EN 71-13:2014: Safety of toys - Part 13: Olfactory board games, cosmetic kits and gustative games

Sécurité des jouets - Partie 13: Jeux de table olfactifs, ensembles cosmétiques et jeux gustatifs

Sicherheit von Spielzeug - Teil 13: Brettspiele für den Geruchsinn, Kosmetikkoffer und Spiele für den Geschmacksinn

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.

All rights of exploitation in any form and by any means reserved worldwide for CEN national Members.

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Foreword

This document (EN 71-13:2014) has been prepared by Technical Committee CEN/TC 52 “Safety of toys”, the secretariat of which is held by DS.

This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by September 2014 and conflicting national standards shall be withdrawn at the latest by September 2014.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.

This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s).

For relationship with EU Directive 2009/48/EC [1], see informative Annex ZA, which is an integral part of this document.

This European Standard constitutes the 13^th part of the European Standard on the safety of toys.

This Part 13 of the EN 71 series is intended to be read in conjunction with EN 71-1 and EN 71-3.

EN 71, Safety of toys consists of the following parts:

Part 1: Mechanical and physical properties
Part 2: Flammability
Part 3: Migration of certain elements
Part 4: Experimental sets for chemistry and related activities
Part 5: Chemical toys (sets) other than experimental sets
Part 7: Finger paints — Requirements and test methods
Part 8: Activity toys for domestic use
Part 9: Organic chemical compounds — Requirements
Part 10: Organic chemical compounds — Sample preparation and extraction
Part 11: Organic chemical compounds — Methods of analysis
Part 12: N-Nitrosamines and N-nitrosatable substances;
Part 13: Olfactory board games, gustative board games, cosmetic kits and gustative kits;
Part 14: Trampolines for domestic use.

NOTE 1 In addition to the above parts of EN 71, the following guidance documents have been published: CEN Report, CR 14379, Classification of toys - Guidelines, CEN Technical Report CEN/TR 15071, Safety of toys - National translations of warnings and instructions for use in EN 71, and CEN Technical Report CEN/TR 15371, Safety of toys – Replies to requests for interpretation of EN 71-1, EN 71-2, and EN 71-8.

NOTE 2 Words in italics are defined in Clause 3 (Terms and definitions).

According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.

Introduction

This European Standard EN 71-13 is intended to reduce the risks and health hazards to a child when olfactory board games, cosmetic kits and gustative games are used as intended or in a foreseeable way, bearing in mind the behaviour of children.

During use of these toys, the hazards should be kept to a minimum by the provision of appropriate information to make the play safe and controllable. Therefore, this European Standard specifies warning phrases and instructions for use for these toys.

As a general rule, toys are designed and manufactured for particular ages of children. Their characteristics are related to the age and stage of development of the children, and their use presupposes certain aptitudes. Therefore age requirements are given.

The requirements of this European Standard do not release parents or carers from their responsibility of watching over the child while he or she is playing. On the contrary, the use of these sets requires close supervision by adults.

1 Scope

This European Standard applies to olfactory board games, cosmetic kits, gustative games and supplementary sets. It specifies requirements on the use of substances and mixtures and in some cases on their amount and concentration in olfactory board games, cosmetic kits, gustative games and supplementary sets to such games or kits.

These substances and mixtures are:

those classified as dangerous by the EC-legislation applying to dangerous substances [15] [16], and dangerous mixtures [17];
substances and mixtures which in excessive amounts could harm the health of the children using them and which are not classified as dangerous by the above mentioned legislation; and
any other chemical substance(s) and mixture(s) delivered with the set.

Furthermore, this European Standard specifies allergenic fragrances which are prohibited in toys, marking requirements, in particular regarding allergenic fragrances, and requirements on a contents list, instructions for use, the equipment intended to be used during the activity and the use of highly flammable liquids.

This European Standard does not apply to cosmetic toys such as play cosmetics for dolls.

NOTE The terms “substance” and “mixture” are defined in the REACH regulation (EC) No. 1907/2006 [18] and in the CLP regulation (EC) No. 1272/2008 [16].

2 Normative references

The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

EN 71-1:2011+A3:2014, Safety of toys — Part 1: Mechanical and physical properties

EN ISO 868, Plastics and ebonite — Determination of indentation hardness by means of a durometer (Shore hardness) (ISO 868)

EN ISO 8317, Child-resistant packaging — Requirements and testing procedures for reclosable packages (ISO 8317)

ISO 7619-1, Rubber, vulcanized or thermoplastic — Determination of indentation hardness — Part 1: Durometer method (Shore hardness)

3 Terms and definitions

For the purposes of this document, the following terms and definitions apply.

