is great. It is of the greatest importance
that all glassware be scrupulously cleaned to remove all organic matter
such as oil, grease, detergent, residues, etc. Examine all glassware
including stoppers and stopcocks, under ultraviolet light to detect any
residual fluorescent contamination. As a precautionary measure it is
recommended practice to rinse all glassware with purified isooctane
immediately before use. No grease is to be used on stopcocks or joints.
Great care to avoid contamination of oil samples in handling and to
assure absence of any extraneous material arising from inadequate
packaging is essential. Because some of the polynuclear hydrocarbons
sought in this test are very susceptible to photo-oxidation, the entire
procedure is to be carried out under subdued light.
Separatory funnels. 250-milliliter, 500-milliliter,
1,000-milliliter, and preferably 2,000-milliliter capacity, equipped
with tetrafluoroethylene polymer stopcocks.
Evaporation flask (optional). 250-milliliter or 500-milliliter
capacity all-glass flask equipped with standard-taper stopper having
inlet and outlet tubes to permit passage of nitrogen across the surface
of contained liquid to be evaporated.
Spectrophotometric cells. Fused quartz cells, optical path length in
the range of 5,000 centimeters 0.005 centimeter; also for checking
spectrophotometer performance only, optical path length in the range
1.000 centimeter 0.005 centimeter. With distilled water in the cells,
determine any absorbance differences.
Spectrophotometer. Special range 250 millicrons-400 millimicrons with
spectral slit width of 2 millimicrons or less; under instrument
operating conditions for these absorbance measurements, the
spectrophotometer shall also meet the following performance
requirements:
Absorbance repeatability, 0.01 at 0.4 absorbance.
Absorbance accuracy,1065 0.05 at 0.4 absorbance.
Wavelength repeatability, 0.2 millimicron.
Wavelength accuracy, 1.0 millimicron.
Soxhlet apparatus. 60-millimeter diameter body tubes fitted with
condenser and 500-milliliter round-bottom boiling flask. A supply of
paper thimbles to fit is required.
Nitrogen cylinder. Water-pumped or equivalent purity nitrogen in
cylinder equipped with regulator and valve to control flow at 5 p.s.i.g.
Organic solvents. All solvents used throughout the procedure shall
meet the specifications and tests described in this specification. The
isooctane (2,2,4-trimethylpentane) shall pass the following test:
Place 180 milliliters of solvent in a 250-milliliter Erlenmeyer
flask, add 1 milliliter of purified n-hexadecane and evaporate on the
steam bath under a stream of nitrogen (a loose aluminum foil jacket
around the flask will speed evaporation). Discontinue evaporation when
not over 1 milliliter of residue remains.
Alternatively, the evaporation time can be reduced by using the
optional evaporation flask. In this case the solvent and n-hexadecane
are placed in the flask on the steam bath, the tube assembly is
inserted, and a stream of nitrogen is fed through the inlet tube while
the outlet tube is connected to a solvent trap and vacuum line in such a
way as to prevent any flow-back of condensate into the flask.
Dissolve the 1 milliliter of hexadecane residue in isooctane and make
to 25 milliliters volume. Determine the absorbance in the 5-centimeter
path length cells compared to isooctane as reference. The absorbance of
the solution of the solvent residue shall not exceed 0.01 per centimeter
path length between 280 and 400 m . Purify, if necessary, by passage
through a column of activated silica gel (Grade 12, Davison Chemical
Co., Baltimore, Maryland, or equivalent) about 90 centimeters in length
and 5 centimeters to 8 centimeters in diameter.
n-Hexadecane, 99-percent olefin-free. Dilute 1.0 milliliter of
n-hexadecane to 25 milliliters with isooctane and determine the
absorbance in a 5-centimeter cell compared to isooctane as reference
point between 280 m -400 m . The absorbance per centimeter path length
shall not exceed 0.00 in this range. Purify, if necessary, by
percolation through activated silica gel or by distillation.
Dimethyl sulfoxide. Spectrophotometric grade (Crown Zellerbach
Corp., Camas, Washington, or equivalent). Absorbance (1-centimeter
cell, distilled water reference, sample completely saturated with
nitrogen).
There shall be no irregularities in the absorbance curve within these
wavelengths.
Phosphoric acid. 85 percent A.C.S. reagent grade.
Sodium sulfate, anhydrous, A.C.S. reagent grade, preferably in
granular form. For each bottle of sodium sulfate reagent used,
establish as follows the necessary sodium sulfate prewash to provide
such filters required in the method: Place approximately 35 grams of
anhydrous sodium sulfate in a 30-milliliter coarse, fritted-glass funnel
or in a 65-milliliter filter funnel with glass wool plug; wash with
successive 15-milliliter portions of the indicated solvent until a
15-milliliter portion of the wash shows 0.00 absorbance per centimeter
path length between 280 m and 400 m when tested as prescribed under
''Organic solvents.'' Usually three portions of wash solvent are
sufficient.
Before proceeding with analysis of a sample, determine the absorbance
in a 5-centimeter path cell between 250 millimicrons and 400
millimicrons for the reagent blank by carrying out the procedure,
without a metal sample. The absorbance per centimeter path length
should not exceed 0.02 in the wavelength range from 280 m to 400 m .
Place 300 milliliters of dimethyl sulfoxide in a 1-liter separatory
funnel and add 75 milliliters of phosphoric acid. Mix the contents of
the funnel and allow to stand for 10 minutes. (The reaction between the
sulfoxide and the acid is exothermic. Release pressure after mixing,
then keep funnel stoppered.) Add 150 milliliters of isooctane and shake
to pre-equilibrate the solvents. Draw off the individual layers and
store in glass-stoppered flasks.
Sample. Select metal foil or sheet stock for the test which has not
been previously contaminated by careless handling or exposure to
atmospheric dust and fumes. A commercial coil in the form supplied for
spindle mounting in a packaging line or wrapping machine is most
suitable. Strip off the outside turn of metal and discard. Carefully
avoid contamination or damage from handling the metal (wear gloves).
Remove a 16-18-foot length from the coil and place it on a flat surface
protected by a length of new kraft paper. Cut four 15-foot strips from
the sample, each 3 inches wide (avoid tearing the edges of the strips).
Using a piece of suitable glass rod, roll the strips of metal into loose
coils and insert each into a Soxhlet thimble. Each turn of coil should
be visibly separated from the adjacent turn.
Extraction. Fill each of the four Soxhlet tubes with purified
isooctane (see under heading ''Reagents and Materials,'' above) until
siphon action occurs and then refill the tube body. Supply heat to the
boiling flask and allow extraction to continue for at least 8 hours or
until repeated weighings of the dried and cooled coil show no further
weight loss.
Combine the isooctane extracts from the four Soxhlet units in a
suitable beaker, rinsing each tube and flask into the beaker with fresh
purified solvent. Evaporate the solvent under an atmosphere of inert
gas (nitrogen) to residual volume of 50-60 milliliters and transfer this
solution to a 500-milliliter separatory funnel containing 100
milliliters of pre-equilibrated sulfoxide-phosphoric acid mixture.
Complete the transfer of the sample with small portions of
pre-equilibrated isooctane to give a total volume of the residue and
solvent of 75 milliliters. Shake the funnel vigorously for 2 minutes.
Set up three 250-milliliter separatory funnels with each containing 30
milliliters of pre-equilibrated isooctane. After separation of liquid
phases, carefully draw off lower layer into the first 250-milliliter
separatory funnel and wash in tandem with the 30-milliliter portion of
isooctane contained in the 250-milliliter separatory funnels. Shaking
time for each wash is 1 minute. Repeat the extraction operation with
two additional portions of the sulfoxide-acid mixture and wash each
extractive in tandem through the same three portions of isooctane.
Collect the successive extractives (300 milliliters total) in a
separatory funnel (preferably 2-liter) containing 480 milliliters of
distilled water; mix, and allow to cool for a few minutes after the
last extractive has been added. Add 80 milliliters of isooctane to the
solution and extract by shaking the funnel vigorously for 2 minutes.
Draw off the lower aqueous layer into a second separatory funnel
(preferably 2-liter) and repeat the extraction with 80 milliliter of
isooctane. Draw off and discard the aqueous layer. Wash each of the 80
milliliter extractives three times with 100-milliliter portions of
distilled water. Shaking time for each wash is 1 minute. Discard the
aqueous layers. Filter the first extractive through anhydrous sodium
sulfate pre-washed with isooctane (see sodium sulfate under ''Reagents
and Materials'' for preparation of filter) into a 250-milliliter
Erlenmeyer flask (or optionally into the evaporation flask). Wash the
first separatory funnel with the second 80-milliliter isooctane
extractive and pass through the sodium sulfate. Then wash the second
and first separatory funnels successively with a 20-milliliter portion
of isooctane and pass the solvent through the sodium sulfate into the
flask. Add 1 milliliter of n-hexadecane and evaporate the isooctane on
the steam bath under nitrogen. Discontinue evaporation when not over 1
milliliter of residue remains. To the residue, add a 10-milliliter
portion of isooctane, reevaporate to 1 milliliter of hexadecane, and
repeat this operation once.
Quantitatively transfer the residue with isooctane to a 25-milliliter
volumetric flask, make to volume, and mix. Determine the absorbance of
the solution in 5-centimeter pathlength cells compared to isooctane as
reference between 280m -400m (take care to lose none of the solution in
filling the sample cell). Correct the absorbance values for any
absorbance derived from reagents as determined by carrying out the
procedure without a metal sample. If the corrected absorbance does not
exceed the limits prescribed in this paragraph, the residue meets the
ultraviolet absorbance specifications.
(b) The following substances may be used in surface lubricants used
to facilitate the drawing, stamping, or forming of metallic articles
from rolled foil or sheet stock by further processing provided that the
total residual lubricant remaining on the metallic article in the form
in which it contacts food does not exceed 0.2 milligram per square inch
of food-contact surface:
(1) Antioxidants used in compliance with regulations in parts 170
through 189 of this chapter.
(2) Substances identified in this subparagraph.
(c) The substances identified in paragraph (a)(2) of this section may
be used in surface lubricants used to facilitate the drawing, stamping,
and forming of metallic articles from rolled foil and sheet stock
provided that total residual lubricant remaining on the metallic article
in the form in which it contacts food does not exceed 0.015 milligram
per square inch of food-contact surface.
(d) Subject to any prescribed limitations, the quantity of surface
lubricant used in the manufacture of metallic articles shall not exceed
the least amount reasonably required to accomplish the intended
technical effect and shall not be intended to nor, in fact, accomplish
any technical effect in the food itself.
(e) The use of the surface lubricants in the manufacture of any
article that is the subject of a regulation in parts 174, 175, 176, 177,
178 and 179.45 of this chapter must comply with any specifications
prescribed by such regulation for the finished form of the article.
(f) Any substance that is listed in this section and the subject of a
regulation in parts 174, 175, 176, 177, 178 and 179.45 of this chapter
shall comply with any applicable specifications prescribed by such
regulation.
(42 FR 14609, Mar. 15, 1977, as amended at 48 FR 238, Jan. 4, 1983;
49 FR 10113, Mar. 19, 1984; 49 FR 29579, July 23, 1984; 50 FR 36874,
Sept. 10, 1985; 52 FR 10223, Mar. 31, 1987; 54 FR 6124, Feb. 8, 1989;
54 FR 24899, June 12, 1989; 56 FR 55456, Oct. 28, 1991)
0651As determined by procedure using potassium chromate for reference
standard and described in National Bureau of Standards Circular 484,
Spectrometry, U.S. Department of Commerce (1949), which is incorporated
by reference. Copies are available from the Division of Food and Color
Additives, Center for Food Safety and Applied Nutrition (HFF-330), 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. The accuracy is to be determined by
comparison with the standard values at 210, 345, and 400 millimicrons.
21 CFR 178.3930 Terpene resins.
The terpene resins identified in paragraph (a) of this section may be
safely used as components of polypropylene film intended for use in
contact with food, and the terpene resins identified in paragraph (b) of
this section may be safely used as components of polyolefin film
intended for use in contact with food;
(a) Terpene resins consisting of the hydrogenated polymers of terpene
hydrocarbons obtainable from sulfate turpentine and meeting the
following specifications: Drop-softening point of 118 -138 C; iodine
value less than 20.
(b) Terpene resins consisting of polymers of beta-pinene and meeting
the following specifications: Acid value less than 1; saponification
number less than 1; color less than 4 on the Gardner scale as measured
in 50 percent mineral spirits solution.
21 CFR 178.3940 Tetraethylene glycol di-(2-ethylhexoate).
Tetraethylene glycol di-(2-ethylhexoate) containing not more than 22
parts per million ethylene and/or diethylene glycols may be used at a
level not to exceed 0.7 percent by weight of twine as a finish on twine
to be used for tying meat provided the twine fibers are produced from
nylon resins complying with 177.1500 of this chapter.
21 CFR 178.3950 Tetrahydrofuran.
Tetrahydrofuran may be safely used in the fabrication of articles
intended for packaging, transporting, or storing foods, subject to the
provisions of this section.
(a) It is used as a solvent in the casting of film from a solution of
polymeric resins of vinyl chloride, vinyl acetate, or vinylidene
chloride that have been polymerized singly or copolymerized with one
another in any combination, or it may be used as a solvent in the
casting of film prepared from vinyl chloride copolymers complying with
177.1980 of this chapter.
(b) The residual amount of tetrahydrofuran in the film does not
exceed 1.5 percent by weight of film.
21 CFR 178.3950 PART 179 -- IRRADIATION IN THE PRODUCTION, PROCESSING AND HANDLING OF FOOD
21 CFR 178.3950 Subpart A -- (Reserved)
21 CFR 178.3950 Subpart B -- Radiation and Radiation Sources
Sec.
179.21 Sources of radiation used for inspection of food, for
inspection of packaged food, and for controlling food processing.
179.25 General provisions for food irradiation.
179.26 Ionizing radiation for the treatment of food.
179.30 Radiofrequency radiation for the heating of food, including
microwave frequencies.
179.39 Ultraviolet radiation for the processing and treatment of
food.
21 CFR 178.3950 Subpart C -- Packaging Materials for Irradiated Foods
179.45 Packaging materials for use during the irradiation of
prepackaged foods.
Authority: Secs. 201, 402, 403, 409, 703, 704 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321, 342, 343, 348, 373, 374).
Source: 42 FR 14635, Mar. 15, 1977, unless otherwise noted.
21 CFR 178.3950 Subpart A -- (Reserved)
21 CFR 178.3950 Subpart B -- Radiation and Radiation Sources
21 CFR 179.21 Sources of radiation used for inspection of food, for
inspection of packaged food, and for controlling food processing.
Sources of radiation for the purposes of inspection of foods, for
inspection of packaged food, and for controlling food processing may be
safely used under the following conditions:
(a) The radiation source is one of the following:
(1) X-ray tubes producing X-radiation from operation of the tube
source at energy levels of 300 kilovolt peak or lower.
(2) Sealed units producing radiations at energy levels of not more
than 2.2 million electron volts from one of the following isotopes:
Americium-241, cesium-137, cobalt-60, iodine-125, krypton-85,
radium-226, and strontium-90.
(3) Sealed units producing neutron radiation from the isotope
Californium-252 (CAS Reg. No. 13981-17-4) to measure moisture in food.
(b) To assure safe use of these radiation sources:
(1) The label of the sources shall bear, in addition to the other
information required by the Act:
(i) Appropriate and accurate information identifying the source of
radiation.
(ii) The maximum energy of radiation emitted by X-ray tube sources.
(2) The label or accompanying labeling shall bear:
(i) Adequate directions for installation and use.
(ii) A statement that no food shall be exposed to radiation sources
listed in paragraph (a) (1) and (2) of this section so as to receive an
absorbed dose in excess of 1,000 rads.
(iii) A statement that no food shall be exposed to a radiation source
listed in paragraph (a)(3) of this section so as to receive an absorbed
dose in excess of 200 millirads.
(42 FR 14635, Mar. 15, 1977, as amended at 48 FR 46022, Oct. 11,
1983)
21 CFR 179.25 General provisions for food irradiation.
For the purposes of 179.26, current good manufacturing practice is
defined to include the following restrictions:
(a) Any firm that treats foods with ionizing radiation shall comply
with the requirements of part 110 of this chapter and other applicable
regulations.
(b) Food treated with ionizing radiation shall receive the minimum
radiation dose reasonably required to accomplish its intended technical
effect and not more than the maximum dose specified by the applicable
regulation for that use.
(c) Packaging materials subjected to irradiation incidental to the
radiation treatment and processing of prepackaged foods shall comply
with 179.45.
(d) Radiation treatment of food shall conform to a scheduled process.
A scheduled process for food irradiation is a written procedure that
ensures that the radiation dose range selected by the food irradiation
processor is adequate under commercial processing conditions (including
atmosphere and temperature) for the radiation to achieve its intended
effect on a specific product and in a specific facility. A food
irradiation processor shall operate with a scheduled process established
by qualified persons having expert knowledge in radiation processing
requirements of food and specific for that food and for that irradiation
processor's treatment facility.
(e) A food irradiation processor shall maintain records as specified
in this section for a period of time that exceeds the shelf life of the
irradiated food product by 1 year, up to a maximum of 3 years, whichever
period is shorter, and shall make these records available for inspection
and copy by authorized employees of the Food and Drug Administration.
Such records shall include the food treated, lot identification,
scheduled process, evidence of compliance with the scheduled process,
ionizing energy source, source calibration, dosimetry, dose distribution
in the product, and the date of irradiation.
(Approved by the Office of Management and Budget under control number
0910-0186)
(51 FR 13399, Apr. 18, 1986)
21 CFR 179.26 Ionizing radiation for the treatment of food.
Ionizing radiation for treatment of foods may be safely used under
the following conditions:
(a) Energy sources. Ionizing radiation is limited to:
(1) Gamma rays from sealed units of the radionuclides cobalt-60 or
cesium-137.
(2) Electrons generated from machine sources at energies not to
exceed 10 million electron volts.
(3) X-rays generated from machine sources at energies not to exceed 5
million electron volts.
(b) Limitations.
(c) Labeling. (1) The label and labeling of retail packages of foods
irradiated in conformance with paragraph (b) of this section shall bear
the following logo
along with either the statement ''Treated with radiation'' or the
statement ''Treated by irradiation'' in addition to information required
by other regulations. The logo shall be placed prominently and
conspicuously in conjunction with the required statement.
(2) For irradiated foods not in package form, the required logo and
phrase ''Treated with radiation'' or ''Treated by irradiation'' shall be
displayed to the purchaser with either (i) the labeling of the bulk
container plainly in view or (ii) a counter sign, card, or other
appropriate device bearing the information that the product has been
treated with radiation. As an alternative, each item of food may be
individually labeled. In either case, the information must be
prominently and conspicuously displayed to purchasers. The labeling
requirement applies only to a food that has been irradiated, not to a
food that merely contains an irradiated ingredient but that has not
itself been irradiated.
(3) For a food, any portion of which is irradiated in conformance
with paragraph (b) of this section, the label and labeling and invoices
or bills of lading shall bear either the statement ''Treated with
radiation -- do not irradiate again'' or the statement ''Treated by
irradiation -- do not irradiate again'' when shipped to a food
manufacturer or processor for further processing, labeling, or packing.
(51 FR 13399, Apr. 18, 1986, as amended at 53 FR 12757, Apr. 18,
1988; 53 FR 53209, Dec. 30, 1988; 54 FR 32335, Aug. 7, 1989; 55 FR
14415, Apr. 18, 1990; 55 FR 18544, May 2, 1990)
21 CFR 179.30 Radiofrequency radiation for the heating of food,
including microwave frequencies.
Radiofrequency radiation, including microwave frequencies, may be
safely used for heating food under the following conditions:
(a) The radiation source consists of electronic equipment producing
radio waves with specific frequencies for this purpose authorized by the
Federal Communications Commission.
(b) The radiation is used or intended for use in the production of
heat in food wherever heat is necessary and effective in the treatment
or processing of food.
21 CFR 179.39 Ultraviolet radiation for the processing and treatment of
food.
Ultraviolet radiation for the processing and treatment of food may be
safely used under the following conditions:
(a) The radiation sources consist of ultraviolet emission tubes
designed to emit wavelengths within the range of 2200-3000 Angstrom
units with 90 percent of the emission being the wavelength 2537 Angstrom
units.
(b) The ultraviolet radiation is used or intended for use as follows:
21 CFR 179.39 Subpart C -- Packaging Materials for Irradiated Foods
21 CFR 179.45 Packaging materials for use during the irradiation of
prepackaged foods.
The packaging materials identified in this section may be safely
subjected to irradiation incidental to the radiation treatment and
processing of prepackaged foods, subject to the provisions of this
section and to the requirement that no induced radioactivity is
detectable in the packaging material itself:
(a) The radiation of the food itself shall comply with regulations in
this part.
(b) The following packaging materials may be subjected to a dose of
radiation, not to exceed 1 megarad, unless otherwise indicated,
incidental to the use of gamma radiation in the radiation treatment of
prepackaged foods:
(1) Nitrocellulose-coated or vinylidene chloride copolymer-coated
cellophane complying with 177.1200 of this chapter.
(2) Glassine paper complying with 176.170 of this chapter.
(3) Wax-coated paperboard complying with 176.170 of this chapter.
(4) Polyolefin film prepared from one or more of the basic olefin
polymers complying with 177.1520 of this chapter. The finished film
may contain:
(i) Adjuvant substances used in compliance with 178.3740 and 181.22
through 181.30 of this chapter, sodium citrate, sodium lauryl sulfate,
polyvinyl chloride, and materials as listed in paragraph (c)(2)(i) of
this section.
(ii) Coatings comprising a vinylidene chloride copolymer containing a
minimum of 85 percent vinylidene chloride with one or more of the
following comonomers: Acrylic acid, acrylonitrile, itaconic acid,
methyl acrylate, and methyl methacrylate.
(5) Kraft paper prepared from unbleached sulfate pulp to which rosin,
complying with 178.3870 of this chapter, and alum may be added. The
kraft paper is used only as a container for flour and is irradiated with
a dose not exceeding 50,000 rads.
(6) Polyethylene terephthalate film prepared from the basic polymer
as described in 177.1630(e)(4)(i) and (ii) of this chapter. The
finished film may contain:
(i) Adjuvant substances used in compliance with 178.3740 and 181.22
through 181.30 of this chapter, sodium citrate, sodium lauryl sulfate,
polyvinyl chloride, and materials as listed in paragraph (c)(2)(i) of
this section.
(ii) Coatings comprising a vinylidene chloride copolymer containing a
minimum of 85 percent vinylidene chloride with one or more of the
following comonomers: Acrylic acid, acrylonitrile, itaconic acid,
methyl acrylate, and methyl methacrylate.
(iii) Coatings consisting of polyethylene conforming to 177.1520 of
this chapter.
(7) Polystyrene film prepared from styrene basic polymer. The
finished film may contain adjuvant substances used in compliance with
178.3740 and 181.22 through 181.30 of this chapter.
(8) Rubber hydrochloride film prepared from rubber hydrochloride
basic polymer having a chlorine content of 30-32 weight percent and
having a maximum extractable fraction of 2 weight percent when extracted
with n-hexane at reflux temperature for 2 hours. The finished film may
contain adjuvant substances used in compliance with 178.3740 and
181.22 through 181.30 of this chapter.
(9) Vinylidene chloride-vinyl chloride copolymer film prepared from
vinylidene chloride-vinyl chloride basic copolymers containing not less
than 70 weight percent of vinylidene chloride and having a viscosity of
0.50-1.50 centipoises as determined by ASTM method D729-81, ''Standard
Specification for Vinylidene Chloride Molding Compounds,'' which is
incorporated by reference. Copies may be obtained from the American
Society for Testing Materials, 1916 Race St., Philadelphia, PA 19103, or
may be examined at the Office of the Federal Register, 1100 L St. NW.,
Washington, DC 20408. The finished film may contain adjuvant substances
used in compliance with 178.3740 and 181.22 through 181.30 of this
chapter.
(10) Nylon 11 conforming to 177.1500 of this chapter.
(c) Ethylene-vinyl acetate copolymers complying with 177.1350 of
this chapter. The ethylene-vinyl acetate packaging materials may be
subjected to a dose of radiation, not to exceed 30 kilogray (3
megarads), incidental to the use of gamma, electron beam, or X-radiation
in the radiation treatment of packaged foods.
(d) The following packaging materials may be subjected to a dose of
radiation, not to exceed 6 megarads incidental to the use of gamma or
X-radiation in the radiation processing of prepackaged foods:
(1) Vegetable parchments, consisting of a cellulose material made
from waterleaf paper (unsized) treated with concentrated sulfuric acid,
neutralized, and thoroughly washed with distilled water.
(2) Films prepared from basic polymers and with or without adjuvants,
as follows:
(i) Polyethylene film prepared from the basic polymer as described in
177.1520(a) of this chapter. The finished film may contain one or more
of the following added substances:
(ii) Polyethylene terephthalate film prepared from the basic polymer
as described in 177.1630(e)(4)(ii) of this chapter. The finished film
may contain one or more of the added substances listed in paragraph
(c)(2)(i) of this section.
(iii) Nylon 6 films prepared from the nylon 6 basic polymer as
described in 177.1500(a)(6) of this chapter and meeting the
specifications of item 6.1 of the table in 177.1500(b) of this chapter.
The finished film may contain one or more of the added substances
listed in paragraph (c)(2)(i) of this section.
(iv) Vinyl chloride-vinyl acetate copolymer film prepared from the
basic copolymer containing 88.5 to 90.0 weight percent of vinyl chloride
with 10.0 to 11.5 weight percent of vinyl acetate and having a maximum
volatility of not over 3.0 percent (1 hour at 105 C) and viscosity not
less than 0.30 determined by ASTM method D1243-79, ''Standard Test
Method for Dilute Solution Viscosity of Vinyl Chloride Polymers,''
Method A, which is incorporated by reference. The availability of this
incorporation by reference is given in paragraph (b)(9) of this section.
The finished film may contain one or more of the added substances
listed in paragraph (c)(2)(i) of this section.
(e) Acrylonitrile copolymers identified in this section shall comply
with the provisions of 180.22 of this chapter.
(42 FR 14635, Mar. 15, 1977, as amended at 49 FR 10113, Mar. 19,
1984; 54 FR 7405, Feb. 21, 1989; 54 FR 24899, June 12, 1989)
21 CFR 179.45 PART 180 -- FOOD ADDITIVES PERMITTED IN FOOD ON AN INTERIM BASIS OR IN CONTACT WITH FOOD PENDING ADDITIONAL STUDY
21 CFR 179.45 Subpart A -- General Provisions
Sec.
180.1 General.
21 CFR 179.45 Subpart B -- Specific Requirements for Certain Food
Additives
180.22 Acrylonitrile copolymers.
180.25 Mannitol.
180.30 Brominated vegetable oil.
180.37 Saccharin, ammonium saccharin, calcium saccharin, and sodium
saccharin.
Authority: Secs. 201, 402, 403, 409, 701 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321, 342, 343, 348, 371); sec. 301 of the
Public Health Service Act (42 U.S.C. 241).
21 CFR 179.45 Subpart A -- General Provisions
21 CFR 180.1 General.
(a) Substances having a history of use in food for human consumption
or in food contact surfaces may at any time have their safety or
functionality brought into question by new information that in itself is
not conclusive. An interim food additive regulation for the use of any
such substance may be promulgated in this subpart when new information
raises a substantial question about the safety or functionality of the
substance but there is a reasonable certainty that the substance is not
harmful and that no harm to the public health will result from the
continued use of the substance for a limited period of time while the
question raised is being resolved by further study.
(b) No interim food additive regulation may be promulgated if the new
information is conclusive with respect to the question raised or if
there is a reasonable likelihood that the substance is harmful or that
continued use of the substance will result in harm to the public health.
(c) The Commissioner, on his own initiative or on the petition of any
interested person, pursuant to part 10 of this chapter, may propose an
interim food additive regulation. A final order promulgating an interim
food additive regulation shall provide that continued use of the
substance in food is subject to each of the following conditions:
(1) Use of the substance in food or food contact surfaces must comply
with whatever limitations the Commissioner deems to be appropriate under
the circumstances.
(2) Within 60 days following the effective date of the regulation, an
interested person shall satisfy the Commissioner in writing that studies
adequate and appropriate to resolve the questions raised about the
substance have been undertaken, or the Food and Drug Administration may
undertake the studies. The Commissioner may extend this 60-day period
if necessary to review and act on proposed protocols. If no such
commitment is made, or adequate and appropriate studies are not
undertaken, an order shall immediately be published in the Federal
Register revoking the interim food additive regulation effective upon
publication.
(3) A progress report shall be filed on the studies every January 1
and July 1 until completion. If the progress report is inadequate or if
the Commissioner concludes that the studies are not being pursued
promptly and diligently or if interim results indicate a reasonable
likelihood that a health hazard exists, an order will promptly be
published in the Federal Register revoking the interim food additive
regulation effective upon publication.
(4) If nonclinical laboratory studies are involved, studies filed
with the Commissioner shall include, with respect to each study, 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.
(5) (Reserved)
(6) If clinical investigations involving human subjects are involved,
such investigations filed with the Commissioner shall include, with
respect to each investigation, a statement that the investigation 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 has been
or will be conducted in compliance with the requirements for informed
consent set forth in part 50 of this chapter.
(d) Promptly upon completion of the studies undertaken on the
substance, the Commissioner will review all available data, will
terminate the interim food additive regulation, and will either issue a
food additive regulation or will require elimination of the substance
from the food supply.
(e) The Commissioner may consult with advisory committees,
professional organizations, or other experts in the field, in
evaluating:
(1) Whether an interim food additive regulation is justified,
(2) The type of studies necessary and appropriate to resolve
questions raised about a substance,
(3) Whether interim results indicate the reasonable likelihood that a
health hazard exists, or
(4) Whether the data available at the conclusion of those studies
justify a food additive regulation.
(f) Where appropriate, an emergency action level may be issued for a
substance subject to paragraph (a) of this section that is not an
approved food additive, pending the issuance of a final interim food
additive regulation. Such an action level shall be issued pursuant to
sections 306 and 402(a) of the act to identify, based upon available
data, a safe level of use for the substance. Such an action level shall
be issued in a notice published in the Federal Register and shall be
followed as soon as practicable by a proposed interim food additive
regulation. Where the available data do not permit establishing an
action level for the safe use of a substance, use of the substance may
be prohibited. The identification of a prohibited substance may be made
in part 189 of this chapter when appropriate.
(42 FR 14636, Mar. 15, 1977, as amended at 42 FR 15674, Mar. 22,
1977; 42 FR 52821, Sept. 30, 1977; 46 FR 8952, Jan. 27, 1981; 46 FR
14340, Feb. 27, 1981; 50 FR 7492, Feb. 22, 1985; 54 FR 39634, Sept.
27, 1989)
21 CFR 180.1 Subpart B -- Specific Requirements for Certain Food Additives
21 CFR 180.22 Acrylonitrile copolymers.
Acrylonitrile copolymers may be safely used on an interim basis as
articles or components of articles intended for use in contact with
food, in accordance with the following prescribed conditions:
(a) Limitations for acrylonitrile monomer extraction for finished
food-contact articles, determined by a method of analysis titled
''Gas-Solid Chromatographic Procedure for Determining Acrylonitrile
Monomer in Acrylonitrile-Containing Polymers and Food Simulating
Solvents,'' which is incorporated by reference. Copies are available
from the Division of Food and Color Additives, Center for Food Safety
and Applied Nutrition (HFF-330), 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, are as
follows:
(1) In the case of single-use articles having a volume to surface
ratio of 10 milliliters or more per square inch of food contact surface
-- 0.003 milligram/square inch when extracted to equilibrium at 120 F
with food-simulating solvents appropriate to the intended conditions of
use.
(2) In the case of single-use articles having a volume to surface
ratio of less than 10 milliliters per square inch of food contact
surface -- 0.3 part per million calculated on the basis of the volume of
the container when extracted to equilibrium at 120 F with
food-simulating solvents appropriate to the intended conditions of use.
(3) In the case of repeated-use articles -- 0.003 milligram/square
inch when extracted at a time equivalent to initial batch usage
utilizing food-simulating solvents and temperatures appropriate to the
intended conditions of use.
The food-simulating solvents shall include, where applicable,
distilled water, 8 percent or 50 percent ethanol, 3 percent acetic acid,
and either n-heptane or an appropriate oil or fat.
(b) Where necessary, current regulations permitting the use of
acrylonitrile copolymers shall be revised to specify limitations on
acrylonitrile/mercaptan complexes utilized in the production of
acrylonitrile copolymers. Such copolymers, if they contain reversible
acrylonitrile/mercaptan complexes and are used in other than
repeated-use conditions, shall be tested to determine the identity of
the complex and the level of the complex present in the food-contact
article. Such testing shall include determination of the rate of
decomposition of the complex at temperatures of 100 F, 160 F, and 212
F using 3 percent acetic acid as the hydrolic agent. Acrylonitrile
monomer levels, acrylonitrile/mercaptan complex levels, acrylonitrile
oligomer levels, descriptions of the analytical methods used to
determine the complex and the acrylonitrile migration, and validation
studies of these analytical methods shall be submitted by June 9, 1977,
to the Food and Drug Administration, Bureau of Foods, Division of Food
and Color Additives, 200 C St. SW., Washington, DC 20204, unless an
extension is granted by the Food and Drug Administration for good cause
shown. Analytical methods for the determination of acrylonitrile
complexes with n-dodecyl-mercaptan, n-octyl mercaptan, and
2-mercaptoethanol, titled ''Determination of
-Dodecyl-mercaptopropionitrile in NR-16R Aqueous Extracts'' and
''Measurement of -(2-Hdroxyethylmercapto) Propionitrile in Heptane
Food-Simulating Solvent,'' are incorporated by reference. Copies are
available from the Division of Food and Color Additives, Center for Food
Safety and Applied Nutrition (HFF-330), 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.
(c) The following data shall be provided for finished food-contact
articles intended for repeated use:
(1) Qualitative and quantitative migration values at a time
equivalent to initial batch usage, utilizing solvents and temperatures
appropriate to the intended conditions of use.
(2) Qualitative and quantitative migration values at the time of
equilibrium extractions, utilizing solvents and temperatures appropriate
to the intended conditions of use.
(3) Data on the volume and/or weight of food handled during the
initial batch time period(s), during the equilibrium test period, and
over the estimated life of the food-contact surface.
(d) Where acrylonitrile copolymers represent only a minor component
of a polymer system, calculations based on 100 percent migration of the
acrylonitrile component may be submitted in lieu of the requirements of
paragraphs (a), (b), and (c) of this section in support of the continued
safe use of acrylonitrile copolymers.
(e) On or before September 13, 1976, any interested person shall
satisfy the Commissioner of Food and Drugs that toxicological feeding
studies adequate and appropriate to establish safe conditions for the
use of acrylonitrile copolymers have been, or soon will be, undertaken.
Toxicity studies of acrylonitrile monomer shall include: (1) Lifetime
feeding studies with a mammalian species, preferably with animals
exposed in utero to the chemical, (2) studies of multigeneration
reproduction with oral administration of the test material, (3)
assessment of teratogenic and mutagenic potentials, (4) subchronic oral
administration in a nonrodent mammal, (5) tests to determine any
synergistic toxic effects between acrylonitrile monomer and cyanide ion,
and (6) a literature search on the effects of chronic ingestion of
hydrogen cyanide. Data on levels of acrylamide extractable from
acrylonitrile copolymers shall also be submitted. Protocols of testing
should be submitted for review to the Food and Drug Administration,
Center for Food Safety and Applied Nutrition, Division of Food and Color
Additives (HFF-330), 200 C St. SW., Washington, DC 20204.
(f) Acrylonitrile copolymers may be used in contact with food only if
authorized in parts 174 through 179 or 181.32 of this chapter, except
that other uses of acrylonitrile copolymers in use prior to June 14,
1976, may continue under the following conditions:
(1) On or before August 13, 1976, each use of acrylonitrile
copolymers in a manner not authorized by 181.32 of this chapter or
parts 174 through 179 of this chapter shall be the subject of a notice
to the Food and Drug Administration, Center for Food Safety and Applied
Nutrition, Division of Food and Color Additives (HFF-330), 200 C St.
SW., Washington, DC 20204. Such notice shall be accompanied by a
statement of the basis, including any articles and correspondence, on
which the user in good faith believed the use to be prior-sanctioned.
The Commissioner of Food and Drugs shall, by notice in the Federal
Register, identify any use of acrylonitrile copolymers not in accordance
with this paragraph. Those uses are thereafter unapproved food
additives and consequently unlawful.
(2) Any use of acrylonitrile copolymers subject to paragraph (f)(1)
of this section shall be the subject of a petition submitted on or
before December 13, 1976, in accordance with 171.1 of this chapter,
unless an extension of time is granted by the Food and Drug
Administration for good cause shown. Any application for extension
shall be by petition submitted in accordance with the requirements of
part 10 of this chapter. If a petition is denied, in whole or in part,
those uses subject to the denial are thereafter unapproved food
additives and consequently unlawful.
(3) Any use of acrylonitrile copolymers subject to paragraph (f)(1)
of this section shall meet the acrylonitrile monomer extraction
limitation set forth in paragraph (a) of this section and shall be
subject to the requirements of paragraph (b) of this section.
(g) In addition to the requirements of this section, the use of
acrylonitrile copolymers shall comply with all applicable requirements
in other regulations in this part.
(42 FR 14636, Mar. 15, 1977, as amended at 47 FR 11850, Mar. 19,
1982; 54 FR 24899, June 12, 1989)
21 CFR 180.25 Mannitol.
(a) Mannitol is the chemical 1,2,3,4,5, 6,-hexanehexol (C6H14O6) a
hexahydric alcohol, differing from sorbitol principally by having a
different optical rotation. Mannitol is produced by the electrolytic
reduction, or the transition metal catalytic hydrogenation, of sugar
solutions containing glucose or fructose.
(b) The ingredient meets the specifications of the ''Food Chemicals
Codex,'' 3d Ed. (1981), pp. 188-190, which is incorporated by
reference. 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.
(c) The ingredient is used as an anticaking agent and free-flow agent
as defined in 170.3(o)(1) of this chapter, formulation aid as defined
in 170.3(o) (14) of this chapter, firming agent as defined in
170.3(o)(10) of this chapter, flavoring agent and adjuvant as defined in
170.3(o)(12) of this chapter, lubricant and release agent as defined in
170.3(o)(18) of this chapter, nutritive sweetener as defined in
170.3(o)(21) of this chapter, processing aid as defined in 170.3(o)(24)
of this chapter, stabilizer and thickener as defined in 170.3(o)(28) of
this chapter, surface-finishing agent as defined in 170.3(o)(30) of
this chapter, and texturizer as defined in 170.3(o)(32) of this
chapter.
(d) The ingredient is used in food at levels not to exceed 98 percent
in pressed mints and 5 percent in all other hard candy and cough drops
as defined in 170.3(n)(25) of this chapter, 31 percent in chewing gum
as defined in 170.3(n)(6) of this chapter, 40 percent in soft candy as
defined in 170.3(n)(38) of this chapter, 8 percent in confections and
frostings as defined in 170.3(n)(9) of this chapter, 15 percent in
nonstandardized jams and jellies, commercial, as defined in
170.3(n)(28) of this chapter, and at levels less than 2.5 percent in all
other foods.
(e) The label and labeling of food whose reasonably foreseeable
consumption may result in a daily ingestion of 20 grams of mannitol
shall bear the statement ''Excess consumption may have a laxative
effect''.
(f) In accordance with 180.1, adequate and appropriate feeding
studies have been undertaken for this substance. Continued uses of this
ingredient are contingent upon timely and adequate progress reports of
such tests, and no indication of increased risk to public health during
the test period.
(g) Prior sanctions for this ingredient different from the uses
established in this regulation do not exist or have been waived.
(42 FR 14636, Mar. 15, 1977, as amended at 49 FR 5610, Feb. 14, 1984)
21 CFR 180.30 Brominated vegetable oil.
The food additive brominated vegetable oil may be safely used in
accordance with the following prescribed conditions:
(a) The additive complies with specifications prescribed in the
''Food Chemicals Codex,'' 3d Ed. (1981), pp. 40-41, which is
incorporated by reference, except that free fatty acids (as oleic) shall
not exceed 2.5 percent and iodine value shall not exceed 16. Copies of
the material incorporated by reference 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 20418.
(b) The additive is used on an interim basis as a stabilizer for
flavoring oils used in fruit-flavored beverages, for which any
applicable standards of identity do not preclude such use, in an amount
not to exceed 15 parts per million in the finished beverage, pending the
outcome of additional toxicological studies on which periodic reports at
6-month intervals are to be furnished and final results submitted to the
Food and Drug Administration promptly after completion of the studies.
(42 FR 14636, Mar. 15, 1977, as amended at 49 FR 5610, Feb. 14, 1984)
21 CFR 180.37 Saccharin, ammonium saccharin, calcium saccharin, and
sodium saccharin.
The food additives saccharin, ammonium saccharin, calcium saccharin,
and sodium saccharin may be safely used as sweetening agents in food in
accordance with the following conditions, if the substitution for
nutritive sweeteners is for a valid special dietary purpose and is in
accord with current special dietary food regulations and policies or if
the use or intended use is for an authorized technological purpose other
than calorie reduction:
(a) Saccharin is the chemical, 1,2-benzisothiazolin-3-one - 1,1 -
dioxide (C7H5NO3S). The named salts of saccharin are produced by the
additional neutralization of saccharin with the proper base to yield the
desired salt.
(b) The food additives meet the specifications of the ''Food
Chemicals Codex,'' 3d Ed. (1981), pp. 22, 62, 266-267, 297-299, which
is incorporated by reference. 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.
(c) Authority for such use shall expire when the Commissioner
receives the final reports on the ongoing studies in Canada and
publishes an order on the safety of saccharin and its salts based on
those reports and other available data.
(d) The additives are used or intended for use as a sweetening agent
only in special dietary foods, as follows:
(1) In beverages, fruit juice drinks, and bases or mixes when
prepared for consumption in accordance with directions, in amounts not
to exceed 12 milligrams of the additive, calculated as saccharin, per
fluid ounce.
(2) As a sugar substitute for cooking or table use, in amounts not to
exceed 20 milligrams of the additive, calculated as saccharin, for each
expressed teaspoonful of sugar sweetening equivalency.
(3) In processed foods, in amounts not to exceed 30 milligrams of the
additive, calculated as saccharin, per serving of designated size.
(e) The additives are used or intended for use only for the following
technological purposes:
(1) To reduce bulk and enhance flavors in chewable vitamin tablets,
chewable mineral tablets, or combinations thereof.
(2) To retain flavor and physical properties of chewing gum.
(3) To enhance flavor of flavor chips used in nonstandardized bakery
products.
(f) To assure safe use of the additives, in addition to the other
information required by the Act:
(1) The label of the additive and any intermediate mixes of the
additive for manufacturing purposes shall bear:
(i) The name of the additive.
(ii) A statement of the concentration of the additive, expressed as
saccharin, in any intermediate mix.
(iii) Adequate directions for use to provide a final food product
that complies with the limitations prescribed in paragraphs (d) and (e)
of this section.
(2) The label of any finished food product containing the additive
shall bear:
(i) The name of the additive.
(ii) The amount of the additive, calculated as saccharin, as follows:
(a) For beverages, in milligrams per fluid ounce;
(b) For cooking or table use products, in milligrams per dispensing
unit;
(c) For processed foods, in terms of the weight or size of a serving
which shall be that quantity of the food containing 30 milligrams or
less of the additive.
(iii) When the additive is used for calorie reduction, such other
labeling as is required by part 105 or 100.130 of this chapter.
(42 FR 14636, Mar. 15, 1977, as amended at 49 FR 5610, Feb. 14, 1984)
21 CFR 180.37 PART 181 -- PRIOR-SANCTIONED FOOD INGREDIENTS
21 CFR 180.37 Pt. 181
21 CFR 180.37 Subpart A -- General Provisions
Sec.
181.1 General.
181.5 Prior sanctions.
21 CFR 180.37 Subpart B -- Specific Prior-Sanctioned Food Ingredients
181.22 Certain substances employed in the manufacture of
food-packaging materials.
181.23 Antimycotics.
181.24 Antioxidants.
181.25 Driers.
181.26 Drying oils as components of finished resins.
181.27 Plasticizers.
181.28 Release agents.
181.29 Stabilizers.
181.30 Substances used in the manufacture of paper and paperboard
products used in food packaging.
181.32 Acrylonitrile copolymers and resins.
181.33 Sodium nitrate and potassium nitrate.
181.34 Sodium nitrite and potassium nitrite.
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 14638, Mar. 15, 1977, unless otherwise noted.
21 CFR 180.37 Subpart A -- General Provisions
21 CFR 181.1 General.
(a) An ingredient whose use in food or food packaging is subject to a
prior sanction or approval within the meaning of section 201(s)(4) of
the Act is exempt from classification as a food additive. The
Commissioner will publish in this part all known prior sanctions. Any
interested person may submit to the Commissioner a request for
publication of a prior sanction, supported by evidence to show that it
falls within section 201(s)(4) of the Act.
(b) Based upon scientific data or information that shows that use of
a prior-sanctioned food ingredient may be injurious to health, and thus
in violation of section 402 of the Act, the Commissioner will establish
or amend an applicable prior sanction regulation to impose whatever
limitations or conditions are necessary for the safe use of the
ingredient, or to prohibit use of the ingredient.
(c) Where appropriate, an emergency action level may be issued for a
prior-sanctioned substance, pending the issuance of a final regulation
in accordance with paragraph (b) of this section. Such an action level
shall be issued pursuant to section 402(a) of the Act to identify, based
upon available data, conditions of use of the substance that may be
injurious to health. Such an action level shall be issued in a notice
published in the Federal Register and shall be followed as soon as
practicable by a proposed regulation in accordance with paragraph (b) of
this section. Where the available data demonstrate that the substance
may be injurious at any level, use of the substance may be prohibited.
The identification of a prohibited substance may be made in part 189 of
this chapter when appropriate.
(42 FR 14638, Mar. 15, 1977, as amended at 42 FR 52821, Sept. 30,
1977; 54 FR 39635, Sept. 27, 1989)
21 CFR 181.5 Prior sanctions.
(a) A prior sanction shall exist only for a specific use(s) of a
substance in food, i.e., the level(s), condition(s), product(s), etc.,
for which there was explicit approval by the Food and Drug
Administration or the United States Department of Agriculture prior to
September 6, 1958.
(b) The existence of a prior sanction exempts the sanctioned use(s)
from the food additive provisions of the Act but not from the other
adulteration or the misbranding provisions of the Act.
(c) All known prior sanctions shall be the subject of a regulation
published in this part. Any such regulation is subject to amendment to
impose whatever limitation(s) or condition(s) may be necessary for the
safe use of the ingredient, or revocation to prohibit use of the
ingredient, in order to prevent the adulteration of food in violation of
section 402 of the Act.
(d) In proposing, after a general evaluation of use of an ingredient,
regulations affirming the GRAS status of substances added directly to
human food in part 184 of this chapter or substances in food-contact
surfaces in part 186 of this chapter, or establishing a food additive
regulation for substances added directly to human food in parts 172 and
173 of this chapter or food additives in food-contact surfaces in parts
174, 175, 176, 177, 178 and 179.45 of this chapter, the Commissioner
shall, if he is aware of any prior sanction for use of the ingredient
under conditions different from those proposed in the regulation,
concurrently propose a separate regulation covering such use of the
ingredient under this part. 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 food additive or GRAS regulation
promulgated after a general evaluation of use of an ingredient
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 a 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 this
part, 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.
21 CFR 181.5 Subpart B -- Specific Prior-Sanctioned Food Ingredients
21 CFR 181.22 Certain substances employed in the manufacture of
food-packaging materials.
Prior to the enactment of the food additives amendment to the Federal
Food, Drug, and Cosmetic Act, sanctions were granted for the usage of
the substances listed in 181.23, 181.24, 181.25, 181.26, 181.27,
181.28, 181.29, and 181.30 in the manufacture of packaging materials.
So used, these substances are not considered ''food additives'' within
the meaning of section 201(s) of the Act, provided that they are of good
commercial grade, are suitable for association with food, and are used
in accordance with good manufacturing practice. For the purpose of this
subpart, good manufacturing practice for food-packaging materials
includes the restriction that the quantity of any of these substances
which becomes a component of food as a result of use in food-packaging
materials shall not be intended to accomplish any physical or technical
effect in the food itself, shall be reduced to the least amount
reasonably possible, and shall not exceed any limit specified in this
subpart.
(42 FR 56728, Oct. 28, 1977)
21 CFR 181.23 Antimycotics.
Substances classified as antimycotics, when migrating from
food-packaging material shall include:
Calcium propionate.
Methylparaben (methyl p-hydroxybenzoate).
Propylparaben (propyl p-hydroxybenzoate).
Sodium benzoate.
Sodium propionate.
Sorbic acid.
(42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977)
21 CFR 181.24 Antioxidants.
Substances classified as antioxidants, when migrating from
food-packaging material (limit of addition to food, 0.005 percent) shall
include:
Butylated hydroxyanisole.
Butylated hydroxytoluene.
Dilauryl thiodipropionate.
Distearyl thiodipropionate.
Gum guaiac.
Nordihydroguairetic acid.
Propyl gallate.
Thiodipropionic acid.
2,4,5-Trihydroxy butyrophenone.
(42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977)
21 CFR 181.25 Driers.
Substances classified as driers, when migrating from food-packaging
material shall include:
Cobalt caprylate.
Cobalt linoleate.
Cobalt naphthenate.
Cobalt tallate.
Iron caprylate.
Iron linoleate.
Iron naphthenate.
Iron tallate.
Manganese caprylate.
Manganese linoleate.
Manganese naphthenate.
Manganese tallate.
(42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977)
21 CFR 181.26 Drying oils as components of finished resins.
Substances classified as drying oils, when migrating from
food-packaging material (as components of finished resins) shall
include:
Chinawood oil (tung oil).
Dehydrated castor oil.
Linseed oil.
Tall oil.
(42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977)
21 CFR 181.27 Plasticizers.
Substances classified as plasticizers, when migrating from
food-packaging material shall include:
Acetyl tributyl citrate.
Acetyl triethyl citrate.
p-tert-Butylphenyl salicylate.
Butyl stearate.
Butylphthalyl butyl glycolate.
Dibutyl sebacate.
Di-(2-ethylhexyl) phthalate (for foods of high water content only).
Diethyl phthalate.
Diisobutyl adipate.
Diisooctyl phthalate (for foods of high water content only).
Diphenyl-2-ethylhexyl phosphate.
Epoxidized soybean oil (iodine number maximum 6; and oxirane oxygen,
minimum, 6.0 percent).
Ethylphthalyl ethyl glycolate.
Glycerol monooleate.
Monoisopropyl citrate.
Mono, di-, and tristearyl citrate.
Triacetin (glycerol triacetate).
Triethyl citrate.
3-(2-Xenolyl)-1,2-epoxypropane.
(42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977, as amended
at 50 FR 49536, Dec. 3, 1985)
21 CFR 181.28 Release agents.
Substances classified as release agents, when migrating from
food-packaging material shall include:
Dimethylpolysiloxane (substantially free from hydrolyzable chloride
and alkoxy groups, no more than 18 percent loss in weight after heating
4 hours at 200 C.; viscosity 300 centisokes, 600 centisokes at 25 C,
specific gravity 0.96 to 0.97 at 25 C, refractive index 1.400 to 1.404
at 25 C).
Linoleamide (linoleic acid amide).
Oleamide (oleic acid amide).
Palmitamide (palmitic acid amide).
Stearamide (stearic acid amide).
(42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977)
21 CFR 181.29 Stabilizers.
Substances classified as stabilizers, when migrating from
food-packaging material shall include:
Aluminum mono-, di-, and tristearate.
Ammonium citrate.
Ammonium potassium hydrogen phosphate.
Calcium glycerophosphate.
Calcium phosphate.
Calcium hydrogen phosphate.
Calcium oleate.
Calcium acetate.
Calcium carbonate.
Calcium ricinoleate.
Calcium stearate.
Disodium hydrogen phosphate.
Magnesium glycerophosphate.
Magnesium stearate.
Magnesium phosphate.
Magnesium hydrogen phosphate.
Mono-, di-, and trisodium citrate.
Mono-, di-, and tripotassium citrate.
Potassium oleate.
Potassium stearate.
Sodium pyrophosphate.
Sodium stearate.
Sodium tetrapyrophosphate.
Stannous stearate (not to exceed 50 parts per million tin as a
migrant in finished food).
Zinc orthophosphate (not to exceed 50 parts per million zinc as a
migrant in finished food).
Zinc resinate (not to exceed 50 parts per million zinc as a migrant
in finished food).
(42 FR 14638, Mar. 15, 1977; 42 FR 56728, Oct. 28, 1977)
21 CFR 181.30 Substances used in the manufacture of paper and
paperboard products used in food packaging.
Substances used in the manufacture of paper and paperboard products
used in food packaging shall include:
Aliphatic polyoxyethylene ethers.*067
1-Alkyl (C6-C18)3-amino-3-aminopropane monoacetate.*
Borax or boric acid for use in adhesives, sizes, and coatings.*
Butadiene-styrene copolymer.
Chromium complex of perfluoro-octane sulfonyl glycine for use on
paper and paperboard which is waxed.*
Disodium cyanodithioimidocarbamate with ethylene diamine and
potassium N-methyl dithiocarbamate and/or sodium 2-mercaptobenzothiazole
(slimicides).*
Ethyl acrylate and methyl methacrylate copolymers of itaconic acid or
methacrylic acid for use only on paper and paperboard which is waxed.*
Hexamethylene tetramine as a setting agent for protein, including
casein.*
1-(2-Hydroxyethyl)-1-(4-chlorobutyl)-2-alkyl (C6-C17) imidazolinium
chloride.*
Itaconic acid (polymerized).
Melamine formaldehyde polymer.
Methyl acrylate (polymerized).
Methyl ethers or mono-, di-, and tripropylene glycol.*
Myristo chromic chloride complex.
Nitrocellulose.
Polyethylene glycol 400.
Polyvinyl acetate.
Potassium pentachlorophenate as a slime control agent.*
Potassium trichlorophenate as a slime control agent.*
Resins from high and low viscosity polyvinyl alcohol for fatty foods
only.
Rubber hydrochloride.
Sodium pentachlorophenate as a slime control agent.*
Sodium-trichlorophenate as a slime control agent.*
Stearato-chromic chloride complex.
Titanium dioxide.*
Urea formaldehyde polymer.
Vinylidine chlorides (polymerized).
067*Under the conditions of normal use, these substances would not
reasonably be expected to migrate to food, based on available scientific
information and data.
21 CFR 181.32 Acrylonitrile copolymers and resins.
(a) Acrylonitrile copolymers and resins listed in this section,
containing less than 30 percent acrylonitrile and complying with the
requirements of paragraph (b) of this section, may be safely used as
follows:
(1) Films. (i) Acrylonitrile/butadiene/styrene copolymers -- no
restrictions.
(ii) Acrylonitrile/butadiene copolymers -- no restrictions.
(iii) Acrylonitrile/butadiene copolymer blended with vinyl
chloride-vinyl acetate (optional at level up to 5 percent by weight of
the vinyl chloride resin) resin -- for use only in contact with
oleomargarine.
(iv) Acrylonitrile/styrene copolymer -- no restrictions.
(2) Coatings. (i) Acrylonitrile/butadiene copolymer blended with
polyvinyl chloride resins -- for use only on paper and paperboard in
contact with meats and lard.
(ii) Polyvinyl chloride resin blended with either
acrylonitrile/butadiene copolymer or acrylonitrile/butadiene styrene
copolymer mixed with neoprene, for use as components of conveyor belts
to be used with fresh fruits, vegetables, and fish.
(iii) Acrylonitrile/butadiene/styrene copolymer -- no restrictions.
(iv) Acrylonitrile/styrene copolymer -- no restrictions.
(3) Rigid and semirigid containers. (i)
Acrylonitrile/butadiene/styrene copolymer -- for use only as piping for
handling food products and for repeated-use articles intended to contact
food.
(ii) Acrylonitrile/styrene resin -- no restrictions.
(iii) Acrylonitrile/butadiene copolymer blended with polyvinyl
chloride resin -- for use only as extruded pipe.
(b) Limitations for acrylonitrile monomer extraction for finished
food-contact articles, determined by using the method of analysis titled
''Gas-Solid Chromatographic Procedure for Determining Acrylonitrile
Monomer in Acrylonitrile-Containing Polymers and Food-Simulating
Solvents,'' which is incorporated by reference. Copies are available
from the Division of Food and Color Additives, Center for Food Safety
and Applied Nutrition (HFF-330), 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, are as
follows:
(1) In the case of single-use articles having a volume to surface
ratio of 10 milliliters or more per square inch of food-contact surface
-- 0.003 milligram/square inch when extracted to equilibrium at 120 F
with food-simulating solvents appropriate to the intended conditions of
use.
(2) In the case of single-use articles having a volume to surface
ratio of less than 10 milliliters per square inch of food-contact
surface -- 0.3 part per million calculated on the basis of the volume of
the container when extracted to equilibrium at 120 F with
food-simulating solvents appropriate to the intended conditions of use.
(3) In the case of repeated-use articles -- 0.003 milligram/square
inch when extracted at a time equivalent to initial batch usage
utilizing food-simulating solvents and temperatures appropriate to the
intended conditions of use.
The food-simulating solvents shall include, where applicable,
distilled water, 8 percent or 50 percent ethanol, 3 percent acetic acid,
and either n-heptane or an appropriate oil or fat.
(c) Acrylonitrile monomer may present a hazard to health when
ingested. Accordingly, any food-contact article containing
acrylonitrile copolymers or resins that yield acrylonitrile monomer in
excess of that amount provided for in paragraph (b) of this section
shall be deemed to be adulterated in violation of section 402 of the
Act.
(42 FR 14638, Mar. 15, 1977, as amended at 47 FR 11850, Mar. 19,
1982; 54 FR 24899, June 12, 1989)
21 CFR 181.33 Sodium nitrate and potassium nitrate.
Sodium nitrate and potassium nitrate are subject to prior sanctions
issued by the U.S. Department of Agriculture for use as sources of
nitrite, with or without sodium or potassium nitrite, in the production
of cured red meat products and cured poultry products.
(48 FR 1705, Jan. 14, 1983)
21 CFR 181.34 Sodium nitrite and potassium nitrite.
Sodium nitrite and potassium nitrite are subject to prior sanctions
issued by the U.S. Department of Agriculture for use as color fixatives
and preservative agents, with or without sodium or potassium nitrate, in
the curing of red meat and poultry products.
(48 FR 1705, Jan. 14, 1983)
21 CFR 181.34 Pt. 182
21 CFR 181.34 PART 182 -- SUBSTANCES GENERALLY RECOGNIZED AS SAFE
21 CFR 181.34 Subpart A -- General Provisions
Sec.
182.1 Substances that are generally recognized as safe.
182.10 Spices and other natural seasonings and flavorings.
182.20 Essential oils, oleoresins (solvent-free), and natural
extractives (including distillates).
182.40 Natural extractives (solvent-free) used in conjunction with
spices, seasonings, and flavorings.
182.50 Certain other spices, seasonings, essential oils, oleoresins,
and natural extracts.
182.60 Synthetic flavoring substances and adjuvants.
182.70 Substances migrating from cotton and cotton fabrics used in
dry food packaging.
182.90 Substances migrating to food from paper and paperboard
products.
182.99 Adjuvants for pesticide chemicals.
21 CFR 181.34 Subpart B -- Multiple Purpose GRAS Food Substances
182.1033 Citric acid.
182.1045 Glutamic acid.
182.1047 Glutamic acid hydrochloride.
182.1057 Hydrochloric acid.
182.1073 Phosphoric acid.
182.1087 Sodium acid pyrophosphate.
182.1125 Aluminum sulfate.
182.1127 Aluminum ammonium sulfate.
182.1129 Aluminum potassium sulfate.
182.1131 Aluminum sodium sulfate.
182.1180 Caffeine.
182.1195 Calcium citrate.
182.1217 Calcium phosphate.
182.1235 Caramel.
182.1320 Glycerin.
182.1480 Methylcellulose.
182.1500 Monoammonium glutamate.
182.1516 Monopotassium glutamate.
182.1625 Potassium citrate.
182.1711 Silica aerogel.
182.1745 Sodium carboxymethylcellulose.
182.1748 Sodium caseinate.
182.1751 Sodium citrate.
182.1778 Sodium phosphate.
182.1781 Sodium aluminum phosphate.
182.1810 Sodium tripolyphosphate.
182.1866 High fructose corn syrup.
182.1911 Triethyl citrate.
21 CFR 181.34 Subpart C -- Anticaking Agents
182.2122 Aluminum calcium silicate.
182.2227 Calcium silicate.
182.2437 Magnesium silicate.
182.2727 Sodium aluminosilicate.
182.2729 Sodium calcium aluminosilicate, hydrated.
182.2906 Tricalcium silicate.
21 CFR 181.34 Subpart D -- Chemical Preservatives
182.3013 Ascorbic acid.
182.3041 Erythorbic acid.
182.3089 Sorbic acid.
182.3109 Thiodipropionic acid.
182.3149 Ascorbyl palmitate.
182.3169 Butylated hydroxyanisole.
182.3173 Butylated hydroxytoluene.
182.3189 Calcium ascorbate.
182.3225 Calcium sorbate.
182.3280 Dilauryl thiodipropionate.
182.3616 Potassium bisulfite.
182.3637 Potassium metabisulfite.
182.3640 Potassium sorbate.
182.3731 Sodium ascorbate.
182.3739 Sodium bisulfite.
182.3766 Sodium metabisulfite.
182.3795 Sodium sorbate.
182.3798 Sodium sulfite.
182.3862 Sulfur dioxide.
182.3890 Tocopherols.
21 CFR 181.34 Subpart E -- Emulsifying Agents (Reserved)
21 CFR 181.34 Subpart F -- Dietary Supplements
182.5013 Ascorbic acid.
182.5065 Linoleic acid.
182.5159 Biotin.
182.5191 Calcium carbonate.
182.5195 Calcium citrate.
182.5201 Calcium glycerophosphate.
182.5210 Calcium oxide.
182.5212 Calcium pantothenate.
182.5217 Calcium phosphate.
182.5223 Calcium pyrophosphate.
182.5245 Carotene.
182.5250 Choline bitartrate.
182.5252 Choline chloride.
182.5260 Copper gluconate.
182.5301 Ferric phosphate.
182.5304 Ferric pyrophosphate.
182.5306 Ferric sodium pyrophosphate.
182.5308 Ferrous gluconate.
182.5311 Ferrous lactate.
182.5315 Ferrous sulfate.
182.5370 Inositol.
182.5375 Iron reduced.
182.5431 Magnesium oxide.
182.5434 Magnesium phosphate.
182.5443 Magnesium sulfate.
182.5446 Manganese chloride.
182.5449 Manganese citrate.
182.5452 Manganese gluconate.
182.5455 Manganese glycerophosphate.
182.5461 Manganese sulfate.
182.5464 Manganous oxide.
182.5530 Niacin.
182.5535 Niacinamide.
182.5580 D-Pantothenyl alcohol.
182.5622 Potassium chloride.
182.5628 Potassium glycerophosphate.
182.5676 Pyridoxine hydrochloride.
182.5695 Riboflavin.
182.5697 Riboflavin-5-phosphate.
182.5772 Sodium pantothenate.
182.5778 Sodium phosphate.
182.5875 Thiamine hydrochloride.
182.5878 Thiamine mononitrate.
182.5890 Tocopherols.
182.5892 a-Tocopherol acetate.
182.5930 Vitamin A.
182.5933 Vitamin A acetate.
182.5936 Vitamin A palmitate.
182.5945 Vitamin B12.
182.5950 Vitamin D2.
182.5953 Vitamin D3.
182.5985 Zinc chloride.
182.5988 Zinc gluconate.
182.5991 Zinc oxide.
182.5994 Zinc stearate.
182.5997 Zinc sulfate.
21 CFR 181.34 Subpart G -- Sequestrants
182.6033 Citric acid.
182.6085 Sodium acid phosphate.
182.6195 Calcium citrate.
182.6197 Calcium diacetate.
182.6203 Calcium hexametaphosphate.
182.6215 Monobasic calcium phosphate.
182.6285 Dipotassium phosphate.
182.6290 Disodium phosphate.
182.6386 Isopropyl citrate.
182.6511 Monoisopropyl citrate.
182.6625 Potassium citrate.
182.6751 Sodium citrate.
182.6757 Sodium gluconate.
182.6760 Sodium hexametaphosphate.
182.6769 Sodium metaphosphate.
182.6778 Sodium phosphate.
182.6787 Sodium pyrophosphate.
182.6789 Tetra sodium pyrophosphate.
182.6810 Sodium tripolyphosphate.
182.6851 Stearyl citrate.
21 CFR 181.34 Subpart H -- Stabilizers
182.7255 Chondrus extract.
21 CFR 181.34 Subpart I -- Nutrients
182.8013 Ascorbic acid.
182.8159 Biotin.
182.8195 Calcium citrate.
182.8217 Calcium phosphate.
182.8223 Calcium pyrophosphate.
182.8250 Choline bitartrate.
182.8252 Choline chloride.
182.8458 Manganese hypophosphite.
182.8778 Sodium phosphate.
182.8890 Tocopherols.
182.8892 a-Tocopherol acetate.
182.8985 Zinc chloride.
182.8988 Zinc gluconate.
182.8991 Zinc oxide.
182.8994 Zinc stearate.
182.8997 Zinc sulfate.
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 14640, Mar. 15, 1977, unless otherwise noted.
21 CFR 181.34 Subpart A -- General Provisions
21 CFR 182.1 Substances that are generally recognized as safe.
(a) It is impracticable to list all substances that are generally
recognized as safe for their intended use. However, by way of
illustration, the Commissioner regards such common food ingredients as
salt, pepper, vinegar, baking powder, and monosodium glutamate as safe
for their intended use. This part includes additional substances that,
when used for the purposes indicated, in accordance with good
manufacturing practice, are regarded by the Commissioner as generaly
recognized as safe for such uses.
(b) For the purposes of this section, good manufacturing practice
shall be defined to include the following restrictions:
(1) The quantity of a substance added to food does not exceed the
amount reasonably required to accomplish its intended physical,
nutritional, or other technical effect in food; and
(2) The quantity of a substance that becomes a component of food as a
result of its use in the manufacturing, processing, or packaging of
food, and which is not intended to accomplish any physical or other
technical effect in the food itself, shall be reduced to the extent
reasonably possible.
(3) The substance is of appropriate food grade and is prepared and
handled as a food ingredient. Upon request the Commissioner will offer
an opinion, based on specifications and intended use, as to whether or
not a particular grade or lot of the substance is of suitable purity for
use in food and would generally be regarded as safe for the purpose
intended, by experts qualified to evaluate its safety.
(c) The inclusion of substances in the list of nutrients does not
constitute a finding on the part of the Department that the substance is
useful as a supplement to the diet for humans.
(d) Substances that are generally recognized as safe for their
intended use within the meaning of section 409 of the act are listed in
this part. When the status of a substance has been reevaluated, it will
be deleted from this part, and will be issued as a new regulation under
the appropriate part, e.g., ''affirmed as GRAS'' under part 184 or 186
of this chapter; ''food additive regulation'' under parts 170 through
180 of this chapter; ''interim food additive regulation'' under part
180 of this chapter; or ''prohibited from use in food'' under part 189
of this chapter.
(42 FR 14640, Mar. 15, 1977, as amended at 53 FR 44875, Nov. 7, 1988)
21 CFR 182.10 Spices and other natural seasonings and flavorings.
Spices and other natural seasonings and flavorings that are generally
recognized as safe for their intended use, within the meaning of section
409 of the Act, are as follows:
(42 FR 14640, Mar. 15, 1977, as amended at 43 FR 3705, Jan. 27, 1978;
44 FR 3963, Jan. 19, 1979; 50 FR 21044, May 22, 1985)
21 CFR 182.20 Essential oils, oleoresins (solvent-free), and natural
extractives (including distillates).
Essential oils, oleoresins (solvent-free), and natural extractives
(including distillates) that are generally recognized as safe for their
intended use, within the meaning of section 409 of the Act, are as
follows:
(42 FR 14640, Mar. 15, 1977, as amended at 44 FR 3963, Jan. 19, 1979;
47 FR 29953, July 9, 1982; 48 FR 51613, Nov. 10, 1983; 50 FR 21043
and 21044, May 22, 1985)
21 CFR 182.40 Natural extractives (solvent-free) used in conjunction
with spices, seasonings, and flavorings.
Natural extractives (solvent-free) used in conjunction with spices,
seasonings, and flavorings that are generally recognized as safe for
their intended use, within the meaning of section 409 of the Act, are as
follows:
(42 FR 14640, Mar. 15, 1977, as amended at 47 FR 47375, Oct. 26,
1982)
21 CFR 182.50 Certain other spices, seasonings, essential oils,
oleoresins, and natural extracts.
Certain other spices, seasonings, essential oils, oleoresins, and
natural extracts that are generally recognized as safe for their
intended use, within the meaning of section 409 of the Act, are as
follows:
21 CFR 182.60 Synthetic flavoring substances and adjuvants.
Synthetic flavoring substances and adjuvants that are generally
recognized as safe for their intended use, within the meaning of section
409 of the Act, are as follows:
Acetaldehyde (ethanal).
Acetoin (acetyl methylcarbinol).
Anethole (parapropenyl anisole).
Benzaldehyde (benzoic aldehyde).
N-Butyric acid (butanoic acid).
d- or l-Carvone (carvol).
Cinnamaldehyde (cinnamic aldehyde).
Citral (2,6-dimethyloctadien-2,6-al-8, gera-nial, neral).
Decanal (N-decylaldehyde, capraldehyde, capric aldehyde,
caprinaldehyde, aldehyde C-10).
Ethyl acetate.
Ethyl butyrate.
3-Methyl-3-phenyl glycidic acid ethyl ester
(ethyl-methyl-phenyl-glycidate, so-called strawberry aldehyde, C-16
aldehyde).
Ethyl vanillin.
Geraniol (3,7-dimethyl-2,6 and 3,6-octadien-1-ol).
Geranyl acetate (geraniol acetate).
Limonene (d-, l-, and dl-).
Linalool (linalol, 3,7-dimethyl-1,6-octadien-3-ol).
Linalyl acetate (bergamol).
Methyl anthranilate (methyl-2-aminobenzoate).
Piperonal (3,4-methylenedioxy-benzaldehyde, heliotropin).
Vanillin.
(42 FR 14640, Mar. 15, 1977, as amended at 43 FR 47724, Oct. 17,
1978; 44 FR 3963, Jan. 19, 1979; 44 FR 20656, Apr. 6, 1979; 48 FR
51907, Nov. 15, 1983; 54 FR 7402, Feb. 21, 1989)
21 CFR 182.70 Substances migrating from cotton and cotton fabrics used
in dry food packaging.
Substances migrating to food from cotton and cotton fabrics used in
dry food packaging that are generally recognized as safe for their
intended use, within the meaning of section 409 of the Act, are as
follows:
Beef tallow.
Carboxymethylcellulose.
Coconut oil, refined.
Cornstarch.
Gelatin.
Japan wax.
Lard.
Lard oil.
Oleic acid.
Peanut oil.
Potato starch.
Sodium acetate.
Sodium chloride.
Sodium silicate.
Sodium tripolyphosphate.
Soybean oil (hydrogenated).
Talc.
Tallow (hydrogenated).
Tallow flakes.
Tapioca starch.
Tetrasodium pyrophosphate.
Wheat starch.
Zinc chloride.
(42 FR 14640, Mar. 15, 1977, as amended at 43 FR 11698, Mar. 21,
1978; 44 FR 28323, May 15, 1979; 45 FR 6085, Jan. 25, 1980; 47 FR
27807, 27814, June 25, 1982; 48 FR 51150, Nov. 7, 1983; 48 FR 51616,
Nov. 10, 1983; 48 FR 51909, Nov. 15, 1983; 48 FR 52441, 52443, 52445,
52446, Nov. 18, 1983; 51 FR 16830, May 7, 1986; 51 FR 27171, July 30,
1986)
21 CFR 182.90 Substances migrating to food from paper and paperboard
products.
Substances migrating to food from paper and paperboard products used
in food packaging that are generally recognized as safe for their
intended use, within the meaning of section 409 of the Act, are as
follows:
Alum (double sulfate of aluminum and ammonium potassium, or sodium).
Aluminum hydroxide.
Aluminum oleate.
Aluminum palmitate.
Casein.
Cellulose acetate.
Cornstarch.
Diatomaceous earth filler.
Ethyl cellulose.
Ethyl vanillin.
Glycerin.
Oleic acid.
Potassium sorbate.
Silicon dioxides.
Sodium aluminate.
Sodium chloride.
Sodium hexametaphosphate.
Sodium hydrosulfite.
Sodium phosphoaluminate.
Sodium silicate.
Sodium sorbate.
Sodium tripolyphosphate.
Sorbitol.
Soy protein, isolated.
Starch, acid modified.
Starch, pregelatinized.
Starch, unmodified.
Talc.
Vanillin.
Zinc hydrosulfite.
Zinc sulfate.
(42 FR 14640, Mar. 15, 1977)
Editorial Note: For additional Federal Register citations affecting
182.90, see the List of CFR Sections Affected in the Finding Aids
section of this volume.
21 CFR 182.99 Adjuvants for pesticide chemicals.
Adjuvants, identified and used in accordance with 40 CFR 180.1001 (c)
and (d), which are added to pesticide use dilutions by a grower or
applicator prior to application to the raw agricultural commodity, are
exempt from the requirement of tolerances under section 409 of the Act.
21 CFR 182.99 Subpart B -- Multiple Purpose GRAS Food Substances
21 CFR 182.1033 Citric acid.
(a) Product. Citric acid.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.1045 Glutamic acid.
(a) Product. Glutamic acid.
(b) (Reserved)
(c) Limitations, restrictions, or explanation. This substance is
generally recognized as safe when used as a salt substitute in
accordance with good manufacturing practice.
21 CFR 182.1047 Glutamic acid hydrochloride.
(a) Product. Glutamic acid hydrochloride.
(b) (Reserved)
(c) Limitations, restrictions, or explanation. This substance is
generally recognized as safe when used as a salt substitute in
accordance with good manufacturing practice.
21 CFR 182.1057 Hydrochloric acid.
(a) Product. Hydrochloric acid.
(b) (Reserved)
(c) Limitations, restrictions, or explanation. This substance is
generally recognized as safe when used as a buffer and neutralizing
agent in accordance with good manufacturing practice.
21 CFR 182.1073 Phosphoric acid.
(a) Product. Phosphoric acid.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.1087 Sodium acid pyrophosphate.
(a) Product. Sodium acid pyrophosphate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.1125 Aluminum sulfate.
(a) Product. Aluminum sulfate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.1127 Aluminum ammonium sulfate.
(a) Product. Aluminum ammonium sulfate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.1129 Aluminum potassium sulfate.
(a) Product. Aluminum potassium sulfate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.1131 Aluminum sodium sulfate.
(a) Product. Aluminum sodium sulfate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.1180 Caffeine.
(a) Product. Caffeine.
(b) Tolerance. 0.02 percent.
(c) Limitations, restrictions, or explanation. This substance is
generally recognized as safe when used in cola-type beverages in
accordance with good manufacturing practice.
21 CFR 182.1195 Calcium citrate.
(a) Product. Calcium citrate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.1217 Calcium phosphate.
(a) Product. Calcium phosphate (mono-, di-, and tribasic).
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.1235 Caramel.
(a) Product. Caramel.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.1320 Glycerin.
(a) Product. Glycerin.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.1480 Methylcellulose.
(a) Product. U.S.P. methylcellulose, except that the methoxy content
shall not be less than 27.5 percent and not more than 31.5 percent on a
dry-weight basis.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.1500 Monoammonium glutamate.
(a) Product. Monoammonium glutamate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.1516 Monopotassium glutamate.
(a) Product. Monopotassium glutamate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.1625 Potassium citrate.
(a) Product. Potassium citrate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.1711 Silica aerogel.
(a) Product. Silica aerogel as a finely powdered microcellular
silica foam having a minimum silica content of 89.5 percent.
(b) (Reserved)
(c) Limitations, restrictions, or explanation. This substance is
generally recognized as safe when used as a component of an anti-foaming
agent in accordance with good manufacturing practice.
21 CFR 182.1745 Sodium carboxymethylcellulose.
(a) Product. Sodium carboxymethylcellulose is the sodium salt of
carboxymethylcellulose not less than 99.5 percent on a dry-weight basis,
with maximum substitution of 0.95 carboxymethyl groups per
anhydroglucose unit, and with a minimum viscosity of 25 centipoises for
2 percent by weight aqueous solution at 25 C.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.1748 Sodium caseinate.
(a) Product. Sodium caseinate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.1751 Sodium citrate.
(a) Product. Sodium citrate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.1778 Sodium phosphate.
(a) Product. Sodium phosphate (mono-, di-, and tribasic).
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.1781 Sodium aluminum phosphate.
(a) Product. Sodium aluminum phosphate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.1810 Sodium tripolyphosphate.
(a) Product. Sodium tripolyphosphate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.1866 High fructose corn syrup.
(a) Product. High fructose corn syrup is a sweet, nutritive
saccharide mixture containing approximately 52 percent (dry weight)
glucose, 43 percent (dry weight) fructose, and 5 percent (dry weight)
other saccharides. It is prepared as a clear aqueous solution from high
dextrose equivalent corn starch hydrolysate by partial enzymatic
conversion of glucose (dextrose) to fructose utilizing an insoluble
glucose isomerase enzyme preparation described in 184.1372 of this
chapter.
(b) Limitations, restrictions, or explanations. This substance is
generally recognized as safe when used in food as a nutritive
carbohydrate sweetener at levels not to exceed current good
manufacturing practice.
(48 FR 5719, Feb. 8, 1983)
21 CFR 182.1911 Triethyl citrate.
(a) Product. Triethyl citrate.
(b) Tolerance. 0.25 percent.
(c) Limitations, restrictions, or explanation. This substance is
generally recognized as safe when used in dried egg whites in accordance
with good manufacturing practice.
21 CFR 182.1911 Subpart C -- Anticaking Agents
21 CFR 182.2122 Aluminum calcium silicate.
(a) Product. Aluminum calcium silicate.
(b) Tolerance. 2 percent.
(c) Limitations, restrictions, or explanation. This substance is
generally recognized as safe when used in table salt in accordance with
good manufacturing practice.
21 CFR 182.2227 Calcium silicate.
(a) Product. Calcium silicate.
(b) Tolerance. 2 percent and 5 percent.
(c) Limitations, restrictions, or explanation. This substance is
generally recognized as safe when used at levels not exceeding 2 percent
in table salt and 5 percent in baking powder in accordance with good
manufacturing practice.
21 CFR 182.2437 Magnesium silicate.
(a) Product. Magnesium silicate.
(b) Tolerance. 2 percent.
(c) Limitations, restrictions, or explanation. This substance is
generally recognized as safe when used in table salt in accordance with
good manufacturing practice.
21 CFR 182.2727 Sodium aluminosilicate.
(a) Product. Sodium aluminosilicate (sodium silicoaluminate).
(b) Tolerance. This substance is generally recognized as safe for
use at a level not exceeding 2 percent in accordance with good
manufacturing practice.
21 CFR 182.2729 Sodium calcium aluminosilicate, hydrated.
(a) Product. Hydrated sodium calcium aluminosilicate (sodium calcium
silicoaluminate).
(b) Tolerance. This substance is generally recognized as safe for
use at a level not exceeding 2 percent in accordance with good
manufacturing practice.
21 CFR 182.2906 Tricalcium silicate.
(a) Product. Tricalcium silicate.
(b) Tolerance. 2 percent.
(c) Limitations, restrictions, or explanation. This substance is
generally recognized as safe when used in table salt in accordance with
good manufacturing practice.
21 CFR 182.2906 Subpart D -- Chemical Preservatives
21 CFR 182.3013 Ascorbic acid.
(a) Product. Ascorbic acid.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.3041 Erythorbic acid.
(a) Product. Erythorbic acid.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.3089 Sorbic acid.
(a) Product. Sorbic acid.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.3109 Thiodipropionic acid.
(a) Product. Thiodipropionic acid.
(b) Tolerance. This substance is generally recognized as safe for
use in food when the total content of antioxidants is not over 0.02
percent of fat or oil content, including essential (volatile) oil
content of the food, provided the substance is used in accordance with
good manufacturing practice.
21 CFR 182.3149 Ascorbyl palmitate.
(a) Product. Ascorbyl palmitate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.3169 Butylated hydroxyanisole.
(a) Product. Butylated hydroxyanisole.
(b) Tolerance. This substance is generally recognized as safe for
use in food when the total content of antioxidants is not over 0.02
percent of fat or oil content, including essential (volatile) oil
content of food, provided the substance is used in accordance with good
manufacturing practice.
21 CFR 182.3173 Butylated hydroxytoluene.
(a) Product. Butylated hydroxytoluene.
(b) Tolerance. This substance is generally recognized as safe for
use in food when the total content of antioxidants is not over 0.02
percent of fat or oil content, including essential (volatile) oil
content of food, provided the substance is used in accordance with good
manufacturing practice.
21 CFR 182.3189 Calcium ascorbate.
(a) Product. Calcium ascorbate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.3225 Calcium sorbate.
(a) Product. Calcium sorbate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.3280 Dilauryl thiodipropionate.
(a) Product. Dilauryl thiodipropionate.
(b) Tolerance. This substance is generally recognized as safe for
use in food when the total content of antioxidants is not over 0.02
percent of fat or oil content, including essential (volatile) oil
content of the food, provided the substance is used in accordance with
good manufacturing practice.
21 CFR 182.3616 Potassium bisulfite.
(a) Product. Potassium bisulfite.
(b) (Reserved)
(c) Limitations, restrictions, or explanation. This substance is
generally recognized as safe when used in accordance with current good
manufacturing practice, except that it is not used in meats; in food
recognized as a source of vitamin B1; on fruits or vegetables intended
to be served raw to consumers or sold raw to consumers, or to be
presented to the consumer as fresh; and on ''fresh'' potatoes that are
intended to be served or sold unpackaged and unlabeled to the consumers.
For purposes of this paragraph the term '''fresh' potatoes'' applies to
any form of potato other than frozen, canned, or dehydrated potatoes.
(42 FR 14640, Mar. 15, 1977, as amended at 51 FR 25025, July 9, 1986;
55 FR 9832, Mar. 15, 1990)
21 CFR 182.3637 Potassium metabisulfite.
(a) Product. Potassium metabisulfite.
(b) (Reserved)
(c) Limitations, restrictions, or explanation. This substance is
generally recognized as safe when used in accordance with current good
manufacturing practice, except that it is not used in meats; in food
recognized as a source of vitamin B1; on fruits or vegetables intended
to be served raw to consumers or sold raw to consumers, or to be
presented to the consumers as fresh; and on ''fresh'' potatoes that are
intended to be served or sold unpackaged and unlabeled to the consumer.
For purposes of this paragraph the term '''fresh' potatoes'' applies to
any form of potato other than frozen, canned, or dehydrated potatoes.
(42 FR 14640, Mar. 15, 1977, as amended at 51 FR 25025, July 9, 1986;
55 FR 9832, Mar. 15, 1990)
21 CFR 182.3640 Potassium sorbate.
(a) Product. Potassium sorbate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.3731 Sodium ascorbate.
(a) Product. Sodium ascorbate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.3739 Sodium bisulfite.
(a) Product. Sodium bisulfite.
(b) (Reserved)
(c) Limitations, restrictions, or explanation. This substance is
generally recognized as safe when used in accordance with current good
manufacturing practice, except that it is not used in meats; in food
recognized as a source of vitamin B1; on fruits or vegetables intended
to be served raw to consumers or sold raw to consumers, or to be
presented to the consumer as fresh; and on ''fresh'' potatoes that are
intended to be served or sold unpackaged and unlabeled to the consumer.
For purposes of this paragraph the term '''fresh' potatoes'' applies to
any form of potato other than frozen, canned, or dehydrated potatoes.
(42 FR 14640, Mar. 15, 1977, as amended at 51 FR 25025, July 9, 1986;
55 FR 9832, Mar. 15, 1990)
21 CFR 182.3766 Sodium metabisulfite.
(a) Product. Sodium metabisulfite.
(b) (Reserved)
(c) Limitations, restrictions, or explanation. This substance is
generally recognized as safe when used in accordance with current good
manufacturing practice, except that it is not used in meats; in food
recognized as a source of vitamin B1; on fruits or vegetables intended
to be served raw to consumers or sold raw to consumers, or to be
presented to the consumer as fresh; and on ''fresh'' potatoes that are
intended to be served or sold unpackaged and unlabeled to the consumer.
For purposes of this paragraph the term '''fresh' potatoes'' applies to
any form of potato other than frozen, canned, or dehydrated potatoes.
(42 FR 14640, Mar. 15, 1977, as amended at 51 FR 25025, July 9, 1986;
55 FR 9833, Mar. 15, 1990)
21 CFR 182.3795 Sodium sorbate.
(a) Product. Sodium sorbate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.3798 Sodium sulfite.
(a) Product. Sodium sulfite.
(b) (Reserved)
(c) Limitations, restrictions, or explanation. This substance is
generally recognized as safe when used in accordance with current good
manufacturing practice, except that it is not used in meats; in food
recognized as a source of vitamin B1; on fruits or vegetables intended
to be served raw to consumers or sold raw to consumers, or to be
presented to the consumer as fresh; and on ''fresh'' potatoes that are
intended to be served or sold unpackaged and unlabeled to the consumer.
For purposes of this paragraph the term '''fresh' potatoes'' applies to
any form of potato other than frozen, canned, or dehydrated.
(42 FR 14640, Mar. 15, 1977, as amended at 51 FR 25026, July 9, 1986;
55 FR 9833, Mar. 15, 1990)
21 CFR 182.3862 Sulfur dioxide.
(a) Product. Sulfur dioxide.
