EN Official Journal of the European Union CE 84/386

(2004/C 84 E/0449)

WRITTEN QUESTION E-0391/04

by Alexander de Roo (Verts/ALE) to the Commission

(12 February 2004)

Subject: Hair dye and cancer risks

Many women over the age of 45 and a growing minority of men over the age of 45 dye their hair regularly. New American research (published in the American Journal of Epidemiology, January 2004) shows that women who started dyeing their hair before 1980 have a 40 % higher chance of contracting Non-Hodgkin's Lymphoma, a malignant disease of the lymphatic system.

In 2002 American researchers (University of Southern California) had already ascertained that regularly dyeing the hair led to a doubling in the risk of bladder cancer. The substances in hair dye also cause a higher incidence of cancer of the uterus.

It is probably toxic chemical substances such as para-phenylene diamine (PPD) and tetrahydro-6-nitroquinoxaline that cause these forms of cancer.

Does the Commission agree that the abovementioned toxins must not be allowed to occur in consumer products such as hair dyes?

What is the current situation as regards the scientific investigations being carried out by the Scientific Committee for Cosmetic Products, as announced by the Commission on 17 January 2002 in its answer to a written question by Torben Lund (E-2881/01 (1))?

Answer given by Mr Liikanen on behalf of the Commission

(29 March 2004)

Further to the information already provided in the answer to Written Question E-2881/01 by Mr Lund, the following actions and measures have been taken.

At the level of the Scientific Committee on Cosmetic Products and Non-Food Products (SCCNFP)

The SCCNFP on 27 February 2002 adopted a discussion paper that was placed on the web-site of the Commission, Health and Consumer Protection DG. Interested parties were invited to comment. On 4 June 2002 it adopted A strategy for testing hair-dye cosmetic ingredients for their potential genotoxicity/mutagenicity.' This was supplemented by a recent opinion of 17 December 2002 updating ‘Basic requirements for toxicological dossiers to be evaluated by the SCCNFP’.

Industry is required to submit files that must conform to the above-mentioned principles and 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.

At the level of the Risk Management

In 2003 the Commission, together with Member States and representatives of both consumers and industry, discussed strategy for the systematic evaluation of hair dyes in relation to published reports on a possible link between permanent hair dye use and bladder cancer. The strategy was agreed on July 2003 and published on the web-site of the Commission, Directorate-General Enterprise. 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 SCCNFP. The actions and deadlines for hair dyes for which files are to be submitted alone or in combination are included in the published strategy. The overall objective of this strategy is to regulate the use of substances such as hair dye ingredients on the basis of the most recent scientific evaluation of dossiers.

Substances for which no file has been submitted for risk assessment by the SCCNFP will be banned immediately whereas substances for which information is available will be assessed later on. The Commission is now in the process of consulting Member States with a view to a ban of a first list of more than 100 substances for which no safety file was submitted by the end of September 2003. This measure will be adopted following the comitology procedure. For substances for which a file is available, a deadline of July 2005 is in place for the files to be brought up to date with the new data requirements set by the SCCNFP. A deadline on submissions of tests conducted on combinations of substances to simulate the real life exposure of consumers will be set after consultation with the Member States.

The two substances mentioned by the Honourable Member, para-phenylene diamine and tetrahydro-6-nitroquinoxaline, are also covered by the strategy. As, to date, files for these two substances are available, updated dossiers which meet the new data requirements set by the SCCNFP, have to be submitted by July 2005 at the latest.

With regard to the recent publication in the American Journal of Epidemiology (2) the authors concluded, that they found ‘an increased risk of non-Hodgkin's lymphoma among women who started using darker hair-colouring products before 1980 but not among women who started using products after that. Future studies designed to collect similar exposure information are needed to determine whether our findings for hair dye use before 1980 are replicated in other populations.’ The Commission will conduct a comprehensive literature review on all publications linking the use of hair dyes with various forms of cancer and submit it to the SCCNFP with a view to obtaining its analysis and advice on this issue in a holistic comprehensive manner.

(1) OJ C 115 E, 16.5.2002, p. 185.

(2) Zhang Y, Holford TR, Leaderer Β et al. Hair-colouring products use and risk of Non-Hodkin's Lymphoma: A population-based case-control study in Connecticut. Am J Epidemiol 2004;159:148-154.