Commission Directive 2006/65/EC

of 19 July 2006

amending Council Directive 76/768/EEC, concerning cosmetic products, for the purpose of adapting Annexes II and 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 Cosmetic Products and Non-Food Products intended for Consumers,

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 (the SCCNFP) concluded that the potential risks were of concern. It recommended that the Commission take further steps to control the use of hair dye chemicals.

(2) The SCCNFP recommended in addition an overall safety assessment strategy for hair dyes including the requirements for testing hair dye cosmetic ingredients for their potential genotoxicity/mutagenicity.

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

(4) As a first step in the implementation of the strategy it was decided to give priority to permanent hair dye substances for which no explicit interest was expressed during the public consultation in defence of their use in hair dyes. Those substances should therefore be banned.

(5) According to the opinion of the SCCNFP, certain azo dyes pose a risk to the health of the consumer. They were therefore deleted from the positive list of colouring agents allowed for use in cosmetic products in Annex IV to Directive 76/768/EEC. For the same reason they should also be banned for use in hair dyes.

(6) For hair dye substances provisionally allowed in part 2 of Annex III to Directive 76/768/EEC the provisional period should be extended.

(7) Annexes II and III to 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

Annexes II and III to Directive 76/768/EEC are amended in accordance with the Annex to this Directive.

Article 2

Member States shall take all necessary measures to ensure that from 1 December 2006 at the latest no cosmetic products which fail to comply with this Directive are placed on the market by Community manufacturers or by importers established within the Community, nor sold or disposed of to the final consumer.

Article 3

1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 1 September 2006 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation between those provisions and this Directive.

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 4

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

Article 5

This Directive is addressed to the Member States.

Done at Brussels, 19 July 2006.

For the Commission

G眉nter Verheugen

Vice-President

[1] OJ L 262, 27.9.1976, p. 169. Directive as last amended by Commission Directive 2005/80/EC (OJ L 303, 22.11.2005, p. 32).

--------------------------------------------------

ANNEX

Directive 76/768/EEC is amended as follows:

(1) In Annex II the following reference numbers 1212 to 1233 are added:

Ref. No | Chemical name | CAS No |

"1212 | 6-Methoxy-2,3-Pyridinediamine and its HCl salt, when used as a substance in hair dye products | 94166-62-8 |

1213 | 2,3-Naphthalenediol, when used as a substance in hair dye products | 92-44-4 |

1214 | 2,4-Diaminodiphenylamine, when used as a substance in hair dye products | 136-17-4 |

1215 | 2,6-Bis(2-Hydroxyethoxy)-3,5-Pyridinediamine and its HCl salt, when used as a substance in hair dye products | 117907-42-3 |

1216 | 2-Methoxymethyl-p-Aminophenol and its HCl salt, when used as a substance in hair dye products | 29785-47-5 |

1217 | 4,5-Diamino-1-Methylpyrazole and its HCl salt, when used as a substance in hair dye products | 20055-01-0 |

1218 | 4,5-Diamino-1-((4-Chlorophenyl)Methyl)-1H-Pyrazole Sulfate, when used as a substance in hair dye products | 163183-00-4 |

1219 | 4-Chloro-2-Aminophenol, when used as a substance in hair dye products | 95-85-2 |

1220 | 4-Hydroxyindole, when used as a substance in hair dye products | 2380-94-1 |

1221 | 4-Methoxytoluene-2,5-Diamine and its HCl salt, when used as a substance in hair dye products | 56496-88-9 |

1222 | 5-Amino-4-Fluoro-2-Methylphenol Sulfate, when used as a substance in hair dye products | 163183-01-5 |

1223 | N,N-Diethyl-m-Aminophenol, when used as a substance in hair dye products | 91-68-9 |

1224 | N,N-Dimethyl-2,6-Pyridinediamine and its HCl salt, when used as a substance in hair dye products | |

1225 | N-Cyclopentyl-m-Aminophenol, when used as a substance in hair dye products | 104903-49-3 |

1226 | N-(2-Methoxyethyl)-p-phenylenediamine and its HCl salt, when used as a substance in hair dye products | 72584-59-9 |

1227 | 2,4-Diamino-5-methylphenetol and its HCl salt, when used as a substance in hair dye products | 113715-25-6 |

1228 | 1,7-Naphthalenediol, when used as a substance in hair dye products | 575-38-2 |

1229 | 3,4-Diaminobenzoic acid, when used as a substance in hair dye products | 619-05-6 |

1230 | 2-Aminomethyl-p-aminophenol and its HCl salt, when used as a substance in hair dye products | 79352-72-0 |

1231 | Solvent Red 1 (CI 12150), when used as a substance in hair dye products | 1229-55-6 |

1232 | Acid Orange 24 (CI 20170), when used as a substance in hair dye products | 1320-07-6 |

1233 | Acid Red 73 (CI 27290), when used as a substance in hair dye products | 5413-75-2" |

(2) Column g in Part 2 of Annex III is amended as follows:

(a) the reference numbers 17, 23, 40, 42 are deleted;

(b) in reference numbers 1, 2, 8, 13, 15, 30, 34, 41, 43, 45, 46, 51, 52, 53, 54, 57, 59, 60 the date " 31.8.2006" is replaced by " 31.12.2007";

(c) in reference numbers 3, 4, 5, 6, 7, 9, 10, 11, 12, 14, 16, 18, 19, 20, 21, 22, 24, 25, 26, 27, 28, 29, 31, 32, 33, 35, 36, 37, 38, 39, 44, 47, 48, 49, 50, 55, 56 and 58 the date " 31.12.2006" is replaced by " 31.12.2007".

--------------------------------------------------