(b) (Reserved)
(c) Limitations, restrictions, or explanation. This substance is
generally recognized as safe when used in accordance with current good
manufacturing practice, except that it is not used in meats; in food
recognized as a source of vitamin B1; on fruits or vegetables intended
to be served raw to consumers or sold raw to consumers, or to be
presented to the consumer as fresh; and on ''fresh'' potatoes that are
intended to be served or sold unpackaged and unlabeled to the consumer.
For purposes of this paragraph the term '''fresh' potatoes'' applies to
any form of potato other than frozen, canned, or dehydrated.
(42 FR 14640, Mar. 15, 1977, as amended at 51 FR 25026, July 9, 1986;
55 FR 9833, Mar. 15, 1990)
21 CFR 182.3890 Tocopherols.
(a) Product. Tocopherols.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.3890 Subpart E -- Emulsifying Agents (Reserved)
21 CFR 182.3890 Subpart F -- Dietary Supplements /1/
21 CFR 182.5013 Ascorbic acid.
(a) Product. Ascorbic acid.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
/1/ Amino acids listed in this subpart may be free hydrochloride
salt, hydrated, or anhydrous form, where applicable.
21 CFR 182.5065 Linoleic acid.
(a) Product. Linoleic acid prepared from edible fats and oils and
free from chickedema factor.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.5159 Biotin.
(a) Product. Biotin.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.5191 Calcium carbonate.
(a) Product. Calcium carbonate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.5195 Calcium citrate.
(a) Product. Calcium citrate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.5201 Calcium glycerophosphate.
(a) Product. Calcium glycerophosphate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.5210 Calcium oxide.
(a) Product. Calcium oxide.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.5212 Calcium pantothenate.
(a) Product. Calcium pantothenate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.5217 Calcium phosphate.
(a) Product. Calcium phosphate (mono-, di-, and tribasic).
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.5223 Calcium pyrophosphate.
(a) Product. Calcium pyrophosphate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.5245 Carotene.
(a) Product. Carotene.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.5250 Choline bitartrate.
(a) Product. Choline bitartrate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.5252 Choline chloride.
(a) Product. Choline chloride.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.5260 Copper gluconate.
(a) Product. Copper gluconate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with current good manufacturing practice.
(49 FR 24119, June 12, 1984)
21 CFR 182.5301 Ferric phosphate.
(a) Product. Ferric phosphate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.5304 Ferric pyrophosphate.
(a) Product. Ferric pyrophosphate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.5306 Ferric sodium pyrophosphate.
(a) Product. Ferric sodium pyrophosphate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.5308 Ferrous gluconate.
(a) Product. Ferrous gluconate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.5311 Ferrous lactate.
(a) Product. Ferrous lactate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.5315 Ferrous sulfate.
(a) Product. Ferrous sulfate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.5370 Inositol.
(a) Product. Inositol.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.5375 Iron reduced.
(a) Product. Iron reduced.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.5431 Magnesium oxide.
(a) Product. Magnesium oxide.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.5434 Magnesium phosphate.
(a) Product. Magnesium phosphate (di- and tribasic).
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.5443 Magnesium sulfate.
(a) Product. Magnesium sulfate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.5446 Manganese chloride.
(a) Product. Manganese chloride.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.5449 Manganese citrate.
(a) Product. Manganese citrate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.5452 Manganese gluconate.
(a) Product. Manganese gluconate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.5455 Manganese glycerophosphate.
(a) Product. Manganese glycerophosphate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.5461 Manganese sulfate.
(a) Product. Manganese sulfate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.5464 Manganous oxide.
(a) Product. Manganous oxide.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.5530 Niacin.
(a) Product. Niacin.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.5535 Niacinamide.
(a) Product. Niacinamide.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.5580 D-Pantothenyl alcohol.
(a) Product. D-Pantothenyl alcohol.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.5622 Potassium chloride.
(a) Product. Potassium chloride.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with current good manufacturing practice.
Preparations containing amounts equal to or greater than 100 milligrams
of potassium per tablet or capsule, or 20 milligrams of potassium per
milliliter, are drugs subject to the provisions of 201.306 of this
chapter.
(42 FR 14640, Mar. 15, 1977, as amended at 48 FR 51614, Nov. 10,
1983)
21 CFR 182.5628 Potassium glycerophosphate.
(a) Product. Potassium glycerophosphate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.5676 Pyridoxine hydrochloride.
(a) Product. Pyridoxine hydrochloride.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.5695 Riboflavin.
(a) Product. Riboflavin.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.5697 Riboflavin-5-phosphate.
(a) Product. Riboflavin-5-phosphate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.5772 Sodium pantothenate.
(a) Product. Sodium pantothenate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.5778 Sodium phosphate.
(a) Product. Sodium phosphate (mono-, di-, and tribasic).
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.5875 Thiamine hydrochloride.
(a) Product. Thiamine hydrochloride.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.5878 Thiamine mononitrate.
(a) Product. Thiamine mononitrate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.5890 Tocopherols.
(a) Product. Tocopherols.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.5892 a-Tocopherol acetate.
(a) Product. a-Tocopherol acetate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.5930 Vitamin A.
(a) Product. Vitamin A.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.5933 Vitamin A acetate.
(a) Product. Vitamin A acetate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.5936 Vitamin A palmitate.
(a) Product. Vitamin A palmitate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.5945 Vitamin B12.
(a) Product. Vitamin B12.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.5950 Vitamin D2.
(a) Product. Vitamin D2.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.5953 Vitamin D3.
(a) Product. Vitamin D3.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.5985 Zinc chloride.
(a) Product. Zinc chloride.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.5988 Zinc gluconate.
(a) Product. Zinc gluconate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.5991 Zinc oxide.
(a) Product. Zinc oxide.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.5994 Zinc stearate.
(a) Product. Zinc stearate prepared from stearic acid free from
chickedema factor.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.5997 Zinc sulfate.
(a) Product. Zinc sulfate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.5997 Subpart G -- Sequestrants /1/
21 CFR 182.6033 Citric acid.
(a) Product. Citric acid.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
/1/ For the purpose of this subpart, no attempt has been made to
designate those sequestrants that may also function as chemical
preservatives.
21 CFR 182.6085 Sodium acid phosphate.
(a) Product. Sodium acid phosphate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.6195 Calcium citrate.
(a) Product. Calcium citrate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.6197 Calcium diacetate.
(a) Product. Calcium diacetate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.6203 Calcium hexametaphosphate.
(a) Product. Calcium hexametaphosphate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.6215 Monobasic calcium phosphate.
(a) Product. Monobasic calcium phosphate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.6285 Dipotassium phosphate.
(a) Product. Dipotassium phosphate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.6290 Disodium phosphate.
(a) Product. Disodium phosphate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.6386 Isopropyl citrate.
(a) Product. Isopropyl citrate.
(b) Tolerance. This substance is generally recognized as safe for
use at a level not exceeding 0.02 percent in accordance with good
manufacturing practice.
21 CFR 182.6511 Monoisopropyl citrate.
(a) Product. Monoisopropyl citrate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.6625 Potassium citrate.
(a) Product. Potassium citrate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.6751 Sodium citrate.
(a) Product. Sodium citrate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.6757 Sodium gluconate.
(a) Product. Sodium gluconate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.6760 Sodium hexametaphosphate.
(a) Product. Sodium hexametaphosphate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.6769 Sodium metaphosphate.
(a) Product. Sodium metaphosphate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.6778 Sodium phosphate.
(a) Product. Sodium phosphate (mono-, di-, and tribasic).
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.6787 Sodium pyrophosphate.
(a) Product. Sodium pyrophosphate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.6789 Tetra sodium pyrophosphate.
(a) Product. Tetra sodium pyrophosphate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.6810 Sodium tripolyphosphate.
(a) Product. Sodium tripolyphosphate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.6851 Stearyl citrate.
(a) Product. Stearyl citrate.
(b) Tolerance. This substance is generally recognized as safe for
use at a level not exceeding 0.15 percent in accordance with good
manufacturing practice.
21 CFR 182.6851 Subpart H -- Stabilizers
21 CFR 182.7255 Chondrus extract.
(a) Product. Chondrus extract (carrageenin).
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.7255 Subpart I -- Nutrients
Source: 45 FR 58838, Sept. 5, 1980, unless otherwise noted.
21 CFR 182.8013 Ascorbic acid.
(a) Product. Ascorbic acid.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.8159 Biotin.
(a) Product. Biotin.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.8195 Calcium citrate.
(a) Product. Calcium citrate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.8201 Calcium glycerophosphate.
(a) Product. Calcium glycerophosphate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
Effective Date Note: At 57 FR 10813, Mar. 31, 1992, 182.8201 was
removed, effective April 30, 1992.
21 CFR 182.8217 Calcium phosphate.
(a) Product. Calcium phosphate (mono-, di-, and tribasic).
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.8223 Calcium pyrophosphate.
(a) Product. Calcium pyrophosphate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.8250 Choline bitartrate.
(a) Product. Choline bitartrate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.8252 Choline chloride.
(a) Product. Choline chloride.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.8455 Manganese glycerophosphate.
(a) Product. Manganese glycerophosphate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
Effective Date Note: At 57 FR 10813, Mar. 31, 1992, 182.8455 was
removed, effective April 30, 1992.
21 CFR 182.8458 Manganese hypophosphite.
(a) Product. Manganese hypophosphite.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.8628 Potassium glycerophosphate.
(a) Product. Potassium glycerophosphate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
Effective Date Note: At 57 FR 10813, Mar. 31, 1992, 182.8628 was
removed, effective April 30, 1992.
21 CFR 182.8778 Sodium phosphate.
(a) Product. Sodium phosphate
(mono-, di-, and tribasic).
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.8890 Tocopherols.
(a) Product. Tocopherols.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.8892 -Tocopherol acetate.
(a) Product. -Tocopherol acetate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.8985 Zinc chloride.
(a) Product. Zinc chloride.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.8988 Zinc gluconate.
(a) Product. Zinc gluconate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.8991 Zinc oxide.
(a) Product. Zinc oxide.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.8994 Zinc stearate.
(a) Product. Zinc stearate prepared from stearic acid free from
chickedema factor.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.8997 Zinc sulfate.
(a) Product. Zinc sulfate.
(b) Conditions of use. This substance is generally recognized as
safe when used in accordance with good manufacturing practice.
21 CFR 182.8997 Pt. 184
21 CFR 182.8997 PART 184 -- DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE
21 CFR 182.8997 Subpart A -- General Provisions
Sec.
184.1 Substances added directly to human food affirmed as generally
recognized as safe (GRAS).
21 CFR 182.8997 Subpart B -- Listing of Specific Substances Affirmed as
GRAS
184.1005 Acetic acid.
184.1007 Aconitic acid.
184.1009 Adipic acid.
184.1011 Alginic acid.
184.1021 Benzoic acid.
184.1025 Caprylic acid.
184.1027 Mixed carbohydrase and protease enzyme product.
184.1061 Lactic acid.
184.1065 Linoleic acid.
184.1069 Malic acid.
184.1077 Potassium acid tartrate.
184.1081 Propionic acid.
184.1090 Stearic acid.
184.1091 Succinic acid.
184.1095 Sulfuric acid.
184.1097 Tannic acid.
184.1099 Tartaric acid.
184.1101 Diacetyl tartaric acid esters of mono- and diglycerides.
184.1115 Agar-agar.
184.1120 Brown algae.
184.1121 Red algae.
184.1133 Ammonium alginate.
184.1135 Ammonium bicarbonate.
184.1137 Ammonium carbonate.
184.1138 Ammonium chloride.
184.1139 Ammonium hydroxide.
184.1141a Ammonium phosphate, monobasic.
184.1141b Ammonium phosphate, dibasic.
184.1143 Ammonium sulfate.
184.1155 Bentonite.
184.1157 Benzoyl peroxide.
184.1165 n-Butane and iso-butane.
184.1185 Calcium acetate.
184.1187 Calcium alginate.
184.1191 Calcium carbonate.
184.1193 Calcium chloride.
184.1199 Calcium gluconate.
184.1201 Calcium glycerophosphate.
184.1205 Calcium hydroxide.
184.1206 Calcium iodate.
184.1207 Calcium lactate.
184.1210 Calcium oxide.
184.1212 Calcium pantothenate.
184.1221 Calcium propionate.
184.1229 Calcium stearate.
184.1230 Calcium sulfate.
184.1240 Carbon dioxide.
184.1245 Beta-carotene.
184.1257 Clove and its derivatives.
184.1259 Cocoa butter substitute primarily from palm oil.
184.1260 Copper gluconate.
184.1261 Copper sulfate.
184.1262 Corn silk and corn silk extract.
184.1265 Cuprous iodide.
184.1271 L-Cysteine.
184.1272 L-Cysteine monohydrochloride.
184.1277 Dextrin.
184.1278 Diacetyl.
184.1282 Dill and its derivatives.
184.1287 Enzyme-modified fats.
184.1293 Ethyl alcohol.
184.1295 Ethyl formate.
184.1296 Ferric ammonium citrate.
184.1297 Ferric chloride.
184.1298 Ferric citrate.
184.1301 Ferric phosphate.
184.1304 Ferric pyrophosphate.
184.1307 Ferric sulfate.
184.1307a Ferrous ascorbate.
184.1307b Ferrous carbonate.
184.1307c Ferrous citrate.
184.1307d Ferrous fumarate.
184.1308 Ferrous gluconate.
184.1311 Ferrous lactate.
184.1315 Ferrous sulfate.
184.1317 Garlic and its derivatives.
184.1318 Glucono delta-lactone.
184.1321 Corn gluten.
184.1322 Wheat gluten.
184.1323 Glyceryl monooleate.
184.1324 Glyceryl monostearate.
184.1328 Glyceryl behenate.
184.1330 Acacia (gum arabic).
184.1333 Gum ghatti.
184.1339 Guar gum.
184.1343 Locust (carob) bean gum.
184.1349 Karaya gum (sterculia gum).
184.1351 Gum tragacanth.
184.1355 Helium.
184.1366 Hydrogen peroxide.
184.1370 Inositol.
184.1372 Insoluble glucose isomerase enzyme preparations.
184.1375 Iron, elemental.
184.1388 Lactase enzyme preparation from Kluyveromyces lactis.
184.1400 Lecithin.
184.1408 Licorice and licorice derivatives.
184.1409 Ground limestone.
184.1425 Magnesium carbonate.
184.1426 Magnesium chloride.
184.1428 Magnesium hydroxide.
184.1431 Magnesium oxide.
184.1434 Magnesium phosphate.
184.1440 Magnesium stearate.
184.1443 Magnesium sulfate.
184.1444 Maltodextrin.
184.1445 Malt syrup (malt extract).
184.1446 Manganese chloride.
184.1449 Manganese citrate.
184.1452 Manganese gluconate.
184.1461 Manganese sulfate.
184.1472 Hydrogenated and partially hydrogenated menhaden oils.
184.1490 Methylparaben.
184.1498 Microparticulated protein product.
184.1505 Mono- and diglycerides.
184.1521 Monosodium phosphate derivatives of mono- and diglycerides.
184.1530 Niacin.
184.1535 Niacinamide.
184.1537 Nickel.
184.1538 Nisin preparation.
184.1540 Nitrogen.
184.1545 Nitrous oxide.
184.1553 Peptones.
184.1555 Rapeseed oil.
184.1560 Ox bile extract.
184.1563 Ozone.
184.1585 Papain.
184.1588 Pectins.
184.1610 Potassium alginate.
184.1613 Potassium bicarbonate.
184.1619 Potassium carbonate.
184.1622 Potassium chloride.
184.1631 Potassium hydroxide.
184.1634 Potassium iodide.
184.1635 Potassium iodate.
184.1639 Potassium lactate.
184.1643 Potassium sulfate.
184.1655 Propane.
184.1660 Propyl gallate.
184.1666 Propylene glycol.
184.1670 Propylparaben.
184.1676 Pyridoxine hydrochloride.
184.1685 Rennet (animal-derived) and chymosin preparation
(fermentation-derived).
184.1695 Riboflavin.
184.1697 Riboflavin-5'-phosphate (sodium).
184.1698 Rue.
184.1699 Oil of rue.
184.1721 Sodium acetate.
184.1724 Sodium alginate.
184.1733 Sodium benzoate.
184.1736 Sodium bicarbonate.
184.1742 Sodium carbonate.
184.1754 Sodium diacetate.
184.1763 Sodium hydroxide.
184.1764 Sodium hypophosphite.
184.1768 Sodium lactate.
184.1769a Sodium metasilicate.
184.1784 Sodium propionate.
184.1792 Sodium sesquicarbonate.
184.1801 Sodium tartrate.
184.1804 Sodium potassium tartrate.
184.1807 Sodium thiosulfate.
184.1835 Sorbitol.
184.1845 Stannous chloride (anhydrous and dihydrated).
184.1848 Starter distillate.
184.1854 Sucrose.
184.1857 Corn sugar.
184.1859 Invert sugar.
184.1865 Corn syrup.
184.1875 Thiamine hydrochloride.
184.1878 Thiamine mononitrate.
184.1890 -Tocopherols.
184.1901 Triacetin.
184.1903 Tributyrin.
184.1923 Urea.
184.1930 Vitamin A.
184.1945 Vitamin B12.
184.1950 Vitamin D.
184.1973 Beeswax (yellow and white).
184.1976 Candelilla wax.
184.1978 Carnauba wax.
184.1979 Whey.
184.1979a Reduced lactose whey.
184.1979b Reduced minerals whey.
184.1979c Whey protein concentrate.
184.1983 Bakers yeast extract.
184.1984 Zein.
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 14653, Mar 15, 1977, unless otherwise noted.
21 CFR 182.8997 Subpart A -- General Provisions
21 CFR 184.1 Substances added directly to human food affirmed as
generally recognized as safe (GRAS).
(a) The direct human food ingredients listed in this part have been
reviewed by the Food and Drug Administration and determined to be
generally recognized as safe (GRAS) for the purposes and under the
conditions prescribed. The regulations in this part shall sufficiently
describe each ingredient to identify the characteristics of the
ingredient that has been affirmed as GRAS and to differentiate it from
other possible versions of the ingredient that have not been affirmed as
GRAS. Ingredients affirmed as GRAS in this part are also GRAS as
indirect human food ingredients, subject to any limitations prescribed
in parts 174, 175, 176, 177, 178 or 179.45 of this chapter of in part
186 of this chapter. The purity specifications in this part do not
apply when the ingredient is used in indirect applications. However,
when used in indirect applications, the ingredient must be of a purity
suitable for its intended use in accordance with 170.30(h)(1) of this
chapter.
(b) Any ingredient affirmed as GRAS in this part shall be used in
accordance with current good manufacturing practice. For the purpose of
this part, current good manufacturing practice includes the requirements
that a direct human food ingredient be of appropriate food grade; that
it be prepared and handled as a food ingredient; and that the quantity
of the ingredient added to food does not exceed the amount reasonably
required to accomplish the intended physical, nutritional, or other
technical effect in food.
(1) If the ingredient is affirmed as GRAS with no limitations on its
conditions of use other than current good manufacturing practice, it
shall be regarded as GRAS if its conditions of use are consistent with
the requirements of paragraph (b), (c), and (d) of this section. When
the Food and Drug Administration (FDA) determines that it is
appropriate, the agency will describe one or more current good
manufacturing practice conditions of use in the regulation that affirms
the GRAS status of the ingredient. For example, when the safety of an
ingredient has been evaluated on the basis of limited conditions of use,
the agency will describe in the regulation that affirms the GRAS status
of the ingredient, one or more of these limited conditions of use, which
may include the category of food(s), the technical effect(s) or
functional use(s) of the ingredient, and the level(s) of use. If the
ingredient is used under conditions that are significantly different
from those described in the regulation, that use of the ingredient may
not be GRAS. In such a case, a manufacturer may not rely on the
regulation as authorizing that use but shall independently establish
that that use is GRAS or shall use the ingredient in accordance with a
food additive regulation. Persons seeking FDA approval of an
independent determination that a use of an ingredient is GRAS may submit
a GRAS petition in accordance with 170.35 of this chapter.
(2) If the ingredient is affirmed as GRAS with specific
limitation(s), it shall 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.
(3) If the ingredient is affirmed as GRAS for a specific use, without
a general evaluation of use of the ingredient, other uses may also be
GRAS.
(c) The listing of a food ingredient in this part does not authorize
the use of such substance in a manner that may lead to deception of the
consumer or to any other violation of the Federal Food, Drug, and
Cosmetic Act (the Act).
(d) The listing of more than one ingredient to produce the same
technological effect does not authorize use of a combination of two or
more ingredients to accomplish the same technological effect in any one
food at a combined level greater than the highest level permitted for
one of the ingredients.
(e) If the Commissioner of Food and Drugs is aware of any prior
sanction for use of an ingredient under conditions different from those
proposed to be affirmed as GRAS, 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.
(f) The label and labeling of the ingredient and any intermediate mix
of the ingredient for use in finished food shall bear, in addition to
the other labeling required by the Act:
(1) The name of the ingredient, except where exempted from such
labeling in part 101 of this chapter.
(2) A statement of concentration of the ingredient in any
intermediate mix; or other information to permit a food processor
independently to determine that use of the ingredients will be in
accordance with any limitations and good manufacturing practice
gudelines prescribed.
(3) Adequate directions for use to provide a final food product that
complies with any limitations prescribed for the ingredient(s).
(42 FR 14653, Mar. 15, 1977, as amended at 42 FR 55205, Oct. 14,
1977; 48 FR 48457, 48459, Oct. 19, 1983)
21 CFR 184.1 Subpart B -- Listing of Specific Substances Affirmed as GRAS
21 CFR 184.1005 Acetic acid.
(a) Acetic acid (C2H4O2, CAS Reg. No. 64-19-7) is known as ethanoic
acid. It occurs naturally in plant and animal tissues. It is produced
by fermentation of carbohydrates or by organic synthesis. The principal
synthetic methods currently employed are oxidation of acetaldehyde
derived from ethylene, liquid phase oxidation of butane, and reaction of
carbon monoxide with methanol derived from natural gas.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 8, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) The ingredient is used as a curing and pickling agent as defined
in 170.3(o)(5) of this chapter; flavor enhancer as defined in
170.3(o)(11) of this chapter; flavoring agent and adjuvant as defined
in 170.3(o)(12) of this chapter; pH control agent as defined in
170.3(o)(23) of this chapter; as a solvent and vehicle as defined in
170.3(o)(27) of this chapter; and as a boiler water additive complying
with 173.310 of this chapter.
(d) The ingredient is used in food at levels not to exceed current
good manufacturing practice in accordance with 184.1(b)(1). Current
good manufacturing practice results in a maximum level as served, of
0.25 percent for baked goods as defined in 170.3(n)(1) of this chapter;
0.8 percent for cheeses as defined in 170.3(n)(5) of this chapter and
dairy product analogs as defined in 170.3(n)(10) of this chapter; 0.5
percent for chewing gum as defined in 170.3(n)(6) of this chapter; 9.0
percent for condiments and relishes as defined in 170.3(n)(8) of this
chapter; 0.5 percent for fats and oils as defined in 170.3(n)(12) of
this chapter; 3.0 percent for gravies and sauces as defined in
170.3(n)(24) of this chapter; 0.6 percent for meat products as defined
in 170.3(n)(29) of this chapter; and 0.15 percent or less for all
other food categories. The ingredient may also be used in boiler water
additives at levels not to exceed current good manufacturing practice.
(e) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(47 FR 27814, June 25, 1982)
21 CFR 184.1007 Aconitic acid.
(a) Aconitic acid (1,2,3-propenetricarboxylic acid (C6H6O6), CAS Reg.
No. 000499-12-7) occurs in the leaves and tubers of Aconitum napellus L.
and other Ranunculaceae. Transaconitic acid can be isolated during
sugarcane processing, by precipitation as the calcium salt from cane
sugar or molasses. It may be synthesized by sulfuric acid dehydration
of citric acid, but not by the methanesulfonic acid method.
(b) The ingredient meets the following specifications:
(1) Assay. Not less than 98.0 percent of C3H3(COOH)3, using the
''Food Chemicals Codex,'' 3d Ed. (1981), pp. 86-87, test for citric
acid, which is incorporated by reference, and a molecular weight of
174.11. Copies of the material incorporated by reference 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) Melting point. Not less than 195 C and the determination
results in decomposition of aconitic acid.
(3) Heavy metals (as Pb). Not more than 10 parts per million.
(4) Arsenic (as As). Not more than 3 parts per million.
(5) Oxalate. Passes test.
(6) Readily carbonizable substances. Passes ''Food Chemicals
Codex,'' 3d Ed. (1981), pp. 86-87, test for citric acid, which is
incorporated by reference. The availability of this incorporation by
reference is given in paragraph (b)(1) of this section.
(7) Residue on ignition. Not more than 0.1 percent as determined by
''Food Chemicals Codex,'' 3d Ed. (1981), pp. 86-87, test for citric
acid, which is incorporated by reference. The availability of this
incorporation by reference is given in paragraph (b)(1) of this section.
The substance should have infrared absorption bands at 3030, 2630,
1720, 1430, 1300, 1240, 910, 860, 780, and 750 cm^1. Also, an aqueous
solution of the substance should have major absorption peaks at 411 and
432 nanometers with little or no absorption at 389 nanometers.
(c) The ingredient is used as a flavoring substance and adjuvant as
defined in 170.3(o)(12) of this chapter.
(d) The ingredient is used in food, in accordance with 184.1(b)(1),
at levels not to exceed good manufacturing practice. Current good
manufacturing practice results in a maximum level, as served, of 0.003
percent for baked goods as defined in 170.3(n)(1) of this chapter,
0.002 percent for alcoholic beverages as defined in 170.3(n)(2) of this
chapter, 0.0015 percent for frozen dairy products as defined in
170.3(n)(20) of this chapter, 0.0035 percent for soft candy as defined
in 170.3(n)(38) of this chapter, and 0.0005 percent or less for all
other food categories.
(e) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(43 FR 47724, Oct. 17, 1978, as amended at 49 FR 5610, Feb. 14, 1984)
21 CFR 184.1009 Adipic acid.
(a) Adipic acid (C6H10O4,CAS Reg. No. 00124-04-9) is also known as 1,
4-butanedicarboxylic acid or hexane-dioic acid. It is prepared by
nitric acid oxidation of cyclohexanol or cyclohexanone or a mixture of
the two.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 11, which is incorporated by reference
(copies are available from the National Academy Press, 2101 Constitution
Ave., NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408),
and the following additional specifications:
(1) The adipic acid is converted to its corresponding amide. The
amide is purified by recrystallization from water or aqueous ethanol.
The melting range of the amide is 219 to 220 C.
(2) The adipic acid is converted to its corresponding
bis-p-p-bromophenacyl ester. The ester is purified by recrystallization
from ethanol. The melting range of the ester is 153 to 154 C.
(c) The ingredient is used as a flavoring agent as defined in
170.3(o)(12) of this chapter; leavening agent as defined in
170.3(o)(17) of this chapter; and pH control agent as defined in
170.3(o)(23) of this chapter.
(d) The ingredient is used in foods at levels not to exceed current
good manufacturing practice in accordance with 184.1(b)(1). Current
good manufacturing practice results in maximum levels, as served, of
0.05 percent for baked goods as defined in 170.3(n)(1) of this chapter;
0.005 percent for nonalcoholic beverages as defined in 170.3(n)(3) of
this chapter; 5.0 percent for condiments and relishes as defined in
170.3(n)(8) of this chapter; 0.45 percent for dairy product analogs as
defined in 170.3(n)(10) of this chapter; 0.3 percent for fats and oil
as defined in 170.3(n)(12) of this chapter; 0.0004 percent for frozen
dairy desserts as defined in 170.3(n)(20) of this chapter; 0.55
percent for gelatin and puddings as defined in 170.3(n)(22) of this
chapter; 0.1 percent for gravies as defined in 170.3(n)(24) of this
chapter; 0.3 percent for meat products as defined in 170.3(n)(29) of
this chapter; 1.3 percent for snack foods as defined in 170.3(n)(37)
of this chapter; and 0.02 percent or less for all other food
categories.
(e) Prior sanctions for adipic acid different from the uses
established in this section do not exist or have been waived.
(47 FR 27810, June 25, 1982)
21 CFR 184.1011 Alginic acid.
(a) Alginic acid is a colloidal, hydrophilic polysaccharide obtained
from certain brown algae by alkaline extraction.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 13, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(2), the ingredient is used in food
only within the following specific limitations:
(d) Prior sanctions for this ingredient different from the use
established in this section do not exist or have been waived.
(47 FR 47375, Oct. 26, 1982)
21 CFR 184.1021 Benzoic acid.
(a) Benzoic acid is the chemical benzenecarboxylic acid (C7H6O2),
occurring in nature in free and combined forms. Among the foods in
which benzoic acid occurs naturally are cranberries, prunes, plums,
cinnamon, ripe cloves, and most berries. Benzoic acid is manufactured
by treating molten phthalic anhydride with steam in the presence of a
zinc oxide catalyst, by the hydrolysis of benzotrichloride, or by the
oxidation of toluene with nitric acid or sodium bichromate or with air
in the presence of a transition metal salt catalyst.
(b) The ingredient meets the specifications of the ''Food Chemicals
Codex,'' 3d Ed. (1981), p. 35, which is incorporated by reference.
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.
(c) The ingredient is used as an antimicrobial agent as defined in
170.3(o)(2) of this chapter, and as a flavoring agent and adjuvant as
defined in 170.3(o)(12) of this chapter.
(d) The ingredient is used in food at levels not to exceed good
manufacturing practice. Current usage results in a maximum level of 0.1
percent in food. (The Food and Drug Administration has not determined
whether significantly different conditions of use would be GRAS).
(e) Prior sanctions for this ingredient different from those uses
established in this section, or different from that set forth in part
181 of this chapter, do not exist or have been waived.
(42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5610, Feb. 14, 1984)
21 CFR 184.1025 Caprylic acid.
(a) Caprylic acid (CH3(CH2)6COOH, CAS Reg. No. 124-07-2) is the
chemical name for octanoic acid. It is considered to be a short or
medium chain fatty acid. It occurs normally in various foods and is
commercially prepared by oxidation of n-octanol or by fermentation and
fractional distillation of the volatile fatty acids present in coconut
oil.
(b) The ingredient meets the specifications of the ''Food Chemicals
Codex,'' 3d Ed. (1981), p. 207, which is incorporated by reference.
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.
(c) The ingredient is used as a flavoring agent and adjuvant as
defined in 170.3(o)(12) of this chapter.
(d) The ingredient is used in foods in accordance with 184.1(b)(1),
at levels not to exceed good manufacturing practice. Current good
manufacturing practices result in maximum levels, as served, of: 0.013
percent for baked goods as defined in 170.3(n)(1) of this chapter;
0.04 percent for cheeses as defined in 170.3(n)(5) of this chapter;
0.005 percent for fats and oils as defined in 170.3(n)(12) of this
chapter, for frozen dairy desserts as defined in 170.3(n)(20) of this
chapter, for gelatins and puddings as defined in 170.3(n)(22) of this
chapter, for meat products as defined in 170.3(n)(29) of this chapter,
and for soft candy as defined in 170.3(n)(38) of this chapter; 0.016
percent for snack foods as defined in 170.3(n)(37) of this chapter;
and 0.001 percent or less for all other food categories.
(e) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(43 FR 19843, May 9, 1978, as amended at 49 FR 5611, Feb. 14, 1984)
21 CFR 184.1027 Mixed carbohydrase and protease enzyme product.
(a) Mixed carbohydrase and protease enzyme product is an enzyme
preparation that includes carbohydrase and protease activity. It is
obtained from the culture filtrate resulting from a pure culture
fermentation of a nonpathogenic strain of B. licheniformis.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 107, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe as a
direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as an enzyme, as defined in 170.3(o)(9)
of this chapter, to hydrolyze proteins or carbohydrates.
(2) The ingredient is used in the following foods at levels not to
exceed current good manufacturing practice: alcoholic beverages, as
defined in 170.3(n)(2) of this chapter, candy, nutritive sweeteners,
and protein hydrolyzates.
(48 FR 240, Jan. 4, 1983)
21 CFR 184.1061 Lactic acid.
(a) Lactic acid (C3H6O3, CAS Reg. Nos.: dl mixture, 598-82-3;
l-isomer, 79-33-4; d-isomer, 10326-41-7), the chemical
2-hydroxypropanoic acid, occurs naturally in several foods. It is
produced commercially either by fermentation of carbohydrates such as
glucose, sucrose, or lactose, or by a procedure involving formation of
lactonitrile from acetaldehyde and hydrogen cyanide and subsequent
hydrolysis to lactic acid.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 159, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Avenue, NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L Street NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as an antimicrobial agent as defined in
170.3(o)(2) of this chapter; a curing and pickling agent as defined in
170.3(o)(5) of this chapter; a flavor enhancer as defined in
170.3(o)(11) of this chapter; a flavoring agent and adjuvant as defined
in 170.3(o)(12) of this chapter; a pH control agent as defined in
170.3(o)(23) of this chapter; and a solvent and vehicle as defined in
170.3(o)(27) of this chapter.
(2) The ingredient is used in food, except in infant foods and infant
formulas, at levels not to exceed current good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(49 FR 35367, Sept. 7, 1984)
21 CFR 184.1065 Linoleic acid.
(a) Linoleic acid ((Z, Z)-9, 12-octadecadienoic acid (C17H31COOH)
(CAS Reg. No. 60-33-3)), a straight chain unsaturated fatty acid with a
molecular weight of 280.5, is a colorless oil at room temperature.
Linoleic acid may be prepared from edible fats and oils by various
methods including hydrolysis and saponification, the Twitchell method,
low pressure splitting with catalyst, continuous high pressure counter
current splitting, and medium pressure autoclave splitting with
catalyst.
(b) FDA is developing food-grade specifications for linoleic acid in
cooperation with the National Academy of Sciences. In the interim, this
ingredient must be of a purity suitable for its intended use. The
ingredient must also meet the specifications in 172.860(b) of this
chapter.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a flavoring agent and adjuvant as
defined in 170.3(o)(12) of this chapter and as a nutrient supplement as
defined in 170.3(o)(20) of this chapter.
(2) The ingredient is used in foods at levels not to exceed current
good manufacturing practice. The ingredient may be used in infant
formula in accordance with section 412(g) of the Federal Food, Drug, and
Cosmetic Act (the act) or with regulations promulgated under section
412(a)(2) of the act.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(49 FR 48534, Dec. 13, 1984)
21 CFR 184.1069 Malic acid.
(a) Malic acid (C4H6O5, CAS Reg. No. of L-form 97-67-6, CAS Reg. No.
of DL-form 617-48-1) is the common name for 1-hydroxy-1,
2-ethanedicarboxylic acid. L (+) malic acid, referred to as L-malic
acid, occurs naturally in various foods. Racemic DL-malic acid does not
occur naturally. It is made commercially by hydration of fumaric acid
or maleic acid.
(b) The ingredient meets the specifications of the ''Food Chemicals
Codex,'' 3d Ed. (1981), pp. 183-184, which is incorporated by
reference. 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.
(c) The ingredients are used as a flavor enhancer as defined in
170.3(o)(11) of this chapter, flavoring agent and adjuvant as defined in
170.3(o)(12) of this chapter, and pH control agent as defined in
170.3(o)(23) of this chapter.
(d) The ingredients are used in food, except baby food, at levels not
to exceed good manufacturing practice in accordance with 184.1(b)(1).
Current good manufacturing practice results in a maximum level, as
served, of 3.4 percent for nonalcoholic beverages as defined in
170.3(n)(3) of this chapter; 3.0 percent for chewing gum as defined in
170.3(n)(6) of this chapter; 0.8 percent for gelatins, puddings, and
fillings as defined in 170.3(n)(22) of this chapter; 6.9 percent for
hard candy as defined in 170.3(n)(25) of this chapter; 2.6 percent for
jams and jellies as defined in 170.3(n)(28) of this chapter; 3.5
percent for processed fruits and fruit juices as defined in
170.3(n)(35) of this chapter; 3.0 percent for soft candy as defined in
170.3(n)(38) of this chapter; and 0.7 percent for all other food
categories.
(e) Prior sanctions for malic acid different from the uses
established in this section do not exist or have been waived.
(44 FR 20656, Apr. 6, 1979, as amended at 49 FR 5611, Feb. 14, 1984)
21 CFR 184.1077 Potassium acid tartrate.
(a) Potassium acid tartrate (C4H5KO6, CAS Reg. No. 868-14-4) is the
potassium acid salt of l^(+)^tartaric acid and is also called potassium
bitartrate or cream of tartar. It occurs as colorless or slightly
opaque crystals or as a white, crystalline powder. It has a pleasant,
acid taste. It is obtained as a byproduct of wine manufacture.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), P. 238, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as an anticaking agent as defined in
170.3(o)(1) of this chapter; an antimicrobial agent as defined in
170.3(o)(2) of this chapter; a formulation aid as defined in
170.3(o)(14) of this chapter; a humectant as defined in 170.3(o)(16)
of this chapter; a leavening agent as defined in 170.3(o)(17) of this
chapter; A pH control agent as defined in 170.3(o)(23) of this
chapter; a processing aid as defined in 170.3(o)(24) of this chapter;
a stabilizer and thickener as defined in 170.3(o)(28) of this chapter;
and a surface-active agent as defined in 170.3(o)(29) of this chapter.
(2) The ingredient is used in the following foods at levels not to
exceed current good manufacturing practice: baked goods as defined in
170.3(n)(1) of this chapter; confections and frostings as defined in
170.3(n)(9) of this chapter; gelatins and puddings as defined in
170.3(n)(22) of this chapter; hard candy as defined in 170.3(n)(25) of
this chapter; jams and jellies as defined in 170.3(n)(28) of this
chapter; and soft candy as defined in 170.3(n)(38) of this chapter.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(48 FR 52446, Nov. 18, 1983)
21 CFR 184.1081 Propionic acid.
(a) Propionic acid (C3H6O2, CAS Reg. No. 79-09-4) is an oily liquid
having a slightly pungent, rancid odor. It is manufactured by chemical
synthesis or by bacterial fermentation.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 254, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as an antimicrobial agent as defined in
170.3(o)(2) of this chapter and a flavoring agent as defined in
170.3(o)(12) of this chapter.
(2) The ingredient is used in foods at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(49 FR 13141, Apr. 3, 1984)
21 CFR 184.1090 Stearic acid.
(a) Stearic acid (C16H36O2, CAS Reg. No. 57-11-4) is a white to
yellowish white solid. It occurs naturally as a glyceride in tallow and
other animal or vegetable fats and oils and is a principal constituent
of most commercially hydrogenated fats. It is produced commercially
from hydrolyzed tallow derived from edible sources or from hydrolyzed,
completely hydrogenated vegetable oil derived from edible sources.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 313, which is incorporated by reference, and
the requirements of 172.860(b)(2) of this chapter. Copies of the Food
Chemicals Codex are available from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418, or available for
inspection at the Office of the Federal Register, 1100 L St NW.,
Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a flavoring agent and adjuvant as
defined in 170.3(o)(12) of this chapter.
(2) The ingredient is used in foods at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(48 FR 52445, Nov. 18, 1983, as amended at 50 FR 49536, Dec. 3, 1985)
21 CFR 184.1091 Succinic acid.
(a) Succinic acid (C4H6O4, CAS Reg. No. 110-15-6), also referred to
as amber acid and ethylenesuccinic acid, is the chemical 1,4-butanedioic
acid. It is commercially prepared by hydrogenation of maleic or fumaric
acid. It can also be produced by aqueous alkali or acid hydrolysis of
succinonitrile.
(b) The ingredient meets the specifications of the ''Food Chemicals
Codex,'' 3d Ed. (1981), pp. 314-315, which is incorporated by
reference. 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.
(c) The ingredient is used as a flavor enhancer as defined in
170.3(o)(11) of this chapter and pH control agent as defined in
170.3(o)(23) of this chapter.
(d) The ingredient is used in food at levels not to exceed good
manufacturing practice in accordance with 184.1(b)(1). Current good
manufacturing practice results in a maximum level, as served, of 0.084
percent in condiments and relishes as defined in 170.3(n)(8) of this
chapter and 0.0061 percent in meat products as defined in 170.3(n)(29)
of this chapter.
(e) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(44 FR 20657, Apr. 6, 1979, as amended at 49 FR 5611, Feb. 14, 1984)
21 CFR 184.1095 Sulfuric acid.
(a) Sulfuric acid (H2SO4, CAS Reg. No. 7664-93-9), also known as oil
of vitriol, is a clear, colorless, oily liquid. It is prepared by
reacting sulfur dioxide (SO2) with oxygen and mixing the resultant
sulfur trioxide (SO3) with water, or by reacting nitric oxide (NO) with
sulfur dioxide and water.
(b) The ingredient meets the specifications of the ''Food Chemicals
Codex,'' 3d Ed. (1981), pp. 317-318, which is incorporated by
reference. 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.
(c) The ingredient is used as a pH control agent as defined in
170.3(o)(23) of this chapter and processing aid as defined in
170.3(o)(24) of this chapter.
(d) The ingredient is used in food at levels not to exceed good
manufacturing practice in accordance with 184.1(b)(1). Current good
manufacturing practice results in a maximum level, as served, of 0.014
percent for alcoholic beverages as defined in 170.3(n)(2) of this
chapter and 0.0003 percent for cheeses as defined in 170.3(n)(5) of
this chapter.
(e) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(45 FR 6085, Jan. 25, 1980, as amended at 49 FR 5611, Feb. 14, 1984)
21 CFR 184.1097 Tannic acid.
(a) Tannic acid (CAS Reg. No. 1401-55-4), or hydrolyzable
gallotannin, is a complex polyphenolic organic structure that yields
gallic acid and either glucose or quinic acid as hydrolysis products.
It is a yellowish-white to light brown substance in the form of an
amorphous, bulky powder, glistening scales, or spongy masses. It is
also ordorless, or has a faint characteristic odor, and has an
astringent taste. Tannic acid is obtained by solvent extraction of
nutgalls or excrescences that form on the young twigs of Quercus
infectoria Oliver and related species of Quercus. Tannic acid is also
obtained by solvent extraction of the seed pods of Tara (Caesalpinia
spinosa) or the nutgalls of various sumac species, including Rhus
semialata, R. coriaria, R. galabra, and R. typhia.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 319, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c)(1) In accordance with 184.1(b)(2), the ingredient is used in
food only within the following specific limitations:
(2) Tannic acid may be used in rendered animal fat in accordance with
9 CFR 318.7.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(50 FR 21043, May 22, 1985)
21 CFR 184.1099 Tartaric acid.
(a) Food grade tartaric acid (C4H6O6, CAS Reg. No. 87-69-4) has the l
configuration. The l form of tartaric acid is dextrorotatory in
solution and is also known as l^(+)^tartaric acid. Tartaric acid occurs
as colorless or translucent crystals or as a white, crystalline powder.
It is odorless and has an acid taste. It is obtained as a byproduct of
wine manufacture.
(b) The ingredient meets the specifications of the Food Cnemicals
Codex, 3d Ed. (1981), P. 320, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a firming agent as defined in
170.3(o)(10) of this chapter; a flavor enhancer as defined in
170.3(o)(11) of this chapter; a flavoring agent as defined in
170.3(o)(12) of this chapter; a humectant as defined in 170.3(o)(16)
of this chapter; and a pH control agent as defined in 170.3(o)(23) of
this chapter.
(2) The ingredient is used in foods at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(48 FR 52447, Nov. 18, 1983, as amended at 50 FR 49536, Dec. 3, 1985)
21 CFR 184.1101 Diacetyl tartaric acid esters of mono- and
diglycerides.
(a) Diacetyl tartaric acid esters of mono- and diglycerides (DATEM)
are composed of mixed esters of glycerin in which one or more of the
hydroxyl groups of glycerin has been esterified by diacetyl tartaric
acid and by fatty acids. The ingredient is prepared by the reaction of
diacetyl tartaric anhydride with mono- and diglycerides that are derived
from edible sources.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d. Ed. (1981), pp. 98-99, which is incorporated by reference
in accordance with 5 U.S.C. 552(a). Copies are available from the
National Academy Press, 2101 Constitution Avenue NW., Washington, DC
20418, or available for inspection at the Office of the Federal
Register, 1100 L Street NW., Washington, DC 20005.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used in food as an emulsifier and emulsifier
salt as defined in 170.3(o)(8) of this chapter and a flavoring agent
and adjuvant as defined in 170.3(o)(12) of this chapter.
(2) The ingredient is used in the following foods at levels not to
exceed current good manufacturing practice: baked goods and baking
mixes as defined in 170.3(n)(l) of this chapter; nonalcoholic
beverages as defined in 170.3(n)(3) of this chapter; confections and
frostings as defined in 170.3(n)(9) of this chapter; dairy product
analogs as defined in 170.3(n)(10) of this chapter; and fats and oils
as defined in 170.3(n)(12) of this chapter.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(e) Labeling: The acronym ''DATEM'' has been suggested as an
eventual alternate common or usual name for the ingredient diacetyl
tartaric acid esters of mono- and diglycerides. This term may be used,
in parenthesis, immediately following the name of this ingredient on
food labeling.
(54 FR 7403, Feb. 21, 1989, as amended at 54 FR 13168, Mar. 31, 1989;
54 FR 18382, Apr. 28, 1989)
21 CFR 184.1115 Agar-agar.
(a) Agar-agar (CAS Reg. No. PM 9002-18-0) is a dried, hydrophyllic,
colloidal polysaccharide extracted from one of a number of related
species of red algae (class Rhodophyceae).
(b) The ingredient meets the specifications of the ''Food Chemicals
Codex,'' 3d Ed. (1981), p. 11, which is incorporated by reference.
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.
(c) The ingredient is used in food in accordance with 184.1(b)(2)
under the following conditions:
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(44 FR 19391, Apr. 3, 1979, as amended at 49 FR 5611, Feb. 14, 1984)
21 CFR 184.1120 Brown algae.
(a) Brown algae are seaweeds of the species Analipus japonicus,
Eisenia bicyclis, Hizikia fusiforme, Kjellmaniella gyrata, Laminaria
angustata, Laminaria claustonia, Laminaria digitata, Laminaria japonica,
Laminaria longicruris, Laminaria longissima, Laminaria ochotensis,
Laminaria saccharina, Macrocystis pyrifera, Petalonia fascia,
Scytosiphon lomentaria and Undaria pinnatifida. They are harvested
principally in coastal waters of the northern Atlantic and Pacific
oceans. The material is dried and ground or chopped for use in food.
(b) The ingredient meets the specifications for kelp in the Food
Chemicals Codex, 3d Ed. (1981), p. 157, which is incorporated by
reference. Copies are available from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418, or available for
inspection at the Office of the Federal Register, 1100 L ST. NW.,
Washington, DC 20408.
(c) In accordance with 184.1(b)(2), the ingredient is used in food
only within the following specific limitations:
(d) Prior sanctions for this ingredient different from the use
established in this section do not exist or have been waived.
(47 FR 47376, Oct. 26, 1982)
21 CFR 184.1121 Red algae.
(a) Red algae are seaweeds of the species Gloiopeltis furcata,
Porphyra crispata, Porphyra deutata, Porphyra perforata, Porphyra
suborbiculata, Porphyra tenera and Rhodymenia palmata. Porphyra and
Rhodymenia are harvested principally along the coasts of Japan, Korea,
China, Taiwan, and the East and West coasts of the United States.
Gloiopeltis is harvested principally in southern Pacific coastal waters.
The material is dried and ground or chopped for use in food.
(b) The ingredient meets the specifications for kelp in the Food
Chemicals Codex, 3d Ed. (1981), p. 157, which is incorporated by
reference, except that the loss on drying is not more than 20 percent
and the maximum allowable level for iodine is 0.05 percent. Copies are
available from the National Academy Press, 2101 Constitution Ave. NW.,
Washington, DC 20418, or available for inspection at the Office of the
Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(2), the ingredient is used in food
only within the following specific limitations:
(d) Prior sanctions for this ingredient different from the use
established in this section do not exist or have been waived.
(47 FR 47376, Oct. 26, 1982)
21 CFR 184.1133 Ammonium alginate.
(a) Ammonium alginate (CAS Reg. No. 9005-34-9) is the ammonium salt
of alginic acid, a natural polyuronide constituent of certain brown
algae. Ammonium alginate is prepared by the neutralization of purified
alginic acid with appropriate pH control agents.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 18, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(2), the ingredient is used in food
only within the following specific limitations:
(d) Prior sanctions for ammonium alginate different from the uses
established in this section do not exist or have been waived.
(47 FR 29950, July 9, 1982)
21 CFR 184.1135 Ammonium bicarbonate.
(a) Ammonium bicarbonate (NH4HCO3, CAS Reg. No. 1066-33-7) is
prepared by reacting gaseous carbon dioxide with aqueous ammonia.
Crystals of ammonium bicarbonate are precipitated from solution and
subsequently washed and dried.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 19, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a dough strengthener as defined in
170.3(o)(6) of this chapter; a leavening agent as defined in
170.3(o)(17) of this chapter; a pH control agent as defined in
170.3(o)(23) of this chapter; and a texturizer as defined in
170.3(o)(32) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(48 FR 52439, Nov. 18, 1983)
21 CFR 184.1137 Ammonium carbonate.
(a) Ammonium carbonate ((NH4)2CO3, CAS Reg. No. 8000-73-5) is a
mixture of ammonium bicarbonate (NH4HCO3) and ammonium carbamate
(NH2COONH4). It is prepared by the sublimation of a mixture of ammonium
sulfate and calcium carbonate and occurs as a white powder or a hard,
white or translucent mass.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 19, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a leavening agent as defined in
170.3(o)(17) of this chapter and a pH control agent as defined in
170.3(o)(23) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(48 FR 52439, Nov. 18, 1983)
21 CFR 184.1138 Ammonium chloride.
(a) Ammonium chloride (NH4C1, CAS Reg. No. 12125-02-9) is produced by
the reaction of sodium chloride and an ammonium salt in solution. The
less soluble sodium salt separates out at elevated temperatures, and
ammonium chloride is recovered from the filtrate on cooling.
Alternatively, hydrogen chloride formed by the burning of hydrogen in
chlorine is dissolved in water and then reacted with gaseous ammonia.
Ammonium chloride is crystallized from the solution.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 20, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave, NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a dough strengthener as defined in
170.3(o)(6) of this chapter; a flavor enhancer as defined in
170.3(o)(11) of this chapter; a leavening agent as defined in
170.3(o)(17) of this chapter; and a processing aid as defined in
107.3(o)(24) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(48 FR 52439, Nov. 18, 1983)
21 CFR 184.1139 Ammonium hydroxide.
(a) Ammonium hydroxide (NH4OH, CAS Reg. No. 1336-21-6) is produced by
passing ammonia gas into water.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 20, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a leavening agent as defined in
170.3(o)(17) of this chapter; a pH control agent as defined in
170.3(o)(23) of this chapter; a surface-finishing agent as defined in
170.3(o)(30) of this chapter; and as a boiler water additive complying
with 173.310 of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice. The ingredient may also be used as a
boiler water good additive at levels not to exceed current good
manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(48 FR 52440, Nov. 18, 1983)
21 CFR 184.1141a Ammonium phosphate, monobasic.
(a) Ammonium phosphate, monobasic (NH4H2PO4, CAS Reg. No. 7722-76-1)
is manufactured by reacting ammonia with phosphoric acid at a pH below
5.8.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 21, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a dough strengthener as defined in
170.3(o)(6) of this chapter and a pH control agent as defined in
170.3(o)(23) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(48 FR 52440, Nov. 18, 1983)
21 CFR 184.1141b Ammonium phosphate, dibasic.
(a) Ammonium phosphate, dibasic ((NH4)2HPO4, CAS Reg. No. 7783-28-0)
is manufactured by reacting ammonia with phosphoric acid at a pH above
5.8.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 21, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a dough strengthener as defined in
170.3(o)(6) of this chapter; a firming agent as defined in
170.3(o)(10) of this chapter; a leavening agent as defined in
170.3(o)(17) of this chapter; a pH control agent as defined in
170.3(o)(23) of this chapter; and a processing aid as defined in
170.3(o)(24) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(48 FR 52440, Nov. 18, 1983)
21 CFR 184.1143 Ammonium sulfate.
(a) Ammonium sulfate ((NH4)2SO4, CAS Reg. No. 7783-20-2) occurs
naturally and consists of colorless or white, odorless crystals or
granules. It is prepared by the neutralization of sulfuric acid with
ammonium hydroxide.
(b) The ingredient meets the specifications of the ''Food Chemicals
Codex,'' 3d Ed. (1981), pp. 22-23, which is incorporated by reference.
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.
(c) The ingredient is used as a dough strengthener as defined in
170.3(o)(6) of this chapter, firming agent as defined in 170.3(o)(10)
of this chapter, and processing aid as defined in 170.3(o)(24) of this
chapter.
(d) The ingredient is used in food at levels not to exceed good
manufacturing practice in accordance with 184.1(b)(1). Current good
manufacturing practice results in a maximum level, as served, of 0.15
percent for baked goods as defined in 170.3(n)(1) of this chapter and
0.1 percent for gelatins and puddings as defined in 170.1(n)(22) of
this chapter.
(e) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(45 FR 6086, Jan. 25, 1980; 45 FR 16469, Mar. 14, 1980, as amended
at 49 FR 5611, Feb. 14, 1984)
21 CFR 184.1155 Bentonite.
(a) Bentonite (Al2O34SiO2nH2O, CAS Reg. No. 1302-78-9) is principally
a colloidal hydrated aluminum silicate. Bentonite contains varying
quantities of iron, alkalies, and alkaline earths in the commercial
products. Depending on the cations present, natural deposits of
bentonite range in color from white to gray, yellow, green, or blue.
Bentonite's fine particles provide large total surface area and, hence,
pronounced adsorptive capability.
(b) FDA is developing food-grade specifications for bentonite in
cooperation with the National Academy of Sciences. In the interim, the
ingredient must be of a suitable purity for its intended use.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a processing aid as defined in
170.3(o)(24) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice. Current good manufacturing practice
results in no significant residue in foods.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(47 FR 43367, Oct. 1, 1982)
21 CFR 184.1157 Benzoyl peroxide.
(a) Benzoyl peroxide ((C6H5CO)2O2, CAS Reg. No. 94-36-0) is a
colorless, rhombic crystalline solid. It is prepared by reaction of
benzoyl chloride, sodium hydroxide, and hydrogen peroxide.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 35, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a bleaching agent in food.
(2) The ingredient is used in the following foods at levels not to
exceed current good manufacturing practice: flour; milk used for
production of Asiago fresh and Asiago soft cheese ( 133.102), Asiago
medium cheese ( 133.103), Asiago old cheese ( 133.104), Blue cheese (
133.106), Caciocavallo siciliano chesse ( 133.111), Gorgonzola cheese (
133.141), Parmesan and reggiano cheese ( 133.165), Provolone cheese (
133.181), Romano cheese ( 133.183), and Swiss and emmentaler cheese (
133.195) in part 133 of this chapter; and annatto-colored whey, such
that the final bleached product conforms to the descriptions and
specifications for whey, concentrated whey, or dried whey in
184.1979(a) (1), (2), or (3), respectively.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(51 FR 27173, July 30, 1986)
21 CFR 184.1165 n-Butane and iso-butane.
(a) n-Butane and iso-butane (empirical formula C4H10, CAS Reg. Nos.
106-97-8 and 75-28-5, respectively) are colorless, odorless, flammable
gases at normal temperatures and pressures. They are easily liquefied
under pressure at room temperature and are stored and shipped in the
liquid state. The butanes are obtained from natural gas by
fractionation following absorption in oil, adsorption to surface-active
agents, or refrigeration.
(b) The Food and Drug Administration is developing food-grade
specifications for n-butane and iso-butane in cooperation with the
National Academy of Sciences. In the interim, the ingredients must be
of a purity suitable for their intended use.
(c) In accordance with 184.1(b)(1), these ingredients are used in
food with no limitations other than current good manufacturing practice.
The affirmation of these ingredients as generally recognized as safe
(GRAS) as direct human food ingredients is based upon the following
current good manufacturing practice conditions of use:
(1) The ingredients are used as propellants, aerating agents, and
gases as defined in 170.3(o)(25) of this chapter.
(2) The ingredients are used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for these ingredients different from the uses
established in this section do not exist or have been waived.
(48 FR 57270, Dec. 29, 1983)
21 CFR 184.1185 Calcium acetate.
(a) Calcium acetate (Ca (C2 H3 O2)2, CAS Reg. No. 62-54-4), also
known as acetate of lime or vinegar salts, is the calcium salt of acetic
acid. It may be produced by the calcium hydroxide neutralization of
acetic acid.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 44, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) The ingredient is used as a firming agent as defined in
170.3(o)(10) of this chapter; pH control agent as defined in
170.3(o)(23) of this chapter; processing aid as defined in
170.3(o)(24) of this chapter; sequestrant as defined in 170.3(o)(26)
of this chapter; stabilizer and thickener as defined in 170.3(o)(28)
of this chapter; and texturizer as defined in 170.3(o)(32) of this
chapter.
(d) The ingredient is used in food at levels not to exceed current
good manufacturing practices in accordance with 184.1(b)(1). Current
good manufacturing practices result in a maximum level, as served, of
0.2 percent for baked goods as defined in 170.3(n)(1) of this chapter;
0.02 percent for cheese as defined in 170.3(n)(5) of this chapter; 0.2
percent for gelatins, puddings, and fillings as defined in 170.3(n)(22)
of this chapter; 0.15 percent for sweet sauces, toppings, and syrups as
defined in 170.3(n)(43) of this chapter; and 0.0001 percent for all
other food categories.
(e) Prior sanctions for this ingredient different from the uses
established in this section or in part 181 of this chapter do not exist
or have been waived.
(47 FR 27807, June 25, 1982)
21 CFR 184.1187 Calcium alginate.
(a) Calcium alginate (CAS Reg. No. 9005-35-0) is the calcium salt of
alginic acid, a natural polyuronide constituent of certain brown algae.
Calcium alginate is prepared by the neutralization of purified alginic
acid with appropriate pH control agents, or from sodium alginate by
metathesis with appropriate calcium salts.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 45, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(2), the ingredient is used in food
only within the following specific limitations:
(d) Prior sanctions for calcium alginate different from the uses
established in this section do not exist or have been waived.
(47 FR 29951, July 9, 1982)
21 CFR 184.1191 Calcium carbonate.
(a) Calcium carbonate (CaCO3, CAS Reg. No. 471-34-1) is prepared by
three common methods of manufacture:
(1) As a byproduct in the ''Lime soda process'';
(2) By precipitation of calcium carbonate from calcium hydroxide in
the ''Carbonation process''; or
(3) By precipitation of calcium carbonate from calcium chloride in
the ''Calcium chloride process''.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 46, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section, or different from that set forth in part
181 of this chapter, do not exist or have been waived.
(48 FR 52441, Nov. 18, 1983)
21 CFR 184.1193 Calcium chloride.
(a) Calcium chloride (CaCl2 2H2O, CAS Reg. No. 10035-04-8) or
anhydrous calcium chloride (CaCl2, CAS Reg. No. 10043-52-4) may be
commercially obtained as a byproduct in the ammonia-soda (Solvay)
process and as a joint product from natural salt brines, or it may be
prepared by substitution reactions with other calcium and chloride
salts.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 47, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) The ingredient is used as an anticaking agent as defined in
170.3(o)(1) of this chapter; antimicrobial agent as defined in
170.3(o)(2) of this chapter; curing or pickling agent as defined in
170.3(o)(5) of this chapter; firming agent as defined in 170.3(o)(10)
of this chapter; flavor enhancer as defined in 170.3(o)(11) of this
chapter; humectant as defined in 170.3(o)(16) of this chapter;
nutrient supplement as defined in 170.3(o)(2) of this chapter; pH
control agent as defined in 170.3(o)(23) of this chapter; processing
aid as defined in 170.3(o)(24) of this chapter; stabilizer and
thickener as defined in 170.3(o)(28) of this chapter; surface-active
agent as defined in 170.3(o)(29) of this chapter; synergist as defined
in 170.3(o)(31) of this chapter; and texturizer as defined in
170.3(o)(32) of this chapter.
(d) The ingredient is used in foods at levels not to exceed current
good manufacturing practices in accordance with 184.1(b)(1). Current
good manufacturing practices result in a maximum level, as served, of
0.3 percent for baked goods as defined in 170.3(n)(1) of this chapter
and for dairy product analogs as defined in 170.3(n)(10) of this
chapter; 0.22 percent for nonalcoholic beverages and beverage bases as
defined in 170.3(n)(3) of this chapter; 0.2 percent for cheese as
defined in 170.3(n)(5) of this chapter and for processed fruit and
fruit juices as defined in 170.3(n)(35) of this chapter; 0.32 percent
for coffee and tea as defined in 170.3(n)(7) of this chapter; 0.4
percent for condiments and relishes as defined in 170.3(n)(8) of this
chapter; 0.2 percent for gravies and sauces as defined in 170.3(n)(24)
of this chapter; 0.1 percent for commercial jams and jellies as defined
in 170.3(n)(28) of this chapter; 0.25 percent for meat products as
defined in 170.3(n)(29) of this chapter; 2.0 percent for plant protein
products as defined in 170.3(n)(33) of this chapter; 0.4 percent for
processed vegetables and vegetable juices as defined in 170.3(n)(36) of
this chapter; and 0.05 percent for all other food categories.
(e) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(47 FR 27808, June 25, 1982)
21 CFR 184.1199 Calcium gluconate.
(a) Calcium gluconate ((CH2OH(CHOH)4COO)2Ca, CAS Reg. No. 299-28-5)
is the calcium salt of gluconic acid which may be produced by
neutralization of gluconic acid with lime or calcium carbonate.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 51, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) The ingredient is used as a firming agent as defined in
170.3(o)(10) of this chapter; formulation aid as defined in
170.3(o)(14) of this chapter; sequestrant as defined in 170.3(o)(26)
of this chapter; stabilizer or thickener as defined in 170.3(o)(28) of
this chapter; and texturizer as defined in 170.3(o)(32) of this
chapter.
(d) The ingredient is used in foods at levels not to exceed current
good manufacturing practices in accordance with 184.1(b)(1). Current
good manufacturing practices result in a maximum level, as served, of
1.75 percent for baked goods as defined in 170.3(n)(1) of this chapter;
0.4 percent for dairy product analogs as defined in 170.3(n)(10) of
this chapter; 4.5 percent for gelatins and puddings as defined in
170.3(n)(22) of this chapter; and 0.01 percent for sugar substitutes as
defined in 170.3(n)(42) of this chapter.
(e) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(47 FR 27808, June 25, 1982)
21 CFR 184.1201 Calcium glycerophosphate.
(a) Calcium glycerophosphate (C3H7CaO6P, CAS Reg. No. 27214-00-2) is
a fine, white, odorless, almost tasteless, slightly hygroscopic powder.
It is prepared by neutralizing glycerophosphoric acid with calcium
hydroxide or calcium carbonate. The commercial product is a mixture of
calcium -, and D-, and L- -glycerophosphate.
(b) The ingredient meets the specifications of the ''Food Chemicals
Codex,'' 3d Ed. (1981), pp. 51-52, which is incorporated by reference
in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. 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.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a nutrient supplement as defined in
170.3(o)(20) of this chapter.
(2) The ingredient is used in gelatins, puddings, and fillings as
defined in 170.3(n)(22) of this chapter.
(d) Prior sanctions for this ingredient different from the uses
established in this section or different from that as set forth in part
181 of this chapter, do not exist or have been waived.
(57 FR 10813, Mar. 31, 1992)
Effective Date Note: At 57 FR 10813, Mar. 31, 1992, 184.1201 was
added, effective April 30, 1992.
21 CFR 184.1205 Calcium hydroxide.
(a) Calcium hydroxide (Ca(OH)2, CAS Reg. No. 1305-62-0) is also known
as slaked lime or calcium hydrate. It is produced by the hydration of
lime.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 52, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(49 FR 26714, June 29, 1984)
21 CFR 184.1206 Calcium iodate.
(a) Calcium iodate (Ca(IO3)2 H2O, CAS Reg. No. 7789-80-2), also
referred to as lautarite, does not occur naturally but can be prepared
by passing chlorine into a hot solution of lime (CaCO3) in which iodine
has been dissolved.
(b) The ingredient meets the specifications of the ''Food Chemicals
Codex,'' 3d Ed. (1981), p. 53, which is incorporated by reference.
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.
(c) The ingredient is used as a dough strengthener as defined in
170.3(o)(6) of this chapter.
(d) The ingredient is used in the manufacture of bread in accordance
with 184.1(b)(2) of this chapter in an amount not to exceed 0.0075
percent based on the weight of the flour.
(e) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(43 FR 11699, Mar. 21, 1978, as amended at 49 FR 5611, Feb. 14, 1984)
21 CFR 184.1207 Calcium lactate.
(a) Calcium lactate (C6H10CaO6.xH2O, where x is any integer up to 5,
CAS Reg. No. 814-80-2) is prepared commercially by the neutralization of
lactic acid with calcium carbonate or calcium hydroxide.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 53, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Avenue NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a firming agent as defined in
170.3(o)(10) of this chapter; a flavor enhancer as defined in
170.3(o)(11) of this chapter; a flavoring agent or adjuvant as defined
in 170.3(o)(12) of this chapter; a leavening agent as defined in
170.3(o)(17) of this chapter; a nutrient supplement as defined in
170.3(o)(20) of this chapter; and a stabilizer and thickener as defined
in 170.3(o)(28) of this chapter.
(2) The ingredient is used in food, except in infant foods and infant
formulas, at levels not to exceed current good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(49 FR 35367, Sept. 7, 1984)
21 CFR 184.1210 Calcium oxide.
(a) Calcium oxide (CaO, CAS Reg. No. 1305-78-8) is also known as
lime, quick lime, burnt lime, or calx. It is produced from calcium
carbonate, limestone, or oyster shells by calcination at temperatures of
1,700-2,450 F.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 55, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(49 FR 26714, June 29, 1984)
21 CFR 184.1212 Calcium pantothenate.
(a) Calcium pantothenate ((C9H16NO5)2Ca, CAS Reg. No. of the
D-isomer, 137-08-6) is a salt of pantothenic acid, one of the vitamins
of the B complex. Only the D-isomer of pantothenic acid has vitamin
activity, although both the D-isomer and the DL-racemic mixture of
calcium pantothenate are used in food. Commercial calcium pantothenate
is prepared synthetically from isobutyraldehyde and formaldehyde via
1,1-dimethyl-2-hydroxy-propionaldehyde and pantolactone.
(b) Calcium pantothenate meets the specifications of the Food
Chemicals Codex, 3d Ed. (1981), p. 56, which is incorporated by
reference. Copies are available from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418, or available for
inspection at the Office of the Federal Register, 1100 L St. NW.,
Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a nutrient supplement as defined in
170.3(o)(20) of this chapter.
(2) The ingredient is used in foods at levels not to exceed current
good manufacturing practice. Calcium pantothenate may be used in infant
formula in accordance with section 412(g) of the Federal Food, Drug, and
Cosmetic Act (the act) or with regulations promulgated under section
412(a)(2) of the Act.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(48 FR 51908, Nov. 15, 1983)
21 CFR 184.1221 Calcium propionate.
(a) Calcium propionate (C6H10CaO4, CAS Reg. No. 4075-81-4) is the
calcium salt of propionic acid. It occurs as white crystals or a
crystalline solid, possessing not more than a faint odor of propionic
acid. It is prepared by neutralizing propionic acid with calcium
hydroxide.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 60, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as an antimicrobial agent as defined in
170.3(o)(2) of this chapter.
(2) The ingredient is used in the following foods at levels not to
exceed current good manufacturing practice: baked goods as defined in
170.3(n)(1) of this chapter; cheeses as defined in 170.3(n)(5) of this
chapter; confections and frostings as defined in 170.3(n)(9) of this
chapter; gelatins, puddings, and fillings as defined in 170.3(n)(22)
of this chapter; and jams and jellies as defined in 170.3(n)(28) of
this chapter.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(49 FR 13141, Apr. 3, 1984)
21 CFR 184.1229 Calcium stearate.
(a) Calcium stearate (Ca(C17H35COO)2, CAS Reg. No. 1529-23-0) is the
calcium salt of stearic acid derived from edible sources. It is
prepared as a white precipitate by mixing calcium chloride and sodium
stearate in aqueous solution.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 64, which is incorporated by reference, and
the requirements of 172.860(b)(2) of this chapter. Copies of the Food
Chemicals Codex are available from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418, or available for
inspection at the Office of the Federal Register, 1100 L St. NW.,
Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a flavoring agent and adjuvant as
defined in 170.3(o)(12) of this chapter; a lubricant and release agent
as defined in 170.3(o)(18) of this chapter; and a stabilizer and
thickener as defined in 170.3(o)(28) of this chapter.
(2) The ingredient is used in foods at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(48 FR 52445, Nov. 18, 1983)
21 CFR 184.1230 Calcium sulfate.
(a) Calcium sulfate (CaSO4, CAS Reg. No. 7778-18-9 or CaSO4 2H2O, CAS
Reg. No. 10101-41-4), also known as plaster of Paris, anhydrite, and
gypsum, occurs naturally and exists as a fine, white to slightly
yellow-white odorless powder. The anhydrous form is prepared by
complete dehydration of gypsum, below 300 C, in an electric oven.
(b) The ingredient meets the specifications of the ''Food Chemicals
Codex,'' 3d Ed. (1981), p. 66, which is incorporated by reference.
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.
(c) The ingredient is used as an anticaking agent as defined in
170.3(o)(1) of this chapter, color and coloring adjunct as defined in
170.3(o)(4) of this chapter, dough strengthener as defined in
170.3(o)(6) of this chapter, drying agent as defined in 170.3(o)(7) of
this chapter, firming agent as defined in 170.3(o)(10) of this chapter,
flour treating agent as defined in 170.3(o)(13) of this chapter,
formulation aid as defined in 170.3(o)(14) of this chapter, leavening
agent as defined in 170.3(o)(17) of this chapter, nutrient supplement
as defined in 170.3(o)(20) of this chapter, pH control agent as defined
in 170.3(o)(23) of this chapter, processing aid as defined in
170.3(o)(24) of this chapter, stabilizer and thickener as defined in
170.3(o)(28) of this chapter, synergist as defined in 170.3(o)(31) of
this chapter, and texturizer as defined in 170.3(o)(32) of this
chapter.
(d) The ingredient is used in food at levels not to exceed good
manufacturing practice in accordance with 184.1(b)(1). Current good
manufacturing practice results in a maximum level, as served, of 1.3
percent for baked goods as defined in 170.3(n)(1) of this chapter, 3.0
percent for confections and frostings as defined in 170.3(n)(9) of this
chapter, 0.5 percent for frozen dairy desserts and mixes as defined in
170.3(n)(20) of this chapter, 0.4 percent for gelatins and puddings as
defined in 170.3(n)(22) of this chapter, 0.5 percent for grain products
and pastas as defined in 170.3(n)(23) of this chapter, 0.35 percent for
processed vegetables as defined in 170.3(n)(36) of this chapter, and
0.07 percent or less for all other food categories.
(e) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(45 FR 6086, Jan. 25, 1980; 45 FR 26319, Apr. 18, 1980, as amended
at 49 FR 5611, Feb. 14, 1984)
21 CFR 184.1240 Carbon dioxide.
(a) Carbon dioxide (empirical formula CO2, CAS Reg. No. 124-38-9)
occurs as a colorless, odorless, noncombustible gas at normal
temperatures and pressures. The solid form, dry ice, sublimes under
atmospheric pressure at a temperature of ^78.5 C. Carbon dioxide is
prepared as a byproduct of the manufacture of lime during the
''burning'' of limestone, from the combustion of carbonaceous material,
from fermentation processes, and from gases found in certain natural
springs and wells.
(b) The Food and Drug Administration is developing food-grade
specifications for carbon dioxide in cooperation with the National
Academy of Sciences. In the interim, the ingredient must be of purity
suitable for its intended use.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitations other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a leavening agent as defined in
170.3(o)(17) of this chapter; a processing aid as defined in
170.3(o)(24) of this chapter; and a propellant, aerating agent, and gas
as defined in 170.3(o)(25) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(48 FR 57270, Dec. 29, 1983)
21 CFR 184.1245 Beta-carotene.
(a) Beta-carotene (CAS Reg. No. 7235-40-7) has the molecular formula
C40H56. It is synthesized by saponification of vitamin A acetate. The
resulting alcohol is either reacted to form vitamin A Wittig reagent or
oxidized to vitamin A aldehyde. Vitamin A Wittig reagent and vitamin A
aldehyde are reacted together to form beta-carotene.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 73, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washingtion, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a nutrient supplement as defined in
170.3(o)(20) of this chapter.
(2) The ingredient is used in the following foods at levels not to
exceed current good manufacturing practice: dairy product analogs as
defined in 170.3(n)(10) of this chapter; fats and oils as defined in
170.3(n)(12) of this chapter; and processed fruits and fruit juices as
defined in 170.3(n)(35) of this chapter. Beta-carotene may be used in
infant formula as a source of vitamin A in accordance with section
412(g) of the Federal Food, Drug, and Cosmetic Act or with regulations
promulgated under section 412(g) of the act.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(52 FR 25211, July 6, 1987)
21 CFR 184.1257 Clove and its derivatives.
(a) Cloves are the dried unopened flower buds and calyx tubes,
harvested before the flowers have opened, of the clove tree Eugenia
caryophyllata Thunberg, native to tropical Asia. Their derivatives
include essential oils (cloves, CAS Reg. No. 8000-34-8; buds; leaves,
CAS Reg. No. 8015-97-2; stems, CAS Reg. No. 8015-98-3; and eugenol,
CAS Reg. No. 97-53-0), oleoresins, and natural extractives obtained from
clove buds, leaves, and stems.
(b) Clove bud oil, clove leaf oil, clove stem oil, and eugenol meet
the specifications of the ''Food Chemicals Codex,'' (FCC), 3d Ed.
(1981), pp. 87-89, which is incorporated by reference. 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. As determined by
analytical methods in FCC, clove oleorsin or other natural extractives
(other than clove oils) meet FCC specifications for clove (clove bud)
oil and the following modifications:
(1) The assay for phenols, as eugenol, by the FCC test, 3d Ed. (pp.
87-88), or the volatile oils content by the FCC test, 3d Ed. (pp.
87-88) should conform to the representation of the vendor;
(2) Optical rotation of the volatile oil between ^2 and 0 ;
(3) Refractive index of the volatile oil between 1.527 and 1.538 at
20 C;
(4) Specific gravity of the volatile oil between 1.036 and 1.060;
and
(5) Residual solvent free, except those solvents that are GRAS or
within tolerance levels as specified in part 173, Subpart C, of this
chapter.
(c) Clove and its derivatives are used as flavoring agents and
adjuvants as defined in 170.3(0)(12) of this chapter.
(d) The ingredients are used in food at levels not to exceed good
manufacturing practice in accordance with 184.1(b)(1).
(e) Prior sanctions for these ingredients different from the uses
established in this section do not exist or have been waived.
(44 FR 3964, Jan 19, 1979, as amended at 47 FR 11852, Mar. 19, 1982;
49 FR 5611, Feb. 14, 1984)
21 CFR 184.1259 Cocoa butter substitute primarily from palm oil.
(a) The common or usual name for the triglyceride
1-palmitoyl-2-oleoyl-3-stearin is ''cocoa butter substitute primarily
from palm oil.'' The ingredient is manufactured by --
(1) Directed esterification of fully saturated 1,3-diglycerides
(derived from palm oil) with the anhydride of food-grade oleic acid in
the presence of the catalyst trifluoromethane sulfonic acid ( 173.395 of
this chapter), or
(2) By interesterification of partially saturated 1,2,3-triglycerides
(derived from palm oil) with ethyl stearate in the presence of a
suitable lipase enzyme preparation that is either GRAS or has food
additive approval for such use.
(b) The ingredient meets the following specifications:
(1) Over 90 percent triglycerides, not more than 7 percent
diglycerides, not more than 1 percent monoglycerides, and not more than
1 percent free fatty acids.
(2) Total glycerides -- 98 percent minimum.
(3) Heavy metals (as lead), 10 parts per million maximum (''Food
Chemicals Codex,'' 3d Ed. (1981), pp. 512-513, which is incorporated by
reference, 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).
(4) Color -- clear, bright, and free from suspended matter.
(5) Odor and taste -- free from foreign and rancid odor and taste.
(6) Residual catalyst (''Official Methods of Analysis of the
Association of Official Analytical Chemists,'' 13th Ed. (1980), sections
25.049-25.055, which is incorporated by reference), residual fluorine;
limit of detection 0.2 part per million F; multiply fluoride result by
2.63 to convert to residual catalyst. Copies of the material
incorporated by reference may be obtained from the Association of
Official Analytical Chemists, P.O. Box 540, Benjamin Franklin Station,
Washington, DC 20044, or may be examined at the Office of the Federal
Register, 1100 L St. NW., Washington, DC 20408. The ingredient shall
be washed three times in batches with 0.5 percent sodium bicarbonate to
remove catalyst residuals in accordance with good manufacturing
practice.
(7) Residual methanol -- 5 parts per million maximum.
(8) Residual fatty acid ethyl esters -- not more than 20 parts per
million as determined by a ''Modification of Japan Institute of Oils and
Fats: Analysis Method of Residual Ethyl Esters of Fatty Acids'' issued
by the Fuji Oil Co., which is incorporated by reference. Copies are
available from the Division of Food and Color Additives, Center for Food
Safety and Applied Nutrition (HFF-330), 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.
(9) Hexane -- not more than 5 parts per million as determined by the
method of Dupuy et al., ''Rapid Quantitative Determination of Residual
Hexane in Oils by Direct Gas Chromatography,'' published in the
''Journal of the American Oil Chemists' Society,'' Vol. 52, p.
118-120, 1975, which is incorporated by reference. Copies are available
from the Division of Food and Color Additives, Center for Food Safety
and Applied Nutrition (HFF-330), 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.
(c) In accordance with 184.1(b)(1), the ingredient is used in the
following food categories at levels not to exceed current good
manufacturing practice: Confections and frostings as defined in
170.3(n)(9) of this chapter; coatings of soft candy as defined in
170.3(n)(38) of this chapter; and sweet sauces and toppings as defined
in 170.3(n)(43) of this chapter; except that the ingredient may not be
used in a standardized food unless permitted by the standard of
identity.
(d) The ingredient is used in food in accordance with 184.1(b)(1) at
levels not to exceed good manufacturing practice.
(43 FR 54239, Nov. 11, 1978, as amended at 47 FR 11852, Mar. 19,
1982; 49 FR 5611, Feb. 14, 1984; 49 FR 22799, June 1, 1984; 52 FR
47920, Dec. 17, 1987; 52 FR 48905, Dec. 28, 1987)
21 CFR 184.1260 Copper gluconate.
(a) Copper gluconate (cupric gluconate (CH2OH(CHOH)4COO)2Cu, CAS Reg.
No. 527-09-3) is a substance that occurs as light blue to bluish-green,
odorless crystals, or as a fine, light blue powder. It is prepared by
the reaction of gluconic acid solutions with cupric oxide or basic
cupric carbonate.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 90, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC. 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC. 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a nutrient supplement as defined in
170.3(o)(20) of this chapter and as a synergist as defined in
170.3(o)(31) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice. Copper gluconate may be used in infant
formula in accordance with section 412(g) of the Federal Food, Drug, and
Cosmetic Act (the Act) or with regulations promulgated under section
412(a)(2) of the Act.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(49 FR 24119, June 12, 1984)
21 CFR 184.1261 Copper sulfate.
(a) Copper sulfate (cupric sulfate, CuSO4.5H2O, CAS Reg. No.
7758-98-7) usually is used in the pentahydrate form. This form occurs
as large, deep blue or ultramarine, triclinic crystals; as blue
granules, or as a light blue powder. The ingredient is prepared by the
reaction of sulfuric acid with cupric oxide or with copper metal.
(b) FDA is developing food-grade specifications for copper sulfate in
cooperation with the National Academy of Sciences. In the interim, this
ingredient must be of a purity suitable for its intended use.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a nutrient supplement as defined in
170.3(o)(20) of this chapter and as a processing aid as defined in
170.3(o)(24) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice. Copper sulfate may be used in infant
formula in accordance with section 412(g) of the Federal Food, Drug, and
Cosmetic Act (the Act) or with regulations promulgated under section
412(a)(2) of the Act.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(49 FR 24119, June 12, 1984)
21 CFR 184.1262 Corn silk and corn silk extract.
(a) Corn silk is the fresh styles and stigmas of Zea mays L.
collected when the corn is in milk. The filaments are extracted with
dilute ethanol to produce corn silk extract. The extract may be
concentrated at a temperature not exceeding 60 C.
(b) The Food and Drug Administration, in cooperation with the
National Academy of Sciences, is developing food-grade specifications
for corn silk and corn silk extract. In the interim, this ingredient
must be of a suitable purity for its intended use.
(c) In accordance with 184.1(b)(2), the ingredients are used in food
only within the following specific limitations:
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(47 FR 29953, July 9, 1982)
21 CFR 184.1265 Cuprous iodide.
(a) Cuprous iodide (copper (I) iodide, CuI, CAS Reg. No. 7681-65-4)
is a pure white crystalline powder. It is prepared by the reaction of
copper sulfate with potassium iodide under slightly acidic conditions.
(b) FDA is developing food-grade specifications for cuprous iodide in
cooperation with the National Academy of Sciences. In the interim, this
ingredient must be of a purity suitable for its intended use.
(c) In accordance with 184.1(b)(2), the ingredient is used in food
only within the following specific limitations:
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(49 FR 24119, June 12, 1984)
21 CFR 184.1271 L-Cysteine.
(a) L-Cysteine is the chemical L-2-amino-3-mercaptopropanoic acid
(C3H7O2NS).
(b) The ingredient meets the appropriate part of the specification
set forth in the ''Food Chemicals Codex,'' 3d Ed. (1981), pp. 92-93,
which is incorporated by reference. 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.
(c) The ingredient is used to supply up to 0.009 part of total
L-cysteine per 100 parts of flour in dough as a dough strengthener as
defined in 170.3(o)(6) of this chapter in yeast-leavened baked goods
and baking mixes as defined in 170.3(n)(1) of this chapter.
(d) This regulation is issued prior to a general evaluation of use of
this ingredient in order to affirm as GRAS the specific use named.
(42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5612, Feb. 14, 1984)
21 CFR 184.1272 L-Cysteine monohydrochloride.
(a) L-Cysteine monohydrochloride is the chemical
L-2-amino-3-mercaptopropanoic acid monohydrochloride monohydrate
(C3H7O2NS HCl H2O).
(b) The ingredient meets the specifications of the ''Food Chemicals
Codex,'' 3d Ed. (1981), pp. 92-93, which is incorporated by reference.
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.
(c) The ingredient is used to supply up to 0.009 part of total
L-cysteine per 100 parts of flour in dough as a dough strengthener as
defined in 170.3(o)(6) of this chapter in yeast-leavened baked goods
and baking mixes as defined in 170.3(n)(1) of this chapter.
(d) This regulation is issued prior to a general evaluation of use of
this ingredient in order to affirm as GRAS the specific use named.
(42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5612, Feb. 14, 1984)
21 CFR 184.1277 Dextrin.
(a) Dextrin ((C6H10O5)n H2O, CAS Reg. No. 9004-53-9) is an
incompletely hydrolyzed starch. It is prepared by dry heating corn,
waxy maize, waxy milo, potato, arrowroot, wheat, rice, tapioca, or sago
starches, or by dry heating the starches after: (1) Treatment with safe
and suitable alkalis, acids, or pH control agents and (2) drying the
acid or alkali treated starch.
(b) The ingredient meets the specification of the Food Chemicals
Codex, 3d Ed. (1981), p. 96, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a formulation aid as defined in
170.3(o)(14) of this chapter; as a processing aid as defined in
170.3(o)(24) of this chapter; as a stabilizer and thickener as defined
in 170.3(o)(28) of this chapter; and as a surface-finishing agent as
defined in 170.3(o)(30) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(48 FR 51909, Nov. 15, 1983)
21 CFR 184.1278 Diacetyl.
(a) Diacetyl (C4H6O2, CAS Reg. No. 431-03-8) is a clear yellow to
yellowish green liquid with a strong pungent odor. It is also known as
2,3-butanedione and is chemically synthesized from methyl ethyl ketone.
It is miscible in water, glycerin, alcohol, and ether, and in very
dilute water solution, it has a typical buttery odor and flavor.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 368, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a flavoring agent and adjuvant as
defined in 170.3(o)(12) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(48 FR 51907, Nov. 15, 1983)
21 CFR 184.1282 Dill and its derivatives.
(a) Dill (American or European) is the herb and seeds from Anethum
graveolens L., and dill (Indian) is the herb and seeds from Anethum
sowa, D.C. Its derivatives include essential oils, oleoresins, and
natural extractives obtained from these sources of dill.
(b) Dill oils meet the description and specifications of the ''Food
Chemicals Codex,'' 3d Ed. (1981), pp. 100-102, which is incorporated
by reference. 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.
(c) Dill and its derivatives are used as flavoring agents and
adjuvants as defined in 170.3(o)(12) of this chapter.
(d) The ingredients are used in food at levels not to exceed good
manufacturing practice.
(e) (Reserved)
(f) Prior sanctions for these ingredients different from the uses
established in this section do not exist or have been waived.
(42 FR 14653, Mar. 15, 1977, as amended at 42 FR 55205, Oct. 14,
1977; 49 FR 5612, Feb. 14, 1984)
21 CFR 184.1287 Enzyme-modified fats.
(a) Enzyme-modified refined beef fat, enzyme-modified butterfat, and
enzyme-modified steam-rendered chicken fat are prepared from refined
beef fat; butterfat or milkfat; and steam-rendered chicken fat,
respectively, with enzymes that are generally recognized as safe (GRAS).
Enzyme-modified milk powder may be prepared with GRAS enzymes from
reconstituted milk powder, whole milk, condensed or concentrated whole
milk, evaporated milk, or milk powder. The lipolysis is maintained at a
temperature that is optimal for the action of the enzyme until
appropriate acid development is attained. The enzymes are then
inactivated. The resulting product is concentrated or dried.
(b) FDA is developing food-grade specifications for these
enzyme-modified ingredients in cooperation with the National Academy of
Sciences. In the interim, the ingredients must be of purity suitable
for their intended use.
