EN Official Journal of the European Union CE 84/687

(2004/C 84 E/0773)

WRITTEN QUESTION P-0859/04

by Torben Lund (PSE) to the Commission

(11 March 2004)

Subject: Hair dyes and serious damage to health

On 4 March 2004, the Danish newspaper Jyllands Posten carried a report concerning several investigations which indicate that a number of authorised hair dyes cause serious damage to consumers' health. The sector is regulated by the Cosmetics Directive.

In the light of the abovementioned investigations, does the Commission believe that a positive list should be drawn up for hair dyes and that hair dyes should be tested for risk of cancer and allergy before they are approved? The extent of the health hazards are not fully known as the industry will not allow access to its records. Is this information known to the Commission and how many reports concerning allergies caused by hair dyes does the Commission receive each year? Will the Commission also say whether a revision of the Cosmetics Directive will compel the industry to allow public access to reports concerning health problems caused by their products? Finally, will the Commission say when the eighth amendment of the Cosmetics Directive — or other relevant initiatives — is expected to commence, what changes may be proposed and whether the Commission will make the precautionary principle a key feature of the forthcoming revision?

Answer given by Mr Liikanen on behalf of the Commission

(15 April 2004)

In 2003 the Commission, together with Member States and representatives of both consumers and industry, discussed a strategy for the systematic evaluation of hair dyes. The strategy was agreed on July 2003 and published on the web-site of the Commission, (Enterprise Directorate-General (DG)) (1). The main element of the strategy is a tiered, modulated approach requiring industry to submit by certain deadlines safety dossiers on hair dyes to be evaluated by the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP). The overall objective of this strategy is to regulate the use of substances as hair dye ingredients on the basis of the most recent scientific evaluation of safety dossiers.

These dossiers must conform to the ‘Notes of Guidance for testing of cosmetic ingredients for their safety evaluation’. The 5th revision of these notes was adopted on 20 October 2003 and was published on the web-site of the Commission, (Health and Consumer Safety DG) (2). The basic toxicological requirements include data requirement on skin sensitization and on genotoxicity/mutagenicity. In its ‘Assessment Strategies for Hair Dyes’ the SCCNFP recommended that ‘in particular, for the risk assessment of hair dyes, the following must be submitted: … data on genotoxicity — the studies must be consistent with internationally accepted guidelines (Organization for Economic Cooperation and Development (OECD), EU) and/or with modern testing strategies …’

This strategy received a wide consensus between Member States, consumers and industry represented in the Cosmetics Working Party and should eventually lead to the setting up of a positive list for hair-dyes.

In relation to concrete measures already being taken, the Commission refers as well to the reply given recently in relation to the Written Question E-0391/04 by Mr De Roo (3).

Article 7a of the Cosmetics Directive 76/768/EEC (4) stipulates that the manufacturer or importer of a cosmetic product should keep information on their cosmetic products readily accessible for the competent control authorities of the Member States. This information includes the assessment of the safety for human health of the finished product as well as existing data on undesirable effects on human health resulting from use of the cosmetic products. Allergies are included in this category. Further to the adoption of the 7th amendment to the Cosmetics Directive 2003/15/EC (5) this information should be made ‘easily accessible to the public by any appropriate means, including electronic means’.

In view of strengthening the competitiveness of the cosmetic sector and improving consumer safety, the Commission will carry out an analysis of the current situation of the sector and the application of the legislation.

(1) http://pharmacos.eudra.org/F3/cosmetic/doc/HairDyeStrategyInternet.pdf

(2) http://europa.eu.int/comm/health/ph_risk/committees/sccp/documents/out242_en.pdf

(3) See page 386.

(4) 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.

(5) Directive 2003/15/EC of the Parliament and of the Council of 27 February 2003 amending Council Directive 76/768/EEC, OJ L 66, 11.3.2003.