3.1 olfactory board game

toy, the purpose of which is to assist a child to learn to recognize different odours or flavours

NOTE 1 to entry: Olfactory board games include activities of smelling and/or tasting as olfactive recognition can be done by retro-olfaction.

3.2 cosmetic kit

toy, the purpose of which is to assist a child to learn to make products such as fragrances, soaps, creams, shampoos, bath foams, glosses, lipsticks, other make-up, tooth-paste and conditioners

3.3 gustative game

toy, the purpose of which is to allow children to make sweets or dishes which involve the use of food ingredients such as sweets, liquids, powders and aromas

NOTE 1 to entry: Commonly used terms for gustative game are “gustative kit” and “food kit”.

3.4 supplementary set

incomplete olfactory board game, cosmetic kit or gustative game which is intended to be used with a complete game or kit

3.5 packaging

material accompanying the toy when purchased but having no intended play function

4 Requirements (see A.4)

4.1 Olfactory board games

4.1.1 General

Olfactory board games shall be supplied with instructions for use and first aid informations if applicable (see Clauses 7 and 8).

NOTE With regard to the following requirements (4.1.2) it is important to consider Regulation (EC) No. 1272/2008 [16].

4.1.2 Substances and mixtures

4.1.2.1 Olfactory board games using substances, mixtures and flavours recognized as food flavours or food ingredients

Only substances, mixtures and flavours recognized as food flavours and food ingredients shall be used.

NOTE Food flavours and food ingredients are subject to the relevant food legislation, e.g. Regulation (EC) No 1334/2008 [7] (flavours), and Regulation (EC) No 1333/2008 [6] and Regulation (EU) No 1129/2011 [20] (food additives), Regulation (EC) No 178/2002 [8] (“general food law”) and Directive 2000/13/EC [9] (labelling) and Regulation (EU) No 1169/2011 [10] (food information to consumers).

4.1.2.2 Olfactory board games using not only substances, mixtures and flavours recognized as food flavours or food ingredients

Besides substances, mixtures and flavours recognized as food flavours and food ingredients also substances or mixtures classified after assessment as not dangerous to health under normal conditions of use, in particular regarding eye or skin contact, may be used.

NOTE Food ingredients are subject to the relevant food legislation, e.g. Regulation (EC) No 1334/2008 [7] (flavours), and Regulation (EC) No 1333/2008 [6] and Regulation (EU) No 1129/2011 [20] (food additives), Regulation (EC) No 178/2002 [8] (“general food law”) and Directive 2000/13/EC [9] (labelling) and Regulation (EU) No 1169/2011 [10] (food information to consumers).

4.1.2.3 Further requirements for all types of olfactory board games

If any preservatives are used in olfactory board games and supplementary for olfactory board games, they shall be assessed to be not dangerous to health under normal conditions of use.

NOTE 1 Regulation (EC) No 1223/2009 [2] and Regulation (EC) 1129/2011 [20] contain requirements on the use of preservatives. It is important to consider these requirements in the assessment.

Olfactory board games and supplementary sets for olfactory board games may contain the fragrances listed in Table 1 except those substances not allowed by food legislation.

NOTE 2 Certain substances, e.g “coumarin”, are restricted/not permitted in Regulation (EC) No 1334/2008 [7].

If any of the fragrances specified in Table 1 are supplied in the olfactory board game or supplementary set, specific warning requirements apply (see 6.1 and 6.3).

Olfactory board games and supplementary sets for olfactory board games shall not contain the allergenic fragrances listed in Table 2. However, the presence of traces of these fragrances is permitted provided that such presence is technically unavoidable under good manufacturing practice and does not exceed 100 mg/kg per fragrance.

Table 1 — Allergenic fragrances which require a warning
Name of the allergenic fragrance	CAS number
Amyl cinnamal	122–40–7
Amylcinnamyl alcohol	101–85–9
Benzyl alcohol	100–51–6
Benzyl salicylate	118–58–1
Cinnamyl alcohol	104–54–1
Cinnamal	104–55–2
Citral	5392–40–5
Coumarin	91–64–5
Eugenol	97–53–0
Geraniol	106–24–1
Hydroxy-citronellal	107–75–5
Hydroxy-methylpentylcyclohexenecarboxaldehyde	31906–04–4
Isoeugenol	97–54–1
Oakmoss extracts	90028–68–5
Treemoss extracts	90028–67–4
Anisyl alcohol	105–13–5
Benzyl benzoate	120–51–4
Benzyl cinnamate	103–41–3
Citronellol	106–22–9
Farnesol	4602–84–0
Hexyl cinnamaldehyde	101–86–0
Lilial	80–54–6
d-Limonene	5989–27–5
Linalool	78–70–6
Methyl heptine carbonate	111–12–6
3-methyl-4-(2.6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one	127–51–5

