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Parliamentary questions
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2 September 2010
E-5895/2010(ASW)
Answer given by Mr Dalli on behalf of the Commission
Question reference: E-5895/2010

According to Council Directive 76/768/EEC(1) (Cosmetics Directive), cosmetic products placed on the market must be safe for human health. Only the substances listed in Annex VII to the Cosmetics Directive are authorised, under the conditions laid down in that annex, for use as UV filters in cosmetic products placed on the EU market. All the UV filters permitted in the EU have been evaluated by the Scientific Committee on Consumer Safety (SCCS). It is on the basis of the SCCS opinions that these substances have been included in Annex VII to the Cosmetics Directive.

With regard to the substances mentioned by the Honourable Membert, 4-Methylbenzylidene Camphor is indeed authorised in the EU for use as UV filter. Moreover, Mexoryl SX, Tinosorb M, Tinosorb S, Neo Heliopan AP and Uvinul T 150 correspond to substances which are also listed in Annex VII to the Cosmetics Directive. All those substances have been assessed by the SCCS. The Commission is not aware of safety concerns in relation to substances which are allowed for use as UV filters in the European Union, but which are not approved for such use by the US Food and Drug Administration (FDA). Therefore, currently it does not see any reason to take measures regarding these substances.

As regards vitamin A, it is not specifically regulated in the annexes to the Cosmetics Directive. The Commission has not been informed about safety problems in relation to cosmetic products containing that substance either. However, it is the responsibility of the manufacturers to ensure the safety of the cosmetic products and document it through a product safety file, which is subject to controls by the national authorities.

(1)Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products, OJ L 262, 27.9.1976.

OJ C 216 E, 22/07/2011
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