(c) In accordance with 184.1(b)(1), the ingredients are used in food
with no limitation other than current good manufacturing practice. The
affirmation of these ingredients as generally recognized as safe (GRAS)
as direct human food ingredients is based upon the following current
good manufacturing practice conditions of use:
(1) The ingredients are used as flavoring agents and adjuvants as
defined in 170.3(o)(12) of this chapter.
(2) The ingredients are used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for these ingredients different from the uses
established in this section do not exist or have been waived.
(52 FR 25976, July 10, 1987)
21 CFR 184.1293 Ethyl alcohol.
(a) Ethyl alcohol (ethanol) is the chemical C2H5OH.
(b) The ingredient meets the specifications of the ''Food Chemicals
Codex,'' 3d Ed. (1981), pp. 112-113, which is incorporated by
reference. 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.
(c) The ingredient is used as an antimicrobial agent as defined in
170.3(o)(2) of this chapter on pizza crusts prior to final baking at
levels not to exceed 2.0 percent by product weight.
(d) This regulation is issued prior to general evaluation of use of
this ingredient in order to affirm as GRAS the specific use named.
(42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5612, Feb. 14, 1984)
21 CFR 184.1295 Ethyl formate.
(a) Ethyl formate (C3H6O2, CAS Reg. No. 109-94-4) is also referred to
as ethyl methanoate. It is an ester of formic acid and is prepared by
esterification of formic acid with ethyl alcohol or by distillation of
ethyl acetate and formic acid in the presence of concentrated sulfuric
acid. Ethyl formate occurs naturally in some plant oils, fruits, and
juices but does not occur naturally in the animal kingdom.
(b) The ingredient meets the specifications of the ''Food Chemicals
Codex,'' 3d Ed. (1981), p. 376, which is incorporated by reference.
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.
(c) The ingredient is used as a flavoring agent and adjuvant as
defined in 170.3(o)(12) of this chapter.
(d) The ingredient is used in food at levels not to exceed good
manufacturing practice in accordance with 184.1(b)(1). Current good
manufacturing practice results in a maximum level, as served, of 0.05
percent in baked goods as defined in 170.3(n)(1) of this chapter; 0.04
percent in chewing gum as defined in 170.3(n)(6), hard candy as defined
in 170.3(n)(25), and soft candy as defined in 170.3(n)(38) of this
chapter; 0.02 percent in frozen dairy desserts as defined in
170.3(n)(20) of this chapter; 0.03 percent in gelatins, puddings, and
fillings as defined in 170.3(n)(22) of this chapter; and 0.01 percent
in all other food categories.
(e) Prior sanctions for ethyl formate different from the uses
established in this section do not exist or have been waived.
(45 FR 22915, Apr. 4, 1980, as amended at 49 FR 5612, Feb. 14, 1984)
21 CFR 184.1296 Ferric ammonium citrate.
(a) Ferric ammonium citrate (iron (III) ammonium citrate) is prepared
by the reaction of ferric hydroxide with citric acid, followed by
treatment with ammonium hydroxide, evaporating, and drying. The
resulting product occurs in two forms depending on the stoichiometry of
the initial reactants.
(1) Ferric ammonium citrate (iron (III) ammonium citrate, CAS Reg.
No. 1332-98-5) is a complex salt of undetermined structure composed of
16.5 to 18.5 percent iron, approximately 9 percent ammonia, and 65
percent citric acid and occurs as reddish brown or garnet red scales or
granules or as a brownish-yellowish powder.
(2) Ferric ammonium citrate (iron (III) ammonium citrate, CAS Reg.
No. 1333-00-2) is a complex salt of undetermined structure composed of
14.5 to 16 percent iron, approximately 7.5 percent ammonia, and 75
percent citric acid and occurs as thin transparent green scales, as
granules, as a powder, or as transparent green crystals.
(b) The ingredients meet the specifications of the Food Chemicals
Codex, 3d Ed. (1981), pp. 116-117 (Ferric ammonium citrate, brown) and
p. 117 (Ferric ammonium citrate, green), which is incorporated by
reference. Copies are available from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418, or available for
inspection at the Office of the Federal Register, 1100 L St. NW.,
Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredients are used in food
as nutrient supplements as defined in 170.3(o)(20) of this chapter,
with no limitation other than current good manufacturing practice. The
ingredients may also be used in infant formula in accordance with
section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) (21
U.S.C. 350a(g)) or with regulations promulgated under section 412(a)(2)
of the act (21 U.S.C. 350a(a)(2)).
(d) Prior sanctions for these ingredients different from the uses
established in this section do not exist or have been waived.
(53 FR 16864, May 12, 1988)
21 CFR 184.1297 Ferric chloride.
(a) Ferric chloride (iron (III) chloride, FeC13, CAS Reg. No.
7705-08-0) may be prepared from iron and chlorine or from ferric oxide
and hydrogen chloride. The pure material occurs as hydroscopic,
hexagonal, dark crystals. Ferric chloride hexahydrate (iron (III)
chloride hexahydrate, FeC13. 6H20, CAS Reg. No. 10025-77-1) is readily
formed when ferric chloride is exposed to moisture.
(b) The Food and Drug Administration is developing food-grade
specifications for ferric chloride in cooperation with the National
Academy of Sciences. In the interim, this ingredient must be of a
purity suitable for its intended use.
(c) In accordance with 184.1(b)(1) the ingredient is used in food as
a flavoring agent as defined in 170.3(o)(12) of this chapter, with no
limitation other than current good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(53 FR 16864, May 12, 1988)
21 CFR 184.1298 Ferric citrate.
(a) Ferric citrate (iron (III) citrate, C6H5FeO7, CAS Reg. No.
2338-05-8) is prepared from reaction of citric acid with ferric
hydroxide. It is a compound of indefinite ratio of citric acid and
iron.
(b) The Food and Drug Administration is developing food-grade
specifications for ferric citrate in cooperation with the National
Academy of Sciences. In the interim, this ingredient must be of a
purity suitable for its intended use.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
as a nutrient supplement as defined in 170.3(o)(20) of this chapter,
with no limitation other than current good manufacturing practice. The
ingredient may also be used in infant formula in accordance with section
412(g) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C.
350a(g)) or with regulations promulgated under section 412(a)(2) of the
act (21 U.S.C. 350a(a)(2)).
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(53 FR 16865, May 12, 1988)
21 CFR 184.1301 Ferric phosphate.
(a) Ferric phosphate (ferric orthophosphate, iron (III) phosphate,
FePO4.xH2O, CAS Reg. No. 10045-86-0) is an odorless, yellowish-white to
buff-colored powder and contains from one to four molecules of water of
hydration. It is prepared by reaction of sodium phosphate with ferric
chloride or ferric citrate.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), pp. 118-120, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
as nutrient supplement as defined in 170.3(o)(20) of this chapter, with
no limitation other than current good manufacturing practice. The
ingredient may also be used in infant formula in accordance with section
412(g) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C.
350a(g)) or with regulations promulgated under section 412(a)(2) of the
act (21 U.S.C. 350a(a)(2)).
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(53 FR 16865, May 12, 1988)
21 CFR 184.1304 Ferric pyrophosphate.
(a) Ferric pyrophosphate (iron (III) pyrophosphate, Fe4(P207)3.xH2O,
CAS Reg. No. 10058-44-3) is a tan or yellowish white colorless powder.
It is prepared by reacting sodium pyrophosphate with ferric citrate.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 120, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
as a nutrient supplement as defined in 170.3(o)(20) of this chapter,
with no limitation other than current good manufacturing practice. The
ingredient may also be used in infant formula in accordance with section
412(g) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C.
350a(g)) or with regulations promulgated under section 412(a)(2) of the
act (21 U.S.C. 350a(a)(2)).
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(53 FR 16865, May 12, 1988; 53 FR 20939, June 7, 1988)
21 CFR 184.1307 Ferric sulfate.
(a) Ferric sulfate (iron (III) sulfate, Fe2(SO4)3, CAS Reg. No.
10028-22-5) is a yellow substance that may be prepared by oxidizing iron
(II) sulfate or by treating ferric oxide or ferric hydroxide with
sulfuric acid.
(b) The Food and Drug Administration is developing food-grade
specifications for ferric sulfate in cooperation with the National
Academy of Sciences. In the interim, this ingredient must be of a
purity suitable for its intended use.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
as a flavoring agent as defined in 170.3(o)(12) of this chapter, with
no limitation other than current good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(53 FR 16865, May 12, 1988)
21 CFR 184.1307a Ferrous ascorbate.
(a) Ferrous ascorbate (CAS Reg. No. 14536-17-5) is a reaction product
of ferrous hydroxide and ascorbic acid. It is a blue-violet product
containing 16 percent iron.
(b) The Food and Drug Administration is developing food-grade
specifications for ferrous ascorbate in cooperation with the National
Academy of Sciences. In the interim, this ingredient must be of a
purity suitable for its intended use.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
as a nutrient supplement as defined in 170.3(o)(20) of this chapter,
with no limitation other than current good manufacturing practice. The
ingredient may also be used in infant formula in accordance with section
412(g) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C.
350a(g)) or with regulations promulgated under section 412(a)(2) of the
act (21 U.S.C. 350a(a)(2)).
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(53 FR 16865, May 12, 1988)
21 CFR 184.1307b Ferrous carbonate.
(a) Ferrous carbonate (iron (II) carbonate, FeCO3, CAS Reg. No.
563-71-3) is an odorless, white solid prepared by treating solutions of
iron (II) salts with alkali carbonate salts.
(b) The Food and Drug Administration is developing food-grade
specifications for ferrous carbonate in cooperation with the National
Academy of Sciences. In the interim, this ingredient must be of a
purity suitable for its intended use.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
as a nutrient supplement as defined in 170.3(o)(20) of this chapter,
with no limitation other than current good manufacturing practice. The
ingredient may also be used in infant formula in accordance with section
412(g) of the Federal Foods, Drug, and Cosmetic Act (the act) (21 U.S.C.
350a(g)) or with regulations promulgated under section 412(a)(2) of the
act (21 U.S.C. 350a(a)(2)).
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(53 FR 16865, May 12, 1988)
21 CFR 184.1307c Ferrous citrate.
(a) Ferrous citrate (iron (II) citrate, (C6H6FeO7), CAS Reg. No.
23383-11-1) is a slightly colored powder or white crystals. It is
prepared from the reaction of sodium citrate with ferrous sulfate or by
direct action of citric acid on iron filings.
(b) The Food and Drug Administration is developing food-grade
specifications for ferrous citrate in cooperation with the National
Academy of Sciences. In the interim, this ingredient must be of a
purity suitable for its intended use.
(c) In accordance with 184.1(b)(1) the ingredient is used in food as
a nutrient supplement as defined in 170.3(o)(20) of this chapter, with
no limitation other than current good manufacturing practice. The
ingredient may also be used in infant formula in accordance with section
412(g) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C.
350a(g)) or with regulations promulgated under section 412(a)(2) of the
act (21 U.S.C. 350a(a)(2)).
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(53 FR 16866, May 12, 1988)
21 CFR 184.1307d Ferrous fumarate.
(a) Ferrous fumarate (iron (II) fumarate, (C4H2FeO4), CAS Reg. No.
141-01-5) is an odorless, reddish-orange to reddish-brown powder. It
may contain soft lumps that produce a yellow streak when crushed. It is
prepared by admixing hot solutions of ferrous sulfate and sodium
fumarate.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), pp. 120-122, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave NW., Washington, DC 20418, or available for inspection at the Office
of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1) the ingredient is used in food as
a nutrient supplement as defined in 170.3(o)(20) of this chapter, with
no limitation other than current good manufacturing practice. The
ingredient may also be used in infant formula in accordance with section
412(g) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C.
350a(g)), or with regulations promulgated under section 412(a)(2) of the
act (21 U.S.C. 350a(a)(2)).
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(53 FR 16866, May 12, 1988)
21 CFR 184.1308 Ferrous gluconate.
(a) Ferrous gluconate (iron (II) gluconate dihydrate,
C12H22FeO14.2H2O, CAS Reg. No. 6047-12-7) is a fine yellowish-gray or
pale greenish-yellow powder or granules. It is prepared by reacting hot
solutions of barium or calcium gluconate with ferrous sulfate or by
heating freshly prepared ferrous carbonate with gluconic acid in aqueous
solution.
(b) The ingredient meets the specifications of the Food Chemcials
Codex, 3d Ed. (1981), pp. 122-123, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Avenue NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L Street NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
as a nutrient supplement as defined in 170.3(o)(20) of this chapter,
with no limitation other than current good manufacturing practice. The
ingredient may also be used in infant formula in accordance with section
412(g) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C.
350a(g)) or with regulations promulgated under section 412(a)(2) of the
act (21 U.S.C. 350a(a)(2)).
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(53 FR 16866, May 12, 1988; 53 FR 20939, June 7, 1988)
21 CFR 184.1311 Ferrous lactate.
(a) Ferrous lactate (iron (II) lactate, C6H10FeO6, CAS Reg. No.
5905-52-2) in the trihydrate form is a greenish-white powder of
crystalline mass. It is prepared by reacting calcium lactate or sodium
lactate with ferrous sulfate or by direct reaction of lactic acid with
iron filings.
(b) The Food and Drug Administration is developing food-grade
specifications for ferrous lactate in cooperation with the National
Academy of Sciences. In the interim, this ingredient must be of a
purity suitable for its intended use.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
as a nutrient supplement as defined in 170.3(o)(20) of this chapter,
with no limitation other than current good manufacturing practice. The
ingredient may also be used in infant formula in accordance with section
412(g) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C.
350a(g)) or with regulations promulgated under section 412(a)(2) of the
act (21 U.S.C. 350a(a)(2)).
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(53 FR 16866, May 12, 1988)
21 CFR 184.1315 Ferrous sulfate.
(a) Ferrous sulfate heptahydrate (iron (II) sulfate heptahydrate,
FeSO4.7H2O, CAS Reg. No. 7782-63-0) is prepared by the action of
sulfuric acid on iron. It occurs as pale, bluish-green crystals or
granules. Progressive heating of ferrous sulfate heptahydrate produces
ferrous sulfate (dried). Ferrous sulfate (dried) consists primarily of
ferrous sulfate monohydrate (CAS Reg. No. 17375-41-6) with varying
amounts of ferrous sulfate tetrahydrate (CAS Reg. No. 20908-72-9) and
occurs as a grayish-white to buff-colored powder.
(b) The ingredients meet the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 123 (Ferrous sulfate heptahydrate) and p.
124 (ferrous sulfate, dried), which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave., NW., Washington, DC 20418, or available for inspection at the
Office of Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredients are used in food
as nutrient supplements as defined in 170.3(o)(20) of this chapter and
as a processing aid as defined in 170.3(o)(24) of this chapter, with no
limitation other than current good manufacturing practice. The
ingredients may also be used in infant formula in accordance with
section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) (21
U.S.C. 350a(g)) or with regulations promulgated under section 412(a)(2)
of the act (21 U.S.C. 350a(a)(2)).
(d) Prior sanctions for these ingredients different from the uses
established in this section do not exist or have been waived.
(53 FR 16866, May 12, 1988)
21 CFR 184.1317 Garlic and its derivatives.
(a) Garlic is the fresh or dehydrated bulb or cloves obtained from
Allium sativum, a genus of the lily family. Its derivatives include
essential oils, oleo-resins, and natural extractives obtained from
garlic.
(b) Garlic oil meets the specifications of the ''Food Chemicals
Codex,'' 3d Ed. (1981), p. 132, which is incorporated by reference.
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.
(c) Garlic and its derivatives are used as flavoring agents and
adjuvants as defined in 170.3(o)(12) of this chapter.
(d) The ingredients are used in food at levels not to exceed good
manufacturing practice.
(e) (Reserved)
(f) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(42 FR 14653, Mar. 15, 1977, as amended at 42 FR 55205, Oct. 14,
1977; 49 FR 5612, Feb. 14, 1984)
21 CFR 184.1318 Glucono delta-lactone.
(a) Glucono delta-lactone (C6H10O6, CAS Reg. No. 90-80-2), also
called D-gluconic acid delta-lactone or D-glucono-1,5-lactone, is the
cyclic 1,5-intramolecular ester of D-gluconic acid. It is prepared by
direct crystallization from the aqueous solution of gluconic acid.
Gluconic acid may be produced by the oxidation of D-glucose with bromine
water, by the oxidation of D-glucose by microorganisms that are
nonpathogenic and nontoxicogenic to man or other animals, or by the
oxidation of D-glucose with enzymes derived from these microorganisms.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 134, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a curing and pickling agent as defined
in 170.3(o)(5) of this chapter, leavening agent as defined in
170.3(o)(17) of this chapter; pH control agent as defined in
170.3(o)(23) of this chapter; and sequestrant as defined in
170.3(o)(26) of this chapter.
(2) The ingredient is used at levels not to exceed current good
manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(51 FR 33896, Sept. 24, 1986)
21 CFR 184.1321 Corn gluten.
(a) Corn gluten (CAS Reg. No. 66071-96-3), also known as corn gluten
meal, is the principal protein component of corn endosperm. It consists
mainly of zein and glutelin. Corn gluten is a byproduct of the wet
milling of corn for starch. The gluten fraction is washed to remove
residual water soluble proteins. Corn gluten is also produced as a
byproduct during the conversion of the starch in whole or various
fractions of dry milled corn to corn syrups.
(b) FDA is developing food-grade specifications for corn gluten in
cooperation with the National Academy of Sciences. In the interim, the
ingredient must be of a purity suitable for its intended use.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a nutrient supplement as defined in
170.3(o)(20) of this chapter and a texturizer as defined in
170.3(o)(32) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(50 FR 8998, Mar. 6, 1985)
21 CFR 184.1322 Wheat gluten.
(a) Wheat gluten (CAS Reg. No. 8002-80-0) is the principal protein
component of wheat and consists mainly of gliadin and glutenin. Wheat
gluten is obtained by hydrating wheat flour and mechanically working the
sticky mass to separate the wheat gluten from the starch and other flour
components. Vital gluten is dried gluten that has retained its elastic
properties.
(b) FDA is developing food-grade specifications for wheat gluten in
cooperation with the National Academy of Sciences. In the interim, the
ingredient must be of a purity suitable for its intended use.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a dough strengthener as defined in
170.3(o)(6) of this chapter; a formulation aid as defined in
170.3(o)(14) of this chapter; a nutrient supplement as defined in
170.3(o)(20) of this chapter; a processing aid as defined in
170.3(o)(24) of this chapter; a stabilizer and thickener as defined in
170.3(o)(28) of this chapter; a surface-finishing agent as defined in
170.3(o)(30) of this chapter; and a texturizing agent as defined in
170.3(o)(32) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(50 FR 8998, Mar. 6, 1985)
21 CFR 184.1323 Glyceryl monooleate.
(a) Glyceryl monooleate is prepared by esterification of commerical
oleic acid that is derived either from edible sources or from tall oil
fatty acids meeting the requirements of 172.862 of this chapter. It
contains glyceryl monooleate (C21H40O4, CAS Reg. No. 25496-72-4) and
glyceryl esters of fatty acids present in commercial oleic acid.
(b) FDA is developing food-grade specifications for glyceryl
monooleate in cooperation with the National Academy of Sciences. In the
interim, this ingredient must be of a purity suitable for its intended
use.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a flavoring agent and adjuvant as
defined in 170.3(o)(12) of this chapter and as a solvent and vehicle as
defined in 170.3(o)(27) of this chapter.
(2) The ingredient is used in the following foods at levels not to
exceed current good manufacturing practice: baked goods and baking
mixes as defined in 170.3(n)(1) of this chapter; nonalcoholic
beverages and beverage bases as defined in 170.3(n)(3) of this chapter;
chewing gum as defined in 170.3(n)(6) of this chapter; and meat
products as defined in 170.3(n)(29) of this chapter.
(d) Prior sanctions for this ingredient different from the use
established in this section do not exist or have been waived.
(54 FR 7403 Feb. 21, 1989)
21 CFR 184.1324 Glyceryl monostearate.
(a) Glyceryl monostearate, also known as monostearin, is a mixture of
variable proportions of glyceryl monostearate (C21H42O4, CAS Reg. No.
31566-31-1), glyceryl monopalmitate (C19H38O4, CAS Reg. No. 26657-96-5)
and glyceryl esters of fatty acids present in commercial stearic acid.
Glyceryl monostearate is prepared by glycerolysis of certain fats or
oils that are derived from edible sources or by esterification, with
glycerin, of stearic acid that is derived from edible sources.
(b) FDA is developing food-grade specifications for glyceryl
monostearate in cooperation with the National Academy of Sciences. In
the interim, this ingredient must be of a purity suitable for its
intended use.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not not exist or have been waived.
(54 FR 7403 Feb. 21, 1989)
21 CFR 184.1328 Glyceryl behenate.
(a) Glyceryl behenate is a mixture of glyceryl esters of behenic acid
made from glycerin and behenic acid (a saturated C22 fatty acid). The
mixture contains predominately glyceryl dibehenate.
(b) The ingredient meets the following specifications:
(1) 10 to 20 percent monoglyceride, 47 to 59 percent diglyceride, 26
to 38 percent triglyceride, and not more than 2.5 percent free fatty
acids.
(2) Behenic acid. Between 80 and 90 percent of the total fatty acid
content.
(3) Acid value. Not more than 4.
(4) Saponification value. Between 145 and 165.
(5) Iodine number. Not more than 3.
(6) Heavy metals (as Pb). Not more than 10 parts per million.
(c) In accordance with 184.1(b)(1) of this chapter, the ingredient
is used in food with no limitation other than current good manufacturing
practice. The affirmation of this ingredient is generally recognized as
safe (GRAS) as a direct human food ingredient is based upon the
following current good manufacturing practice conditions of use:
(1) The ingredient is used as a formulation aid, as defined in
170.3(o)(14) of this chapter.
(2) The ingredient is used in excipient formulations for use in
tablets at levels not to exceed good manufacturing practice.
(52 FR 42430, Nov. 5, 1987)
21 CFR 184.1330 Acacia (gum arabic).
(a) Acacia (gum arabic) is the dried gummy exudate from stems and
branches of trees of various species of the genus Acacia, family
Leguminosae.
(b) The ingredient meets the specifications of the ''Food Chemicals
Codex,'' 3d Ed. (1981), p. 7, which is incorporated by reference.
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.
(c) The ingredient is used in food under the following conditions:
(d) (Reserved)
(e) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(42 FR 14653, Mar. 15, 1977, as amended at 42 FR 55205, Oct. 14,
1977; 49 FR 5612, Feb. 14, 1983; 53 FR 5766, Feb. 26, 1988)
21 CFR 184.1333 Gum ghatti.
(a) Gum ghatti (Indian gum) is an exudate from wounds in the bark of
Anogeissus latifolia, a large tree found in the dry deciduous forests of
India and Ceylon.
(b) The ingredient complies with the following specifications:
(1) Viscosity of a 1-percent solution. Not less than the minimum or
within the range claimed by the vendor.
(2) Limits of impurities -- (i) Arsenic (as AL). Not more than 3
parts per million (0.0003 percent);
(ii) Ash (acid-insoluble). Not more than 1.75 percent;
(iii) Ash (total). Not more than 6.0 percent;
(iv) Heavy metals (as Pb). Not more than 40 parts per million (0.004
percent); and
(v) Lead. Not more than 10 parts per million (0.001 percent).
(3) Loss on drying. Not more than 14 percent dried at 105 C for 5
hours.
(4) Identification test. Add 0.2 ml of diluted lead acetate as
outlined in ''Official Methods of Analysis of the Association of
Official Analytical Chemists,'' 13th Ed. (1980), section 31.178(b), p.
529, under ''Dilute Basic Lead Acetate Standard Solution,'' 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 may be examined at the Office of the Federal
Register, 1100 L St. NW., Washington, DC 20408), to 5 ml of a cold
1-in-100 aqueous solution of the gum. An immediate, voluminous, opaque
precipitate indicates acacia. A small precipitate or clear solution
which produces an opaque flocculent precipitate upon the additon of 1 ml
of 3 N ammonimum hydroxide indicates gum ghatti.
(c) The ingredient is used in food under the following conditions:
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5612, Feb. 14, 1984)
21 CFR 184.1339 Guar gum.
(a) Guar gum is the natural substance obtained from the maceration of
the seed of the guar plant, Cyamopsis tetragonoloba (Linne) Taub., or
Cyamopsis psoraloides (Lam.) D.C.
(b) The ingredient meets the specifications of the ''Food Chemicals
Codex,'' 3d Ed. (1981), p. 141, which is incorporated by reference.
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.
(c) The ingredient is used in food under the following conditions:
(d) (Reserved)
(e) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(42 FR 14653, Mar. 15, 1977, as amended at 42 FR 55205, Oct. 14,
1977; 49 FR 5612, Feb. 14, 1984)
21 CFR 184.1343 Locust (carob) bean gum.
(a) Locust (carob) bean gum is primarily the macerated endosperm of
the seed of the locust (carob) bean tree, Ceratonia siliqua (Linne), a
leguminous evergreen tree, with lesser quantities of seed coat and germ.
(b) The ingredient meets the specifications of the ''Food Chemicals
Codex,'' 3d Ed. (1981), pp. 174-175, which is incorporated by
reference. 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.
(c) The ingredient is used at levels not to exceed the following
maximum levels:
(d) (Reserved)
(e) Prior sanctions for this ingredient different from the uses
established in this regulation do not exist or have been waived.
(42 FR 14653, Mar. 15, 1977, as amended at 42 FR 55205, Oct. 14,
1977; 49 FR 5612, Feb. 14, 1984)
21 CFR 184.1349 Karaya gum (sterculia gum).
(a) Karaya gum (sterculia gum) is the dried gummy exudate from the
trunk of trees of various species of the genus Sterculia.
(b) The ingredient meets the specifications of the ''Food Chemicals
Codex,'' 3d Ed. (1981), p. 157, which is incorporated by reference.
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.
(c) The ingredient is used in food under the following conditions:
(d) (Reserved)
(e) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(42 FR 14653, Mar. 15, 1977, as amended at 42 FR 55205, Oct. 14,
1977; 49 FR 5612, Feb. 14, 1984)
21 CFR 184.1351 Gum tragacanth.
(a) Gum tragacanth is the exudate from one of several species of
Astragalus gummifier Labillardiere, a shrub that grows wild in
mountainous regions of the Middle East.
(b) The ingredient meets the specifications of the ''Food Chemicals
Codex,'' 3d Ed. (1981), p. 337, which is incorporated by reference.
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.
(c) The ingredient is used in food under the following conditions:
(d) (Reserved)
(e) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(42 FR 14653, Mar. 15, 1977, as amended at 42 FR 55205, Oct. 14,
1977; 49 FR 5612, Feb. 14, 1984)
21 CFR 184.1355 Helium.
(a) Helium (empirical formula He, CAS Reg. No. 7440-59-7) is a
colorless, odorless, flavorless, nonflammable, inert gas. It is lighter
than air and is produced by the liquefaction and purification of natural
gas.
(b) The Food and Drug Administration is developing food-grade
specifications for helium in cooperation with the National Academy of
Sciences. In the interim, the ingredient must be of a purity suitable
for its intended use.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitations other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a processing aid as defined in
170.3(o)(24) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(48 FR 57270, Dec. 29, 1983)
21 CFR 184.1366 Hydrogen peroxide.
(a) Hydrogen peroxide (H2O2, CAS Reg. No. 7722-84-1) is also referred
to as hydrogen dioxide. It is made by the electrolytic oxidation of
sulfuric acid or a sulfate to persulfuric acid or a persulfuric acid
salt with subsequent hydrolysis and distillation of the hydrogen
peroxide formed; by decomposition of barium peroxide with sulfuric or
phosphoric acid; by hydrogen reduction of 2-ethylanthraquinone,
followed by oxidation with air, to regenerate the quinone and produce
hydrogen peroxide; or by electrical discharge through a mixture of
hydrogen, oxygen, and water vapor.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d ed. (1981), pp. 146-147,1 which is incorporated by
reference.
(c) In accordance with 184.1(b)(2), the ingredient is used to treat
food only within the following specific limitations:
(d) Residual hydrogen peroxide is removed by appropriate physical and
chemical means during the processing of food where it has been used
according to paragraph (c) of this section.
(e) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(46 FR 44439, Sept. 4, 1981, as amended at 51 FR 27172, July 30,
1986)
1Copies may be obtained from the National Academy of Sciences, 2101
Constitution Ave. NW, Washington, DC 20037, or examined at the Office
of the Federal Register, 1100 L St. NW, Washington, DC 20408.
21 CFR 184.1370 Inositol.
(a) Inositol, or myo-inositol (C6H12O6, CAS Reg. No. 87-89-8), is
cis-1,2,3,5-trans-4,6-cyclohexanehexol. It occurs naturally and is
prepared from an aqueous (0.2 percent sulfur dioxide) extract of corn
kernels by precipitation and hydrolysis of crude phytate.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 150, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitations other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a nutrient supplement as defined in
170.3(o)(20) of this chapter.
(2) The ingredient is used in special dietary foods as defined in
part 105 of this chapter at levels not to exceed current good
manufacturing practice. It may also be used in infant formula in
accordance with section 412(g) of the Act, or with regulations
promulgated under section 412(a)(2) of the Act.
(d) Prior sanctions for this ingredient different from the uses
established by this section do not exist or have been waived.
(47 FR 38278, Aug. 31, 1982)
21 CFR 184.1372 Insoluble glucose isomerase enzyme preparations.
(a) Insoluble glucose isomerase enzyme preparations are used in the
production of high fructose corn syrup described in 182.1866 of this
chapter. They are derived from recognized species of precisely
classified, nonpathogenic, and nontoxicogenic microorganisms, including
Streptomyces rubiginosus, Actinoplanes missouriensis, Streptomyces
olivaceus, Streptomyces olivochromogenes, and Bacillus coagulans, that
have been grown in a pure culture fermentation that produces no
antibiotics. They are fixed (rendered insoluble) for batch production
with GRAS ingredients or may be fixed for further immobilization with
either GRAS ingredients or materials approved under 173.357 of this
chapter.
(b) The ingredient meets the general and additional requirements for
enzyme preparations in the Food Chemicals Codex, 3d Ed. (1981), p.
107, which is incorporated by reference. Copies are available from the
National Academy Press, 2101 Constitution Ave. NW., Washington, DC
20418, or available for inspection at the Office of the Federal
Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as an enzyme, as defined in 170.3(o)(9)
of this chapter, to convert glucose to fructose.
(2) The ingredient is used in high fructose corn syrup, at levels not
to exceed current good manufacturing practice.
(48 FR 5720, Feb. 8, 1983)
21 CFR 184.1375 Iron, elemental.
(a) Iron, elemental (CAS Reg. No. 7439-89-6) is metallic iron
obtained by any of the following processes: reduced iron, electrolytic
iron, and carbonyl iron.
(1) Reduced iron is prepared by reacting ground ferric oxide with
hydrogen or carbon monoxide at an elevated temperature. The process
results in a grayish-black powder, all of which should pass through a
100-mesh sieve. It is lusterless or has not more than a slight luster.
When viewed under a microscope, it appears as an amorphous powder free
from particles having a crystalline structure. It is stable in dry air.
(2) Electrolytic iron is prepared by electrodeposition. It is an
amorphous, lusterless, grayish-black powder. It is stable in dry air.
(3) Carbonyl iron is prepared by the decomposition of iron
pentacarbonyl. It occurs as a dark gray powder. When viewed under a
microscope, it appears as spheres built up with concentric shells. It
is stable in dry air.
(b) Iron, elemental (carbonyl, electrolytic, or reduced) meets the
specifications of the Food Chemicals Codex, 3d Ed. (1981) (iron,
carbonyl, p. 151; iron, electrolytic, pp. 151-152; iron, reduced; pp.
152-153), which is incorporated by reference. Copies are available from
the National Academy Press, 2101 Constitution Ave. NW., Washington, DC
20418, or available for inspection at the Office of the Federal
Register, 1100 L St., NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
as a nutrient supplement as defined in 170.3(o)(20) of this chapter,
with no limitation other than current good manufacturing practice. The
ingredient may also be used in accordance with section 412(g) of the
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 350a(g)) or
with regulations promulgated under section 412(a)(2) of the act (21
U.S.C. 350a(2)).
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(53 FR 16867, May 12, 1988)
21 CFR 184.1388 Lactase enzyme preparation from Kluyveromyces lactis.
(a) This enzyme preparation is derived from the nonpathogenic,
nontoxicogenic yeast Kluyveromyces lactis (previously named
Saccharomyces lactis). It contains the enzyme B-galactoside
galactohydrase (CAS Reg. No. CBS 683), which converts lactose to glucose
and galactose. It is prepared from yeast that has been grown in a pure
culture fermentation and by using materials that are generally
recognized as safe or are food additives that have been approved for
this use by the Food and Drug Administration.
(b) The ingredient meets the general and additional requirements for
enzyme preparations in the Food Chemicals Codex, 3d Ed. (1981), p.
107-110, which is incorporated by reference. Copies are available from
the National Academy Press, 2101 Constitution Ave. NW., Washington, DC
20418, or available for inspection at the Office of the Federal
Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe as a
direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as an enzyme as defined in 170.3(o)(9) of
this chapter to convert lactose to glucose and galactose.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice. Current good manufacturing practice is to
use this ingredient in milk to produce lactase-treated milk, which
contains less lactose than regular milk, or lactose-reduced milk, which
contains at least 70 percent less lactose than regular milk.
(49 FR 47387, Dec. 4, 1984)
21 CFR 184.1400 Lecithin.
(a) Commercial lecithin is a naturally occurring mixture of the
phosphatides of choline, ethanolamine, and inositol, with smaller
amounts of othe lipids. It is isolated as a gum following hydration of
solvent-extracted soy, safflower, or corn oils. Lecithin is bleached,
if desired, by hydrogen peroxide and benzoyl peroxide and dried by
heating.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), pp. 166-167, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(48 FR 51150, Nov. 7, 1983)
21 CFR 184.1408 Licorice and licorice derivatives.
(a) (1) Licorice (glycyrrhiza) root is the dried and ground rhizome
and root portions of Glycyrrhiza glabra or other species of Glycyrrhiza.
Licorice extract is that portion of the licorice root that is, after
maceration, extracted by boiling water. The extract can be further
purified by filtration and by treatment with acids and ethyl alcohol.
Licorice extract is sold as a liquid, paste (''block''), or spray-dried
powder.
(2) Ammoniated glycyrrhizin is prepared from the water extract of
licorice root by acid precipitation followed by neutralization with
dilute ammonia. Monoammonium glycyrrhizinate (C42H61O16NH45H2O, CAS
Reg. No. 1407-03-0) is prepared from ammoniated glycyrrhizin by solvent
extraction and separation techniques.
(b) The ingredients shall meet the following specifications when
analyzed:
(1) Assay. The glycyrrhizin content of each flavoring ingredient
shall be determined by the method in the Official Methods of Analysis of
the Association of Official Analytical Chemists, 13th Ed.,
19.136-19.140, which is incorporated by reference, or by methods 19.CO1
through 19.CO4 in the Journal of the Association of Official Analytical
Chemists, 65:471-472 (1982), which are also incorporated by reference.
Copies of all of these methods 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.
(2) Ash. Not more than 9.5 percent for licorice, 2.5 percent for
ammoniated glycyrrhizin, and 0.5 percent for monoammonium
glycyrrhizinate on an anhydrous basis as determined by the method in the
Food Chemicals Codex, 3d Ed. (1981), p. 466, which is incorporated by
reference. Copies are available from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418, or available for
inspection at the Office of the Federal Register, 1100 L St. NW.,
Washington, DC 20408.
(3) Acid unsoluble ash. Not more than 2.5 percent for licorice on an
anhydrous basis as determined by the method in the Food Chemicals Codex,
3d Ed. (1981), p. 466, which is incorporated by reference.
(4) Heavy metals (as Pb). Not more than 40 parts per million as
determined by method II in the Food Chemicals Codex, 3d Ed. (1981), p.
512, which is incorporated by reference.
(5) Arsenic (As). Not more than 3 parts per million as determined by
the method in the Food Chemicals Codex. 3d Ed. (1981), p. 464, which
is incorporated by reference.
(c) In accordance with 184.1(b)(2), these ingredients are used in
food only within the following specific limitations:
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(50 FR 21044, May 22, 1985, as amended at 54 FR 24899, June 12, 1989)
21 CFR 184.1409 Ground limestone.
(a) Ground limestone consists essentially (not less than 94 percent)
of calcium carbonate (CaCO3) and is prepared by the crushing, grinding,
and classifying of naturally occurring limestone.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 173, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(48 FR 52442, Nov. 18, 1983)
21 CFR 184.1425 Magnesium carbonate.
(a) Magnesium carbonate (molecular formula approximately (MgCO3)4
Mg(OH)2 5H2O, CAS Reg. No. 39409-82-0) is also known as magnesium
carbonate hydroxide. It is a white powder formed either by adding an
alkaline carbonate (such as sodium carbonate) to a solution of magnesium
sulfate or by carbonation of a slurry of magnesium hydroxide followed by
boiling of the resulting magnesium carbonate.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 177, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as an anticaking and free-flow agent as
defined in 170.3(o)(1) of this chapter; a flour treating agent as
defined in 170.3(o)(13) of this chapter; a lubricant and release agent
as defined in 170.3(o)(18) of this chapter; a nutrient supplement as
defined in 170.3(o)(20) of this chapter; a pH control agent as defined
in 170.3(o)(23) of this chapter; a processing aid as defined in
170.3(o)(24) of this chapter; and a synergist as defined in
170.3(o)(31) of this chapter.
(2) The ingredient is used in foods at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(50 FR 13558, Apr. 5, 1985; 50 FR 16080, Apr. 24, 1985)
21 CFR 184.1426 Magnesium chloride.
(a) Magnesium chloride (MgC12.6H2O, CAS Reg. No. 7786-30-3) is a
colorless, deliquescent, crystalline material that occurs naturally as
the mineral bischofite. It is prepared by dissolving magnesium oxide,
hydroxide, or carbonate in aqueous hydrochloric acid solution and
crystallizing out magnesium chloride hexahydrate.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 177, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a flavoring agent and adjuvant as
defined in 170.3(o)(12) of this chapter and a nutrient supplement as
defined in 170.3(o)(20) of this chapter.
(2) The ingredient is used in foods at levels not to exceed current
good manufacturing practice. The ingredient also may be used in infant
formula in accordance with section 412(g) of the Federal Food, Drug, and
Cosmetic Act (the act) or with regulations promulgated under section
412(a)(2) of the act.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(50 FR 13559, Apr. 5, 1985; 50 FR 16080, Apr. 24, 1985)
21 CFR 184.1428 Magnesium hydroxide.
(a) Magnesium hydroxide (Mg(OH)2, CAS Reg. No. 1409-42-8) occurs
naturally as the colorless, crystalline mineral brucite. It is prepared
as a white precipitate by the addition of sodium hydroxide to a water
soluble magnesium salt or by hydration of reactive grades of magnesium
oxide.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 178, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a nutrient supplement as defined in
170.3(o)(20) of this chapter; a pH control agent as defined in
170.3(o)(23) of this chapter; and a processing aid as defined in
170.3(o)(24) of this chapter.
(2) The ingredient is used in foods at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(50 FR 13559, Apr. 5, 1985)
21 CFR 184.1431 Magnesium oxide.
(a) Magnesium oxide (MgO, CAS Reg. No. 1309-48-4) occurs naturally as
the colorless, crystalline mineral periclase. It is produced either as
a bulky white powder (light) or a relatively dense white powder (heavy)
by heating magnesium hydroxide or carbonate. Heating these magnesium
salts under moderate conditions (400 to 900 C for a few hours)
produces light magnesium oxide. Heating the salts under more rigorous
conditions (1200 C for 12 hours) produces heavy magnesium oxide. Light
magnesium oxide is converted to heavy magnesium oxide by sustained
heating at high temperatures.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 178, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as an anticaking and free-flow agent as
defined in 170.3(o)(1) of this chapter; a firming agent as defined in
170.3(o)(10) of this chapter; a lubricant and release agent as defined
in 170.3(o)(18) of this chapter; a nutrient supplement as defined in
170.3(o)(20) of this chapter; and a pH control agent as defined in
170.3(o)(23) of this chapter.
(2) The ingredient is used in foods at levels not be exceed current
good manufacturing practice. The ingredient also may be used in infant
formula in accordance with section 412(g) of the Federal Food, Drug, and
Cosmetic Act (the act) or with regulations promulgated under section
412(a)(2) of the act.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(50 FR 13559, Apr. 5, 1985)
21 CFR 184.1434 Magnesium phosphate.
(a) Magnesium phosphate includes both magnesium phosphate, dibasic,
and magnesium phosphate, tribasic. Magnesium phosphate, dibasic (MgHPO4
3H2O, CAS Reg. No. 7782-75-4) occurs naturally as the white, crystalline
mineral newberyite. It is prepared commercially as a precipitate formed
by treating a solution of magnesium sulfate with disodium phosphate
under controlled conditions. Magnesium phosphate, tribasic (Mg3(PO4)2
xH2O, CAS Reg. No. 7727-87-1) may contain 4, 5, or 8 molecules of water
of hydration. It is produced as a precipitate from a solution of
magnesite with phosphoric acid.
(b) Magnesium phosphate, dibasic, meets the specifications of the
Food Chemicals Codex, 3d Ed. (1981), p. 179, which is incorporated by
reference. Magnesium phosphate, tribasic, meets the specifications of
the Food Chemicals Codex, 3d Ed. (1981), p. 180, which is incorporated
by reference. Copies are available from the National Academy Press,
2101 Constitution Ave. NW., Washington, DC 20418, or available for
inspection at the Office of the Federal Register, 1100 L Street, NW.,
Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a nutrient supplement as defined in
170.3(o)(20) of this chapter and a pH control agent as defined in
170.3(o)(23) of this chapter.
(2) The ingredient is used in foods at levels not to exceed current
good manufacturing practice. The ingredient also may be used in infant
formula in accordance with section 412(g) of the Federal Food, Drug, and
Cosmetic Act (the act) or with regulations promulgated under section
412(a)(2) of the Act.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(50 FR 13560, Apr. 5, 1985)
21 CFR 184.1440 Magnesium stearate.
(a) Magnesium stearate (Mg(C17H34COO)2, CAS Reg. No. 557-04-0) is the
magnesium salt of stearic acid. It is produced as a white precipitate
by the addition of an aqueous solution of magnesium chloride to an
aqueous solution of sodium stearate derived from stearic acid that is
obtained from edible sources and that conforms to the requirements of
172.860(b)(2) of this chapter.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 182, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a lubricant and release agent as
defined in 170.3(o)(18) of this chapter; a nutrient supplement as
defined in 170.3(o)(20) of this chapter; and a processing aid as
defined in 170.3(o)(24) of this chapter.
(2) The ingredient is used in foods at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(50 FR 13560, Apr. 5, 1985)
21 CFR 184.1443 Magnesium sulfate.
(a) Magnesium sulfate (MgSO4 7H2O, CAS Reg. No. 10034-99-8) occurs
naturally as the mineral epsomite. It is prepared by neutralization of
magnesium oxide, hydroxide, or carbonate with sulfuric acid and
evaporating the solution to crystallization.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 183, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a flavor enhancer as defined in
170.3(o)(11) of this chapter; a nutrient supplement as defined in
170.3(o)(20) of this chapter; and a processing aid as defined in
170.3(o)(24) of this chapter.
(2) The ingredient is used in foods at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(50 FR 13560, Apr. 5, 1985)
21 CFR 184.1444 Maltodextrin.
(a) Maltodextrin ((C6H10O5)n, CAS Reg. No. 9050-36-6) is a nonsweet
nutritive saccharide polymer that consists of D-glucose units linked
primarily by a-1-4 bonds and that has a dextrose equivalent (D.E.) of
less than 20. It is prepared as a white powder or concentrated solution
by partial hydrolysis of corn starch with safe and suitable acids and
enzymes.
(b) FDA is developing food-grade specifications for maltodextrin in
cooperation with the National Academy of Sciences. In the interim, this
ingredient must be of a purity suitable for its intended use.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(48 FR 51911, Nov. 15, 1983)
21 CFR 184.1445 Malt syrup (malt extract).
(a) Malt is the product of barley (Hordeum vulgare L.) germinated
under controlled conditions. Malt syrup and malt extract are
interchangeable terms for a viscous concentrate of water extract of
germinated barley grain, with or without added safe preservative. Malt
syrup is usually a brown, sweet, and viscous liquid containing varying
amounts of amylolytic enzymes and plant constituents. Barley is first
softened after cleaning by steeping operations and then allowed to
germinate under controlled conditions. The germinated grain then
undergoes processing, such as drying, grinding, extracting, filtering,
and evaporating, to produce malt syrup (malt extract) with 75 to 80
percent solids or dried malt syrup with higher solids content.
(b) FDA is developing food-grade specifications for malt syrup (malt
extract) in cooperation with the National Academy of Sciences. In the
interim, the ingredient must be of a purity suitable for its intended
use.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a flavoring agent and adjuvant as
defined in 170.3(o)(12) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(48 FR 51613, Nov. 10, 1983)
21 CFR 184.1446 Manganese chloride.
(a) Manganese chloride (MnCl2.4H2O, CAS Reg. No. 7773-01-5) is a
pink, translucent, crystalline product. It is also known as manganese
dichloride. It is prepared by dissolving manganous oxide, pyrolusite
ore (MnO2), or reduced manganese ore in hydrochloric acid. The
resulting solution is neutralized to precipitate heavy metals, filtered,
concentrated, and crystallized.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 186, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a nutrient supplement as defined in
170.3(o)(20) of this chapter.
(2) The ingredient may be used in infant formulas in accordance with
section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) or
with regulations promulgated under section 412(a)(2) of the act.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(50 FR 19165, May 7, 1985)
21 CFR 184.1449 Manganese citrate.
(a) Manganese citrate (Mn3(C6H5O7)2, CAS Reg. No. 1002-46-65) is a
pale orange or pinkish white powder. It is obtained by precipitating
manganese carbonate from manganese sulfate and sodium carbonate
solutions. The filtered and washed precipitate is digested first with
sufficient citric acid solution to form manganous citrate and then with
sodium citrate to complete the reaction.
(b) FDA is developing food-grade specifications for manganese citrate
in cooperation with the National Academy of Sciences. In the interim,
this ingredient must be of purity suitable for its intended use.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a nutrient supplement as defined in
170.3(o)(20) of this chapter.
(2) The ingredient is used in the following foods at levels not to
exceed current good manufacturing practice: baked goods as defined in
170.3(n)(1) of this chapter; nonalcoholic beverages as defined in
170.3(n)(3) of this chapter; dairy product analogs as defined in
170.3(n)(10) of this chapter; fish products as defined in 170.3(n)(13)
of this chapter; meat products as defined in 170.3(n)(29) of this
chapter; milk products as defined in 170.3(n)(31) of this chapter;
and poultry products as defined in 170.3(n)(34) of this chapter. The
ingredient may be used in infant formulas in accordance with section
412(g) of the Federal Food, Drug, and Cosmetic Act (the act) or with
regulations promulgated under section 412(a)(2) of the act.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(50 FR 19166, May 7, 1985)
21 CFR 184.1452 Manganese gluconate.
(a) Manganese gluconate (C12H22MnO14 2H2O, CAS Reg. No. 648-53-98) is
a slightly pink colored powder. It is obtained by reacting manganese
carbonate with gluconic acid in aqueous medium and then crystallizing
the product.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 186, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a nutrient supplement as defined in
170.3(o)(20) of this chapter.
(2) The ingredient is used in the following foods at levels not to
exceed current good manufacturing practice: baked goods as defined in
170.3(n)(1) of this chapter; nonalcoholic beverages as defined in
170.3(n)(3) of this chapter; dairy product analogs as defined in
170.3(n)(10) of this chapter; fish products as defined in 170.3(n)(13)
of this chapter; meat products as defined in 170.3(n)(29) of this
chapter; milk products as defined in 170.3(n)(31) of this chapter;
and poultry products as defined in 170.3(n)(34) of this chapter. The
ingredient may be used in infant formulas in accordance with section
412(g) of the Federal Food, Drug, and Cosmetic Act (the act) or with
regulations promulgated under section 412(a)(2) of the act.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(50 FR 19166, May 7, 1985)
21 CFR 184.1461 Manganese sulfate.
(a) Manganese sulfate (MnSO4 H2O, CAS Reg. No. 7785-87-7) is a pale
pink, granular, odorless powder. It is obtained by reacting manganese
compounds with sulfuric acid. It is also obtained as a byproduct in the
manufacture of hydroquinone. Other manufacturing processes include the
action of sulfur dioxide on a slurry of manganese dioxide in sulfuric
acid, and the roasting of pyrolusite (MnO2) ore with solid ferrous
sulfate and coal, followed by leaching and crystallization.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 188, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a nutrient supplement as defined in
170.3(o)(20) of this chapter.
(2) The ingredient is used in the following foods at levels not to
exceed current good manufacturing practice: baked goods as defined in
170.3(n)(1) of this chapter; nonalcoholic beverages as defined in
170.3(n)(3) of this chapter; dairy product analogs as defined in
170.3(n)(10) of this chapter; fish products as defined in 170.3(n(13)
of this chapter; meat products as defined in 170.3(n)(29) of this
chapter; milk products as defined in 170.3(n)(31) of this chapter;
and poultry products as defined in 170.3(n)(34) of this chapter.
The ingredient may be used in infant formulas in accordance with
section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) or
with regulations promulgated under section 412(a)(2) of the act.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(50 FR 19166, May 7, 1985)
21 CFR 184.1472 Hydrogenated and partially hydrogenated menhaden oils.
(a) Partially hydrogenated and hydrogenated menhaden oils are
prepared by feeding hydrogen gas under pressure to a converter
containing crude menhaden oil and a nickel catalyst. The reaction is
begun at 150 to 160 C and after 1 hour the temperature is raised to 180
C until the desired degree of hydrogenation is reached. Hydrogenated
menhaden oil is fully hydrogenated.
(b) Partially hydrogenated and hydrogenated menhaden oils meet the
following specifications:
(1) Color. Opaque white solid.
(2) Odor. Odorless.
(3) Saponification value. Between 180 and 200.
(4) Iodine number. Not more than 85 for partially hydrogenated
menhaden oil and not more than 10 for fully hydrogenated menhaden oil.
(5) Unsaponifiable matter. Not more than 1.5 percent.
(6) Free fatty acids. Not more than 0.1 percent.
(7) Peroxide value. Not more than 5 milliequivalents per kilogram of
oil.
(8) Nickel. Not more than 0.5 part per million.
(9) Mercury. Not more than 0.5 part per million.
(10) Arsenic (as As). Not more than 0.1 part per million.
(11) Lead. Not more than 0.1 part per million.
(c) Partially hydrogenated and hydrogenated menhaden oils are used as
edible fats or oils, as defined in 170.3(n)(12) of this chapter, in
food at levels not to exceed current good manufacturing practice.
(d) If the fat or oil is fully hydrogenated, the name to be used on
the label of a product containing it shall include the term
''hydrogenated,'' or if it is partially hydrogenated, the name shall
include the term ''partially hydrogenated,'' in accordance with
101.4(b)(14) of this chapter.
(54 FR 38223, Sept. 15, 1989)
21 CFR 184.1490 Methylparaben.
(a) Methylparaben is the chemical methyl p-hydroxybenzoate. It is
produced by the methanol esterification of p-hydroxybenzoic acid in the
presence of sulfuric acid, with subsequent distillation.
(b) The ingredient meets the specifications of the ''Food Chemicals
Codex,'' 3d Ed. (1981), p. 199, which is incorporated by reference.
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.
(c) The ingredient is used as an antimicrobial agent as defined in
170.3(o)(2) of this chapter.
(d) The ingredient is used in food at levels not to exceed good
manufacturing practices. Current good manufacturing practice results in
a maximum level of 0.1 percent in food.
(e) Prior sanctions for this ingredient different from the uses
established in this regulation do not exist or have been waived.
(42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5612, Feb. 14, 1984)
21 CFR 184.1498 Microparticulated protein product.
(a) Microparticulated protein product is prepared from egg whites or
milk protein or a combination of egg whites and milk protein. These
protein sources may be used alone or in combination with other safe and
suitable ingredients to form the microparticulated product. The mixture
of ingredients is high-shear heat processed to achieve a smooth and
creamy texture similar to that of fat. Safe and suitable ingredients
used in the preparation of the microparticulated protein product must be
used in compliance with the limitations of the appropriate regulations
in parts 172, 182, and 184 of this chapter.
(b) The ingredient is used in food in accordance with 184.1(b)(2) at
levels not to exceed current good manufacturing practice. The
affirmation of the use of this ingredient as generally recognized as
safe (GRAS) as a direct human food ingredient is based upon the
following conditions of use:
(1) The ingredient is used in food as a thickener as defined in
170.3(o)(28) of this chapter or as a texturizer as defined in
170.3(o)(32) of this chapter.
(2) The ingredient is used in frozen dessert-type products except
that the ingredient may not be used to replace the milk fat required in
standardized frozen desserts.
(3) The name of the ingredient used in the ingredient statement on
both bulk and packaged food must include the source of the protein
(e.g., ''microparticulated egg white protein''), followed by a
parenthetical listing of each of the ingredients in the
microparticulated protein product, in descending order of predominance.
Microparticulated protein product must be used in accordance with this
requirement or its addition to food will be considered by FDA to
constitute the use of an unapproved food additive (see 184.1(b)(2)).
(55 FR 6391, Feb. 23, 1990)
21 CFR 184.1505 Mono- and diglycerides.
(a) Mono- and diglycerides consist of a mixture of glyceryl mono- and
diesters, and minor amounts of triesters, that are prepared from fats or
oils or fat-forming acids that are derived from edible sources. The
most prevalent fatty acids include lauric, linoleic, myristic, oleic,
palmitic, and stearic. Mono- and diglycerides are manufactured by the
reaction of glycerin with fatty acids or the reaction of glycerin with
triglycerides in the presence of an alkaline catalyst. The products are
further purified to obtain a mixture of glycerides, free fatty acids,
and free glycerin that contains at least 90 percent-by-weight
glycerides.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 201, which is incorporated by reference in
accordance with 5 U.S.C. 552(a). Copies are available from the National
Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or
available for inspection at the Office of the Federal Register, 1100 L
St. NW., Washington, DC 20005.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used in food as a dough strengthener as defined
in 170.3(o)(6) of this chapter; an emulsifier and emulsifier salt as
defined in 170.3(o)(8) of this chapter; a flavoring agent and adjuvant
as defined in 170.3(o)(12) of this chapter; a formulation aid as
defined in 170.3(o)(14) of this chapter; a lubricant and release agent
as defined in 170.3(o)(18) of this chapter; a solvent and vehicle as
defined in 170.3(o)(27) of this chapter; a stabilizer and thickener as
defined in 170.3(o)(28) of this chapter; a surface-active agent as
defined in 170.3(o)(29) of this chapter; a surface-finishing agent as
defined in 170.3(o)(30) of this chapter; and a texturizer as defined
in 170.3(o)(32) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(54 FR 7403, Feb. 21, 1989, as amended at 57 FR 10616, Mar.27, 1992)
21 CFR 184.1521 Monosodium phosphate derivatives of mono- and
diglycerides.
(a) Monosodium phophate derivatives of mono- and diglycerides are
composed of glyceride derivatives formed by reacting mono- and
diglycerides that are derived from edible sources with phosphorus
pentoxide (tetraphosphorus decoxide) followed by neutralization with
sodium carbonate.
(b) FDA is developing food-grade specifications for monosodium
phosphate mono- and diglycerides in cooperation with the National
Academy of Sciences. In the interim, this ingredient must be of a
purity suitable for its intended use.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used in food as an emulsifier and emulsifier
salt as defined in 170.3(o)(8) of this chapter, a lubricant and release
agent as defined in 170.3(o)(18) of this chapter, and as a
surface-active agent as defined in 170.3(o)(29) of this chapter.
(2) The ingredient is used in the following foods at levels not to
exceed current good manufacturing practice: dairy product analogs as
defined in 170.3(n)(10) of this chapter and soft candy as defined in
170.3(n)(38) of this chapter.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(54 FR 7404, Feb. 21, 1989)
21 CFR 184.1530 Niacin.
(a) Niacin (C6H5NO2, CAS Reg. No. 59-67-6) is the chemical
3-pyridinecarboxylic acid (nicotinic acid). It is a non-hygroscopic,
stable, white, crystalline solid that sublimes without decomposition at
about 230 C. It is soluble in water and alcohol. It is insoluble in
ether.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 205, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a nutrient supplement as defined in
170.3(o)(20) of this chapter.
(2) The ingredient is used in foods at levels not to exceed current
good manufacturing practice. The ingredient may also be used in infant
formula in accordance with section 412(g) of the Federal Food, Drug, and
Cosmetic Act (the Act) or with regulations promulgated under section
412(a)(2) of the Act.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(48 FR 52033, Nov. 16, 1983; 48 FR 54336, Dec. 2, 1983)
21 CFR 184.1535 Niacinamide.
(a) Niacinamide (C6H6N2O, CAS Reg. No. 98-92-0) is the chemical
3-pyridinecarboxylic acid amide (nicotinamide). It is a white
crystalline powder that is soluble in water, alcohol, ether, and
glycerol. It melts between 128 and 131 C.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 205, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a nutrient supplement as defined in
170.3(o)(20) of this chapter.
(2) The ingredient is used in foods at levels not to exceed current
good manufacturing practice. The ingredient may also be used in infant
formula in accordance with section 412(g) of the Federal Food, Drug, and
Cosmetic Act (the act) or with regulations promulgated under section
412(a)(2) of the Act.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(48 FR 52033, Nov. 16, 1983; 48 FR 54336, Dec. 2, 1983)
21 CFR 184.1537 Nickel.
(a) Elemental nickel (CAS Reg. No. 7440-02-0) is obtained from nickel
ore by transforming it to nickel sulfide (Ni3S2). The sulfide is
roasted in air to give nickel oxide (NiO). The oxide is then reduced
with carbon to give elemental nickel.
(b) The Food and Drug Administration is developing food-grade
specifications for nickel in cooperation with the National Academy of
Sciences. In the interim, this ingredient must be of a purity suitable
for its intended use.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a catalyst as defined in 170.3(o)(24)
of this chapter.
(2) The ingredient is used in the hydrogenation of fats and oils as
defined in 170.3(n)(12) of this chapter at levels not to exceed current
good manufacturing practice. Current good manufacturing practice
includes the removal of nickel from fats and oils following
hydrogenation.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(48 FR 51618, Nov. 10, 1983)
21 CFR 184.1538 Nisin preparation.
(a) Nisin preparation is derived from pure culture fermentations of
certain strains of Streptococcus lactis Lancefield Group N. Nisin
preparation contains nisin (CAS Reg. No. 1414-45-5), a group of related
peptides with antibiotic activity.
(b) The ingredient is a concentrate or dry material that meets the
specifications that follow when it is tested as described in
''Specifications for Identity and Purity of Some Antibiotics,'' World
Health Organization, FAO Nutrition Meeting Report Series, No. 45A,
1969, 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 20408.
(1) Nisin content, not less than 900 international units per
milligram.
(2) Arsenic, not more than 1 part per million.
(3) Lead, not more than 2 parts per million.
(4) Zinc, not more than 25 parts per million.
(5) Copper, zinc plus copper not more than 50 parts per million.
(6) Total plate count, not more than 10 per gram.
(7) Escherichia coli, absent in 10 grams.
(8) Salmonella, absent in 10 grams.
(9) Coagulase positive staphylococci, absent in 10 grams.
(c) The ingredient is used as an antimicrobial agent as defined in
170.3(o)(2) of this chapter to inhibit the outgrowth of Clostridium
botulinum spores and toxin formation in pasteurized cheese spreads and
pasteurized process cheese spreads listed in 133.175; pasteurized
cheese spread with fruits, vegetables, or meats as defined in 133.176;
pasteurized process cheese spread as defined in 133.179; pasteurized
process cheese spread with fruits, vegetables, or meats as defined in
133.180 of this chapter.
(d) The ingredient is used at levels not to exceed good manufacturing
practice in accordance with 184.1(b)(1) of this chapter. The current
good manufacturing practice level is the quantity of the ingredient that
delivers a maximum of 250 parts per million of nisin in the finished
product as determined by the British Standards Institution Methods,
''Methods for the Estimation and Differentiation of Nisin in Processed
Cheese,'' BS 4020 (1974), 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 Street NW., Washington, DC 20408.
(53 FR 11250, Apr. 6, 1988)
21 CFR 184.1540 Nitrogen.
(a) Nitrogen (empirical formula N2, CAS Reg. No. 7727-37-9) is a
colorless, odorless, flavorless gas that is produced commercially by the
fractionation of liquid air.
(b) The Food and Drug Administration is developing food-grade
specifications for nitrogen in cooperation with the National Academy of
Sciences. In the interim, the ingredient must be of a purity suitable
for its intended use.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitations other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a propellant, aerating agent, and gas
as defined in 170.3(o)(25) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(48 FR 57270, Dec. 29, 1983)
21 CFR 184.1545 Nitrous oxide.
(a) Nitrous oxide (empirical formula N2O, CAS Reg. No. 10024-97-2) is
also known as dinitrogen monoxide or laughing gas. It is a colorless
gas, about 50 percent heavier than air, with a slightly sweet smell. It
does not burn but will support combustion. Nitrous oxide is
manufactured by the thermal decomposition of ammonium nitrate. Higher
oxides of nitrogen are removed by passing the dry gas through a series
of scrubbing towers.
(b) The Food and Drug Administration is developing food-grade
specifications for nitrous oxide in cooperation with the National
Academy of Sciences. In the interim, the ingredient must be of a purity
suitable for its intended use.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitations other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a propellant, aerating agent, and gas
as defined in 170.3(o)(25) of this chapter.
(2) The ingredient is used in dairy product analogs as defined in
170.3(n)(10) of this chapter at levels not to exceed current good
manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(48 FR 57270, Dec. 29, 1983)
21 CFR 184.1553 Peptones.
(a) Peptones are a variable mixture of polypeptides, oligopeptides,
and amino acids that are produced by partial hydrolysis of casein,
animal tissue, soy protein isolate, gelatin, defatted fatty tissue, egg
albumin, or lactalbumin (whey protein). Peptones are produced from
these proteins using proteolytic enzymes that either are considered to
be generally recognized as safe (GRAS) or are regulated as food
additives. Peptones are also produced by denaturing any of the proteins
listed in this paragraph with safe and suitable acids or heat.
(b) FDA is developing food-grade specifications for peptones in
cooperation with the National Academy of Sciences. In the interim,
these ingredients must be of a purity suitable for their intended use.
(c) In accordance with 184.1(b)(1), these ingredients are used in
food with no limitation other than current good manufacturing practice.
The affirmation of these ingredients as GRAS as direct human food
ingredients is based upon the following current good manufacturing
practice conditions of use:
(1) These ingredients are used as nutrient supplements as defined in
170.3(o)(20) of this chapter; as processing aids as defined in
170.3(o)(24) of this chapter; and as surface-active agents as defined
in 170.3(o)(29) of this chapter.
(2) These ingredients are used in food at levels not to exceed
current good manufacturing practice.
(d) Prior sanctions for these ingredients different from the uses
established in this section do not exist or have been waived.
(49 FR 25430, June 21, 1984, as amended at 50 FR 49536, Dec. 3, 1985)
21 CFR 184.1555 Rapeseed oil.
(a) Fully hydrogenated rapeseed oil. (1) Fully hydrogenated rapeseed
oil is a mixture of triglycerides in which the fatty acid composition is
a mixture of saturated fatty acids. The fatty acids are present in the
same porportions which result from the full hydrogenation of fatty acids
occurring in natural rapeseed oil. The rapeseed oil is obtained from
the napus and campestris varieties of Brassica of the family Cruciferae.
It is prepared by fully hydrogenating refined and bleached rapeseed oil
at 310-375 F, using a catalyst such as nickel, until the iodine number
is 4 or less.
(2) The ingredient meets the following specifications: Acid value
not more than 6, arsenic not more than 3 parts per million, free
glycerin not more than 7 percent, heavy metals (as Pb) not more than 10
parts per million, iodine number not more than 4, residue on ignition
not more than 0.5 percent.
(3) The ingredient is used as a stabilizer and thickener as defined
in 170.3(o)(28) of this chapter in peanut butter. The use level of the
ingredient is limited by good manufacturing practice (GMP) to the
minimum amount required to produce the intended effect. Current good
manufacturing practices result in a maximum level of 2 percent in peanut
butter.
(b) Superglycerinated fully hydrogenated rapeseed oil. (1)
Superglycerinated fully hydrogenated rapeseed oil is a mixture of mono-
and diglycerides with triglycerides as a minor component. The fatty
acid composition is a mixture of saturated fatty acids present in the
same proportions as those resulting from the full hydrogenation of fatty
acids in natural rapeseed oil. It is made by adding excess glycerol to
the fully hydrogenated rapeseed oil and heating, in the presence of a
sodium hydroxide catalyst, to 330 F under partial vacuum and steam
sparging agitation.
(2) The ingredient meets the specifications of the ''Food Chemicals
Codex,'' 3d Ed. (1981), p. 201, relating to mono- and diglycerides,
which is incorporated by reference. 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. An additional specification requires
the iodine number to be 4 or less.
(3) The ingredient is used as an emulsifier as defined in
170.3(o)(8) of this chapter in shortenings for cake mixes. The use
level of the ingredient is limited by good manufacturing practice (GMP)
to the minimum amount required to produce the intended effect. Current
good manufacturing practices result in a maximum level, as served, of 4
percent of the shortening or 0.5 percent of the total weight of the cake
mix.
(c) Low erucic acid rapeseed oil. (1) Low erucic acid rapeseed oil,
also known as canola oil, is the fully refined, bleached, and deodorized
edible oil obtained from certain varieties of Brassica Napus or B.
Campestris of the family Cruciferae. The plant varieties are those
producing oil-bearing seeds with a low erucic acid content. Chemically,
low erucic acid rapeseed oil is a mixture of triglycerides, composed of
both saturated and unsaturated fatty acids, with an erucic acid content
of no more than 2 percent of the component fatty acids.
(2) Low erucic acid rapeseed oil as defined in paragraph (c)(1) of
this section may be partially hydrogenated to reduce the proportion of
unsaturated fatty acids. When the partially hydrogenated low erucic
acid rapeseed oil is used, it shall be referred to as partially
hydrogenated low erucic acid rapeseed oil.
(3) In addition to limiting the content of erucic acid to a level not
exceeding 2 percent of the component fatty acids, FDA is developing
other food-grade specifications for low erucic acid rapeseed oil and
partially hydrogenated low erucic acid rapeseed oil in cooperation with
the National Academy of Sciences. In the interim, the ingredients must
be of a purity suitable for their intended use.
(4) Low erucic acid rapeseed oil and partially hydrogenated low
erucic acid rapeseed oil are used as edible fats and oils in food,
except in infant formula, at levels not to exceed current good
manufacturing practice.
(42 FR 48336, Sept. 23, 1977, as amended at 49 FR 5613, Feb. 14,
1984; 50 FR 3755, Jan. 28, 1985; 53 FR 52682, Dec. 29, 1988)
21 CFR 184.1560 Ox bile extract.
(a) Ox bile extract (CAS Reg. No. 8008-63-7), also known as purified
oxgall or sodium choleate, is a yellowish green, soft solid, with a
partly sweet, partly bitter, disagreeable taste. It is the purified
portion of the bile of an ox obtained by evaporating the alcohol extract
of concentrated bile.
(b) Food-grade ox bile extract shall meet the specifications of the
U.S. Pharmacopeia (USP), XIV, 1950, p. 410. /1/
(c) The ingredient is used as a surfactant as defined in 170.3
(o)(29) of this chapter.
(d) The ingredient is used in food in accordance with 184.1(b)(1) at
levels not to exceed good manufacturing practice. Current good
manufacturing practice results in a maximum level, as served, of 0.002
percent for cheese as defined in 170.3(n)(5) of this chapter.
(e) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(43 FR 36064, Aug. 15, 1978. Redesignated and amended at 50 FR 49537,
Dec. 3, 1985)
/1/ Copies may be obtained from: U.S. Pharmacopeial Convention,
Inc., 12601 Twinbrook Parkway, Rockville, MD 20852.
21 CFR 184.1563 Ozone.
(a) Ozone (O3, CAS Reg. No. 10028-15-6) is an unstable blue gas with
a pungent, characteristic odor, which occurs freely in nature, It is
produced commercially by passing electrical discharges or ionizing
radiation through air or oxygen.
(b) The ingredient must be of a purity suitable for its intended use
in accordance with 170.30(h)(1) of this chapter.
(c) In accordance with 184.1(b)(2), the ingredient is used to treat
food only within the following specific limitations:
(47 FR 50210, Nov. 5, 1982)
21 CFR 184.1585 Papain.
(a) Papain (CAS Reg. No. 9001-73-4) is a proteolytic enzyme derived
from Carica papaya L. Crude latex containing the enzyme is collected
from slashed unripe papaya. The food-grade product is obtained by
repeated filtration of the crude latex or an aqueous solution of latex
or by precipitation from an aqueous solution of latex. The resulting
enzyme preparation may be used in a liquid or dry form.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), pp. 107-110, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than currect good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing conditions of use:
(1) The ingredient is used as an enzyme as defined in 170.3(o)(9) of
this chapter; processing aid as defined in 170.3(o)(24) of this
chapter; and texturizer as defined in 170.3(o)(32) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(48 FR 48806, Oct. 21, 1983)
21 CFR 184.1588 Pectins.
(a) The pectins (CAS Reg. No. 9000-69-5) are a group of complex, high
molecular weight polysaccharides found in plants and composed chiefly of
partially methylated polygalacturonic acid units. Portions of the
carboxly group occur as methyl esters, and the remaining carboxyl groups
exist in the form of the free acid or as its ammonium, potassium, or
sodium (CAS Reg. No. 9000-59-8) salts, and in some types as the acid
amide. Thus, the pectins regulated in this section are the high-ester
pectins, low-ester pectins, amidated pectins, pectinic acids, and
pectinates. Pectin is produced commercially by extracting citrus peel,
apple pomace, or beet pulp with hot dilute acid (pH 1.0 to 3.5, 70 to
90 C). The extract is filtered, and pectin is then precipitated from
the clear extract with ethanol or isopropanol, or as the copper or
aluminum salt. The acid extract is sometimes spray- or roller-dried, or
it is concentrated to be sold as liquid pectin.
(b) The ingredients meet the specifications of the Food Chemical
Codex, 3d Ed. (1981), p. 215, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredients are used in food
with no limitation other than current good manufacturing practice. The
affirmation of these ingredients as generally recognized as safe (GRAS)
as direct human food ingredients is based upon the following current
good manufacturing practice conditions of use:
(1) The ingredients are used as emulsifiers as defined in
170.3(o)(8) of this chapter and as stabilizers and thickeners as defined
in 170.3(o)(28) of this chapter.
(2) The ingredients are used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for these ingredients different from the uses
established in this section do not exist or have been waived.
(48 FR 51149, Nov. 7, 1983)
21 CFR 184.1610 Potassium alginate.
(a) Potassium alginate (CAS Reg. No. 9005-36-1) is the potassium salt
of alginic acid, a natural polyuronide constituent of certain brown
algae. Potassium alginate is prepared by the neutralization of purified
alginic acid with appropriate pH control agents.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 239, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(2), the ingredient is used in food
only within the following specific limitations:
(d) Prior sanctions for potassium alginate different from the uses
established in this section do not exist or have been waived.
(47 FR 29951, July 9, 1982)
21 CFR 184.1613 Potassium bicarbonate.
(a) Potassium bicarbonate (KHCO3, CAS Reg. No. 298-14-6) is made by
the following processes:
(1) By treating a solution of potassium hydroxide with carbon
dioxide;
(2) By treating a solution of potassium carbonate with carbon
dioxide.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 239, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a formulation aid as defined in
170.3(o)(14) of this chapter; nutrient supplemlent as defined in
170.3(o)(20) of this chapter; pH control agent as defined in
170.3(o)(23) of this chapter; and processing aid as defined in
170.3(o)(24) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(48 FR 52442, Nov. 18, 1983)
21 CFR 184.1619 Potassium carbonate.
(a) Potassium carbonate (K2CO3, CAS Reg. No. 584-08-7) is produced by
the following methods of manufacture:
(1) By electrolysis of potassium chloride followed by exposing the
resultant potassium to carbon dioxide;
(2) By treating a solution of potassium hydroxide with excess carbon
dioxide to produce potassium carbonate;
(3) By treating a solution of potassium hydroxide with carbon dioxide
to produce potassium bicarbonate, which is then heated to yield
potassium carbonate.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 240, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, D.C. 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, D.C. 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. the
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used in food as a flavoring agent and adjuvant
as defined in 170.3(o)(12) of this chapter; nutrient supplement as
defined in 170.3(o)(20) of this chapter; pH control agent as defined
in 170.3(o)(23) of this chapter; and processing aid as defined in
170.3(o)(24) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(48 FR 52442, Nov. 18, 1983)
21 CFR 184.1622 Potassium chloride.
(a) Potassium chloride (KCl, CAS Reg. No. 7447-40-7) is a white,
odorless solid prepared from source minerals by fractional
crystallization or flotation. It is soluble in water and glycerol and
has a saline taste at low concentration levels.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 241, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a flavor enhancer as defined in
170.3(o)(11) of this chapter; as a flavoring agent as defined in
170.3(o)(12) of this chapter; as a nutrient supplement as defined in
170.3(o)(20) of this chapter; as a pH control agent as defined in
170.3(o)(23) of this chapter; and as a stabilizer or thickener as
defined in 170.3(o)(28) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice. Potassium chloride may be used in infant
formula in accordance with section 412(g) of the Federal Food, Drug, and
Cosmetic Act (the Act) or with regulations promulgated under section
412(a)(2) of the Act.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(48 FR 51614, Nov. 10, 1983)
21 CFR 184.1631 Potassium hydroxide.
(a) Potassium hydroxide (KOH, CAS Reg. No. 1310-58-3) is also known
as caustic potash, potash lye, and potassa. The empirical formula is
KOH. It is a white, highly deliquescent caustic solid, which is
marketed in several forms, including pellets, flakes, sticks, lumps, and
powders. Potassium hydroxide is obtained commercially from the
electrolysis of potassium chloride solution in the presence of a porous
diaphragm.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), which is incorporated by reference. Copies are
available from the National Academy Press, 2101 Constitution Ave. NW.,
Washington, DC 20418, or available from inspection at the Office of the
Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a formulation aid as defined in
170.3(o)(14) of this chapter; a pH control agent as defined in
170.3(o)(23) of the chapter; a processing aid as defined in
170.3(o)(24) of this chapter; and a stabilizer and thickener as defined
in 170.3(o)(28) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(48 FR 52444, Nov. 18, 1983)
21 CFR 184.1634 Potassium iodide.
(a) Potassium iodide (KI, CAS Reg. No. 7681-11-0) is the potassium
salt of hydriodic acid. It occurs naturally in sea water and is salt
deposits, but can be prepared by reacting hydriodic acid (HI) with
potassium bicarbonate (KHCO3).
(b) The ingredient meets the specifications of the ''Food Chemicals
Codex,'' 3d Ed. (1981), pp. 246-247, which is incorporated by
reference. 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.
(c) The ingredient is used as a nutrient supplement as defined in
170.3(o)(20) of this chapter.
(d) The ingredient is used in table salt in accordance with
184.1(b)(2) of this chapter as a source of dietary iodine at a maximum
level of 0.01 percent.
(e) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(43 FR 11699, Mar. 21, 1978, as amended at 49 FR 5613, Feb. 14, 1984)
21 CFR 184.1635 Potassium iodate.
(a) Potassium iodate (KIO3, CAS Reg. No. 7758-05-6) does not occur
naturally but can be prepared by reacting iodine with potassium
hydroxide.
(b) The ingredient meets the specifications of the ''Food Chemicals
Codex,'' 3d Ed. (1981), pp. 245-246, which is incorporated by
reference. 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.
(c) The ingredient is used as a dough strengthener as defined in
170.3(o)(6) of this chapter.
(d) The ingredient is used in the manufacture of bread in accordance
with 184.1(b)(2) of this chapter in an amount not to exceed 0.0075
percent based on the weight of the flour.
(e) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(43 FR 11699, Mar. 21, 1978, as amended at 49 FR 5613, Feb. 14, 1983)
21 CFR 184.1639 Potassium lactate.
(a) Potassium lactate (C3H5O3K, CAS Reg. No. 996-31-6) is the
potassium salt of lactic acid. It is a hydroscopic, white, odorless
solid and is prepared commercially by the neutralization of lactic acid
with potassium hydroxide.
(b) FDA is developing food-grade specifications for potassium lactate
in cooperation with the National Academy of Sciences. In the interim,
this ingredient must be of a purity suitable for its intended use.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. This
regulation does not authorize its use in infant foods and infant
formulas. The affirmation of this ingredient as generally recognized as
safe (GRAS) as a direct human food ingredient is based upon the
following current good manufacturing practice conditions of use:
(1) The ingredient is used as a flavor enhancer as defined in
170.3(o)(11) of this chapter; a flavoring agent or adjuvant as defined
in 170.3(o)(12) of this chapter; a humectant as defined in
170.3(o)(16) of this chapter; and a pH control agent as defined in
170.3(o)(23) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(52 FR 10886, Apr. 6, 1987)
21 CFR 184.1643 Potassium sulfate.
(a) Potassium sulfate (K2SO4, CAS Reg. No. 7778-80-5) occurs
naturally and consists of colorless or white crystals or crystalline
powder having a bitter, saline taste. It is prepared by the
neutralization of sulfuric acid with potassium hydroxide or potassium
carbonate.
(b) The ingredient meets the specifications of the ''Food Chemicals
Codex,'' 3d Ed. (1981), p. 252, which is incorporated by reference.
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.
(c) The ingredient is used as a flavoring agent and adjuvant as
defined in 170.3(o)(12) of this chapter.
(d) The ingredient is used in food at levels not to exceed good
manufacturing practice in accordance with 184.1(b)(1). Current good
manufacturing practice results in a maximum level, as served, of 0.015
percent for nonalcoholic beverages as defined in 170.3(n)(3) of this
chapter.
(e) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(45 FR 6086, Jan. 25, 1980, as amended at 49 FR 5613, Feb. 14, 1984)
21 CFR 184.1655 Propane.
(a) Propane (empirical formula C3H8, CAS Reg. No. 74-98-6) is also
known as dimethylmethane or propyl hydrid. It is a colorless, odorless,
flammable gas at normal temperatures and pressures. It is easily
liquefied under pressure at room temperature and is stored and shipped
in the liquid state. Propane is obtained from natural gas by
fractionation following absorption in oil, adsorption to surface-active
agents, or refrigeration.
(b) The Food and Drug Administration is developing food-grade
specifications for propane in cooperation with the National Academy of
Sciences. In the interim, the ingredient must be of a purity suitable
for its intended use.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitations other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a propellant, aerating agent, and gas
as defined in 170.3(o)(25) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(48 FR 57271, Dec. 29, 1983)
21 CFR 184.1660 Propyl gallate.
(a) Propyl gallate is the n-propylester of 3,4,5-trihydroxybenzoic
acid (C10H12O5). Natural occurrence of propyl gallate has not been
reported. It is commercially prepared by esterification of gallic acid
with propyl alcohol followed by distillation to remove excess alcohol.
(b) The ingredient meets the specifications of the ''Food Chemicals
Codex,'' 3d Ed. (1981), pp. 257-258, which is incorporated by
reference. 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.
(c) The ingredient is used as an antioxidant as defined in
170.3(o)(3) of this chapter.
(d) The ingredient is used in food at levels not to exceed good
manufacturing practice in accordance with 184.1(b)(1). Good
manufacturing practice results in a maximum total content of
antioxidants of 0.02 percent of the fat or oil content, including the
essential (volatile) oil content, of the food.
(e) Prior sanctions for this ingredient different from the uses
established in this section, or different from that stated in part 181
of this chapter, do not exist or have been waived.
(42 FR 14653, Mar. 15, 1977, as amended at 44 FR 52826, Sept. 11,
1979; 49 FR 5613, Feb. 14, 1984)
21 CFR 184.1666 Propylene glycol.
(a) Propylene glycol (C3H8O2, CAS Reg. No. 57-55-6) is known as
1,2-propanediol. It does not occur in nature. Propylene glycol is
manufactured by treating propylene with chlorinated water to form the
chlorohydrin which is converted to the glycol by treatment with sodium
carbonate solution. It is also prepared by heating glyercol with sodium
hydroxide.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 255, which is incorporated by reference.
Copies may be obtained from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418. It is also available for
inspection at the Office of the Federal Register, 1100 L St. NW.,
Washington, DC 20408.
(c) The ingredient is used as an anticaking agent as defined in
170.3(o)(1) of this chapter; antioxidant as defined in 170.3(o)(3) of
this chapter; dough strengthener as defined in 170.3(o)(6) of this
chapter; emulsifier as defined in 170.3(o)(8) of this chapter; flavor
agent as defined in 170.3(o)(12) of this chapter; formulation aid as
defined in 170.3(o)(14) of this chapter; humectant as defined in
170.3(o)(16) of this chapter; processing aid as defined in
170.3(o)(24) of this chapter; solvent and vehicle as defined in
170.3(o)(27) of this chapter; stabilizer and thickener as defined in
170.3(o)(28) of this chapter; surface-active agent as defined in
170.3(o)(29) of this chapter; and texturizer as defined in
170.3(o)(32) of this chapter.
(d) The ingredient is used in foods at levels not to exceed current
good manufacturing practice in accordance with 184.1(b)(1). Current
good manufacturing practice results in maximum levels, as served, of 5
percent for alcoholic beverages, as defined in 170.3(n)(2) of this
chapter; 24 percent for confections and frostings as defined in
170.3(n)(9) of this chapter; 2.5 percent for frozen dairy products as
defined in 170.3(n)(20) of this chapter; 97 percent for seasonings and
flavorings as defined in 170.3(n)(26) of this chapter; 5 percent for
nuts and nut products as defined in 170.3(n)(32) of this chapter; and
2.0 percent for all other food categories.
(e) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(47 FR 27812, June 25, 1982)
21 CFR 184.1670 Propylparaben.
(a) Propylparaben is the chemical propyl p-hydroxybenzoate. It is
produced by the n-propanol esterification of p-hydroxybenzoic acid in
the presence of sulfuric acid, with subsequent distillation.
(b) The ingredient meets the specifications of the ''Food Chemicals
Codex,'' 3d Ed. (1981), p. 258, which is incorporated by reference.
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.
(c) The ingredient is used as an antimicrobial agent as defined in
170.3(o)(2) of this chapter.
(d) The ingredient is used in food at levels not to exceed good
manufacturing practices. Current good manufacturing practice results in
a maximum level of 0.1 percent in food.
(e) Prior sanctions for this ingredient different from the uses
established in this regulation do not exist or have been waived.
(42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5613, Feb. 14, 1984)
21 CFR 184.1676 Pyridoxine hydrochloride.
(a) Pyridoxine hydrochloride (C8H11NO3 HC1, CAS Reg. No. 58-56-0) is
the chemical 3-hydroxy-4,5-dihydroxymethy-2-methylpyridine hydrochloride
that is prepared by chemical synthesis.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 260, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a nutrient supplement as defined in
170.3(o)(20) of this chapter.
(2) The ingredient is used in the following foods at levels not to
exceed current good manufacturing practice: baked goods as defined in
170.3(n)(1) of this chapter; nonalcoholic beverages and beverage bases
as defined in 170.3(n)(3) of this chapter; breakfast cereals as
defined in 170.3(n)(4) of this chapter; dairy product analogs as
defined in 170.3(n)(10) of this chapter; meat products as defined in
170.3(n)(29) of this chapter; milk products as defined in 170.3(n)(31)
of this chapter; plant protein products as defined in 170.3(n)(33) of
this chapter; and snack foods as defined in 170.3(n)(37) of this
chapter. Pyridoxine hydrochloride may be used in infant formula in
accordance with section 412(g) of the Federal Food, Drug, and Cosmetic
Act (the Act) or with regulations promulgated under section 412(a)(2) of
the Act.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(48 FR 51615, Nov. 10, 1983)
21 CFR 184.1685 Rennet (animal-derived) and chymosin preparation
(fermentation-derived).
(a)(1) Rennet and bovine rennet are commercial extracts containing
the active enzyme rennin (CAS Reg. No. 9001-98-3), also known as
chymosin (International Union of Biochemistry Enzyme Commission (E.C.)
3.4.23.4). Rennet is the aqueous extract prepared from cleaned, frozen,
salted, or dried fourth stomachs (abomasa) of calves, kids, or lambs.
Bovine rennet is the product from adults of the animals listed above.
Both products are called rennet and are clear amber to dark brown liquid
preparations or white to tan powders.
(2) Chymosin preparation is a clear solution containing the active
enzyme chymosin (E.C. 3.4.23.4). It is derived, via fermentation, from a
nonpathogenic and nontoxigenic strain of Escherichia coli K-12
containing the prochymosin gene. The prochymosin is isolated as an
insoluble aggregate that is acid-treated to destroy residual cellular
material and, after solubilization, is acid-treated to form chymosin.
It must be processed with materials that are generally recognized as
safe, or are food additives that have been approved by the Food and Drug
Administration for this use.
(3) Chymosin preparation is a clear solution containing the active
enzyme chymosin (E.C. 3.4.23.4). It is derived, via fermentation, from a
nonpathogenic and nontoxigenic strain of Kluyveromyces marxianus variety
lactis, containing the prochymosin gene. The prochymosin is secreted by
cells into fermentation broth and converted to chymosin by acid
treatment. All materials used in the processing and formulating of
chymosin must be either generally recognized as safe (GRAS), or be food
additives that have been approved by the Food and Drug Administration
for this use.
(b) Rennet and chymosin preparation meet the general and additional
requirements for enzyme preparations of the ''Food Chemicals Codex,'' 3d
Ed. (1981), pp. 107-110, which is incorporated by reference in
accordance with 5 U.S.C. 552(a). Copies are available from the National
Academy Press, 2101 Constitution Avenue NW., Washington, DC 20418, or
are available for inspection at the Office of the Federal Register, 1100
L Street NW., Washington, DC.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe as a
direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as an enzyme as defined in 170.3(o)(9) of
this chapter; a processing aid as defined in 170.3(o)(24) of this
chapter; and a stabilizer and thickener as defined in 170.3(o)(28) of
this chapter.