Table 2 — Allergenic fragrances which shall not be supplied in toys covered by this European
Name of the allergenic fragrance	CAS number
Alanroot oil (Inula helenium)	97676–35–2
Allylisothiocyanate	57–06–7
Benzyl cyanide	140–29–4
4 tert-Butylphenol	98–54–4
Chenopodium oil	8006–99–3
Cyclamen alcohol	4756–19–8
Diethyl maleate	141–05–9
Dihydrocoumarin	119–84–6
2,4-Dihydroxy-3-methylbenzaldehyde	6248–20–0
3,7-Dimethyl-2-octen-1-ol (6,7-Dihydrogeraniol)	40607–48–5
4,6-Dimethyl-8-tert-butylcoumarin	17874–34–9
Dimethyl citraconate	617–54–9
7,11-Dimethyldodeca-4.6,10-trien-3-one	26651–96–7
6,10-Dimethylundeca-3.5,9-trien-2-one	141–10–6
Diphenylamine	122–39–4
Ethyl acrylate	140–88–5
Fig leaf, fresh and preparations	68916–52–9
trans-2-Heptenal	18829–55–5
trans-2-Hexenal diethyl acetal	67746–30–9
trans-2-Hexenal dimethyl acetal	18318–83–7
Hydroabietyl alcohol	13393–93–6
4-Ethoxy-phenol	622–62–8
6-lsopropyl-2-decahydronaphthalenol	34131–99–2
7-Methoxycoumarin	531–59–9
4-Methoxyphenol	150–76–5
4-(p-Methoxyphenyl)-3-butene-2-one	943–88–4
1-(p-Methoxyphenyl)-1-penten-3-one	104–27–8
Methyl trans-2-butenoate	623–43–8
6-Methylcoumarin	92–48–8
7-Methylcoumarin	2445–83–2
5-Methyl-2,3-hexanedione	13706–86–0
Costus root oil (Saussurea lappa Clarke)	8023–88–9
7-Ethoxy-4-methylcoumarin	87–05–8
Hexahydrocoumarin	700–82–3
Peru balsam, crude (Exudation of Myroxylon pereirae (Royle) Klotzsch)	8007–00–9
2-Pentylidene-cyclohexanone	25677–40–1
3.6,10-Trimethylundeca-3.5,9-trien-2-one	1117–41–5
Verbena oil (Lippia citriodora Kunth)	8024–12–2
Musk ambrette (4-tert-Butyl-3-methoxy-2,6-dinitrotoluene)	83–66–9
4-Phenyl-3-buten-2-one	122–57–6

4.2 Cosmetic kits

4.2.1 General

Cosmetic kits shall be supplied with instructions for use (see Clause 7) and a contents list with first aid information (see Clause 8).

The first aid information and the instructions for use can be on the packaging and/or the instruction sheet.

4.2.2 Substances and mixtures

NOTE 1 With regard to the following requirements it is important to consider Regulation No:1272/2008 EC [16].

Cosmetic kits shall contain only components which are cosmetic products.

NOTE 2 Cosmetic products are subject to the relevant Cosmetic legislation, Regulation (EC) No 1223/2009 [2].

Cosmetic kits and supplementary sets for cosmetic kits may contain the substances listed in Table 1. If any of the fragrances specified in Table 1 are supplied in the cosmetic kit specific warning requirements apply (see 6.1).

The intended and possible reactions between all ingredients of cosmetic kits shall be checked by the manufacturer in order to evaluate that no reaction products or mixtures could be formed, which could harm the health of children (including: skin reaction etc.) using the kit.

Cosmetic kits and supplementary sets for cosmetic kits shall not contain any of the allergenic fragrances listed in Table 2. However, the presence of traces of these fragrances is permitted provided that such presence is technically unavoidable under good manufacturing practice and does not exceed 100 mg/kg per fragrance.

4.2.3 Resulting products - Stability (see A.2)

The resulting product(s) made by a child using a cosmetic kit in accordance with the instructions for use shall be in compliance with the relevant requirements of relevant legislation on cosmetics.

NOTE The relevant legislation on cosmetics is Regulation (EC) No 1223/2009 [2].

