WRITTEN QUESTION P-0090/03

by Torben Lund (PSE) to the Commission

(20 January 2003)

Subject: Hair dyes and cancer

It is not safe for European citizens to use hair dyes given that they contain harmful chemical substances. Use of hair dyes is rising. Unfortunately, no-one knows the real extent of the damage as the adverse effects of using the dyes are only apparent several years later when it is too late to intervene. The Commission should therefore apply the cautionary principle and introduce further market regulation.

By far the most oxidative hair dyes contain paraphenylenediamine (PPD) or toluene-2.5-diamine. These substances are very potent contact allergens and are allowed in hair dyes in concentrations which are known to sensitize consumers and produce eczema reactions in people who are allergic to hair dye.

Since the EU's scientific committee on cosmetics (SCCNFP) has linked oxidative hair dyes with the presence of bladder cancer in women, will the Commission say whether it will ban PPD and related substances until data is available to establish what concentrations of these substances do not cause any short-term or long-term harm to human health (e.g. cancer and contact allergies)?

Answer given by Mr Liikanen on behalf of the Commission

(13 February 2003)

The Commission is aware of the concerns expressed in relation to the use of hair dyes. The Commission is considering all aspects of the use of hair dyes in cosmetic products and their impact upon consumer health.

In particular, the Commission points out that in the specific area of oxidative hair dyes the majority of substances have already been banned or their use is subject to specific conditions. These decisions are scientifically-based which means that they are based on a risk assessment made by the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP). The Commission refers to its reply to the Honourable Member's Written Question E-3101/02(1) and wishes further to highlight the following.

With regard to para-Phenylenediamine (PPD) and Toluene-2,5-diamine, the current legislation covers labeling and fixes very strict maximum concentrations for the use of the two substances. The maximum use concentration in hair dyes for PPD and Toluene-2,5-diamine is based on opinions of the SCCNFP and the resulting entry in Annex III/1/8 and Annex III/1/9 of the Cosmetics Directive(2). The maximum concentration is given as 6 % and 10 % respectively. Furthermore, the use of these substances is subject to other conditions, as stated in Annex III. The following wording must be printed on the label: Can cause allergic reactions, Do not use to dye eyelashes or eyebrows and Contains phenylenediamines.

With regard to the general aspects of the risk assessment of hair dyes the SCCNFP on 27 February 2002 adopted a discussion paper that was placed on the web-site of the SCCNFP(3). 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 which was adopted on 24 October 2000.

Finally, the Commission is discussing with Member States and representatives of both consumers and industry the prioritisation of substances to be assessed or re-assessed. This includes setting up timetables and actions to be put into force in relation to substances for which no appropriate file has been submitted for risk assessment by the SCCNFP.

(1) OJ C 110 E, 8.5.2003, p. 164.

(2) 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.

(3) http://europa.eu.int/comm/food/fs/sc/sccp/index_en.html.