(2) The ingredient is used in the following foods at levels not to
exceed current good manufacturing practice: In cheeses as defined in
170.3(n)(5) of this chapter; frozen dairy desserts and mixes as defined
in 170.3(n)(20) of this chapter; gelatins, puddings, and fillings as
defined in 170.3(n)(22) of this chapter; and milk products as defined
in 170.3(n)(31) of this chapter.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(55 FR 10935, Mar. 23, 1990, as amended at 57 FR 6479, Feb. 25, 1992)
21 CFR 184.1695 Riboflavin.
(a) Riboflavin (C17H20N4O6, CAS Reg. No. 83-88-5) occurs as yellow to
orange-yellow needles that are crystallized from 2N acetic acid,
alcohol, water, or pyridine. It may be prepared by chemical synthesis,
biosynthetically by the organism Eremothecium ashbyii, or isolated from
natural sources.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 262, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a nutrient supplement as defined in
170.3(o)(20) of this chapter.
(2) The ingredient is used in foods at levels not to exceed current
good manufacturing practice. The ingredient may also be used in infant
formula in accordance with section 412(g) of the Federal Food, Drug, and
Cosmetic Act (the Act) or with regulations promulgated under section
412(a)(2) of the Act.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(48 FR 51148, Nov. 7, 1983)
21 CFR 184.1697 Riboflavin-5'-phosphate (sodium).
(a) Riboflavin-5'-phosphate (sodium) (C17H20N4O9PNa.2H2O,CAS Reg. No
130-40-5) occurs as the dihydrate in yellow to orange-yellow crystals.
It is prepared by phosphorylation of riboflavin with chlorophosphoric
acid, pyrophosphoric acid, metaphosphoric acid, or pyrocatechol cyclic
phosphate.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 263, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a nutrient supplement as defined in
170.3(o)(20) of this chapter.
(2) The ingredient is used in milk products, as defined in
170.3(n)(31) of this chapter, at levels not to exceed current good
manufacturing practice. The ingredient may also be used in infant
formulas in accordance with section 412(g) of the Federal Food, Drug,
and Cosmetic Act (the Act) or with regulations promulgated under section
412(a)(2) of the Act.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(48 FR 51148, Nov. 7, 1983)
21 CFR 184.1698 Rue.
(a) Rue is the perennial herb of several species of Ruta (Ruta
montana L., Ruta graveolens L., Ruta bracteosa L., and Ruta calepensis
L.). The leaves, buds, and stems from the top of the plant are gathered,
dried, and then crushed in preparation for use, or left whole.
(b) The ingredient is used in all categories of food in accordance
with 184.1(b)(2) of this chapter at concentrations not to exceed 2
parts per million.
(c) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(43 FR 3705, Jan. 27, 1978)
21 CFR 184.1699 Oil of rue.
(a) Oil of rue is the natural substance obtained by steam
distillation of the fresh blossoming plants of rue, the perennial herb
of several species of Ruta -- Ruta montana L., Ruta graveolens L., Ruta
bracteosa L., and Ruta calepensis L.
(b) Oil of rue meets the specifications of the ''Food Chemicals
Codex,'' 3d Ed. (1981), p. 266, which is incorporated by reference.
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.
(c) The ingredient is used in food under the following conditions:
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5613, Feb. 14, 1984)
21 CFR 184.1721 Sodium acetate.
(a) Sodium acetate (C2H3O2Na, CAS Reg. No. 127-09-3 or C2H3O2Na.3H2O,
CAS Reg. No. 6131-90-4) is the sodium salt of acetic acid and occurs
naturally in plant and animal tissues. Sodium acetate may occur in
either the anhydrous or trihydrated form. It is produced synthetically
by the neutralization of acetic acid with sodium carbonate or by
treating calcium acetate with sodium sulfate and sodium bicarbonate.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), pp. 272, 273 which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) The ingredient is used as a flavoring agent and adjuvant as
defined in 170.3(o)(12) of this chapter; and as a pH control agent as
defined in 170.3(o)(23) of this chapter.
(d) The ingredient is used in food at levels not to exceed current
good manufacturing practice in accordance with 184.1(b)(1). Current good
manufacturing practice results in a maximum level, as served, of 0.007
percent for breakfast cereals as defined in 170.3(n)(4) of this
chapter; 0.5 percent for fats and oils as defined in 170.3(n)(12) of
this chapter; 0.6 percent for grain products and pastas as defined in
170.3(n)(23) of this chapter and snack foods as defined in 170.3(n)(37)
of this chapter; 0.15 percent for hard candy as defined in
170.3(n)(25) of this chapter; 0.12 percent for jams and jellies as
defined in 170.3(n)(28) of this chapter and meat products as defined in
170.3(n)(29) of this chapter; 0.2 percent for soft candy as defined in
170.3(n)(38) of this chapter; 0.05 percent for soups and soup mixes as
defined in 170.3(n)(40) of this chapter and sweet sauces as defined in
170.3(n)(43) of this chapter.
(e) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(47 FR 27815, June 25, 1982)
21 CFR 184.1724 Sodium alginate.
(a) Sodium alginate (CAS Reg. No. 9005-38-3) is the sodium salt of
alginic acid, a natural polyuronide constituent of certain brown algae.
Sodium alginate is prepared by the neutralization of purified alginic
acid with appropriate pH control agents.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 274, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(2), the ingredient is used in food
only within the following specific limitations:
(d) Prior sanctions for sodium alginate different from the uses
established in this section do not exist or have been waived.
(47 FR 29951, July 9, 1982, as amended at 48 FR 52448, Nov. 18, 1983)
21 CFR 184.1733 Sodium benzoate.
(a) Sodium benzoate is the chemical benzoate of soda (C7H5NaO2),
produced by the neutralization of benzoic acid with sodium bicarbonate,
sodium carbonate, or sodium hydroxide. The salt is not found to occur
naturally.
(b) The ingredient meets the specifications of the ''Food Chemicals
Codex,'' 3d Ed. (1981), p. 278, which is incorporated by reference.
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.
(c) The ingredient is used as an antimicrobial agent as defined in
170.3(o)(2) of this chapter, and as a flavoring agent and adjuvant as
defined in 170.3(o)(12) of this chapter.
(d) The ingredient is used in food at levels not to exceed good
manufacturing practice. Current usage results in a maximum level of 0.1
percent in food. (The Food and Drug Administration has not determined
whether significally different conditions of use would be GRAS.)
(e) Prior sanctions for this ingredient different from the uses
established in this section, or different from that set forth in part
181 of this chapter, do not exist or have been waived.
(42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5613, Feb. 14, 1984)
21 CFR 184.1736 Sodium bicarbonate.
(a) Sodium bicarbonate (NaHCO3, CAS Reg. No. 144-55-8) is prepared by
treating a sodium carbonate or a sodium carbonate and sodium bicarbonate
solution with carbon dioxide. As carbon dioxide is absorbed, a
suspension of sodium bicarbonate forms. The slurry is filtered, forming
a cake which is washed and dried.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 278, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(48 FR 52442, Nov. 18, 1983)
21 CFR 184.1742 Sodium carbonate.
(a) Sodium carbonate (Na2CO3, CAS Reg. No. 497-19-8) is produced (1)
from purified trona ore that has been calcined to soda ash; (2) from
trona ore calcined to impure soda ash and then purified; or (3)
synthesized from limestone by the Solvay process.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 280, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used in food as an antioxidant as defined in
170.3(o)(3) of this chapter; curing and pickling agent as defined in
170.3(o)(5) of this chapter; flavoring agent and adjuvant as defined in
170.3(o)(12) of this chapter; pH control agent as defined in
170.3(o)(23) of this chapter; and processing aid as defined in
170.3(o)(24) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(48 FR 52442, Nov. 18, 1983, as amended at 50 FR 49536, Dec. 3, 1985)
21 CFR 184.1754 Sodium diacetate.
(a) Sodium diacetate (C4H7O4 Na.xH2O, CAS Reg. No. 126-96-5) is a
molecular compound of acetic acid, sodium acetate, and water of
hydration. The technical grade is prepared synthetically by reacting
sodium carbonate with acetic acid. Special grades are produced by
reacting anhydrous sodium acetate and acetic acid.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 284, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) The ingredient is used as an antimicrobial agent as defined in
170.3(o)(2) of this chapter; flavoring agent and adjuvant as defined in
170.3(o)(12) of this chapter; and pH control agent as defined in
170.3(o)(23) of this chapter.
(d) The ingredient is used in food at levels not to exceed current
good manufacturing practice in accordance with 184.1(b)(1). Current
good manufacturing practice results in a maximum level, as served, 0.4
percent for baked goods as defined in 170.3(n)(1) of this chapter; 0.1
percent for fats and oils as defined in 170.3(n)(12) of this chapter,
meat products as defined in 170.3(n)(29) of this chapter and soft candy
as defined in 170.3(n)(38) of this chapter; 0.25 percent for gravies
and sauces as defined in 170.3(n)(24) of this chapter; and 0.05
percent for snack foods as defined in 170.3(n)(37) of this chapter and
soups and soup mixes as defined in 170.3(n)(40) of this chapter.
(e) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(47 FR 27815, June 25, 1982)
21 CFR 184.1763 Sodium hydroxide.
(a) Sodium hydroxide (NaOH, CAS Reg. No. 1310-73-2) is also known as
sodium hydrate, soda lye, caustic soda, white caustic, and lye. The
empirical formula is NaOH. Sodium hydroxide is prepared commercially by
the electrolysis of sodium chloride solution and also by reacting
calcium hydroxide with sodium carbonate.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), which is incorporated by reference. Copies are
available from the National Academy Press, 2101 Constitution Ave. NW.,
Washington, DC 20418, or available for inspection at the Office of the
Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a pH control agent as defined in
170.3(o)(23) of this chapter and as a processing aid as defined in
170.3(o)(24) of this chapter.
(2) The ingredient is used in foods at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(48 FR 52444, Nov. 18, 1983)
21 CFR 184.1764 Sodium hypophosphite.
(a) Sodium hypophosphite (NaH2PO2, CAS Reg. No. 7681-53-0) is a
white, odorless, deliquescent granular powder with a saline taste. It
is also prepared as colorless, pearly crystalline plates. It is soluble
in water, alcohol, and glycerol. It is prepared by neutralization of
hypophosphorous acid or by direct aqueous alkaline hydrolysis of white
phosphorus.
(b) FDA is developing food-grade specifications for sodium
hypophosphite in cooperation with the National Academy of Sciences. In
the interim, the ingredient must be of a suitable purity for its
intended use.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitations other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as an emulsifier or stabilizer, as defined
in 170.3(o)(8) and 170.3(o)(28) of this chapter.
(2) The ingredient is used in cod-liver oil emulsions at levels not
to exceed current good manufacturing practice.
(d) Prior sanctions for this ingredient different from the use
established in this section do not exist or have been waived.
(47 FR 38277, Aug. 31, 1982)
21 CFR 184.1768 Sodium lactate.
(a) Sodium lactate (C3H5O3Na, CAS Reg. No. 72-17-3) is the sodium
salt of lactic acid. It is prepared commercially by the neutralization
of lactic acid with sodium hydroxide.
(b) FDA is developing food-grade specifications for sodium lactate in
cooperation with the National Academy of Sciences. In the interim, this
ingredient must be of a purity suitable for its intended use.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. This
regulation does not authorize its use in infant foods and infant
formulas. The affirmation of this ingredient as generally recognized as
safe (GRAS) as a direct human food ingredient is based upon the
following current good manufacturing practice conditions of use:
(1) The ingredient is used as an emulsifier as defined in
170.3(o)(8) of this chapter; a flavor enhancer as defined in
170.3(o)(11) of this chapter; a flavoring agent or adjuvant as defined
in 170.3(o)(12) of this chapter; a humectant as defined in
170.3(o)(16) of this chapter; and a pH control agent as defined in
170.3(o)(23) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(52 FR 10886, Apr. 6, 1987)
21 CFR 184.1769a Sodium metasilicate.
(a) Sodium metasilicate (CAS Reg. No. 6834-92-0) is a strongly
alkaline white powder. It does not occur naturally but rather is
synthesized by melting sand with sodium carbonate at 1400 C. The
commercially available forms of sodium metasilicate are the anhydrous
form (Na2SiO3), the pentahydrate (Na2SiO3 5H2O), and the nonahydrate
(Na2SiO3 9H2O).
(b) FDA is developing food-grade specifications for sodium
metasilicate in cooperation with the National Academy of Sciences. In
the interim, the ingredient must be of a purity suitable for its
intended use.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a processing aid as defined in
170.3(o)(24) of this chapter.
(2) The ingredient is used to treat the following foods at levels not
to exceed current good manufacturing practice: for use in washing and
lye peeling of fruits, vegetables, and nuts when used in accordance with
173.315 of this chapter; for use as a denuding agent in tripe; for
use as a hog scald agent in removing hair; and for use as a corrosion
preventative in canned and bottled water when used in accordance with
103.35 of this chapter.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(50 FR 38781, Sept. 25, 1985; 50 FR 42011, Oct. 17, 1985)
21 CFR 184.1784 Sodium propionate.
(a) Sodium propionate (C3H5NaO2, CAS Reg. No. 137-40-6) is the sodium
salt of propionic acid. It occurs as colorless, transparent crystals or
a granular crystalline powder. It is odorless, or has a faint
acetic-butyric acid odor, and is deliquescent. It is prepared by
neutralizing propionic acid with sodium hydroxide.
(b) The ingredients meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 296, which is incorporated by reference.
Copies are available from the the National Academy Press, 2101
Constitution Ave. NW., Washington DC 20418, or available for inspection
at the Office of the Federal Register, 1100 L St. NW., Washington, DC
20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as an antimicrobial agent as defined in
170.3(o)(2) of this chapter and a flavoring agent as defined in
170.3(o)(12) of this chapter.
(2) The ingredient is used in the following foods at levels not to
exceed current good manufacturing practice: baked goods as defined in
170.3(n)(1) of this chapter; nonalcoholic beverages as defined in
170.3(n)(3) of this chapter; cheeses as defined in 170.3(n)(5) of this
chapter; confections and frostings as defined in 170.3(n)(9) of this
chapter; gelatins, puddings, and fillings as defined in 170.3(n)(22)
of this chapter; jams and jellies as defined in 170.3(n)(28) of this
chapter; meat products as defined in 170.3(n)(29) of this chapter;
and soft candy as defined in 170.3(n)(38) of this chapter.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(49 FR 13142, Apr. 3, 1984)
21 CFR 184.1792 Sodium sesquicarbonate.
(a) Sodium sesquicarbonate (Na2CO3.NaHCO3.2H2O, CAS Reg. No.
533-96-0) is prepared by: (1) Partial carbonation of soda ash solution
followed by crystallization, centrifugation, and drying; (2) double
refining of trona ore, a naturally occurring impure sodium
sesquicarbonate.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 299, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a pH control agent as defined in
170.3(o)(23) of this chapter.
(2) The ingredient is used in cream at levels not to exceed current
good manufacturing practice. Current good manufacturing practice
utilizes a level of the ingredient sufficient to control lactic acid
prior to pasteurization and churning of cream into butter.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(48 FR 52443, Nov. 18, 1983)
21 CFR 184.1801 Sodium tartrate.
(a) Sodium tartrate (C4H4Na2O6.2H2O, CAS Reg. No. 868-18-8) is the
disodium salt of l^(+)^tartaric acid. It occurs as transparent,
colorless, and odorless crystals. It is obtained as a byproduct of wine
manufacture.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 303, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as an emulsifier as defined in
170.3(o)(8) of this chapter and as a pH control agent as defined in
170.3(o)(23) of this chapter.
(2) The ingredient is used in the following foods at levels not to
exceed current good manufacturing practice: cheeses as defined in
170.3(n)(5) of this chapter; fats and oils as defined in 170.3(n)(12)
of this chapter; and jams and jellies as defined in 170.3(n)(28) of
this chapter.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(48 FR 52447, Nov. 18, 1983)
21 CFR 184.1804 Sodium potassium tartrate.
(a) Sodium potassium tartrate (C4H4KNaO6.4H2O, CAS Reg. No.
304-59-6) is the sodium potassium salt of l^(+)^tartaric acid and is
also called the Rochelle salt. It occurs as colorless crystals or as a
white, crystalline powder and has a cooling saline taste. It is
obtained as a byproduct of wine manufacture.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 296, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as an emulsifier as defined in
170.3(o)(8) of this chapter and as a pH control agent as defined in
170.3(o)(23) of this chapter.
(2) The ingredient is used in the following foods at levels not to
exceed current good manufacturing practice: cheeses as defined in
170.3(n)(5) of this chapter and jams and jellies as defined in
170.3(n)(28) of this chapter.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(48 FR 52447, Nov. 18, 1983)
21 CFR 184.1807 Sodium thiosulfate.
(a) Sodium thiosulfate (Na2S2O3
5H2O, CAS Reg. No. 010102-17-7) is also known as sodium hyposulfite.
It is prepared synthetically by the reaction of sulfides and sulfur
dioxide (SO2), the reaction of sulfur and sulfite, or the oxidation of
metal sulfides and hydrosulfides.
(b) The ingredient meets the specifications of the ''Food Chemicals
Codex,'' 3d Ed. (1981), p. 304, which is incorporated by reference.
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.
(c) The ingredient is used as a formulation aid as defined in
170.3(o)(14) of this chapter and reducing agent as defined in
170.3(o)(22) of this chapter.
(d) The ingredient is used in alcoholic beverages and table salt in
accordance with 184.1(b)(1) at levels not to exceed good manufacturing
practice. Current good manufacturing practice results in a maximum
level, as served, of 0.00005 percent for alcoholic beverages as defined
in 170.3(n)(2) of this chapter and 0.1 percent for table salt as
defined in 170.3(n)(26) of this chapter.
(e) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(43 FR 22938, May 30, 1978, as amended at 49 FR 5613, Feb. 4, 1984)
21 CFR 184.1835 Sorbitol.
(a) Sorbitol is the chemical 1,2,3,4,5,6-hexanehexol (C6H14O6), a
hexahydric alcohol, differing from mannitol principally by having a
different optical rotation. Sorbitol is produced by the electrolytic
reduction, or the transition metal catalytic hydrogenation of sugar
solutions containing glucose or fructose.
(b) The ingredient meets the specifications of the ''Food Chemicals
Codex,'' 3d Ed. (1981), p. 308, which is incorporated by reference.
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.
(c) The ingredient is used as an anticaking agent and free-flow agent
as defined in 170.3(o)(1) of this chapter, curing and pickling agent as
defined in 170.3(o)(5) of this chapter, drying agent as defined in
170.3(o)(7) of this chapter, emulsifier and emulsifier salt as defined
in 170.3(o)(8) of this chapter, firming agent as defined in
170.3(o)(10) of this chapter, flavoring agent and adjuvant as defined in
170.3(o)(12) of this chapter, formulation aid as defined in
170.3(o)(14) of this chapter, humectant as defined in 170.3(o)(16) of
this chapter, lubricant and release agent as defined in 170.3(o)(18) of
this chapter, nutritive sweetener as defined in 170.3(o)(21) of this
chapter, sequestrant as defined in 170.3(o)(26) of this chapter,
stabilizer and thickener as defined in 170.3(o)(28) of this chapter,
surface-finishing agent as defined in 170.3(o)(30) of this chapter, and
texturizer as defined in 170.3(o)(32) of this chapter.
(d) The ingredient is used in food at levels not to exceed good
manufacturing practices. Current good manufacturing practice in the use
of sorbitol results in a maximum level of 99 percent in hard candy and
cough drops as defined in 170.3(n)(25) of this chapter, 75 percent in
chewing gum as defined in 170.3(n)(6) of this chapter, 98 percent in
soft candy as defined in 170.3(n)(38) of this chapter, 30 percent in
nonstandardized jams and jellies, commercial, as defined in
170.3(n)(28) of this chapter, 30 percent in baked goods and baking mixes
as defined in 170.3(n)(1) of this chapter, 17 percent in frozen dairy
desserts and mixes as defined in 170.3(n)(20) of this chapter, and 12
percent in all other foods.
(e) The label and labeling of food whose reasonably foreseeable
consumption may result in a daily ingestion of 50 grams of sorbitol
shall bear the statement: ''Excess consumption may have a laxative
effect.''
(f) Prior sanctions for this ingredient different from the uses
established in this regulation do not exist or have been waived.
(42 FR 14653, Mar. 15, 1977, as amended at 49 FR 5613, Feb. 14, 1984)
21 CFR 184.1845 Stannous chloride (anhydrous and dihydrated).
(a) Stannous chloride is anhydrous or contains two molecules of water
of hydration. Anhydrous stannous chloride (SnCl2,CAS Reg. No.
7772-99-8) is the chloride salt of metallic tin. It is prepared by
reacting molten tin with either chlorine or gaseous tin tetrachloride.
Dihydrated stannous chloride (SnCl2 2H2O, CAS Reg. No. 10025-69-1) is
the chloride salt of metallic tin that contains two molecules of water.
It is prepared from granulated tin suspended in water and hydrochloric
acid or chlorine.
(b) Both forms of the ingredient meet the specifications of the Food
Chemicals Codex, 3d Ed. (1981), p. 312, which is incorporated by
reference. Copies are available from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418, or available for
inspection at the Office of the Federal Register, 1100 L St. NW.,
Washington, DC 20408.
(c) The ingredient is used as an antioxidant as defined in
170.3(o)(3) of this chapter.
(d) The ingredient is used in food at levels not to exceed current
good manufacturing practice in accordance with 184.(b)(1). Current good
manufacturing practice results in a maximum level, as served, of 0.0015
percent or less; calculated as tin, for all food categories.
(e) Prior sanctions for this ingredient different from those uses
established in this section do not exist or have been waived.
(47 FR 27816, June 25, 1982)
21 CFR 184.1848 Starter distillate.
(a) Starter distillate (butter starter distillate) is a steam
distillate of the culture of any or all of the following species of
bacteria grown on a medium consisting of skim milk usually fortified
with about 0.1 percent citric acid: Streptococcus lactis, S. cremoris,
S. lactis subsp. diacetylactis, Leuconostoc citrovorum, and L.
dextranicum. The ingredient contains more than 98 percent water, and the
remainder is a mixture of butterlike flavor compounds. Diacetyl is the
major flavor component, constituting as much as 80 to 90 percent of the
mixture of organic flavor compounds. Besides diacetyl, starter
distillate contains minor amounts of acetaldehyde, ethyl formate, ethyl
acetate, acetone, ethyl alcohol, 2-butanone, acetic acid, and acetoin.
(b) FDA is developing food-grade specifications for starter
distillate in cooperation with the National Academy of Sciences. In the
interim, this ingredient must be of a purity suitable for its intended
use.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a flavoring agent and adjuvant as
defined in 170.3(o)(12) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(48 FR 51907, Nov. 15, 1983)
21 CFR 184.1854 Sucrose.
(a) Sucrose (C12H22O11, CAS Reg. No. 57-50-11-1) sugar, cane sugar,
or beet sugar is the chemical b-D-fructofuranosyl-a-D-glucopyranoside.
Sucrose is obtained by crystallization from sugar cane or sugar beet
juice that has been extracted by pressing or diffusion, then clarified
and evaporated.
(b) FDA is developing food-grade specifications for sucrose in
cooperation with the National Academy of Sciences. In the interim, this
ingredient must be of a purity suitable for its intended use.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(53 FR 44876, Nov. 7, 1988; 54 FR 228, Jan. 4, 1989)
21 CFR 184.1857 Corn sugar.
(a) Corn sugar (C6H12O6, CAS Reg. No. 50-99-7), commonly called
D-glucose or dextrose, is the chemical a-D-glucopyranose. It occurs as
the anhydrous or the monohydrate form and is produced by the complete
hydrolysis of corn starch with safe and suitable acids or enzymes,
followed by refinement and crystallization from the resulting
hydrolysate.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), pp. 97-98 under the heading ''Dextrose,'' which
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1
CFR part 1. Copies are available from the National Academy Press, 2101
Constitution Ave., NW., Washington, DC 20418, or available for
inspection at the Office of the Federal Register, 1100 L St. NW.,
Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(53 FR 44876, Nov. 7, 1988)
21 CFR 184.1859 Invert sugar.
(a) Invert sugar (CAS Reg. No. 8013-17-0) is 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. The
solution is colorless, odorless, and flavorless, except for sweetness.
It is produced by the hydrolysis or partial hydrolysis of sucrose with
safe and suitable acids or enzymes.
(b) FDA is developing food-grade specifications for invert sugar in
cooperation with the National Academy of Sciences. In the interim, this
ingredient must be of a purity suitable for its intended use.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(53 FR 44876, Nov. 7, 1988; 54 FR 228, Jan. 4, 1989)
21 CFR 184.1865 Corn syrup.
(a) Corn syrup, commonly called ''glucose sirup'' or ''glucose
syrup,'' is obtained by partial hydrolysis of corn starch with safe and
suitable acids or enzymes. It may also occur in the dehydrated form
(dried glucose sirup). Depending on the degree of hydrolysis, corn
syrup may contain, in addition to glucose, maltose and higher
saccharides.
(b) The ingredient meets the specifications as defined and determined
in 168.120(b) or 168.121(a) of this chapter, as appropriate. FDA, in
cooperation with the National Academy of Sciences, is undertaking a
study to determine if additional food-grade specifications for corn
syrup are necessary.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(53 FR 44876, Nov. 7, 1988)
21 CFR 184.1875 Thiamine hydrochloride.
(a) Thiamine hydrochloride (C12H17C1N4OS.HCl, CAS Reg. No. 67-03-8)
is the chloride-hydrochloride salt of thiamine. It occurs as
hygroscopic white crystals or a white crystalline powder. The usual
method of preparing this substance is by linking the preformed thiazole
and pyrimidine ring systems.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 324, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a flavoring agent and adjuvant as
defined in 170.3(o)(12) of this chapter or as a nutrient supplement as
defined in 170.3(o)(20) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice. Thiamine hydrochloride may be used in
infant formula in accordance with section 412(g) of the Federal Food,
Drug, and Cosmetic Act (the Act) or with regulations promulgated under
section 412(a)(2) of the Act.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(48 FR 55124, Dec. 9, 1983)
21 CFR 184.1878 Thiamine mononitrate.
(a) Thiamine mononitrate (C12H17N5O4S, CAS Reg. No. 532-43-4) is the
mononitrate salt of thiamine. It occurs as white crystals or a white
crystalline powder and is prepared from thiamine hydrochloride by
dissolving the hydrochloride salt in alkaline solution followed by
precipitation of the nitrate half-salt with a stoichiometric amount of
nitric acid.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 325, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a nutrient supplement as defined in
170.3(o)(20) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice. Thiamine mononitrate may be used in infant
formula in accordance with section 412(g) of the Federal Food, Drug, and
Cosmetic Act (the Act) or with regulations promulgated under section
412(a)(2) of the Act.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(48 FR 55124, Dec. 9, 1983)
21 CFR 184.1890 -Tocopherols.
(a) The -tocopherols that are the subject of this GRAS affirmation
regulation are limited to the following:
(1) d- -Tocopherol (CAS Reg. No. 59-02-9) is the chemical
(2R,4'R,8'R)-2,5,7,8-tetramethyl-2-(4',8',12'-trimethyl-tridecyl)-6-chr
omanol. It occurs commercially as a concentrate and is a red, nearly
odorless, viscous oil. It is obtained by vacuum steam distillation of
edible vegetable oil products.
(2) dl- -Tocopherol (CAS Reg. No. 10191-41-0) is a mixture of
stereoisomers of 2,5,7,8-tetramethyl-2-(4',8',12'-trimeth-chromanol. It
is chemically synthesized by condensing racemic isophytol with trimethyl
hydroquinone. It is a pale yellow viscous oil at room temperature.
(b) The ingredients meet the specifications of the Food Chemicals
Codex, 3d Ed. (1981), pp. 330-331, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L. St. NW., Washington, DC 20408..
(c) In accordance with 184.1(b)(3), the affirmation of the
ingredients as generally recognized as safe is limited to the following
conditions of use while the agency concludes the general evaluation of
all food uses of tocopherols:
(1) The ingredients are used as inhibitors of nitrosamine formation.
(2) The ingredients are used in pump-cured bacon at levels not to
exceed current good manufacturing practice.
(49 FR 13348, Apr. 4, 1984)
21 CFR 184.1901 Triacetin.
(a) Triacetin (C8H1406, CAS Reg. No. 102-76-1), also known as
1,2,3,-propanetriol triacetate or glyceryl triacetate, is the triester
of glycerin and acetic acid. Triacetin can be prepared by heating
glycerin with acetic anhydride alone or in the presence of finely
divided potassium hydrogen sulfate. It can also be prepared by the
reaction of oxygen with a liquid-phase mixture of allyl acetate and
acetic acid using a bromide salt as a catalyst.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), pp. 337-338, as revised by the First Supplement
to the 3d Ed., which is incorporated by reference in accordance with 5
U.S.C. 552(a). Copies are available from the National Academy Press,
2102 Constitution Ave., NW., Washington, DC 20418, or available for
inspection at the Office of the Federal Register, 1100 L St., NW.,
Washington, DC 20005.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used in food as a flavoring agent and adjuvant
as defined in 170.3(o)(12) of this chapter; a formulation aid as
defined in 170.3(o)(14) of this chapter; and humectant as defined in
170.3(o)(16) of this chapter; and a solvent and vehicle as defined in
170.3(o)(27) of this chapter.
(2) The ingredient is used in the following foods at levels not to
exceed current good manufacturing practice: baked goods and baking
mixes as defined in 170.3(n)(1) of this chapter, alcoholic beverages as
defined in 170.3(n)(2) of this chapter; nonalcoholic beverages and
beverage bases as defined in 170.3(n)(3) of this chapter; chewing gum
as defined in 170.3(n)(6) of this chapter; confections and frostings
as defined in 170.3(n)(9) of this chapter; frozen dairy dessert and
mixes as defined in 170.3(n)(20) of this chapter; gelatins, puddings,
and fillngs as defined in 170.3(n)(22) of this chapter; hard candy as
defined in 170.3(n)(25) of this chapter; and soft candy as defined in
170.3(n)(38) of this chapter.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(54 FR 7404, Feb. 21, 1989)
21 CFR 184.1903 Tributyrin.
(a) Tributyrin (C15H2606, CAS Reg. No. 60-01-5), also known as
butyrin or glyceryl tributyrate, is the triester of glycerin and butyric
acid. It is prepared by esterification of glycerin with excess butyric
acid.
(b) The ingredient meets the specification of the Food Chemicals
Codex, 3d Ed. (1981), p. 416, which is incorporated by reference in
accordance with 5 U.S.C. 552(a). Copies are available from the National
Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or
available for inspection at the Office of the Federal Register, 1100 L
St., NW., Washington, DC 20005.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generaly recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used in food as a flavoring agent and adjuvant
as defined in 170.3(o)(12) of this chapter.
(2) The ingredient is used in the following foods at levels not to
exceed current good manufacturing practice; baked goods as defined in
170.3(n)(1) of this chapter; alcoholic beverages as defined in
170.3(n)(2) of this chapter; nonalcoholic beverages as defined in
170.3(n)(3) of this chapter; fats and oils as defined in 170.3(n)(12)
of this chapter; frozen dairy desserts and mixes as defined in
170.3(n)(20) of this chapter; gelatins, puddings and fillngs as defined
in 170.3(n)(22) of this chapter; and soft candy as defined in
170.3(n)(38) of this chapter.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(54 FR 7404, Feb. 21, 1989; 54 FR 10482, Mar. 13, 1989)
21 CFR 184.1923 Urea.
(a) Urea (CO(NH2)2, CAS Reg. No. 57-13-6) is the diamide of carbonic
acid and is also known as carbamide. It is a white, odorless solid and
is commonly produced from CO2 by ammonolysis or from cyanamide by
hydrolysis.
(b) FDA is developing food-grade specifications for urea in
cooperation with the National Academy of Sciences. In the interim, this
ingredient must be of a purity suitable for its intended use.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe as a
direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a formulation aid as defined in
170.3(o)(14) of this chapter and as a fermentation aid.
(2) The ingredient is used in yeast-raised bakery products; in
alcoholic beverages as defined in 170.3(n)(2) of this chapter; and in
gelatin products.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(48 FR 51616, Nov. 10, 1983, as amended at 49 FR 19816, May 10, 1984)
21 CFR 184.1930 Vitamin A.
(a)(1) Vitamin A (retinol; CAS Reg. No. 68-26-8) is the alcohol
9,13-dimethyl-7-(1,1,5-trimethyl-6-cyclohexen-5-yl)-7,9,11,13-nonatetra
en-15-ol. It may be nearly odorless or have a mild fishy odor. Vitamin
A is extracted from fish liver oils or produced by total synthesis from
b-ionone and a propargyl halide.
(2) Vitamin A acetate (retinyl acetate; CAS Reg. No. 127-47-9) is
the acetate ester of retinol. It is prepared by esterifying retinol
with acetic acid.
(3) Vitamin A palmitate (retinyl palmitate; CAS Reg. No. 79-81-2) is
the palmitate ester of retinol. It is prepared by esterifying retinol
with palmitic acid.
(b) The ingredient meets the specifications for vitamin A in the Food
Chemicals Codex, 3d Ed. (1981), p. 342, which is incorporated by
reference. Copies are available from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418, or available for
inspection at the Office of the Federal Register, 1100 L St. NW.,
Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used in food as a nutrient supplement as
defined in 170.3(o)(20) of this chapter.
(2) The ingredient is used in foods at levels not to exceed current
good manufacturing practice. Vitamin A may be used in infant formula in
accordance with section 412(g) of the Federal Food, Drug, and Cosmetic
Act (the act) or with regulations promulgated under section 412(a)(2) of
the Act.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(48 FR 51610, Nov. 10, 1983)
21 CFR 184.1945 Vitamin B12.
(a) Vitamin B12, also known as cyanocobalamin (C63H88CoN14O14P, CAS
Reg. No. 68-19-9), is produced commercially from cultures of
Streptomyces griseus.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 343, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a nutrient supplement as defined in
170.3(o)(20) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice. Vitamin B12 also may be used in infant
formula in accordance with section 412(g) of the Federal Food, Drug, and
Cosmetic Act (the act) or with regulations promulgated under section
412(a)(2) of the act.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(50 FR 6341, Feb. 15, 1985)
21 CFR 184.1950 Vitamin D.
(a) Vitamin D is added to food as the following food ingredients:
(1) Crystalline vitamin D2 (C28H44O, CAS Reg. No. 50-14-6), also
known as ergocalciferol, is the chemical
9,10-seco(5Z,7E,22E)-5,7,10(19),22-ergostatetraen-3-ol. The ingredient
is produced by ultraviolet irradiation of ergosterol isolated from yeast
and related fungi and is purified by crystallization.
(2) Crystalline vitamin D3 (C27H44O, CAS Reg. No. 67-97-0), also
known as cholecalciferol, is the chemical
9,10-seco(5Z,7E,)-5,7,10(19)-cholestatrien-3-ol. Vitamin D3 occurs in,
and is isolated from, fish liver oils. It is also manufactured by
ultraviolet irradiation of 7-dehydrocholesterol produced from
cholesterol. It is purified by crystallization. Vitamin D3 is the
vitamin D form that is produced endogenously in humans through sunlight
activation of 7-dehydrocholesterol in the skin.
(3) Vitamin D2 resin and vitamin D3 resin are the concentrated forms
of irradiated ergosterol (D2) and irradiated 7-dehydrocholesterol (D3)
that are separated from the reacting materials in paragraphs (a) (1) and
(2) of this section. The resulting products are sold as food sources of
vitamin D without further purification.
(b) Vitamin D2 and vitamin D3 as crystals meet the specifications of
the Food Chemicals Codex, 3d Ed. (1981), pp. 344 and 345, which is
incorporated by reference. Copies are available from the National
Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or
available for inspection at the Office of the Federal Register, 1100 L
St. NW., Washington, DC 20408. FDA is developing food-grade
specifications for vitamin D2 resin and vitamin D3 resin in cooperation
with the National Academy of Sciences. In the interim, these resins
must be of a purity suitable for their intended use.
(c)(1) In accordance with 184.1(b)(2), the ingredients are used in
food as the sole source of added vitamin D only within the following
specific limitations:
(2) Vitamin D may be used in infant formula in accordance with
section 412(g) of the Federal Food, Drug, and Cosmetic Act (the act) or
with regulations promulgated under section 412(a)(2) of the act.
(3) Vitamin D may be used in margarine in accordance with 166.110 of
this chapter.
(d) Prior sanctions for these ingredients different from the uses
established in this section do not exist or have been waived.
(50 FR 30152, July 24, 1985)
21 CFR 184.1973 Beeswax (yellow and white).
(a) Beeswax (CAS Reg. No. 8012-89-3) is a secretory product of honey
bees used as a structural material in honeycombs. Beeswax is prepared
from honeycombs after removal of the honey by draining or centrifuging.
The combs are melted in hot water or steam or with solar heat, and
strained. The wax is refined by melting in hot water to which sulfuric
acid or alkali may be added to extract impurities. The resulting wax is
referred to as yellow beeswax. White beeswax is produced by bleaching
the constituent pigments of yellow beeswax with peroxides, or preferably
it is bleached by sun light.
(b) The ingredient meets the specifications of the ''Food Chemicals
Codex,'' 3d Ed. (1981), pp. 34-35, which is incorporated by reference.
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.
(c) The ingredient is used as a flavoring agent and adjuvant as
defined in 170.3(o)(12) of this chapter, as a lubricant as defined in
170.3(o)(18) of this chapter, and as a surface-finishing agent as
defined in 170.3(o)(30) of this chapter.
(d) The ingredient is used in food, in accordance with 184.1(b)(1)
of this chapter, at levels not to exceed good manufacturing practice.
Current good manufacturing practice results in a maximum level, as
served, of: 0.065 percent for chewing gum as defined in 170.3(n)(6) of
this chapter; 0.005 percent for confections and frostings as defined in
170.3(n)(9) of this chapter; 0.04 percent for hard candy as defined in
170.3(n)(25) of this chapter; 0.1 percent for soft candy as defined in
170.3(n)(38) of this chapter; and 0.002 percent or less for all other
food categories.
(43 FR 14644, Apr. 7, 1978, as amended at 49 FR 5613, Feb. 14, 1984;
50 FR 49536, Dec. 3, 1985)
21 CFR 184.1976 Candelilla wax.
(a) Candelilla wax (CAS Reg. No. 8006-44-8) is obtained from the
candelilla plant. It is a hard, yellowish-brown, opaque-to-translucent
wax. Candelilla wax is prepared by immersing the plants in boiling
water containing sulfuric acid and skimming off the wax that rises to
the surface. It is composed of about 50 percent hydrocarbons with
smaller amounts of esters and free acids.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 67, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a lubricant as defined in 170.3(o)(18)
of this chapter and as a surface-finishing agent as defined in
170.3(o)(30) of this chapter.
(2) The ingredient is used in the following foods at levels not to
exceed current good manufacturing practice: in chewing gum as defined
in 170.3(n)(6) of this chapter and in hard candy as defined in
170.3(n)(25) of this chapter.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(48 FR 51617, Nov. 10, 1983)
21 CFR 184.1978 Carnauba wax.
(a) Carnauba wax (CAS Reg. No. 008-015-869) is obtained from the
leaves and buds of the Brazilian wax palm Copernicia cerifera Martius.
The wax is hard, brittle, sparingly soluble in cold organic solvents and
insoluble in water. It is marketed in five grades designated No. 1
through No. 5. Grades No. 4 and No. 5 represent the bulk of the
commercial trade volume. These commercial grades consist chiefly of C24
to C32 normal saturated monofunctional fatty acids and normal saturated
monofunctional primary alcohols.
(b) The ingredient meets the specifications of the Food Chemicals
Codex, 3d Ed. (1981), p. 73, which is incorporated by reference.
Copies are available from the National Academy Press, 2101 Constitution
Ave. NW., Washington, DC 20418, or available for inspection at the
Office of the Federal Register, 1100 L St. NW., Washington, DC 20408.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as an anticaking agent as defined
170.3(o)(1) of this chapter; as a formulation aid as defined in
170.3(o)(14) of this chapter; as a lubricant and release agent as
defined in 170.3(o)(18) of this chapter; and as a surface-finishing
agent as defined in 170.3(o)(30) of this chapter.
(2) The ingredient is used in the following foods at levels not to
exceed current good manufacturing practice: baked goods and baking
mixes as defined in 170.3(n)(1) of this chapter; chewing gun as
defined in 170.3(n)(6) of this chapter; confections and frostings as
defined in 170.3(n)(9) of this chapter; fresh fruits and fruit juices
as defined in 170.3(n)(16) of this chapter; gravies and sauces as
defined in 170.3(n)(24) of this chapter; processed fruits and fruit
juices as defined in 170.3(n)(35) of this chapter; and soft candy as
defined in 170.3(n)(38) of this chapter.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(48 FR 51147, Nov. 7, 1983)
21 CFR 184.1979 Whey.
(a)(1) Whey. Whey is the liquid substance obtained by separating the
coagulum from milk, cream, or skim milk in cheesemaking. Whey obtained
from a procedure, in which a significant amount of lactose is converted
to lactic acid, or from the curd formation by direct acidification of
milk, is known as acid whey. Whey obtained from a procedure in which
there is insignificant conversion of lactose to lactic acid is known as
sweet whey. Sweet whey has a maximum titratable acidity of not more
than 0.16 percent, calculated as lactic acid, and an alkalinity of ash
of not more than 225 milliliters of 0.1N hydrochloric acid per 100
grams. The acidity of whey, sweet or acid, may be adjusted by the
addition of safe and suitable pH-adjusting ingredients.
(2) Concentrated whey. Concentrated whey is the liquid substance
obtained by the partial removal of water from whey, while leaving all
other constituents in the same relative proportions as in whey.
(3) Dry or dried whey. Dry or dried whey is the dry substance
obtained by the removal of water from whey, while leaving all other
constituents in the same relative proportions as in whey.
(b) The ingredients meet the following specifications:
(1) The analysis of whey, concentrated whey, and dry (dried) whey, on
a dry product basis, based on analytical methods in the referenced
sections of ''Official Methods of Analysis of the Association of
Official Analytical Chemists,'' 13th ed. (1980), /2/ which is
incorporated by reference, is:
(i) Protein content, 10 to 15 percent -- as determined by the methods
prescribed in section 16.036 (liquid sample), entitled ''Total Nitrogen
-- Official Final Action'' under the heading ''Total Solids,'' or in
section 16.193 (dry sample), entitled ''Kjeldahl Method'' under the
heading ''Protein -- Official Final Action.''
(ii) Fat content, 0.2 to 2.0 percent -- as determined by the methods
prescribed in section 16.059 (liquid sample), ''Reese-Gottlieb Method
(Reference Method) (11) -- Official Final Action'' under the heading
''Fat,'' or in section 16.199 (dry sample), entitled ''Fat in Dried Milk
(45) -- Official Final Action.''
(iii) Ash content, 7 to 14 percent -- as determined by the methods
prescribed in section 16.035 (liquid sample), entitled ''Ash (5) --
Official Final Action'' under the heading ''Total Solids,'' or in
section 16.196 (dry sample), entitled ''Ash -- Official Final Action''
under the heading ''Dried Milk, Nonfat Dry Milk, and Malted Milk.''
(iv) Lactose content, 61 to 75 percent -- as determined by the
methods prescribed in section 16.057 (liquid sample), entitled
''Gravimetric Method -- Official Final Action'' under the heading
''Lactose,'' or in section 31.061 (dry sample), entitled ''Lane-Eynon
General Volumetric Method'' under the heading ''Lactose -- Chemical
Methods -- Official Final Action.''
(v) Moisture content, 1 to 8 percent -- as determined by the methods
prescribed in section 16.192, entitled ''Moisture (41) -- Official Final
Action'' under the heading ''Dried Milk, Nonfat Dry Milk, and Malted
Milk.''
(vi) Solids content, variable -- as determined by the methods
prescribed in section 16.032, entitled ''Method I -- Official Final
Action'' under the heading ''Total Solids.''
(vii) Titratable Acidity, variable -- as determined by the methods
prescribed in section 16.023, entitled ''Acidity (2) -- Official Final
Action'' under the heading ''Milk,'' or by an equivalent potentiometric
method.
(2) Limits of impurities are:
Heavy metals (as lead). Not more than 10 parts per million (0.001
percent) as determined by the method described in the Food Chemicals
Codex, 3d ed. (1981), pp. 512-513, /1/ which is incorporated by
reference.
(3) The whey must be derived from milk that has been pasteurized, or
the whey and modified whey product must be subjected to pasteurization
techniques or its equivalent before use in food.
(c) Whey, concentrated whey, and dry (dried) whey may be used in food
in accordance with good manufacturing practice as indicated in
184.1(b)(1).
(d) The label on the whey form sold to food manufacturers shall read
as follows:
(1) For whey: ''(Sweet or acid) whey'' or ''whey ( ---- % titratable
acidity).
(2) For concentrated whey: ''Concentrated (sweet or acid) whey, ----
% solids'' or ''Concentrated whey ( ---- % titratable acidity), ---- %
solids''.
(3) For dry (dried) whey: ''Dry (dried) (sweet or acid) whey'' or
''dry (dried) whey, ( ---- % titratable acidity)''.
(e) Whey, concentrated whey, or dry (dried) whey in a finished food
product shall be listed as ''whey.''
(46 FR 44439, Sept. 4, 1981; 47 FR 7410, Feb. 19, 1982; 54 FR
24899, June 12, 1989)
/2/ Copies may be obtained from: Association of Official Analytical
Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or
examined at the office of the Federal Register, 1100 L St. NW,
Washington, DC 20408.
/1/ Copies may be obtained from the National Academy of Sciences,
2101 Constitution Ave. NW, Washington, DC 20037, or examined at the
Office of the Federal Register, 1100 L St. NW, Washington, DC 20408.
21 CFR 184.1979a Reduced lactose whey.
(a) Reduced lactose whey is the substance obtained by the removal of
lactose from whey. The lactose content of the finished dry product
shall not exceed 60 percent. Removal of the lactose is accomplished by
physical separation techniques such as precipitation, filtration, or
dialysis. As with whey, reduced lactose whey can be used as a fluid,
concentrate, or a dry product form. The acidity of reduced lactose whey
may be adjusted by the addition of safe and suitable pH-adjusting
ingredients.
(b) The reduced lactose whey meets the following specifications:
(1) The analysis of reduced lactose whey, on a dry product basis,
based on analytical methods in the referenced sections of ''Official
Methods of Analysis of the Association of Official Analytical
Chemists,'' 13th ed. (1980), /2/ which is incorporated by reference,
is:
(i) Protein content, 16 to 24 percent -- as determined by the methods
prescribed in section 16.036 (liquid sample), entitled ''Total Nitrogen
-- Official Final Action'' under the heading ''Total Solids,'' or in
section 16.193 (dry sample), entitled ''Kjeldahl Method'' under the
heading ''Protein -- Official Final Action.''
(ii) Fat content, 1 to 4 percent -- as determined by the methods
prescribed in section 16.059 (liquid sample), ''Reese-Gottlieb Method
(Reference Method) (11) -- Official Final Action'' under the heading
''Fat,'' or in section 16.199 (dry sample), entitled ''Fat in Dried Milk
(45) -- Official Final Action.''
(iii) Ash content, 11 to 27 percent -- as determined by the methods
prescribed in section 16.035 (liquid sample), entitled ''Ash (5) --
Official Final Action'' under the heading ''Total Solids,'' or in
section 16.196 (dry sample), entitled ''Ash -- Official Final Action''
under the heading ''Dried Milk, Nonfat Dry Milk, and Malted Milk.''
(iv) Lactose content, not more than 60 percent -- as determined by
the methods prescribed in section 16.057 (liquid sample), entitled
''Gravimetric Method -- Official Final Action'' under the heading
''Lactose,'' or in section 31.061 (dry sample), entitled ''Lane-Eynon
General Volumetric Method'' under the heading ''Lactose -- Chemical
Methods -- Official Final Action.''
(v) Moisture content, 1 to 6 percent -- as determined by the method
prescribed in section 16.192, entitled ''Moisture (41) -- Official Final
Action'' under the heading ''Dried Milk, Nonfat Dry Milk, and Malted
Milk.''
(vi) Solids content, variable -- as determined by the methods
prescribed in section 16.032, entitled ''Method I -- Official Final
Action'' under the heading ''Total Solids.''
(vii) Titratable Acidity, variable -- as determined by the methods
prescribed in section 16.023, entitled ''Acidity (2) -- Official Final
Action'' under the heading ''Milk,'' or by an equivalent potentiometric
method.
(2) Limits of impurities are:
Heavy metals (as lead). Not more than 10 parts per million (0.001
percent), as determined by the method described in the Food Chemicals
Codex, 3d ed. (1981), pp. 512-513, /1/ which is incorporated by
reference.
(3) The reduced lactose whey shall be derived from milk that has been
pasteurized, or the reduced lactose whey shall be subjected to
pasteurization techniques or its equivalent before use in food.
(c) Reduced lactose whey may be used in food in accordance with good
manufacturing practice as indicated in 184.1(b)(1).
(d) The percent of lactose present on a dry product basis, i.e.,
''reduced lactose whey ( ---- % lactose)'', shall be declared on the
label of the package sold to food manufacturers. The percent of lactose
may be declared in 5-percent increments, expressed as a multiple of 5,
not greater than the actual percentage of lactose in the product, or as
a actual percentage provided that an analysis of the product on which
the actual percentage is based is supplied to the food manufacturer.
(e) The presence of reduced lactose whey in a finished food product
shall be listed as ''reduced lactose whey.''
(46 FR 44440, Sept. 4, 1981, as amended at 54 FR 24899, June 12,
1989)
/2/ Copies may be obtained from: Association of Official Analytical
Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or
examined at the office of the Federal Register, 1100 L St. NW,
Washington, DC 20408.
/1/ Copies may be obtained from the National Academy of Sciences,
2101 Constitution Ave. NW, Washington, DC 20037, or examined at the
Office of the Federal Register, 1100 L St. NW, Washington, DC 20408.
21 CFR 184.1979b Reduced minerals whey.
(a) Reduced minerals whey is the substance obtained by the removal of
a portion of the minerals from whey. The dry product shall not contain
more than 7 percent ash. Reduced minerals whey is produced by physical
separation techniques such as precipitation, filtration, or dialysis.
As with whey, reduced minerals whey can be used as a fluid, concentrate,
or a dry product form. The acidity of reduced minerals whey may be
adjusted by the additional of safe and suitable pH-adjusting
ingredients.
(b) The reduced minerals whey meets the following specifications:
(1) The analysis of reduced minerals whey, on a dry product basis,
based on analytical methods in the referenced sections of ''Official
Methods of Analysis of the Association of Official Analytical Chemists,
13th ed. (1980),2 which is incorporated by reference, is:
(i) Protein content, 10 to 24 percent -- as determined by the methods
prescribed in section 16.036 (liquid sample), entitled ''Total Nitrogen
-- Official Final Action'' under the heading ''Total Solids,'' or in
section 16.193 (dry sample), entitled ''Kjeldahl Method'' under the
heading ''Protein -- Official Final Action.''
(ii) Fat content, 1 to 4 percent -- as determined by the methods
prescribed in section 16.059 (liquid sample), ''Reese-Gottlieb Method
(Reference Method) (11) -- Official Final Action'' under the heading
''Fat,'' or in section 16.199 (dry sample), entitled ''Fat in Dried Milk
(45) -- Official Final Action.''
(iii) Ash content, maximum 7 percent -- as determined by the methods
prescribed in section 16.035 (liquid sample), entitled ''Ash (5) --
Official Final Action'' under the heading ''Total Solids,'' or in
section 16.196 (dry sample), entitled ''Ash -- Official Final Action''
under the heading ''Dried Milk, Nonfat Dry Milk, and Malted Milk.''
(iv) Lactose content, maximum 85 percent -- as determined by the
methods prescribed in section 16.057 (liquid sample), entitled
''Gravimetric Method -- Official Final Action'' under the heading
''Lactose,'' or in section 31.061 (dry sample), entitled ''Lane-Eynon
General Volumetric Method'' under the heading ''Lactose -- Chemical
Methods -- Official Final Action.''
(v) Moisture content, 1 to 6 percent -- as determined by the methods
prescribed in section 16.192, entitled ''Moisture (41) -- Official Final
Action'' under the heading ''Dried Milk, Nonfat Dry Milk, and Malted
Milk.''
(vi) Solids content, variable -- as determined by the methods
prescribed in section 16.032, entitled ''Method I -- Official Final
Action'' under the heading ''Total Solid.''
(vii) Titratable Acidity, variable -- as determined by the methods
prescribed in section 16.023, entitled ''Acidity (2) -- Official Final
Action'' under the heading ''Milk,'' or by an equivalent potentiometric
method.
(2) Limits of impurities are: Heavy metals (as lead). Not more than
10 parts per million (0.001 percent), as determined by the method
described in the Food Chemicals Codex, 3d ed. (1981), pp. 512-513,1
which is incorporated by reference.
(3) The reduced minerals whey shall be derived from milk that has
been pasteurized, or the reduced minerals whey shall be subjected to
pasteurization techniques or its equivalent before use in food.
(c) The reduced minerals whey may be used in food in accordance with
good manufacturing practice as indicated in 184.1(b)(1).
(d) The percent of minerals present on a dry product basis, i.e.,
''reduced minerals whey ( ---- % minerals)'', shall be declared on the
label of the package sold to food manufacturers. The percent of
minerals may be declared in 2-percent increments expressed as a multiple
of 2, not greater than the actual percentage of minerals in the product,
or as an actual percentage provided that an analysis of the product on
which the actual percentage is based is supplied to the food
manufacturer.
(e) The presence of reduced minerals whey in a finished food product
shall be listed as ''reduced minerals whey''.
(46 FR 44441, Sept. 4, 1981, as amended at 54 FR 24899, June 12,
1989)
/2/ Copies may be obtained from: Association of Official Analytical
Chemists, 2200 Wilson Blvd., Suite 400, Arlington, VA 22201-3301, or
examined at the Office of the Federal Register, 1100 L St. NW,
Washington, DC 20408.
1Copies may be obtained from the National Academy of Sciences, 2101
Constitution Ave. NW, Washington, DC 20037, or examined at the Office
of the Federal Register, 1100 L St. NW, Washington, DC 20408.
21 CFR 184.1979c Whey protein concentrate.
(a) Whey protein concentrate is the substance obtained by the removal
of sufficient nonprotein constituents from whey so that the finished dry
product contains not less than 25 percent protein. Whey protein
concentrate is produced by physical separation techniques such as
precipitation, filtration, or dialysis. As with whey, whey protein
concentrate can be used as a fluid, concentrate, or dry product form.
The acidity of whey protein concentrate may be adjusted by the addition
of safe and suitable pH-adjusting ingredients.
(b) The whey protein concentrate meets the following specifications:
(1) The analysis of whey protein concentrate, on a dry product basis,
based on analytical methods in the referenced sections of ''Official
Methods of Analysis of the Association of Official Analytical
Chemists,'' 13th ed. (1980),2 which is incorporated by reference, is:
(i) Protein content, minimum 25 percent -- as determined by the
methods prescribed in section 16.036 (liquid sample), entitled ''Total
Nitrogen -- Officials Final Action'' under the heading ''Total Solids,''
or in section 16.193 (dry sample), entitled ''Kjeldahl Method'' under
the heading ''Protein -- Official Final Action.''
(ii) Fat content, 1 to 10 percent -- as determined by the methods
prescribed in section 16.059 (liquid sample), ''Reese-Gottlieb Method
(Reference Method) (11) -- Official Final Action'' under the heading
''Fat,'' or in section 16.199 (dry sample), entitled ''Fat in Dried Milk
(45) -- Official Final Action.''
(iii) Ash content, 2 to 15 percent -- as determined by the methods
prescribed in section 16.035 (liquid sample), entitled ''Ash (5) --
Official Final Action'' under the heading ''Total Solids,'' or in
section 16.196 (dry sample), entitled ''Ash -- Official Final Action''
under the heading ''Dried Milk, Nonfat Dry Milk, and Malted Milk.''
(iv) Lactose content, maximum 60 percent -- as determined by the
methods prescribed in section 16.057 (liquid sample), entitled
''Gravimetric Method -- Official Final Action'' under the heading
''Lactose,'' or in section 31.061 (dry sample), entitled ''Lane-Eynon
General Volumetric Method'' under the heading ''Lactose -- Chemical
Methods -- Official Final Action.''
(v) Moisture content, 1 to 6 percent -- as determined by the methods
prescribed in section 16.192, entitled ''Moisture (41) -- Official Final
Action'' under the heading ''Dried Milk, Nonfat Dry Milk, and Malted
Milk.''
(vi) Solids content, variable -- as determined by the methods
prescribed in section 16.032, entitled ''Method I -- Official Final
Action'' under the heading ''Total Solids.''
(vii) Titratable Acidity, variable -- as determined by the methods
prescribed in section 16.023, entitled ''Acidity (2) -- Official Final
Action'' under the heading ''Milk,'' or by an equivalent potentiometric
method.
(2) Limits of impurities are:
Heavy metals (as lead). Not more than 10 parts per million (0.001
percent), as determined by the method described in the Food Chemicals
Codex, 3d ed. (1981), pp. 512-513, /1/ which is incorporated by
reference.
(3) The whey protein concentrate shall be derived from milk that has
been pasteurized, or the whey protein concentrate shall be subjected to
pasteurization techniques or its equivalent before use in food.
(c) The whey protein concentrate may be used in food in accordance
with good manufacturing practice as indicated in 184.1(b)(1).
(d) The percent of protein present on a dry product basis, i.e.,
''whey protein concentrate ( ---- % protein)'', shall be declared on the
label of the package sold to food manufacturers. The percent of protein
may be declared in 5-percent increments, expressed as a multiple of 5,
not greater than the actual percentage of protein in the product, or as
an actual percentage provided that an analysis of the product on which
the actual percentage is based is supplied to the food manufacturer.
(e) The presence of whey protein concentrate in a finished food
product shall be listed as ''whey protein concentrate''.
(46 FR 44441, Sept. 4, 1981, as amended at 54 FR 24899, June 12,
1989)
/2/ Copies may be obtained from: Association of Official Analytical
Chemists, 2200 Wilson Blvd., Suite 400, Arlington VA 22201-3301, or
examined at the office of the Federal Register, 1100 L St. NW,
Washington, DC 20408.
/1/ Copies may be obtained from the National Academy of Sciences,
2101 Constitution Ave. NW, Washington, DC 20037, or examined at the
Office of the Federal Register, 1100 L St. NW, Washington, DC 20408.
21 CFR 184.1983 Bakers yeast extract.
(a) Bakers yeast extract is the food ingredient resulting from
concentration of the solubles of mechanically ruptured cells of a
selected strain of yeast, Saccharomyces cerevisiae. It may be
concentrated or dried.
(b) The ingredient meets the following specifications on a dry weight
basis: Less than 0.4 part per million (ppm) arsenic, 0.13 ppm cadmium,
0.2 ppm lead, 0.05 ppm mercury, 0.09 ppm selenium, and 10 ppm zinc.
(c) The viable microbial content of the finished ingredient as a
concentrate or dry material is:
(1) Less than 10,000 organisms/gram by aerobic plate count.
(2) Less than 10 yeasts and molds/gram.
(3) Negative for Salmonella, E. coli, coagulase positive
Staphylococci, Clostridium perfringens, Clostridium botulinum, or any
other recognized microbial pathogen or any harmful microbial toxin.
(d) The ingredient is used as a flavoring agent and adjuvant as
defined in 170.3(o)(12) of this chapter at a level not to exceed 5
percent in food.
(e) This regulation is issued prior to general evaluation of use of
this ingredient in order to affirm as GRAS the specific use named.
21 CFR 184.1984 Zein.
(a) Zein (CAS Reg. No. 9010-66-6) is one of the components of corn
gluten. It is produced commercially by extraction from corn gluten with
alkaline aqueous isopropyl alcohol containing sodium hydroxide. The
extract is then cooled, which causes the zein to precipitate.
(b) FDA is developing food-grade specifications for zein in
cooperation with the National Academy of Sciences. In the interim, the
igredient must be of a purity suitable for its intended use.
(c) In accordance with 184.1(b)(1), the ingredient is used in food
with no limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
a direct human food ingredient is based upon the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a surface-finishing agent as defined in
170.3(o)(30) of this chapter.
(2) The ingredient is used in food at levels not to exceed current
good manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(50 FR 8999, Mar. 6, 1985)
21 CFR 184.1984 PART 186 -- INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE
21 CFR 184.1984 Subpart A -- General Provisions
Sec.
186.1 Substances added indirectly to human food affirmed as generally
recognized as safe (GRAS).
21 CFR 184.1984 Subpart B -- Listing of Specific Substances Affirmed as
GRAS
186.1025 Caprylic acid.
186.1093 Sulfamic acid.
186.1256 Clay (kaolin).
186.1275 Dextrans.
186.1300 Ferric oxide.
186.1316 Formic acid.
186.1374 Iron oxides.
186.1551 Hydrogenated fish oil.
186.1557 Tall oil.
186.1673 Pulp.
186.1750 Sodium chlorite.
186.1756 Sodium formate.
186.1770 Sodium oleate.
186.1771 Sodium palmitate.
186.1797 Sodium sulfate.
186.1839 Sorbose.
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 14658, Mar. 15, 1977, unless otherwise noted.
21 CFR 184.1984 Subpart A -- General Provisions
21 CFR 186.1 Substances added indirectly to human food affirmed as
generally recognized as safe (GRAS).
(a) The indirect human food ingredients listed in this part have been
reviewed by the Food and Drug Administration and determined to be
generally recognized as safe (GRAS) for the purposes and under the
conditions prescribed, providing they comply with the purity
specifications listed in this part or, in the absence of purity
specifications, are of a purity suitable for their intended use in
accordance with 170.30(h)(1) of this chapter. Certain ingredients in
this part may also be used in food-contact surfaces in accordance with
parts 174, 175, 176, 177, 178 or 179.45 of this chapter. Ingredients
affirmed as GRAS for direct use in part 184 of this chapter are also
GRAS as indirect human food ingredients in accordance with 184.1(a) of
this chapter.
(b) The regulations in this part do not authorize direct addition of
any food ingredient to a food. They authorize only the use of these
ingredients as indirect ingredients of food, through migration from
their immediate wrapper, container, or other food-contact surface. Any
ingredient affirmed as GRAS in this part shall be used in accordance
with current good manufacturing practice. For the purpose of this part,
current good manufacturing practice includes the requirements that an
indirect human food ingredient be of a purity suitable for its intended
use, and that it be used at a level no higher than reasonably required
to achieve its intended technical effect in the food-contact article.
(1) If the ingredient is affirmed as GRAS with no limitations on its
conditions of use other than current good manufacturing practice, it
shall be regarded as GRAS if its conditions of use are consistent with
the requirements of paragraphs (b), (c), and (d) of this section. When
the Food and Drug Administration (FDA) determines that it is
appropriate, the agency will describe one or more current good
manufacturing practice conditions of use in the regulation that affirms
the GRAS status of the indirect ingredient. For example, when the
safety of an ingredient has been evaluated on the basis of limited
conditions of use, the agency will describe in the regulation that
affirms the GRAS status of the indirect ingredient, one or more of these
limited conditions of use, which may include the category of
food-contact surface(s), technical effect(s) or functional use(s) of the
indirect ingredient, and the level(s) of use. If the ingredient is used
under conditions that are significantly different from those described
in the regulation, such use of a substance may not be GRAS. In such a
case, a manufacturer may not rely on the regulation as authorizing that
use but shall independently establish that the use is GRAS or shall use
the ingredient in accordance with a food additive regulation. Persons
seeking FDA approval of an independent determination that a use of an
ingredient is GRAS may submit a GRAS petition in accordance with 170.35
of this chapter.
(2) If the ingredient is affirmed as GRAS with specific
limitation(s), it shall be used in food-contact surfaces only within
such limitation(s), including the category of food-contact surface(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.
(3) If the ingredient is affirmed as GRAS for a specific use, prior
to general evaluation of use of the ingredient, other uses may also be
GRAS.
(c) The listing of a food ingredient in this part does not authorize
the use of such substance for the purpose of adding the ingredient to
the food through extraction from the food-contact surface.
(d) The listing of a food ingredient in this part does not authorize
the use of such substance in a manner that may lead to deception to the
consumer or to any other violation of the Federal Food, Drug, and
Cosmetic Act (the Act).
(e) If the Commissioner of Food and Drugs is aware of any prior
sanction for use of an ingredient under conditions different from those
proposed to be affirmed as GRAS, 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 14658, Mar. 15, 1977, as amended at 48 FR 48457, 48459, Oct.
19, 1983)
21 CFR 186.1 Subpart B -- Listing of Specific Substances Affirmed as GRAS
21 CFR 186.1025 Caprylic acid.
(a) Caprylic acid (CH3(CH2)6COOH, CAS Reg. No. 124-07-2) is the
chemical name for octanoic acid. It is considered to be a short or
medium chain fatty acid. It occurs normally in various foods and is
commercially prepared by oxidation of n-octanol or by fermentation and
fractional distillation of the volatile fatty acids present in coconut
oil.
(b) The ingredient meets the specifications of the ''Food Chemicals
Codex,'' 3d Ed. (1981), p. 207, which is incorporated by reference.
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.
(c) The ingredient is used as an antimicrobial (preservative) in
cheese wraps as defined in 170.3(o)(2) at levels not to exceed good
manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(43 FR 19843, May 9, 1978, as amended at 49 FR 5613, Feb. 14, 1984)
21 CFR 186.1093 Sulfamic acid.
(a) Sulfamic acid (H3NO3S, CAS Reg. No. 5329-14-6) is a white
crystalline solid manufactured from urea, sulfur trioxide, and sulfuric
acid. It is soluble and highly ionized in water.
(b) In accordance with 186.1(b)(1), the ingredient is used as an
indirect food ingredient with no limitations other than current good
manufacturing practice. The affirmation of this ingredient as generally
recognized as safe (GRAS) as an indirect human food ingredient is based
upon the current good manufacturing practice of using this ingredient in
the manufacture of paper and paperboard that contact food.
(c) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(47 FR 29954, July 9, 1982)
21 CFR 186.1256 Clay (kaolin).
(a) Clay (kaolin) Al2O3.2SiO2.nH2O, Cas Reg. No. 1332-58-7) consists
of hydrated aluminum silicate. The commercial products of clay (kaolin)
contain varying quantities of alkalies and alkaline earths. Clay
(kaolin) is a white to yellowish or grayish fine powder. There are at
least three different minerals, kaolinite, dickite, and nacrite,
classified as kaolin. Kaolinite or china clay is whiter, less
contaminated with extraneous minerals, and less plastic in water.
(b) In accordance with 186.1(b)(1), the ingredient is used as an
indirect human food ingredient with no limitation other than current
good manufacturing practice. The affirmation of this ingredient as
generally recognized as safe (GRAS) as an indirect human food ingredient
is based upon the following current good manufacturing practice
conditions of use:
(1) The ingredient is used in the manufacture of paper and paperboard
that contact food.
(2) The ingredient is used at levels not to exceed current good
manufacturing practice.
(c) Prior sanctions for this ingredient different from the uses
established in this regulation do not exist or have been waived.
(47 FR 43367, Oct. 1, 1982)
21 CFR 186.1275 Dextrans.
(a) Dextrans (CAS Reg. No. 9004-54-0) are high molecular weight
polysaccharides produced by bacterial fermentation of sucrose.
Commercially available dextrans are synthesized from sucrose by
Leuconostoc mesenteroides strain NRRL B-512(F). Partial
depolymerization and purification of the fermented mixture shall produce
a product that is free of viable microorganisms.
(b) The ingredient is used or intended for use as a constituent of
food-contact surfaces.
(c) The ingredient is used at levels not to exceed good manufacturing
practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(43 FR 29288, July 7, 1978, as amended at 48 FR 48457, Oct. 19, 1983)
21 CFR 186.1300 Ferric oxide.
(a) Ferric oxide (iron (III) oxide, Fe2O3, CAS Reg. No. 1309-37-1)
occurs naturally as the mineral hematite. It may be prepared
synthetically by heating brown iron hydroxide oxide. The product is
red-brown to black trigonal crystals.
(b) In accordance with 186.1(b)(1), the ingredient is used as an
indirect human food ingredient with no limitation other than current
good manufacturing practice. The affirmation of this ingredient as
generally recognized as safe (GRAS) as an indirect human food ingredient
is based upon the following current good manufacturing practice
conditions of use:
(1) The ingredient is used as a constituent of paper and paperboard
used for food packaging.
(2) The ingredient is used at levels not to exceed current good
manufacturing practice.
(c) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(53 FR 16867, May 12, 1988; 53 FR 20939, June 7, 1988)
21 CFR 186.1316 Formic acid.
(a) Formic acid (CH2O2, CAS Reg. No. 64-18-6) is also referred to as
methanoic acid or hydrogen carboxylic acid. It occurs naturally in some
insects and is contained in the free acid state in a number of plants.
Formic acid is prepared by the reaction of sodium formate with sulfuric
acid and is isolated by distillation.
(b) Formic acid is used as a constituent of paper and paperboard used
for food packaging.
(c) The ingredient is used at levels not to exceed good manufacturing
practice in accordance with 186.1(b)(1).
(d) Prior sanctions for formic acid different from the uses
established in this section do not exist or have been waived.
(45 FR 22915, Apr. 4, 1980)
21 CFR 186.1374 Iron oxides.
(a) Iron oxides (oxides of iron, CAS Reg. No. 97705-33-85) are
undefined mixtures of iron (II) oxide (CAS Reg. No. 1345-25-1, black
cubic crystals) and iron (III) oxide (CAS Reg. No. 1309-37-1, red-brown
to black trigonal crystals).
(b) In accordance with 186.1(b)(1), the ingredient is used as an
indirect human food ingredient with no limitation other than current
good manufacturing practice. The affirmation of this ingredient as
generally recognized as safe (GRAS) as an indirect human food ingredient
is based upon the following current good manufacturing practice
conditions of use:
(1) The ingredient is used as a constituent of paper and paperboard
used for food packaging.
(2) The ingredient is used at levels not to exceed current good
manufacturing practice.
(c) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(53 FR 16867, May 12, 1988; 53 FR 20939, June 7, 1988)
21 CFR 186.1551 Hydrogenated fish oil.
(a) Hydrogenated fish oil (CAS Reg. No. 8016-14-6) is a class of oils
produced by partial hydrogenation of oils expressed from fish, primarily
menhaden, and secondarily herring or tuna. Hydrogenation of fish oils
uses catalysts composed of either elemental nickel, elemental copper, or
a mixture of these elements. The crude hydrogenated fish oil is further
processed by alkali refining, bleaching, and deodorization by steam
stripping.
(b) Hydrogenation of fish oils results in a final product with a
melting point greater than 32 C as determined by Section Cc 1-25,
Official and Tentative Methods of the American Oil Chemists' Society
method (reapproved 1973) or equivalent. The product has an approximate
fatty acid composition of 30 to 45 percent saturated fatty acids, 40 to
55 percent monoenoic fatty acids, 7 to 15 percent dienoic fatty acids, 3
to 10 percent trienoic fatty acids, and less than 2 percent tetraenoic
or higher polyenoic fatty acids. The approximate percentages of total
fatty acids by carbon chain length are 15 to 30 percent each of C16,
C18, C20, C22, less than 10 percent C14 or lower carbon chain length,
and less than 1 percent C24 or higher carbon chain length fatty acids.
(c) The ingredient is used as a constituent of cotton and cotton
fabrics used for dry food packaging.
(d) The ingredient is used at levels not to exceed good manufacturing
practice in accordance with 186.1(b)(1).
(e) Prior sanctions for this ingredient different from the use
established in this section do not exist or have been waived.
(44 FR 28323, May 15, 1979, as amended at 49 FR 5614, Feb. 14. 1984)
21 CFR 186.1557 Tall oil.
(a) Tall oil (CAS Reg. No. 8002-26-4) is essentially the sap of the
pine tree. It is obtained commercially from the waste liquors of
pinewood pulp mills and consists mainly of tall oil resin acids and tall
oil fatty acids.
(b) In accordance with 186.1(b)(1), the ingredient is used as an
indirect human food ingredient with no limitation other than current
good manufacturing practice. The affirmation of this ingredient as
generally recognized as safe (GRAS) as an indirect human food ingredient
is based on the following current good manufacturing practice conditions
of use:
(1) The ingredient is used as a constituent of cotton and cotton
fabrics used for dry food packaging.
(2) The ingredient is used at levels not to exceed current good
manufacturing practice.
(c) Prior sanctions for this ingredient different from the uses
established in this section, or from those listed in part 181 of this
chapter, do not exist or have been waived.
(51 FR 16830, May 7, 1986)
21 CFR 186.1673 Pulp.
(a) Pulp is the soft, spongy pith inside the stem of a plant such as
wood, straw, sugarcane, or other natural plant sources.
(b) The ingredient is used or intended for use as a constituent of
food packaging containers.
(c) The ingredient is used in paper and paperboard made by
conventional paper-making processes at levels not to exceed good
manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
21 CFR 186.1750 Sodium chlorite.
(a) Sodium chlorite (NaCLO2, CAS Reg. No. 7758-19-2) exists as
slightly hygroscopic white crystals or flakes. It is manufactured by
passing chlorine dioxide into a solution of sodium hydroxide and
hydrogen peroxide.
(b) the ingredient is used at levels from 125 to 250 parts per
million as a slimicide in the manufacture of paper and paperboard that
contact food.
(45 FR 16470, Mar. 14, 1980)
21 CFR 186.1756 Sodium formate.
(a) Sodium formate (CHNaO2, CAS Reg. No. 141-53-7) is the sodium salt
of formic acid. It is produced by the reaction of carbon monoxide with
sodium hydroxide.
(b) The ingredient is used as a constituent of paper and paperboard
used for food packaging.
(c) The ingredient is used at levels not to exceed good manufacturing
practice in accordance with 186.1(b)(1).
(d) Prior sanctions for sodium formate different from the uses
established in this section do not exist or have been waived.
(45 FR 22915, Apr. 4, 1980)
21 CFR 186.1770 Sodium oleate.
(a) Sodium oleate (C18H33O2Na, CAS Reg. No. 143-19-1) is the sodium
salt of oleic acid (cis-9-octadecenoic acid). It exists as a white to
yellowish powder with a slight tallow-like odor. Commercially, sodium
oleate is made by mixing and heating flaked sodium hydroxide and oleic
acid.
(b) In accordance with 186.1(b)(1), the ingredient is used as a
constituent of paper and paperboard for food packaging and as a
component of lubricants with incidental food contact in accordance with
178.3570 of this chapter, with no limitation other than current good
manufacturing practice.
(c) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(51 FR 39372, Oct. 28, 1986)
21 CFR 186.1771 Sodium palmitate.
(a) Sodium palmitate (C16H31O2Na, CAS Reg. No. 408-35-5) is the
sodium salt of palmitic acid (hexadecanoic acid). It exists as a white
to yellow powder. Commercially, sodium palmitate is made by mixing and
heating flaked sodium hydroxide and palmitic acid.
(b) In accordance with 186.1(b)(1), the ingredient is used as a
constituent of paper and paperboard for food packaging with no
limitation other than current good manufacturing practice.
(c) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(51 FR 39372, Oct. 28, 1986)
21 CFR 186.1797 Sodium sulfate.
(a) Sodium sulfate (Na2SO4, CAS Reg. No. 7757-82-6), also known as
Glauber's salt, occurs naturally and exists as colorless crystals or as
a fine, white crystalline powder. It is prepared by the neutralization
of sulfuric acid with sodium hydroxide.
(b) The ingredient is used as a constituent of paper and paperboard
used for food packaging, and cotton and cotton fabric used for dry food
packaging.
(c) The ingredient is used at levels not to exceed good manufacturing
practice in accordance with 186.1(b)(1).
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(45 FR 6086, Jan. 25, 1980)
21 CFR 186.1839 Sorbose.
(a) Sorbose (L-sorbose, sorbinose) (C6H12O6, CAS Reg. No. 87-79-6) is
an orthorhombic, bisphenoidal crystalline ketohexose. It was originally
identifed in the juice of mature berries from the mountain ash (Sorbus
aucuparia) where it occurs as the result of microbial oxidation of
sorbitol. It also occurs naturally in other plants. Sorbose can be
synthesized by the catalytic hydrogenation of glucose to D-sorbitol.
The resulting sorbitol can be oxidized by Acetobacter xylinum or by
Acetobacter suboxydans.
(b) The ingredient is used or intended for indirect food use as a
constituent of cotton, cotton fabrics, paper, and paperboard in contact
with dry food.
(c) The ingredient migrates to food at levels not to exceed good
manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
(43 FR 11698, Mar. 21, 1978, as amended at 48 FR 48457, Oct. 19,
1983)
21 CFR 186.1839 PART 189 -- SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD
21 CFR 186.1839 Subpart A -- General Provisions
Sec.
189.1 Substances prohibited from use in human food.
21 CFR 186.1839 Subpart B -- Substances Generally Prohibited From
Direct Addition or Use as Human Food
189.110 Calamus and its derivatives.
189.113 Cinnamyl anthranilate.
189.120 Cobaltous salts and its derivatives.
189.130 Coumarin.
189.135 Cyclamate and its derivatives.
189.140 Diethylpyrocarbonate (DEPC).
189.145 Dulcin.
189.155 Monochloroacetic acid.
189.165 Nordihydroguaiaretic acid (NDGA).
189.175 P-4000.
189.180 Safrole.
189.190 Thiourea.
189.191 Chlorofluorocarbon propellants.
21 CFR 186.1839 Subpart C -- Substances Prohibited From Indirect
Addition to Human Food Through Food-Contact Surfaces
189.220 Flectol H.
189.250 Mercaptoimidazoline and 2-mercaptoimidazoline.
189.280 4,4'-Methylenebis (2-chloroanaline).
189.300 Hydrogenated 4,4'-isopropylidene-diphenolphosphite ester
resins.
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 14659, Mar. 15, 1977, unless otherwise noted.
21 CFR 186.1839 Subpart A -- General Provisions
21 CFR 189.1 Substances prohibited from use in human food.
(a) The food ingredients listed in this section have been prohibited
from use in human food by the Food and Drug Administration because of a
determination that they present a potential risk to the public health or
have not been shown by adequate scientific data to be safe for use in
human food. Use of any of these substances in violation of this section
causes the food involved to be adulterated in violation of the act.
(b) This section includes only a partial list of substances
prohibited from use in human food, for easy reference purposes, and is
not a complete list of substances that may not lawfully be used in human
food. No substance may be used in human food unless it meets all
applicable requirements of the act.
(c) 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 establish, amend, or repeal a regulation under
this section on the basis of new scientific evaluation or information.
Any such petition shall include an adequate scientific basis to support
the petition, pursuant to part 10 of this chapter, and will be published
for comment if it contains reasonable grounds.
(42 FR 14659, Mar. 15, 1977, as amended at 54 FR 24899, June 12,
1989)
21 CFR 189.1 Subpart B -- Substances Generally Prohibited From Direct Addition or Use as Human Food
21 CFR 189.110 Calamus and its derivatives.
(a) Calamus is the dried rhizome of Acorus calamus L. It has been
used as a flavoring compound, especially as the oil or extract.
(b) Food containing any added calamus, oil of calamus, or extract of
calamus is deemed to be adulterated in violation of the act based upon
an order published in the Federal Register of May 9, 1968 (33 FR 6967).
(c) The analytical method used for detecting oil of calamus (
-asarone) is in the Journal of the Association of Official Analytical
Chemists, Volume 56, (Number 5), pages 1281 to 1283, September 1973,
which is incorporated by reference. Copies are available from the
Association of Official Analytical Chemists, 2200 Wilson Blvd., Suite
400, Arlington, VA 22201-3301, also from the Division of Food and Color
Additives, Center for Food Safety and Applied Nutrition (HFF-330), 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.
(42 FR 14659, Mar. 15, 1977, as amended at 47 FR 11855, Mar. 19,
1982; 54 FR 24899, June 12, 1989)
21 CFR 189.113 Cinnamyl anthranilate.
(a) The food additive cinnamyl anthranilate (C16H15NO2, CAS Reg. No.
87-29-6) is the ester of cinnamyl alcohol and anthranilic acid.
Cinnamyl anthranilate is a synthetic chemical that has not been
identified in natural products at levels detectable by available
methodology. It has been used as a flavoring agent in food.
(b) Food containing any added cinnamyl anthranilate is deemed to be
adulterated in violation of the act based upon an order published in the
Federal Register of October 23, 1985.
(50 FR 42932, Oct. 23, 1985)
21 CFR 189.120 Cobaltous salts and its derivatives.
(a) Cobaltous salts are the chemicals, CoC4H6O4, CoCl2, and
CoSO4.They have been used in fermented malt beverages as a foam
stabilizer and to prevent ''gushing.''
(b) Food containing any added cobaltous salts is deemed to be
adulterated in violation of the act based upon an order published in the
Federal Register of August 12, 1966 (31 FR 8788).
21 CFR 189.130 Coumarin.
(a) Coumarin is the chemical 1,2-benzopyrone, C9H6O2. It is found in
tonka beans and extract of tonka beans, among other natural sources, and
is also synthesized. It has been used as a flavoring compound.
(b) Food containing any added coumarin as such or as a constituent of
tonka beans or tonka extract is deemed to be adulterated under the act,
based upon an order published in the Federal Register of March 5, 1954
(19 FR 1239).
(c) The analytical methods used for detecting coumarin in food are in
sections 19.016-19.024 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.
(42 FR 14659, Mar. 15, 1977, as amended at 49 FR 10114, Mar. 19,
1984; 54 FR 24899, June 12, 1989)
21 CFR 189.135 Cyclamate and its derivatives.
(a) Calcium, sodium, magnesium and potassium salts of cyclohexane
sulfamic acid, (C6H12NO3S)2Ca, (C6H12NO3S)Na, (C6H12NO3S)2 Mg, and
(C6H12NO3S)K. Cyclamates are synthetic chemicals having a sweet taste
30 to 40 times that of sucrose, are not found in natural products at
levels detectable by the official methodology, and have been used as
artificial sweeteners.
(b) Food containing any added or detectable level of cyclamate is
deemed to be adulterated in violation of the act based upon an order
published in the Federal Register of October 21, 1969 (34 FR 17063).
(c) The analytical methods used for detecting cyclamate in food are
in sections 20.162-20.172 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.
(42 FR 14659, Mar. 15, 1977, as amended at 49 FR 10114, Mar. 19,
1984; 54 FR 24899, June 12, 1989)
21 CFR 189.140 Diethylpyrocarbonate (DEPC).
(a) Diethylpyrocarbonate is the chemical pyrocarbonic acid diethyl
ester, C6H10O5. It is a synthetic chemical not found in natural
products at levels detectable by available methodology and has been used
as a ferment inhibitor in alcoholic and nonalcoholic beverages.
(b) Food containing any added or detectable level of DEPC is deemed
to be adulterated in violation of the act based upon an order published
in the Federal Register of August 2, 1972 (37 FR 15426).
21 CFR 189.145 Dulcin.
(a) Dulcin is the chemical 4-ethoxyphenylurea, C9H12N2O2. It is a
synthetic chemical having a sweet taste about 250 times that of sucrose,
is not found in natural products at levels detectable by the official
methodology, and has been proposed for use as an artificial sweetener.
(b) Food containing any added or detectable level of dulcin is deemed
to be adulterated in violation of the act, based upon an order published
in the Federal Register of January 19, 1950 (15 FR 321).
(c) The analytical methods used for detecting dulcin in food are in
sections 20.173-20.176 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.
(42 FR 14659, Mar. 15, 1977, as amended at 49 FR 10114, Mar. 19,
1984; 54 FR 24899, June 12, 1989)
21 CFR 189.155 Monochloroacetic acid.
(a) Monochloroacetic acid is the chemical chloroacetic acid,
C2H3C1O2. It is a synthetic chemical not found in natural products, and
has been proposed as a preservative in alcoholic and nonalcoholic
beverages. Monochloroacetic acid is permitted in food package adhesives
with an accepted migration level up to 10 parts per billion (ppb) under
175.105 of this chapter. The official methods do not detect
monochloroacetic acid at the 10 ppb level.
(b) Food containing any added or detectable level of monochloroacetic
acid is deemed to be adulterated in violation of the act based upon
trade correspondence dated December 29, 1941 (TC-377).
(c) The analytical methods used for detecting monochloroacetic acid
in food are in sections 20.067-20.072 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.
(42 FR 14659, Mar. 15, 1977, as amended at 49 FR 10114, Mar. 19,
1984; 54 FR 24899, June 12, 1989)
21 CFR 189.165 Nordihydroguaiaretic acid (NDGA).
(a) Nordihydroguaiaretic acid is the chemical
4,4'-(2,3-dimethyltetramethylene) dipyrocatechol, C18H22O4. It occurs
naturally in the resinous exudates of certain plants. The commercial
product, which is synthesized, has been used as an antioxidant in foods.
(b) Food containing any added NDGA is deemed to be adulterated in
violation of the act based upon an order published in the Federal
Register of April 11, 1968 (33 FR 5619).
(c) The analytical method used for detecting NDGA in food is in
section 20.008(b) 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.
(42 FR 14659, Mar. 15, 1977, as amended at 49 FR 10114, Mar. 19,
1984; 54 FR 24900, June 12, 1989)
21 CFR 189.175 P-4000.
(a) P-4000 is the chemical 5-nitro-2-n-propoxyaniline, C9H12N2O3. It
is a synthetic chemical having a sweet taste about 4000 times that of
sucrose, is not found in natural products at levels detectable by the
official methodology, and has been proposed for use as an artificial
sweetener.
(b) Food containing any added or detectable level of P-4000 is deemed
to be adulterated in violation of the act based upon an order published
in the Federal Register of January 19, 1950 (15 FR 321).
(c) The analytical methods used for detecting P-4000 in food are in
sections 20.177-20.181 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.