4.3 Gustative games

4.3.1 General

Gustative games shall be supplied with instructions for use (see Clause 7), a contents list with warnings and first aid information (see Clause 8).

The first aid information and the instructions for use can be on the packaging and/or the instruction sheet.

4.3.2 Substances and mixtures

NOTE 1 With regard to the following requirements it is important to consider Regulation No 1272/2008 EC [16].

The ingredients, substances and mixtures supplied shall be in compliance with the relevant food legislation.

The intended and possible reactions between all ingredients of gustative games shall be assessed by the manufacturer in order to ascertain that no reaction products or mixtures could be formed that could harm the health of the children using the kit.

NOTE 2 Food ingredients are subject to the relevant food legislation, e.g. Regulation (EC) No 1334/2008 [7] (flavours), and Regulation (EC) No 1333/2008 [6] and Regulation (EU) No 1129/2011 [20] (food additives), Regulation (EC) No 11 178/2002 [8] (“general food law”) and Directive 2000/13/EC [9] (labelling) and Regulation (EU) No 1169/2011 [10] (food information to consumers).

Gustative games and supplementary sets for gustative games may contain the substances listed in Table 1 except those substances not allowed by food legislation. If any of the fragrances specified in Table 1 are supplied in the gustative game, specific warning requirements apply (see 6.1 and 6.3).

Gustative games and supplementary sets for gustative games shall not contain the allergenic fragrances listed in Table 2. However, the presence of traces of these fragrances is permitted provided that such presence is technically unavoidable under good manufacturing practice and does not exceed 100 mg/kg per fragrance.

4.3.3 Resulting products

The resulting product(s) made by a child using a gustative game in accordance with the instructions for use shall be in compliance with the relevant requirements of legislation on food. Heating as part of the activity used to obtain the resulting product, shall only be specified in the instructions for use if the manufacturer has ensured that such heating does not lead to a harm to the health of the children using the game.

NOTE Food ingredients are subject to the relevant food legislation, e.g. Regulation (EC) No 1334/2008 [7] (flavours), Regulation (EC) No 1333/2008 [6], Regulation (EU) No 1129/2011 [20] (food additives), Regulation (EC) No 178/2002 [8] (“general food law”), Directive 2000/13/EC [9] (labelling) and Regulation (EU) No 1169/2011 [10] (food information to consumers).

4.3.4 Food allergens

If allergenic food ingredients are supplied with the gustative game, these ingredients shall be labelled on the packaging.

NOTE For information on the labelling of allergenic food ingredients see Directive 2003/89/EC [3]. This Directive also lists commonly known food allergens.

5 Equipment

5.1 Containers and glassware

5.1.1 Glassware

In sets where the instructions for use include activities in which glassware is heated, all glassware intended to be heated shall be made of borosilicate glass in order to be heat resistant.

When necessary, borosilicate glass shall be identified by the test method described in Annex B.

5.1.2 Containers for fragrances, cosmetic products or food ingredients

5.1.2.1 General

Containers, except if made of glass, for fragrances, cosmetic products and food ingredients shall not break or crack when tested according to the drop test specified in EN 71-1.

Containers made of glass do not have to be tested as they are covered by EN 71-1:2011+A3:2014, 4.5 a) (accessible glass may be used where its use is necessary to the function of the toy).

Containers shall differ in size and shape from laboratory glassware to avoid them being mistaken as glassware for use in the activities specified in the instructions for use.

All containers supplied in gustative games shall be in compliance with relevant food contact material legislation.

NOTE Relevant legislation for food contact material are Regulation (EC) No 1935/2004 [4] and Regulation (EU) No 10/2011 [5].

5.1.2.2 Maximum content of flammable liquids in cosmetic kits and gustative games

The maximum content of a container shall not exceed:

10 ml for liquids having a flash point < 23 °C and an initial boiling point > 35 °C;
30 ml for liquids having a flash point ≥ 23 °C and ≤ 60 °C.

5.1.3 Child-resistant containers

If, after the safety assessment made by the manufacturer, child-resistant containers are needed for substances and mixtures classified as dangerous by the EC-legislation applying to dangerous substances [15], [16], [18], and dangerous mixtures [16], [17], [18], the child-resistant containers shall fulfil at least one of the following requirements:

NOTE 1 Regulation (EC) No. 1272/2008 [16] specifies requirements on child resistant containers.

they shall comply with EN ISO 8317;
they shall require two independent movements to be opened: a vertical force downwards and a torque in the clockwise or anticlockwise direction (e.g. bayonet joint). When tested in accordance with C.1 (closure test A), the closure shall not open;
they shall include a snap-in stopper and shall require an external specifically designed tool to open. When tested in accordance with C.2 (closure test B), the closure shall not open.

