EN Official Journal of the European Union L 268/5

COMMISSION DIRECTIVE 2009/130/EC

of 12 October 2009

amending Council Directive 76/768/EEC, concerning cosmetic products, for the purpose of adapting Annex III thereto to technical progress

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

After consulting the Scientific Committee on Consumer Safety,

Whereas:

(1) Following the publication of a scientific study in 2001, entitled ‘Use of permanent hair dyes and bladder cancer risk’, the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers, currently the Scientific Committee on Consumer Safety (hereinafter SCCS) (2), concluded that the potential risks were of concern. It recommended that the Commission take further steps to control the use of hair dye substances.

(2) The SCCS further recommended an overall safety assessment strategy for hair dye substances including the requirements for testing substances used in hair dye products for their potential genotoxicity/mutagenicity.

(3) Following the opinions of the SCCS, the Commission, together with Member States and stakeholders, agreed on an overall strategy to regulate substances used in hair dye products, according to which the industry was required to submit files containing the scientific data on hair dye substances to be evaluated by the SCCS.

(4) Substances p-Phenylenediamine (PPD) and toluene-2,5-diamine (PTD) are currently regulated under generic entries 8 and 9 in part 1 of Annex III to Council Directive 76/768/EEC. The SCCS classified these substances as extreme sensitisers contributing to a great extent to the incidence of skin allergies among consumers to hair dye products. The risk assessment of the submitted additional data on PPD and PTD, and final decisions made by the SCCS on the safety of these substances might still require a considerable amount of time. As a precautionary measure to reduce the risk of allergies to hair dye products among consumers, the maximum authorised concentrations of PPD and PTD should be immediately decreased to the levels for which the industry submitted the safety files.

(5) Since substances PPD and PTD are currently regulated under generic entries in part 1 of Annex III separate reference numbers should be created for these substances with decreased maximum authorised concentrations.

(6) Commission Directive 2008/88/EC (3) banned the use of hydroquinone in oxidative hair dye products by deleting the respective field of application in column ‘c’ of reference number 14 in Annex III, part 1. For the sake of clarity, the authorised concentration of 0,3 % in column ‘d’ and the conditions of use and warnings which must be printed on the label listed in paragraph (a) in column ‘f’ of reference number 14 should be deleted as well.

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

(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:

Article 1

Annex III to Directive 76/768/EEC is amended in accordance with the Annex to this Directive.

Article 2

1. Member States shall adopt and publish, by 15 April 2010 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions.

They shall apply the provisions set out in the Annex to this Directive from 15 July 2010.

When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

Article 3

This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 12 October 2009. For the Commission Günter VERHEUGEN Vice-President

(1) OJ L 262, 27.9.1976, p. 169.

(2) The name of the committee was changed by Commission Decision 2008/721/EC (OJ L 241, 10.9.2008, p. 21).

(3) OJ L 256, 24.9.2008, p. 12.