(42 FR 14659, Mar. 15, 1977, as amended at 49 FR 10114, Mar. 19,
1984; 54 FR 24900, June 12, 1989)
21 CFR 189.180 Safrole.
(a) Safrole is the chemical 4-allyl-1,2-methylenedioxy-benzene,
C10H10O2. It is a natural constituent of the sassafras plant. Oil of
sassafras is about 80 percent safrole. Isosafrole and dihydrosafrole
are derivatives of safrole, and have been used as flavoring compounds.
(b) Food containing any added safrole, oil of sassafras, isosafrole,
or dihydrosafrole, as such, or food containing any safrole, oil of
sassafras, isosafrole, or dihydrosafrole, e.g., sassafras bark, which is
intended solely or primarily as a vehicle for imparting such substances
to another food, e.g., sassafras tea, is deemed to be adulterated in
violation of the act based upon an order published in the Federal
Register of December 3, 1960 (25 FR 12412).
(c) The analytical method used for detecting safrole, isosafrole and
dihydrosafrole is in the Journal of the Association of Official
Analytical Chemists, Volume 54 (Number 4), pages 900 to 902, July 1971,
which is incorporated by reference. Copies are available from the
Division of Food and Color Additives, Center for Food Safety and Applied
Nutrition (HFF-330), 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.
(42 FR 14659, Mar. 15, 1977, as amended at 42 FR 56729, Oct. 28,
1977; 47 FR 11855, Mar. 19, 1982; 54 FR 24900, June 12, 1989)
21 CFR 189.190 Thiourea.
(a) Thiourea is the chemical thiocarbamide, CH4N2S. It is a
synthetic chemical, is not found in natural products at levels
detectable by the official methodology, and has been proposed as an
antimycotic for use in dipping citrus.
(b) Food containing any added or detectable level of thiourea is
deemed to be adulterated under the act.
(c) The analytical methods used for detecting thiourea are in
sections 20.115-20.126 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.
(42 FR 14659, Mar. 15, 1977, as amended at 49 FR 10114, Mar. 19,
1984; 54 FR 24900, June 12, 1989)
21 CFR 189.191 Chlorofluorocarbon propellants.
The use of chlorofluorocarbons in human food as propellants in
self-pressurized containers is prohibited as provided by 2.125 of this
chapter.
(43 FR 11317, Mar. 17, 1978)
21 CFR 189.191 Subpart C -- Substances Prohibited From Indirect Addition to Human Food Through Food-Contact Surfaces
21 CFR 189.220 Flectol H.
(a) Flectol H is the chemical 1,2-dihydro-2,2,4-trimethylquinoline,
polymerized, C12H17N. It is a synthetic chemical not found in natural
products, and has been used as a component of food packaging adhesives.
(b) Food containing any added or detectable level of this substance
is deemed to be adulterated in violation of the act based upon an order
published in the Federal Register of April 7, 1967 (32 FR 5675).
21 CFR 189.250 Mercaptoimidazoline and 2-mercaptoimidazoline.
(a) Mercaptoimidazoline and 2-mercaptoimidazoline both have the
molecular formula C3H6N2S. They are synthetic chemicals not found in
natural products and have been used in the production of rubber articles
that may come into contact with food.
(b) Food containing any added or delectable levels of these
substances is deemed to be adulterated in violation of the act based
upon an order published in the Federal Register of November 30, 1973 (38
FR 33072).
21 CFR 189.280 4,4'-Methylenebis (2-chloroanaline).
(a) 4,4'-Methylenebis (2-chloroanaline) has the molecular formula,
C13H12Cl2N2. It is a synthetic chemical not found in natural products
and has been used as a polyurethane curing agent and as a component of
food packaging adhesives and polyurethane resins.
(b) Food containing any added or detectable level of this substance
is deemed to be adulterated in violation of the act based upon an order
published in the Federal Register of December 2, 1969 (34 FR 19073).
21 CFR 189.300 Hydrogenated 4,4'-isopropylidene-diphenolphosphite ester
resins.
(a) Hydrogenated 4,4'-isopropylidene-diphenolphosphite ester resins
are the condensation product of 1 mole of triphenyl phosphite and 1.5
moles of hydrogenated 4,4'-isopropylidene-diphenol such that the
finished resins have a molecular weight in the range of 2,400 to 3,000.
They are synthetic chemicals not found in natural products and have been
used as antioxidants and as stabilizers in vinyl chloride polymer resins
when such polymer resins are used in the manufacture of rigid vinyl
chloride polymer bottles.
(b) Food containing any added or detectable levels of these
substances is deemed to be adulterated and in violation of the Federal
Food, Drug, and Cosmetic Act, based upon an order published in the
Federal Register of September 9, 1987 (52 FR 33929).
(54 FR 7188, Feb. 17, 1989)
21 CFR 189.300 PART 197 -- SEAFOOD INSPECTION PROGRAM
21 CFR 189.300 Subparts A -- C (Reserved)
21 CFR 189.300 Subpart D -- Inspection of Canned Oysters
Sec.
197.310 Application for inspection service.
197.312 Granting or refusing inspection service; cancellation of
application.
197.315 Suspension and withdrawal of inspection service.
197.320 Inspection periods.
197.325 Assignment of inspectors.
197.329 Uninspected oysters excluded from inspected establishments.
197.330 General requirements for plant and equipment.
197.340 General operating conditions.
197.350 Code marking.
197.355 Processing.
197.360 Examination after canning.
197.370 Labeling.
197.380 Certificates of inspection; warehousing and export permits.
197.385 Inspection fees.
21 CFR 189.300 Subparts E -- H (Reserved)
21 CFR 189.300 Subpart I -- Inspection of Processed Shrimp
197.810 Application for inspection service.
197.812 Granting or refusing inspection service; cancellation of
application.
197.815 Suspension and withdrawal of inspection service.
197.820 Inspection periods.
197.825 Assignment of inspectors.
197.829 Uninspected shrimp excluded from inspected establishments.
197.830 General requirements for plant and equipment.
197.840 General operating conditions.
197.850 Code marking.
197.855 Processing.
197.860 Examination after processing.
197.870 Labeling.
197.880 Certificates of inspection; warehousing and export permits.
197.885 Inspection fees.
Authority: Secs. 701, 702a, 704 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 371, 372a, 374).
Source: 42 FR 14661, Mar. 15, 1977, unless otherwise noted.
21 CFR 189.300 Subparts A -- C (Reserved)
21 CFR 189.300 Subpart D -- Inspection of Canned Oysters
21 CFR 197.310 Application for inspection service.
(a) Applications for inspection service on canned oysters under the
provisions of section 702a of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 372a) shall be on forms supplied by the Food and Drug
Administration. No application for a regular inspection period filed
with the Food and Drug Administration after September 1 preceding such
period in any year shall be considered unless the applicant shows
substantial cause for failure to file such application on or before
September 1 of such year. The opening date of the canning season in
each State shall be the date set by the State agency responsible for
controlling the opening date of the canning season in that State. A
separate application shall be made for each inspection period in each
establishment for which the service is applied. Each application for a
regular inspection period shall be accompanied by a payment of $600.00
as prescribed by 197.385(a)(1). Such deposit shall be paid in the
manner prescribed by 197.385(e).
(b) For the purpose of 197.310 through 197.385, an establishment is
defined as a factory where oysters may be processed and warehouses under
the control and direction of the packer where such canned oysters are
stored.
21 CFR 197.312 Granting or refusing inspection service; cancellation
of application.
(a) The Secretary of Health and Human Services may grant the
inspection service applied for upon determining that the establishment
covered by such application complies with the requirements of 197.330.
(b) The Secretary may refuse to grant the inspection service at any
establishment for cause. In case of refusal the applicant shall be
notified of the reason therefor and shall have returned to him all
advance payments and production deposits made, less any expenses
incurred for preliminary inspection of the establishment, or for other
purposes incident to such application.
(c) The applicant, by written notice to the Secretary, may withdraw
his application for inspection service before an inspector is assigned
to the establishment. In case of such withdrawal, the Secretary shall
return to such applicant all advance payments and production deposits
made, less any salary and other expense incurred incident to such
application.
21 CFR 197.315 Suspension and withdrawal of inspection service.
(a) The Administration may suspend and the Secretary may withdraw
inspection service in any establishment upon failure of the packer to
comply with any applicable provision of 197.310 through 197.385 or
upon the dissemination by the packer or any person in privity with him
of any representation that is false or misleading in any particular
regarding the application to any seafood of the inspection service
provided by the regulations in this part.
(b) When inspection service is suspended in an establishment, as
authorized by paragraph (a) of this section, the Food and Drug
Administration shall not lengthen the inspection period in such
establishment to compensate for any of the time of suspension.
21 CFR 197.320 Inspection periods.
(a) The regular inspection period in each establishment in which
inspection service under 197.310 through 197.385 is granted consists
of 4 consecutive months. The date of the beginning of such regular
inspection period shall be regarded as the date, on or after October 1
but not later than March 1, specified for the beginning of the service
in the application therefor, or such other date as may be specified by
amendment to such application and approved; but if the Secretary is not
prepared to begin the service on the specified date then the period
shall start on the date on which service is begun.
(b) Extension inspection periods shall begin at the close of the
preceding inspection period. Extension inspection periods may be
granted for periods of 1 month and/or fractional parts of 1 month, but
in no case less than 1 day. Extension inspection periods for 1 month
may be granted in such establishment if application therefor,
accompanied by a payment of $600.00, as prescribed by 197.385(a)(3), is
made at least 2 weeks in advance of the close of such preceding
inspection period. Applications for extension inspection periods for
fractional parts of a month may be accepted when accompanied by the
payment prescribed by 197.385(a)(3) for such extensions. No regular or
extension inspection period shall extend beyond June 30 of any year.
(c) Upon request of the packer, and with the approval of the Food and
Drug Administration, such service during any inspection period may be
transferred from one establishment to another to be operated by the same
packer; but such transfer shall not serve to lengthen any inspection
period or to take the place of an extension inspection period. In case
of such transfer the packer shall furnish all necessary transportation
of inspectors.
(d) The inspection service shall be continuous throughout the
inspection period.
21 CFR 197.325 Assignment of inspectors.
(a) An initial assignment of at least one inspector shall be made to
each establishment in which inspection service under 197.310 through
197.385 is granted. Thereafter, the Food and Drug Administration shall
adjust the number of inspectors assigned to each establishment and tour
of duty of each inspector to the requirements for continuous and
efficient inspection.
(b) Any inspector of the Food and Drug Administration shall have free
access at all times to all parts of the establishment and to all fishing
and freight boats and other conveyances dredging oysters for or
transporting oysters to such establishments.
21 CFR 197.329 Uninspected oysters excluded from inspected
establishments.
(a) No establishment to which inspection service on canned oysters
has been granted shall at any time thereafter can oysters that have not
been so inspected, or handle or store in such establishment any canned
oysters that have not been so inspected; but this paragraph shall not
apply to an establishment after termination of inspection service
therein, or withdrawal therefrom as authorized by 197.315.
(b) All oysters delivered to or held in an inspected establishment
may be subject to inspection, but certificates of inspection shall be
issued under 197.380 only on canned oysters.
21 CFR 197.330 General requirements for plant and equipment.
(a) All exterior openings of the cannery, including those of the
shucking sheds, shall be adequately screened, and roofs and exterior
walls shall be tight. When necessary, fly traps, fans, blowers, or
other approved insect-control devices shall be installed.
(b) Shucking sheds and packing rooms shall be separate, and fixtures
and equipment shall be so constructed and arranged as to permit thorough
cleaning. Such sheds and rooms shall be adequately lighted and
ventilated, and the floors shall be tight and arranged for thorough
cleaning and proper drainage. Open drains from shucking shed shall not
enter packing room. If shucking shed and packing room are in separate
buildings, such buildings shall be not more than 100 yards apart, unless
adequate provisions are made to enable efficient inspection.
(c) All surfaces of washers, tanks, belts, tables, flumes, utensils,
and other equipment with which unshucked or shucked oysters come in
contact after delivery to the establishment shall be of metal or of
other smooth nonporous and easily cleanable material, provided such
materials are not lead or other toxic substances. Metal seams shall be
smoothly soldered or smoothly welded. Shucking tables shall be so
constructed as to preclude contamination of working surfaces or products
thereon from foot traffic or wheelbarrows or other containers used in
delivering steamed oysters to such tables.
(d) Adequate supplies of suitable detergents and sanitizing agents
approved by the Food and Drug Administration; clean, unpolluted running
water; and steam shall be provided for washing, cleaning, and otherwise
maintaining the establishment in a sanitary condition.
(e) Adequate toilet facilities of sanitary type which comply fully
with applicable State laws and local ordinances shall be provided.
(f) An adequate number of sanitary washbasins, with liquid or
powdered soap, shall be provided in both the shucking shed and the
packing room. Paper towels shall be provided in the packing room.
(g) Signs requiring employees handling oysters to wash their hands
after each absence from post of duty shall be conspicuously posted in
the shucking shed and packing room and elsewhere about the premises as
conditions require.
(h) One or more suitable washing devices and one or more suitable
inspection belts shall be installed for the washing and subsequent
inspection of the oysters before delivery for steaming or other means of
opening.
(i) If steam boxes are used for opening the oysters, they shall be
provided with adequate steam inlets, exhausts, drains, a safety valve,
and a pressure gauge.
(j) Suitable means shall be provided for removing shells and debris
from shucking shed.
(k) One or more suitable devices shall be provided for removing shell
and grit from shucked oysters, for washing such oysters, and for their
subsequent drainage.
(l) One or more suitable inspection belts shall be installed for the
inspection of shucked oysters.
(m) Equipment shall be provided for code-marking cans.
(n) An automatic container-counting device shall be installed in each
cannery line.
(o) Each sterilizing retort shall be fitted with at least the
following equipment:
(1) An automatic control for regulating temperatures.
(2) An indicating mercury thermometer of a range from 170 F to 270
F, with scale divisions not greater than 2 F, installed either within a
fitting attached to the shell of the retort or within the door or shell
of the retort. If the thermometer is installed within a fitting, such
fitting shall communicate with the chamber of the retort through an
opening at least 1 inch in diameter. Such fitting shall be equipped
with a bleeder at least one-eighth inch in diameter. If the thermometer
is installed within the door or shell of the retort, the bulb shall
project at least two-thirds of its length into the principal chamber.
(3) A recording thermometer of a range from 170 F to 270 F, with
scale divisions not greater than 2 F. The bulb of such thermometer
shall be installed as prescribed for the indicating mercury thermometer.
The case which houses the charts and recording mechanism shall be
provided with an approved lock, all keys to which shall be in the sole
custody of the inspector.
(4) A pressure gauge of a range from 0 to 30 pounds, with scale
divisions not greater than 1 pound and diameter of not less than 5
inches. Such gauge shall be connected to the chamber of the retort by a
short gooseneck tube. The gauge shall be not more than 4 inches higher
than the gooseneck.
(5) A blow-off vent of at least 3/4-inch inside diameter in the top
of the retort.
(6) A 1/8-inch bleeder in top of the retort.
(p) Suitable space and facilities shall be provided for the inspector
to prepare records and examine samples and for the safekeeping of
records and equipment.
21 CFR 197.340 General operating conditions.
(a) The decks and holds of all boats tonging or dredging oysters for
or transporting oysters to an inspected establishment, and the bodies of
other conveyances so transporting oysters shall be kept in a sanitary
condition. Such boats shall be equipped with adequate means for
protecting the oysters against contamination with bilge water.
(b) Inspected establishments, freight boats, and other conveyances
serving such establishments shall accept only live, clean, sound oysters
taken from unpolluted areas. When necessary, ice or other suitable
refrigeration shall be provided to prevent spoilage.
(c) After delivery of each load of oysters to the establishment,
decks and holds of each boat and the body of each other conveyance or
container making such delivery shall be washed down with clean,
unpolluted water, and all debris shall be cleaned therefrom before such
boat or other conveyance or container leaves the establishment premises.
(d) Before being steamed or opened by other means, the oysters shall
be washed with clean, unpolluted water and then passed over the
inspection belt and culled to remove dirty, muddy, dead, or decomposed
oysters and extraneous material. Muddy oysters may be returned to the
washer for rewashing.
(e) As often as is necessary to maintain sanitary conditions,
unloading platforms and equipment shall be washed with clean, unpolluted
water, and all debris shall be cleaned therefrom.
(f) Shells shall be removed from the shucking shed continuously.
(g) Offal, debris, or refuse from any source whatever shall not be
allowed to accumulate in the cannery or, except for shells, about the
premises. Shells shall not be allowed to accumulate about the premises
in such a manner as to create a nuisance.
(h) The delivery of steamed oysters to shuckers by means of manually
rolling, trundling, or wheelbarrowing such oysters on or above shucking
tables will not be permitted.
(i) Shucking knives and shucking cups shall be thoroughly washed with
soap and water and chlorinated before use each day. Chlorine solution
shall be maintained at a strength of 200 parts per million.
(j) No shucked oysters shall be returned to shucker after delivery to
the weigher. Shucking cups shall be cleaned and sanitized after each
delivery to the weigher.
(k) Shucked oysters being transported from one building to another
shall be properly covered and protected against contamination.
(l) The shucked oysters shall be washed, separated from the shell and
grit by suitable devices, and then immediately drained. The time of
washing shall not exceed the minimum time necessary for cleansing.
(m) From the time of delivery to the cannery up to the time of final
processing, oysters shall be handled expeditiously and under such
conditions as to prevent contamination or spoilage.
(n) The packer shall destroy for food purposes under the immediate
supervision of the inspector all oysters in his possession condemned by
the inspector as filthy, decomposed, putrid, or unfit for food. Oysters
condemned on the boat or on the unloading platform shall not be taken
into the cannery, but shall be either destroyed or returned to a bedding
ground.
(o) All portions of the establishment shall be adequately lighted to
enable the inspector to perform his duties properly.
(p) All floors and other parts of the establishment, including
unloading platforms, and all fixtures, equipment, and utensils shall be
cleaned as often as may be necessary to maintain them in a sanitary
condition.
(q) The packer shall require all employees handling oysters to wash
their hands after each absence from post of duty and to observe other
proper habits of cleanliness.
(r) The packer shall not knowingly employ in or about the
establishment any person afflicted with an infectious or contagious
disease or with any open sores on exposed portions of the body.
21 CFR 197.350 Code marking.
(a) Code marks shall be affixed to all cans and other immediate
containers before they are placed in the processing retorts. Such marks
shall show at least:
(1) The date of packing;
(2) The establishment where packed;
(3) The conveyance; and
(4) The size of the oysters when such oysters are graded for size.
(b) Keys to all code marks shall be given to the inspector.
(c) Each lot shall be stored separately pending final inspection,
with a space of not less than 6 inches between stacks of each lot. For
the purposes of the regulations in this part all cans or other
containers bearing the same code marks shall be regarded as comprising a
lot.
21 CFR 197.355 Processing.
(a) The closure of the can or other immediate container and the time
and temperature of sterilizing the canned oysters shall be adequate to
prevent bacterial spoilage.
(b) The following times and temperatures shall be the minimum
employed for the containers indicated:
For the purposes of this section, initial temperature is defined as
the average temperature of the contents of the container at the moment
steam is admitted to the sterilizing retort.
(c) The blow-off vent shall be open during the coming-up period until
the mercury thermometer registers at least 215 F. Bleeders shall emit
steam during the entire cooking period.
(d) The inspector shall identify each record on the thermometer chart
with the code mark of the lot to which such record relates and the date
of such record. The Food and Drug Administration shall keep such charts
for at least 5 years, and upon request shall make them available to the
packer.
(e) The packer shall keep for at least 2 years all shipping records
covering shipments from each lot, and upon request shall furnish such
records to any inspector of the Food and Drug Administration.
21 CFR 197.360 Examination after canning.
(a) Adequate samples shall be drawn by the inspector from each lot of
canned oysters and shall be examined to determine whether or not such
canned oysters conform to all requirements of the Federal Food, Drug,
and Cosmetic Act, amendments thereto, and regulations thereunder.
(b) The packer shall destroy for food purposes, under the immediate
supervision of the inspector, all canned oysters condemned by the
inspector as not complying with 197.355, or as filthy, decomposed,
putrid, or otherwise unfit for food.
21 CFR 197.370 Labeling.
(a) Labels on canned oysters packed and certified under 197.310
through 197.385 may bear the mark ''Production Supervised by the U.S.
Food and Drug Administration.'' Such mark, if used, shall be plainly and
conspicuously displayed, in type of uniform size and style, on a
strongly contrasting, uniform background.
(b) Two proofs, or one proof and one photostat thereof, or eight
specimens of all labeling intended for use on inspected canned oysters
or on or within the cases therefor shall be submitted to the Food and
Drug Administration for approval. If the proofs or photostat and proof
are submitted, eight specimens of the labeling shall be sent to the Food
and Drug Administration after printing. The Food and Drug
Administration is hereby authorized to approve labeling for use on
canned oysters inspected under 197.310 through 197.385. Approval shall
be subject to the condition that such labeling shall be so used as to
comply with the provisions of the Federal Food, Drug and Cosmetic Act,
amendments, thereto, and regulations thereunder. The Food and Drug
Administration is also authorized to revoke any such approval for cause.
The Food and Drug Administration shall not approve labeling for canned
oysters intended for export under the provisions of 197.380(e).
(c) No commercial brand or brand name appearing on labeling approved
as authorized under paragraph (b) of this section and bearing the mark
described in paragraph (a) of this section, and no labeling simulating
any such approved labeling, shall be used after such approval on canned
oysters other than those that have been handled, prepared, and packed in
compliance with all provisions of 197.310 through 197.385; but this
section shall not apply to any packer's labeling not bearing such mark
after termination of inspection or withdrawal thereof as authorized by
197.315 or to any distributor's labeling not bearing such mark after
written notice by the owner thereof to the Food and Drug Administration
that the use of such labeling on inspected canned oysters has been
discontinued and will not be resumed.
(d) Canned-oyster labeling authorized by paragraph (a) of this
section or approved under paragraph (b) of this section shall be used
only as authorized by 197.310 through 197.385. Unauthorized use of
such labeling renders the user liable to the penalties prescribed by the
Food, Drug, and Cosmetic Act, as amended.
21 CFR 197.380 Certificates of inspection; warehousing and export
permits.
(a) After finding that the canned oysters comprising any parcel have
been handled, prepared, and packed in compliance with all provisions of
197.310 through 197.385; bear labeling approved as authorized under
197.370(b); and comply with all the provisions of the Federal Food,
Drug, and Cosmetic Act, amendments thereto, and regulations thereunder,
the inspector shall issue a certificate showing that such canned oysters
so comply. The certificate shall specify the code marks to which it
applies, the quantity of the parcel so marked, the place where such
parcel is stored, the size and kind of containers, the commercial brand
name on the labels, the condition of the oysters if they are broken or
if they are substandard in fill, and the destination of the lot if
known. Such certificate shall become void if such labeling is removed,
altered, obliterated, or replaced; but such canned oysters may be
relabeled under supervision of an inspector and recertified if the
inspector finds that, after being relabeled, they comply with the
requirements laid down by this paragraph for the issuance of a
certificate.
(b) Unless covered by certificate, canned oysters shall be moved from
an inspected establishment only for storage authorized under paragraph
(c) of this section, or for export authorized under paragraph (e) of
this section, or for destruction as provided by 197.360(b).
(c) Applications to move unlabeled canned oysters for storage in a
warehouse elsewhere than in the establishment where such oysters were
packed shall be on forms supplied by the Administration. The
application shall give the name and location of the warehouse in which
such canned oysters are to be stored, and shall be accompanied by an
agreement signed by the operator of such warehouse that inspectors shall
have free access at all times to all canned oysters so stored, and that
conditions which will preserve the identity of each parcel of such
canned oysters shall be continuously maintained pending issuance of a
certificate thereon or removal as authorized by paragraph (d) of this
section. If such application is approved and it appears to the
inspector that the canned oysters comprising any parcel have been packed
in compliance with 197.310 through 197.385 and conform, except for the
absence of labeling, to all requirements of the Federal Food, Drug, and
Cosmetic Act, amendments thereto, and regulations thereunder, the
inspector shall issue to the applicant, on his request, a warehousing
permit covering such canned oysters. Such permit shall specify the code
marks to which it applies, the quantity of the parcel so marked, the
place from and to which such parcel is to be moved, the size of the
oysters, the size and kind of containers, and the condition of the
oysters if they are broken or if they are substandard in fill and, if
such be the case, that they are intended for export under paragraph (e)
of this section. When any provision of the agreement is violated, the
Food and Drug Administration may revoke any permit issued pursuant to
such agreement, and may also revoke its approval of the application for
warehousing which accompanied such agreement.
(d) Unless covered by certificate, canned oysters stored under the
authority of paragraph (c) of this section shall be moved from the
warehouse where stored only for re-storage under such authority, or for
return upon written permission of the inspector to the establishment
where packed, or for export authorized under paragraph (e) of this
section, or for destruction as provided by 197.360(b).
(e) An application to export canned oysters under the provisions of
section 801(d) of the act shall be accompanied by the original or a
verified copy of the specifications of the foreign purchaser; if
required by the Food and Drug Administration, evidence showing that such
canned oysters are not in conflict with the laws of the country to which
they are intended for export; and, if shipment of labeled canned
oysters is specified or directed, eight specimens of the labeling
therefor. If canned oysters prepared or packed according to such
specifications are not in conflict with the laws of such country, the
Administration shall direct the inspector to issue to the applicant an
export permit covering such canned oysters comprising any parcel ordered
by such purchaser under such specifications, when the inspector finds
that such canned oysters were packed in compliance with the requirements
of 197.310 through 197.385 regarding sanitary conditions and
processing; are not filthy, decomposed, putrid, or otherwise unfit for
food; accord to such specifications, and are labeled on the outside of
the shipping package to show that they are intended for export. Such
permit shall specify the code marks to which it applies and the quantity
of the parcel so marked, and shall show that such canned oysters were
packed under sanitary conditions, are wholesome, and accord to such
specifications. The applicant shall furnish to the inspector
documentary evidence showing the exportation of all such canned oysters.
21 CFR 197.385 Inspection fees.
(a)(1) Except as otherwise provided by the regulations in this part,
an initial payment of $600.00 shall accompany each application;
thereafter, three additional advance payments of $600.00 each shall be
made, as follows: One payment on or before the date of the beginning of
the regular inspection period specified in the application for
inspection; the remaining two payments on or before the first day of
each succeeding month, except that the Food and Drug Administration may
require the full amount of all advance payments prescribed by this
paragraph to accompany the application of an applicant who has defaulted
in any payment due for any prior packing season: Provided, That a
packer who is concurrently receiving inspection service and making
payments under the regulations for the inspection of processed shrimp
shall not make any additional payments under this subparagraph.
(2) Whenever it is determined, without hearing, by the Food and Drug
Administration that an establishment having the inspection service has
been damaged by wind, fire, flood, or other calamity to such an extent
that packing operations cannot be resumed before the end of the fiscal
year then current, no advance payments falling due after such calamity
shall be required from the packer for that fiscal year; but whenever it
is determined, without hearing, by the Food and Drug Administration that
an establishment having the inspection service has been so damaged by
any such calamity that operations must be suspended temporarily, but can
be resumed before the end of the fiscal year then current, advance
payments falling due after such calamity and before the month of
resumption of operations shall be postponed until operations are
resumed, and thereupon shall be paid in equal monthly installments
during the period between the time of resumption of operations and June
1 of the fiscal year then current: Provided, That in the event of a
determination described in this subparagraph the total payments and
production deposits made by the packer involved shall be charged with
the cost of the service made available for the establishment, without
regard to the method provided hereinafter for computing charges against
payments and production deposits, and the balance of the total payments
and deposits remaining after such charges shall be refunded by the Food
and Drug Administration to the packer after the completion of the fiscal
year.
(3) Each application for an extension inspection period of 1 month
shall be accompanied by a payment of $600.00, and at subsequent monthly
intervals thereafter additional payments of $600.00 shall be made; but
if the final payment is to cover a period of less than 30 days, then
such payment shall be at the rate of $20.00 for each day of such period.
(b)(1) In addition to the payments prescribed in paragraph (a) of
this section, advance deposits based upon the quantity of oysters canned
by the subscribing establishment shall be made to underwrite adequately
the cost of the inspection service. Such deposits shall be paid in
advance in amounts of not less than $300.00, unless the Food and Drug
Administration on an estimate of production authorizes other amounts,
and shall be computed at the rate of 15 cents for each case of 48 cans,
size 211 x 300. Any advance production deposits in excess of those
required for actual oysters canned for the fiscal year (July 1 through
June 30) will be refunded to the packers by the Food and Drug
Administration after the completion of the fiscal year.
(2) Production deposits as computed under paragraph (b)(1) of this
section, together with deposits for shrimp received as prescribed under
197.885(b)(1), in the case of processed shrimp, shall be charged with
the balance of the total cost of the inspection service which has not
been provided for by the combined total payments under paragraph (a) of
this section and paragraph (a) of 197.885, in the case of processed
shrimp. The balance of the production deposits remaining after such
charges have been made shall be refunded by the Administration to the
packers after the completion of the fiscal year in the ratio which each
packer's production deposits for oysters canned and deposits for shrimp
received bears to the combined total of such deposits for oysters canned
and shrimp received by all packers for the fiscal year.
(3) When inspection service is withdrawn from an establishment as
authorized under 197.315(a), the Food and Drug Administration shall not
return to the packer any advance payments and/or deposits required to
the date of withdrawal of the service. Such payments and/or deposits
shall be charged with the cost of the service made available for the
establishment, without regard to the method described in this section,
and the balance that would have accrued to such packer shall remain to
the credit of the Food and Drug Administration in the special account
''Salaries and Expenses, Certification and Inspection Services.''
(c) A separate fee shall be paid to cover all expenses incurred in
accordance with the regulations of the United States Government, for
salary, travel, subsistence, and for other purposes incident to
inspection for the purpose of issuing a certificate or warehousing or
export permit on canned oysters stored or held at any place other than
an establishment to which a seafood inspector is then assigned.
(d) When the cannery and the cannery warehouse of an establishment
are located at different points of such distance apart that
transportation between them is required for the inspector to perform his
duties in the establishment, the packer shall furnish such
transportation or shall pay a separate fee to cover all expenses
therefor.
(e) All payments required by the regulations in this part shall be by
bank draft or certified check, collectible at par drawn to the order of
the Food and Drug Administration, and payable at Washington, DC. All
such drafts and checks except those for the payment required by
197.310(a), shall be delivered to the inspector and promptly scheduled
to the Food and Drug Administration, Department of Health and Human
Services, Washington, DC, whereupon after appropriate records thereof
have been made they shall be transmitted to the Chief Disbursing
Officer, Division of Disbursement, Treasury Department, for deposit to
the special account ''Certification and Inspection Services, Food and
Drug Administration.''
(f) All refunds to packers shall be by check drawn on the Treasury of
the United States pursuant to refund vouchers duly certified and
approved by the designated administrative officers.
21 CFR 197.385 Subparts E -- H (Reserved)
21 CFR 197.385 Subpart I -- Inspection of Processed Shrimp
21 CFR 197.810 Application for inspection service.
(a) Applications for inspection service on the processing of shrimp
under the provisions of section 702a of the Federal Food, Drug, and
Cosmetic Act shall be on forms supplied by the Food and Drug
Administration. The processing of shrimp comprises all the operations
including labeling and storage, necessary to prepare for the market
shrimp in any of the following forms: Iced or frozen raw headless, raw
peeled or cooked peeled (any of which may be deveined); iced or frozen
deveined shrimp, partially or completely peeled (which may be battered
and breaded before freezing), and canned shrimp. No application for a
regular inspection period filed with the Food and Drug Administration
after May 1, preceding such period in any year, shall be considered
unless the applicant shows substantial cause for failure to file such
application on or before May 1 of such year. A separate application
shall be made for each inspection period in each establishment for which
the service is applied. Each application for a regular inspection
period shall be accompanied by an advance payment of $500.00 as
prescribed by 197.885(a)(1). Such payment shall be made in the manner
prescribed by 197.885(e).
(b) For the purposes of 197.810 through 197.885, an establishment
is defined as a factory where shrimp may be processed and warehouses and
cold storage plants under the control and direction of the packer where
such shrimp is stored.
21 CFR 197.812 Granting or refusing inspection service; cancellation
of application.
(a) The Secretary of Health and Human Services may grant the
inspection service applied for upon determining that the establishment
covered by such application complies with the requirements of 197.830.
(b) The Secretary may refuse to grant inspection service at any
establishment for cause. In case of refusal, the applicant shall be
notified of the reason therefor and shall have returned all advance
payments and deposits made, less any expenses incurred for preliminary
inspection of the establishment or for other purposes incident to such
application.
(c) The applicant, by written notice to the Secretary, may withdraw
his application for inspection service before July 1 preceding the
inspection period covered by the application. In case of such
withdrawal, the Secretary shall return to such applicant all advance
payments and deposits made, less any salary and other expense incurred
incident to such application.
21 CFR 197.815 Suspension and withdrawal of inspection service.
(a) The Food and Drug Administration may suspend and the Secretary
may withdraw inspection service in any establishment:
(1) Upon failure of the packer to comply with any applicable
provision of 197.810 through 197.885; or
(2) Upon the dissemination by the packer or any person in privity
with him of any representation that is false or misleading in any
particular regarding the application to any seafood of the inspection
service provided by the regulations in this part.
(b) When inspection service is suspended in an establishment, as
authorized by paragraph (a) of this section, the Food and Drug
Administration shall not lengthen the inspection period in such
establishment to compensate for any of the time of suspension.
21 CFR 197.820 Inspection periods.
(a) The regular inspection period in each establishment in which
inspection service under 197.810 through 197.885 is granted consists
of 9 consecutive months. The date of the beginning of such regular
inspection period shall be regarded as the date, on or after July 1, but
not later than October 1, specified for the beginning of the service in
the application therefor, or such other date as may be specified by
amendment to such application and approved; but if the Secretary is not
prepared to begin the service on the specified date, then the period
shall start on the date on which service is begun.
(b) Extension inspection periods shall begin at the close of the
preceding inspection period. Extension inspection periods may be
granted for periods of 1 month and/or fractional parts of 1 month, but
in no case less than 1 day. Extension inspection periods for 1 month
may be granted in such establishment if application therefor,
accompanied by a payment of $600.00 as prescribed by 197.885(a)(3), is
made at least 2 weeks in advance of the close of such preceding
inspection period. Applications for extension inspection periods for
fractional parts of a month may be accepted when accompanied by the
payment prescribed by 197.885(a)(3) for such extensions. No regular or
extension inspection period shall extend beyond June 30 of any year.
(c) Upon request of the packer, and with the approval of the Food and
Drug Administration, such service during any inspection period may be
transferred from one establishment to another to be operated by the same
packer; but such transfer shall not serve to lengthen any inspection
period or to take the place of an extension inspection period. In case
of such transfer the packer shall furnish all necessary transportation
of inspectors.
(d) The inspection service shall be continuous throughout the
inspection period.
21 CFR 197.825 Assignment of inspectors.
(a) An initial assignment of at least one inspector shall be made to
each establishment in which inspection service under 197.810 through
197.885 is granted. Thereafter, the Food and Drug Administration shall
adjust the number of inspectors assigned to each establishment and tour
of duty of each inspector to the requirements for continuous and
efficient inspection.
(b) Any inspector of the Food and Drug Administration shall have free
access at all times to all parts of the establishment, to plants
supplying materials to the inspected establishment, and to all fishing
and freight boats and other conveyances catching shrimp for, or
transporting shrimp to, such establishment.
21 CFR 197.829 Uninspected shrimp excluded from inspected
establishments.
(a) No establishment to which inspection service has been granted
shall at any time thereafter process shrimp which has not been so
inspected or handle or store in such establishment any processed shrimp
which has not been so inspected; but this paragraph shall not apply to
an establishment after termination of inspection service therein or
withdrawal therefrom as authorized by 197.815.
(b) All shrimp and other ingredients entering into the finished
product may be subject to inspection prior to delivery to the
establishment or at any time thereafter, and all shrimp processed in
such establishment shall be subject to certification under 197.880.
21 CFR 197.830 General requirements for plant and equipment.
(a) All exterior openings of the establishment shall be adequately
screened and roofs and exterior walls shall be tight. When necessary
fly traps, fans, blowers, or other approved insect-control devices shall
be installed.
(b) Except for raw headless shrimp which may or may not be deveined,
picking and packing rooms shall be separate, provided that this
requirement may be waived by the Food and Drug Administration where
separation of picking and packing rooms is not necessary for adequate
sanitation. Blanching tanks shall not be located in picking room.
Fixtures and equipment shall be so constructed and arranged as to permit
thorough cleaning. Such rooms shall be adequately lighted and
ventilated, and the floors shall be tight and arranged for thorough
cleaning and proper drainage. Open drains from picking room shall not
enter packing or blanching room. If picking and packing rooms are in
separate buildings, such buildings shall be not more than 100 yards
apart unless adequate provisions are made to enable efficient
inspection.
(c) All surfaces of tanks, belts, tables, flumes, utensils, and other
equipment with which either picked or unpicked shrimp come in contact
after delivery to the establishment shall be of metal or of other smooth
nonporous and easily cleanable materials, provided such materials are
not lead or other toxic substances. Metal seams shall be smoothly
soldered or smoothly welded.
(d) Adequate supplies of suitable detergents and sanitizing agents
approved by the Food and Drug Administration; clean, unpolluted running
water; and, if necessary, steam shall be provided for washing,
cleaning, and otherwise maintaining the establishment in a sanitary
condition.
(e) Adequate toilet facilities of sanitary type which comply fully
with applicable State laws and local ordinances shall be provided.
(f) An adequate number of sanitary washbasins, with liquid or
powdered soap, shall be provided in both the picking and packing rooms.
Paper towels shall be provided in the packing room. Provision shall be
made for sanitizing the hands of employees by the use of suitable
sanitizing agents.
(g) Signs requiring employees handling shrimp to wash and sanitize
their hands after each absence from post of duty shall be conspicuously
posted in the picking and packing rooms and elsewhere about the premises
as conditions require.
(h) One or more suitable washing devices and one or more suitable
inspection belts shall be installed for the washing and subsequent
inspection of the shrimp before processing.
(i) Suitable containers, flumes, chutes, or conveyors shall be
provided for removing offal from picking room.
(j) Picking or heading tables shall be equipped with flumes supplied
with clean, unpolluted water or with mechanical conveyors for removing
the picked or headed shrimp.
(k) Equipment shall be provided for code-marking cans and other
immediate containers and master cartons used in packaging other than
canned shrimp.
(l) An automatic container-counting device shall be installed in each
cannery line.
(m) Each sterilizing retort shall be fitted with at least the
following equipment:
(1) An automatic control for regulating temperatures.
(2) An indicating mercury thermometer of a range from 170 F to 270
F with scale divisions not greater than 2 F. For steam cook such
thermometers shall be installed either within a fitting attached to the
shell of the retort or within the door or shell of the retort. For
water cook such thermometers shall be installed in the door or shell of
the retort below the water level. If the thermometer is installed
within a fitting such fitting shall communicate with the chamber of the
retort through an opening at least 1 inch in diameter. Such fitting
shall be equipped with a bleeder at least one-eighth of an inch in
diameter. If the thermometer is installed within the door or shell of
the retort, the bulb shall project at least two-thirds of its length
into the principal chamber.
(3) A recording thermometer of a range from 170 F to 270 F with
scale divisions not greater than 2 F. The bulb of such thermometer
shall be installed as prescribed for the indicating mercury thermometer.
The case which houses the charts and recording mechanism shall be
provided with an approved lock, all keys to which shall be in the sole
custody of the inspector.
(4) A pressure gauge of a range from 0 to 30 pounds, with scale
divisions not greater than 1 pound and diameter of not less than 5
inches. Such gauge shall be connected to the chamber of the retort by a
short gooseneck tube. The gauge shall be not more than 4 inches higher
than the gooseneck.
(5) For steam cook, a blow-off vent of at least 3/4-inch inside
diameter in the top of the retort.
(6) For steam cook, a 1/8-inch bleeder in top of retort.
(n) Each cold storage compartment shall be fitted with at least the
following equipment:
(1) An automatic control for regulating temperature.
(2) An indicating thermometer so installed as to indicate accurately
the temperature within the storage compartment.
(3) A recording thermometer so installed as to indicate accurately
the temperature within the compartment at all times. The case which
houses the charts and recording mechanism shall be provided with an
approved lock, all keys to which shall be in the sole custody of the
inspector.
(o) Provision shall be made for water-glazing where such glazing is
necessary to maintain the quality of frozen shrimp. Glazing shall be
done with clean, unpolluted water.
(p) Provision shall be made for immediate icing or cold storage of
all packaged shrimp which is destined for sale as unfrozen shrimp.
(q) Suitable space and facilities shall be provided for the inspector
to prepare records and examine samples, and for the safekeeping of
records and equipment.
21 CFR 197.840 General operating conditions.
(a) Plants supplying raw headless or frozen raw headless shrimp to an
inspected establishment, decks and holds of all boats catching shrimp
for or transporting shrimp to an inspected establishment, and the bodies
of other conveyances so transporting shrimp shall be kept in a sanitary
condition.
(b) Inspected establishments, plants supplying inspected
establishments, freight boats, and other conveyances serving such
establishments shall accept only fresh, clean, sound shrimp. The shrimp
shall be iced or refrigerated immediately after they are caught, and
shall be kept adequately iced or refrigerated until delivery to the
establishment.
(c) After delivery of each load of shrimp to the establishment, decks
and holds of each boat and the body of each other conveyance or
container making such delivery shall be washed down with clean,
unpolluted water, and all debris shall be cleaned therefrom before such
boat or other conveyance or container leaves the establishment premises.
(d) Before being headed, picked, or deveined, the shrimp shall be
adequately washed with clean, unpolluted water and then passed over the
inspection belt and culled to remove all shrimp that are filthy,
decomposed, putrid, or otherwise unfit for food, and all extraneous
material.
(e) Offal from picking tables shall not be piled on the floor, but
shall be placed in suitable containers for frequent removal, or shall be
removed by flumes, conveyors, or chutes. Offal, debris, or refuse from
any source whatever shall not be allowed to accumulate in or about the
establishment.
(f) Shrimp shall be picked into flumes that immediately remove the
picked meats from the picking tables; except that shrimp may be picked
into seamless containers of not more than 3 pints capacity if the picked
meats are not held in such containers for more than 20 minutes before
being flumed or conveyed from the picking tables. If shrimp are picked
into such containers, the containers shall be cleaned and sanitized as
often as may be necessary to maintain them in a sanitary condition, but
in no case less frequently than every 2 hours. Whenever a picker is
absent from his or her post of duty, the container used by such picker
shall be cleaned and sanitized before picking is resumed. For the
purposes of this paragraph, the term ''picked'' shall include the
operation whereby a portion of the shell is removed, leaving the tail in
place, and the back of the shrimp is sliced open to remove the
alimentary canal or vein.
(g) Picked shrimp being transported from one building to another
shall be properly covered and protected against contamination.
(h) From the time of delivery to the establishment up to the time of
final processing, shrimp shall be handled expeditiously and under such
conditions as to prevent contamination or spoilage. Shrimp other than
that to be canned shall be precooled immediately after the final
cleaning or blanching operation to a temperature not exceeding 50 F if
it is to be packaged immediately, or to a temperature not exceeding 40
F if it is not to be packaged immediately. If such shrimp are to be
frozen, they shall be placed in the freezing compartment within 1 hour
after final preparation.
(i) If batter is employed, it shall be used within 1 hour after it is
prepared. The temperature of the batter shall not exceed 50 F.
(j) The packer shall destroy for food purposes under the immediate
supervision of the inspector all shrimp in his possession condemned by
the inspector as filthy, decomposed, putrid, or otherwise unfit for
food. Shrimp condemned on boat or unloading platform shall not be taken
into the icebox or picking room.
(k) Raw materials other than shrimp that enter into the finished
product shall not be used if condemned by the inspector as unfit for
food. Such condemned raw materials shall be segregated from usable
materials and be held for disposal as directed by the inspector, or they
may be destroyed forthwith by the packer if he so desires.
(l) All portions of the establishment shall be adequately lighted to
enable the inspector to perform his duties properly.
(m) All floors and other parts of the establishment, including
unloading platforms, and all fixtures, equipment, and utensils shall be
cleaned as often as may be necessary to maintain them in a sanitary
condition. Containers for mixing or holding batter shall be adequately
cleaned and sanitized before they are used for a new batch of batter.
Equipment for applying batter shall be adequately cleaned and sanitized
at least once each hour while in operation.
(n) The packer shall require all employees handling shrimp to wash
and sanitize their hands after each absence from post of duty, and to
observe other proper habits of cleanliness.
(o) The packer shall not knowingly employ in or about the
establishment any person afflicted with an infectious or contagious
disease, or with any open sores on exposed portions of the body.
21 CFR 197.850 Code marking.
(a) Permanently legible code marks shall be placed on all immediate
containers at the time of packaging. Such marks shall show at least:
(1) The date of packing;
(2) The establishment where packed; and
(3) The size of the shrimp when such shrimp are graded for size and
are not in containers through which they are clearly visible.
Corresponding code marks shall also be placed on the master cartons
containing individual packages of shrimp other than canned.
(b) Keys to all code marks shall be given to the inspector.
(c) Each lot shall be stored separately pending final inspection,
with a space of not less than 6 inches between stacks of each lot. For
the purposes of the regulations in this part, all cans or other
containers bearing the same code marks shall be regarded as comprising a
lot.
21 CFR 197.855 Processing.
(a) The closure of the can or other immediate container and the time
and temperature of sterilizing the canned shrimp shall be adequate to
prevent bacterial spoilage.
(b) The following times and temperatures shall be the minimums
employed for the containers indicated:
For wet-pack shrimp in cans 307 x 400 and smaller, a cook of 12
minutes at 250 F, and for wet-pack shrimp in cans 502 x 510, a cook of
15 minutes at 250 F, may be approved if adequate provisions are made to
insure an initial temperature of not less than 120 F in each individual
can. For the purposes of this section, initial temperature is defined
as the average temperature of the contents of the container at the
moment steam is admitted to the sterilizing retort.
(c) For steam cook, blow-off vent shall be open during the coming-up
period until the mercury thermometer registers at least 215 F.
Bleeders shall emit steam during the entire cooking period.
(d) The method of freezing is not specified by the regulations in
this part. Whatever method is used must be such as will produce a
hard-frozen product in a sufficiently short time to prevent
decomposition. Bulk packages containing 5 pounds or more of shrimp per
package shall be hard frozen within 24 hours; smaller packages should
be hard frozen within 12 hours. After freezing, the shrimp shall be
stored in such a manner that its temperature does not exceed 0 F, and
shall be handled in such manner as will maintain the hard-frozen
condition.
(e) The storage temperatures for shrimp that are not frozen or canned
are as follows:
(1) Cooked and peeled shrimp shall be stored at a room temperature
not exceeding 35 F.
(2) Raw headless shrimp shall be stored at a room temperature not
exceeding 35 F, except that it may be stored at a higher room
temperature if sufficiently iced at all times to prevent spoilage.
(f) The inspector shall identify each record on the thermometer chart
with the code mark of the lot to which such record relates and the date
of such record. The Food and Drug Administration shall keep such charts
for at least 5 years, and upon request shall make them available to the
packer.
(g) The packer shall keep for at least 2 years all shipping records
covering shipments from each lot, and upon request shall furnish such
records to any inspector of the Food and Drug Administration.
21 CFR 197.860 Examination after processing.
(a) Adequate samples shall be drawn by the inspector from each lot of
processed shrimp and shall be examined to determine whether or not such
processed shrimp conforms to all requirements of the Federal Food, Drug,
and Cosmetic Act, amendments thereto, and regulations thereunder.
(b) The packer shall destroy for food purposes, under the immediate
supervision of the inspector, all processed shrimp condemned by the
inspector as not complying with 197.855(a), or as filthy, decomposed,
putrid, or otherwise unfit for food.
21 CFR 197.870 Labeling.
(a) Labels on shrimp packed and certified under 197.810 through
197.885 may bear a mark attesting to such packing and certification.
Depending upon the type of processing, such marks, if used, shall read
as follows:
(1) For canned shrimp: ''Production supervised by U.S. Food and Drug
Administration.''
(2) For frozen shrimp: ''Packing and freezing supervised by U.S.
Food and Drug Administration. Perishable product -- Not warranted
against mishandling after freezing.''
(3) For fresh, iced, or refrigerated shrimp: ''Packing supervised by
U.S. Food and Drug Administration. Perishable product -- Not warranted
against mishandling after packing.'' Such marks if used shall be plainly
and conspicuously displayed in type of uniform size and style on a
strongly contrasting uniform background. The marks referred to in
paragraph (a) (2) and (3) of this section shall not be used on the
master carton unless such marks will be defaced by the opening of the
cartons.
(b) Labels on inspected processed shrimp, other than canned shrimp,
not bearing the marks referred to in paragraph (a) (2) and (3) of this
section, and all master cartons for inspected shrimp other than canned
shrimp, shall bear the statement ''Perishable -- Keep frozen'' or
''Perishable -- Keep refrigerated,'' whichever is applicable to the
product.
(c) Two proofs, or one proof and one photostat thereof, or eight
specimens of all labeling intended for use on inspected shrimp, or on or
within the cases therefor, shall be submitted to the Food and Drug
Administration for approval. If proofs or photostat and proof are
submitted, eight specimens of the labeling shall be sent to the Food and
Drug Administration after printing. The Food and Drug Administration is
authorized to approve labeling for use on or with processed shrimp
inspected under 197.810 through 197.885; approval shall be subject to
the condition that such labeling shall be so used as to comply with the
provisions of the Federal Food, Drug, and Cosmetic Act, amendments
thereto and regulations thereunder. The Food and Drug Administration is
also authorized to revoke any such approval for cause. The Food and
Drug Administration shall not approve labeling for processed shrimp
intended for export under the provisions of 197.880(e).
(d) No commercial brand or brand name appearing on labeling approved
as authorized under paragraph (c) of this section and bearing the marks
described in paragraph (a) of this section, and no labeling simulating
any such approved labeling, shall be used, after such approval, on
processed shrimp other than that which has been handled, prepared,
packed, and stored in compliance with all provisions of 197.810
through 197.885; but this section shall not apply to any packer's
labeling not bearing such mark after termination of inspection or
withdrawal thereof as authorized by 197.815 or to any distributor's
labeling not bearing such mark after written notice by the owner thereof
to the Food and Drug Administration that the use of such labeling on
inspected processed shrimp has been discontinued and will not be
resumed.
(e) Shrimp labeling authorized by paragraph (a) of this section or
approved under paragraph (c) of this section shall be used only as
authorized by 197.810 through 197.885. Unauthorized use of such
labeling renders the user liable to the penalties prescribed by the
Federal Food, Drug, and Cosmetic Act, as amended.
21 CFR 197.880 Certificates of inspection; warehousing and export
permits.
(a) After finding that the processed shrimp comprising any parcel has
been handled, prepared, and packed in compliance with all provisions of
197.810 through 197.885, bears labeling approved as authorized under
197.870(c), and complies with all the provisions of the Federal Food,
Drug, and Cosmetic Act, amendments thereto, and regulations thereunder,
the inspector shall issue a certificate showing that such processed
shrimp so complies. The certificate shall specify the code marks to
which it applies, the quantity of the parcel so marked, the place where
such parcel is stored, the size of the shrimp, the size and kind of
containers, the type of pack, the commercial brand name on the labels,
the quality grade of the shrimp if it is fancy, the condition of the
shrimp if it is broken or if it is substandard in fill and the
destination of the lot if known. Such certificate shall become void if
such labeling is removed, altered, obliterated, or replaced, or if
mishandling, improper storage, or other circumstances so change the
product that it no longer complies with the requirements for the
issuance of a certificate; but such processed shrimp may be relabeled
under the supervision of an inspector and recertified if the inspector
finds that, after being relabeled, it complies with the requirements
laid down by this paragraph for the issuance of a certificate.
(b) Unless covered by certificate, processed shrimp shall be moved
from an inspected establishment only for storage authorized under
paragraph (c) of this section, or for export authorized under paragraph
(e) of this section, or for destruction as provided by 197.860(b).
(c) Applications to move unlabeled processed shrimp for storage in a
warehouse or cold storage plant elsewhere than in the establishment
where such shrimp was processed shall be on forms supplied by the Food
and Drug Administration. The application shall give the name and
location of the warehouse or cold storage plant in which such processed
shrimp is to be stored, and shall be accompanied by an agreement signed
by the operator of such warehouse or cold storage plant that inspectors
shall have free access at all times to all processed shrimp so stored
and that conditions which will preserve the identity of each parcel of
such processed shrimp shall be continuously maintained pending issuance
of a certificate thereon or removal as authorized by paragraph (d) of
this section. If such application is approved and it appears to the
inspector that the processed shrimp comprising any parcel has been
packed in compliance with 197.810 through 197.885 and conforms, except
for the absence of labeling, to all requirements of the Federal Food,
Drug, and Cosmetic Act, amendments thereto, and regulations thereunder,
the inspector shall issue to the applicant, on his request, a
warehousing permit covering such processed shrimp. Such permit shall
specify the code marks to which it applies, the quantity of the parcel
so marked, the places from and to which such parcel is to be moved, the
size of the shrimp, the size and kind of containers, the type of pack,
whether or not it is fancy grade, the condition of the shrimp if it is
broken or if it is substandard in fill, and, if such be the case, that
it is intended for export under paragraph (e) of this section. When any
provision of the agreement is violated, the Food and Drug Administration
may revoke any permit issued pursuant to such agreement, and may also
revoke its approval of the application for warehousing or cold storage
which accompanied such agreement.
(d) Unless covered by certificate, processed shrimp stored under the
authority of paragraph (c) of this section shall be moved from the
warehouse or cold storage plant where stored only for re-storage under
such authority, or for return upon written permission of the inspector
to the establishment where processed, or for export authorized under
paragraph (e) of this section, or for destruction as provided by
197.860(b).
(e) An application to export processed shrimp under the provisions of
section 801(d) of the act shall be accompanied by the original or a
verified copy of the specifications of the foreign purchaser; if
required by the Food and Drug Administration, evidence showing that such
processed shrimp is not in conflict with the laws of the country to
which it is intended for export; and, if shipment of labeled processed
shrimp is specified or directed, eight specimens of the labeling
therefor. If processed shrimp prepared or packed according to such
specifications is not in conflict with the laws of such country, the
Food and Drug Administration shall direct the inspector to issue to the
applicant an export permit covering such processed shrimp comprising any
parcel ordered by such purchaser under such specifications when the
inspector finds that such processed shrimp was packed in compliance with
the requirements of 197.810 through 197.885 regarding sanitary
conditions and processing; is not filthy, decomposed, putrid, or
otherwise unfit for food, accords to such specifications; and is
labeled on the outside of the shipping package to show that it is
intended for export. Such permit shall specify the code marks to which
it applies and the quantity of the parcel so marked, and shall show that
such processed shrimp was packed under sanitary conditions, is
wholesome, and accords to such specifications. The applicant shall
furnish to the inspector documentary evidence showing the exportation of
all such processed shrimp.
21 CFR 197.885 Inspection fees.
(a)(1) Except as otherwise provided by the regulations in this part,
an initial payment of $500.00 shall accompany each application;
thereafter, eight additional advance payments of $500.00 shall be made
on or before the first day of each month beginning July 1 and continuing
through February 1 for the regular inspection period; except that the
Food and Drug Administration may require the full amount of advance
payments prescribed by this paragraph to accompany the application of an
applicant who has defaulted in any payment due for any prior packing
season.
(2) Whenever it is determined, without hearing, by the Food and Drug
Administration that an establishment having the inspection service has
been damaged by wind, fire, flood, or other calamity, to such an extent
that packing operations cannot be resumed before the end of the fiscal
year then current, no advance payments falling due after such calamity
shall be required from the packer for that fiscal year; but whenever it
is determined, without hearing, by the Food and Drug Administration that
an establishment having the inspection service has been so damaged by
any such calamity that operations must be suspended temporarily, but can
be resumed before the end of the fiscal year then current, advance
payments falling due after such calamity and before the month of
resumption of operations shall be postponed until operations are
resumed, and thereupon shall be paid in equal monthly installments
during the period between the time of resumption of operations and June
1 of the fiscal year then current: Provided, That in the event of a
determination described in paragraph (a)(2) of this section the total
payments and deposits made by the packer involved shall be charged with
the cost of the service made available for the establishment without
regard to the method provided hereinafter for computing charges against
payments and deposits for shrimp received, and the balance of the total
payments and deposits for shrimp received remaining after such charges
shall be refunded by the Administration to the packer after the
completion of the fiscal year.
(3) Each application for an extension inspection period of 1 month
shall be accompanied by a payment of $600.00, and at subsequent monthly
intervals thereafter additional payments of $600.00 shall be made; but
if the final payment is to cover a period of less than 30 days, then
such payment shall be at the rate of $20.00 for each day of such period.
(b) (1) In addition to the payments prescribed in paragraph (a) of
this section, advance deposits based upon the quantity of shrimp
received by the subscribing establishment shall be made to underwrite
adequately the cost of the inspection service. Such deposits shall be
paid in advance in amounts of not less than $300.00, unless the Food and
Drug Administration on an estimate of receipt of shrimp authorizes other
amounts, and shall be computed at the rate of 20 cents per 100 pounds of
whole raw shrimp, or 35 cents per 100 pounds of raw headless shrimp,
received by the plant. For the purposes of this section, the quantity
of shrimp received by an establishment shall be determined by weighing
on a suitable scale immediately after such shrimp leaves the initial
inspection belt: Provided, however, That other arrangements for
determining accurately the weight of shrimp received may be employed if
approved in advance by the Food and Drug Administration. A record of
such weights shall be maintained and made available to the inspector
upon his request. Any advance deposits in excess of those required for
actual shrimp received for the fiscal year (July 1 through June 30)
shall be refunded to the packer by the Food and Drug Administration
after the completion of the fiscal year.
(2) Deposits for shrimp received as computed under paragraph (b)(1)
of this section, together with production deposits prescribed for
oysters canned under 197.385(b)(1), shall be charged with the balance
of the total cost of the inspection service that has not been provided
for by the combined total payments under paragraph (a) of this section
and 197.385(a), in the case of canned oysters. The balance of the
deposits remaining for shrimp received after such charges have been made
shall be refunded by the Food and Drug Administration to the packers
after the completion of the fiscal year, in the ratio which each
packer's deposits for shrimp received and production deposits for
oysters canned bears to the combined total of such deposits for shrimp
received and oysters canned by all packers for the fiscal year.
(3) When inspection service is withdrawn from an establishment as
authorized under 197.815(a), the Food and Drug Administration shall not
return to the packer any advance payments and/or deposits required to
the date of withdrawal of the service. Such payments and/or deposits
shall be charged with the cost of the service made available for the
establishment, without regard to the method described in this section,
and the balance which would have accrued to such packer shall remain to
the credit of the Food and Drug Administration in the special account
''Salaries and Expenses, Certification and Inspection Services.''
(c) A separate fee shall be paid to cover all expenses, incurred in
accordance with the regulations of the United States Government for
salary, travel, subsistence, and other purposes incident to inspection
described under 197.825(b) of suppliers of any materials to
establishments under the inspection service or for the purpose of
issuing a certificate or warehousing or export permit on processed
shrimp stored or held at any place other than an establishment to which
a seafood inspector is then assigned.
(d) When the processing plant and the warehouse or cold storage plant
of an establishment are located at different points of such distance
apart that transportation between them is required for the inspector to
perform his duties in the establishment, the packer shall furnish such
transportation or shall pay a separate fee to cover all expenses
therefor.
(e) All payments required by the regulations in this part shall be by
bank draft or certified check collectible at par drawn to the order of
the Food and Drug Administration, and payable at Washington, DC. All
such drafts and checks, except those for the payment required by
197.810(a), shall be delivered to the inspector and promptly scheduled
to the Food and Drug Administration, Department of Health and Human
Services, Washington, DC, whereupon after appropriate records thereof
have been made, they shall be transmitted to the Chief Disbursing
Officer, Division of Disbursement, Treasury Department, for deposit to
the special account, ''Certification and Inspection Services, Food and
Drug Administration.''
(f) All refunds to the packers shall be by check drawn on the
Treasury of the United States pursuant to refund vouchers duly certified
and approved by the designated administrative officers.
21 CFR 197.885 PARTS 198-199 -- (RESERVED)
21 CFR 197.885 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
Redesignation Table
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 197.885 21 CFR CHAPTER I (PARTS 170 TO 199)
FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR
American Oil Chemist's Society
P.O. Box 5037, Station A, Champaign, IL 61820
AOCS Method Trla-64T Titer Test 178.3780(b)(2)
AOCS Method Tlla-64T Saponification Value 178.3780(b)(3)
AOCS Method Te 3a-64 Acid Value and Free Amine Value of Fatty
Quaternary Ammonium Chlorides, Second Printing including additions and
revisions, 1990 173.400(b)
American Society for Testing and Materials
1916 Race St. Philadelphia, PA 19103
ASTM D 5-73 (Reapproved 1978) Standard Method of Test for Penetration
of Bituminous Materials 176.170(a)(5)
ASTM D 36-76 Standard Test Method for Softening Point of Asphalts and
Tar Pitches (Ring and Ball Apparatus) 176.170(a)(5)
ASTM D 86-82 Standard Method of Test for Distillation of Petroleum
Products 172.250(b)(3); 172.864(b)(2); 172.882(a); 178.3530(a);
178.3620(d)(1)(i); 178.3910(a)(4)(i)(a)
ASTM D 88-81 Standard Method of Test for Saybolt Viscosity
178.3870(f)(4); 178.3910
ASTM D 127-60 Standard Method of Test for Melting Point of Petrolatum
and Microcrystalline Wax 176.180(b)(2); 177.1200(c)
ASTM D 156-82 Standard Method of Test for Saybolt Color of Petroluem
Products (Saybolt Chromometer Method) 178.3620(b)(1)(i);
178.3910(a)(4)(i)(c)
ASTM D 381-80 Standard Method of Test for Existent Gum in Fuels by
Jet Evaporation 172.882(a); 172.250; 178.3530(a);
178.3910(a)(4)(i)(b) and (b)(2)
ASTM D 388-38 Standard Specifications for Classification of Coals by
Rank 173.25(a)(2)
ASTM D 445-74 Standard Test Method for Kinematic Viscosity of
Transparent and Opaque Liquids (and the Calculations of Dynamic
Viscosity) 177.1430(c)(2); 177.1520(d)(5); 178.3740(b)
ASTM D 445-82 Test Method for Kinematic Viscosity of Transparent
Opaque Liquids (and the Calculations of Dynamic Viscosity) 178.3740(b)
ASTM D 465-82 Standard Test Methods of Test for Acid Number of Rosin
178.3870(f)(3)
ASTM D 509-70 (Reapproved 1981) Standard Methods of Sampling and
Grading Rosin 178.3870(f)(1)
ASTM D 566-76 (Reapproved 1982) Standard Method for Dropping Point of
Lubricating Grease 172.210; 178.3690(b)(1); 178.3770(a)(1), (b)(1),
and (d)(1)
ASTM D 611-82 Standard Test Methods for Aniline Point and Mixed
Aniline Point of Petroleum Products and Hydrocarbon Solvents 176.170
ASTM D 721-56T Tentative Method of Test for Oil Content of Petroleum
Waxes 172.615(a); 175.250(b)(2)
ASTM D 729-81 Standard Specifications for Vinylidene Chloride Molding
Compounds 179.45
ASTM D 938-71 (Reapproved 1980) Standard Method of Test for
Congealing Point of Petroleum Waxes, including Petrolatum 172.615(a);
175.250(b)(1)
ASTM D 968-81 Standard Test Methods for Abrasion Resistance of
Organic Coatings by the Falling Abrasive Tester 177.1590; 177.1650
ASTM D 1218-82 Standard Test Method for Refractive Index and
Refractive Dispersion of Hydrocarbon Liquids 178.2010
ASTM D 1238-82 Standard Method of Measuring Flow Rates of
Thermoplastics by Extrusion Plastometer 176.170(b)(2); 177.1520(d)(7);
177.1550(d)(2); 177.1570(b)(1)(iii)
ASTM D 1240-82 Standard Method of Test for Rosin Acids in Fatty Acids
172.862(b)(2)
ASTM D 1243-79 Standard Methods of Test for Dilute Solution Viscosity
of Vinyl Chloride Polymers 175.270(b); 175.300(b)(3)(xxix);
176.170(a)(5); 177.1480(b)(1)(ii); 177.1950(c)(1)(ii);
177.1960(b)(1)(ii); 177.2460(c)(1); 177.1970(c)(1)(ii);
177.1980(c)(1)(ii); 179.45(c)(2)(iv)
ASTM D 1303-55 (Reapproved 1979) Standard Method of Test for Total
Chlorine in Vinyl Chloride Polymers and Copolymers 177.1610(a)
ASTM D 1353-78 Standard Test Method for Nonvolatile Matter in
Volatile Solvents for Use in Paint, Varnish, Lacquer, and Related
Products 172.882; 178.3530; 178.3910
ASTM D 1386-78 Standard Test Method for Saponification Number
(Empirical) of Synthetic and Natural Waxes 178.3690(b)(2);
178.3770(a)(2), (b)(2), and (d)(2)
ASTM D 1387-78 Standard Test Method for Acid Number (Empirical) of
Synthetic and Natural Waxes 178.3690(b)(3); 178.3770(a)(3), (b)(3), and
(d)(3)
ASTM D 1418-81 Standard Practice for Rubber and Rubber Latices --
Nomenclature 177.2600(c)(4)(i)
ASTM D 1434-82 Standard Method for Determining Gas Permeability
Characteristics of Plastic Film and Sheeting 177.1040
ASTM D 1457-56T Test for Thermal Instability Index of
Tetrafluoroethylene Homopolymer 177.1550(d)(3)
ASTM D 1492-78 Standard Test Method for Bromine Index of Aromatic
Hydrocarbons by Coulometric Titration 177.1430(c)(3); 178.3740
ASTM D 1500-82 Standard Method of Test for ASTM Color of Petroleum
Products (ASTM Color Scale) 178.3620(c)(1)(ii)
ASTM D 1505-68 (Reapproved 1979) Standard Test Method for Density of
Plastics by the Density-Gradient Technique 177.1320(c)(1)(iii);
177.1570; 177.1520(d)(1); 177.1630; 177.2480(c)(3)
ASTM D 1545-76 (Reapproved 1981) Standard Method of Test for
Viscosity of Transparent Liquids by Bubble Time Method 176.170(a)(5)
ASTM D 1601-78 Standard Test Method for Dilute Solution Viscosity of
Ethylene Polymers 177.1520(d)(9); 177.1570(b)(1)(ii)
ASTM D 1646-81 Standard Test Method for Rubber-Viscosity and
Volcanization Characteristics (Mooney Viscometer) 177.1210(b)(5);
177.1520(d)(6)
ASTM D 1747-62 (Reapproved 1978) Standard Test Method for Refractive
Index of Viscous Materials and Organosols at Low Shear Rates by
Brookfield Viscometer 178.3870(f)(2)
ASTM D 1824-66 (Reapproved 1980) Standard Test Method for Apparent
Viscosity of Plastisols and Organosols at Low Shear Rates by Brookfield
Viscometer 178.3870(f)(4)
ASTM D 1962-67 (Reapproved 1979) Saponification Value of Drying Oils,
Fatty Acids, and Polymerized Fatty Acids 178.2010(b)
ASTM D 2117-62T Tentative Method of Test for Melting Point of
Semicrystalline Polymers by the Hot Stage Microscopy Method
177.1520(d)(2)(i); 177.1630(d)(4)(v)
ASTM D 2133-66 Specifications for Acetal Resin Injection Molding and
Extrusion Materials 177.2480(c)(4)
ASTM D 2236-70 Standard Method of Test for Dynamic Mechanical
Properties of Plastics by Means of a Torsional Pendulum
177.1810(c)(1)(i)
ASTM D 2161-66 Standard Method of Conversion of Kinematic Viscosity
to Saybolt Universal Viscosity or to Saybolt Furol Viscosity 178.3740(b)
ASTM D 2503-82 Standard Method of Test for Molecular Weight of
Hydrocarbons by Thermoelectric Measurement of Vapor Pressure
175.300(b)(3)(xxxiii); 176.170(b)(2); 177.1430(c)(1)
ASTM D 2857-70 (Reapproved 1977) Standard Method of Test for Dilute
Solution Viscosity of Polymers 177.1560; 177.2210(b); 177.2440(a)
ASTM D 3275-89 Standard Specification for E-CTFE-Flouroplastic
Molding, Extrusion, and Coating Materials 177.1380(a)(4)
ASTM D 3418-82 Standard Test Method for Transition Temperatures of
Polymers by Thermal Analysis 177.1520(d)(8)
ASTM D 3536-76 Standard Test Method for Molecular Weight Averages and
Molecular Weight Distribution of Polystyrene by Liquid Exclusion
Chromatography (Gel Permeation Chromatography -- GPC) 177.1990;
177.2000
ASTM D 3835-79 (Reapproved 1983) Standard Test Method for Rheological
Properties of Thermoplastics with a Capillary Rheometer 177.1520(b)
ASTM E 28-67 (Reapproved 1982) Standard Test Method for Softening
Point by Ring-and-Ball Apparatus 172.215; 172.280; 176.170;
177.1520(d)(2)(ii); 178.3870(b)(5)
ASTM E 131-61T Definition of Terms and Symbols Relating to Absorption
Spectroscopy (Revised 1961) 175.250(b)(3)
ASTM E 169-63 (Reapproved 1981) Recommended Practices for General
Techniques of Ultraviolet Quantitative Analysis 178.3620(d)(3)
ASTM E 324-79 Standard Test Method for Relative Initial and Final
Melting Range of Organic Chemicals 178.2010
ASTM F 34-76 (Reapproved 1980) Standard Test Methods for Liquid
Extraction of Flexible Barrier Materials 176.170(d)(3); 177.1330(e)(4);
177.1360(b); 177.1670(b)
Association of Official Analytical Chemists
2200 Wilson Blvd., Suite 400, Arlington, VA 22201-3301
Journal of the Association of Official Analytical Chemists
Changes in Methods: ''Glycyrrhizic Acid or Glycyrrhizic Acid Salts
in Licorice'' Vol. 65, pp. 471-472 (1982) 184.1408
''Flavors and Nonalcoholic Beverages'' Vol. 56(5) 1281-1283 (1973)
189.110(c)
''Gas Chromatographc Determination of Safrole and Related Compounds
in Nonalcoholic Beverages: Collaborative'' Vol. 54(4) 900-902 (1971)
189.180(c)
''Gas-Solid Chromatographic Procedures for Determining Acrylonitrile
Monomer in Acrylonitrile-Containing Polymers and Food Simulating
Solvents'' (Vol. 61, No. 6, pp. 1383-1388) 177.1030(c)(2);
177.1050(e)(4); 180.22(a)
''Headspace Sampling and Gas-Solid Chromatographic Determination of
Residual Acrylonitrile in Acrylonitrile Copolymer Solutions'' Vol. 65,
No. 2, p. 270 (1981) 177.1040
''Oils, Fats, and Waxes'' Vol. 50(1) 216-218 (1967) 172.860(c)(3)
''Oils, Fats, and Waxes'' Vol. 51(2) 489-490 (1968) 172.860(c)(3)
''Spectrophotometric Measurements under Specification'' Vol. 45, p.
66 (1962) 172.878(a)(3); 172.882(a); 178.3530(a); 178.3620(b)(1)(ii)
Official Methods of Analysis, 13th Ed., 1980 172.340(b); 172.372;
172.385; 172.510; 172.860; 173.395; 176.170(d)(3); 177.2450;
178.3690; 184.1245; 184.1366; 184.1408(b)(1); 184.1979(a) and
(b)(1); 184. 1979a(b)(1); 184.1979b(b)(1); 184.1979c(b)(1); 189.130;
189.135; 189.145; 189.155; 189.165; 189.175; 189.190
National Academy of Sciences, National Research Council
2101 Constitution Ave. NW., Washington, DC 20037.
Food Chemicals Codex, 3rd Ed., 1981 172.280; 172.320(b)(1);
172.800; 172.804; 172.810; 172.812; 172.846; 172.852; 172.858;
172.862; 173.160; 173.165; 173.228; 173.280; 173.310; 178.1005;
180.25; 180.30; 180.37; 182.1625; 184.1005; 184.1007; 184.1009;
184.1011; 184.1021; 184.1025; 184.1027(b); 184.1061; 184.1069;
184.1077; 184.1081; 184.1090; 184.1091; 184.1095; 184.1099;
184.1101; 184.1115; 184.1120; 184.1121; 184.1133;
184.1135; 184.1137; 184.1138; 184.1139; 184.1141(a);
184.1141(b); 184.1143; 184.1157; 184.1165; 184.1185; 184.1187;
184.1191; 184.1193; 184.1199; 184.1205; 184.1206; 184.1207;
184.1210; 184.1212; 184.1221; 184.1229; 184.1230; 184.1240;
184.1243; 184.1245(b); 184.1257; 184.1259; 184.1260; 184.1271;
184.1272; 184.1277; 184.1278; 184.1282; 184.1293; 184.1295;
184.1296; 184.1301; 184.1304; 184.1307; 184.1308;
184.1315; 184.1317; 184.1318; 184.1330; 184.1333;
184.1339; 184.1349; 184.1351; 184.1355; 184.1366; 184.1370;
184.1372; 184.1375; 184.1388; 184.1400; 184.1408; 184.1409;
184.1425; 184.1426; 184.1428; 184.1431; 184.1434; 184.1444;
184.1445; 184.1446; 184.1452; 184.1461; 184.1490; 184.1505;
184.1530; 184.1535; 184.1537;
184.1540; 184.1545; 184.1555; 184.1585; 184.1588;
184.1610; 184.1613; 184.1619; 184.1622; 184.1631; 184.1634;
184.1635; 184.1643; 184.1655; 184.1660; 184.1666; 184.1670;
184.1676; 184.1685; 184.1695; 184.1697; 184.1699; 184.1721;
184.1724; 184.1733; 184.1736; 184.1742; 184.1754; 184.1763;
184.1764; 184.1784; 184.1792; 184.1801; 184.1804; 184.1807;
184.1835; 184.1845; 184.1848; 184.1857; 184.1875;
184.1878; 184.1890; 184.1901; 184.1903; 184.1923;
184.1930; 184.1945; 184.1950; 184.1973; 184.1976; 184.1978;
184.1979; 184.1979(a); 184.1979(b); 184.1979(c); 186.1025; 186.1551
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
Absorptivity Methods ''Determination of Softening Point (Drop
Method)'' Appendix A-2 ''Determination of Unsaturation of Resin 1977''
Appendix A-3 178.3610(a)
Acesulfame Potassium Assay
172.800(b)(1)
''Amide-Imide Polymer Content -- Analysis of Monomer Content''
177.2450(b)(3)
''Analysis of Cycopaco Resin for Residual B-(2-Hydroxyethyl mercapto)
propionitrile'' 177.1020(b); 177.1030(b)
''Analysis for Dicholorbenzene in Ryton Polyphenylene Sulfide''
177.2490(a)(3)
Analytical Chemistry, Vol. 49 P. 1090 (1977) ''Atomic Absorption
Spectrometric Determination of Sub-Part-Per-Million Quantities of Tin in
Extracts and Biological Materials with a Graphite Furnace''
178.2650(b)(1)(ii)
Analytical Method for 10% Solution Viscosity of Tyril 177.1040(c)(2)
Analytical Method, ''Determination of Free Phenol in Cyclized Rubber
Resin'' 176.170(b)(2)
Analytical Methods ''Determination of Abietic Acid and Dehydroabietic
Acid, in Rosins,'' ''Determination of Softening Point of Solid Resins,''
''Determination of Saponification Number of Rosin Esters,'' and
''Determination of Phenolic Modification of Rosin Derivatives''
178.3870(f)(6)
''Chlorine and Bromine -- Coulmetric Method by Aminco Chloridometer''
177.2210(b)
Colorimetric Determination of Residual Quaternary Ammonium Compounds
(Arquad HTL8) in Sugar and Sugar Solutions, June 13, 1990 173.400(c)
''Determination of B-Dodecylmercaplopropionitrile in NR-16 Polymer''
177.1050(b)
Determination of Copolymer Ratio in Vinylidene Chloride/Methyl
Acrylate Copolymer 177.1990
''Determination of Dimethyl Sulfoxide 172.859
Determination of Divinylbenzene in Alcohol Extracts in Amberlite
XAD-4 173.65
''Determination of Ethyl Acetate'' Test Method U.1, Sept. 29, 1981
172.859
Determination of Isobutyl Alcohol 172.859
''Determination of Melt Viscosity, Molecular Weight Distribution
Index and Viscosity Stability'' 177.1550(d)(2)(ii)
Determination of Molecular Weight Distribution of Poly (Maleic Acid)
173.45
''Determination of Residual Acrylonitrile and Styrene Monomers Gas
Chromatographic Internal Standard Method'' 177.1020(c)(2);
177.1030(c)(2); 177.1040(c); 177.1050(c)(3)
''Determination of Residual Maleic Anhydride in Polymers by Gas
Chromatography'' 177.1820(c)(3)
Determination of Residual Vinylidene Chloride and Methyl Acrylate in
Vinylidene Chloride/Methyl Acrylate Copolymer Resins and Films
177.1990(c)
Determination of Tert-Butyl Alcohol in Polypropylene 177.1520
Determination of Weight Average and Number Average Molecular Weight
of 60/40 AA/AMPS (October 23, 1987) 173.310(c)
Determination of Weight Average and Number Average Molecular Weight
of Sodium Polyacrylate 173.73(a)
''Differentiation of Nisin in Processed Cheese'', British Standards
Institution, BS 4020, 1974 184.1538
Exhibit 33B of the report of the NAS/NRC A Comprehensive Survey of
Industry on the use of Food Chemicals -- GRAS, Sept. 1972 170.3(n) and
(o)
Fishers Johns Method 18 in ''Semimiero Qualitative Organic
Analysis'' Second Ed. 178.3780(b)(1)
Food Chemicals Codex, 2nd Ed., 1972 172.804(b)
''Formaldehyde Release and Formaldehyde Analysis'' 177.2480(d)(2)(i)
Gas Chromatographic Determination of PMS and PET in PPMS Basic
Polymers 177.1635(c)
Gas Chromatography Method for Dimethyl Carbonate Impurity in Dimethyl
Dicarbonate 172.133(a)(2)
''General Procedure for Determining Relative Viscosity of Polymers''
177.1630
''Hypalon Synthetic Rubber -- Determination of Sulfur by Parr Bomb''
177.2210(b)
''Infrared Spectrophotometric Determination of Polymers Extracted
from Borex# 210 Resin Pellets'' 177.1050(d); 177.1480(b)(2)
Intrinsic Viscosity Method-E-4 ''Molecular Weight of Matrix Copolymer
by Solution Viscosity'' 177.1050(c)(2)
Intrinsic Viscosity of ULTEM Polyetherimide Using chloroform as a
Solvent 177.1595
Iodometric Method for the Determination of Available Chlorine Dioxide
(50-250 ppm available Cl02) 178.1010(c)(29)
Japan Institute of Fats and Oils Analysis Method of Residual Ethyl
Esters of Fatty Acids 184.1259
Journal of the American Oil Chemists' Society, Volume 52, January 4,
1975, ''Rapid Quantitative Determination of Residual Hexane in Oils by
Direct Gas Chromatography'' 184.1259
Low Molecular Weight Anoxomer Analysis 172.105
Method for Determination of Intrinsic Viscosity of Maleic Anhydride
Adduct of Crystalline Polypropylene 175.300(b)(3)(xix)
Method for Determining Residual Level of Poly(alkylacrylate) in
Petroleum Wax 177.866
Method for Determining Weight-Average and Number-Average Molecular
Weight and for Determining Alkylcrylate Monomer Content of
Poly(alkylacrylate) used as Processing Aid in Manufacture of Petroleum
Wax 177.866
Methodology for Ethylenimine Detection in Polyethylinimine 173.357
Methodology for Ethylene-dichloride Detection in Polyethylenimine
173.357
Methodology for Molecular Weight Determination of Polyethylenimine
173.357
Measurement of B-(2-Hydroxyethylmercapto) Propionitrile in Heptane
Food-Stimulating Solvent 180.22(b)
Methyl Ethyl Ketone Test; Methyl Alcohol Test 172.859(b)(9)
Mooney Viscosity 177.1520
NBS Circular 484, U.S. Dept. of Commerce, 1949 172.250(b)(3);
172.886(b); 178.3770(a)(4); 178.3910(a)(4)(iii)
Nonviolative Extractives Method ''Determination of Non-Volative
Chloroform Soluble Residues in Retort Pouch Water Extractives''
177.1390(c)(3)(i)
Number Average Molecular Weight 2.4 ''Osmometry'' 177.2470(c)(2)
Plastics-Polyamides-Determination of Viscosity Number, ISO
307-1984(E) 177.1500(c)(5)
Phillips Petroleum Company Method VO-65R ''Oxygen Flask
Combustion-Gravemetric Method For Determination of Sulfur in Organic
Compounds'' (1965) 177.2490(a)(1)
Phillips Petroleum Company Method 6936-BH ''Determination of the
Inherent Viscosity of Polyphenylene Sulfide (1969) 177.2490(a)(2)
''Preparation of Extracts'' 177.1550(e)
''Protein,'' NAS in RDA's, NAS Pub. No. 1694, 7th Ed., 1968
172.320(c)(1)
''Qualitative Identification of Kalrez by Infrared Examination of
Pyrolystate'' 177.2400(c)
Recommended Dietary Allowances, NAS Publication No. 1694, 7th Ed.
(1968) 172.320(c)(1)
Residual Acrylonitrile Monomer Method ''Extracted Acrylonitrile
Monomer by Differential Pulse Polarography'' ''Procedure'' for the
Determination of Molecular Weight of Acrylonitrile/Styrene Copolymers
177.1020(c)(2); 177.1030(d)(2); 177.1040(c)
Residual Methyl Acrylate and Vinylidene Chloride Monomers in Saran
MA/VDC Resins and Pellets by Headspace Gas Chromatography, March 3, 1986
177.1990(c)(3)
''Solution Viscosity'' 177.2450(b)(2)
Specifications and Criteria for Biochemical Compounds, NAS/NRC Pub.
3rd Ed., 1972 172.320(b)(2)
''Specifications for Identity and Purity of Some Antibiotics'', WHO,
FAO, Nutrition Report Series, No. 45A, 1969 184.1538
Standard Test Method for Molecular Weight Averages and Molecular
Weight Distribution of Polystyrene by Liquid Chromatography (Gel
Permation Chromatography-GPC) 177.1990
Sucrose Fatty Acid Esters, Method of Assay 172.859
Synthetic Fatty Alcohols Method ''Diols in Monohydroxy Alcohol by
Miniature Thin Layer Chromatography (MTLC)'' 178.3480(c)
The Determination of Epichlorophydrin and 1,3-Dichloro-2-Propanol in
Dimethylamine-Epichlorohydrin Copolymer 173.60(b)
Total Amine Value 178.3130(b)
Viscoelastometric method ''Direct Reading Viscoelastometric Method
for Determining Class Transition Points of Styrene Block Polymers''
177.1810(c)(1)(ii)
''Yeasts -- A Toxonomic Study,'' 2nd Ed., 1970 by Jacomina Lodder
173.160(b)(2); 173.165(b)(2)
Chap.
21 CFR 197.885 Table of CFR Titles and Chapters
21 CFR 197.885 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 197.885 Title 2 -- (Reserved)
21 CFR 197.885 Title 3 -- The President
I Executive Office of the President (Parts 100 -- 199)
21 CFR 197.885 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 197.885 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 197.885 Title 6 -- Economic Stabilization (Reserved)
21 CFR 197.885 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 197.885 Title 8 -- Aliens and Nationality
I Immigration and Naturalization Service, Department of Justice
(Parts 1 -- 499)
21 CFR 197.885 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 197.885 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 197.885 Title 11 -- Federal Elections
I Federal Election Commission (Parts 1 -- 9099)
21 CFR 197.885 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 197.885 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 197.885 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 197.885 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 197.885 Title 16 -- Commercial Practices
I Federal Trade Commission (Parts 0 -- 999)
II Consumer Product Safety Commission (Parts 1000 -- 1799)
21 CFR 197.885 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 197.885 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 197.885 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 197.885 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 197.885 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 197.885 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 197.885 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 197.885 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 197.885 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 197.885 Title 26 -- Internal Revenue
I Internal Revenue Service, Department of the Treasury (Parts 1 --
799)
21 CFR 197.885 Title 27 -- Alcohol, Tobacco Products and Firearms
I Bureau of Alcohol, Tobacco and Firearms, Department of the Treasury
(Parts 1 -- 299)
21 CFR 197.885 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 197.885 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 197.885 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 197.885 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 197.885 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 197.885 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 197.885 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 197.885 Title 35 -- Panama Canal
I Panama Canal Regulations (Parts 1 -- 299)
21 CFR 197.885 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 197.885 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 197.885 Title 38 -- Pensions, Bonuses, and Veterans' Relief
I Department of Veterans Affairs (Parts 0 -- 99)
21 CFR 197.885 Title 39 -- Postal Service
I United States Postal Service (Parts 1 -- 999)
III Postal Rate Commission (Parts 3000 -- 3099)
21 CFR 197.885 Title 40 -- Protection of Environment
I Environmental Protection Agency (Parts 1 -- 799)
V Council on Environmental Quality (Parts 1500 -- 1599)
21 CFR 197.885 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 197.885 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 197.885 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 197.885 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 197.885 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 197.885 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 197.885 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 197.885 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 197.885 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 197.885 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 197.885 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 197.885 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 197.885 21 CFR (4-1-92 Edition)
21 CFR 197.885 Redesignation Table II
21 CFR 197.885
21 CFR 197.885
21 CFR 197.885 Redesignation Table
At 53 FR 24668, June 29, 1988, 21 CFR part 193 was redesignated as 40
CFR part 185.
The following table shows the relationship of the regulations under
their assigned section numbers in 21 CFR part 193 prior to this
publication, and their redesignations as reflected in new 40 CFR part
185.
