Directive 2009/130 - Amendment of Council Directive 76/768/EEC, concerning cosmetic products, for the purpose of adapting Annex III thereto to technical progress

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1.

Current status

This directive was in effect from November  2, 2009 until July 11, 2013 and should have been implemented in national regulation on April 15, 2010 at the latest.

2.

Key information

official title

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
 
Legal instrument Directive
Number legal act Directive 2009/130
CELEX number i 32009L0130

3.

Key dates

Document 12-10-2009
Publication in Official Journal 13-10-2009; Special edition in Croatian: Chapter 13 Volume 056,OJ L 268, 13.10.2009
Effect 02-11-2009; Entry into force Date pub. + 20 See Art 3
End of validity 11-07-2013; Implicitly repealed by 32009R1223
Transposition 15-04-2010; At the latest See Art 2

4.

Legislative text

13.10.2009   

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...


More

This text has been adopted from EUR-Lex.

 

5.

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