[F1Part 3E+W+S Chemical Properties
Textual Amendments
F1Schs. 1-7 inserted (E.W.S.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/696), reg. 1, Sch. 15 para. 43 (with Sch. 15 para. 3) (as amended by S.I. 2020/676, regs. 1(1), 2 and S.I. 2020/1460, reg. 1(4), Sch. 3 para. 9(5)); 2020 c. 1, Sch. 5 para. 1(1)
1. Toys must be designed and manufactured in such a way that there are no risks of adverse effects on human health due to exposure to the chemical substances or mixtures of which the toys are composed or which they contain when the toys are used as intended or in a foreseeable way, bearing in mind the behaviour of children.E+W+S
2. Toys that are themselves substances or mixtures must comply also with Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, as applicable, relating to the classification, packaging and labelling of certain substances and mixtures (“Regulation 1272/2008”).E+W+S
3. Without prejudice to the restrictions referred to in the second paragraph of point 1, substances that are classified as carcinogenic, mutagenic or toxic for reproduction (CMR) of category 1A, 1B or 2 under Regulation 1272/2008 must not be used in toys, in components of toys or in micro-structurally distinct parts of toys.E+W+S
4. By way of derogation from point 3, substances or mixtures classified as CMR of the categories laid down in Section 3 of Appendix B may be used in toys, in components of toys or micro-structurally distinct parts of toys provided that one or more of the following conditions is met:E+W+S
(a)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;
(b)these substances and mixtures are inaccessible to children in any form, including inhalation, when the toy is used as intended or in a foreseeable way, bearing in mind the behaviour of children;
(c)regulations have been made under regulation 39D.
5. By way of derogation from point 3, substances or mixtures classified as CMR of the categories laid down in Section 4 of Appendix B may be used in toys, in components of toys or micro-structurally distinct parts of toys provided that one of the following conditions is met:E+W+S
(a)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;
(b)these substances and mixtures are inaccessible to children in any form, including inhalation, when the toy is used as intended or in a foreseeable way, bearing in mind the behaviour of children; or
(c)regulations have been made under regulation 39D.
6. Points 3, 4 and 5 do not apply to nickel in stainless steel.E+W+S
7. Points 3, 4 and 5 do not apply to materials that comply with the specific limit values set out in Appendix C.E+W+S
8. Without prejudice to the application of points 3 and 4, nitrosamines and nitrosable substances are be prohibited for use in toys intended for use by children under 36 months or in other toys intended to be placed in the mouth if the migration of the substances is equal to or higher than 0,05 mg/kg for nitrosamines and 1 mg/kg for nitrosable substances.E+W+S
9. Not applicable.E+W+S
10. Cosmetic toys, such as play cosmetics for dolls, must comply with the compositional and labelling requirements laid down in Regulation (EC) 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products.E+W+S
11. Toys must not contain the following allergenic fragrances:E+W+S
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 is 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 must 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 |
12. The use of the fragrances set out in points 41 to 55 of the list set out in the first paragraph of point 11 and of the fragrances set out in points 1 to 11 of the list set out in the third paragraph of that point are allowed in olfactory board games, cosmetic kits and gustative games, provided thatE+W+S
(i)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;
(ii)if applicable, the resulting products made by the child in accordance with the instructions comply with the requirements of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products; and
(iii)if applicable, those fragrances comply with the relevant legislation on food.
Such olfactory board games, cosmetic kits and gustative games must not be used by children under 36 months and must comply with point 1 of Part B of Schedule 5.
13. Without prejudice to points 3, 4 and 5, the following migration limits, from toys or components of toys, must not be exceeded:E+W+S
Element | mg/kg | mg/kg | mg/kg |
---|---|---|---|
in dry, brittle, powder-like or pliable toy material | in liquid or sticky toy material | in scraped-off toy material | |
Aluminium | 5 625 | 1 406 | 70 000 |
Antimony | 45 | 11,3 | 560 |
Arsenic | 3,8 | 0,9 | 47 |
Barium | 1 500 | 375 | 18 570 |
Boron | 1 200 | 300 | 15 000 |
Cadmium | 1,3 | 0,3 | 17 |
Chromium (III) | 37,5 | 9,4 | 460 |
Chromium (VI) | 0,02 | 0,005 | 0,053 |
Cobalt | 10,5 | 2,6 | 130 |
Copper | 622,5 | 156 | 7 700 |
Lead | 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 |
These limit values do 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 intended or in a foreseeable way, bearing in mind the behaviour of children.]