Closures for containers intended to be used for liquids shall not break, crack or leak when tested in accordance with C.3 (closure test C).

NOTE 2 Compliance with these requirements is intended to prevent younger children accessing materials contained in such containers.

5.2 Equipment for the transfer of liquid

Mouth-actuated pipettes shall not be supplied. Where the transfer of liquid is required, a mechanical means which does not permit aspiration by the mouth shall be provided (e.g. a dropper with a permanently fitted teat).

5.3 Eye protection

If after the safety assessment made by the manufacturer an eye protection is needed during the play, the eye protection shall conform to the relevant legislation for personal protective equipment.

NOTE Relevant legislation for personal protective equipment is Directive 89/686/EEC [19].

6 Warnings and markings (see A.4)

6.1 General markings and warnings

NOTE 1 The text of this note is for information only and the indents do not constitute requirements of this European Standard. The information is not exhaustive. Further details can be found in the Directive 2009/48/EC [1] and the associated guidance documents.

Toys made available on the market must bear the CE marking. The CE marking is subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008. The CE marking must be affixed visibly, legibly and indelibly to the toy, to an affixed label or to the packaging. In the case of small toys and toys consisting of small parts, the CE 13 marking may alternatively be affixed to a label or an accompanying leaflet. Where, in the case of toys sold in counter displays, that is not technically possible, and on condition that the counter display was originally used as packaging for the toy, the CE marking may be affixed to the counter display. Where the CE marking is not visible from outside a packaging, it shall as a minimum be affixed to the packaging. Where specific legislation does not impose specific dimensions, the CE marking must be at least 5 mm high.
The manufacturer’s¹ name, registered trade name or registered trade mark and the address at which the manufacturer can be contacted must be indicated on the toy or, where that is not possible, on its packaging or in a document accompanying the toy. This requirement applies also to the name and address, etc. of any importer.²
Manufacturers must ensure that their toys bear a type, batch, serial or model number or other element allowing their identification, or where the size or nature of the toy does not allow it, that the required information is provided on the packaging or in a document accompanying the toy.
Manufacturers and importers must ensure that the toy is accompanied by instructions and safety information in a language or languages easily understood by consumers, as determined by the Member State concerned.
A Member State may, within its territory, stipulate that warnings and safety instructions shall be written in a language or languages easily understood by consumers, as determined by that Member State.
Information relating to the age grading of toys and, in particular, which toys are intended for children under 36 months and which toys are not, can be found in CR 14379, the CPSC Age determination guidelines [11], CEN-CENELEC Guide 11 and the European Commission’s Guidance Documents [12].

¹ A manufacturer is any natural or legal person who manufactures a toy or has a toy designed or manufactured, and markets that toy under his name or trademark.

²An importer is any natural or legal person established within the Community who places a toy from a third country on the Community market.

When applicable, olfactory board games, cosmetic kits, gustative games and supplementary sets for such games/kits shall comply with the warning requirement in EN 71-1:2011+A3:2014, 7.2. As indicated in EN 71-1, a brief indication of the specific hazard calling for the the restriction (i.e. the warning) shall also be given.

NOTE 2 According to Directive 2009/48/EC, Annex II, III., 12. [1] “olfactory board games, cosmetic kits and gustative games [containing substances of Table 1] shall not be used by children under 36 months” and shall comply with point 1 of Part B of Annex V of this Directive.

Olfactory board games, gustative games, cosmetic kits, and supplementary kits shall bear the following markings:

batch number, on the packaging;
if relevant, an exhaustive list of the ingredients contained in the game or kit, including any of the allergenic fragrances listed in Table 1. As a minimum, this information shall be listed on the packaging;
if relevant, the shelf life or “used by” date or a period after opening on the packaging which shall be clearly legible.

NOTE 3 The cosmetic legislation and food stuff legislation lay down additional marking requirements, e.g. list of ingredients, batch numbers on individual containers for cosmetic kits and gustative games.

Gustative games, cosmetic kits, and supplementary sets shall bear the following warnings on the packaging:

“Warning. Not suitable for children under (*) years. For use under adult supervision.
Read the instructions before use, follow them and keep them for reference.
Keep the game/kit out of reach of children under (*) years old.”

(*) The age is to be specified by the manufacturer or authorized representative.

The packaging of olfactory board games, cosmetic kits, gustative games and supplementary sets to such games/kits, that contain one or more of the allergenic fragrances listed in Table 1 shall carry the following warning:

“Warning. Contains fragrances that may cause allergies.”.

