Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (Text with EEA relevance)
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Toys shall comply with the relevant Community legislation relating to certain categories of products or to restrictions for certain substances and mixtures.
these substances and mixtures are contained in individual concentrations equal to or smaller than the relevant concentrations established in the Community legal acts referred to in Section 2 of Appendix B for the classification of mixtures containing these substances;
these substances and mixtures are inaccessible to children in any form, including inhalation, when the toy is used as specified in the first subparagraph of Article 10(2);
a decision in accordance with Article 46(3) has been taken to permit the substance or mixture and its use, and the substance or mixture and its permitted uses have been listed in Appendix A.
That decision may be taken if the following conditions are met:
the use of the substance or mixture has been evaluated by the relevant Scientific Committee and found to be safe, in particular in view of exposure;
there are no suitable alternative substances or mixtures available, as documented in an analysis of alternatives; and
the substance or mixture is not prohibited for use in consumer articles under Regulation (EC) No 1907/2006.
The Commission shall mandate the relevant Scientific Committee to re-evaluate those substances or mixtures as soon as safety concerns arise and at the latest every five years from the date that a decision in accordance with Article 46(3) was taken.
these substances and mixtures are contained in individual concentrations equal to or smaller than the relevant concentrations established in the Community legal acts referred to in Section 2 of Appendix B for the classification of mixtures containing these substances;
these substances and mixtures are inaccessible to children in any form, including inhalation, when the toy is used as specified in the first subparagraph of Article 10(2); or
a decision in accordance with Article 46(3) has been taken to permit the substance or mixture and its use, and the substance or mixture and its permitted uses have been listed in Appendix A.
That decision may be taken if the following conditions are met:
the use of the substance or mixture has been evaluated by the relevant Scientific Committee and found to be safe, in particular in view of exposure; and
the substance or mixture is not prohibited for use in consumer articles under Regulation (EC) No 1907/2006.
The Commission shall mandate the relevant Scientific Committee to re-evaluate those substances or mixtures as soon as safety concerns arise and at the latest every five years from the date that a decision in accordance with Article 46(3) was taken.
| No | Name of the allergenic fragrance | CAS number |
|---|---|---|
| (1) | Alanroot oil (Inula helenium) | 97676-35-2 |
| (2) | Allylisothiocyanate | 57-06-7 |
| (3) | Benzyl cyanide | 140-29-4 |
| (4) | 4 tert-Butylphenol | 98-54-4 |
| (5) | Chenopodium oil | 8006-99-3 |
| (6) | Cyclamen alcohol | 4756-19-8 |
| (7) | Diethyl maleate | 141-05-9 |
| (8) | Dihydrocoumarin | 119-84-6 |
| (9) | 2,4-Dihydroxy-3-methylbenzaldehyde | 6248-20-0 |
| (10) | 3,7-Dimethyl-2-octen-1-ol (6,7-Dihydrogeraniol) | 40607-48-5 |
| (11) | 4,6-Dimethyl-8-tert-butylcoumarin | 17874-34-9 |
| (12) | Dimethyl citraconate | 617-54-9 |
| (13) | 7,11-Dimethyl-4.6,10-dodecatrien-3-one | 26651-96-7 |
| (14) | 6,10-Dimethyl-3.5,9-undecatrien-2-one | 141-10-6 |
| (15) | Diphenylamine | 122-39-4 |
| (16) | Ethyl acrylate | 140-88-5 |
| (17) | Fig leaf, fresh and preparations | 68916-52-9 |
| (18) | trans-2-Heptenal | 18829-55-5 |
| (19) | trans-2-Hexenal diethyl acetal | 67746-30-9 |
| (20) | trans-2-Hexenal dimethyl acetal | 18318-83-7 |
| (21) | Hydroabietyl alcohol | 13393-93-6 |
| (22) | 4-Ethoxy-phenol | 622-62-8 |
| (23) | 6-lsopropyl-2-decahydronaphthalenol | 34131-99-2 |
| (24) | 7-Methoxycoumarin | 531-59-9 |
| (25) | 4-Methoxyphenol | 150-76-5 |
| (26) | 4-(p-Methoxyphenyl)-3-butene-2-one | 943-88-4 |