21 CFR 197.885 21 CFR Ch. I (4-1-92 Edition)
21 CFR 197.885 List of CFR Sections Affected
21 CFR 197.885 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 197.885 1986
21 CFR
51 FR
Page
Chapter I
Mandatory compliance date 1-1-89 34085
172.210 (b)(2) table amended 2693
172.515 (b) amendment confirmed; request for deferral denied 37909
172.804 (c) (8) and (9) added 43000
(c)(10) added 43001
(c)(5)(ii) amended; (c)(11) added 43002
172.834 Technical correction 1495
172.846 Introductory text corrected 1495, 3333
172.859 (a) amended; (b)(10) and (11) added 40161
172.886 (c)(2) revised 19544
173.5 -- 173.75 (Subpart A) Heading revised 11719
173.45 Added 5315
173.60 Technical correction 1495
173.75 Added 11720
175 Authority citation revised; section authority citations removed
19545
175.105 (c)(5) table amended 5316,
19545, 30059-60, 31099, 33889
Technical correction 1495,
6520, 43120
175.250 (a) amended; (b)(1) revised 47010
175.300 (b)(3)(xxxi) amended 4312
176.170 (b)(2) table amended 881,
28546, 47011
Technical correction 1495
176.180 (b)(2) table amended 16167,
17012, 47011
176.300 (c) table amended 19059
(d) amended 43734
177.1310 (a) and (b) revised; (c) redesignated as (d); new (c)
added 19060
177.1315 (b) revised 22929
177.1500 (a)(10) revised; (b) table amended 33250
177.1520 (b) table amended 43191
(a)(3)(i)(b) and (c) amended; (a)(3)(i)(d) added 45315
177.1630 (e)(4) amended 3772
177.1655 Added 882
(b) table and (d) corrected 4165
177.1810 (b) table and (c)(3) revised 16828
Technical correction 18774
177.2500 Removed 883
178 Authority citation revised; section authority citations removed
19544
Authority citation corrected 43120
178.1005 (e)(1) revised 45881
178.1010 (b)(29) and (c)(24) added 7437
(b)(30) and (c)(25) added 7438
(b)(31) and (c)(26) added 33892
(b)(33) and (c)(28) added 47226
178.2010 (b) table amended 5317,
12608, 19061, 29462, 31100, 32212, 35512, 47012
(b) table corrected 15763, 39372
Technical correction 1495, 6520
178.3130 (b) table amended 28932
178.3297 (e) table amended 7552, 19168
(e) table corrected 23535
178.3400 (c) table amended 31763
Technical correction 39747
178.3570 (a)(3) table amended 7552
178.3710 (f) added 19545
178.3740 (b) table amended 47011
178.3770 (c) added 33895
179 Authority citation revised 13398
179.21 Authority citation removed 13398
179.22 Removed 13398
179.24 Removed 13398
179.25 Added 13399
179.26 Added 13399
179.45 Authority citation removed 13398
182 Authority citation revised 16830, 25025
182.70 Amended 16830, 27171
Effective date corrected 18774
182.90 Amended 39372
182.1366 Removed 27171
182.3616 (c) revised 25025
Effective date corrected 25198
Technical correction 26876
182.3637 (c) revised 25025
Effective date corrected 25198
Technical correction 26876
182.3739 (c) revised 25025
Effective date corrected 25198
Technical correction 26876
182.3766 (c) revised 25025
Effective date corrected 25198
Technical correction 26876
182.3798 (c) revised 25026
Effective date corrected 25198
Technical correction 26876
182.3862 (c) revised 25026
Effective date corrected 25198
Technical correction 26876
184 Authority citation corrected 1495
184.1157 Added 27173
184.1318 Added 33896
184.1366 (c), (d), and (e) revised 27172
186 Authority citation revised; section authority citations removed
16830
186.1557 Added 16830
Effective date corrected 18774
186.1770 Added 39372
186.1771 Added 39372
189.113 Addition confirmed; request for deferral denied 37909
193.35 Removed 25686
193.110 Removed 46617
193.120 Removed 46617
193.137 Added 11437
193.186 (b) table amended 31325
193.450 Revised 46617
193.468 (c) added 28224
21 CFR 197.885 1987
21 CFR
52 FR
Page
Chapter I
172.210 (b)(4) table amended 18911
172.859 (a) amended 10883
173.357 (a)(2) table amended 39512
175.105 (c)(5) table amended 10884,
12380, 27800, 29180
(c)(5) table corrected 19857
175.300 (b)(3)(xxxii) amended 41987
176.170 (b)(2) table amended 530, 19724
(a)(5) table amended 3604,
17553, 29667, 43058, 46746
Technical correction 6649
177 Authority citation revised 33803, 39635
177.1040 (c) table amended 33803
177.1390 Heading revised 33575
177.1395 Added 33575
Technical correction 36863
177.1430 Revised 11641
177.1500 (a)(12) added; (b) table amended 26667
Technical correction 28067
(a)(4) revised; (b) table amended 33575
(a)(13) and (c)(5) added; (b) table amended 39635
(b) table corrected 42760
177.1520 (b) table amended 23804
177.1555 Added 35540
177.1630 (e)(4)(i) amended 32917
177.1660 (c)(1) amended 20069
177.2470 (a) revised; (b)(1) amended 4493
177.2550 (a) revised 29668
177.2600 (c)(4)(iii) amended 35910
178.1005 (d) revised 26146
178.1010 (b)(32) and (c)(27) added 409
(b)(34) and (c)(29) added 29842
(c)(29) corrected 34047
178.2010 (b) table amended; eff. 4-2-87 6324
(b) table amended 20070,
22301, 30150, 33930, 35541, 35911, 37446, 43059, 43323
Technical correction 24090
(b) table corrected 26764
178.3295 Table amended 30920
178.3910 (a)(4)(i)(a) amended 10223
179.22 Petitions for deferral of effective date denied 5450
179.24 Petitions for deferral of effective date denied 5450
179.25 Petitions for deferral of effective date denied 5450
179.26 Petitions for deferral of effective date denied 5450
182.8245 Removed 25211
184.1245 Added 25211
184.1259 (a) revised; (b) (8) and (9) revised 47920
(a)(2) corrected 48905
184.1287 Added 25976
184.1328 Added 42430
184.1639 Added 10886
184.1768 Added 10886
193.98 Added 29009
(b) corrected 31846
193.137 Existing text designated as (a); (b) added 17941
193.142 Heading and text nomenclature change 32293
193.253 Table amended 10562
193.277 (d) added 41418
(d) corrected 42760
193.410 Revised 27543
193.430 Heading and text nomenclature change 32293
193.472 Added 10563
193.473 Added 17942
Technical correction 23137,
23916, 34903
193.475 Added 43324
193.476 Added 39222
21 CFR 197.885 1988
21 CFR
53 FR
Page
Chapter I
Uniform compliance date 1-1-91 44861
170 Authority citation revised 16546
170.3 (f) revised 16546
170.30 (c) redesignated as (c)(1); new (c)(1) amended; (c)(2) added
16546
170.35 (c)(1) introductory text revised; OMB number 16547
172.133 Added 41329
Technical correction 49638
172.800 Added 28382
172.804 (c) (8), (9), (10), and (11) request for stay denied and
effective date confirmed 6595
(c)(13) added 20838
(c)(12) added 20839
(c)(14) added 20840
(c)(15) added 20841
(c) (16) and (17) added 20842
Technical correction 23340
(c)(18) added 40879
(b) revised 51273
172.811 Added 21632
172.859 (c)(3) revised 22294
(a) amendment and (b) (10) and (11) additions in 51 FR 40161
republished 22297
Technical correction 26559, 36785
173 Authority citation revised 15199, 39456
173.73 Added 39456
(a)(2) corrected 43319, 49823
173.310 (c) table amended 15199
(c) table corrected 18194
175.105 (c)(5) table amended 29454,
32606, 52131
175.300 (b)(3)(xxxiii) amended 34279
176.170 (a)(5) table corrected 97
(a)(5) table amended 8620, 28636, 34045, 50211, 50952
177.1310 (b) revised 44009
177.1330 (c) amended 44009
177.1390 (c)(3)(i)(a) (1) and (2) and (b) (1) and (2) amended;
(c)(2)(vi) and (3)(i)(b)(3) added 39084
177.1395 (b)(4) table amended 19773
177.1500 (a)(14) added; (b) table amended; (c)(5) redesignated as
(c)(5)(i); (c)(5)(ii) added 19773
177.1580 (b) table amended 29656
177.1990 (c)(3) and (e) revised 47185
177.2550 (a) revised 31835
(a)(3) added 32215
Technical correction 36391
177.2910 Introductory text revised; (a) redesignated as (a)(1) and
revised; new (a)(2) added 17925
178.1005 (e)(1) revised 47186
178.1010 (b)(35) and (c)(30) added 31837
178.2010 (b) table amended 15200,
18087, 29657, 32375, 47526, 49551, 52133
178.3295 Table amended 30049
Technical correction 18194
178.3297 (e) table amended 52132
178.3570 (a)(3) table amended 8441, 44397
179.26 (c)(4) amended 12757
Effective date corrected 16615
(b) table amended 53209
182 Authority citation revised 16864
182.1 (a) amended 44875
182.90 Amended 16864, 44876
182.8301 Removed 16864
182.8304 Removed 16864
182.8306 Removed 16864
182.8308 Removed 16864
182.8311 Removed 16864
182.8315 Removed 16864
182.8375 Removed 16864
184.1259 Technical correction 4384
184.1296 Added 16864
184.1297 Added 16864
184.1298 Added 16865
184.1301 Added 16865
184.1304 Added 16865
(a) and (d) corrected 20939
184.1307 Added 16865
184.1307a Added 16865
184.1307b Added 16865
184.1307c Added 16866
184.1307d Added 16866
184.1308 Added 16866
(b) corrected 20939
184.1311 Added 16866
184.1315 Added 16866
184.1375 Added 16867
184.1538 Added 11250
Technical correction 16837
184.1555 (c)(1) amended 52682
184.1854 Added 44876
184.1857 Added 44876
184.1859 Added 44876
184.1865 Added 44876
186.1300 Added 16867
(b)(2) corrected 20939
184.1330 (c) table amended 5766
186.1374 Added 16867
(b)(2) corrected 20939
193 Redesignated as 40 CFR Part 185 24666
Correctly redesignated as 40 CFR Part 185 26131
193.15 (b) removed 8874
193.70 Removed 9434
193.84 Removed 8874
193.85 (c) removed 9434
193.87 Removed 8874
193.98 (a) added 1917
(c) added 18837
193.100 Revised 9434
193.137 (b) amended 20308
193.142 Introductory text revised 23389
193.145 Removed 9434
193.152 (c) removed 8874
193.156 (b), (c) and (d) removed 8874
193.186 (a) table amended 5367
193.215 Removed 9434
193.219 Removed 9434
193.235 (b) removed 9434
193.277 (c) removed 8874
193.284 Removed 9434
193.301 Removed 9434
193.400 Revised 9434
193.415 Removed 9434
193.430 Revised 23389
193.468 Revised 8874
193.469 Removed 8874
193.473 Amended 23107
193.477 Added 21, 12943
193.479 Added 234
Amended 23388
193.480 Added; eff. to 6-30-89 23386
193.481 Added 23387
21 CFR 197.885 1989
21 CFR
54 FR
Page
Chapter I
170 Authority citation revised; sectional authority citations
removed 39634
170.3 (n) and (o) introductory text amended 24896
170.6 (e) amended 24896
170.38 (b)(3) amended 24896
171 Authority citation revised 39634
172 Authority citation revised; sectional authority citations
removed 39634
172.105 (b) (1), (2), and (3) amended 24896
172.250 (b)(3) footnote 1 amended 24896
172.320 (b)(2), (c)(1), and (d) amended 24897
172.340 (b) introductory text footnote 1 amended 24897
172.372 (d) amended 24897
172.385 (c)(1) amended 24897
172.510 (b) table footnote 1 amended 24897
172.515 (b) amended 7402
172.804 (c)(19) added 23647
(c)(20) added 23647
(c)(21) added 31333
172.859 (b) (1), (5), and (9) amended 24897
172.860 (c) (1) and (2) amended 24897
172.864 (b)(3) footnote 1 amended 24897
172.878 (a)(3) amended 24897
172.882 (a) amended 24897
172.886 (b) footnote 1 amended 24897
173 Authority citation revised; sectional authority citations
removed 39634
173.60 (b)(3) amended 24897
173.145 (b) footnote 1 amended 24897
173.160 (b)(1) footnote 1 and (2) amended 24897
173.165 (b)(2) amended 24897
173.310 (c) table amended 31012
173.395 (d) amended 24897
174 Authority citation revised 39634
175 Authority citation revised 39634
175.105 (c)(5) table amended 15750, 24554, 50500
175.300 (b)(3)(xix) amended 24897
(b)(3)(xxxiii) amended 30732,
47765, 47766
(b)(3)(vii)(e) added 48858
176 Authority citation revised 39634
176.170 (a)(5) table amended 19363, 38968
Authority citation removed 39634
(d)(3) introductory text amended 24897
176.180 (b)(2) table amended 10630, 13881, 14075
Technical correction 13606
176.210 (d)(3) amended 24897
176.300 (c) table revised 18103
177 Authority citation revised; sectional authority citations
removed 39634
177.1020 (c)(2) and (d)(2) amended 24897
177.1030 (c)(2) and (d)(2) amended 24898
177.1050 (b) table, (c) (2) and (3), (d) introductory text, and
(e)(4) amended 24898
177.1060 Added 20382
177.1330 (e)(4) amended 24898
177.1350 (d) (1), (3), and (e)(1) revised 35874
177.1390 (c)(3)(i)(a)(1) amended 24898
177.1480 (b)(2) introductory text amended 24898
177.1500 (b) table amended 29019
177.1520 (b) table amended 10632
(a)(5) added; (c) table amended 40383
(a)(3)(i)(c) redesignated as (a)(3)(i)(c)(1); (a)(3)(i)(c)(2) added;
(c) table amended; (d)(7) revised 49079
(c) table corrected 51342
177.1550 (e) footnote 1 amended 24898
177.1630 (j) added 15750
Technical correction 19283
(e)(4)(iii) amended 24898
177.1635 (c)(1) amended 24898
177.1810 (c)(2)(ii) amended 24898
177.1820 (c)(3) amended 24898
177.1990 (c)(1) amended 24898
177.2210 (b)(3) amended 24898
177.2420 (b) table amended 48858
177.2450 (b) (1), (2), and (3) amended 24898
(a) and (b) revised; (c) introductory text amended 43170
177.2470 (c)(2) amended 24898
177.2480 (d)(2)(i) amended 24898
177.2490 (a) introductory text amended 24898
177.2600 (c)(4)(iv) heading revised and text amended 35638
(c)(4)(i) amended 38969
178 Authority citation revised 39634
178.1005 (e)(1) table amended 5604, 13167
(e)(1) table corrected 6365
178.1010 (b)(36) and (c)(31) added 21621
(b)(38) and (c)(33) added 21939
(b)(36) corrected 23739
Technical correction 24789
(b)(16) amended 24898
(b)(37) and (c)(32) added 31014
178.2010 (b) table amended 6125, 9775, 13878, 17705, 39357
Technical correction 42886
178.2650 Introductory text and (a) introductory text revised; (a)(7)
and (b)(1)(iii) added 6658
(b)(1)(ii) amended 24898
178.3295 Table amended 12432
Table corrected 14734
178.3297 (e) table amended 21053, 35875
(c) amended 24898
178.3480 (c) introductory text amended 24898
178.3570 (a)(3) table amended 31519
178.3610 (a) amended 24898
178.3620 (b)(1)(ii) and (c)(3) footnote 1 amended 24898
178.3690 (b)(4) amended 24898
178.3770 (a)(4) footnote 1 amended 24898
178.3780 (b)(1) amended 24899
178.3870 (f)(6)(iv) amended 24899
178.3910 (a)(2) table amended 6124
Technical correction 7920
(a)(4)(iii) footnote 1 and (b) introductory text amended 24899
179 Authority citation revised 39634
179.26 Technical correction 6475
Regulation at 53 FR 53209 effective date confirmed 32335
179.45 (c) and (d) redesignated as (d) and (e); new (c) added 7405
(b)(6) introductory text amended 24899
180 Authority citation revised 39635
180.1 Authority citation removed 39634
180.22 (a) introductory text, (b), (e), and (f) (1) and (2) amended
24899
181 Authority citation revised 39635
181.1 Authority citation removed 39635
181.32 (b) introductory text amended 24899
182 Authority citation corrected 6365
Authority citation revised 39635
182.60 Amended 7402
182.90 Amended 7402
182.1324 Removed 7402
182.1901 Removed 7402
182.4101 Removed 7402
182.4505 Removed 7402
182.4521 Removed 7402
184 Authority citation revised 39635
184.1101 Added 7403
(a) revised; (e) added; eff. 5-1-89 13168
Effective date and (e) corrected 18382
184.1323 Added 7403
184.1324 Added 7403
184.1408 (b)(1) amended 24899
184.1472 Added 38223
184.1505 Added 7403
184.1521 Added 7404
184.1854 (b) corrected 228
184.1859 (a) corrected 228
184.1901 Added 7404
184.1903 Added 7404
(c)(2) corrected 10482
184.1979 (b)(1) introductory text footnote 2 amended 24899
184.1979a (b)(1) introductory text footnote 2 amended 24899
184.1979b (b)(1) introductory text footnote 2 amended 24899
184.1979c (b)(1) introductory text footnote 2 amended 24899
186 Authority citation revised 39635
189 Authority citation revised; sectional authority citations
removed 39635
189.1 (c) amended 24899
189.110 (c) amended 24899
189.130 (c) amended 24899
189.135 (c) amended 24899
189.145 (c) amended 24899
189.155 (c) amended 24899
189.165 (c) amended 24900
189.175 (c) amended 24900
189.180 (c) amended 24900
189.190 (c) amended 24900
189.300 Added 7188
197 Authority citation revised 39635
21 CFR 197.885 1990
21 CFR
55 FR
Page
Chapter I
172.665 Added 39614
173.310 (c) table amended 12172
173.342 Added 8913
173.357 (a)(2) table amended 12172
175.105 (c)(5) table amended 10235, 30215
176.170 (a)(5) table amended 1673, 10236
(b)(2) table amended 13520
176.300 (c) table amended 31825
177.1210 (b)(5) table amended 34555
177.1350 (a)(6) added 18595
177.1520 (b) table amended 18596
(c) table amended 31826
(b) table corrected 19701
(b) table amended 34710
177.1635 (e) revised 52989
177.2550 (d)(1) revised; (d)(2) and (3) redesignated as (d)(3) and
(4); (a)(4) and new (d)(2) added 8139
177.2600 (c)(4)(i) amended 34555
178 Technical correction 50279
178.1005 (e)(1) table amended 47055
178.2010 (b) table amended 13521, 18597, 22901, 30216
178.3280 (b) table amended 8914
178.3295 Table amended 52990
178.3297 (e) table amended 3585, 12344, 18721, 31827
178.3570 (a)(3) table amended 30218, 47323
178.3700 (a) and (d) amended 12172
178.3770 Heading, introductory text, (a) introductory text, (b)
introductory text, (c) introductory text and (c)(1) amended; (d) added
28020
179 Authority citation revised 9079
179.26 (c)(4) removed 14415
(c)(4) correctly removed 18227
(b) Table revised 18544
Technical correction 19701
182.3616 (c) revised; eff. 4-16-90 9832
182.3637 (c) revised; eff. 4-16-90 9832
182.3739 (c) revised; eff. 4-16-90 9832
182.3766 (c) revised; eff. 4-16-90 9833
182.3798 (c) revised; eff. 4-16-90 9833
182.3862 (c) revised; eff. 4-16-90 9833
184.1498 Added 6391
Technical correction 10030
184.1685 Revised 10935
21 CFR 197.885 1991
21 CFR
56 FR
Page
Chapter I
172.540 Added 6968
172.712 Removed 42686
Technical correction 46667
172.861 Added 66970
173.25 (a)(20) and (b)(5) added; (b) introductory text and (d)
revised 16268
173.400 Added 42686
Technical correction 46667
175.105 (c)(5) table amended 14316
175.300 (b)(3)(xxvi) revised 42932
175.320 (b)(3) table amended 49674
176 Technical correction 2585
176.170 (a)(5) table amended 18, 368
(b)(2) table amended 19930, 49674
(b)(1) and (2) table amended 42932
(b)(2) table corrected 65782
177.1350 (a)(3) revised 42932
177.1460 (b) table amended 42933
177.1520 (b) table amended 21447, 42933
(b) table corrected 25446
177.1680 (a)(2) and (b) table amended 15278
Technical correction 22910
(b) table amended 42933
177.2250 (d) revised 42933
177.2260 (d)(5) revised 42933
177.2600 (c)(4)(vi) revised 42933
177.2800 (d)(5) table amended 42933
178.2010 (b) table amended 1084, 43698
178.3130 (b) table amended 41457
178.3295 Table amended 1085
178.3297 (c) revised; (d) added; (e) table amended 42933
(e) table corrected 65782
178.3400 (c) table amended 41457
178.3550 Removed 42935
178.3570 (a)(3) table amended 41456
178.3910 (a)(2) table amended 55456
178.3970 Removed 42935
21 CFR 197.885 1992
21 CFR
57 FR
Page
Chapter I
172 Hearing denied 3698
Technical correction 9472
172.804 (c)(22) added 3702
(c)(1) and (3) revised; (e)(4) added 3703
(c)(13) revised 3704
172.861 Heading corrected 2814
172.880 Request for stay and hearing denied 6667
173.320 (b) introductory text amended; (b)(6) added 8065
175.105 (c)(5) table amended 10810
176.170 (a)(5) table amended 3123
(a)(5) table amended 10616
177.1380 (a)(4) added; (b) revised 185
177.1520 (c) table amended 10616
177.1585 Added 3940
Technical correction 5294
177.1632 Added 3125
177.2600 (c)(4)(i) amended 3128
178.2010 (b) table amended 2019, 10811, 10992
182.8201 Removed; eff. 4-30-92 10813
182.8455 Removed; eff. 4-30-92 10813
182.8628 Removed; eff. 4-30-92 10813
184.1201 Added; eff. 4-30-92 10813
184.1505 (c) introductory text and (1) amended 10616
184.1685 (a)(3) added 6479
21
Food and Drugs
PARTS 170 TO 199
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 197.885 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
Redesignation Table
List of CFR Sections Affected
21 CFR 197.885 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
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Martha L. Girard,
Director,
Office of the Federal Register.
April 1, 1992.
21 CFR 197.885 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, Gertrude E. Belton 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 200 to 299)
Part
chapter i -- Food and Drug Administration, Department of Health and
Human Services (Continued) 200
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.
U.S. 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,
21 CFR 0.0 DEPARTMENT OF HEALTH AND
21 CFR 0.0 HUMAN SERVICES
21 CFR 0.0 (Parts 200 to 299)
Editorial Note: The Food and Drug Administration published a
document 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 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.
21 CFR 0.0 SUBCHAPTER C -- DRUGS: GENERAL
Part
Page
200 General
201 Labeling
202 Prescription drug advertising
205 Guidelines for state licensing of wholesale prescription drug
distributors
207 Registration of producers of drugs and listing of drugs in
commercial distribution
210 Current good manufacturing practice in manufacturing, processing,
packing, or holding of drugs; general
211 Current good manufacturing practice for finished pharmaceuticals
225 Current good manufacturing practice for medicated feeds
226 Current good manufacturing practice for Type A medicated articles
250 Special requirements for specific human drugs
290 Controlled drugs
291 Drugs used for treatment of narcotic addicts
299 Drugs; official names and established names
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 C -- DRUGS: GENERAL
21 CFR 0.0 PART 200 -- GENERAL
21 CFR 0.0 Subpart A -- General Provisions
Sec.
200.5 Mailing of important information about drugs.
200.7 Supplying pharmacists with indications and dosage information.
200.10 Contract facilities (including consulting laboratories)
utilized as extramural facilities by pharmaceutical manufacturers.
200.11 Use of octadecylamine in steam lines of drug establishments.
200.15 Definition of term ''insulin.''
21 CFR 0.0 Subpart B -- Manufacturing Procedures Affecting New Drug
Status
200.30 Sterilization of drugs by irradiation.
200.31 Timed release dosage forms.
21 CFR 0.0 Subpart C -- Requirements for Specific Classes of Drugs
200.50 Ophthalmic preparations and dispensers.
21 CFR 0.0 Subpart D -- Suitability of Specific Drug Components
200.100 Use of ox bile from condemned livers from slaughtered animals
in the manufacture of drugs.
200.101 Suprarenal glands from hog carcasses prior to final
inspection.
21 CFR 0.0 Subpart E -- Prescription Drug Consumer Price Listing
200.200 Prescription drugs; reminder advertisements and reminder
labeling to provide price information to consumers.
Authority: Secs. 201, 301, 501, 502, 503, 505, 506, 507, 508, 515,
701, 704, 705 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321, 331, 351, 352, 353, 355, 356, 357, 358, 360e, 371, 374, 375).
Source: 40 FR 13996, Mar. 27, 1975, unless otherwise noted.
21 CFR 0.0 Subpart A -- General Provisions
21 CFR 200.5 Mailing of important information about drugs.
Manufacturers and distributors of drugs and the Food and Drug
Administration occasionally are required to mail important information
about drugs to physicians and others responsible for patient care. In
the public interest, such mail should be distinctive in appearance so
that it will be promptly recognized and read. The Food and Drug
Administration will make such mailings in accordance with the
specifications set forth in this section. Manufacturers and
distributors of drugs are asked to make such mailings as prescribed by
this section and not to use the distinctive envelopes for ordinary mail.
(a) Use first class mail and No. 10 white envelopes.
(b) The name and address of the agency or the drug manufacturer or
distributor is to appear in the upper left corner of the envelope.
(c) The following statements are to appear in the far left third of
the envelope front, in the type and size indicated, centered in a
rectangular space approximately 3 inches wide and 2 1/4 inches high with
an approximately 3/8 inch-wide border in the color indicated:
(1) When the information concerns a significant hazard to health, the
statement:
The statement shall be in three lines, all capitals, and centered.
''Important'' shall be in 36 point Gothic Bold type. ''Drug'' and
''Warning'' shall be in 36 point Gothic Condensed type. The rectangle's
border and the statement therein shall be red.
(2) When the information concerns important changes in drug package
labeling, the statement:
The statement shall be in three lines, all capitals, and centered.
''Important'' shall be in 36 point Gothic Bold type. ''Prescribing''
and ''Information'' shall be in 36 point Gothic Condensed type. The
rectangle's border and the statement therein shall be blue.
(3) When the information concerns a correction of prescription drug
advertising or labeling, the statement:
The statement shall be in four lines, all capitals, and centered.
''Important'' shall be in 36 point Gothic Bold type. ''Correction,''
''Of Drug,'' and ''Information'' shall be in 36 point Gothic Condensed
type. The rectangle's border and the statement therein shall be brown.
21 CFR 200.7 Supplying pharmacists with indications and dosage
information.
There are presently no regulations under the Federal Food, Drug, and
Cosmetic Act that prevent a manufacturer of prescription drugs from
sending the pharmacist data he needs on indications and dosage in
exercising his important professional function of checking against
possible mistakes in a prescription. The Food and Drug Administration
believes manufacturers should be encouraged to supply such printed
matter to the pharmacist for his professional information. Obviously,
such printed matter should not be displayed to prospective purchasers to
promote over-the-counter sale of prescription drugs.
21 CFR 200.10 Contract facilities (including consulting laboratories)
utilized as extramural facilities by pharmaceutical manufacturers.
(a) Section 704(a) of the Federal Food, Drug, and Cosmetic Act
specifically authorizes inspection of consulting laboratories as well as
any factory, warehouse, or establishment in which prescription drugs are
manufactured, processed, packed, or held.
(b) The Food and Drug Administration is aware that many manufacturers
of pharmaceutical products utilize extramural independent contract
facilities, such as testing laboratories, contract packers or labelers,
and custom grinders, and regards extramural facilities as an extension
of the manufacturer's own facility.
(c) The Food and Drug Administration reserves the right to disclose
to the pharmaceutical manufacturer, or to the applicant of a new drug
application (NDA) or to the sponsor of an Investigational New Drug (IND)
Application, any information obtained during the inspection of an
extramural facility having a specific bearing on the compliance of the
manufacturer's, applicant's, or sponsor's product with the Federal Food,
Drug, and Cosmetic Act. The Food and Drug Administration's position is
that by the acceptance of such contract work, the extramural facility
authorizes such disclosures.
(d) The Food and Drug Administration does not consider results of
validation studies of analytical and assay methods and control
procedures to be trade secrets that may be withheld from the drug
manufacturer by the contracted extramural facility.
(40 FR 13996, Mar. 27, 1975, as amended at 55 FR 11576, Mar. 29,
1990)
21 CFR 200.11 Use of octadecylamine in steam lines of drug
establishments.
The Food and Drug Administration will not object to the use of
octadecylamine in steam lines where the steam may be used for
autoclaving surgical instruments and gauze if the octadecylamine in the
steam is not more than 2.4 parts per million.
21 CFR 200.15 Definition of term ''insulin.''
For the purposes of sections 502(k) and 506 of the act:
(a) The term ''insulin'' as used therein means the active principle
of pancreas which affects the metabolism of carbohydrate in the animal
body and which is of value in the treatment of diabetes mellitus.
(b) The following substances, when they are intended for use in the
manufacture of insulin-containing drugs that will subsequently be
submitted for certification, shall not be considered to be subject to
certification as ''drugs composed wholly or partly of insulin'':
(1) Pancreas glands; and
(2) Materials prepared from pancreas glands, such as ''salt cake''
and ''isoelectric precipitate,'' which materials must be subjected to
further purification in order to meet the standards of purity
established by part 429 of this chapter.
21 CFR 200.15 Subpart B -- Manufacturing Procedures Affecting New Drug Status
21 CFR 200.30 Sterilization of drugs by irradiation.
There is a current interest in the utilization of newly developed
sources of radiation for the sterilization of drugs. Prior to the
marketing of a drug sterilized by such means, it is necessary in the
interest of protecting the public health to establish by adequate
investigations that the irradiation treatment does not cause the drug to
become unsafe or otherwise unsuitable for use. Accordingly, all drug
products, including injections, ophthalmic solutions, surgical sutures,
and surgical dressings sterilized by means of irradiation are regarded
as new drugs within the meaning of section 201(p) of the Federal Food,
Drug, and Cosmetic Act. An effective new-drug application pursuant to
section 505 of the act is therefore a prerequisite to interstate
shipment of such articles, except as provided by section 505(i).
21 CFR 200.31 Timed release dosage forms.
(a) Many drugs are now being offered in dosage forms that are
designed to release the active ingredients over a prolonged period.
There is a possibility of unsafe overdosage if such products are
improperly made and the active ingredients are released at one time or
over too short a time interval. Any such dosage form that contains per
dosage unit (for example, capsule or tablet), a quantity of active drug
ingredients which is not generally recognized as safe for administration
as a single dose under the conditions suggested in its labeling, is
regarded as a new drug within the meaning of section 201(p) of the
Federal Food, Drug, and Cosmetic Act.
(b) The fact that the labeling of this type of drug may claim delayed
or prolonged release of all or some of the active ingredients does not
affect the new-drug status of such articles. A new-drug application is
required in any such case to demonstrate that the drug is in fact safe
because it is properly made and controlled to release the total dose at
a safe rate. It should be noted particularly that such dosage forms are
regarded as new drugs even when the total daily dosage recommended in
the labeling is generally recognized as safe. For example, a capsule
containing 50 milligrams of pyrilamine maleate and 15 milligrams of
phenylephrine hydrochloride, offered for sale without prescription, is
regarded as a new drug for which the distributor should have an
effective new-drug application, even though the directions call for
taking no more than two capsules daily. While the daily intake under
such directions is within the range regarded as safe for use in
self-medication, the single dose is too high for such use unless the
release of the drug is sufficiently prolonged. It is obvious that, in
filing a new-drug application for such an article, particular attention
should be given to data which establish that the active ingredients are
released over a period of time, as represented in the labeling.
21 CFR 200.31 Subpart C -- Requirements for Specific Classes of Drugs
21 CFR 200.50 Ophthalmic preparations and dispensers.
(a)(1) Informed medical opinion is in agreement that all preparations
offered or intended for ophthalmic use, including preparations for
cleansing the eyes, should be sterile. It is further evident that such
preparations purport to be of such purity and quality as to be suitable
for safe use in the eye.
(2) The Food and Drug Administration concludes that all such
preparations, if they are not sterile, fall below their professed
standard of purity or quality and may be unsafe. In a statement of
policy issued on September 1, 1964, the Food and Drug Administration
ruled that liquid preparations offered or intended for ophthalmic use
that are not sterile may be regarded as adulterated within the meaning
of section 501(c) of the Federal Food, Drug, and Cosmetic Act (the act),
and, further, may be deemed misbranded within the meaning of section
502(j) of the act. This ruling is extended to affect all preparations
for ophthalmic use. By this regulation, this ruling is applicable to
ophthalmic preparations that are regulated as drugs. By the regulation
in 800.10 of this chapter, this ruling is applicable to ophthalmic
preparations that are regulated as medical devices.
(3) The containers of ophthalmic preparations shall be sterile at the
time of filling and closing, and the container or individual carton
shall be so sealed that the contents cannot be used without destroying
the seal. The packaging and labeling of ophthalmic preparations that
are over-the-counter drugs shall also comply with 211.132 of this
chapter on tamper-resistant packaging requirements.
(b) Liquid ophthalmic preparations packed in multiple-dose containers
should:
(1) Contain one or more suitable and harmless substances that will
inhibit the growth of microorganisms; or
(2) Be so packaged as to volume and type of container and so labeled
as to duration of use and with such necessary warnings as to afford
adequate protection and minimize the hazard of injury resulting from
contamination during use.
(c) Eye cups, eye droppers, and other dispensers intended for
ophthalmic use should be sterile, and may be regarded as falling below
their professed standard of purity or quality if they are not sterile.
These articles, which are regulated as drugs if packaged with the drugs
with which they are to be used, should be packaged so as to maintain
sterility until the package is opened and be labeled, on or within the
retail package, so as to afford adequate directions and necessary
warnings to minimize the hazard of injury resulting from contamination
during use.
(40 FR 13996, Mar. 27, 1975, as amended at 48 FR 50455, Nov. 5, 1982)
21 CFR 200.50 Subpart D -- Suitability of Specific Drug Components
21 CFR 200.100 Use of ox bile from condemned livers from slaughtered
animals in the manufacture of drugs.
(a) Conferences have recently been held between members of the
Department of Health and Human Services and representatives of the
Agricultural Research Service, Department of Agriculture, concerning
requests made to that agency for the release of ox bile from condemned
livers of slaughtered animals for use in the manufacture of certain
drugs.
(b) The Secretary of Health and Human Services has given careful
consideration to this problem and has reached the conclusion that no
hazard to public health will be involved in the release of such ox bile,
after the addition to it of sufficient sodium hydroxide to give the
mixture a sodium hydroxide content of not less than 5 percent, the
mixture then being allowed to stand at least 24 hours. This Department
will not regard as in violation of the provisions of the Federal Food,
Drug, and Cosmetic Act such alkalized and aged ox bile, if labeled ''Ox
Bile and Sodium Hydroxide (or Ox Bile and Sodium Hydroxide Solution).
Sodium hydroxide not less than 5 percent by weight. For manufacturing
use only,'' together with a statement of the quantity of contents in the
container (for example, ''50 gallons'') and the name and address of the
manufacturer, packer, or shipper.
(c) Bile from the condemned livers of sheep and goats also may be
released, under the same conditions as outlined in the preceding
paragraph, except that the words ''Sheep Bile'' or ''Goat Bile,'' as the
case may be, shall be substituted for the words ''Ox Bile'' upon the
label. In the case of mixtures of bile from any two or all three of the
sources mentioned, the label shall indicate the sources of such bile.
21 CFR 200.101 Suprarenal glands from hog carcasses prior to final
inspection.
(a) The Agricultural Research Service of the U.S. Department of
Agriculture has informed the Food and Drug Administration of the
Department of Health and Human Services that, under appropriate
conditions, it will permit the removal of suprarenal glands from hogs
that have not been finally inspected by Federal inspectors. The glands
to be so obtained are intended for use in manufacturing extracts
containing one or more of the therapeutically useful constituents of
suprarenal glands.
(b) Under the conditions specified in this section, the Secretary of
Health and Human Services has determined that the public health will be
adequately protected from any danger from the use of drugs, made in
whole or in part from suprarenal glands of hogs that may be condemned by
Federal inspectors of the Department of Agriculture after removal of
such glands from the carcasses, arising from any abnormality of such
carcasses if such glands are subjected to the following prescribed
treatment, which will destroy or eliminate any microorganisms or toxins
that might be present in the glands:
(c) The glands are subjected to quick freezing promptly upon removal
from the carcasses and maintained in a frozen state until they are
ground and immersed in 95 percent to 100 percent acetone. The ground
tissues remain in the acetone for a period of not less than 6 days, the
mixture is filtered, and the residue is burned.
21 CFR 200.101 Subpart E -- Prescription Drug Consumer Price Listing
21 CFR 200.200 Prescription drugs; reminder advertisements and
reminder labeling to provide price information to consumers.
(a) Prescription drug reminder advertisements and reminder labeling
intended to provide price information to consumers are exempt from the
requirements of 201 .100 and 202.1 of this chapter if all of the
following conditions are met:
(1) The only purpose of the reminder advertisement or reminder
labeling is to provide consumers with information concerning the price
charged for a prescription for a particular drug product, and the
reminder advertisement or reminder labeling contains no representation
or suggestion concerning the drug product's safety, effectiveness, or
indications for use.
(2) The reminder advertisement or reminder labeling contains the
proprietary name of the drug product, if any; the established (generic)
name of the drug product, if any; the drug product's strength if the
product contains a single active ingredient or if the product contains
more than one active ingredient and a relevant strength can be
associated with the product without indicating each active ingredient
(the established name and quantity of each active ingredient are not
required); the dosage form; and the price charged for a prescription
for a specific quantity of the drug product.
(3) The reminder advertisement or reminder labeling may also include
other written, printed, or graphic matter, e.g., identification of
professional or convenience services provided by the pharmacy:
Provided, That such information is neither false nor misleading and
contains no representation or suggestion concerning the drug product's
safety, effectiveness, or indications for use.
(4) The price stated in the reminder advertisement or reminder
labeling as that charged for a prescription shall include all charges to
the consumer including, but not limited to, the cost of the drug
product, professional fees, and handling fees, if any. Mailing fees and
delivery fees, if any, may be stated separately and without repetition.
(b) This exemption from 201.100 and 202.1 of this chapter is
applicable to all prescription drug reminder labeling and reminder
advertisements solely intended to provide consumers with information
regarding the price charged for prescriptions including price lists,
catalogs, and other promotional material, whether mailed, posted in a
pharmacy, placed in a newspaper, or aired on radio or television.
(c) Any reminder advertisement or reminder labeling intended to
provide consumers with prescription price information which is not in
compliance with this section shall be the subject of appropriate
regulatory action. Such action may be taken against the product and/or
the responsible person.
(40 FR 58799, Dec. 18, 1975)
21 CFR 200.200 Pt. 201
21 CFR 200.200 PART 201 -- LABELING
21 CFR 200.200 Subpart A -- General Labeling Provisions
Sec.
201.1 Drugs; name and place of business of manufacturer, packer, or
distributor.
201.2 Drugs and devices; National Drug Code numbers.
201.5 Drugs; adequate directions for use.
201.6 Drugs; misleading statements.
201.10 Drugs; statement of ingredients.
201.15 Drugs; prominence of required label statements.
201.16 Drugs; Spanish-language version of certain required
statements.
201.17 Drugs; location of expiration date.
201.18 Drugs; significance of control numbers.
201.19 Drugs; use of term ''infant''.
201.20 Declaration of presence of FD&C Yellow No. 5 and/or FD&C
Yellow No. 6 in certain drugs for human use.
201.21 Declaration of presence of phenylalanine as a component of
aspartame in over-the-counter and prescription drugs for human use.
201.22 Prescription drugs containing sulfites; required warning
statements.
21 CFR 200.200 Subpart B -- Labeling Requirements for Prescription
Drugs and/or Insulin
201.50 Statement of identity.
201.51 Declaration of net quantity of contents.
201.55 Statement of dosage.
201.56 General requirements on content and format of labeling for
human prescription drugs.
201.57 Specific requirements on content and format of labeling for
human prescription drugs.
201.58 Requests for waiver of requirement for adequate and
well-controlled studies to substantiate certain labeling statements.
201.59 Effective date of 201.56, 201.57, 201.100(d)(3), and
201.100(e).
21 CFR 200.200 Subpart C -- Labeling Requirements for Over-the-Counter
Drugs
201.60 Principal display panel.
201.61 Statement of identity.
201.62 Declaration of net quantity of contents.
201.63 Pregnancy-nursing warning.
21 CFR 200.200 Subpart D -- Exemptions from Adequate Directions for Use
201.100 Prescription drugs for human use.
201.105 Veterinary drugs.
201.110 Retail exemption for veterinary drugs.
201.115 New drugs or new animal drugs.
201.116 Drugs having commonly known directions.
201.117 Inactive ingredients.
201.119 In vitro diagnostic products.
201.120 Prescription chemicals and other prescription components.
201.122 Drugs for processing, repacking, or manufacturing.
201.125 Drugs for use in teaching, law enforcement, research, and
analysis.
201.127 Drugs; expiration of exemptions.
201.128 Meaning of ''intended uses''.
201.129 Drugs; exemption for radioactive drugs for research use.
21 CFR 200.200 Subpart E -- Other Exemptions
201.150 Drugs; processing, labeling, or repacking.
201.161 Carbon dioxide and certain other gases.
21 CFR 200.200 Subpart F -- Labeling Claims for Drugs in Drug Efficacy
Study
201.200 Disclosure of drug efficacy study evaluations in labeling and
advertising.
21 CFR 200.200 Subpart G -- Specific Labeling Requirements for Specific
Drug Products
201.300 Notice to manufacturers, packers, and distributors of
glandular preparations.
201.301 Notice to manufacturers, packers, and distributors of
estrogenic hormone preparations.
201.302 Notice to manufacturers, packers, and distributors of drugs
for internal use which contain mineral oil.
201.303 Labeling of drug preparations containing significant
proportions of wintergreen oil.
201.304 Tannic acid and barium enema preparations.
201.305 Isoproterenol inhalation preparations (pressurized aerosols,
nebulizers, powders) for human use; warnings.
201.306 Potassium salt preparations intended for oral ingestion by
man.
201.307 Chlorcyclizine, cyclizine, meclizine; warnings; labeling
requirements.
201.308 Ipecac syrup; warnings and directions for use for
over-the-counter sale.
201.309 Acetophenetidin (phenacetin)- containing preparations;
necessary warning statement.
201.310 Phenindione; labeling of drug preparations intended for use
by man.
201.311 (Reserved)
201.312 Magnesium sulfate heptahydrate; label declaration on drug
products.
201.313 Estradiol labeling.
201.314 Labeling of drug preparations containing salicylates.
201.315 Over-the-counter drugs for minor sore throats; suggested
warning.
201.316 Drugs with thyroid hormone activity for human use; required
warning.
201.317 Digitalis and related cardiotonic drugs for human use in oral
dosage forms; required warning.
Authority: Secs. 201, 301, 501, 502, 503, 505, 506, 507, 508, 510,
512, 701, 704, 706 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321, 331, 351, 352, 353, 355, 356, 357, 358, 360, 360b, 371, 374,
376); secs. 215, 301, 351, 354-360F, 361 of the Public Health Service
Act (42 U.S.C. 216, 241, 262, 263b-263n, 264).
Source: 40 FR 13998, Mar. 27, 1975, unless otherwise noted.
21 CFR 200.200 Subpart A -- General Labeling Provisions
21 CFR 201.1 Drugs; name and place of business of manufacturer,
packer, or distributor.
(a) A drug or drug product (as defined in 320.1 of this chapter) in
finished package form is misbranded under section 502(a) and (b)(1) of
the act if its label does not bear conspicuously the name and place of
business of the manufacturer, packer, or distributor. This paragraph
does not apply to any drug or drug product dispensed in accordance with
section 503(b)(1) of the act.
(b) As used in this section, and for purposes of section 502(a) and
(b)(1) of the act, the manufacturer of a drug product is the person who
performs all of the following operations that are required to produce
the product: (1) Mixing, (2) granulating, (3) milling, (4) molding, (5)
lyophilizing, (6) tableting, (7) encapsulating, (8) coating, (9)
sterilizing, and (10) filling sterile, aerosol, or gaseous drugs into
dispensing containers.
(c) If no person performs all of the applicable operations listed in
paragraph (b) of this section, no person may be represented as
manufacturer except as follows:
(1) If the person performs more than one half of the applicable
operations listed in paragraph (b) of this section and acknowledges the
contribution of other persons who have performed the remaining
applicable operations by stating on the product label that ''Certain
manufacturing operations have been performed by other firms.''; or
(2) If the person performs at least one applicable operation listed
in paragraph (b) of this section and identifies by appropriate
designation all other persons who have performed the remaining
applicable operations, e.g., ''Made by (Person A), Filled by (Person B),
Sterilized by (Person C)''; or
(3) If the person performs at least one applicable operation listed
in paragraph (b) of this section and the person is listed along with all
other persons who have performed the remaining applicable operations as
''joint manufacturers.'' A list of joint manufacturers shall be
qualified by the phrase ''Jointly Manufactured By ------------ ,'' and
the names of all of the manufacturers shall be printed together in the
same type size and style; or
(4) If the person performs all applicable operations listed in
paragraph (b) of this section except for those operations listed in
paragraph (d) of this section. For purposes of this paragraph, person,
when it identifies a corporation, includes a parent, subsidiary, or
affiliate company where the related companies are under common ownership
and control.
(d) The Food and Drug Administration finds that it is the common
practice in the drug industry to contract out the performance of certain
manufacturing operations listed in paragraph (b) of this section. These
operations include: (1) Soft-gelatin encapsulating, (2) aerosol
filling, (3) sterilizing by irradiation, (4) lyophilizing, and (5)
ethylene oxide sterilization.
(e) A person performs an operation listed in paragraph (b) of this
section only if the operation is performed, including the performance of
the appropriate in-process quality control operations, except laboratory
testing of samples taken during processing, as follows:
(1) By individuals, a majority of whom are employees of the person
and, throughout the performance of the operation, are subject to the
person's direction and control;
(2) On premises that are continuously owned or leased by the person
and subject to the person's direction and control; and
(3) On equipment that is continuously owned or leased by the person.
As used in this paragraph, person, when it identifies a corporation,
includes a parent, subsidiary, or affiliate company where the related
companies are under common ownership and control.
(f) The name of the person represented as manufacturer under
paragraph (b) or (c) of this section must be the same as either (1) the
name of the establishment (as defined in 207.3(b) of this chapter)
under which that person is registered at the time the labeled product is
produced or (2) the registered establishment name of a parent,
subsidiary, or affiliate company where the related companies are under
common ownership and control. In addition, the name shall meet the
requirements of paragraph (g) of this section.
(g) THe requirement for declaration of the name of the manufacturer,
packer, or distributor shall be deemed to be satisfied, in the case of a
corporate person, only by the actual corporate name, except that the
corporate name may be the name of a parent, subsidiary, or affiliate
company where the related companies are under common ownership and
control. The corporate name may be preceded or followed by the name of
the particular division of the corporation. ''Company,''
''Incorporated,'' etc., may be abbreviated or omitted and ''The'' may be
omitted. In the case of an individual, partnership, or association, the
name under which the business is conducted shall be used.
(h)(1) Except as provided in this section, no person other than the
manufacturer, packer, or distributor may be identified on the label of a
drug or drug product.
(2) The appearance on a drug product label of a person's name without
qualification is a representation that the named person is the sole
manufacturer of the product. That representation is false and
misleading, and the drug product is misbranded under section 502(a) of
the act, if the person is not the manufacturer of the product in
accordance with this section.
(3) If the names of two or more persons appear on the label of a drug
or drug product, the label may identify which of the persons is to be
contacted for further information about the product.
(4) If a trademark appears on the drug or drug product label or
appears as a mark directly on the drug product (e.g., tablet or
capsule), the label may identify the holder or licensee of the
trademark. The label may also state whether the person identified holds
the trademark or is licensee of the trademark.
(5) If the distributor is named on the label, the name shall be
qualified by one of the following phrases: ''Manufactured for
------------ '', ''Distributed by ------------ '', ''Manufactured by
------------ for ------------ '', ''Manufactured for ---------- by
---------- '', ''Distributor: ------------ '', ''Marketed by
------------ ''. The qualifying phrases may be abbreviated.
(6) If the packer is identified on the label, the name shall be
qualified by the phrase ''Packed by ------------ '' or ''Packaged by
------------ ''. The qualifying phrases may be abbreviated.
(i) The statement of the place of business shall include the street
address, city, State, and ZIP Code. For a foreign manufacturer, the
statement of the place of business shall include the street address,
city, country, and any applicable mailing code. 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 to
consumer commodity labels developed or revised after July 1, 1969. In
the case of nonconsumer packages, the ZIP Code shall appear either on
the label or the labeling (including the invoice).
(j) If a person manufactures, packs, or distributes a drug or drug
product at a place other than the person's principal place of business,
the label may state the principal place of business in lieu of the
actual place where such drug or drug product was manufactured or packed
or is to be distributed, unless such statement would be misleading.
(k) Paragraphs (b), (c), (d), (e), and (f) of this section, do not
apply to the labeling of drug components.
(l) A drug product is misbranded under section 502(a) of the act if
its labeling identifies a person as manufacturer, packer, or
distributor, and that identification does not meet the requirements of
this section.
(m) This section does not apply to biological drug products that are
subject to the requirements of section 351 of the Public Health Service
Act, 42 U.S.C. 262.
(45 FR 25775, Apr. 15, 1980; 45 FR 72118, Oct. 31, 1980, as amended
at 48 FR 37620, Aug. 19, 1983)
21 CFR 201.2 Drugs and devices; National Drug Code numbers.
The National Drug Code (NDC) number is requested but not required to
appear on all drug labels and in all drug labeling, including the label
of any prescription drug container furnished to a consumer. If the NDC
number is shown on a drug label, it shall be displayed as required in
207.35(b)(3) of this chapter.
(40 FR 52002, Nov. 7, 1975)
21 CFR 201.5 Drugs; adequate directions for use.
''Adequate directions for use'' means directions under which the
layman can use a drug safely and for the purposes for which it is
intended. (Section 201.128 defines ''intended use.'') Directions for
use may be inadequate because, among other reasons, of omission, in
whole or in part, or incorrect specification of:
(a) Statements of all conditions, purposes, or uses for which such
drug is intended, including conditions, purposes, or uses for which it
is prescribed, recommended, or suggested in its oral, written, printed,
or graphic advertising, and conditions, purposes, or uses for which the
drug is commonly used; except that such statements shall not refer to
conditions, uses, or purposes for which the drug can be safely used only
under the supervision of a practitioner licensed by law and for which it
is advertised solely to such practitioner.
(b) Quantity of dose, including usual quantities for each of the uses
for which it is intended and usual quantities for persons of different
ages and different physical conditions.
(c) Frequency of administration or application.
(d) Duration of administration or application.
(e) Time of administration or application (in relation to time of
meals, time of onset of symptoms, or other time factors).
(f) Route or method of administration or application.
(g) Preparation for use, i.e., shaking, dilution, adjustment of
temperature, or, other manipulation or process.
(41 FR 6908, Feb. 13, 1976)
21 CFR 201.6 Drugs; misleading statements.
(a) Among representations in the labeling of a drug which render such
drug misbranded is a false or misleading representation with respect to
another drug or a device or a food or cosmetic.
(b) The labeling of a drug which contains two or more ingredients may
be misleading by reason, among other reasons, of the designation of such
drug 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.
(41 FR 6908, Feb. 13, 1976)
21 CFR 201.10 Drugs; statement of ingredients.
(a) The ingredient information required by section 502(e) of the
Federal Food, Drug, and Cosmetic Act shall appear together, without any
intervening written, printed, or graphic matter, except the proprietary
names of ingredients, which may be included with the listing of
established names, and such statements as ''Warning -- May be habit
forming'' that are specifically required for certain ingredients by the
act or regulations in this chapter.
(b) The term ''ingredient'' applies to any substance in the drug,
whether added to the formulation as a single substance or in admixture
with other substances.
(c) The labeling of a drug may be misleading by reason (among other
reasons) of:
(1) The order in which the names of the ingredients present in the
drug appear in the labeling, or the relative prominence otherwise given
such names.
(2) Failure to reveal the proportion of, or other fact with respect
to, an ingredient present in such drug, when such proportion or other
fact is material in the light of the representation that such ingredient
is present in such drug.
(3) The employment of a fanciful proprietary name for a drug or
ingredient in such a manner as to imply that the drug or ingredient has
some unique effectiveness or composition when, in fact, the drug or
ingredient is a common substance, the limitations of which are readily
recognized when the drug or ingredient is listed by its established
name.
(4) The featuring in the labeling of inert or inactive ingredients in
a manner that creates an impression of value greater than their true
functional role in the formulation.
(5) Designation of a drug or ingredient by a proprietary name that,
because of similarity in spelling or pronunciation, may be confused with
the proprietary name or the established name of a different drug or
ingredient.
(d) (1) If the drug is in tablet or capsule form or other unit dosage
form, any statement of the quantity of an ingredient contained therein
shall express the quantity of such ingredient in each such unit. If the
drug is not in unit dosage form, any statement of the quantity of an
ingredient contained therein shall express the amount of such ingredient
in a specified unit of weight or measure of the drug, or the percentage
of such ingredient in such drug. Such statements shall be in terms that
are informative to licensed practitioners, in the case of a prescription
drug, and to the layman, in the case of a nonprescription drug.
(2) A statement of the percentage of an ingredient in a drug shall,
if the term ''percent'' is used without qualification, mean percent
weight-in-weight, if the ingredient and the drug are both solids, or if
the ingredient is a liquid and the drug is a solid; percent weight in
volume at 68 F. (20 C.), if the ingredient is a solid and the drug is
a liquid; and percent volume in volume at 68 F. (20 C.), if both the
ingredient and the drug are liquids, except that alcohol shall be stated
in terms of percent volume of absolute alcohol at 60 F. (15.56 C.).
(e) A derivative or preparation of a substance named in section
502(e) of the act is an article derived or prepared from such substance
by any method, including actual or theoretical chemical action.
(f) If an ingredient is a derivative or preparation of a substance
specifically named in section 502(e) of the act and the established name
of such ingredient does not indicate that it is a derivative or
preparation of the parent substance named in section 502(e) of the act,
the labeling shall, in conjunction with the listing of the established
name of such ingredient, declare that such article is a derivative or
preparation of such parent substance.
(g) (1) If the label or labeling of a prescription drug bears a
proprietary name or designation for the drug or any ingredient thereof,
the established name, if such there be, corresponding to such
proprietary name or designation shall accompany such proprietary name or
designation each time it is featured on the label or in the labeling for
the drug; but, except as provided in this subparagraph, the established
name need not be used with the proprietary name or designation in the
running text of the label or labeling. On any label or page of labeling
in which the proprietary name or designation is not featured but is used
in the running text, the established name shall be used at least once in
the running text in association with such proprietary name or
designation and in the same type size used in such running text:
Provided, however, That if the proprietary name or designation is used
in the running text in larger size type, the established name shall be
used at least once in association with, and in type at least half as
large as the type used for, the most prominent presentation of the
proprietary name or designation in such running text. If any labeling
includes a column with running text containing detailed information as
to composition, prescribing, side effects, or contraindications and the
proprietary name or designation is used in such column but is not
featured above or below the column, the established name shall be used
at least once in such column of running text in association with such
proprietary name or designation and in the same type size used in such
column of running text: Provided, however, That if the proprietary name
or designation is used in such column of running text in larger size
type, the established name shall be used at least once in association
with, and in type at least half as large as the type used for, the most
prominent presentation of the proprietary name or designation in such
column of running text. Where the established name is required to
accompany or to be used in association with the proprietary name or
designation, the established name shall be placed in direct conjunction
with the proprietary name or designation, and the relationship between
the proprietary name or designation and the established name shall be
made clear by use of a phrase such as ''brand of'' preceding the
established name, by brackets surrounding the established name, or by
other suitable means.
(2) The established name shall be printed in letters that are at
least half as large as the letters comprising the proprietary name or
designation with which it is joined, and the established name shall have
a prominence commensurate with the prominence with which such
proprietary name or designation appears, taking into account all
pertinent factors, including typography, layout, contrast, and other
printing features.
(h) (1) In the case of a prescription drug containing two or more
active ingredients, if the label bears a proprietary name or designation
for such mixture and there is no established name corresponding to such
proprietary name or designation, the quantitative ingredient information
required on the label by section 502(e) of the act shall be placed in
direct conjunction with the most prominent display of the proprietary
name or designation. The prominence of the quantitative ingredient
information shall bear a reasonable relationship to the prominence of
the proprietary name.
(2) If the drug is packaged in a container too small to bear the
quantitative ingredient information on the main display panel, the
quantitative ingredient information required by section 502(e) of the
act may appear elsewhere on the label, even though the proprietary name
or designation appears on the main display panel of the label; but
side- or back-panel placement shall in this case be so arranged and
printed as to provide size and prominence of display reasonably related
to the size and prominence of the front-panel display.
(i) A drug packaged in a container too small or otherwise unable to
accommodate a label with sufficient space to bear the information
required for compliance with section 502(e)(1)(A)(ii) and (B) of the act
shall be exempt from compliance with those clauses: Provided, That:
(1) The label bears:
(i) The proprietary name of the drug;
(ii) The established name, if such there be, of the drug;
(iii) An identifying lot or control number; and
(iv) The name of the manufacturer, packer, or distributor of the
drug; and
(2) All the information required to appear on the label by the act
and the regulations in this chapter appears on the carton or other outer
container or wrapper if such carton, outer container, or wrapper has
sufficient space to bear such information, or such complete label
information appears on a leaflet with the package.
21 CFR 201.15 Drugs; prominence of required label 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 502(c) 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 502(b) or (e) 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 502(c)
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.
(3) If the labeling 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 the labeling in the foreign language.
(41 FR 6908, Feb. 13, 1976)
21 CFR 201.16 Drugs; Spanish-language version of certain required
statements.
An increasing number of medications restricted to prescription use
only are being labeled solely in Spanish for distribution in the
Commonwealth of Puerto Rico where Spanish is the predominant language.
Such labeling is authorized under 201.15(c). Two required warnings, the
wording of which is fixed by law in the English language, are presently
being translated in various ways, from literal translation to loose
interpretation. The statutory nature of these two statements requires
that the translation must convey the meaning properly, in order to avoid
confusion and dilution of the purposes of the warnings. The
Commissioner of Food and Drugs hereby adopts the following
Spanish-language versions as the accepted equivalents of the English
wording of the following:
(a) Section 503(b) (4) of the Federal Food, Drug, and Cosmetic Act
requires the statement ''Caution: Federal law prohibits dispensing
without prescription.'' The Spanish version of this shall be:
''Precaucion: La ley Federal prohibe su despacho sin prescripcion
facultativa.''
(b) Section 502(d) of the Federal Food, Drug, and Cosmetic Act
requires the statement ''Warning -- May be habit forming'' on
habit-forming drugs. The Spanish version of this shall be: ''Aviso --
Puede formar habito o vicio.''
(41 FR 6908, Feb. 13, 1976)
21 CFR 201.17 Drugs; location of expiration date.
When an expiration date of a drug is required, e.g., expiration
dating of drug products required by 211.137 of this chapter, it shall
appear on the immediate container and also the outer package, if any,
unless it is easily legible through such outer package. However, when
single-dose containers are packed in individual cartons, the expiration
date may properly appear on the individual carton instead of the
immediate product container.
(43 FR 45076, Sept. 29, 1978)
21 CFR 201.18 Drugs; significance of control numbers.
The lot number on the label of a drug should be capable of yielding
the complete manufacturing history of the package. An incorrect lot
number may be regarded as causing the article to be misbranded.
21 CFR 201.19 Drugs; use of term ''infant''.
The regulations affecting special dietary foods ( 105.3(e) of this
chapter) define an infant as a child not more than 12 months old. Apart
from this, the Food and Drug Administration has not established any
definition of the term ''infant.'' Some question has arisen whether, for
the purposes of drug labeling, an infant means a child up to 1 year of
age or a child up to 2 years of age. Until the term is more precisely
defined by legislation or formal regulation, where the exact meaning of
the term is significant, manufacturers should qualify any reference to
''infant'' to indicate whether it refers to a child who is not more than
1 year of age, or a child not more than 2 years of age.
(40 FR 13998, Mar. 27, 1975, as amended at 42 FR 14091, Mar. 15,
1977; 44 FR 16006, Mar. 16, 1979)
21 CFR 201.20 Declaration of presence of FD&C Yellow No. 5 and/or FD&C
Yellow No. 6 in certain drugs for human use.
(a) The label for over-the-counter and prescription drug products
intended for human use administered orally, nasally, rectally, or
vaginally containing FD&C Yellow No. 5 shall specifically declare the
presence of FD&C Yellow No. 5 as a color additive using the names FD&C
Yellow No. 5 and tartrazine. The labeling for over-the-counter and
prescription drug products shall bear a statement such as ''Contains
FD&C Yellow No. 5 (tartrazine) as a color additive'' or ''Contains
color additives including FD&C Yellow No. 5 (tartrazine)''. The labels
of certain drug products subject to this labeling requirement that are
also cosmetics, such as antibacterial mouthwashes and fluoride
toothpastes, need not comply with this requirement provided they comply
with the requirements of 701.3 of this chapter.
(b) The labeling required by 201.100(d) of this part for
prescription drugs for human use containing FD&C Yellow No. 5 that are
administered orally, nasally, vaginally, or rectally shall bear the
warning statement ''This product contains FD&C Yellow No. 5
(tartrazine) which may cause allergic-type reactions (including
bronchial asthma) in certain susceptible persons. Although the overall
incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general
population is low, it is frequently seen in patients who also have
aspirin hypersensitivity.'' This warning statement shall appear in the
''Precautions'' section of the labeling.
(c) The label for over-the-counter drug products intended for human
use administered orally, nasally, rectally, or vaginally containing FD&C
Yellow No. 6 shall specifically declare the presence of FD&C Yellow No.
6 by listing the color additive using the name FD&C Yellow No. 6. The
labeling for over-the-counter and prescription drug products containing
FD&C Yellow No. 6 shall declare the presence of FD&C Yellow No. 6. The
labels of certain drug products subject to this labeling requirement
that are also cosmetics, such as antibacterial mouthwashes and fluoride
toothpastes, need not comply with this requirement provided they comply
with the requirements of 701.3 of this chapter.
(45 FR 60422, Sept. 12, 1980, as amended at 51 FR 41783, Nov. 19,
1986; 52 FR 21509, June 8, 1987)
Effective Date Note: At 53 FR 49138, Dec. 6, 1988, 201.20(c) was
suspended pending further agency action.
21 CFR 201.21 Declaration of presence of phenylalanine as a component
of aspartame in over-the-counter and prescription drugs for human use.
(a) Aspartame is the methylester of a dipeptide composed of two amino
acids, phenylalanine and aspartic acid. When these two amino acids are
so combined to form aspartame (1-methyl N-L-a-aspartyl-L-phenylalanine),
they produce an intensely sweet-tasting substance, approximately 180
times as sweet as sucrose. The Food and Drug Administration has
determined that aspartame when used at a level no higher than reasonably
required to perform its intended technical function is safe for use as
an inactive ingredient in human drug products, provided persons with
phenylketonuria, who must restrict carefully their phenylalanine intake,
are alerted to the presence of phenylalanine in the drug product and the
amount of the ingredient in each dosage unit.
(b) The label and labeling of all over-the-counter human drug
products containing aspartame as an inactive ingredient shall bear a
statement to the following effect: Phenylketonurics: Contains
Phenylalanine( ---- )mg Per (Dosage Unit).
(c) The package labeling and other labeling providing professional
use information concerning prescription drugs for human use containing
aspartame as an inactive ingredient shall bear a statement to the
following effect under the ''Precautions'' section of the labeling, as
required in 201.57(f)(2): Phenylketonurics: Contains Phenylalanine(
---- )mg Per (Dosage Unit) .
(d) Holders of approved new drug applications who reformulate their
drug products under the provisions of this section shall submit
supplements under 314.70 of this chapter to provide for the new
composition and the labeling changes.
(Approved by the Office of Management and Budget under control number
0910-0242)
(52 FR 2111, Jan. 20, 1987; 52 FR 12152, April 15, 1987; 53 FR
4135, Feb. 12, 1988)
21 CFR 201.22 Prescription drugs containing sulfites; required warning
statements.
(a) Sulfites are chemical substances that are added to certain drug
products to inhibit the oxidation of the active drug ingredient.
Oxidation of the active drug ingredient may result in instability and a
loss of potency of the drug product. Examples of specific sulfites used
to inhibit this oxidation process include sodium bisulfite, sodium
metabisulfite, sodium sulfite, potassium bisulfite, and potassium
metabisulfite. Recent studies have demonstrated that sulfites may cause
allergic-type reactions in certain susceptible persons, especially
asthmatics. The labeling for any prescription drug product to which
sulfites have been added as an inactive ingredient, regardless of the
amount added, must bear the warning specified in paragraph (b) or (c) of
this section.
(b) The labeling required by 201.57 and 201.100(d) for prescription
drugs for human use containing a sulfite, except epinephrine for
injection when intended for use in allergic or other emergency
situations, shall bear the warning statement ''Contains (insert the name
of the sulfite, e.g., sodium metabisulfite), a sulfite that may cause
allergic-type reactions including anaphylactic symptoms and
life-threatening or less severe asthmatic episodes in certain
susceptible people. The overall prevalence of sulfite sensitivity in
the general population is unknown and probably low. Sulfite sensitivity
is seen more frequently in asthmatic than in nonasthmatic people.'' This
statement shall appear in the ''Warnings'' section of the labeling.
(c) The labeling required by 201.57 and 201.100(d) for
sulfite-containing epinephrine for injection for use in allergic
emergency situations shall bear the warning statement ''Epinephrine is
the preferred treatment for serious allergic or other emergency
situations even though this product contains (insert the name of the
sulfite, e.g., sodium metabisulfite), a sulfite that may in other
products cause allergic-type reactions including anaphylactic symptoms
or life-threatening or less severe asthmatic episodes in certain
susceptible persons. The alternatives to using epinephrine in a
life-threatening situation may not be satisfactory. The presence of a
sulfite(s) in this product should not deter administration of the drug
for treatment of serious allergic or other emergency situations.'' This
statement shall appear in the ''Warnings'' section of the labeling.
(51 FR 43904, Dec. 5, 1986)
21 CFR 201.22 Subpart B -- Labeling Requirements for Prescription Drugs and/or Insulin
21 CFR 201.50 Statement of identity.
(a) The label of prescription and insulin-containing drugs in package
form shall bear as one of its principal features a statement of the
identity of the drug.
(b) Such statement of identity shall be in terms of the established
name of the drug. An insulin-containing drug shall be further
identified by placement on the outside container or wrapper of the
package, and on the label of the immediate container, of the
distinguishing color(s) required by 429.12 of this chapter. In the
case of a prescription drug that is a mixture and that has no
established name, the requirement for statement of identity shall be
deemed to be satisfied by a listing of the quantitative ingredient
information as prescribed by 201.10.
(c) The statement of identity of a prescription drug shall also
comply with the placement, size and prominence requirements of 201.10.
21 CFR 201.51 Declaration of net quantity of contents.
(a) The label of a prescription or insulin-containing drug 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
of quantity of drugs in tablet, capsule, ampule, or other unit dosage
form shall be expressed in terms of numerical count; the statement of
quantity for drugs in other dosage forms shall be in terms of weight if
the drug is solid, semi-solid, or viscous, or in terms of fluid measure
if the drug is liquid. When the drug quantity statement is in terms of
the numerical count of the drug units, it shall be augmented to give the
weight or measure of the drug units or the quantity of each active
ingredient in each drug unit or, when quantity does not accurately
reflect drug potency, a statement of the drug potency.
(b) Statements of weight of the contents shall in the case of
prescription drugs be expressed in terms of avoirdupois pound, ounce,
and grain or of kilogram, gram, and subdivisions thereof. A statement
of liquid measure of the contents shall in the case of prescription
drugs be expressed in terms of the U.S. gallon of 231 cubic inches and
quart, pint, fluid-ounce, and fluid-dram subdivisions thereof, or of the
liter and milliliter, or cubic centimeter, and shall express the volume
at 68 F. (20 C.). A statement of the liquid measure of the contents
in the case of insulin-containing drugs shall be expressed in terms of
the liter and milliliter, or cubic centimeter, and shall express the
volume at 68 F. (20 C.).
(c) The declaration shall contain only such fractions as are
generally used in expressing the quantity of the drug. A common
fraction shall be reduced to its lowest terms; a decimal fraction shall
not be carried out to more than three places, except in the case of a
statement of the quantity of an active ingredient in a unit of a drug.
(d) The declaration shall appear as a distinct item on the label and,
in the case of large volume parenterals, may be embossed on the glass.
(e) The declaration shall accurately reveal the quantity of drug in
the package exclusive of wrappers and other material packed therewith.
(f) A statement of the quantity of a prescription or
insulin-containing drug in terms of weight or measure applicable to such
drug, under the provisions of paragraph (a) of this section, shall
express with prominence and conspicuousness the number of the largest
whole unit, as specified in paragraph (b) of this section, that are
contained in the package. Any remainder shall be expressed in terms of
common or decimal fractions of such unit or in terms of the next smaller
whole unit and common or decimal fractions thereof.
(g) 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. In the case of a
liquid drug in ampules or vials, intended for injection, the declaration
shall be considered to express the minimum quantity and the variation
above the stated measure shall comply with the excess volume prescribed
by the National Formulary or the U.S. Pharmacopeia for filling of
ampules. In the case of a solid drug in ampules or vials, the
declaration shall be considered to express the accurate net weight.
Variations shall comply with the limitations provided in the U.S.
Pharmacopeia or the National Formulary.
(h) A drug shall be exempt from compliance with the net quantity
declaration required by this section if it is an ointment labeled
''sample'', ''physician's sample'', or a substantially similar statement
and the contents of the package do not exceed 8 grams.
21 CFR 201.55 Statement of dosage.
Section 201.100(b)(2) requires that labels for prescription drugs
bear a statement of the recommended or usual dosage. Since the dosage
for some prescription drugs varies within extremely wide limits,
depending upon the conditions being treated, it may not be possible in
all cases to present an informative or useful statement of the
recommended or usual dosage in the space available on the label or
carton of the package. It is the view of the Food and Drug
Administration that when such a situation prevails, compliance with this
requirement would be met by a statement such as ''See package insert for
dosage information'', where the detailed information is contained in
such insert. However, if an informative, realistic, recommended or
usual dosage can readily be set forth on the label, it should appear
thereon.
21 CFR 201.56 General requirements on content and format of labeling
for human prescription drugs.
Prescription drug labeling described in 201.100(d) shall contain the
information in the format required by 201.57 and shall meet the
following general requirements:
(a) The labeling shall contain a summary of the essential scientific
information needed for the safe and effective use of the drug.
(b) The labeling shall be informative and accurate and neither
promotional in tone nor false or misleading in any particular.
(c) The labeling shall be based whenever possible on data derived
from human experience. No implied claims or suggestions of drug use may
be made if there is inadequate evidence of safety or a lack of
substantial evidence of effectiveness. Conclusions based on animal data
but necessary for safe and effective use of the drug in humans shall be
identified as such and included with human data in the appropriate
section of the labeling, headings for which are listed in paragraph (d)
of this section.
(d)(1) The labeling shall contain specific information required under
201.57 under the following section headings and in the following order:
Description.
Clinical Pharmacology.
Indications and Usage.
Contraindications.
Warnings.
Precautions.
Adverse Reactions.
Drug Abuse and Dependence.
Overdosage.
Dosage and Administration.
How Supplied.
(2) The labeling may contain the following additional section
headings if appropriate and if in compliance with 201.57(l) and (m):
Animal Pharmacology and/or Animal Toxicology.
Clinical Studies.
References.
(3) The labeling may omit any section or subsection of the labeling
format if clearly inapplicable.
(4) The labeling may contain a ''Product Title'' section preceding
the ''Description'' section and containing only the information required
by 201.57(a)(1)(i), (ii), (iii), and (iv) and 201.100(e). The
information required by 201.57(a)(1)(i), (ii), (iii), and (iv) shall
appear in the ''Description'' section of the labeling, whether or not it
also appears in a ''Product Title.''
(e) The labeling shall contain the date of the most recent revision
of the labeling, identified as such, placed prominently immediately
after the last section of the labeling.
(44 FR 37462, June 26, 1979)
21 CFR 201.57 Specific requirements on content and format of labeling
for human prescription drugs.
Each section heading listed in 201.56(d), if not omitted under
201.56(d)(3), shall contain the following information in the following
order:
(a) ''Description'':
(1) Under this section heading, the labeling shall contain:
(i) The proprietary name and the established name, if any, as defined
in section 502(e)(2) of the act, of the drug;
(ii) The type of dosage form and the route of administration to which
the labeling applies;
(iii) The same qualitative and/or quantitative ingredient information
as required under 201.100(b) for labels;
(iv) If the product is sterile, a statement of that fact;
(v) The pharmacological or therapeutic class of the drug;
(vi) The chemical name and structural formula of the drug;
(vii) If the product is radioactive, a statement of the important
nuclear physical characteristics, such as the principal radiation
emission data, external radiation, and physical decay characteristics.
(2) If appropriate, other important chemical or physical information,
such as physical constants, or pH, shall be stated.
(b) ''Clinical Pharmacology'':
(1) Under this section heading, the labeling shall contain a concise
factual summary of the clinical pharmacology and actions of the drug in
humans. The summary may include information based on in vitro and/or
animal data if the information is essential to a description of the
biochemical and/or physiological mode of action of the drug or is
otherwise pertinent to human therapeutics. Pharmacokinetic information
that is important to safe and effective use of the drug is required, if
known, e.g., degree and rate of absorption, pathways of
biotransformation, percentage of dose as unchanged drug and metabolites,
rate or half-time of elimination, concentration in body fluids
associated with therapeutic and/or toxic effects, degree of binding to
plasma proteins, degree of uptake by a particular organ or in the fetus,
and passage across the blood brain barrier. Inclusion of
pharmacokinetic information is restricted to that which relates to
clinical use of the drug. If the pharmacological mode of action of the
drug is unknown or if important metabolic or pharmacokinetic data in
humans are unavailable, the labeling shall contain a statement about the
lack of information.
(2) Data that demonstrate activity or effectiveness in in vitro or
animal tests and that have not been shown by adequate and
well-controlled clinical studies to be pertinent to clinical use may be
included under this section of the labeling only under the following
circumstances:
(i) In vitro data for anti-infective drugs may be included if the
data are immediately preceded by the statement ''The following in vitro
data are available but their clinical significance is unknown.''
(ii) For other classes of drugs, in vitro and animal data that have
not been shown by adequate and well-controlled clinical studies, as
defined in 314.126(b) of this chapter, to be pertinent to clinical use
may be used only if a waiver is granted under 201.58 or 314.126(b) of
this chapter.
(c) ''Indications and Usage'':
(1) Under this section heading, the labeling shall state that:
(i) The drug is indicated in the treatment, prevention, or diagnosis
of a recognized disease or condition, e.g., penicillin is indicated for
the treatment of pneumonia due to susceptible pneumococci; and/or
(ii) The drug is indicated for the treatment, prevention, or
diagnosis of an important manifestation of a disease or condition, e.g.,
chlorothiazide is indicated for the treatment of edema in patients with
congestive heart failure; and/or
(iii) The drug is indicated for the relief of symptoms associated
with a disease or syndrome, e.g., chlorpheniramine is indicated for the
symptomatic relief of nasal congestion in patients with vasomotor
rhinitis; and/or
(iv) The drug, if used for a particular indication only in conjuction
with a primary mode of therapy, e.g., diet, surgery, or some other drug,
is an adjunct to the mode of therapy.
(2) All indications shall be supported by substantial evidence of
effectiveness based on adequate and well-controlled studies as defined
in 314.126(b) of this chapter unless the requirement is waived under
201.58 or 314.126(b) of this chapter.
(3) This section of the labeling shall also contain the following
additional information:
(i) If evidence is available to support the safety and effectiveness
of the drug only in selected subgroups of the larger population with a
disease, syndrome, or symptom under consideration, e.g., patients with
mild disease or patients in a special age group, the labeling shall
describe the available evidence and state the limitations of usefulness
of the drug. The labeling shall also identify specific tests needed for
selection or monitoring of the patients who need the drug, e.g., microbe
susceptibility tests. Information on the approximate kind, degree, and
duration of improvement to be anticipated shall be stated if available
and shall be based on substantial evidence derived from adequate and
well-controlled studies as defined in 314.126(b) of this chapter unless
the requirement is waived under 201.58 or 314.126(b) of this chapter.
If the information is relevant to the recommended intervals between
doses, the usual duration of treatment, or any modification of dosage,
it shall be stated in the ''Dosage and Administration'' section of the
labeling and referenced in this section.
(ii) If safety considerations are such that the drug should be
reserved for certain situations, e.g., cases refractory to other drugs,
this information shall be stated in this section.
(iii) If there are specific conditions that should be met before the
drug is used on a long-term basis, e.g., demonstration of responsiveness
to the drug in a short-term trial, the labeling shall identify the
conditions; or, if the indications for long-term use are different from
those for short-term use, the labeling shall identify the specific
indications for each use.
(iv) If there is a common belief that the drug may be effective for a
certain use or if there is a common use of the drug for a condition, but
the preponderance of evidence related to the use or condition shows that
the drug is ineffective, the Food and Drug Administration may require
that the labeling state that there is a lack of evidence that the drug
is effective for that use or condition.
(v) Any statements comparing the safety or effectiveness, either
greater or less, of the drug with other agents for the same indication
shall be supported by adequate and well-controlled studies as defined in
314.126(b) of this chapter unless this requirement is waived under
201.58 or 314.126(b) of this chapter.
(d) ''Contraindications'': Under this section heading, the labeling
shall describe those situations in which the drug should not be used
because the risk of use clearly outweighs any possible benefit. These
situations include administration of the drug to patients known to have
a hypersensitivity to it; use of the drug in patients who, because of
their particular age, sex, concomitant therapy, disease state, or other
condition, have a substantial risk of being harmed by it; or continued
use of the drug in the face of an unacceptably hazardous adverse
reaction. Known hazards and not theoretical possibilities shall be
listed, e.g., if hypersensitivity to the drug has not been demonstrated,
it should not be listed as a contraindication. If no contraindications
are known, this section of the labeling shall state ''None known.''
(e) ''Warnings'': Under this section heading, the labeling shall
describe serious adverse reactions and potential safety hazards,
limitations in use imposed by them, and steps that should be taken if
they occur. The labeling shall be revised to include a warning as soon
as there is reasonable evidence of an association of a serious hazard
with a drug; a causal relationship need not have been proved. A
specific warning relating to a use not provided for under the
''Indications and Usage'' section of the labeling may be required by the
Food and Drug Administration if the drug is commonly prescribed for a
disease or condition, and there is lack of substantial evidence of
effectivenes for that disease or condition, and such usage is associated
with serious risk or hazard. Special problems, particularly those that
may lead to death or serious injury, may be required by the Food and
Drug Administration to be placed in a prominently displayed box. The
boxed warning ordinarily shall be based on clinical data, but serious
animal toxicity may also be the basis of a boxed warning in the absence
of clinical data. If a boxed warning is required, its location will be
specified by the Food and Drug Administration. The frequency of these
serious adverse reactions and, if known, the approximate mortality and
morbidity rates for patients sustaining the reaction, which are
important to safe and effective use of the drug, shall be expressed as
provided under the ''Adverse Reactions'' section of the labeling.
(f) ''Precautions'': Under this section heading, the labeling shall
contain the following subsections as appropriate for the drug:
(1) General: This subsection of the labeling shall contain
information regarding any special care to be exercised by the
practitioner for safe and effective use of the drug, e.g., precautions
not required under any other specific section or subsection of the
labeling.
(2) Information for patients: This subsection of the labeling shall
contain information to be given to patients for safe and effective use
of the drug, e.g., precautions concerning driving or the concomitant use
of other substances that may have harmful additive effects. Any printed
patient information required under this chapter to be distributed to the
patient shall be referenced under the ''Precautions'' section of the
labeling and the full text of such patient information shall be
reprinted at the end of the labeling.
(3) Laboratory tests: This subsection of the labeling shall identify
any laboratory tests that may be helpful in following the patient's
response or in identifying possible adverse reactions. If appropriate,
information shall be provided on such factors as the range of normal and
abnormal values expected in the particular situation and the recommended
frequency with which tests should be done before, during, and after
therapy.
(4)(i) Drug interactions: This subsection of the labeling shall
contain specific practical guidance for the physician on preventing
clinically significant drug/drug and drug/food interactions that may
occur in vivo in patients taking the drug. Specific drugs or classes of
drugs with which the drug to which the labeling applies may interact in
vivo shall be identified, and the mechanism(s) of the interaction shall
be briefly described. Information in this subsection of the labeling
shall be limited to that pertaining to clinical use of the drug in
patients. Drug interactions supported only by animal or in vitro
experiments may not ordinarily be included, but animal or in vitro data
may be used if shown to be clinically relevant. Drug incompatibilities,
i.e., drug interactions that may occur when drugs are mixed in vitro, as
in a solution for intravenous administration, shall be discussed under
the ''Dosage and Administration'' section of the labeling rather than
under this subsection of the labeling.
(ii) Drug/laboratory test interactions: This subsection of the
labeling shall contain practical guidance on known interference of the
drug with laboratory tests.
(5) Carcinogenesis, mutagenesis, impairment of fertility: This
subsection of the labeling shall state whether long-term studies in
animals have been performed to evaluate carcinogenic potential and, if
so, the species and results. If reproduction studies or other data in
animals reveal a problem or potential problem concerning mutagenesis or
impairment of fertility in either males or females, the information
shall be described. Any precautionary statement on these topics shall
include practical, relevant advice to the physician on the significance
of these animal findings. If there is evidence from human data that the
drug may be carcinogenic or mutagenic or that it impairs fertility, this
information shall be included under the ''Warnings'' section of the
labeling. Also, under ''Precautions,'' the labeling shall state: ''See
'Warnings' section for information on carcinogenesis, mutagenesis, and
impairment of fertility.''
(6) Pregnancy: This subsection of the labeling may be omitted only
if the drug is not absorbed systemically and the drug is not known to
have a potential for indirect harm to the fetus. For all other drugs,
this subsection of the labeling shall contain the following information:
(i) Teratogenic effects. Under this heading the labeling shall
identify one of the following categories that applies to the drug, and
the labeling shall bear the statement required under the category:
(a) Pregnancy category A. If adequate and well-controlled studies in
pregnant women have failed to demonstrate a risk to the fetus in the
first trimester of pregnancy (and there is no evidence of a risk in
later trimesters), the labeling shall state: ''Pregnancy Category A.
Studies in pregnant women have not shown that (name of drug) increases
the risk of fetal abnormalities if administered during the first
(second, third, or all) trimester(s) of pregnancy. If this drug is used
during pregnancy, the possibility of fetal harm appears remote. Because
studies cannot rule out the possibility of harm, however, (name of drug)
should be used during pregnancy only if clearly needed.'' The labeling
shall also contain a description of the human studies. If animal
reproduction studies are available and they fail to demonstrate a risk
to the fetus, the labeling shall also state: ''Reproduction studies
have been performed in (kinds of animal(s)) at doses up to (x) times the
human dose and have revealed no evidence of impaired fertility or harm
to the fetus due to (name of drug).'' The labeling shall also contain a
description of available data on the effect of the drug on the later
growth, development, and functional maturation of the child.
(b) Pregnancy category B. If animal reproduction studies have failed
to demonstrate a risk to the fetus and there are no adequate and
well-controlled studies in pregnant women, the labeling shall state:
''Pregnancy Category B. Reproduction studies have been performed in
(kind(s) of animal(s)) at doses up to (x) times the human dose and have
revealed no evidence of impaired fertility or harm to the fetus due to
(name of drug). There are, however, no adequate and well-controlled
studies in pregnant women. Because animal reproduction studies are not
always predictive of human response, this drug should be used during
pregnancy only if clearly needed.'' If animal reproduction studies have
shown an adverse effect (other than decrease in fertility), but adequate
and well-controlled studies in pregnant women have failed to demonstrate
a risk to the fetus during the first trimester of pregnancy (and there
is no evidence of a risk in later trimesters), the labeling shall state:
''Pregnancy Category B. Reproduction studies in (kind(s) of animal(s))
have shown (describe findings) at (x) times the human dose. Studies in
pregnant women, however, have not shown that (name of drug) increases
the risk of abnormalities when administered during the first (second,
third, or all) trimester(s) of pregnancy. Despite the animal findings,
it would appear that the possibility of fetal harm is remote, if the
drug is used during pregnancy. Nevertheless, because the studies in
humans cannot rule out the possibility of harm, (name of drug) should be
used during pregnancy only if clearly needed.'' The labeling shall also
contain a description of the human studies and a description of
available data on the effect of the drug on the later growth,
development, and functional maturation of the child.
(c) Pregnancy category C. If animal reproduction studies have shown
an adverse effect on the fetus, if there are no adequate and
well-controlled studies in humans, and if the benefits from the use of
the drug in pregnant women may be acceptable despite its potential
risks, the labeling shall state: ''Pregnancy Category C. (Name of
drug) has been shown to be teratogenic (or to have an embryocidal effect
or other adverse effect) in (name(s) of species) when given in doses (x)
times the human dose. There are no adequate and well-controlled studies
in pregnant women. (Name of drug) should be used during pregnancy only
if the potential benefit justifies the potential risk to the fetus.''
The labeling shall contain a description of the animal studies. If
there are no animal reproduction studies and no adequate and
well-controlled studies in humans, the labeling shall state:
''Pregnancy Category C. Animal reproduction studies have not been
conducted with (name of drug). It is also not known whether (name of
drug) can cause fetal harm when administered to a pregnant woman or can
affect reproduction capacity. (Name of drug) should be given to a
pregnant woman only if clearly needed.'' The labeling shall contain a
description of any available data on the effect of the drug on the later
growth, development, and functional maturation of the child.