The packaging of olfactory board games, cosmetic kits, gustative games and supplementary sets to such games/kits, that contain highly flammable liquids shall carry the following warning:

“Warning. Contains highly flammable liquids. Not to be used by children under 8 years”.

6.2 Markings on individual containers for reagents, substances or mixtures

Individual containers shall be marked with the content (e.g. substance name, mixture name or material name or other identifying element).

Any child-resistant container shall be marked and bear warnings in accordance with the appropriate requirements.

NOTE These specifications are detailed in Regulation (EC) No. 1272/2008 [16].

6.3 Warning phrase for food allergens

The packaging of gustative games, olfactory board games, and supplementary sets to such games, that contain allergenic food ingredients shall carry the following warning:

“Warning. Contains (*) that may cause food allergy.”.

(*) The name(s) of the ingredient(s) shall be given in the warning text.

NOTE For information on commonly known food allergens, see Directive 2003/89/EC [3].

6.4 Warning phrase when glass is used as container

When glass containers are supplied, the following warning shall be marked on the packaging or in the instructions for use:

“Warning. Contains glass that may break.”.

7 Instructions for use

Detailed information on how to perform each activity shall be given.

Any known hazards arising from the use of the set, especially during the activity, shall be addressed in detail in the instructions for use (e.g. handling of food ingredients and handling of glassware).

The first aid information (see Clause 8) shall be on the packaging and/or the instructions for use.

If applicable, the instructions for use shall contain an indication of the shelf life of the products made according to the instructions as determined by the manufacturer.

8 Contents list with warnings and first aid information

The contents list of cosmetic kits and gustative games and supplementary sets shall contain the following information:

a list of the chemicals supplied;
as appropriate for the product, general first aid information such as:
“In case of eye contact: Wash out eye with plenty of water. Seek immediate medical advice if necessary.”

For cosmetic kits, add the following information:

“If swallowed: Wash out mouth with water and drink some fresh water. Do not induce vomiting. Seek immediate medical advice.”

Annex A (informative)
Rationale

A.1 Allergenic fragrances (see Clause 4, Table 1 and Table 2)

Directive 2009/48/EC [1], Annex II, III, 11. specifies particular safety requirements regarding allergenic fragrances. In particular, the first table in this part of the Directive specifies 55 allergenic fragrances which shall not be contained in toys and the second table specifies 11 allergenic fragrances for which certain marking requirements apply.

In this European Standard, the tables of Directive 2009/48/EC [1] have been reorganized by moving the last 15 allergenic fragrances from the first to the second table. This reflects Directive 2009/48/EC [1], Annex II, III., 12 which allows the use of the last 15 fragrances from the first table of the Directive and the 11 fragrances from the second table of the Directive under certain conditions (see A.4).

A.2 Safety assessment for cosmetic kits (see 4.2.3)

In addition to the safety assessment required by the Directive 2009/48/EC [1], a safety assessment of the products which can be made according to the instructions for use, should be carried out in accordance with the cosmetic legislation. This safety assessment should include one or more of the following considerations: dermatological test, eye irritation test and/or photo toxicity test. In addition, the efficiency of preservation should be tested according to the European Pharmacopeia or ISO 11930 and an additional and an assessment based on Annex I, Part B of Regulation (EC) No 1223/2009 [2] should also be made.

A.3 Safety procedures

Cosmetic formulations should be deposited to poison control centre or notified through European dedicated portal, according to Regulation (EC) No 1223/2009 [2].

A.4 Requirements which need to be fulfilled when using certain fragrances (see Clause 4 and Clause 6)

Directive 2009/48/EC [1], Annex II, III., 12 sets certain conditions under which the fragrances specified in Table 1 may be used:

“those fragrances are clearly labelled on the packaging, and the packaging contains the warning set out in point 10 of Part B of Annex V”;
“if applicable, the resulting products made by the child in accordance with the instructions comply with the requirements of Directive 76/768/EEC”;
“if applicable, those fragrances comply with the relevant legislation on food.”;
“such olfactory board games, cosmetic kits and gustative games shall not be used by children under 36 months and shall comply with point 1 of Part B of Annex V.”.

These conditions have been taken into account in Clause 4 (compliance with the relevant legislation of food), 4.2.3 (compliance of resulting products made by the child in accordance with the instructions with the requirements of Directive 76/768/EEC, i.e. Regulation (EC) No 1223/2009 [2])) and 6.1 (compliance with point 1 of Part B of Annex V of Directive 2009/48/EC [1]) and 6.1 (warning set out in point 10 of Part B of Annex V of Directive 2009/48/EC [1]).

