WRITTEN QUESTION E-2392/02

by Kathleen Van Brempt (PSE) to the Commission

(2 August 2002)

Subject: Phthalates in cosmetics

The American Food and Drug Administration has recently announced that it intends to carry out detailed investigations on the use of phthalates in cosmetics. Phthalates are carcinogenic substances which cause damage to kidneys, liver and lungs and affect fertility. Three American environmental groups carried out independent studies on phthalates in a number of gels, perfumes and creams. The studies looked at 72 samples of which 52 proved to contain phthalates. These included several well-known brands which are also marketed in Europe, such as Poison by Christian Dior, Nivea Crème, deodorants and hair gels by Revlon, Calvin Klein and Procter & Gamble.

Is the Commission aware of this study?

Does the Commission know of any European studies on the use of phthalates in cosmetics?

Does the Commission agree with the view that phthalates are not really essential for the quality of a cosmetic product?

Is there not a need for stricter legislation on phthalates?

Should there not be a ban on phthalates in cosmetics until more is known about them and their effects?

Answer given by Mr Liikanen on behalf of the Commission

(20 September 2002)

The Commission is aware of the study Not too pretty Phthalates, Beauty Products & the Food and Health Administration (FDA) published 8 July 2002 by three American environmental groups.

Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products(1) is laying down the principles which regulate the composition, labelling and packaging of cosmetic products and the procedures to adapt this Directive to technical progress. According to this Directive a cosmetic product put on the market must not cause damage to human health when applied under normal or reasonably foreseeable conditions of use. Further to this general obligation the Directive provides for measures either to prohibit the use of ingredients (Annex II of the Directive) or to allow their use under certain conditions (Annex III), after having consulted the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP).

In the above-mentioned study five phthalates have been found in cosmetic products: dibutyl phthalate (DBP), diethyl phthalate (DEP), diethylhexyl phthalate (DEHP), butylbenzyl phthalate (BBzP) and dimethylphthalate (DMP). Although all these substances are phthalates, their toxicological profile is different and has to be evaluated case by case.

DBP and DEHP have been classified toxic to reproduction (category 2) in the Dangerous Substances Directive(2) and will be included in the Restrictions on Marketing and Use Directive(3). The Commission is just preparing a 28th Directive adapting to technical progress Annex II to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products. This draft amends Annex II to include all carcinogenic, mutagenic or substances toxic to reproduction, which were classified category 1 and 2 and restricted according to Directive 76/769/EEC, via a cross-reference to that Directive. Annex II is the list of substances, which must not form part of the composition of cosmetic products. Therefore, those substances will be automatically banned from use in the cosmetic products unless a specific safety assessment allows for their safe use in cosmetics. Concerning DBP, the Commission has asked the SCCNFP for its safety assessment.

The SCCNFP has recently evaluated DEP (Opinion of The Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers concerning Diethyl Phthalate adopted by the SCCNFP during the 20th Plenary meeting of 4 June 2002 http://europa.eu.int/comm/food/fs/sc/sccp/out168_en.pdf). In its opinion the SCCNFP stated that the safety profile of diethyl phthalate supports its use in cosmetic products at current levels. At present the SCCNFP does not recommend any specific warnings or restrictions under the currently proposed conditions of use.

The Commission will take the necessary steps to complete the safety assessment of the other phthalates (BBzP and DMP) in cosmetic products including the appropriate consultation of the Scientific Committee, and will act accordingly.

(1) OJ L 262, 27.9.1976.

(2) Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances, OJ P 196, 16.8.1967.

(3) Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations, OJ L 262, 27.9.1976.