(d) Pregnancy category D. If there is positive evidence of human
fetal risk based on adverse reaction data from investigational or
marketing experience or studies in humans, but the potential benefits
from the use of the drug in pregnant women may be acceptable despite its
potential risks (for example, if the drug is needed in a
life-threatening situation or serious disease for which safer drugs
cannot be used or are ineffective), the labeling shall state:
''Pregnancy Category D. See 'Warnings' section.'' Under the
''Warnings'' section, the labeling states: ''(Name of drug) can cause
fetal harm when administered to a pregnant woman. (Describe the human
data and any pertinent animal data.) If this drug is used during
pregnancy, or if the patient becomes pregnant while taking this drug,
the patient should be apprised of the potential hazard to the fetus.''
(e) Pregnancy category X. If studies in animals or humans have
demonstrated fetal abnormalities or if there is positive evidence of
fetal risk based on adverse reaction reports from investigational or
marketing experience, or both, and the risk of the use of the drug in a
pregnant woman clearly outweighs any possible benefit (for example,
safer drugs or other forms of therapy are available), the labeling shall
state: ''Pregnancy Category X. See 'Contraindications' section.''
Under ''Contraindications,'' the labeling shall state: ''(Name of drug)
may (can) cause fetal harm when administered to a pregnant woman.
(Describe the human data and any pertinant animal data.) (Name of drug)
is contraindicated in women who are or may become pregnant. If this
drug is used during pregnancy, or if the patient becomes pregnant while
taking this drug, the patient should be apprised of the potential hazard
to the fetus.''
(ii) Nonteratogenic effects. Under this heading the labeling shall
contain other information on the drug's effects on reproduction and the
drug's use during pregnancy that is not required specifically by one of
the pregnancy categories, if the information is relevant to the safe and
effective use of the drug. Information required under this heading
shall include nonteratogenic effects in the fetus or newborn infant (for
example, withdrawal symptoms or hypoglycemia) that may occur because of
a pregnant woman's chronic use of the drug for a preexisting condition
or disease.
(7) Labor and delivery: If the drug has a recognized use during
labor or delivery (vaginal or abdominal delivery), whether or not the
use is stated in the indications section of the labeling, this
subsection of the labeling shall describe the available information
about the effect of the drug on the mother and the fetus, on the
duration of labor or delivery, on the possibility that forceps delivery
or other intervention or resuscitation of the newborn will be necessary,
and the effect of the drug on the later growth, development, and
functional maturation of the child. If any information required under
this subsection is unknown, this subsection of the labeling shall state
that the information is unknown.
(8) Nursing mothers:
(i) If a drug is absorbed systemically, this subsection of the
labeling shall contain, if known, information about excretion of the
drug in human milk and effects on the nursing infant. Pertinent adverse
effects observed in animal offspring shall be described.
(ii) If a drug is absorbed systemically and is known to be excreted
in human milk, this subsection of the labeling shall contain one of the
following statements, as appropriate. If the drug is associated with
serious adverse reactions or if the drug has a known tumorigenic
potential, the labeling shall state: ''Because of the potential for
serious adverse reactions in nursing infants from (name of drug) (or,
''Because of the potential for tumorigenicity shown for (name of drug)
in (animal or human) studies), a decision should be made whether to
discontinue nursing or to discontinue the drug, taking into account the
importance of the drug to the mother.'' If the drug is not associated
with serious adverse reactions and does not have a known tumorigenic
potential, the labeling shall state: ''Caution should be exercised when
(name of drug) is administered to a nursing woman.''
(iii) If a drug is absorbed systemically and information on excretion
in human milk is unknown, this subsection of the labeling shall contain
one of the following statements, as appropriate. If the drug is
associated with serious adverse reactions or has a known tumorigenic
potential, the labeling shall state: ''It is not known whether this
drug is excreted in human milk. Because many drugs are excreted in
human milk and because of the potential for serious adverse reactions in
nursing infants from (name of drug) (or, ''Because of the potential for
tumorigenicity shown for (name of drug) in (animal or human) studies), a
decision should be made whether to discontinue nursing or to discontinue
the drug, taking into account the importance of the drug to the
mother.'' If the drug is not associated with serious adverse reactions
and does not have a known tumorigenic potential, the labeling shall
state: ''It is not known whether this drug is excreted in human milk.
Because many drugs are excreted in human milk, caution should be
exercised when (name of drug) is administered to a nursing woman.''
(9) Pediatric use: A specific pediatric indication, if any, shall be
described under the ''Indications and Usage'' section of the labeling,
and appropriate pediatric dosage shall be stated under the ''Dosage and
Administration'' section of the labeling. Statements on pediatric use
of the drug for an indication approved for adults shall be based on
substantial evidence derived from adequate and well-controlled studies
as defined in 314.126(b) of this chapter unless this requirement is
waived under 201.58 or 314.126(b) of this chapter. If the
requirements of 314.126(b) of this chapter cannot be met, this section
of the labeling shall contain one of the following statements: ''Safety
and effectiveness in children have not been established,'' or ''Safety
and effectiveness in children below the age of ( ) have not been
established.'' If use of the drug in premature or neonatal infants, or
in older children, is associated with a specific hazard, the hazard
shall be described in this subsection of the labeling; or, if
appropriate, the hazard shall be stated in the ''Contraindications'' or
''Warnings'' section of the labeling and this subsection of the labeling
shall refer to it.
(g) ''Adverse Reactions'': An adverse reaction is an undesirable
effect, reasonably associated with the use of the drug, that may occur
as part of the pharmacological action of the drug or may be
unpredictable in its occurrence.
(1) This section of the labeling shall list the adverse reactions
that occur with the drug and with drugs in the same pharmacologically
active and chemically related class, if applicable.
(2) In this listing, adverse reactions may be categorized by organ
system, by severity of the reaction, by frequency, or by toxicological
mechanism, or by a combination of these, as appropriate. If frequency
information from adequate clinical studies is available, the categories
and the adverse reactions within each category shall be listed in
decreasing order of frequency. An adverse reaction that is
significantly more severe than the other reactions listed in a category,
however, shall be listed before those reactions, regardless of its
frequency. If frequency information from adequate clinical studies is
not available, the categories and adverse reactions within each category
shall be listed in decreasing order of severity. The approximate
frequency of each adverse reaction shall be expressed in rough estimates
or orders of magnitude essentially as follows: ''The most frequent
adverse reaction(s) to (name of drug) is (are) (list reactions). This
(these) occur(s) in about (e.g., one-third of patients; one in 30
patients; less than one-tenth of patients). Less frequent adverse
reactions are (list reactions), which occur in approximately (e.g., one
in 100 patients). Other adverse reactions, which occur rarely, in
approximately (e.g., one in 1,000 patients), are (list reactions).''
Percent figures may not ordinarily be used unless they are documented by
adequate and well-controlled studies as defined in 314.126(b) of this
chapter, they are shown to reflect general experience, and they do not
falsely imply a greater degree of accuracy than actually exists.
(3) The ''Warnings'' section of the labeling or, if appropriate, the
''Contraindications'' section of the labeling shall identify any
potentially fatal adverse reaction.
(4) Any claim comparing the drug to which the labeling applies with
other drugs in terms of frequency, severity, or character of adverse
reactions shall be based on adequate and well-controlled studies as
defined in 314.126(b) of this chapter unless this requirement is waived
under 201.58 or 314.126(b) of this chapter.
(h) ''Drug Abuse and Dependence'': Under this section heading, the
labeling shall contain the following subsections, as appropriate for the
drug:
(1) Controlled Substance: If the drug is controlled by the Drug
Enforcement Administration, the schedule in which it is controlled shall
be stated.
(2) Abuse: This subsection of the labeling shall be based primarily
on human data and human experience, but pertinent animal data may also
be used. This subsection shall state the types of abuse that can occur
with the drug and the adverse reactions pertinent to them. Particularly
susceptible patient populations shall be identified.
(3) Dependence: This subsection of the labeling shall describe
characteristic effects resulting from both psychological and physical
dependence that occur with the drug and shall identify the quantity of
the drug over a period of time that may lead to tolerance or dependence,
or both. Details shall be provided on the adverse effects of chronic
abuse and the effects of abrupt withdrawal. Procedures necessary to
diagnose the dependent state shall be provided, and the principles of
treating the effects of abrupt withdrawal shall be described.
(i) ''Overdosage'': Under this section heading, the labeling shall
describe the signs, symptoms, and laboratory findings of acute
overdosage and the general principles of treatment. This section shall
be based on human data, when available. If human data are unavailable,
appropriate animal and in vitro data may be used. Specific information
shall be provided about the following:
(1) Signs, symptoms, and laboratory findings associated with an
overdosage of the drug.
(2) Complications that can occur with the drug (for example, organ
toxicity or delayed acidosis).
(3) Oral LD50 of the drug in animals; concentrations of the drug in
biologic fluids associated with toxicity and/or death; physiologic
variables influencing excretion of the drug, such as urine pH; and
factors that influence the dose response relationship of the drug, such
as tolerance. The pharmacokinetic data given in the ''Clinical
Pharmacology'' section also may be referenced here, if applicable to
overdoses.
(4) The amount of the drug in a single dose that is ordinarily
associated with symptoms of overdosage and the amount of the drug in a
single dose that is likely to be life-threatening.
(5) Whether the drug is dialyzable.
(6) Recommended general treatment procedures and specific measures
for support of vital functions, such as proven antidotes, induced
emesis, gastric lavage, and forced diuresis. Unqualified
recommendations for which data are lacking with the specific drug or
class of drugs, especially treatment using another drug (for example,
central nervous system stimulants, respiratory stimulants) may not be
stated unless specific data or scientific rationale exists to support
safe and effective use.
(j) ''Dosage and Administration'': This section of the labeling
shall state the recommended usual dose, the usual dosage range, and, if
appropriate, an upper limit beyond which safety and effectiveness have
not been established; dosages shall be stated for each indication when
appropriate. This section shall also state the intervals recommended
between doses, the optimal method of titrating dosage, the usual
duration of treatment, and any modification of dosage needed in special
patient populations, e.g., in children, in geriatric age groups, or in
patients with renal or hepatic disease. Specific tables or monographs
may be included to clarify dosage schedules. Radiation dosimetry
information shall be stated for both the patient receiving a radioactive
drug and the person administering it. This section shall also contain
specific direction on dilution, preparation (including the strength of
the final dosage solution, when prepared according to instructions, in
terms of milligrams active ingredient per milliliter of reconstituted
solution, unless another measure of the strength is more appropriate),
and administration of the dosage form, if needed, e.g., the rate of
administration of parenteral drug in milligrams per minute; storage
conditions for stability of the drug or reconstituted drug, when
important; essential information on drug incompatibilities if the drug
is mixed in vitro with other drugs; and the following statement for
parenterals: ''Parenteral drug products should be inspected visually
for particulate matter and discoloration prior to administration,
whenever solution and container permit.''
(k) ''How Supplied'': This section of the labeling shall contain
information on the available dosage forms to which the labeling applies
and for which the manufacturer or distributor is responsible. The
information shall ordinarily include:
(1) The strength of the dosage form, e.g., 10-milligram tablets, in
metric system and, if the apothecary system is used, a statement of the
strength is placed in parentheses after the metric designation;
(2) The units in which the dosage form is ordinarily available for
prescribing by practitioners, e.g., bottles of 100;
(3) Appropriate information to facilitate identification of the
dosage forms, such as shape, color, coating, scoring, and National Drug
Code; and
(4) Special handling and storage conditions.
(l) ''Animal Pharmacology and/or Animal Toxicology'': In most cases,
the labeling need not include this section. Significant animal data
necessary for safe and effective use of the drug in humans shall
ordinarily be included in one or more of the other sections of the
labeling, as appropriate. Commonly for a drug that has been marketed
for a long time, and in rare cases for a new drug, chronic animal
toxicity studies have not been performed or completed for a drug that is
administered over prolonged periods or is implanted in the body. The
unavailability of such data shall be stated in the appropriate section
of the labeling for the drug. If the pertinent animal data cannot be
appropriately incorporated into other sections of the labeling, this
section may be used.
(m) ''Clinical Studies'' and ''References'': These sections may
appear in labeling in the place of a detailed discussion of a subject
that is of limited interest but nonetheless important. A reference to a
specific important clinical study may be made in any section of the
format required under 201.56 and 201.57 if the study is essential to
an understandable presentation of the available information. References
may appear in sections of the labeling format, other than the ''Clinical
Studies'' or ''References'' section, in rare circumstances only. A
clinical study or reference may be cited in prescription drug labeling
only under the following conditions:
(1) If the clinical study or reference is cited in the labeling in
the place of a detailed discussion of data and information concerning an
indication for use of the drug, the reference shall be based upon, or
the clinical study shall constitute, an adequate and well-controlled
clinical investigation under 314.126(b) of this chapter.
(2) If the clinical study or reference is cited in the labeling in
the place of a detailed discussion of data and information concerning a
risk or risks from the use of the drug, the risk or risks shall also be
identified or discussed in the appropriate section of the labeling for
the drug.
(44 FR 37462, June 26, 1979, as amended at 55 FR 11576, Mar. 29,
1990)
21 CFR 201.58 Requests for waiver of requirement for adequate and
well-controlled studies to substantiate certain labeling statements.
A request under 201.57(b)(2)(ii), (c)(2), (c)(3)(i), (c)(3)(v),
(f)(9), and (g)(4) for a waiver of the requirements of 314.126(b) of
this chapter shall be submitted in writing as provided in 314.126(b) to
the Director, Center for Drug Evaluation and Research, Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20587, or, if
applicable, the Director, Center for Biologics Evaluation and Research,
8800 Rockville Pike, Bethesda, MD 20892. The waiver shall be granted or
denied in writing by such Director or the Director's designee.
(55 FR 11576, Mar. 29, 1990)
21 CFR 201.59 Effective date of 201.56, 201.57, 201.100(d)(3), and
201.100(e).
(a) On and after December 26, 1979, no person may initially introduce
or initially deliver for introduction into interstate commerce any drug
to which 201.56, 201.57, 201.100(d)(3) apply unless the drug's
labeling complies with the requirements set forth in the regulations,
with the following exceptions:
(1) If the drug is a prescription drug that is not a biologic, not
subject to section 505 of the act (21 U.S.C. 355), and not subject to
section 507 of the act (21 U.S.C. 357), 201.56, 201.57, and
201.100(d)(3) are effective on April 10, 1981.
(2) If the drug is a prescription drug that on December 26, 1979 is
(i) a licensed biologic, (ii) a new drug subject to an approved new drug
application or abbreviated new drug application under section 505 of the
act or (iii) an antibiotic drug subject to an approved antibiotic form,
201.56, 201.57, and 201.100(d)(3) are effective on the date listed
below for the class of drugs to which the drug belongs. Dates are also
listed below for the submission of supplemental applications,
amendments, and license changes.
(3) If the drug is approved after December 26, 1979 but is a
duplicate of a drug approved on or before that date (for example, a drug
approved under an abbreviated new drug application or an antibiotic
form), 201.56, 201.57, and 201.100(d)(3) are effective on the date
listed below for the class of drugs to which the drug belongs. Dates
are also listed below for the submission of supplemental applications,
amendments, and license changes.
(b) Section 201.100(e) is effective April 10, 1981.
(45 FR 32552, May 16, 1980, as amended at 46 FR 7272, Jan. 23, 1981;
49 FR 14331, Apr. 11, 1984; 50 FR 8995, Mar. 6, 1985; 55 FR 11576,
Mar. 29, 1990)
21 CFR 201.59 Subpart C -- Labeling Requirements for Over-the-Counter
Drugs
Source: 41 FR 6908, Feb. 13, 1976, unless otherwise noted.
21 CFR 201.60 Principal display panel.
The term ''principal display panel,'' as it applies to
over-the-counter drugs 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
designs, 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; and
(c) In the case of any other shape of 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, the area shall consist of the
entire top surface.
In determining the area of the principal display panel, exclude tops,
bottoms, flanges at the 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 201.61 Statement of identity.
(a) The principal display panel of an over-the-counter drug 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 the established
name of the drug, if any there be, followed by an accurate statement of
the general pharmacological category(ies) of the drug or the principal
intended action(s) of the drug. In the case of an over-the-counter drug
that is a mixture and that has no established name, this requirement
shall be deemed to be satisfied by a prominent and conspicuous statement
of the general pharmacological action(s) of the mixture or of its
principal intended action(s) in terms that are meaningful to the layman.
Such statements shall be placed in direct conjunction with the most
prominent display of the proprietary name or designation and shall
employ terms descriptive of general pharmacological category(ies) or
principal intended action(s); for example, ''antacid,'' ''analgesic,''
''decongestant,'' ''antihistaminic,'' etc. The indications for use
shall be included in the directions for use of the drug, as required by
section 502(f)(1) of the act and by the regulations in this part.
(c) The statement of identity shall be presented in bold face 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.
21 CFR 201.62 Declaration of net quantity of contents.
(a) The label of an over-the-counter drug 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 or
numerical count and weight, measure, or size. The statement of quantity
of drugs in tablet, capsule, ampule, or other unit form and the quantity
of devices shall be expressed in terms of numerical count; the
statement of quantity for drugs in other dosage forms shall be in terms
of weight if the drug is solid, semisolid, or viscous, or in terms of
fluid measure if the drug is liquid. The drug quantity statement shall
be augmented when necessary to give accurate information as to the
strength of such drug in the package; for example, to differentiate
between several strengths of the same drug ''100 tablets, 5 grains
each'' or ''100 capsules, 125 milligrams each'' or ''100 capsules, 250
milligrams each'': Provided, That:
(1) In the case of a firmly established, general consumer usage and
trade custom of declaring the quantity of a drug in terms of linear
measure or measure of area, such respective term may be used. Such term
shall be augmented when necessary for accuracy of information by a
statement of the weight, measure, or size of the individual units or of
the entire drug; for example, the net quantity of adhesive tape in
package form shall be expressed in terms of linear measure augmented by
a statement of its width.
(2) Whenever the Commissioner determines for a specific packaged drug
that an existing practice of declaring net quantity of contents by
weight, measure, numerical count, or a combination of these does not
facilitate value comparisons by consumers, he shall by regulation
designate the appropriate term or terms to be used for such article.
(b) Statements of weight of the contents shall be expressed in terms
of avoirdupois pound and ounce. A statement of liquid measure of the
contents shall be expressed in terms of the U.S. gallon of 231 cubic
inches and quart, pint, and fluid-ounce subdivisions thereof, and shall
express the volume at 68 F (20 C). See also paragraph (p) of this
section.
(c) The declaration may contain common or decimal fractions. A
common fraction shall be in terms of halves, quarters, eights,
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.
(d) 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.
(e) 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 ''giant pint'' and ''full quart'', that tends to
exaggerate the amount of the drug 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:
(1) 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; and
(2) In the case of a drug that is marketed with both outer and inner
retail containers bearing the mandatory label information required by
this part and the inner container is not intended to be sold separately,
the net quantity of contents placement requirement of this section
applicable to such inner container is waived.
(3) The principal display panel of a drug marketed on a display card
to which the immediate container is affixed may be considered to be the
display panel of the card, and the type size of the net quantity of
contents statement is governed by the dimensions of the display card.
(f) The declaration shall accurately reveal the quantity of drug or
device in the package exclusive of wrappers and other material packed
therewith: Provided, That in the case of drugs packed in containers
designed to deliver the drug 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.
(g) 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, i.e., 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.
(h) 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 five 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 one-half 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.
(i) 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
(k) (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 set forth in
paragraphs (k) (3) and (4) of this section). If the net weight of the
package is less than 1 ounce avoirdupois or the net fluid measure is
less than 1 fluid ounce, the declaration shall be in terms of common or
decimal fractions of the respective ounce and not in terms of drams.
(2) 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''.
(j) 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 fractions of the pound; in the case of fluid measure,
it shall be expressed in the largest whole unit (gallons, followed by
common or decimal fractions 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 (k) (5) of this section.
(k) Examples:
(1) A declaration of 1 1/2 pounds weight shall be expressed as ''Net
wt. 24 oz (1 lb 8 oz),'' or ''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 contents 32 fl oz (1 qt)'' or ''32 fl oz (1 qt)''.
(4) A declaration of 1 3/4 quarts liquid measure shall be expressed
as ''Net contents 56 fl oz (1 qt 1 pt 8 oz)'' or ''Net contents 56 fl oz
(1 qt 1.5 pt),'' but not in terms of quart and ounce such as ''Net 56 fl
oz (1 qt 24 oz).''
(5) A declaration of 2 1/2 gallons liquid measure shall be expressed
as ''Net contents 2 gal 2 qt,'' ''Net contents 2.5 gallons,'' or ''Net
contents 2 1/2 gal'' but not as ''2 gal 4 pt''.
(l) For quantities, the following abbreviations and none other may be
employed. Periods and plural forms are optional:
(m) On packages labeled in terms of linear measure, the declaration
shall be expressed both in terms of inches and, if applicable (1 foot or
more), the largest whole units (yards, yards and feet, feet). The
declaration in terms of the largest whole units shall be in parentheses
following the declaration in terms of inches and any remainder shall be
in terms of inches or common or decimal fractions of the foot or yard;
if applicable, as in the case of adhesive tape, the initial declaration
in linear inches shall be preceded by a statement of the width.
Examples of linear measure are ''86 inches (2 yd 1 ft 2 in),'' ''90
inches (2 1/2 yd),'' ''30 inches (2.5 ft),'' '' 3/4 inch by 36 in (1
yd),'' etc.
(n) On packages labeled in terms of area measure, the declaration
shall be expressed both in terms of square inches and, if applicable (1
square foot or more), the largest whole square unit (square yards,
square yards and square feet, square feet). The declaration in terms of
the largest whole units shall be in parentheses following the
declaration in terms of square inches and any remainder shall be in
terms of square inches or common or decimal fractions of the square foot
or square yard; for example, ''158 sq inches (1 sq ft 14 sq in).''
(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 drug contained in the package; for
example, ''giant pint'' and ''full quart.'' Dual or combination
declarations of net quantity of contents as provided for in paragraphs
(a) and (i) of this section are not regarded as supplemental net
quantity statements and shall be located on the principal display panel.
(p) A separate statement of net quantity of contents in terms of the
metric system of weight or measure 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) A drug shall be exempt from compliance with the net quantity
declaration required by this section if it is an ointment labeled
''sample,'' ''physician's sample,'' or a substantially similar statement
and the contents of the package do not exceed 8 grams.
21 CFR 201.63 Pregnancy-nursing warning.
(a) The labeling for all over-the-counter (OTC) drugs that are
intended for systemic absorption, unless specifically exempted, shall
contain a general warning under the heading Warning (or Warnings if it
appears with additional warning statements) as follows: ''As with any
drug, if you are pregnant or nursing a baby, seek the advice of a health
professional before using this product.'' In addition to the written
warning, a symbol that conveys the intent of the warning may be used in
labeling.
(b) Where a specific warning relating to use during pregnancy or
while nursing has been established for a particular drug product in a
new drug application (NDA) or for a product covered by an OTC drug final
monograph in part 330 of this chapter, the specific warning shall be
used in place of the warning in paragraph (a) of this section, unless
otherwise stated in the NDA or in the final OTC drug monograph.
(c) The following OTC drugs are exempt from the provisions of
paragraph (a) of this section:
(1) Drugs that are intended to benefit the fetus or nursing infant
during the period of pregnancy or nursing.
(2) Drugs that are labeled exclusively for pediatric use.
(d) The Food and Drug Administration will grant an exemption from
paragraph (a) of this section where appropriate upon petition under the
provisions of 10.30 of this chapter. Decisions with respect to
requests for exemptions shall be maintained in a permanent file for
public review by the Dockets Management Branch (HFA-305), Food and Drug
Administration, Rm. 4-62, 5600 Fishers Lane, Rockville, MD 20857.
(e) The labeling of orally or rectally administered OTC aspirin and
aspirin-containing drug products must bear a warning that immediately
follows the general warning identified in paragraph (a) of this section.
The warning shall be as follows:
''IT IS ESPECIALLY IMPORTANT NOT TO USE'' (select ''ASPIRIN'' or
''CARBASPIRIN CALCIUM,'' as appropriate) ''DURING THE LAST 3 MONTHS OF
PREGNANCY UNLESS SPECIFICALLY DIRECTED TO DO SO BY A DOCTOR BECAUSE IT
MAY CAUSE PROBLEMS IN THE UNBORN CHILD OR COMPLICATIONS DURING
DELIVERY.''
(47 FR 54757, Dec. 3, 1982, as amended at 55 FR 27784, July 5, 1990)
21 CFR 201.63 Subpart D -- Exemptions From Adequate Directions for Use
21 CFR 201.100 Prescription drugs for human use.
A drug subject to the requirements of section 503(b)(1) of the act
shall be exempt from section 502(f)(1) if all the following conditions
are met:
(a) The drug is:
(1) (i) In the possession of a person (or his agents or employees)
regularly and lawfully engaged in the manufacture, transportation,
storage, or wholesale distribution of prescription drugs; or
(ii) In the possession of a retail, hospital, or clinic pharmacy, or
a public health agency, regularly and lawfully engaged in dispensing
prescription drugs; or
(iii) In the possession of a practitioner licensed by law to
administer or prescribe such drugs; and
(2) It is to be dispensed in accordance with section 503(b)
(b) The label of the drug bears:
(1) The statement ''Caution: Federal law prohibits dispensing
without prescription'' and
(2) The recommended or usual dosage and
(3) The route of administration, if it is not for oral use; and
(4) The quantity or proportion of each active ingredient, as well as
the information required by section 502 (d) and (e); and
(5) If it is for other than oral use, the names of all inactive
ingredients, except that:
(i) Flavorings and perfumes may be designated as such without naming
their components.
(ii) Color additives may be designated as coloring without naming
specific color components unless the naming of such components is
required by a color additive regulation prescribed in Subchapter A of
this chapter.
(iii) Trace amounts of harmless substances added solely for
individual product identification need not be named. If it is intended
for administration by parenteral injection, the quantity or proportion
of all inactive ingredients, except that ingredients added to adjust the
pH or to make the drug isotonic may be declared by name and a statement
of their effect; and if the vehicle is water for injection it need not
be named.
(6) An identifying lot or control number from which it is possible to
determine the complete manufacturing history of the package of the drug.
(7) A statement directed to the pharmacist specifying the type of
container to be used in dispensing the drug product to maintain its
identity, strength, quality, and purity. Where there are standards and
test procedures for determining that the container meets the
requirements for specified types of containers as defined in an official
compendium, such terms may be used. For example, ''Dispense in tight,
light-resistant container as defined in the National Formulary''. Where
standards and test procedures for determining the types of containers to
be used in dispensing the drug product are not included in an official
compendium, the specific container or types of containers known to be
adequate to maintain the identity, strength, quality, and purity of the
drug products shall be described. For example, ''Dispense in containers
which (statement of specifications which clearly enable the dispensing
pharmacist to select an adequate container)'': Provided, however, That
in the case of containers too small or otherwise unable to accommodate a
label with sufficient space to bear all such information, but which are
packaged within an outer container from which they are removed for
dispensing or use, the information required by paragraph (b) (2), (3),
(5), and (7) of this section may be contained in other labeling on or
within the package from which it is to be dispensed; the information
referred to in paragraph (b)(1) of this section may be placed on such
outer container only; and the information required by paragraph (b)(6)
of this section may be on the crimp of the dispensing tube. The
information required by this paragraph (b)(7) is not required for
prescription drug products packaged in unit-dose, unit-of-use, on other
packaging format in which the manufacturer's original package is
designed and intended to be dispensed to patients without repackaging.
(c)(1) Labeling on or within the package from which the drug is to be
dispensed bears adequate information for its use, including indications,
effects, dosages, routes, methods, and frequency and duration of
administration, and any relevant hazards, contraindications, side
effects, and precautions under which practitioners licensed by law to
administer the drug can use the drug safely and for the purposes for
which it is intended, including all purposes for which it is advertised
or represented; and
(2) If the article is subject to section 505, 506, or 507 of the act,
the labeling bearing such information is the labeling authorized by the
approved new drug application or required as a condition for the
certification or the exemption from certification requirements
applicable to preparations of insulin or antibiotic drugs.
(d) Any labeling, as defined in section 201(m) of the act, whether or
not it is on or within a package from which the drug is to be dispensed,
distributed by or on behalf of the manufacturer, packer, or distributor
of the drug, that furnishes or purports to furnish information for use
or which prescribes, recommends, or suggests a dosage for the use of the
drug (other than dose information required by paragraph (b) (2) of this
section and 201.105(b) (2) contains:
(1) Adequate information for such use, including indications,
effects, dosages, routes, methods, and frequency and duration of
administration and any relevant warnings, hazards, contraindications,
side effects, and precautions, under which practitioners licensed by law
to administer the drug can use the drug safely and for the purposes for
which it is intended, including all conditions for which it is
advertised or represented; and if the article is subject to section 505
or 507 of the act, the parts of the labeling providing such information
are the same in language and emphasis as labeling approved or permitted,
under the provisions of section 505 or 507, respectively, and any other
parts of the labeling are consistent with and not contrary to such
approved or permitted labeling; and
(2) The same information concerning the ingredients of the drug as
appears on the label and labeling on or within the package from which
the drug is to be dispensed.
(3) The information required, and in the format specified, by
201.56 and 201.57.
(e) All labeling described in paragraph (d) of this section bears
conspicuously the name and place of business of the manufacturer,
packer, or distributor, as required for the label of the drug under
201.1.
(f) Reminder labeling which calls attention to the name of the drug
product but does not include indications or dosage recommendations for
use of the drug product is exempted from the provisions of paragraph (d)
of this section. This reminder labeling shall contain only the
proprietary name of the drug product, if any; the established name of
the drug product, if any; the established name of each active
ingredient in the drug product; and, optionally, information relating
to quantitative ingredient statements, dosage form, quantity of package
contents, price, the name and address of the manufacturer, packer, or
distributor or other written, printed, or graphic matter containing no
representation or suggestion relating to the drug product. If the
Commissioner finds that there is evidence of significant incidence of
fatalities or serious injury associated with the use of a particular
prescription drug, he may withdraw this exemption by so notifying the
manufacturer, packer, or distributor of the drug by letter. Reminder
labeling, other than price lists and catalogs solely intended to convey
price information including, but not limited to, those subject to the
requirements of 200.200 of this chapter, is not permitted for a
prescription drug product whose labeling contains a boxed warning
relating to a serious hazard associated with the use of the drug
product. Reminder labeling which is intended to provide consumers with
information concerning the price charged for a prescription for a
particular drug product shall meet all of the conditions contained in
200.200 of this chapter. Reminder labeling, other than that subject to
the requirements of 200.200 of this chapter, is not permitted for a
drug for which an announcement has been published pursuant to a review
of the labeling claims for the drug by the National Academy of
Sciences/National Research Council (NAS/NRC), Drug Efficacy Study Group,
and for which no claim has been evaluated as higher than ''possibly
effective.'' If the Commissioner finds the circumstances are such that
reminder labeling may be misleading to prescribers of drugs subject to
NAS/NRC evaluation, such reminder labeling will not be allowed and the
manufacturer, packer, or distributor will be notified either in the
publication of the conclusions on the effectiveness of the drug or by
letter.
(40 FR 13998, Mar. 27, 1975, as amended at 40 FR 58799, Dec. 18,
1975; 42 FR 15674, Mar. 22, 1977; 43 FR 37989, Aug. 25, 1978; 44 FR
20659, Apr. 6, 1979; 44 FR 37467, June 26, 1979; 45 FR 25777, Apr.
15, 1980)
21 CFR 201.105 Veterinary drugs.
A drug intended for veterinary use which, because of toxicity or
other potentiality for harmful effect, or the method of its use, is not
safe for animal use except under the supervision of a licensed
veterinarian, and hence for which ''adequate directions for use'' cannot
be prepared, shall be exempt from section 502(f) (1) of the act if all
the following conditions are met:
(a) The drug is:
(1) In the possession of a person (or his agents or employees)
regularly and lawfully engaged in the manufacture, transportation,
storage, or wholesale or retail distribution of veterinary drugs and is
to be sold only to or on the prescription or other order of a licensed
veterinarian for use in the course of his professional practice; or
(2) In the possession of a licensed veterinarian for use in the
course of his professional practice.
(b) The label of the drug bears:
(1) The statement ''Caution: Federal law restricts this drug to use
by or on the order of a licensed veterinarian''; and
(2) The recommended or usual dosage; and
(3) The route of administration, if it is not for oral use; and
(4) The quantity or proportion of each active ingredient as well as
the information required by section 502(e) of the act; and
(5) If it is for other than oral use, the names of all inactive
ingredients, except that:
(i) Flavorings and perfumes may be designated as such without naming
their components.
(ii) Color additives may be designated as coloring without naming
specific color components unless the naming of such components is
required by a color additive regulation prescribed in Subchapter A of
this chapter.
(iii) Trace amounts of harmless substances added solely for
individual product identification need not be named.
If it is intended for administration by parenteral injection, the
quantity or proportion of all inactive ingredients, except that
ingredients added to adjust the pH or to make the drug isotonic may be
declared by name and a statement of their effect; and if the vehicle is
water for injection, it need not be named.
(6) An identifying lot or control number from which it is possible to
determine the complete manufacturing history of the package of the drug;
Provided, however, That in the case of containers too small or
otherwise unable to accommodate a label with sufficient space to bear
all such information, but which are packaged within an outer container
from which they are removed for dispensing or use, the information
required by paragraphs (b) (2), (3), and (5) of this section may be
contained in other labeling on or within the package from which it is to
be so dispensed, and the information referred to in paragraph (b) (1) of
this section may be placed on such outer container only, and the
information required by paragraph (b) (6) of this section may be on the
crimp of the dispensing tube.
(c)(1) Labeling on or within the package from which the drug is to be
dispensed bears adequate information for its use, including indications,
effects, dosages, routes, methods, and frequency and duration of
administration, and any relevant hazards, contraindications, side
effects, and precautions under which veterinarians licensed by law to
administer the drug can use the drug safely and for the purposes for
which it is intended, including all purposes for which it is advertised
or represented; and
(2) If the article is subject to section 512 of the act, the labeling
bearing such information is the labeling authorized by the approved new
animal drug application or required as a condition for the certification
or the exemption from certification requirements applicable to
preparations of antibiotic drugs: Provided, however, That the
information required by paragraph (c) (1) of this section may be omitted
from the dispensing package if, but only if, the article is a drug for
which directions, hazards, warnings, and use information are commonly
known to veterinarians licensed by law to administer the drug. Upon
written request, stating reasonable grounds therefore, the Commissioner
will offer an opinion on a proposal to omit such information from the
dispensing package under this proviso.
(d) Any labeling, as defined in section 201(m) of the act, whether or
not it is on or within a package from which the drug is to be dispensed,
distributed by or on behalf of the manufacturer, packer, or distributor
of the drug, that furnishes or purports to furnish information for use
or which prescribes, recommends, or suggests a dosage for the use of the
drug (other than dose information required by paragraph (b)(2) of this
section and 201.100(b)(2)) contains:
(1) Adequate information for such use, including indications,
effects, dosages, routes, methods, and frequency and duration of
administration, and any relevant warnings, hazards, contraindications,
side effects, and precautions, and including information relevant to
compliance with the new animal drug provisions of the act, under which
veterinarians licensed by law to administer the drug can use the drug
safely and for the purposes for which it is intended, including all
conditions for which it is advertised or represented; and if the
article is subject to section 512 of the act, the parts of the labeling
providing such information are the same in language and emphasis as
labeling approved or permitted under the provisions of section 512, and
any other parts of the labeling are consistent with and not contrary to
such approved or permitted labeling; and
(2) The same information concerning the ingredients of the drug as
appears on the label and labeling on or within the package from which
the drug is to be dispensed;
Provided, however, That the information required by paragraphs (d)
(1) and (2) of this section is not required on the so-called
reminder-piece labeling which calls attention to the name of the drug
but does not include indications or dosage recommendations for use of
the drug.
(e) All labeling, except labels and cartons, bearing information for
use of the drug also bears the date of the issuance or the date of the
latest revision of such labeling.
(f) A prescription drug intended for both human and veterinary use
shall comply with paragraphs (e) and (f) of this section and 201.100.
(40 FR 13998, Mar. 27, 1975, as amended at 42 FR 15674, Mar. 22,
1977)
21 CFR 201.110 Retail exemption for veterinary drugs.
A drug subject to 201.105 shall be exempt at the time of delivery to
the ultimate purchaser or user from section 502(f)(1) of the act if it
is delivered by a licensed practitioner in the course of his
professional practice or upon a prescription or other order lawfully
issued in the course of his professional practice, with labeling bearing
the name and address of such licensed practitioner and the directions
for use and cautionary statements, if any, contained in such order.
(41 FR 6910, Feb. 13, 1976)
21 CFR 201.115 New drugs or new animal drugs.
A new drug shall be exempt from section 502(f)(1) of the act:
(a) To the extent to which such exemption is claimed in an approved
application with respect to such drug under section 505 or 512 of the
act; or
(b) If no application under section 505 of the act is approved with
respect to such drug but it complies with section 505(i) or 512 of the
act and regulations thereunder.
No exemption shall apply to any other drug which would be a new drug
if its labeling bore representations for its intended uses.
21 CFR 201.116 Drugs having commonly known directions.
A drug shall be exempt from section 502(f)(1) of the act insofar as
adequate directions for common uses thereof are known to the ordinary
individual.
(41 FR 6910, Feb. 13, 1976)
21 CFR 201.117 Inactive ingredients.
A harmless drug that is ordinarily used as an inactive ingredient,
such as a coloring, emulsifier, excipient, flavoring, lubricant,
preservative, or solvent, in the preparation of other drugs shall be
exempt from section 502(f)(1) of the act. This exemption shall not
apply to any substance intended for a use which results in the
preparation of a new drug, unless an approved new-drug application
provides for such use.
21 CFR 201.119 In vitro diagnostic products.
(a) ''In vitro diagnostic products'' are those reagents, instruments
and systems intended for use in the diagnosis of disease or in the
determination of the state of health in order to cure, mitigate, treat,
or prevent disease or its sequelae. Such products are intended for use
in the collection, preparation and examination of specimens taken from
the human body. These products are drugs or devices as defined in
section 201(g) and 201(h), respectively, of the Federal Food, Drug, and
Cosmetic Act (the act) or are a combination of drugs and devices, and
may also be a biological product subject to section 351 of the Public
Health Service Act.
(b) A product intended for use in the diagnosis of disease and which
is an in vitro diagnostic product as defined in paragraph (a) of this
section shall be deemed to be in compliance with the requirements of
this section and section 502(f)(1) of the act if it meets the
requirements of 809.10 of this chapter.
(41 FR 6910, Feb. 13, 1976)
21 CFR 201.120 Prescription chemicals and other prescription
components.
A drug prepared, packaged, and primarily sold as a prescription
chemical or other component for use by registered pharmacists in
compounding prescriptions or for dispensing in dosage unit form upon
prescriptions shall be exempt from section 502(f)(1) of the act if all
the following conditions are met:
(a) The drug is an official liquid acid or official liquid alkali, or
is not a liquid solution, emulsion, suspension, tablet, capsule, or
other dosage unit form; and
(b) The label of the drug bears:
(1) The statement ''For prescription compounding''; and
(2) If in substantially all dosage forms in which it may be dispensed
it is subject to section 503(b)(1) of the act, the statement ''Caution:
Federal law prohibits dispensing without prescription''; or
(3) If it is not subject to section 503(b)(1) of the act and is by
custom among retail pharmacists sold in or from the interstate package
for use by consumers, ''adequate directions for use'' in the conditions
for which it is so sold.
Provided, however, That the information referred to in paragraph
(b)(3) of this section may be contained in the labeling on or within the
package from which it is to be dispensed.
(c) This exemption shall not apply to any substance intended for use
in compounding which results in a new drug, unless an approved new-drug
application covers such use of the drug in compounding prescriptions.
21 CFR 201.122 Drugs for processing, repacking, or manufacturing.
A drug in a bulk package, except tablets, capsules, or other dosage
unit forms, intended for processing, repacking, or use in the
manufacture of another drug shall be exempt from section 502(f)(1) of
the act if its label bears the statement ''Caution: For manufacturing,
processing, or repacking''; and, if in substantially all dosage forms
in which it may be dispensed it is subject to section 503(b)(1), the
statement ''Caution: Federal law prohibits dispensing without
prescription''. This exemption and the exemption under 201.120 may be
claimed for the same article. But the exemption shall not apply to a
substance intended for a use in manufacture, processing, or repacking
which causes the finished article to be a new drug, unless:
(a) An approved new drug application or new animal drug application
covers the production and delivery of the drug substance to the
application holder by persons named in the application, and, for a new
drug substance, the export of it by such persons under 314.410 of this
chapter; or
(b) If no application is approved with respect to such new drug or
new animal drug, the label statement ''Caution: For manufacturing,
processing, or repacking'' is immediately supplemented by the words ''in
the preparation of a new drug or new animal drug limited by Federal law
to investigational use'', and the delivery is made for use only in the
manufacture of such new drug or new animal drug limited to
investigational use as provided in part 312 or 511.1 of this chapter;
or
(c) A new drug application or new animal drug application covering
the use of the drug substance in the production and marketing of a
finished drug product has been submitted but not yet approved or
disapproved, the bulk drug is not exported, and the finished drug
product is not further distributed after it is manufactured until after
the new drug application or new animal drug application is approved.
(41 FR 6911, Feb. 13, 1976, as amended at 41 FR 15844, Apr. 15, 1976;
50 FR 7492, Feb. 22, 1985; 55 FR 11576, Mar. 29, 1990)
21 CFR 201.125 Drugs for use in teaching, law enforcement, research,
and analysis.
A drug subject to 201.100 or 201.105, shall be exempt from section
502(f)(1) of the act if shipped or sold to, or in the possession of,
persons regularly and lawfully engaged in instruction in pharmacy,
chemistry, or medicine not involving clinical use, or engaged in law
enforcement, or in research not involving clinical use, or in chemical
analysis, or physical testing, and is to be used only for such
instruction, law enforcement, research, analysis, or testing.
(41 FR 6911, Feb. 13, 1976)
21 CFR 201.127 Drugs; expiration of exemptions.
(a) If a shipment or delivery, or any part thereof, of a drug which
is exempt under the regulations in this section is made to a person in
whose possession the article is not exempt, or is made for any purpose
other than those specified, such exemption shall expire, with respect to
such shipment or delivery or part thereof, at the beginning of that
shipment or delivery. The causing of an exemption to expire shall be
considered an act which results in such drug being misbranded unless it
is disposed of under circumstances in which it ceases to be a drug or
device.
(b) The exemptions conferred by 201.117, 201.119, 201.120, 201.122,
and 201.125 shall continue until the drugs are used for the purposes for
which they are exempted, or until they are relabeled to comply with
section 502(f)(1) of the act. If, however, the drug is converted,
compounded, or manufactured into a dosage form limited to prescription
dispensing, no exemption shall thereafter apply to the article unless
the dosage form is labeled as required by section 503(b) and 201.100
or 201.105.
(41 FR 6911, Feb. 13, 1976)
21 CFR 201.128 Meaning of ''intended uses''.
The words ''intended uses'' or words of similar import in 201.5,
201.115, 201.117, 201.119, 201.120, and 201.122 refer to the objective
intent of the persons legally responsible for the labeling of drugs.
The intent is determined by such persons' expressions or may be shown by
the circumstances surrounding the distribution of the article. This
objective intent may, for example, be shown by labeling claims,
advertising matter, or oral or written statements by such persons or
their representatives. It may be shown by the circumstances that the
article is, with the knowledge of such persons or their representatives,
offered and used for a purpose for which it is neither labeled nor
advertised. The intended uses of an article may change after it has
been introduced into interstate commerce by its manufacturer. If, for
example, a packer, distributor, or seller intends an article for
different uses than those intended by the person from whom he received
the drug, such packer, distributor, or seller is required to supply
adequate labeling in accordance with the new intended uses. But if a
manufacturer knows, or has knowledge of facts that would give him
notice, that a drug introduced into interstate commerce by him is to be
used for conditions, purposes, or uses other than the ones for which he
offers it, he is required to provide adequate labeling for such a drug
which accords with such other uses to which the article is to be put.
(41 FR 6911, Feb. 13, 1976)
21 CFR 201.129 Drugs; exemption for radioactive drugs for research
use.
A radioactive drug intended for administration to human research
subjects during the course of a research project intended to obtain
basic research information regarding metabolism (including kinetics,
distribution, and localization) of a radioactively labeled drug or
regarding human physiology, pathophysiology, or biochemistry (but not
intended for immediate therapeutic, diagnostic, or similar purposes),
under the conditions set forth in 361.1 of this chapter, shall be
exempt from section 502(f)(1) of the act if the packaging, label, and
labeling are in compliance with 361.1(f) of this chapter.
(41 FR 6911, Feb. 13, 1976)
21 CFR 201.129 Subpart E -- Other Exemptions
21 CFR 201.150 Drugs; processing, labeling, or repacking.
(a) Except as provided by paragraphs (b) and (c) of this section, a
shipment or other delivery of a drug 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 and
packaging requirements of sections 501(b) and 502 (b), (d), (e), (f),
and (g) of the act if:
(1) The person who introduced such shipment or delivery into
interstate commerce is the operator of the establishment where such drug
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 drug in such
establishment as will insure, if such specifications are followed, that
such drug 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 drug 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.
(b) An exemption of a shipment or other delivery of a drug under
paragraph (a)(1) 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 drug comprising such
shipment, delivery, or part is adulterated or misbranded within the
meaning of the act when so removed.
(c) An exemption of a shipment or other delivery of a drug under
paragraph (a)(2) 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 such paragraph (a)(2)
of this section.
(d) An exemption of a shipment or other delivery of a drug under
paragraph (a)(2) of this section shall expire:
(1) At the beginning of the act of removing such shipment or
delivery, or any part thereof, from such establishment if the drug
comprising such shipment, delivery, or part is adulterated or misbranded
within the meaning of the act when so removed; or
(2) Upon refusal by the operator of the establishment where such drug
is to be processed, labeled, or repacked, to make available for
inspection a copy of the agreement, as required by such clause.
(e) Except as provided in paragraphs (g) and (h) of this section, a
shipment or other delivery of a drug which is subject to section 507 of
the act and which is, in accordance with the practice of the trade, to
be processed or repacked in a substantial quantity at an establishment
other than that where originally processed or packed shall be exempt
from compliance with the labeling requirements of section 502(f) of the
act during the time such drug is also exempt from the requirements of
section 502(l) of the act or, in the case of a new animal drug, is
exempt from certification under section 512(n) of the act under the
provisions of 433.15 or 433.16 of this chapter.
(f) Except as provided by paragraphs (g) and (h) of this section, a
shipment or other delivery of a drug which is subject to section 507 of
the act and which is, in accordance with the practice of the trade, to
be labeled in substantial quantity at an establishment other than that
where originally processed or packed shall be exempt from compliance
with the labeling requirements of section 502 (b), (e) and (f) of the
act during the time such drug is also exempt from the requirements of
section 502(l) of the act or, in the case of a new animal drug, is
exempt from certification under section 512(n) of the act under 433.12
of this chapter, if the words, statements, and other information
required by section 502 (b) and (e) of the act appear on each shipping
container of such drug.
(g) In case the person who introduced such shipment or other delivery
into interstate commerce is the operator of the establishment where such
drug is to be processed, labeled, or repacked, an exemption of such
shipment or delivery under paragraph (e) or (f) of this section shall
become void at the beginning of the act of removing such shipment or
delivery or any part thereof from such establishment if the drug
comprising such shipment, delivery, or part is adulterated or misbranded
within the meaning of the act when so removed.
(h) In case the person who introduced such shipment or delivery into
interstate commerce is not the operator of the establishment where such
drug is to be processed, labeled, or repacked, an exemption of a
shipment or other delivery of such drug under paragraph (e) or (f) of
this section shall expire at the beginning of the act of removing such
shipment or delivery or any part thereof from such establishment if the
drug comprising such shipment, delivery, or part is adulterated or
misbranded within the meaning of the act when so removed.
(41 FR 6911, Feb. 13, 1976)
21 CFR 201.161 Carbon dioxide and certain other gases.
(a) Carbon dioxide, cyclopropane, ethylene, helium, and nitrous oxide
gases intended for drug use are exempted from the requirements of
201.100(b) (2), (3), and (c)(1) provided the labeling bears, in addition
to any other information required by the Federal Food, Drug, and
Cosmetic Act, the following:
(1) The warning statement ''Warning -- Administration of (name of
gas) may be hazardous or contraindicated. For use only by or under the
supervision of a licensed practitioner who is experienced in the use and
administration of (name of gas) and is familiar with the indications,
effects, dosages, methods, and frequency and duration of administration,
and with the hazards, contraindications, and side effects and the
precautions to be taken''; and
(2) Any needed directions concerning the conditions for storage and
warnings against the inherent dangers in the handling of the specific
compressed gas.
(b) This labeling exemption does not apply to mixtures of any one or
more of these gases with oxygen or with each other.
(c) Regulatory action may be initiated with respect to any article
shipped within the jurisdiction of the Act contrary to the provisions of
this section after 60 days following publication of this section in the
Federal Register.
21 CFR 201.161 Subpart F -- Labeling Claims for Drugs in Drug Efficacy Study
21 CFR 201.200 Disclosure of drug efficacy study evaluations in
labeling and advertising.
(a)(1) The National Academy of Sciences -- National Research Council,
Drug Efficacy Study Group, has completed an exhaustive review of
labeling claims made for drugs marketed under new-drug and antibiotic
drug procedures between 1938 and 1962. The results are compiled in
''Drug Efficacy Study, A Report to the Commissioner of Food and Drugs
from the National Academy of Sciences (1969).'' As the report notes,
this review has made ''an audit of the state of the art of drug usage
that has been uniquely extensive in scope and uniquely intensive in
time'' and is applicable to more than 80 percent of the currently
marketed drugs. The report further notes that the quality of the
evidence of efficacy, as well as the quality of the labeling claims, is
poor. Labeling and other promotional claims have been evaluated as
''effective,'' ''probably effective,'' ''possibly effective,''
''ineffective,'' ''ineffective as a fixed combination,'' and ''effective
but,'' and a report for each drug in the study has been submitted to the
Commissioner.
(2) The Food and Drug Administration is processing the reports,
seeking voluntary action on the part of the drug manufacturers and
distributors in the elimination or modification of unsupported
promotional claims, and initiating administrative actions as necessary
to require product and labeling changes.
(3) Delays have been encountered in bringing to the attention of the
prescribers of prescription items the conclusions of the expert panels
that reviewed the promotional claims.
(b) The Commissioner of Food and Drugs concludes that:
(1) The failure to disclose in the labeling of a drug and in other
promotional material the conclusions of the Academy experts that a claim
is ''ineffective,'' ''possibly effective,'' ''probably effective,'' or
''ineffective as a fixed combination,'' while labeling and promotional
material bearing any such claim are being used, is a failure to disclose
facts that are material in light of the representations made and causes
the drug to be misbranded.
(2) The Academy classification of a drug as other than ''effective''
for a claim for which such drug is recommended establishes that there is
a material weight of opinion among qualified experts contrary to the
representation made or suggested in the labeling, and failure to reveal
this fact causes such labeling to be misleading.
(c) Therefore, after publication in the Federal Register of a Drug
Efficacy Study Implementation notice on a prescription drug, unless
exempted or otherwise provided for in the notice, all package labeling
(other than the immediate container or carton label, unless such
labeling contains information required by 201.100(c)(1) in lieu of a
package insert), promotional labeling, and advertisements shall include,
as part of the information for practitioners under which the drug can be
safely and effectively used, an appropriate qualification of all claims
evaluated as other than ''effective'' by a panel of the National Academy
of Sciences -- National Research Council, Drug Efficacy Study Group, if
such claims continue to be included in either the labeling or
advertisements. However, this qualifying information will be required
in advertisements only if promotional material is included therein for
claims evaluated as less than ''effective'' or if such claims are
included in the indications section of the portion of the advertisement
containing the information required in brief summary by 202.1(e)(1) of
this chapter. When, however, the Food and Drug Administration
classification of such claim is ''effective'' (for example, on the basis
of revision of the language of the claim or submission or existence of
adequate data), such qualification is not necessary. When the Food and
Drug Administration classification of the claim, as stated in the
implementation notice, differs from that of the Academy but is other
than ''effective,'' the qualifying statement shall refer to this
classification in lieu of the Academy's classification.
(d) For new drugs and antibiotics, supplements to provide for revised
labeling in accord with paragraph (c) of this section shall be submitted
under the provisions of 314.70 and 514.8 of this chapter within 90
days after publication of the implementation notice in the Federal
Register or by May 15, 1972, for those drugs for which notices have been
published and such labeling shall be put into use as soon as possible
but not later than the end of the time period allowed for submitting
supplements to provide for revised labeling.
(e) Qualifying information required in drug labeling by paragraph (c)
of this section in order to advise prescribers of a drug of the findings
made by a panel of the Academy in evaluating a claim as other than
''effective'' shall be at least of the same size and color and degree of
prominence as other printing in the labeling and shall be presented in a
prominent box using one of the following formats and procedures:
(1) In drug labeling the box statement may entirely replace the
indications section and be in the following format:
Based on a review of this drug by the National Academy of Sciences --
National Research Council and/or other information, FDA has classified
the indication(s) as follows:
Effective: (list or state in paragraph form).
''Probably'' effective: (list or state in paragraph form).
''Possibly'' effective: (list or state in paragraph form).
Final classification of the less-than-effective indications requires
further investigation.
(2) Or the indication(s) for which the drug has been found effective
may appear outside the boxed statement and be followed immediately by
the following boxed statement:
Based on a review of this drug by the National Academy of Sciences --
National Research Council and/or other information, FDA has classified
the other indication(s) as follows:
''Probably'' effective: (list or state in paragraph form).
''Possibly'' effective: (list or state in paragraph form).
Final classification of the less-than-effective indications requires
further investigation.
(3) In drug labeling (other than that which is required by
201.100(c)(1)) which may contain a promotional message, the promotional
message shall be keyed to the boxed statement by the same means as those
provided for advertisements in paragraph (f)(2) of this section.
(f) Qualifying information required in prescription drug advertising
by paragraph (c) of this section shall contain a prominent boxed
statement of the advertised indication(s) and of the limitations of
effectiveness using the same format, language, and emphasis as that
required in labeling by paragraph (e) of this section.
(1) The boxed statement shall appear in (or next to) the information
required in brief summary by 202.1(e)(1) of this chapter and shall have
prominence at least equal to that provided for other information
presented in the brief summary and shall have type size, captions,
color, and other physical characteristics comparable to the information
required in the brief summary.
(2) Less-than-effective indication(s) in the promotional message of
an advertisement which is a single page or less shall be keyed to the
boxed statement by asterisk, by an appropriate statement, or by other
suitable means providing adequate emphasis on the boxed statement. On
each page where less-than-effective indication(s) appear in a mutiple
page advertisement, an asterisk shall be placed after the most prominent
mention of the indi- cation(s); if the degree of prominence does not
vary, an asterisk shall be placed after the first mention of the
indication. The asterisk shall refer to a notation at the bottom of the
page which shall state ''This drug has been evaluated as probably
effective (or possibly effective whichever is appropriate) for this
indication'' and ''See Brief Summary'' or ''See Prescribing
Information,'' the latter legend to be used only if the advertisement
carries the required information for professional use as set forth in
201.100(c)(1).
(3) For less-than-effective indications which are included in the
advertisement only as a part of the information required in brief
summary, the disclosure information shall appear in this portion of the
advertisement in the same manner as is specified for labeling in
paragraph (e) of this section.
(g) The Commissioner may find circumstances are such that, while the
elimination of claims evaluated as other than effective will generally
eliminate the need for disclosure about such claims, there will be
instances in which the change in the prescribing or promotional profile
of the drug is so substantial as to require a disclosure of the reason
for the change so that the purchaser or prescriber is not misled by
being left unaware through the sponsor's silence that a basic change has
taken place. The Food and Drug Administration will identify these
situations in direct correspondence with the drug promoters, after which
the failure to make the disclosure will be regarded as misleading and
appropriate action will be taken.
(40 FR 13998, Mar. 27, 1975, as amended at 55 FR 11576, Mar. 29,
1990)
21 CFR 201.200 Subpart G -- Specific Labeling Requirements for Specific Drug Products
21 CFR 201.300 Notice to manufacturers, packers, and distributors of
glandular preparations.
(a) Under date of December 4, 1941, in a notice to manufacturers of
glandular preparations, the Food and Drug Administration expressed the
opinion that preparations of inert glandular materials intended for
medicinal use should, in view of the requirement of section 201(n) of
the Federal Food, Drug, and Cosmetic Act (52 Stat. 1041; 21 U.S.C.
321(n)), be labeled with a statement of the material fact that there is
no scientific evidence that the articles contain any therapeutic or
physiologically active constituents. Numerous preparations of such
inert glandular materials were subsequently marketed with disclaimers of
the type suggested. The term ''inert glandular materials'' means
preparations incapable of exerting an action or effect of some
significant or measurable benefit in one way or another, i.e., in the
diagnosis, cure, mitigation, treatment, or prevention of disease, or in
affecting the structure or any function of the body.
(b) Manufacturers have heretofore taken advantage of 201.100
permitting omission of directions for use when the label bears the
prescription legend. Section 201.100(c) requires that the labeling of
the drug, which may include brochures readily available to licensed
practitioners, bear information as to the use of the drug by
practitioners licensed by law to administer it. Obviously, information
adequate for the use of an inert glandular preparation is not available
to practitioners licensed by law.
(c) The Department of Health and Human Services is of the opinion
that inert glandular materials may not be exempted from the requirements
of section 502 (f) (1) of the act that they bear adequate directions for
use; and, accordingly, that their labeling must include among other
things, representations as to the conditions for which such articles are
intended to be used or as to the structure or function of the human body
that they are intended to affect. Since any such representations
offering these articles for use as drugs would be false or misleading,
such articles will be considered to be misbranded if they are
distributed for use as drugs.
(d) The amended regulations provide also that in the case of drugs
intended for parenteral administration there shall be no exemption from
the requirement that their labelings bear adequate directions for use.
Such inert glandular materials for parenteral use are therefore subject
to the same comment as applies to those intended for oral
administration.
21 CFR 201.301 Notice to manufacturers, packers, and distributors of
estrogenic hormone preparations.
Some drug preparations fabricated wholly or in part from estradiol
and labeled as to potency in terms of international units or in terms of
international units of estrone activity have been marketed. The
international unit of the estrus-producing hormone was established by
the International Conference on the Standardization of Sex Hormones at
London, England, on August 1, 1932. This unit was defined as ''the
specific estrus-producing activity contained in 0.1 gamma (=0.0001 mg.)
of the standard'' hydroxyketonic hormone found in urine (estrone). The
International Conference declared that it did not recommend the
determination of the activity of nonhydroxyketonic forms of estrogenic
hormones in units of estrone because of the varying ratios between the
activity of such nonhydroxyketonic estrogenic hormones and estrone, when
measured by different methods on test animals. There is no
international unit for measuring the activity of estradiol and no
accepted relationship between its activity and that of estrone, either
in test animals or in humans. The declaration of potency of estradiol
in terms of international units or in terms of international units of
estrone activity is therefore considered misleading, within the meaning
of 21 U.S.C. 352(a). The declaration of the estradiol content of an
estrogenic hormone preparation in terms of weight is considered
appropriate.
21 CFR 201.302 Notice to manufacturers, packers, and distributors of
drugs for internal use which contain mineral oil.
(a) In the past few years research studies have altered medical
opinion as to the usefulness and harmfulness of mineral oil in the human
body. These studies have indicated that when mineral oil is used orally
near mealtime it interferes with absorption from the digestive tract of
provitamin A and the fat-soluble vitamins A, D, and K, and consequently
interferes with the utilization of calcium and phosphorus, with the
result that the user is left liable to deficiency diseases. When so
used in pregnancy it predisposes to hemorrhagic disease of the newborn.
(b) There is accumulated evidence that the indiscriminate
administration of mineral oil to infants may be followed by aspiration
of the mineral oil and subsequent ''lipoid pneumonia.''
(c) In view of these facts, the Department of Health and Human
Services will regard as misbranded under the provisions of the Federal
Food, Drug, and Cosmetic Act a drug for oral administration consisting
in whole or in part of mineral oil, the labeling of which encourages its
use in pregnancy or indicates or implies that such drug is for
administration to infants.
(d) It is also this Department's view that the act requires the
labelings of such drugs to bear a warning against consumption other than
at bedtime and against administration to infants. The following form of
warning is suggested: ''Caution: To be taken only at bedtime. Do not
use at any other time or administer to infants, except upon the advice
of a physician.''
(e) This statement of interpretation does not in any way exempt
mineral oil or preparations containing mineral oil from complying in all
other respects with the requirements of the Federal Food, Drug, and
Cosmetic Act.
21 CFR 201.303 Labeling of drug preparations containing significant
proportions of wintergreen oil.
(a) Because methyl salicylate (wintergreen oil) manifests no toxicity
in the minute amounts in which it is used as a flavoring, it is
mistakenly regarded by the public as harmless even when taken in
substantially larger amounts. Actually, it is quite toxic when taken in
quantities of a teaspoonful or more. Wintergreen oil and preparations
containing it have caused a number of deaths through accidental misuse
by both adults and children. Children are particularly attracted by the
odor and are likely to swallow these products when left within reach.
(b) To safeguard against fatalities from this cause, the Department
of Health and Human Services will regard as misbranded under the
provisions of the Federal Food, Drug, and Cosmetic Act any drug
containing more than 5 percent methyl salicylate (wintergreen oil), the
labeling of which fails to warn that use otherwise than as directed
therein may be dangerous and that the article should be kept out of
reach of children to prevent accidental poisoning.
(c) This statement of interpretation in no way exempts methyl
salicylate (wintergreen oil) or its preparations from complying in all
other respects with the requirements of the Federal Food, Drug, and
Cosmetic Act.
21 CFR 201.304 Tannic acid and barium enema preparations.
(a) It has become a widespread practice for tannic acid to be added
to barium enemas to improve X-ray pictures. Tannic acid is capable of
causing diminished liver function and severe liver necrosis when
absorbed in sufficient amounts. The medical literature reports a number
of deaths associated with the addition of tannic acid to barium enemas.
There is a lack of scientific evidence to establish the conditions, if
any, under which tannic acid is safe and effective for use in enemas.
Tannic acid for rectal use to enhance X-ray visualization is regarded as
a new drug within the meaning of section 201(p) of the Federal Food,
Drug, and Cosmetic Act.
(b) In view of the hazards involved when tannic acid is used in
barium enemas, any shipments of tannic acid labeled to come within the
exemptions under 502(f) of the Act containing such phrases as:
''Caution: For manufacturing, processing, or repackaging,'' ''For
prescription compounding,'' or ''Diagnostic reagent -- For professional
use only'' will be regarded by the Commissioner of Food and Drugs as
misbranded within the meaning of section 502(f) of the Federal Food,
Drug, and Cosmetic Act unless the label and the labeling bear
conspicuously a warning to the effect: ''Warning -- Not for use in
enemas.''
(c) Any tannic acid intended for use by man and found within the
jurisdiction of the Federal Food, Drug, and Cosmetic Act labeled
contrary to this section after 60 days from the date of its publication
in the Federal Register may be made the subject of regulatory
proceedings.
21 CFR 201.305 Isoproterenol inhalation preparations (pressurized
aerosols, nebulizers, powders) for human use; warnings.
(a) Accumulating reports have been received by the Food and Drug
Administration and have appeared in the medical literature of severe
paradoxical bronchoconstriction associated with repeated, excessive use
of isoproterenol inhalation preparations in the treatment of bronchial
asthma and other chronic bronchopulmonary disorders. The cause of this
paradoxical reaction is unknown; it has been observed, however, that
patients have not responded completely to other forms of therapy until
use of the isoproterenol inhalation preparation was discontinued. In
addition, sudden unexpected deaths have been associated with the
excessive use of isoproterenol inhalation preparations. The mechanism
of these deaths and their relationship, if any, to the cases of severe
paradoxical bronchospasm are not clear. Cardiac arrest was noted in
several of these cases of sudden death.
(b) On the basis of the above information and after discussion with
and concurrence of the Respiratory and Anesthetic Drugs Advisory
Committee for Food and Drug Administration, the Commissioner of Food and
Drugs concludes that in order for the labeling of such drugs to bear
adequate information for their safe use, as required by 201.100, such
labeling must include the following:
Warning: Occasional patients have been reported to develop severe
paradoxical airway resistance with repeated, excessive use of
isoproterenol inhalation preparations. The cause of this refractory
state is unknown. It is advisable that in such instances the use of
this preparation be discontinued immediately and alternative therapy
instituted, since in the reported cases the patients did not respond to
other forms of therapy until the drug was withdrawn.
Deaths have been reported following excessive use of isoproterenol
inhalation preparations and the exact cause is unknown. Cardiac arrest
was noted in several instances.
(c)(1) The Commissioner also concludes that in view of the manner in
which these preparations are self-administered for relief of attacks of
bronchial asthma and other chronic bronchopulmonary disorders, it is
necessary for the protection of users that warning information to
patients be included as a part of the label and as part of any
instructions to patients included in the package dispensed to the
patient as follows:
Warning: Do not exceed the dose prescribed by your physician. If
difficulty in breathing persists, contact your physician immediately.
(2) The warning on the label may be accomplished (i) by including it
on the immediate container label with a statement directed to
pharmacists not to remove the label or (ii) by including in the package
a printed warning with instructions to pharmacists to place the warning
on the container prior to dispensing.
(d) The marketing of isoproterenol inhalation preparations may be
continued if all the following conditions are met:
(1) Within 30 days following the date of publication of this section
in the Federal Register:
(i) The label and labeling of such preparations shipped within the
jurisdiction of the act are in accordance with paragraphs (b) and (c) of
this section.
(ii) The holder of an approved new-drug application for such
preparation submits a supplement to his new-drug application to provide
for appropriate labeling changes as described in paragraphs (b) and (c)
of this section.
(2) Within 90 days following the date of publication of this section
in the Federal Register, the manufacturer, packer, or distributor of any
drug containing isoproterenol intended for inhalation for which a
new-drug approval is not in effect submits a new-drug application
containing satisfactory information of the kinds required by 314.50 of
this chapter, including appropriate labeling as described in paragraphs
(b) and (c) of this section.
(3) The applicant submits additional information required for the
approval of the application as may be specified in a written
communication from the Food and Drug Administration.
(e) After 270 days following expiration of said 90 days, regulatory
proceedings based on section 505(a) of the Federal Food, Drug, and
Cosmetic Act may be initiated with regard to any such drug shipped
within the jurisdiction of the act for which an approved new-drug
application is not in effect.
(40 FR 13998, Mar. 27, 1975, as amended at 55 FR 11576, Mar. 29,
1990)
21 CFR 201.306 Potassium salt preparations intended for oral ingestion
by man.
(a) The Food and Drug Administration will initiate no regulatory
action with respect to the continued marketing of coated tablets
containing potassium chloride or other potassium salts which supply 100
milligrams or more of potassium per tablet provided all the following
conditions are met:
(1) Within 30 days from the date of publication of this statement of
policy in the Federal Register:
(i) The labeling of the drug bears the prescription caution statement
quoted in section 503(b)(4) of the Federal Food, Drug, and Cosmetic Act;
(ii) The labeling on or within the package from which the drug is to
be dispensed bears adequate information for its use by practitioners in
accord with the ''full disclosure'' labeling requirements of 201.100 of
this chapter, including the following warning statement: ''Warning --
There have been several reports, published and unpublished, concerning
nonspecific small-bowel lesions consisting of stenosis, with or without
ulceration, associated with the administration of enteric-coated
thiazides with potassium salts. These lesions may occur with
enteric-coated potassium tablets alone or when they are used with
nonenteric-coated thiazides, or certain other oral diuretics. These
small-bowel lesions have caused obstruction, hemorrhage, and
perforation. Surgery was frequently required and deaths have occurred.
Based on a large survey of physicians and hospitals, both United States
and foreign, the incidence of these lesions is low, and a causal
relationship in man has not been definitely established. Available
information tends to implicate enteric-coated potassium salts, although
lesions of this type also occur spontaneously. Therefore, coated
potassium-containing formulations should be administered only when
indicated, and should be discontinued immediately if abdominal pain,
distention, nausea, vomiting, or gastrointestinal bleeding occur.
Coated potassium tablets should be used only when adequate dietary
supplementation is not practicable.''
(Although the warning statement includes references to enteric-coated
potassium salt preparations, it applies to any capsule or coated tablet
of a potassium salt intended for oral ingestion without prior dilution
with an adequate volume of liquid to preclude gastrointestinal injury.)
(iii) Any other labeling or additional advertising for the drug
conforms to the labeling described in paragraph (a) (1) (ii) of this
section, in accordance with 202.1 and 201.100 of this chapter.
(2) Within 90 days from the date of publication of this statement of
policy in the Federal Register, the manufacturer, packer, or distributor
of the drug shall submit a new-drug application containing satisfactory
information of the kind required by 314.50 of this chapter, with
appropriate labeling as described in this paragraph.
(b) The Food and Drug Administration may initiate regulatory
proceedings after 30 days from the date of publication of this section,
with respect to the marketing of uncoated tablets containing potassium
chloride or other potassium salts which supply 100 milligrams or more of
potassium per tablet or with respect to liquid preparations containing
potassium chloride or other potassium salts which supply 20 milligrams
or more of potassium per milliliter, labeled or intended for human use,
unless all the following conditions are met:
(1) The labeling of the drug bears the prescription caution statement
quoted in section 503(b) (4) of the Federal Food, Drug, and Cosmetic
Act; and
(2) The labeling on or within the package from which the drug is to
be dispensed bears adequate information for its use by practitioners in
accord with the ''full disclosure'' labeling requirements of 201.100 of
this chapter, including a recommendation that patients be directed to
dissolve any such tablets in an appropriate amount of liquid and to
dilute any such liquid preparations adequately to assure against
gastrointestinal injury associated with the oral ingestion of
concentrated potassium salt preparations.
(40 FR 13998, Mar. 27, 1975, as amended at 55 FR 11576, Mar. 29,
1990)
21 CFR 201.307 Chlorcyclizine, cyclizine, meclizine; warnings;
labeling requirements.
(a) The Food and Drug Administration, pursuant to its responsibility
for the safety and effectiveness of drugs, has conducted active
investigations of reports of available animal data which reveal that
chlorcyclizine hydrochloride, cyclizine hydrochloride and lactate, and
meclizine hydrochloride exert a teratogenic response in animals such as
the rat, mouse, rabbit, pig, and dog. While clinical studies to date
are inconclusive, scientific experts are of the opinion that these drugs
may possess a potential for adverse effects on the human fetus.
Investigations have led to the conclusion that there exists sufficient
evidence of teratogenicity in animals administered these drugs to
justify warnings against their use in pregnancy except on advice of a
physician. An Ad Hoc Advisory Committee on the Teratogenic Effect of
Certain Drugs, comprised of scientists in various branches of medicine
concerned with the problem, has submitted its findings and conclusions
to the Commissioner of Food and Drugs and has recommended that all
over-the-counter preparations containing chlorcyclizine, cyclizine, or
meclizine or their salts bear a warning.
(b) On the basis of studies made by the Food and Drug Administration
and on the recommendations of the Advisory Committee, the Commissioner
of Food and Drugs has concluded that it is necessary for the protection
of users that the label and labeling of all over-the-counter
preparations containing chlorcyclizine, cyclizine, or meclizine or their
salts bear a statement to the following effect: ''Warning -- Not for
use by women who are pregnant or who may possibly become pregnant,
unless directed by a physician, since this drug may have the
potentiality of injuring the unborn child.''
(c) The marketing of oral and parenteral drugs containing
chlorcyclizine, cyclizine, or meclizine or their salts may be continued
provided that all the following conditions are met:
(1) Within 30 days from the date of publication of this statement in
the Federal Register.
(i) The label and applicable labeling of drugs containing
chlorcyclizine, cyclizine, or meclizine or their salts at acceptable
levels for over-the-counter distribution, shall prominently and
conspicuously display the statement: ''Warning -- Not for use by women
who are pregnant or who may possibly become pregnant, unless directed by
a physician, since this drug may have the potentiality of injuring the
unborn child.''
(ii) The package labeling and other labeling providing professional
use information concerning prescription drugs containing chlorcyclizine,
cyclizine, or meclizine or their salts and not contraindicated for use
in pregnancy because of some other ingredient, shall bear, in accordance
with 201.100* of this chapter, a section under ''Adverse Reactions''
headed ''Use in Pregnancy,'' as follows:
The following information should be taken into account in determining
whether the potential benefits of (chlorcyclizine, cyclizine, meclizine,
or their salts) outweigh the risks of their use in women of childbearing
age and particularly during pregnancy. A review of available animal
data reveals that this drug exerts a teratogenic response in the (rat,
mouse, rabbit, pig, dog). While available clinical data are
inconclusive, scientific experts are of the opinion that this drug may
possess a potential for adverse effects on the human fetus.
Consequently, consideration should be given to initial use of a
nonphenothiazine agent that is not suspected of having a teratogenic
potential. In any case, the dosage and duration of treatment should be
kept to a minimum.
This statement shall be followed with an appropriate summary of the
pertinent animal studies and adverse clinical experiences, with adequate
references to the scientific literature. Also, the labeling shall
contain, in juxtaposition with any representation for use in the
treatment of nausea and vomiting in pregnancy, the following statement:
The effectiveness of ------ for the prevention and treatment of
nausea and vomiting of pregnancy has not been established, and the
decision to use ------ should be based on the seriousness of the
situation, remembering that while this drug has been used clinically for
a decade, there are yet no controlled studies to demonstrate its
usefulness in an objective fashion. In most cases, nausea and vomiting
of pregnancy may be unpleasant but do not present a serious threat to
the health of the patient or to the progress of her pregnancy. In view
of the desirability of keeping the administration of all drugs to a
minimum during pregnancy, management by physiologic means such as proper
nutrition and by psychologic support is preferable to antiemetic
therapy.
(2) Within 30 days from the date of publication of this statement of
policy in the Federal Register, the applicant under an approved new-drug
application for a drug containing chlorcyclizine, cyclizine, or
meclizine or their salts shall submit a supplement to his new-drug
application, providing for appropriate labeling changes as described in
paragraphs (c) (1) (i) or (ii) of this section.
(3) Within 90 days from the date of publication of this statement of
policy in the Federal Register, the manufacturer, packer, or distributor
of any drug containing chlorcyclizine, cyclizine, or meclizine or their
salts for which a new-drug approval is not in effect shall submit a
new-drug application containing satisfactory information of the kinds
required in the new-drug application (see 314.50 of this chapter),
including appropriate labeling as described in paragraphs (c) (1) (i) or
(ii) of this section.
(d) In view of the fact that no substantial evidence has been offered
for the effectiveness of chlorcyclizine, cyclizine, and meclizine or
their salts in the prevention and treatment of nausea and vomiting of
pregnancy, but mindful of the fact that some practicing physicians
believe that these drugs exert a beneficial effect upon this condition,
the Food and Drug Administration will permit a modified claim in
indications for this use for a period not exceeding 2 years. However,
this modified indication for use of these drugs in the prevention and
treatment of nausea and vomiting of pregnancy will be deleted from the
labeling unless substantial evidence is offered before the expiration of
this period of time. The Food and Drug Administration will also
continue to follow the large-scale surveys of clinical experience and
any reports of adverse reaction that may be due to the use of these
drugs under the revised labeling.
(40 FR 13998, Mar. 27, 1975, as amended at 55 FR 11576, Mar. 29,
1990)
*Section 202.1 will require that prescription drug advertising
contain this warning.
21 CFR 201.308 Ipecac syrup; warnings and directions for use for
over-the-counter sale.
(a) It is estimated that each year about 500,000 accidental
poisonings occur in the United States and result in approximately 1,500
deaths, of which over 400 are children. In the emergency treatment of
these poisonings, ipecac syrup is considered the emetic of choice. The
immediate availability of this drug for use in such situations is
critical, since rapid treatment may be the difference between life and
death. The restriction of this drug to prescription sale limits its
availability in emergencies. On the other hand, it is the consensus of
informed medical opinion that ipecac syrup should be used only under
medical supervision in the emergency treatment of poisonings. In view
of these facts, the question of whether ipecac syrup labeled as an
emergency treatment for use in poisonings should be available over the
counter has been controversial.
(b) In connection with its study of this problem, the Food and Drug
Administration has obtained the views of medical authorities. It is the
unanimous recommendation of the American Academy of Pediatrics, the
American Association of Poison Control Centers, the American Medical
Association, and the Medical Advisory Board of the Food and Drug
Administration that ipecac syrup in 1 fluid ounce containers be
permitted to be sold without prescription so that it will be readily
available in the household for emergency treatment of poisonings, under
medical supervision, and that the drug be appropriately packaged and
labeled for this purpose.
(c) In view of the above recommendations, the Commissioner of Food
and Drugs has determined that it is in the interest of the public health
for ipecac syrup to be available for sale without prescription, provided
that it is packaged in a quantity of 1 fluid ounce (30 milliliters), and
its label bears, in addition to other required label information, the
following, in a prominent and conspicuous manner:
(1) A statement conspicuously boxed and in red letters, to the
effect: ''For emergency use to cause vomiting in poisoning. Before
using, call physician, the Poison Control Center, or hospital emergency
room immediately for advice.''
(2) A warning to the effect: ''Warning -- Keep out of reach of
children. Do not use in unconscious persons. Ordinarily, this drug
should not be used if strychnine, corrosives such as alkalies (lye) and
strong acids, or petroleum distillates such as kerosine, gasoline, coal
oil, fuel oil, paint thinner, or cleaning fluid have been ingested.''
(3) Usual dosage: 1 tablespoon (15 milliliters) in persons over 1
year of age.
21 CFR 201.309 Acetophenetidin (phenacetin)-containing preparations;
necessary warning statement.
(a) In 1961, the Food and Drug Administration, pursuant to its
statutory responsibility for the safety and effectiveness of drugs
shipped in interstate commerce, began an active investigation of reports
of possible toxic effects and renal damage due to misuse of the drug
acetophenetidin. This study led to the decision that there was probable
cause to conclude that misuse and prolonged use of the drug were in fact
responsible for kidney lesions and disease. The Commissioner of Food
and Drugs, in December 1963, appointed an ad hoc Advisory Committee of
Inquiry on Possible Nephrotoxicity Associated With the Abuse of
Acetophenetidin (Phenacetin)-Containing Preparations. This committee,
composed of scientists in the fields of pharmacology and medicine, on
April 23, 1964, submitted its findings and conclusions in the matter and
recommended that all acetophenetidin (phenacetin)-containing
preparations bear a warning as provided in section 502(f)(2) of the
Federal Food, Drug, and Cosmetic Act.
(b) On the basis of the studies made by the Food and Drug
Administration and the report of the Advisory Committee, the
Commissioner of Food and Drugs has concluded that it is necessary for
the protection of users that the label and labeling of all
acetophenetidin (phenacetin)-containing preparations bear a warning
statement to the following effect: ''Warning -- This medication may
damage the kidneys when used in large amounts or for a long period of
time. Do not take more than the recommended dosage, nor take regularly
for longer than 10 days without consulting your physician.''
21 CFR 201.310 Phenindione; labeling of drug preparations intended for
use by man.
(a) Reports in the medical literature and data accumulated by the
Food and Drug Administration indicate that phenindione, a synthetic
anticoagulant drug, has caused a number of cases of agranulocytosis
(with two fatalities). There are also reports implicating the drug in
cases of hepatitis and hypersensitivity reactions. In view of the
potentially serious effects found to be associated with preparations of
this drug intended for use by man, the Commissioner of Food and Drugs
will regard such preparations as misbranded within the meaning of
section 502(f) (1) and (2) of the Federal Food, Drug, and Cosmetic Act,
unless the label and labeling on or within the package from which the
drug is to be dispensed, and any other labeling furnishing or purporting
to furnish information for use of the drug, bear a conspicuous warning
statement to the following effect: ''Warning: Agranulocytosis and
hepatitis have been associated with the use of phenindione. Patients
should be instructed to report promptly prodromal symptoms such as
marked fatigue, chill, fever, and sore throat. Periodic blood studies
and liver function tests should be performed. Use of the drug should be
discontinued if leukopenia occurs or if evidence of hypersensitivity,
such as dermatitis or fever, appears.''
(b) Regulatory action may be initiated with respect to preparations
of phenindione intended for use by man found within the jurisdiction of
the act on or after November 25, 1961, unless such preparations are
labeled in accordance with paragraph (a) of this section.
201.311 (Reserved)
21 CFR 201.312 Magnesium sulfate heptahydrate; label declaration on
drug products.
Magnesium sulfate heptahydrate should be listed on the label of a
drug product as epsom salt, which is its common or usual name.
21 CFR 201.313 Estradiol labeling.
The article presently recognized in The National Formulary under the
heading ''Estradiol'' and which is said to be ''17-cis-beta estradiol''
is the same substance formerly recognized in the United States
Pharmacopeia under the designation ''Alpha Estradiol.'' The substance
should no longer be referred to in drug labeling as ''Alpha Estradiol.''
The Food and Drug Administration would not object to label references to
the article as simply ''Estradiol''; nor would it object if the label
of a preparation containing this substance referred to the presence of
''Estradiol (formerly known as Alpha Estradiol).''
21 CFR 201.314 Labeling of drug preparations containing salicylates.
(a) The label of any oral drug preparation intended for sale without
prescription and which contains any salicylate ingredient (including
aspirin, salicylamide, other salicylates, and combinations) must bear a
conspicuous warning statement in heavy block type on clearly contrasting
background, such as: ''Warning -- Keep this and all medicines out of
children's reach. In case of accidental overdose, contact a physician
immediately,'' or ''Warning -- Keep out of the reach of children,''
except that if the article is an aspirin preparation, it shall bear the
first of these warning statements. Such a warning statement is required
for compliance with section 502(f)(2) of the Federal Food, Drug, and
Cosmetic Act and is intended to guard against accidental poisonings.
Safety closures that prevent access to the drug by young children are
also recommended to guard against accidental poisonings.
(b) Effervescent preparations and preparations containing
para-aminosalicylate as the only salicylate ingredient are exempted from
this labeling requirement.
(c) Aspirin tablets sold as such and containing no other active
ingredients, except tablets which cannot be readily subdivided into a
child's dose because of their coating or size, should always bear dosage
directions for each age group down to 3 years of age, with a statement
such as ''For children under 3 years of age, consult your physician.''
It is recommended that:
(1) Aspirin tablets especially made for pediatric use be produced
only in 1 1/4-grain size to reduce the hazard of errors in dosage;
(2) By June 1, 1967, manufacturers and distributors of 1 1/4-grain
size aspirin tablets discontinue the distribution of such tablets in
retail containers containing more than 36 tablets, to reduce the hazard
of accidental poisoning;
(3) The flavoring of 5-grain aspirin tablets or other ''adult aspirin
tablets'' be discontinued; and
(4) Labeling giving undue emphasis to the pleasant flavor of flavored
aspirin tablets be discontinued.
(d) Salicylate preparations other than aspirin tablets sold as such
may, at the option of the distributor, be labeled for use by adults
only. If their labeling and advertising clearly offer them for
administration to adults only.
(e) (1) It is the obligation of the distributor who labels a
salicylate preparation for administration to children to make certain
that the article is suitable for such use and labeled with adequate
directions for use in the age group for which it is offered, but in no
case should such an article bear directions for use in children under 3
years of age. If the directions provide for administration to children
as young as 3 years of age, the label should bear the statement, ''For
children under 3 years of age consult your physician.'' However, if the
directions provide for administration to children only of an age greater
than 3 years (for example, the dosage instructions provide for
administration of the article to children only down to age 6), the label
should bear a statement such as, ''For younger children consult your
physician.''
(2) A statement such as, ''For children under 3 years of age consult
your physician'' or ''For younger children consult your physician'' is
not required on the label of an article clearly offered for
administration to adults only.
(f) If the labeling or advertising of a salicylate preparation offers
it for use in arthritis or rheumatism, the label and labeling should
clearly state that the beneficial effects claimed are limited to: ''For
the temporary relief of minor aches and pains of arthritis and
rheumatism.'' The qualifying phrase ''for the temporary relief of minor
aches and pains'' should appear with the same degree of prominence and
conspicuousness as the phrase ''arthritis and rheumatism''. The label
and labeling should bear in juxtaposition with such directions for use
conspicuous warning statements to the effect: ''Caution: If pain
persists for more than 10 days, or redness is present, or in conditions
affecting children under 12 years of age, consult a physician
immediately.'' The salicylate dosage should not exceed 60 grains in a
24-hour period or 10 grains in a 4-hour period. If the article contains
other analgesics, the salicylate dosage should be appropriately reduced.
(g)(1) The label of any drug containing more than 5 percent methyl
salicylate (wintergreen oil) should bear a conspicuous warning such as:
''Warning: Do not use otherwise than as directed. Keep out of the
reach of children to avoid accidental poisoning.''
(2) If the preparation is a counterirritant or rubefacient, it should
also bear a caution such as, ''Caution: Discontinue use if excessive
irritation of the skin develops. Avoid getting into the eyes or on
mucous membranes.'' (See also 201.303.)
(h)(1) The labeling of orally or rectally administered
over-the-counter aspirin and aspirin-containing drug products subject to
this paragraph is required to prominently bear a warning. The warning
shall be as follows: ''WARNING: Children and teenagers should not use
this medicine for chicken pox or flu symptoms before a doctor is
consulted about Reye syndrome, a rare but serious illness reported to be
associated with aspirin.''
(2) This warning statement shall appear on the immediate container
labeling. In cases where the immediate container is not the retail
package, the retail package also must bear the warning statement. In
addition, the warning statement shall appear on any labeling that
contains warnings and, in such cases, the warning statement shall be the
first warning statement under the heading ''Warnings.''
(3) Over-the-counter drug products subject to this paragraph and
labeled solely for use by children (pediatric products) shall not
recommend the product for use in treating flu or chicken pox.