A.5 Current relevant directives and regulations on cosmetics and food stuff

Besides the requirements of Directive 2009/48/EC [1] olfactory board games, cosmetic kits and gustative games should comply with additional relevant legislation. In particular cosmetic kits are subject to Regulation (EC) No 1223/2009 [2] and the following legislation is relevant for gustative games and for olfactory board games with tasting activity:

Directive 2003/89/EC [3];
Regulation (EC) No 1935/2004 [4];
Regulation (EU) No 10/2011 [5];
Regulation (EC) No 1333/2008 [6];
Regulation (EC) No 1334/2008 [7];
Regulation (EC) No 178/2002 [8];
Directive 2000/13/EC [9];
Regulation (EU) No 1169/2011 [10].

A.6 Explanations of Regulations relevant to this European Standard

Some substances and mixtures used in olfactory board games and cosmetic kits which are not food ingredients or cosmetic products, should be classified and labelled in accordance with Regulation (EC) No. 1272/2008 [16].

The precautionary classifications and labelling requirements should be reasonable for educational purposes and should ensure harmonized labelling and safety requirements.

Annex B (normative)
Test method for identification of borosilicate glass

B.1 General

Several methods exist to distinguish borosilicate glass, e.g. determination of density and refractive index. A density method is given here. Alternative methods are acceptable only if it has been proven that the achieved results are equivalent to those results of the described method.

B.2 Apparatus and reagent

B.2.1 25-ml pycnometer

B.2.2 Water bath,

capable of maintaining a temperature of (20 ± 1) °C

B.2.3 Deionised water

B.2.4 Analytical balance, accuracy 0,1 mg

B.3 Procedure

Weigh the pycnometer (m₀). Make sure that the fraction from the glass sample is clean. Place the fraction in the pycnometer and re-weigh the pycnometer (m₂). Then fill up the pycnometer with water and place it in a water bath until the contents equilibrate at 20 °C. Top up the pycnometer with water. Remove the pycnometer from the water bath, dry the exterior and weigh the pycnometer (m₃). Empty the pycnometer. Fill up the pycnometer with water and place it in a water bath until the contents equilibrate at 20 °C. Top up the pycnometer with water, dry the exterior and weigh the pycnometer. Record the weight (m₁).

$ρ_{Glass} = \frac{(m_{2} - m_{0})}{(m_{1} - m_{3} + m_{2} - m_{0})} \cdot ρ Water (20 ° c)$

where

ρ_Glass is the density of the glass sample in g/cm³ ;

ρ_{Water (20 °C)} is the density of water at 20 °C ( ρ_{Water (20 °C )} = 0,988 2 g / cm³ );

m₀ is the mass of the empty pycnometer in g;

m₁ is the mass of the pycnometer filled with water in g;

m₂ is the mass of the pycnometer with the glass sample in g;

m₃ is the mass of the pycnometer with glass sample and water in g.

NOTE Reference densities for certain types of glass are:

(2,40 ± 0,05) g/cm³ for sheet window glass;
(2,48 ± 0,05) g/cm³ for soft soda glass;
(2,25 ± 0,05) g/cm³ for borosilicate glass;
(2,21 ± 0,05) g/cm³ for fused silica glass.

Annex C (normative)
Test method for closures of containers (child-resistant packaging)

C.1 Closure test A

Open the closure and re-close it 10 times. Apply an upward vertical force of (70 ± 2) N on the cap. Examine whether the cap is still closed.

Apply a downward vertical force of (30 ± 2) N on the cap. Rotate the cap in a clockwise and then anticlockwise direction by applying a maximum torque of (0,5 ± 0,05) Nm and for a maximum of one full turn (360 degrees) in each direction. Examine whether the cap is still closed.

C.2 Closure test B

Open the closure by using the external tool and re-close it. Repeat the procedure 10 times. Remove the external tool. The stopper shall be in the locked position. Apply a downward vertical force of (30 ± 2) N on the cap. Rotate the cap in a clockwise and then anticlockwise direction by applying a maximum torque of (0,5 ± 0,05) Nm for a maximum of one full turn (360 degrees) in each direction. Examine whether the cap is still closed.

Apply an upward vertical force of (70 ± 2) N on the cap. Examine whether the cap is still closed. Attach the external tool and apply a force of 10 N on the tool in the most onerous direction. Examine whether the cap is still closed.

