WRITTEN QUESTION E-3101/02

by Torben Lund (PSE) to the Commission

(29 October 2002)

Subject: Hazardous PPD substances should be banned in cosmetics

Many cosmetic products contain chemicals which have not been adequately researched. Unfortunately popular everyday items such as perfume, hair-spray, nail varnish and mascara seem in a number of cases to provoke an allergic reaction in many users.

The field of cosmetics is constantly developing, and a wide range of analyses are constantly being carried out. When a particular set of analyses shows that certain substances are harmful to health, they should be banned as soon as possible: however, this is rarely done to a sufficient extent. The Danish Toxicology Centre has tested 2-chloro-PPD, which is a permitted substance. The results show that 2-chloro-PPD is at least as allergenic as PPD, which is banned. I would therefore ask the Commission to ensure that the relevant scientific committee gives an opinion on these analyses and carries out evaluations, and that it takes appropriate measures. Could the Commission please also inform me how many substances are present in cosmetics which have not been investigated or evaluated. Finally, can the Commission state the position of EU law vis-à-vis consumers and others who desire to inspect documents relating to a producer's analyses of the health and other risks posed by its products, and can it comment on what it proposes to do to guarantee that consumers are provided with the best possible information?

Answer given by Mr Liikanen on behalf of the Commission

(12 December 2002)

Council Directive 76/768/EEC(1) aims at the safeguarding of public health by ensuring that only safe cosmetic products are put on the market, while taking into account economic and technological requirements. One of its main objectives is to protect public health, the Directive states as a general principle that only cosmetic products that do not cause damage to human health can be put on the market (Article 2 of the Directive). Therefore, cosmetic products can only contain safe ingredients. An ingredient, which is not safe, should not be used.

To ensure this, measures have been taken, for example certain ingredients must not form part of a cosmetic product (Annex II of the Directive) or certain substances shall only be used up to a maximum concentration or under certain conditions of use (Annex III of the Directive). Furthermore, there is an obligation for the manufacturer or his agent or the person to whose order a cosmetic product is manufactured or the person responsible for placing an imported cosmetic product on the Community market to keep information on their cosmetic products readily accessible for the control authorities of the Member States (Article 7a of the Directive). This product safety file must contain the assessment of the safety for human health of the finished product taking into consideration the general toxicological profile of its ingredients.

At present, the Commission is considering all aspects of the use of hair dyes in cosmetic products and their impact upon consumer health. Clearly, it is important that any actions taken are in the interests of consumer information and the protection of public health.

To this end, the Scientific Committee on Cosmetic Products and Non-Food Products (SCCNFP) is mandated to give opinion on consumer health and safety issues in the field of cosmetics, based on scientific data. Once the SCCNFP finalises its opinions on each file submitted for risk evaluation the Commission takes appropriate steps to adapt the Annexes to Directive 76/768/EEC. Currently, there are 17 hair-dyes (out of which 12 are used in permanent hair-dye formulations) that have been banned and 60 hair-dyes (out of which 47 are used in permanent formulations) that have been included in Annex III of the Directive.

On the basis of an opinion from SCCNFP, a maximum concentration of 6 % in cosmetic products was introduced for the specific hair dye para-phenylendiamin (PPD) in the Directive (Annex III, No 8). However, recently, PPD has been subject to a process of re-evaluation. The SCCNFP stated in its opinion adopted on 27 February 2002 that the information submitted is insufficient to allow an adequate risk assessment to be carried out and that additional data would be required before any further consideration. Therefore, the Commission will require the industry to submit urgently the necessary data in order to finalise the risk assessment. The Commission will consider the appropriate measures in relation to PPD. The other hair dye mentioned, 2-Chloro-p-phenylenediamine had been evaluated and an opinion had been adopted on 4 October 1991. Indeed it would be feasible to re-evaluate 2-Chloro-p-phenylenediamine on the basis of new scientific data. Therefore, the Commission will ask for the data the Danish Toxicology Centre had published to transmit them to the SCCNFP and ask for its expert view.

As cosmetic products even under normal conditions of use can produce undesirable effects, the manufacturer or the person responsible for placing cosmetic products on the market already collects data on these effects within the product safety file. The way this information can be made accessible to the public is being considered in the process of adopting the 7th Amendment to the Cosmetics Directive.

(1) 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.