WRITTEN QUESTION E-2881/01

by Torben Lund (PSE) to the Commission

(22 October 2001)

Subject: Hair dyes with extremely damaging effects on health

Many consumers who use hair dyes frequently or daily have, unfortunately, discovered that some dyes have extremely damaging effects on health. The reactions vary from stinging, itching, sores, swelling of the scalp, allergy and hair loss in some cases even fainting. It is also well known that there is a potential risk in using hair dyes of developing bladder cancer. Many of these effects are attributed to the chemical colouring agent, para phenylenediamine (PPD), which is often used in such products.

Will the Commission explain why PPD is allowed in quantities of up to 6 % in hair dyes when it is banned in other products in quantities of more than 5 % (e.g. paint)?

Will the Commission also say why there is no positive list for hair dyes when there is a positive list of dyes in all other cosmetic products?

Answer given by Mr Liikanen on behalf of the Commission

(17 January 2002)

The Commission is aware of the concerns expressed in relation to the use of hair dyes. Different meetings have taken place with representatives of both consumers and industry and of the Member States.

Regarding the marketing and use of para-phenylenediamine (PPD) in paints, there are no general restrictions, although such paints must be classified and labelled with hazard warnings and safety advice according to Directive 1999/45/EC of the Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations(1). This Directive requires paints to be labelled as toxic with a skull-and-crossbones symbol for paints containing over 25 % of PPD, as irritant for concentrations above 20 %, as a skin sensitiser for concentrations above 1 % and as dangerous for the environment at concentrations above 0,25 %. The precise label would vary according to the concentration.

However with regard to the use of PPD in hair dyes, the current legislation covers not only the labelling but also fixes very strict maximum concentrations for the use of this substance. The maximum use concentration in hair dyes for para-phenylenediamine (PPD) is based on the opinion of the Scientific Committee on Cosmetic Products and Non-food Products intended for Consumers No 863/91 and the resulting entry in Annex III/1/8 of the Cosmetics Directive, Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products(2). The maximum concentration is given as 6 % but according to the same opinion the compound is supplied as an oxidative hair dye at concentrations up to 4 % and used at a concentration of 50 % of that supplied after dilution with hydrogen peroxide (resulting in a use concentration of 2 %). Furthermore, the use of this substance is subject to other conditions, as stated in Annex III. The following wording must be printed on the label: Can cause allergic reactions and Do not use to dye eyelashes or eyebrows.

With regard to hair dyes in general, safety files for approximately 150 hair dyes have already been submitted by the industry to the Scientific Committee on Cosmetic Products and Non-food Products intended for Consumers for evaluation and opinions for about half of them have been issued. As an immediate step, 60 hair dyes will be subject to strict regulation by the forthcoming 26th Adaptation to the Cosmetics Directive. This is in addition to a number of hair dyes that are already regulated via Annex II or Annex III of the Cosmetics Directive. In this context, discussions between Members States, the Commission and representatives of the industry, are currently taking place on the issue of a positive list. According to Article 2 of the Cosmetics Directive, it is the responsibility of the industry to market only products, which do not cause damage to the human health when applied under reasonably foreseeable conditions of use. Finally, according to Article 3 of this Directive, Member States shall take all necessary measures to ensure that only cosmetic products, which conform to the provisions of this Directive, may be put on the market.

It is the intention of the Commission to pursue the current scientific evaluation being carried out by the Scientific Committee on Cosmetic Products and Non-food Products intended for Consumers and to continue the discussions with the Member States in order to prioritise the necessary actions.

(1) OJ L 200, 30.7.1999.

(2) OJ L 262, 27.9.1976.