C.3 Closure test C

Fill the container with water. The filling volume shall be 3/4 of the container volume. Attach the closure. Drop the filled container including its closure with its closure facing downwards five times from a height of (850 ± 50) mm on to a 4 mm thick steel plate, which has a 2 mm thick coating of Shore A hardness (75 ± 5) as measured according to EN ISO 868 or ISO 7619-1, and which is placed on a non-flexible horizontal surface.

Check visually for any breaks, cracks or leakages of the closure.

Annex D (informative)
Environmental considerations

Every product affects the environment in the course of its life cycle from raw material acquisition through production, distribution and use, to disposal. The environmental impacts are consequences of the consumption of energy and resources and the generation of waste as well as the emission of substances into air, water and soil. The magnitude of the environmental impacts during the various life cycle changes depends on a number of choices made in the design of the product. These relate to aspects such as choice of materials, production methods, and the possibility of maintenance and recycling. Manufacturers and distributors should consider the environmental impact of their product, for example by:

minimizing the use of environmentally harmful substances;
selecting the best available technology and techniques to reduce consumption of energy and materials;
considering the use of recycled materials for product and packaging;
encouraging responsible end of life disposal by the user including guidance on separation and identification of any recyclable components and packaging;
using materials, components, and manufacturing facilities, which have declared documented environmental policies.

Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 2009/48/EC

This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys.

Once this standard is cited in the Official Journal of the European Union under that Directive compliance with the clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.

Table ZA.1 — Correspondence between this European Standard and Directive 2009/48/EC
Clause(s)/subclause(s) of this Part of EN 71	Essential Requirements (ERs) of Directive 2009/48/EC [1]	Qualifying remarks/Notes
4.1.2.3, 4.2.2, 4.3.2	“Annex II. III,11 (Particular)”
4.1.2, 4.2.2, 4.2.3, 4.3.2, 6.1, 6.3	“Annex II. III,12 (Particular)”
5.1.2.1	Annex II, I, 1 (Particular)
5.1.2.2	“Annex II. II,2 (Particular)”
6.1	“Annex V, Part B,1 (Particular)”
6.1	“Annex V, Part B,4 (Particular)”
6.3	“Annex V, Part B,10 (Particular)”

WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard.

Bibliography

[1] Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys, OJ L 170, 30.6.2009, p. 1–37, available from http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:170:0001:0037:EN:PDF

[2] Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products, OJ L 342, 22.12.2009, p. 59–209, available from http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:342:0059:0209:EN:PDF

[3] Directive 2003/89/EC of the European Parliament and of the Council of 10 November 2003 amending Directive 2000/13/EC as regards indication of the ingredients present in foodstuffs, OJ L 308, 25.11.2003, p. 15–18, available from http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2003:308:0015:0018:EN:PDF

[4] Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC, OJ L 338, 13.11.2004, p. 4–17, available from http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:338:0004:0017:EN:PDF

[5] Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food, OJ L 12, 15.1.2011, p. 1–89, available from http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:012:0001:0089:EN:PDF

[6] Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives, OJ L 354, 31.12.2008, p. 16–33, available from http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:354:0016:0033:EN:PDF

[7] Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods and amending Council Regulation (EEC) No 1601/91, Regulations (EC) No 2232/96 and (EC) No 110/2008 and Directive 2000/13/EC, OJ L 354, 31.12.2008, p. 34–50, available from http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:354:0034:0050:EN:PDF

[8] Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety

[9] Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs

[10] Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004

[11] Age determination guidelines: Relating Children’s Ages to Toy Characteristics and Play Behavior, September 2002, CPSC Staff document

[12] The European Commission, An explanatory guidance document (to Directive 2009/48/EC)

[13] CEN/CENELEC Guide 11, Product information relevant to consumers — Guidelines for standard developers

[14] ISO 11930, Cosmetics — Microbiology — Evaluation of the antimicrobial protection of a cosmetic product

[15] Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances

[16] Regulation (EC) No. 1272/2008 of the European Parliament and of the Council of 16 December 2008 on the classification, labelling and packaging of substances and mixtures

[17] Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations

[18] Regulation (EC) No. 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No. 793/93 and Commission Regulation (EC) No. 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EEC and 2000/21/EC

[19] Council Directive 89/686/EEC of 21 December 1989 on the approximation of the laws of the Member States relating to personal protective equipment

[20] Commission Regulation (EU) No 1129/2011 of 11 November 2011 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council by establishing a Union list of food additives

⇒ PREAMBLE—NOT PART OF THE SPECIFICATION ⇐

Safety of toys - Part 13: Olfactory board games, cosmetic kits and gustative games