Commission Directive 2009/164/EU

of 22 December 2009

amending, for the purpose of adaptation to technical progress, Annexes II and III to Council Directive 76/768/EEC concerning cosmetic products

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on European Union and to the Treaty on the Functioning of the European Union,

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), and in particular Article 8(2) thereof,

After consulting the Scientific Committee on Consumer Safety,

Whereas:

(1) The substance Verbena oil (Lippia citriodora Kunth.) is currently banned for use in cosmetic products, being listed in Annex II to Directive 76/768/EEC, under reference number 450. The ban of this substance was introduced on the basis of an opinion of May 2000 of the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP), subsequently replaced by the ‘Scientific Committee on Consumer Products (SCCP)’ by Commission Decision 2004/210/EC(2), and later by the ‘Scientific Committee on Consumer Safety (SCCS)’ by Commission Decision 2008/721/EC(3). The SCCNFP recommended the prohibition of Verbena (Lippia citriodora Kunth.) essential oils and derivatives, e.g. concrete and absolute, when used as a fragrance ingredient, based on the sensitising potential.

(2) However, the SCCNFP later concluded in an opinion issued in 2001 that Verbena absolute obtained from Lippia citriodora Kunth. should not be used such that the level in the finished cosmetic products exceeds 0,2 %. It is therefore appropriate to include Verbena absolute (Lippia citriodora Kunth.) together with its respective restriction in Annex III, Part 1 to Directive 76/768/EEC. It is also appropriate to amend reference number 450 of Annex II in order to specify that the substances Verbena essential oils (Lippia citriodora Kunth.) and derivatives other than absolute are prohibited when used as a fragrance ingredient.

(3) Directive 2008/42/EC of 3 April 2008 amending Council Directive 76/768/EEC, concerning cosmetic products, for the purpose of adapting Annexes II and III thereto to technical progress(4) included several allyl esters containing allyl alcohol as impurity in Annex III, Part 1 to Directive 76/768/EEC. The substance allyl phenethyl ether may contain allyl alcohol as impurity as well. For this substance, the SCCNFP issued an opinion in 2000 recommending an upper limit of 0,1 % of allyl alcohol as impurity.

(4) In the light of the SCCNFP opinion, as well as for consistency reasons, it is appropriate to include in Annex III, Part 1 to Directive 76/768/EEC the substance allyl phenethyl ether together with its respective restriction.

(5) The group of substances Terpene terpenoids sinpine is currently regulated under reference number 130 in Annex III, Part 1 to Directive 76/768/EEC. However, the word ‘sinpine’ is a trade name and should therefore be deleted from the designation of that group of substances.

(6) Directive 76/768/EEC should therefore be amended accordingly.

(7) In view of a smooth transition from existing formulae of cosmetic products to formulae which comply with the requirements laid down in this Directive, it is necessary to provide for appropriate transitional periods.

(8) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Cosmetic Products,

HAS ADOPTED THIS DIRECTIVE: