Commission Directive 2003/83/EC of 24 September 2003 adapting to technical progress Annexes II, III and VI to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products (Text with EEA relevance)

Commission Directive 2003/83/EC
of 24 September 2003
adapting to technical progress Annexes II, III and VI to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products
(Text with EEA relevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES
,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products(1), as last amended by Commission Directive 2003/80/EC(2), and in particular Article 8(2) thereof,
After consulting the Scientific Committee on Cosmetic Products and Non-Food Products intended for consumers,
Whereas:
(1) Benzoyl peroxide and hydroquinone methylether (synonym of 4-methoxyphenol) are currently listed in Annex II, hydroquinone is already subject to restrictions and conditions laid down in Annex III. The Scientific Committee on Cosmetic Products and Non-Food Products intended for consumers (hereinafter SCCNFP) has come to the conclusion that, due to the very low exposure to the consumer, the use of benzoyl peroxide, hydroquinone and hydroquinone methylether in artificial nail systems does not pose a risk. Therefore, reference No 178 of Annex II and reference No 14 of Annex III, part 1 should be amended accordingly; reference No 382 of Annex II should be deleted and reference Nos 94 and 95 should be added in Annex III, part 1.
(2) It is the opinion of the SCCNFP that the toxicological effects of the dialkanolamine salts, and, in particular, their readiness for nitrosamines' formation are similar to the respective properties of the dialkanolamines and that dialkylamines and their salts have very similar properties with the respective dialkanolamines' analogues with respect to nitrosamines' formation. The terms "dialkanolamines" and "dialkylamines" and synonymous with "secondary alkanolamines" and "secondary alkylamines" and the latter are less ambiguous. Therefore, reference No 411 of Annex II and reference Nos 60, 61 and 62 of Annex III, part 1, should be amended accordingly.
(3) The SCCNFP has come to the conclusion that the compound 2,4-diamino-pyrimidine-3-oxide (CAS No 74638-76-9) can be used safely in cosmetic products at concentrations up to 1,5 %. Therefore, 2,4-diamino-pyrimidine-3-oxide should be included in Annex III, part 1 as reference No 93.
(4) The SCCNFP is of the opinion that the use of 1,2-dibromo-2,4-dicyanobutane should be restricted to rinse-off products at the current maximum permitted level of 0,1 %. Therefore reference No 36 of Annex VI, part 1 should be amended accordingly.
(5) Therefore, Directive 76/768/EEC should be amended accordingly.
(6) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Cosmetic Products,