(4) Any product subject to this paragraph that is not labeled as
required by this paragraph and that is initially introduced or initially
delivered for introduction into interstate commerce after June 5, 1986,
is misbranded under sections 201(n) and 502 (a) and (f) of the Federal
Food, Drug, and Cosmetic Act.
(40 FR 13998, Mar. 27, 1985, as amended at 51 FR 8182, Mar. 7, 1986;
53 FR 21637, June 9, 1988; 53 FR 24830, June 30, 1988)
21 CFR 201.315 Over-the-counter drugs for minor sore throats;
suggested warning.
The Food and Drug Administration has studied the problem of the
labeling of lozenges or troches containing a local anesthetic, chewing
gum containing aspirin, various mouth washes and gargles and other
articles sold over the counter for the relief of minor irritations of
the mouth or throat. It will not object to the labeling of suitable
articles of this type ''For the temporary relief of minor sore
throats'', provided this is immediately followed in the labeling with a
warning statement in prominent type essentially as follows: ''Warning
-- Severe or persistent sore throat or sore throat accompanied by high
fever, headache, nausea, and vomiting may be serious. Consult physician
promptly. Do not use more than 2 days or administer to children under 3
years of age unless directed by physician.''
21 CFR 201.316 Drugs with thyroid hormone activity for human use;
required warning.
(a) Drugs with thyroid hormone activity have been promoted for, and
continue to be dispensed and prescribed for, use in the treatment of
obesity, although their safety and effectiveness for that use have never
been established.
(b) Drugs for human use with thyroid hormone activity are misbranded
within the meaning of section 502 of the Federal Food, Drug, and
Cosmetic Act unless their labeling bears the following boxed warning at
the beginning of the ''Warnings'' section:
Drugs with thyroid hormone activity, alone or together with other
therapeutic agents, have been used for the treatment of obesity. In
euthyroid patients, doses within the range of daily hormonal
requirements are ineffective for weight reduction. Larger doses may
produce serious or even life-threatening manifestations of toxicity,
particularly when given in association with sympathomimetic amines such
as those used for their anorectic effects.
(43 FR 22009, May 23, 1978)
21 CFR 201.317 Digitalis and related cardiotonic drugs for human use in
oral dosage forms; required warning.
(a) Digitalis and related cardiotonic drugs for human use in oral
dosage forms have been promoted for, and continue to be dispensed and
prescribed for, use in the treatment of obesity, although their safety
and effectiveness for that use have never been established.
(b) Digitalis and related cardiotonic drugs for human use in oral
dosage forms are misbranded within the meaning of section 502 of the
Federal Food, Drug, and Cosmetic Act unless their labeling bears the
following boxed warning at the beginning of the ''Warnings'' section:
Digitalis alone or with other drugs has been used in the treatment of
obesity. This use of digoxin or other digitalis glycosides is
unwarranted. Moreover, since they may cause potentially fatal
arrhythmias or other adverse effects, the use of these drugs in the
treatment of obesity is dangerous.
(c) This section does not apply to digoxin products for oral use,
which shall be labeled according to the requirements of 310.500 of this
chapter.
(43 FR 22009, May 23, 1978)
21 CFR 201.317 PART 202 -- PRESCRIPTION DRUG ADVERTISING
Authority: Secs. 201, 301, 502, 505, 507, 512, 701 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 352, 355, 357, 360b,
371).
21 CFR 202.1 Prescription-drug advertisements.
(a)(1) The ingredient information required by section 502(n) of the
Federal Food, Drug, and Cosmetic Act shall appear together, without any
intervening written, printed, or graphic matter, except the proprietary
names of ingredients, which may be included with the listing of
established names.
(2) The order of listing of ingredients in the advertisement shall be
the same as the order of listing of ingredients on the label of the
product, and the information presented in the advertisement concerning
the quantity of each such ingredient shall be the same as the
corresponding information on the label of the product.
(3) The advertisement shall not employ a fanciful proprietary name
for the drug or any ingredient in such a manner as to imply that the
drug or ingredient has some unique effectiveness or composition, when,
in fact, the drug or ingredient is a common substance, the limitations
of which are readily recognized when the drug or ingredient is listed by
its established name.
(4) The advertisement shall not feature inert or inactive ingredients
in a manner that creates an impression of value greater than their true
functional role in the formulation.
(5) The advertisement shall not designate a drug or ingredient by a
proprietary name that, because of similarity in spelling or
pronunciation, may be confused with the proprietary name or the
established name of a different drug or ingredient.
(b)(1) If an advertisement for a prescription drug bears a
proprietary name or designation for the drug or any ingredient thereof,
the established name, if such there be, corresponding to such
proprietary name or designation shall accompany such proprietary name or
designation each time it is featured in the advertisement for the drug;
but, except as provided below in this subparagraph, the established name
need not be used with the proprietary name or designation in the running
text of the advertisement. On any page of an advertisement in which the
proprietary name or designation is not featured but is used in the
running text, the established name shall be used at least once in the
running text in association with such proprietary name or designation
and in the same type size used in the running text: Provided, however,
That if the proprietary name or designation is used in the running text
in larger size type, the established name shall be used at least once in
association with, and in type at least half as large as the type used
for, the most prominent presentation of the proprietary name or
designation in such running text. If any advertisement includes a
column with running text containing detailed information as to
composition, prescribing, side effects, or contraindications and the
proprietary name or designation is used in such column but is not
featured above or below the column, the established name shall be used
at least once in such column of running text in association with such
proprietary name or designation and in the same type size used in such
column of running text: Provided, however, That if the proprietary name
or designation is used in such column of running text in larger size
type, the established name shall be used at least once in association
with, and in type at least half as large as the type used for, the most
prominent presentation of the proprietary name or designation in such
column of running text. Where the established name is required to
accompany or to be used in association with the proprietary name or
designation, the established name shall be placed in direct conjunction
with the proprietary name or designation, and the relationship between
the proprietary name or designation and the established name shall be
made clear by use of a phrase such as ''brand of'' preceding the
established name, by brackets surrounding the established name, or by
other suitable means.
(2) The established name shall be printed in letters that are at
least half as large as the letters comprising the proprietary name or
designation with which it is joined, and the established name shall have
a prominence commensurate with the prominence with which such
proprietary name or designation appears, taking into account all
pertinent factors, including typography, layout, contrast, and other
printing features.
(c) In the case of a prescription drug containing two or more active
ingredients, if the advertisement bears a proprietary name or
designation for such mixture and there is no established name
corresponding to such proprietary name or designation, the quantitative
ingredient information required in the advertisement by section 502(n)
of the act shall be placed in direct conjunction with the most prominent
display of the proprietary name or designation. The prominence of the
quantitative ingredient information shall bear a reasonable relationship
to the prominence of the proprietary name.
(d)(1) If the advertisement employs one proprietary name or
designation to refer to a combination of active ingredients present in
more than one preparation (the individual preparations differing from
each other as to quantities of active ingredients and/or the form of the
finished preparation) and there is no established name corresponding to
such proprietary name or designation, a listing showing the established
names of the active ingredients shall be placed in direct conjunction
with the most prominent display of such proprietary name or designation.
The prominence of this listing of active ingredients shall bear a
reasonable relationship to the prominence of the proprietary name and
the relationship between such proprietary name or designation, and the
listing of active ingredients shall be made clear by use of such phrase
as ''brand of'', preceding the listing of active ingredients.
(2) The advertisement shall prominently display the name of at least
one specific dosage form and shall have the quantitative ingredient
information required by section 502(n) of the act in direct conjunction
with such display. If other dosage forms are listed in the
advertisement, the quantitative ingredient information for such dosage
forms shall appear in direct conjunction and in equal prominence with
the most prominent listing of the names of such dosage forms.
(e) True statement of information in brief summary relating to side
effects, contraindications, and effectiveness:
(1) When required. All advertisements for any prescription drug
(''prescription drug'' as used in this section means drugs defined in
section 503(b) (1) of the act and 201.105, applicable to drugs for use
by man and veterinary drugs, respectively), except advertisements
described in paragraph (e)(2) of this section, shall present a true
statement of information in brief summary relating to side effects,
contraindications (when used in this section ''side effects,
contraindications'' include side effects, warnings, precautions, and
contraindications and include any such information under such headings
as cautions, special considerations, important notes, etc.) and
effectiveness. Advertisements broadcast through media such as radio,
television, or telephone communications systems shall include
information relating to the major side effects and contraindications of
the advertised drugs in the audio or audio and visual parts of the
presentation and unless adequate provision is made for dissemination of
the approved or permitted package labeling in connection with the
broadcast presentation shall contain a brief summary of all necessary
information related to side effects and contraindications.
(2) Exempt advertisements. The following advertisements are exempt
from the requirements of paragraph (e)(1) of this section under the
conditions specified:
(i) Reminder advertisements. Reminder advertisements are those which
call attention to the name of the drug product but do not include
indications or dosage recommendations for use of the drug product.
These reminder advertisements shall contain only the proprietary name of
the drug product, if any; the established name of the drug product, if
any; the established name of each active ingredient in the drug
product; and, optionally, information relating to quantitative
ingredient statements, dosage form, quantity of package contents, price,
the name and address of the manufacturer, packer, or distributor or
other written, printed, or graphic matter containing no representation
or suggestion relating to the advertised drug product. If the
Commissioner finds that there is evidence of significant incidence of
fatalities or serious injury associated with the use of a particular
prescription drug, he may withdraw this exemption by so notifying the
manufacturer, packer, or distributor of the drug by letter. Reminder
advertisements, other than those solely intended to convey price
information including, but not limited to, those subject to the
requirements of 200.200 of this chapter, are not permitted for a
prescription drug product whose labeling contains a boxed warning
relating to a serious hazard associated with the use of the drug
product. Reminder advertisements which are intended to provide
consumers with information concerning the price charged for a
prescription for a drug product are exempt from the requirements of this
section if they meet all of the conditions contained in 200.200 of this
chapter. Reminder advertisements, other than those subject to the
requirements of 200.200 of this chapter, are not permitted for a drug
for which an announcement has been published pursuant to a review on the
labeling claims for the drug by the National Academy of
Sciences/National Research Council (NAS/NRC), Drug Efficacy Study Group,
and for which no claim has been evaluated as higher than ''possibly
effective.'' If the Commissioner finds the circumstances are such that a
reminder advertisement may be misleading to prescribers of drugs subject
to NAS/NRC evaluation, such advertisements will not be allowed and the
manufacturer, packer, or distributor will be notified either in the
publication of the conclusions on the effectiveness of the drug or by
letter.
(ii) Advertisements of bulk-sale drugs. Advertisements of bulk-sale
drugs that promote sale of the drug in bulk packages in accordance with
the practice of the trade solely to be processed, manufactured, labeled,
or repackaged in substantial quantities and that contain no claims for
the therapeutic safety or effectiveness of the drug.
(iii) Advertisements of prescription-compounding drugs.
Advertisements of prescription-compounding drugs that promote sale of a
drug for use as a prescription chemical or other compound for use by
registered pharmacists in compounding prescriptions if the drug
otherwise complies with the conditions for the labeling exemption
contained in 201.120 and the advertisement contains no claims for the
therapeutic safety or effectiveness of the drug.
(3) Scope of information to be included; applicability to the entire
advertisement. (i) The requirement of a true statement of information
relating to side effects, contraindications, and effectiveness applies
to the entire advertisement. Untrue or misleading information in any
part of the advertisement will not be corrected by the inclusion in
another distinct part of the advertisement of a brief statement
containing true information relating to side effects, contraindications,
and effectiveness of the drug. If any part or theme of the
advertisement would make the advertisement false or misleading by reason
of the omission of appropriate qualification or pertinent information,
that part or theme shall include the appropriate qualification or
pertinent information, which may be concise if it is supplemented by a
prominent reference on each page to the presence and location elsewhere
in the advertisement of a more complete discussion of such qualification
or information.
(ii) The information relating to effectiveness is not required to
include information relating to all purposes for which the drug is
intended but may optionally be limited to a true statement of the
effectiveness of the drug for the selected purpose(s) for which the drug
is recommended or suggested in the advertisement. The information
relating to effectiveness shall include specific indications for use of
the drug for purposes claimed in the advertisement; for example, when
an advertisement contains a broad claim that a drug is an antibacterial
agent, the advertisement shall name a type or types of infections and
microorganisms for which the drug is effective clinically as
specifically as required, approved, or permitted in the drug package
labeling.
(iii) The information relating to side effects and contraindications
shall disclose each specific side effect and contraindication (which
include side effects, warnings, precautions, and contraindications and
include any such information under such headings as cautions, special
considerations, important notes, etc.; see paragraph (e)(1) of this
section) contained in required, approved, or permitted labeling for the
advertised drug dosage form(s): Provided, however,
(a) The side effects and contraindications disclosed may be limited
to those pertinent to the indications for which the drug is recommended
or suggested in the advertisement to the extent that such limited
disclosure has previously been approved or permitted in drug labeling
conforming to the provisions of 201.100 or 201.105; and
(b) The use of a single term for a group of side effects and
contraindications (for example, ''blood dyscrasias'' for disclosure of
''leukopenia,'' ''agranulocytosis,'' and ''neutropenia'') is permitted
only to the extent that the use of such a single term in place of
disclosure of each specific side effect and contraindication has been
previously approved or permitted in drug labeling conforming to the
provisions of 201.100 or 201.105.
(4) Substance of information to be included in brief summary. (i)
(a) An advertisement for a prescription drug covered by a new-drug
application approved pursuant to section 505 of the act after October
10, 1962 or section 512 of the act after August 1, 1969, or any approved
supplement thereto, shall not recommend or suggest any use that is not
in the labeling accepted in such approved new-drug application or
supplement. The advertisement shall present information from labeling
required, approved, or permitted in a new-drug application relating to
each specific side effect and contraindication in such labeling that
relates to the uses of the advertised drug dosage form(s) or shall
otherwise conform to the provisions of paragraph (e)(3)(iii) of this
section.
(b) If a prescription drug was covered by a new-drug application or a
supplement thereto that became effective prior to October 10, 1962, an
advertisement may recommend or suggest:
(1) Uses contained in the labeling accepted in such new-drug
application and any effective, approved, or permitted supplement
thereto.
(2) Additional uses contained in labeling in commercial use on
October 9, 1962, to the extent that such uses did not cause the drug to
be an unapproved ''new drug'' as ''new drug'' was defined in section
201(p) of the act as then in force, and to the extent that such uses
would be permitted were the drug subject to paragraph (e)(4)(iii) of
this section.
(3) Additional uses contained in labeling in current commercial use
to the extent that such uses do not cause the drug to be an unapproved
''new drug'' as defined in section 201(p) of the act as amended or a
''new animal drug'' as defined in section 201(w) of the act as amended.
The advertisement shall present information from labeling required,
approved, or permitted in a new-drug application relating to each
specific side effect and contraindication in such labeling that relates
to the uses of the advertised drug dosage form(s) or shall otherwise
conform to the provisions of paragraph (e)(3)(iii) of this section.
(ii) An advertisement for a prescription drug subject to
certification under section 507 or 512 of the act shall not recommend or
suggest any use that is not in the labeling covered by the certification
or the applicable certification regulations or regulations providing for
exemption from certification. The advertisement shall present
information from such labeling covered by the certification or the
applicable certification regulations or regulations providing for
exemption from certification, relating to each specific side effect and
contraindication in such labeling and such regulations for the
advertised drug dosage form(s) or shall otherwise conform to the
provisions of paragraph (e)(3)(iii) of this section.
(iii) In the case of an advertisement for a prescription drug other
than a drug the labeling of which causes it to be an unapproved ''new
drug'' and other than drugs covered by paragraphs (e)(4)(i) and (ii) of
this section, an advertisement may recommend and suggest the drug only
for those uses contained in the labeling thereof:
(a) For which the drug is generally recognized as safe and effective
among experts qualified by scientific training and experience to
evaluate the safety and effectiveness of such drugs; or
(b) For which there exists substantial evidence of safety and
effectiveness, consisting of adequate and well-controlled
investigations, including clinical investigations (as used in this
section ''clinical investigations,'' ''clinical experience,'' and
''clinical significance'' mean in the case of drugs intended for
administration to man, investigations, experience, or significance in
humans, and in the case of drugs intended for administration to other
animals, investigations, experience, or significance in the specie or
species for which the drug is advertised), by experts qualified by
scientific training and experience to evaluate the safety and
effectiveness of the drug involved, on the basis of which it can fairly
and responsibly be concluded by such experts that the drug is safe and
effective for such uses; or
(c) For which there exists substantial clinical experience (as used
in this section this means substantial clinical experience adequately
documented in medical literature or by other data (to be supplied to the
Food and Drug Administration, if requested)), on the basis of which it
can fairly and responsibly be concluded by qualified experts that the
drug is safe and effective for such uses; or
(d) For which safety is supported under any of the preceding clauses
in paragraphs (e)(4)(iii) (a), (b), and (c) of this section and
effectiveness is supported under any other of such clauses.
The advertisement shall present information relating to each specific
side effect and contraindication that is required, approved, or
permitted in the package labeling by 201.100 or 201.105 of this
chapter of the drug dosage form(s) or shall otherwise conform to the
provisions of paragraph (e)(3)(iii) of this section.
(5) ''True statement'' of information. An advertisement does not
satisfy the requirement that it present a ''true statement'' of
information in brief summary relating to side effects,
contraindications, and effectiveness if:
(i) It is false or misleading with respect to side effects,
contraindications, or effectiveness; or
(ii) It fails to present a fair balance between information relating
to side effects and contraindications and information relating to
effectiveness of the drug in that the information relating to
effectiveness is presented in greater scope, depth, or detail than is
required by section 502(n) of the act and this information is not fairly
balanced by a presentation of a summary of true information relating to
side effects and contraindications of the drug; Provided, however, That
no advertisement shall be considered to be in violation of this section
if the presentation of true information relating to side effects and
contraindications is comparable in depth and detail with the claims for
effectiveness or safety.
(iii) It fails to reveal facts material in the light of its
representations or material with respect to consequences that may result
from the use of the drug as recommended or suggested in the
advertisement.
(6) Advertisements that are false, lacking in fair balance, or
otherwise misleading. An advertisement for a prescription drug is
false, lacking in fair balance, or otherwise misleading, or otherwise
violative of section 502(n) of the act, among other reasons, if it:
(i) Contains a representation or suggestion, not approved or
permitted for use in the labeling, that a drug is better, more
effective, useful in a broader range of conditions or patients (as used
in this section ''patients'' means humans and in the case of veterinary
drugs, other animals), safer, has fewer, or less incidence of, or less
serious side effects or contraindications than has been demonstrated by
substantial evidence or substantial clinical experience (as described in
paragraphs (e)(4)(iii) (b) and (c) of this section) whether or not such
representations are made by comparison with other drugs or treatments,
and whether or not such a representation or suggestion is made directly
or through use of published or unpublished literature, quotations, or
other references.
(ii) Contains a drug comparison that represents or suggests that a
drug is safer or more effective than another drug in some particular
when it has not been demonstrated to be safer or more effective in such
particular by substantial evidence or substantial clinical experience.
(iii) Contains favorable information or opinions about a drug
previously regarded as valid but which have been rendered invalid by
contrary and more credible recent information, or contains literature
references or quotations that are significantly more favorable to the
drug than has been demonstrated by substantial evidence or substantial
clinical experience.
(iv) Contains a representation or suggestion that a drug is safer
than it has been demonstrated to be by substantial evidence or
substantial clinical experience, by selective presentation of
information from published articles or other references that report no
side effects or minimal side effects with the drug or otherwise selects
information from any source in a way that makes a drug appear to be
safer than has been demonstrated.
(v) Presents information from a study in a way that implies that the
study represents larger or more general experience with the drug than it
actually does.
(vi) Contains references to literature or studies that misrepresent
the effectiveness of a drug by failure to disclose that claimed results
may be due to concomitant therapy, or by failure to disclose the
credible information available concerning the extent to which claimed
results may be due to placebo effect (information concerning placebo
effect is not required unless the advertisement promotes the drug for
use by man).
(vii) Contains favorable data or conclusions from nonclinical studies
of a drug, such as in laboratory animals or in vitro, in a way that
suggests they have clinical significance when in fact no such clinical
significance has been demonstrated.
(viii) Uses a statement by a recognized authority that is apparently
favorable about a drug but fails to refer to concurrent or more recent
unfavorable data or statements from the same authority on the same
subject or subjects.
(ix) Uses a quote or paraphrase out of context to convey a false or
misleading idea.
(x) Uses literature, quotations, or references that purport to
support an advertising claim but in fact do not support the claim or
have relevance to the claim.
(xi) Uses literature, quotations, or references for the purpose of
recommending or suggesting conditions of drug use that are not approved
or permitted in the drug package labeling.
(xii) Offers a combination of drugs for the treatment of patients
suffering from a condition amenable to treatment by any of the
components rather than limiting the indications for use to patients for
whom concomitant therapy as provided by the fixed combination drug is
indicated, unless such condition is included in the uses permitted under
paragraph (e)(4) of this section.
(xiii) Uses a study on normal individuals without disclosing that the
subjects were normal, unless the drug is intended for use on normal
individuals.
(xiv) Uses ''statistics'' on numbers of patients, or counts of
favorable results or side effects, derived from pooling data from
various insignificant or dissimilar studies in a way that suggests
either that such ''statistics'' are valid if they are not or that they
are derived from large or significant studies supporting favorable
conclusions when such is not the case.
(xv) Uses erroneously a statistical finding of ''no significant
difference'' to claim clinical equivalence or to deny or conceal the
potential existence of a real clinical difference.
(xvi) Uses statements or representations that a drug differs from or
does not contain a named drug or category of drugs, or that it has a
greater potency per unit of weight, in a way that suggests falsely or
misleadingly or without substantial evidence or substantial clinical
experience that the advertised drug is safer or more effective than such
other drug or drugs.
(xvii) Uses data favorable to a drug derived from patients treated
with dosages different from those recommended in approved or permitted
labeling if the drug advertised is subject to section 505, 507, or 512
of the act, or, in the case of other drugs, if the dosages employed were
different from those recommended in the labeling and generally
recognized as safe and effective. This provision is not intended to
prevent citation of reports of studies that include some patients
treated with dosages different from those authorized, if the results in
such patients are not used.
(xviii) Uses headline, subheadline, or pictorial or other graphic
matter in a way that is misleading.
(xix) Represents or suggests that drug dosages properly recommended
for use in the treatment of certain classes of patients or disease
conditions are safe and effective for the treatment of other classes of
patients or disease conditions when such is not the case.
(xx) Presents required information relating to side effects or
contraindications by means of a general term for a group in place of
disclosing each specific side effect and contraindication (for example
employs the term ''blood dyscrasias'' instead of ''leukopenia,''
''agranulocytosis,'' ''neutropenia,'' etc.) unless the use of such
general term conforms to the provisions of paragraph (e)(3)(iii) of this
section.
Provided, however, That any provision of this paragraph shall be
waived with respect to a specified advertisement as set forth in a
written communication from the Food and Drug Administration on a
petition for such a waiver from a person who would be adversely affected
by the enforcement of such provision on the basis of a showing that the
advertisement is not false, lacking in fair balance, or otherwise
misleading, or otherwise violative of section 502(n) of the act. A
petition for such a waiver shall set forth clearly and concisely the
petitioner's interest in the advertisement, the specific provision of
this paragraph from which a waiver is sought, a complete copy of the
advertisement, and a showing that the advertisement is not false,
lacking in fair balance, or otherwise misleading, or otherwise violative
of section 502(n) of the act.
(7) Advertisements that may be false, lacking in fair balance, or
otherwise misleading. An advertisement may be false, lacking in fair
balance, or otherwise misleading or otherwise violative of section
502(n) of the act if it:
(i) Contains favorable information or conclusions from a study that
is inadequate in design, scope, or conduct to furnish significant
support for such information or conclusions.
(ii) Uses the concept of ''statistical significance'' to support a
claim that has not been demonstrated to have clinical significance or
validity, or fails to reveal the range of variations around the quoted
average results.
(iii) Uses statistical analyses and techniques on a retrospective
basis to discover and cite findings not soundly supported by the study,
or to suggest scientific validity and rigor for data from studies the
design or protocol of which are not amenable to formal statistical
evaluations.
(iv) Uses tables or graphs to distort or misrepresent the
relationships, trends, differences, or changes among the variables or
products studied; for example, by failing to label abscissa and
ordinate so that the graph creates a misleading impression.
(v) Uses reports or statements represented to be statistical
analyses, interpretations, or evaluations that are inconsistent with or
violate the established principles of statistical theory, methodology,
applied practice, and inference, or that are derived from clinical
studies the design, data, or conduct of which substantially invalidate
the application of statistical analyses, interpretations, or
evaluations.
(vi) Contains claims concerning the mechanism or site of drug action
that are not generally regarded as established by scientific evidence by
experts qualified by scientific training and experience without
disclosing that the claims are not established and the limitations of
the supporting evidence.
(vii) Fails to provide sufficient emphasis for the information
relating to side effects and contraindications, when such information is
contained in a distinct part of an advertisement, because of repetition
or other emphasis in that part of the advertisement of claims for
effectiveness or safety of the drug.
(viii) Fails to present information relating to side effects and
contraindications with a prominence and readability reasonably
comparable with the presentation of information relating to
effectiveness of the drug, taking into account all implementing factors
such as typography, layout, contrast, headlines, paragraphing, white
space, and any other techniques apt to achieve emphasis.
(ix) Fails to provide adequate emphasis (for example, by the use of
color scheme, borders, headlines, or copy that extends across the
gutter) for the fact that two facing pages are part of the same
advertisement when one page contains information relating to side
effects and contraindications.
(x) In an advertisement promoting use of the drug in a selected class
of patients (for example, geriatric patients or depressed patients),
fails to present with adequate emphasis the significant side effects and
contraindications or the significant dosage considerations, when dosage
recommendations are included in an advertisement, especially applicable
to that selected class of patients.
(xi) Fails to present on a page facing another page (or on another
full page) of an advertisement on more than one page, information
relating to side effects and contraindications when such information is
in a distinct part of the advertisement.
(xii) Fails to include on each page or spread of an advertisement the
information relating to side effects and contraindications or a
prominent reference to its presence and location when it is presented as
a distinct part of an advertisement.
(xiii) Contains information from published or unpublished reports or
opinions falsely or misleadingly represented or suggested to be
authentic or authoritative.
(f) -- (i) (Reserved)
(j)(1) No advertisement concerning a particular prescription drug may
be disseminated without prior approval by the Food and Drug
Administration if:
(i) The sponsor or the Food and Drug Administration has received
information that has not been widely publicized in medical literature
that the use of the drug may cause fatalities or serious damage;
(ii) The Commissioner (or in his absence the officer acting as
Commissioner), after evaluating the reliability of such information, has
notified the sponsor that the information must be a part of the
advertisements for the drug; and
(iii) The sponsor has failed within a reasonable time as specified in
such notification to present to the Food and Drug Administration a
program, adequate in light of the nature of the information, for
assuring that such information will be publicized promptly and
adequately to the medical profession in subsequent advertisements.
If the Commissioner finds that the program presented is not being
followed, he will notify the sponsor that prior approval of all
advertisements for the particular drug will be required. Nothing in
this paragraph is to be construed as limiting the Commissioner's or the
Secretary's rights, as authorized by law, to issue publicity, to suspend
any new-drug application, to decertify any antibiotic, or to recommend
any regulatory action.
(2) Within a reasonable time after information concerning the
possibility that a drug may cause fatalities or serious damage has been
widely publicized in medical literature, the Food and Drug
Administration shall notify the sponsor of the drug by mail that prior
approval of advertisements for the drug is no longer necessary.
(3) Dissemination of an advertisement not in compliance with this
paragraph shall be deemed to be an act that causes the drug to be
misbranded under section 502(n) of the act.
(4) Any advertisement may be submitted to the Food and Drug
Administration prior to publication for comment. If the advertiser is
notified that the submitted advertisement is not in violation and, at
some subsequent time, the Food and Drug Administration changes its
opinion, the advertiser will be so notified and will be given a
reasonable time for correction before any regulatory action is taken
under this section. Notification to the advertiser that a proposed
advertisement is or is not considered to be in violation shall be in
written form.
(5) The sponsor shall have an opportunity for a regulatory hearing
before the Food and Drug Administration pursuant to part 16 of this
chapter with respect to any determination that prior approval is
required for advertisements concerning a particular prescription drug,
or that a particular advertisement is not approvable.
(k) An advertisement issued or caused to be issued by the
manufacturer, packer, or distributor of the drug promoted by the
advertisement and which is not in compliance with section 502(n) of the
act and the applicable regulations thereunder shall cause stocks of such
drug in possession of the person responsible for issuing or causing the
issuance of the advertisement, and stocks of the drug distributed by
such person and still in the channels of commerce, to be misbranded
under section 502(n) of the act.
(l)(1) Advertisements subject to section 502(n) of the act include
advertisements in published journals, magazines, other periodicals, and
newspapers, and advertisements broadcast through media such as radio,
television, and telephone communication systems.
(2) Brochures, booklets, mailing pieces, detailing pieces, file
cards, bulletins, calendars, price lists, catalogs, house organs,
letters, motion picture films, film strips, lantern slides, sound
recordings, exhibits, literature, and reprints and similar pieces of
printed, audio, or visual matter descriptive of a drug and references
published (for example, the ''Physicians Desk Reference'') for use by
medical practitioners, pharmacists, or nurses, containing drug
information supplied by the manufacturer, packer, or distributor of the
drug and which are disseminated by or on behalf of its manufacturer,
packer, or distributor are hereby determined to be labeling as defined
in section 201(m) of the act.
(40 FR 14016, Mar. 27, 1975, as amended at 40 FR 58799, Dec. 18,
1975; 41 FR 48266, Nov. 2, 1976; 42 FR 15674, Mar. 22, 1977)
Effective Date Note: At 44 FR 37467, June 26, 1979, 202.1(e)(6)(ii)
and (vii) were revised. At 44 FR 74817, Dec. 18, 1979, paragraphs
(e)(6)(ii) and (vii) were stayed indefinitely. For the convenience of
the user, paragraphs (e)(6)(ii) and (vii), published at 44 FR 37467, are
set forth below:
202.1 Prescription-drug advertisements.
(e) * * *
(6) * * *
(ii) Represents or suggests that a prescription drug is safer or more
effective than another drug in some particular when the difference has
not been demonstrated by substantial evidence. An advertisement for a
prescription drug may not, either directly or by implication, e.g., by
use of comparative test data or reference to published reports,
represent that the drug is safer or more effective than another drug,
nor may an advertisement contain a quantitative statement of safety or
effectiveness (a) unless the representation has been approved as part of
the labeling in a new drug or antibiotic application or biologic
license, or (b) if the drug is not a new drug or a certified or released
antibiotic, or biologic, unless the representation of safety or
effectiveness is supported by substantial evidence derived from adequate
and well-controlled studies as defined in 314.111(a)(5)(ii) of this
chapter, or unless the requirement for adequate and well-controlled
studies is waived as provided in 314.111(a)(5)(ii) of this chapter.
(vii) Suggests, on the basis of favorable data or conclusions from
nonclinical studies of a prescription drug, such as studies in
laboratory animals or in vitro, that the studies have clinical
significance, if clinical significance has not been demonstrated. Data
that demonstrate activity or effectiveness for a prescription drug in
animal or in vitro tests and have not been shown by adequate and
well-controlled clinical studies to pertain to clinical use may be used
in advertising except that (a), in the case of anti-infective drugs, in
vitro data may be included in the advertisement, if data are immediately
preceded by the statement ''The following in vitro data are available
but their clinical significance is unknown'' and (b), in the case of
other drug classes, in vitro and animal data that have not been shown to
pertain to clinical use by adequate and well-controlled clinical studies
as defined in 314.111(a)(5)(ii) of this chapter may not be used unless
the requirement for adequate and well-controlled studies is waived as
provided in 314.111(a)(5)(ii) of this chapter.
21 CFR 202.1 PART 205 -- GUIDELINES FOR STATE LICENSING OF WHOLESALE
PRESCRIPTION DRUG DISTRIBUTORS
Sec.
205.1 Scope.
205.2 Purpose.
205.3 Definitions.
205.4 Wholesale drug distributor licensing requirement.
205.5 Minimum required information for licensure.
205.6 Minimum qualifications.
205.7 Personnel.
205.8 Violations and penalties.
205.50 Minimum requirements for the storage and handling of
prescription drugs and for the establishment and maintenance of
prescription drug distribution records.
Authority: Secs. 501, 502, 503, 701, 704 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 351, 352, 353, 371, 374).
Source: 55 FR 38023, Sept. 14, 1990, unless otherwise noted.
21 CFR 205.1 Scope.
This part applies to any person, partnership, corporation, or
business firm in a State engaging in the wholesale distribution of human
prescription drugs in interstate commerce.
21 CFR 205.2 Purpose.
The purpose of this part is to implement the Prescription Drug
Marketing Act of 1987 by providing minimum standards, terms, and
conditions for the licensing by State licensing authorities of persons
who engage in wholesale distributions in interstate commerce of
prescription drugs.
21 CFR 205.3 Definitions.
(a) Blood means whole blood collected from a single donor and
processed either for transfusion or further manufacturing.
(b) Blood component means that part of blood separated by physical or
mechanical means.
(c) Drug sample means a unit of a prescription drug that is not
intended to be sold and is intended to promote the sale of the drug.
(d) Manufacturer means anyone who is engaged in manufacturing,
preparing, propagating, compounding, processing, packaging, repackaging,
or labeling of a prescription drug.
(e) Prescription drug means any human drug required by Federal law or
regulation to be dispensed only by a prescription, including finished
dosage forms and active ingredients subject to section 503(b) of the
Federal Food, Drug, and Cosmetic Act.
(f) Wholesale distribution and wholesale distribution means
distribution of prescription drugs to persons other than a consumer or
patient, but does not include:
(1) Intracompany sales;
(2) The purchase or other acquisition by a hospital or other health
care entity that is a member of a group purchasing organization of a
drug for its own use from the group purchasing organization or from
other hospitals or health care entities that are members of such
organizations;
(3) The sale, purchase, or trade of a drug or an offer to sell,
purchase, or trade a drug by a charitable organization described in
section 501(c)(3) of the Internal Revenue Code of 1954 to a nonprofit
affiliate of the organization to the extent otherwise permitted by law;
(4) The sale, purchase, or trade of a drug or an offer to sell,
purchase, or trade a drug among hospitals or other health care entities
that are under common control; for purposes of this section, common
control means the power to direct or cause the direction of the
management and policies of a person or an organization, whether by
ownership of stock, voting rights, by contract, or otherwise;
(5) The sale, purchase, or trade of a drug or an offer to sell,
purchase, or trade a drug for emergency medical reasons; for purposes
of this section, emergency medical reasons includes transfers of
prescription drugs by a retail pharmacy to another retail pharmacy to
alleviate a temporary shortage;
(6) The sale, purchase, or trade of a drug, an offer to sell,
purchase, or trade a drug, or the dispensing of a drug pursuant to a
prescription;
(7) The distribution of drug samples by manufacturers'
representatives or distributors' representatives; or
(8) The sale, purchase, or trade of blood and blood components
intended for transfusion.
(g) Wholesale distributor means any one engaged in wholesale
distribution of prescription drugs, including, but not limited to,
manufacturers; repackers; own-label distributors; private-label
distributors; jobbers; brokers; warehouses, including manufacturers'
and distributors' warehouses, chain drug warehouses, and wholesale drug
warehouses; independent wholesale drug traders; and retail pharmacies
that conduct wholesale distributions.
21 CFR 205.4 Wholesale drug distributor licensing requirement.
Every wholesale distributor in a State who engages in wholesale
distributions of prescription drugs in interstate commerce must be
licensed by the State licensing authority in accordance with this part
before engaging in wholesale distributions of prescription drugs in
interstate commerce.
21 CFR 205.5 Minimum required information for licensure.
(a) The State licensing authority shall require the following minimum
information from each wholesale drug distributor as part of the license
described in 205.4 and as part of any renewal of such license:
(1) The name, full business address, and telephone number of the
licensee;
(2) All trade or business names used by the licensee;
(3) Addresses, telephone numbers, and the names of contact persons
for all facilities used by the licensee for the storage, handling, and
distribution of prescription drugs;
(4) The type of ownership or operation (i.e., partnership,
corporation, or sole proprietorship); and
(5) The name(s) of the owner and/or operator of the licensee,
including:
(i) If a person, the name of the person;
(ii) If a partnership, the name of each partner, and the name of the
partnership;
(iii) If a corporation, the name and title of each corporate officer
and director, the corporate names, and the name of the State of
incorporation; and
(iv) If a sole proprietorship, the full name of the sole proprietor
and the name of the business entity.
(b) The State licensing authority may provide for a single license
for a business entity operating more than one facility within that
State, or for a parent entity with divisions, subsidiaries, and/or
affiliate companies within that State when operations are conducted at
more than one location and there exists joint ownership and control
among all the entities.
(c) Changes in any information in paragraph (a) of this section shall
be submitted to the State licensing authority as required by such
authority.
(Approved by the Office of Management and Budget under control number
0910-0251)
21 CFR 205.6 Minimum qualifications.
(a) The State licensing authority shall consider, at a minimum, the
following factors in reviewing the qualifications of persons who engage
in wholesale distribution of prescription drugs within the State:
(1) Any convictions of the applicant under any Federal, State, or
local laws relating to drug samples, wholesale or retail drug
distribution, or distribution of controlled substances;
(2) Any felony convictions of the applicant under Federal, State, or
local laws;
(3) The applicant's past experience in the manufacture or
distribution of prescription drugs, including controlled substances;
(4) The furnishing by the applicant of false or fraudulent material
in any application made in connection with drug manufacturing or
distribution;
(5) Suspension or revocation by Federal, State, or local government
of any license currently or previously held by the applicant for the
manufacture or distribution of any drugs, including controlled
substances;
(6) Compliance with licensing requirements under previously granted
licenses, if any;
(7) Compliance with requirements to maintain and/or make available to
the State licensing authority or to Federal, State, or local law
enforcement officials those records required under this section; and
(8) Any other factors or qualifications the State licensing authority
considers relevant to and consistent with the public health and safety.
(b) The State licensing authority shall have the right to deny a
license to an applicant if it determines that the granting of such a
license would not be in the public interest.
21 CFR 205.7 Personnel.
The State licensing authority shall require that personnel employed
in wholesale distribution have appropriate education and/or experience
to assume responsibility for positions related to compliance with State
licensing requirements.
21 CFR 205.8 Violations and penalties.
(a) State licensing laws shall provide for the suspension or
revocation of licenses upon conviction of violations of Federal, State,
or local drug laws or regulations, and may provide for fines,
imprisonment, or civil penalties.
(b) State licensing laws shall provide for suspension or revocation
of licenses, where appropriate, for violations of its provisions.
21 CFR 205.50 Minimum requirements for the storage and handling of
prescription drugs and for the establishment and maintenance of
prescription drug distribution records.
The State licensing law shall include the following minimum
requirements for the storage and handling of prescription drugs, and for
the establishment and maintenance of prescription drug distribution
records by wholesale drug distributors and their officers, agents,
representatives, and employees:
(a) Facilities. All facilities at which prescription drugs are
stored, warehoused, handled, held, offered, marketed, or displayed
shall:
(1) Be of suitable size and construction to facilitate cleaning,
maintenance, and proper operations;
(2) Have storage areas designed to provide adequate lighting,
ventilation, temperature, sanitation, humidity, space, equipment, and
security conditions;
(3) Have a quarantine area for storage of prescription drugs that are
outdated, damaged, deteriorated, misbranded, or adulterated, or that are
in immediate or sealed, secondary containers that have been opened;
(4) Be maintained in a clean and orderly condition; and
(5) Be free from infestation by insects, rodents, birds, or vermin of
any kind.
(b) Security. (1) All facilities used for wholesale drug
distribution shall be secure from unauthorized entry.
(i) Access from outside the premises shall be kept to a minimum and
be well-controlled.
(ii) The outside perimeter of the premises shall be well-lighted.
(iii) Entry into areas where prescription drugs are held shall be
limited to authorized personnel.
(2) All facilities shall be equipped with an alarm system to detect
entry after hours.
(3) All facilities shall be equipped with a security system that will
provide suitable protection against theft and diversion. When
appropriate, the security system shall provide protection against theft
or diversion that is facilitated or hidden by tampering with computers
or electronic records.
(c) Storage. All prescription drugs shall be stored at appropriate
temperatures and under appropriate conditions in accordance with
requirements, if any, in the labeling of such drugs, or with
requirements in the current edition of an official compendium, such as
the United States Pharmacopeia/National Formulary (USP/NF).
(1) If no storage requirements are established for a prescription
drug, the drug may be held at ''controlled'' room temperature, as
defined in an official compendium, to help ensure that its identity,
strength, quality, and purity are not adversely affected.
(2) Appropriate manual, electromechanical, or electronic temperature
and humidity recording equipment, devices, and/or logs shall be utilized
to document proper storage of prescription drugs.
(3) The recordkeeping requirements in paragraph (f) of this section
shall be followed for all stored drugs.
(d) Examination of materials. (1) Upon receipt, each outside
shipping container shall be visually examined for identity and to
prevent the acceptance of contaminated prescription drugs or
prescription drugs that are otherwise unfit for distribution. This
examination shall be adequate to reveal container damage that would
suggest possible contamination or other damage to the contents.
(2) Each outgoing shipment shall be carefully inspected for identity
of the prescription drug products and to ensure that there is no
delivery of prescription drugs that have been damaged in storage or held
under improper conditions.
(3) The recordkeeping requirements in paragraph (f) of this section
shall be followed for all incoming and outgoing prescription drugs.
(e) Returned, damaged, and outdated prescription drugs. (1)
Prescription drugs that are outdated, damaged, deteriorated, misbranded,
or adulterated shall be quarantined and physically separated from other
prescription drugs until they are destroyed or returned to their
supplier.
(2) Any prescription drugs whose immediate or sealed outer or sealed
secondary containers have been opened or used shall be identified as
such, and shall be quarantined and physically separated from other
prescription drugs until they are either destroyed or returned to the
supplier.
(3) If the conditions under which a prescription drug has been
returned cast doubt on the drug's safety, identity, strength, quality,
or purity, then the drug shall be destroyed, or returned to the
supplier, unless examination, testing, or other investigation proves
that the drug meets appropriate standards of safety, identity, strength,
quality, and purity. In determining whether the conditions under which
a drug has been returned cast doubt on the drug's safety, identity,
strength, quality, or purity, the wholesale drug distributor shall
consider, among other things, the conditions under which the drug has
been held, stored, or shipped before or during its return and the
condition of the drug and its container, carton, or labeling, as a
result of storage or shipping.
(4) The recordkeeping requirements in paragraph (f) of this section
shall be followed for all outdated, damaged, deteriorated, misbranded,
or adulterated prescription drugs.
(f) Recordkeeping. (1) Wholesale drug distributors shall establish
and maintain inventories and records of all transactions regarding the
receipt and distribution or other disposition of prescription drugs.
These records shall include the following information:
(i) The source of the drugs, including the name and principal address
of the seller or transferor, and the address of the location from which
the drugs were shipped;
(ii) The identity and quantity of the drugs received and distributed
or disposed of; and
(iii) The dates of receipt and distribution or other disposition of
the drugs.
(2) Inventories and records shall be made available for inspection
and photocopying by authorized Federal, State, or local law enforcement
agency officials for a period of 2 years following disposition of the
drugs.
(3) Records described in this section that are kept at the inspection
site or that can be immediately retrieved by computer or other
electronic means shall be readily available for authorized inspection
during the retention period. Records kept at a central location apart
from the inspection site and not electronically retrievable shall be
made available for inspection within 2 working days of a request by an
authorized official of a Federal, State, or local law enforcement
agency.
(g) Written policies and procedures. Wholesale drug distributors
shall establish, maintain, and adhere to written policies and
procedures, which shall be followed for the receipt, security, storage,
inventory, and distribution of prescription drugs, including policies
and procedures for identifying, recording, and reporting losses or
thefts, and for correcting all errors and inaccuracies in inventories.
Wholesale drug distributors shall include in their written policies and
procedures the following:
(1) A procedure whereby the oldest approved stock of a prescription
drug product is distributed first. The procedure may permit deviation
from this requirement, if such deviation is temporary and appropriate.
(2) A procedure to be followed for handling recalls and withdrawals
of prescription drugs. Such procedure shall be adequate to deal with
recalls and withdrawals due to:
(i) Any action initiated at the request of the Food and Drug
Administration or other Federal, State, or local law enforcement or
other government agency, including the State licensing agency;
(ii) Any voluntary action by the manufacturer to remove defective or
potentially defective drugs from the market; or
(iii) Any action undertaken to promote public health and safety by
replacing of existing merchandise with an improved product or new
package design.
(3) A procedure to ensure that wholesale drug distributors prepare
for, protect against, and handle any crisis that affects security or
operation of any facility in the event of strike, fire, flood, or other
natural disaster, or other situations of local, State, or national
emergency.
(4) A procedure to ensure that any outdated prescription drugs shall
be segregated from other drugs and either returned to the manufacturer
or destroyed. This procedure shall provide for written documentation of
the disposition of outdated prescription drugs. This documentation
shall be maintained for 2 years after disposition of the outdated drugs.
(h) Responsible persons. Wholesale drug distributors shall establish
and maintain lists of officers, directors, managers, and other persons
in charge of wholesale drug distribution, storage, and handling,
including a description of their duties and a summary of their
qualifications.
(i) Compliance with Federal, State, and local law. Wholesale drug
distributors shall operate in compliance with applicable Federal, State,
and local laws and regulations.
(1) Wholesale drug distributors shall permit the State licensing
authority and authorized Federal, State, and local law enforcement
officials to enter and inspect their premises and delivery vehicles, and
to audit their records and written operating procedures, at reasonable
times and in a reasonable manner, to the extent authorized by law.
(2) Wholesale drug distributors that deal in controlled substances
shall register with the appropriate State controlled substance authority
and with the Drug Enforcement Administration (DEA), and shall comply
with all applicable State, local, and DEA regulations.
(j) Salvaging and reprocessing. Wholesale drug distributors shall be
subject to the provisions of any applicable Federal, State, or local
laws or regulations that relate to prescription drug product salvaging
or reprocessing, including parts 207, 210, and 211 of this chapter.
(Approved by the Office of Management and Budget under control number
0910-0251)
21 CFR 205.50 Pt. 207
21 CFR 205.50 PART 207 -- REGISTRATION OF PRODUCERS OF DRUGS AND LISTING OF DRUGS IN COMMERCIAL DISTRIBUTION
21 CFR 205.50 Subpart A -- General
Sec.
207.3 Definitions.
207.7 Establishment registration and product listing for human blood
and blood products and for medical devices.
21 CFR 205.50 Subpart B -- Exemptions
207.10 Exemptions for domestic establishments.
21 CFR 205.50 Subpart C -- Procedures for Domestic Drug Establishments
207.20 Who must register and submit a drug list.
207.21 Times for registration and drug listing.
207.22 How and where to register and list drugs.
207.25 Information required in registration and drug listing.
207.26 Amendments to registration.
207.30 Updating drug listing information.
207.31 Additional drug listing information.
207.35 Notification of registrant; drug establishment registration
number and drug listing number.
207.37 Inspection of registrations and drug listings.
207.39 Misbranding by reference to registration or to registration
number.
21 CFR 205.50 Subpart D -- Procedure for Foreign Drug Establishments
207.40 Drug listing requirements for foreign drug establishments.
Authority: Secs. 301, 501, 502, 505, 506, 507, 510, 512, 701, 704 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331, 351, 352, 355,
356, 357, 360, 360b, 371, 374); sec. 351 of the Public Health Service
Act (42 U.S.C. 262).
Source: 45 FR 38043, June 6, 1980, unless otherwise noted.
21 CFR 205.50 Subpart A -- General
21 CFR 207.3 Definitions.
(a) The following definitions apply to this part:
(1) Act means the Federal Food, Drug, and Cosmetic Act approved June
25, 1938 (52 Stat. 1040 et seq., as amended (21 U.S.C. 301-392)), except
as otherwise provided.
(2) Advertising and labeling include the promotional material
described in 202.1(l) (1) and (2) respectively.
(3) Any material change includes but is not limited to any change in
the name of the drug, any change in the identity or quantity of the
active ingredient(s), any change in the identity or quantity of the
inactive ingredient(s) where quantitative listing of all ingredients is
required by 207.31(a)(2), any significant change in the labeling of a
prescription drug, and any significant change in the label or package
insert of an over-the-counter drug. Changes that are not significant
include changes in arrangement or printing or changes of an editorial
nature.
(4) Bulk drug substance means any substance that is represented for
use in a drug and that, when used in the manufacturing, processing, or
packaging of a drug, becomes an active ingredient or a finished dosage
form of the drug, but the term does not include intermediates used in
the synthesis of such substances.
(5) Commercial distribution means any distribution of a human drug
except for investigational use under part 312 of this chapter, and any
distribution of an animal drug or an animal feed bearing or containing
an animal drug for noninvestigational uses, but the term does not
include internal or interplant transfer of a bulk drug substance between
registered domestic establishments within the same parent, subsidiary,
and/or affiliate company.
(6) Drug product salvaging means the act of segregating drug products
that may have been subjected to improper storage conditions, such as
extremes in temperature, humidity, smoke, fumes, pressure, age, or
radiation, for the purpose of returning some or all of the products to
the marketplace.
(7) Establishment means a place of business under one management at
one general physical location. The term includes, among others,
independent laboratories that engage in control activities for a
registered drug establishment (e.g., consulting laboratories),
manufacturers of medicated feeds and of vitamin products that are drugs
in accordance with section 201(g) of the act, human blood donor centers,
and animal facilities used for the production or control testing of
licensed biologicals, and establishments engaged in drug product
salvaging.
(8) Manufacturing or processing means the manufacture, preparation,
propagation, compounding, or processing of a drug or drugs as used in
section 510 of the act and is the making by chemical, physical,
biological, or other procedures of any articles that meet the definition
of drugs in section 201(g) of the act. The term includes manipulation,
sampling, testing, or control procedures applied to the final product or
to any part of the process. The term also includes repackaging or
otherwise changing the container, wrapper, or labeling of any drug
package to further the distribution of the drug from the original place
of manufacture to the person who makes final delivery or sale to the
ultimate consumer.
(9) Representative sampling of advertisements means typical
advertising material (excluding labeling as determined in 202.1(l) (1)
and (2)) that gives a balanced picture of the promotional claims used
for the drug, e.g., if more than one medical journal advertisement is
used but the promotional content is essentially identical, only one need
be submitted.
(10) Representative sampling of any other labeling means typical
labeling material (excluding labels and package inserts) that gives a
balanced picture of the promotional claims used for the drug, e.g., if
more than one brochure is used but the promotional content is
essentially identical, only one need be submitted.
(b) The definitions and interpretations of terms in sections 201,
502(e), and 510 of the act apply to the use of terms in this part.
(45 FR 38043, June 6, 1980, as amended at 55 FR 11576, Mar. 29, 1990)
21 CFR 207.7 Establishment registration and product listing for human
blood and blood products and for medical devices.
(a) Owners and operators of human blood and blood product
establishments shall register and list their products with the Division
of Product Certification, Office of Biological Product Review (HFB-240),
Center for Biologics Evaluation and Research, 8800 Rockville Pike,
Bethesda, MD 20892, on Form FDA-2830 (Blood Establishment Registration
and Product Listing), in acordance with part 607. Such owners and
operators who also manufature or process other drug products at the same
establishment shall, in addition, register and list all such other drug
products with the Drug Listing Branch in accordance with this part.
(b) (Reserved)
(c) Owners and operators of establishments engaged in manufacture or
processing of medical devices shall register and list their products
with the Center for Devices and Radiological Health, FDA, on Form
FDA-2891 (Initial Registration of Device Establishments), FDA-2891a
(Registration of Device Establishment), and FDA-2892 (Medical Device
Listing), in accordance with part 807.
(d) Owners and operators of establishments engaged in the manufacture
or processing at the same establishment of both drug products and
medical devices shall (1) register with the Drug Listing Branch
(HFD-334), Center for Drug Evaluation and Research, FDA, and list their
drug products in accordance with this part, and (2) register with the
Center for Devices and Radiological Health and list their medical
devices in accordance with part 807.
(45 FR 38043, June 6, 1980, as amended at 50 FR 8995, Mar. 6, 1985;
55 FR 11576, Mar. 29, 1990)
21 CFR 207.7 Subpart B -- Exemptions
21 CFR 207.10 Exemptions for domestic establishments.
The following classes of persons are exempt from registration and
drug listing in accordance with this part under section 510(g) (1), (2),
and (3) of the act, or because FDA has found, under section 510(g)(4),
that their registration is not necessary for the protection of the
public health.
(a) Pharmacies that operate under applicable local laws regulating
dispensing of prescription drugs and that do not manufacture or process
drugs for sale other than in the regular course of the practice of the
profession of pharmacy, including dispensing and selling drugs at
retail. The supplying of prescription drugs by these pharmacies to a
practitioner licensed to administer these drugs for his or her use in
the course of professional practice or to other pharmacies to meet
temporary inventory shortages are not acts that require pharmacies to
register.
(b) Hospitals, clinics, and public health agencies that maintain
establishments in conformance with any applicable local laws regulating
the practices of pharmacy or medicine and that regularly engage in
dispensing prescription drugs, other than human blood or blood products,
upon prescription of practitioners licensed by law to administer these
drugs to patients under their professional care.
(c) Practitioners who are licensed by law to prescribe or administer
drugs and who manufacture or process drugs solely for use in their
professional practice.
(d) Persons who manufacture or process drugs not for sale but solely
for use in research, teaching, or chemical analysis.
(e) Manufacturers of harmless inactive ingredients that are
excipients, colorings, flavorings, emulsifiers, lubricants,
preservatives, or solvents that become components of drugs, and who
otherwise would not be required to register under this part.
(f) Persons who manufacture Type B or Type C medicated feed using
Category I, Type A medicated articles; Category I, Type B medicated
feeds; and/or Category II, Type B medicated feeds, as defined in 558.3
of this chapter, as drug sources.
(g) Any manufacturer of a virus, serum, toxin, or analogous product
intended for treatment of domestic animals who holds an unsuspended and
unrevoked license issued by the Secretary of Agriculture under the
animal virus-serum-toxin law of March 4, 1913 (37 Stat. 832 (21 U.S.C.
151 et seq.)), provided that this exemption from registration applies
only to the manufacture or processing of that animal virus, serum,
toxin, or analogous product.
(h) Carriers, in their receipt, carriage, holding, or delivery of
drugs in the usual course of business as carriers.
(45 FR 38043, June 6, 1980, as amended at 51 FR 7389, Mar. 3, 1986)
21 CFR 207.10 Subpart C -- Procedures for Domestic Drug Establishments
21 CFR 207.20 Who must register and submit a drug list.
(a) Owners or operators of all drug establishments, not exempt under
section 510(g) of the act or subpart D of this part 207, that engage in
the manufacture, preparation, propagation, compounding, or processing of
a drug or drugs are required to register and to submit a list of every
drug in commercial distribution (except that listing information may be
submitted by the parent, subsidiary, and/or affiliate company for all
establishments when operations are conducted at more than one
establishment and there exists joint ownership and control among all the
establishments). Such owners or operators are required to register and
to submit a list of every drug in commercial distribution (except that
listing information may be submitted by the parent, subsidiary, and/or
affiliate company for all establishments when operations are conducted
at more than one establishment and there exists joint ownership and
control among all the establishments), whether or not the output of such
establishment or any particular drug so listed enters interstate
commerce, except that drug listing is not required at this time for the
manufacturing, preparation, propagation, compounding, or processing of
an animal feed (including a Type B and Type C medicated feed) bearing or
containing an animal drug, nor is drug listing required for
establishments engaged in drug product salvaging. No owner or operator
may register an establishment, if any part of the establishment is
registered by any other owner or operator.
(b) Owners or operators of establishments not otherwise required to
register under section 510 of the act that distribute under their own
label or trade name a drug manufactured or processed by a registered
establishment may elect to submit listing information directly to FDA
and to obtain a Labeler Code. A distributor who submits drug listing
information shall include the registration number of the drug
establishment that manufactured, prepared, propagated, compounded, or
processed each drug listed. All distributors who submit drug listing
information to FDA assume full responsibility for compliance with all of
the requirements of this part. Each such distributor at the time of
submitting or updating drug listing information as required under
207.30 shall certify to the registered establishment that the submission
has been made by providing a signed copy of Form FDA-2656 (Registration
of Drug Establishment) to the registered establishment that manufactures
or processes the drug. Each such distributor shall submit the original
of Form FDA-2656 showing this certification to FDA, and shall accompany
the certification with a list showing the National Drug Code number that
the distributor has assigned to each drug product. If a distributor
does not elect to submit drug listing information directly to FDA and to
obtain a Labeler Code, the registered establishment shall submit the
drug listing information. Distributors or registered establishments
shall use Form FDA-2658 (Registered Establishments' Report of Private
Label Distributors) to submit drug listing information or to request a
Labeler Code, or both.
(c) Before beginning manufacture or processing of a drug subject to
one of the following applications, an owner or operator of an
establishment is required to register before the agency approves it: a
new drug application, a new animal drug application, a medicated feed
application, an antibiotic application, or an establishment license
application to manufacture a biological product.
(d) No registration fee is required.
(e) Registration and listing do not constitute an admission, or
agreement, or determination that a product is a drug as defined in
section 201(g) of the act.
(45 FR 38043, June 6, 1980, as amended at 45 FR 32293, May 16, 1980;
52 FR 2682, Jan. 26, 1987; 55 FR 11576, Mar. 29, 1990)
21 CFR 207.21 Times for registration and drug listing.
(a) The owner or operator of an establishment entering into the
manufacture or processing of a drug or drugs shall register the
establishment within 5 days after the beginning of the operation and
shall submit a list of every drug in commercial distribution at that
time. If the owner or operator of the establishment has not previously
entered into such an operation, the owner or operator shall register
within 5 days after submitting a new drug application, new animal drug
application, medicated feed application, antibiotic application, or an
establishment license application to manufacture a biological product.
Owners or operators of all establishments engaged in the drug activities
described in 207.3(a)(8) shall register annually within 30 days after
receiving registration forms from FDA. FDA will mail Forms FDA-2656
(Registration of Drug Establishment) to registered establishments
according to a schedule based on the first letter of the name of the
establishment's parent company as stated on the firm's registration
form. If no parent company name is given on that form, the schedule is
based on the first letter of the establishment's name. In scheduling
the mailing of forms based on the first letter of the company name, FDA
will not consider the word ''the'' when it appears as the first word in
the name of the parent company or establishment.
The schedule is as follows:
(b) Owners and operators of all registered establishments shall
update their drug listing information every June and December.
(45 FR 38043, June 6, 1980, as amended at 55 FR 11576, Mar. 29, 1990)
21 CFR 207.22 How and where to register and list drugs.
(a) An establishment shall register the first time on Form FDA-2656
(Registration of Drug Establishment), obtainable on request from the
Drug Listing Branch (HFD-334), Center for Drug Evaluation and Research,
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, or
from FDA district offices. An establishment whose drug registration for
that year was validated under 207.35 shall make subsequent annual
registration on Form FDA-2656 as described in 207.21(a) by mailing the
completed form to the above address within 30 days after receipt from
FDA.
(b) The first list of drugs and later June and December updatings
shall be on Form FDA-2657 (Drug Product Listing), obtainable upon
request as described in paragraph (a) of this section. An establishment
may submit, in lieu of Form FDA-2657, tapes for computer inputs
containing the information specified in Form FDA-2657 if formats
proposed for this use were reviewed and approved by the Drug Listing
Branch (HFD-334), Center for Drug Evaluation and Research, FDA.
(45 FR 38043, June 6, 1980, as amended at 50 FR 8995, Mar. 6, 1985;
55 FR 11576, Mar. 29, 1990)
21 CFR 207.25 Information required in registration and drug listing.
(a) Form FDA-2656 (Registration of Drug Establishment) provides for
furnishing or confirming information required by the act. This
information includes, for each establishment, the name and full address
of the drug establishment; all trade names used by the establishment;
the kind of ownership or operation (that is, individually owned,
partnership or corporation); and the name of the owner or operator of
the establishment. The term ''name of the owner or operator'' includes
in the case of a partnership the name of each partner, and in the case
of a corporation the name and title of each corporate officer and
director and the name of the State of incorporation.
(b) Form FDA-2657 (Drug Product Listing) provides that information
required by the act be furnished as follows:
(1) A list of drugs, including bulk drug substances and Type A
articles for use in the manufacture of animal feeds as well as finished
dosage forms, by established name and by proprietary name, that are
being manufactured or processed for commercial distribution and that
have not been included in any list previously submitted to FDA on Form
FDA-2657 or in conjunction with the FDA voluntary inventory on Form
FDA-2422 (Survey Report of Marketed Drugs), or Form FDA-2250 (National
Drug Code Directory Input).
(2) For each drug listed that the registrant regards as subject to
section 505, 506, 507, or 512 of the act, the new drug application
number, abbreviated new drug application number, new animal drug
application number, or antibiotic application number, and a copy of all
current labeling, except that only one representative container or
carton label need be submitted where differences exist only in the
quantity of contents statement.
(3) For each drug listed that the registrant regards as subject to
section 351 of the Public Health Service Act, the license number of the
manufacturer.
(4) For each human prescription drug listed that the registrant
regards as not subject to section 505, 506, or 507 of the act or 351 of
the Public Health Service Act, and that is not manufactured by a
registered blood bank, a copy of all current labeling (except that only
one representative container or carton label need be submitted where
differences exist only in the quantity of contents statement) and a
representative sampling of advertisements.
(5) For each human over-the-counter drug listed, or each animal drug
listed, that the registrant regards as not subject to section 505, 506,
507, or 512 of the act or 351 of the Public Health Service Act, a copy
of the label (except that only one representative container or carton
label need be submitted where differences exist only in the quantity of
contents statement), the package insert, and a representative sampling
of any other labeling.
(6) For each prescription or over-the-counter drug so listed that the
registrant regards as not subject to section 505, 506, 507, or 512 of
the act or 351 of the Public Health Service Act, and that is not
manufactured by a registered blood bank, a quantitative listing of the
active ingredient(s). Unless the quantitative listing is expressed as a
percentage in the offical compendium or the ingredient is a
nonantibiotic ingredient in a Type A medicated article for use in the
manufacture of animal feeds, the quantity of an ingredient shall be
expressed in terms of the amount, not the percent, of that ingredient in
each dosage unit or, if the drug is not in unit dosage form, the amount
of the ingredient in a specific unit of weight or measure of the drug.
For a drug formulation that is a Type A medicated article subject to
207.35(b)(2)(iii), the registrant may limit the quantitative listing of
ingredients to each variation of level of active drug ingredient.
(7) For each drug listed, the registration number of every drug
establishment within the parent company at which it is manufactured or
processed.
(8) For each drug listed, the National Drug Code (NDC) number. If
FDA has not assigned an NDC Labeler Code, the registrant shall include a
Product Code and Package Code and FDA will assign a Labeler Code as
described in 207.35(b)(2)(i).
(45 FR 38043, June 6, 1980, as amended at 52 FR 2682, Jan. 26, 1987;
55 FR 11577, Mar. 29, 1990)
21 CFR 207.26 Amendments to registration.
Changes in individual ownership, corporate or partnership structure
location or drug-handling activity, shall be submitted by Form FDA-2656
(Registration of Drug Establishment) as amendment to registration within
5 days of such changes. A change in a registered establishment's firm
name within 6 months of the registration of the establishment is
required to be supported by a signed statement of the establishment's
owner or operator that the change is not made for the purpose of
changing the name of the manufacturer of a drug product under 201.1 of
this chapter. Changes in the names of officers and directors of the
corporations do not require such amendment but must be shown at time of
annual registration.
(45 FR 25777, Apr. 15, 1980, as amended at 55 FR 11577, Mar. 29,
1990)
21 CFR 207.30 Updating drug listing information.
(a) After submitting the initial drug listing information, every
person who is required to list drugs under 207.20 shall submit on Form
FDA-2657 (Drug Product Listing) during each subsequent June and
December, or at the discretion of the registrant when the change occurs,
the following information:
(1) A list of each drug introduced by the registrant for commerical
distribution which has not been included in any list previously
submitted. The registrant shall provide all of the information required
by 207.25(b) for each such drug.
(2) A list of each drug formerly listed in accordance with 207.25(b)
for which commercial distribution has been discontinued, including for
each drug so listed the National Drug Code (NDC) number, the identity by
established name and by proprietary name, and date of discontinuance.
It is requested but not required that the reason for discontinuance of
distribution be included with this information.
(3) A list of each drug for which a notice of discontinuance was
submitted under paragraph (a)(2) of this section and for which
commercial distribution has been resumed, including for each drug so
listed the NDC number, the identity by established name and by
proprietary name, the date of resumption, and any other information
required by 207.25(b) not previously submitted.
(4) Any material change in any information previously submitted.
(b) When no changes have occurred since the previously submitted
list, no report is required.
21 CFR 207.31 Additional drug listing information.
(a) In addition to the information routinely required by 207.25 and
207.30, FDA may require submission of the following information by
letter or by Federal Register notice:
(1) For a particular prescription drug so listed that the registrant
regards as not subject to section 505, 506, or 507 of the act, upon
request by FDA for good cause, a copy of all advertisements.
(2) For a particular drug product so listed that the registrant
regards as not subject to section 505, 506, 507, or 512 of the act, upon
a finding by FDA that it is necessary to carry out the purposes of the
act, a quantitative listing of all ingredients.
(3) For a particular drug product, upon request by FDA, a brief
statement of the basis for the registrant's belief that the drug product
is not subject to section 505, 506, 507, or 512 of the act.
(4) For each registrant, upon a finding by FDA that it is necessary
to carry out the purposes of the act, a list of each listed drug product
containing a particular ingredient.
(b) It is requested but not required that a qualitative listing of
the inactive ingredients be submitted for all listed drugs in the format
prescribed in Form FDA-2657 (Drug Product Listing).
(c) It is requested but not required that a quantitative listing of
the active ingredients be submitted for all drugs listed that are
subject to section 505, 506, 507, or 512 of the act or section 351 of
the Public Health Service Act.
21 CFR 207.35 Notification of registrant; drug establishment
registration number and drug listing number.
(a) FDA will provide to the registrant a validated copy of Form
FDA-2656 (Registration of Drug Establishment) as evidence of
registration. This validated copy will be sent to the mailing address
shown on the form. FDA will assign a permanent registration number to
each drug establishment registered in accordance with these regulations.
(b) Using the National Drug Code (NDC) numbering system, FDA assigns
a drug listing number to each drug or class of drugs listed as follows:
(1) If a drug is already listed in the National Drug Code System or
in the National Health Related Items Code System, the number is the same
as that assigned under those codes. FDA adds a lead zero to the first
three characters of the code, which identifies the manufacturer or
distributor, to expand the ''Labeler Code'' segment to four characters.
The National Drug Code, Product Code, and Package Code configurations
used to describe these drugs, or any drugs added to the product line,
remain the same, i.e., a four-character Product Code and a two-character
Package Code. A manufacturer or distributor may either retain
alphanumeric characters that are already used in the Product Code and
Package Code segments of the National Drug Code or convert these
alphanumeric characters to all numeric digits. The manufacturer or
distributor shall inform FDA of a decision to convert the alphanumeric
characters to all numeric digits.
(2) If a registered establishment or distributor has not previously
participated in the National Drug Code System or in the National Health
Related Items Code System, FDA uses the National Drug Code numbering
system in assigning a number, as follows (only numerals are used):
(i) The first 5 numeric characters of the 10-character code identify
the manufacturer or distributor and are known as the Labeler Code. FDA
will expand the Labeler Code from five to six numeric characters when
the available five-character code combinations are exhausted. FDA will
assign Labeler Code numbers and provide them to the registrant along
with the validated copy of Form FDA-2656. Any registered firm that does
not have an assigned Labeler Code will be assigned one when registration
and listing information are submitted.
(ii) The last 5 numeric characters of the 10-character code identify
the drug and the trade package size and type. The segment that
identifies the drug formulation is known as the Product Code and the
segment that identifies the trade package size and type is known as the
Package Code. The manufacturer or distributor will assign the Product
Code and the Package Code before drug listing and include these codes in
Form FDA-2657 (Drug Product Listing). The manufacturer or distributor
may use either of two methods in assigning the Product and Package
Codes: a 3-2 Product-Package Code configuration (e.g., 542-12) or a 4-1
Product-Package Code configuration (e.g., 5421-2). A manufacturer or
distributor with a given Labeler Code shall use only one such
Product-Package Code configuration and shall use this same configuration
in assigning the Product-Package Codes for all drugs included in the
drug listing. The manufacturer or distributor shall report to FDA the
Product-Package Code configuration used in assigning these codes.
(iii) If the drug formulation is a Type A medicated article intended
for use in the manufacture of an animal feed, FDA assigns a separate
Product Code only for each variation of level of active drug ingredient.
(3) FDA requests but does not require that the NDC number appear on
all drug labels and in other drug labeling, including the label of any
prescription drug container furnished to a consumer. If the NDC number
is shown on a drug label, it shall be placed as follows:
(i) The NDC number shall appear prominently in the top third of the
principal display panel of the label on the immediate container and of
any outside container or wrapper. Instead of appearing in the top third
of the label, the NDC number may appear as part of and contiguous to any
bar-code symbol for any drug product if two conditions are met. First,
the symbol appears prominently on the immediate container and on any
outside container or wrapper and in a conspicuous location; this
condition is not satisfied by the appearance of the symbol only on the
natural bottom of a container or wrapper. Second, the bar-code symbol
is compatible with the NDC, i.e., the symbol provides a format capable
of encoding the numeric characters of an NDC Number. The term
''principal display panel,'' as used in this paragraph, means that part
of a label most likely to be displayed, presented, shown, or examined
under customary conditions of display to the consumer (for
over-the-counter drug products) or to the dispenser (for prescription
drug products).
(ii) The NDC number shall be preceded by the prefix ''NDC'' or ''N''
when it is used on a label or in labeling. The prefix used for a drug
product shall be used consistently on the label of the immediate
container, outside container, or wrapper, if any, and on other labeling
for that drug product.
(iii) The Product-Package Code configuration shall be indicated and
the segments of the number shall be separated by a dash, e.g., NDC
15643-542-12 or N 15643-542-12.
(iv) All 10 characters shall appear and the leading zeros in any
segment of the NDC number shall be shown, except that leading zeros may
be omitted from any segment of the NDC number when the NDC number is
used for product identification by direct imprinting on dosage forms or
in the case of containers too small or otherwise unable to accommodate a
label with sufficent space to bear both required and optional labeling
information.
(v) The placing of the assigned NDC number on a label or in other
labeling does not require the submission of a supplemental new drug
application, supplemental new animal drug application, or supplemental
antibiotic application.
(4)(i) If any change occurs in those product characteristics that
clearly distinguish one drug product version from another, the
registrant shall assign a new NDC number to the new product version and
submit that information to FDA. Such a change includes, but is not
limited to, a change in active ingredient(s); strength or concentration
of active ingredient(s); dosage form; route of administration, if it
also includes a change in product formulation; product name; and a
change in marketing status from prescription to over-the-counter or
over-the-counter to prescription. If, by notice in the Federal
Register, FDA requires a change in drug product characteristics and
determines the change will require assignment of a new product code to
the reformulated product, FDA will announce its determination in the
Federal Register publication that requires the change, setting forth its
reasoning and justification for its determination. If a change only in
the trade package is involved, the registrant may revise the trade
package code without the assignment of a new product code segment, but
shall inform FDA of the new code for the trade package and the
characteristics of the new trade package.
(ii) When a registrant has discontinued a drug product, its product
code may be reassigned to another drug product 5 years after the
expiration date of the discontinued product, or, if there is no
expiration date, 5 years after the last shipment of the discontinued
product into commercial distribution. Reuse of product codes may occur,
under the specified conditions, regardless of the NDC, Product Code, and
Package Code configuration used.
(c) Although registration and drug listing are required to engage in
the drug activities described in 207.20, validation of registration
and the assignment of a drug listing number do not, in themselves,
establish that the holder of the registration is legally qualified to
deal in such drugs.
(45 FR 38043, June 6, 1980, as amended at 48 FR 54007, Nov. 30, 1983;
52 FR 2682, Jan. 26, 1987; 55 FR 11577, Mar. 29, 1990)
21 CFR 207.37 Inspection of registrations and drug listings.
(a) A copy of the Form FDA-2656 (Registration of Drug Establishment)
filed by the registrant will be available for inspection in accordance
with section 510(f) of the act, at the Drug Listing Branch (HFD-334),
Center for Drug Evaluation and Research, Food and Drug Administration,
5600 Fishers Lane, Rockville, MD 20857. In addition, there will be
available for inspection at each of the FDA district offices the same
information concerning firms within the geographical area of each
district office. Upon request and receipt of a self-addressed stamped
envelope, the Drug Listing Branch, Center for Drug Evaluation and
Research or appropriate FDA district office will verify registration
number or provide the location of a registered establishment.
(1) The following types of information submitted under the drug
listing requirements will be available for public disclosure when
compiled:
(i) A list of all drug products.
(ii) A list of all drug products arranged by labeled indications or
pharmacological category.
(iii) A list of all drug products arranged by manufacturer.
(iv) A list of a drug product's active ingredients.
(v) A list of drug products newly marketed or for which marketing is
resumed.
(vi) A list of drug products discontinued.
(vii) Labeling.
(viii) Advertising.
(ix) Information that has become a matter of public knowledge.
(x) A list of drug products containing a particular active
ingredient.
(2) The following types of information submitted in accordance with
the drug listing requirements will not be available for public
disclosure (except that any of the information will be available for
public disclosure if it has become a matter of public knowledge or if
FDA finds that confidentiality would be inconsistent with protection of
the public health):
(i) Any information submitted as the basis upon which it has been
determined that a particular drug product is not subject to section 505,
506, 507, or 512 of the act.
(ii) A list of a drug product's inactive ingredients.
(iii) A list of drugs containing a particular inactive ingredient.
(b) Requests for information about registrations and drug listings of
an establishment should be directed to Drug Listing Branch (HFD-334),
Center for Drug Evaluation and Research, Food and Drug Administration,
5600 Fishers Lane, Rockville, MD 20857 or, with respect to the
information described in paragraph (a) of this section, to the FDA
district office responsible for the geographical area in which the
establishment is located.
(45 FR 38043, June 6, 1980, as amended at 50 FR 8996, Mar. 6, 1985;
55 FR 11577, Mar. 29, 1990)
21 CFR 207.39 Misbranding by reference to registration or to
registration number.
Registration of a drug establishment or drug wholesaler, or
assignment of a registration number, or assignment of a NDC number does
not in any way denote approval of the firm or its products. Any
representation that creates an impression of official approval because
of registration or possession of registration number or NDC number is
misleading and constitutes misbranding.
21 CFR 207.39 Subpart D -- Procedure for Foreign Drug Establishments
21 CFR 207.40 Drug listing requirements for foreign drug
establishments.
(a) Every foreign drug establishment whose drugs are imported or
offered for import into the United States shall comply with the drug
listing requirements in subpart C of this part, unless exempt under
subpart B of this part, whether or not it is also registered.
(b) No drug, unless it is listed as required in subpart C of this
part, may be imported from a foreign drug establishment into the United
States except a drug imported or offered for import under the
investigational use provisions of part 312 of this chapter. Foreign
drug establishments shall submit the drug listing information in the
English language.
(c) Every foreign drug establishment shall submit, as part of drug
listing, the name and address of the establishment and the name of the
individual responsible for submitting drug listing information. The
establishment shall report to FDA any changes in this information at the
intervals specified in 207.30(a) for updating drug listing information.
(45 FR 38043, June 6, 1980, as amended at 55 FR 11577, Mar. 29, 1990)
21 CFR 207.40 Pt. 210
21 CFR 207.40 PART 210 -- CURRENT GOOD MANUFACTURING PRACTICE IN
MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL
Sec.
210.1 Status of current good manufacturing practice regulations.
210.2 Applicability of current good manufacturing practice
regulations.
210.3 Definitions.
Authority: Secs. 201, 501, 502, 505, 506, 507, 512, 701, 704 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 351, 352, 355, 356,
357, 360b, 371, 374).
Source: 43 FR 45076, Sept, 29, 1978, unless otherwise noted.
21 CFR 210.1 Status of current good manufacturing practice regulations.
(a) The regulations set forth in this part and in parts 211 through
226 of this chapter contain the minimum current good manufacturing
practice for methods to be used in, and the facilities or controls to be
used for, the manufacture, processing, packing, or holding of a drug to
assure that such drug meets the requirements of the act as to safety,
and has the identity and strength and meets the quality and purity
characteristics that it purports or is represented to possess.
(b) The failure to comply with any regulation set forth in this part
and in parts 211 through 226 of this chapter in the manufacture,
processing, packing, or holding of a drug shall render such drug to be
adulterated under section 501(a)(2)(B) of the act and such drug, as well
as the person who is responsible for the failure to comply, shall be
subject to regulatory action.
21 CFR 210.2 Applicability of current good manufacturing practice
regulations.
(a) The regulations in this part and in parts 211 through 226 of this
chapter as they may pertain to a drug and in parts 600 through 680 of
this chapter as they may pertain to a biological product for human use,
shall be considered to supplement, not supersede, each other, unless the
regulations explicitly provide otherwise. In the event that it is
impossible to comply with all applicable regulations in these parts, the
regulations specifically applicable to the drug in question shall
supersede the more general.
(b) If a person engages in only some operations subject to the
regulations in this part and in parts 211 through 226 and parts 600
through 680 of this chapter, and not in others, that person need only
comply with those regulations applicable to the operations in which he
or she is engaged.
21 CFR 210.3 Definitions.
(a) The definitions and interpretations contained in section 201 of
the act shall be applicable to such terms when used in this part and in
parts 211 through 226 of this chapter.
(b) The following definitions of terms apply to this part and to
parts 211 through 226 of this chapter.
(1) Act means the Federal Food, Drug, and Cosmetic Act, as amended
(21 U.S.C. 301 et seq.).
(2) Batch means a specific quantity of a drug or other material that
is intended to have uniform character and quality, within specified
limits, and is produced according to a single manufacturing order during
the same cycle of manufacture.
(3) Component means any ingredient intended for use in the
manufacture of a drug product, including those that may not appear in
such drug product.
(4) Drug product means a finished dosage form, for example, tablet,
capsule, solution, etc., that contains an active drug ingredient
generally, but not necessarily, in association with inactive
ingredients. The term also includes a finished dosage form that does
not contain an active ingredient but is intended to be used as a
placebo.
(5) Fiber means any particulate contaminant with a length at least
three times greater than its width.
(6) Non-fiber-releasing filter means any filter, which after any
appropriate pretreatment such as washing or flushing, will not release
fibers into the component or drug product that is being filtered. All
filters composed of asbestos are deemed to be fiber-releasing filters.
(7) Active ingredient means any component that is intended to furnish
pharmacological activity or other direct effect in the diagnosis, cure,
mitigation, treatment, or prevention of disease, or to affect the
structure or any function of the body of man or other animals. The term
includes those components that may undergo chemical change in the
manufacture of the drug product and be present in the drug product in a
modified form intended to furnish the specified activity or effect.
(8) Inactive ingredient means any component other than an active
ingredient.
(9) In-process material means any material fabricated, compounded,
blended, or derived by chemical reaction that is produced for, and used
in, the preparation of the drug product.
(10) Lot means a batch, or a specific identified portion of a batch,
having uniform character and quality within specified limits; or, in
the case of a drug product produced by continuous process, it is a
specific identified amount produced in a unit of time or quantity in a
manner that assures its having uniform character and quality within
specified limits.
(11) Lot number, control number, or batch number means any
distinctive combination of letters, numbers, or symbols, or any
combination of them, from which the complete history of the manufacture,
processing, packing, holding, and distribution of a batch or lot of drug
product or other material can be determined.
(12) Manufacture, processing, packing, or holding of a drug product
includes packaging and labeling operations, testing, and quality control
of drug products.
(13) The term medicated feed means any Type B or Type C medicated
feed as defined in 558.3 of this chapter. The feed contains one or
more drugs as defined in section 201(g) of the act. The manufacture of
medicated feeds is subject to the requirements of part 225 of this
chapter.
(14) The term medicated premix means a Type A medicated article as
defined in 558.3 of this chapter. The article contains one or more
drugs as defined in section 201(g) of the act. The manufacture of
medicated premixes is subject to the requirements of part 226 of this
chapter.
(15) Quality control unit means any person or organizational element
designated by the firm to be responsible for the duties relating to
quality control.
(16) Strength means:
(i) The concentration of the drug substance (for example,
weight/weight, weight/volume, or unit dose/volume basis), and/or
(ii) The potency, that is, the therapeutic activity of the drug
product as indicated by appropriate laboratory tests or by adequately
developed and controlled clinical data (expressed, for example, in terms
of units by reference to a standard).
(17) Theoretical yield means the quantity that would be produced at
any appropriate phase of manufacture, processing, or packing of a
particular drug product, based upon the quantity of components to be
used, in the absence of any loss or error in actual production.
(18) Actual yield means the quantity that is actually produced at any
appropriate phase of manufacture, processing, or packing of a particular
drug product.
(19) Percentage of theoretical yield means the ratio of the actual
yield (at any appropriate phase of manufacture, processing, or packing
of a particular drug product) to the theoretical yield (at the same
phase), stated as a percentage.
(20) Acceptance criteria means the product specifications and
acceptance/rejection criteria, such as acceptable quality level and
unacceptable quality level, with an associated sampling plan, that are
necessary for making a decision to accept or reject a lot or batch (or
any other convenient subgroups of manufactured units).
(21) Representative sample means a sample that consists of a number
of units that are drawn based on rational criteria such as random
sampling and intended to assure that the sample accurately portrays the
material being sampled.
(43 FR 45076, Sept. 29, 1978, as amended at 51 FR 7389, Mar. 3, 1986)
21 CFR 210.3 Pt. 211
21 CFR 210.3 PART 211 -- CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS
21 CFR 210.3 Subpart A -- General Provisions
Sec.
211.1 Scope.
211.3 Definitions.
21 CFR 210.3 Subpart B -- Organization and Personnel
211.22 Responsibilities of quality control unit.
211.25 Personnel qualifications.
211.28 Personnel responsibilities.
211.34 Consultants.
21 CFR 210.3 Subpart C -- Buildings and Facilities
211.42 Design and construction features.
211.44 Lighting.
211.46 Ventilation, air filtration, air heating and cooling.
211.48 Plumbing.
211.50 Sewage and refuse.
211.52 Washing and toilet facilities.
211.56 Sanitation.
211.58 Maintenance.
21 CFR 210.3 Subpart D -- Equipment
211.63 Equipment design, size, and location.
211.65 Equipment construction.
211.67 Equipment cleaning and maintenance.
211.68 Automatic, mechanical, and electronic equipment.
211.72 Filters.
21 CFR 210.3 Subpart E -- Control of Components and Drug Product
Containers and Closures
211.80 General requirements.
211.82 Receipt and storage of untested components, drug product
containers, and closures.
211.84 Testing and approval or rejection of components, drug product
containers, and closures.
211.86 Use of approved components, drug product containers, and
closures.
211.87 Retesting of approved components, drug product containers, and
closures.
211.89 Rejected components, drug product containers, and closures.
211.94 Drug product containers and closures.
21 CFR 210.3 Subpart F -- Production and Process Controls
211.100 Written procedures; deviations.
211.101 Charge-in of components.
211.103 Calculation of yield.
211.105 Equipment identification.
211.110 Sampling and testing of in-process materials and drug
products.
211.111 Time limitations on production.
211.113 Control of microbiological contamination.
211.115 Reproccessing.
21 CFR 210.3 Subpart G -- Packaging and Labeling Control
211.122 Materials examination and usage criteria.
211.125 Labeling issuance.
211.130 Packaging and labeling operations.
211.132 Tamper-resistant packaging requirements for over-the-counter
human drug products.
211.134 Drug product inspection.
211.137 Expiration dating.
21 CFR 210.3 Subpart H -- Holding and Distribution
211.142 Warehousing procedures.
211.150 Distribution procedures.
21 CFR 210.3 Subpart I -- Laboratory Controls
211.160 General requirements.
211.165 Testing and release for distribution.
211.166 Stability testing.
211.167 Special testing requirements.
211.170 Reserve samples.
211.173 Laboratory animals.
211.176 Penicillin contamination.
21 CFR 210.3 Subpart J -- Records and Reports
211.180 General requirements.
211.182 Equipment cleaning and use log.
211.184 Component, drug product container, closure, and labeling
records.
211.186 Master production and control records.
211.188 Batch production and control records.
211.192 Production record review.
211.194 Laboratory records.
211.196 Distribution records.
211.198 Complaint files.
21 CFR 210.3 Subpart K -- Returned and Salvaged Drug Products
211.204 Returned drug products.
211.208 Drug product salvaging.
Authority: Secs. 201, 501, 502, 505, 506, 507, 512, 701, 704 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 351, 352, 355, 356,
357, 360b, 371, 374).
Source: 43 FR 45077, Sept. 29, 1978, unless otherwise noted.
21 CFR 210.3 Subpart A -- General Provisions
21 CFR 211.1 Scope.
(a) The regulations in this part contain the minimum current good
manufacturing practice for preparation of drug products for
administration to humans or animals.
(b) The current good manufacturing practice regulations in this
chapter, as they pertain to drug products, and in parts 600 through 680
of this chapter, as they pertain to biological products for human use,
shall be considered to supplement, not supersede, the regulations in
this part unless the regulations explicitly provide otherwise. In the
event it is impossible to comply with applicable regulations both in
this part and in other parts of this chapter or in parts 600 through 680
of this chapter, the regulation specifically applicable to the drug
product in question shall supersede the regulation in this part.
(c) Pending consideration of a proposed exemption, published in the
Federal Register of September 29, 1978, the requirements in this part
shall not be enforced for OTC drug products if the products and all
their ingredients are ordinarily marketed and consumed as human foods,
and which products may also fall within the legal definition of drugs by
virtue of their intended use. Therefore, until further notice,
regulations under part 110 of this chapter, and where applicable, parts
113 to 129 of this chapter, shall be applied in determining whether
these OTC drug products that are also foods are manufactured, processed,
packed, or held under current good manufacturing practice.