| (27) | 1-(p-Methoxyphenyl)-1-penten-3-one | 104-27-8 |
| (28) | Methyl trans-2-butenoate | 623-43-8 |
| (29) | 6-Methylcoumarin | 92-48-8 |
| (30) | 7-Methylcoumarin | 2445-83-2 |
| (31) | 5-Methyl-2,3-hexanedione | 13706-86-0 |
| (32) | Costus root oil (Saussurea lappa Clarke) | 8023-88-9 |
| (33) | 7-Ethoxy-4-methylcoumarin | 87-05-8 |
| (34) | Hexahydrocoumarin | 700-82-3 |
| (35) | Peru balsam, crude (Exudation of Myroxylon pereirae (Royle) Klotzsch) | 8007-00-9 |
| (36) | 2-Pentylidene-cyclohexanone | 25677-40-1 |
| (37) | 3.6,10-Trimethyl-3.5,9-undecatrien-2-one | 1117-41-5 |
| (38) | Verbena oil (Lippia citriodora Kunth) | 8024-12-2 |
| (39) | Musk ambrette (4-tert-Butyl-3-methoxy-2,6-dinitrotoluene) | 83-66-9 |
| (40) | 4-Phenyl-3-buten-2-one | 122-57-6 |
| (41) | Amyl cinnamal | 122-40-7 |
| (42) | Amylcinnamyl alcohol | 101-85-9 |
| (43) | Benzyl alcohol | 100-51-6 |
| (44) | Benzyl salicylate | 118-58-1 |
| (45) | Cinnamyl alcohol | 104-54-1 |
| (46) | Cinnamal | 104-55-2 |
| (47) | Citral | 5392-40-5 |
| (48) | Coumarin | 91-64-5 |
| (49) | Eugenol | 97-53-0 |
| (50) | Geraniol | 106-24-1 |
| (51) | Hydroxy-citronellal | 107-75-5 |
| (52) | Hydroxy-methylpentylcyclohexenecarboxaldehyde | 31906-04-4 |
| (53) | Isoeugenol | 97-54-1 |
| (54) | Oakmoss extracts | 90028-68-5 |
| (55) | Treemoss extracts | 90028-67-4 |
However, the presence of traces of these fragrances shall be allowed provided that such presence is technically unavoidable under good manufacturing practice and does not exceed 100 mg/kg.
In addition, the names of the following allergenic fragrances shall be listed on the toy, on an affixed label, on the packaging or in an accompanying leaflet, if added to a toy, as such, at concentrations exceeding 100 mg/kg in the toy or components thereof:
| No | Name of the allergenic fragrance | CAS number |
|---|---|---|
| (1) | Anisyl alcohol | 105-13-5 |
| (2) | Benzyl benzoate | 120-51-4 |
| (3) | Benzyl cinnamate | 103-41-3 |
| (4) | Citronellol | 106-22-9 |
| (5) | Farnesol | 4602-84-0 |
| (6) | Hexyl cinnamaldehyde | 101-86-0 |
| (7) | Lilial | 80-54-6 |
| (8) | d-Limonene | 5989-27-5 |
| (9) | Linalool | 78-70-6 |
| (10) | Methyl heptine carbonate | 111-12-6 |
| (11) | 3-methyl-4-(2.6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one | 127-51-5 |
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; and
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.
| Element | mg/kgin dry, brittle, powder-like or pliable toy material | mg/kgin liquid or sticky toy material | mg/kgin scraped-off toy material |
|---|---|---|---|
| Aluminium | 5 625 | 1 406 | 70 000 |
| Antimony | 45 | 11,3 | 560 |
| Arsenic | 3,8 | 0,9 | 47 |
| [F1Barium | 1 500 | 375 | 18 750] |
| Boron | 1 200 | 300 | 15 000 |
| [F2Cadmium | 1,3 | 0,3 | 17] |
| Chromium (III) | 37,5 | 9,4 | 460 |
| [F3Chromium (VI) | 0,02 | 0,005 | 0,053] |
| Cobalt | 10,5 | 2,6 | 130 |
| Copper | 622,5 | 156 | 7 700 |
| [F4Lead | 2,0 | 0,5 | 23] |
| Manganese | 1 200 | 300 | 15 000 |
| Mercury | 7,5 | 1,9 | 94 |
| Nickel | 75 | 18,8 | 930 |
| Selenium | 37,5 | 9,4 | 460 |
| Strontium | 4 500 | 1 125 | 56 000 |
| Tin | 15 000 | 3 750 | 180 000 |
| Organic tin | 0,9 | 0,2 | 12 |
| Zinc | 3 750 | 938 | 46 000 |
Textual Amendments
F1 Substituted by Commission Regulation (EU) No 681/2013 of 17 July 2013 amending part III of Annex II to Directive 2009/48/EC of the European Parliament and of the Council on the safety of toys (Text with EEA relevance).
F2 Substituted by Commission Directive 2012/7/EU of 2 March 2012 amending, for the purpose of adaptation to technical progress, part III of Annex II to Directive 2009/48/EC of the European Parliament and of the Council relating to toy safety (Text with EEA relevance).
These limit values shall not apply to toys or components of toys which, due to their accessibility, function, volume or mass, clearly exclude any hazard due to sucking, licking, swallowing or prolonged contact with skin when used as specified in the first subparagraph of Article 10(2).
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