(2004/C 78 E/0510)

WRITTEN QUESTION E-3207/03

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

(30 October 2003)

Subject:   Peroxide in toothpaste

The Commission is planning to permit an increase in the concentration of peroxide in cosmetic products from 0,1 % to 6 %, with a view to admitting new dental care products onto the market.

Peroxide is inherently dangerous. For that reason, Japan and Brazil recently banned the use of peroxide in this connection, especially since there are safe teeth-whitening alternatives not containing peroxide. The American Dental Association also cautions against the use of products with a high concentration of peroxide, which may damage teeth and cause gastric problems.

The World Health organisation is also concerned about the presence of peroxide in cosmetic products.

Does the Commission not think that, on the basis of the precautionary principle, an increase in the concentration of peroxide is not conducive to (public) health?

Answer given by Mr Liikanen on behalf of the Commission

(1 December 2003)

One of the main objectives of Council Directive 76/768/EEC (1) is to protect public health. Therefore, 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). 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). Reference number 12 of Annex III regulates hydrogen peroxide, and other compounds or mixtures that release hydrogen peroxide, including carbamide peroxide and zinc peroxide in oral hygiene products up to a maximum authorized concentration of 0,1 %.

The Scientific Committee on Cosmetic Products and Non-Food Products (SCCNFP) is mandated to give its opinion on consumer health and safety issues in the field of cosmetics, based on scientific data. The SCCNFP was asked by the Commission to evaluate, if higher concentrations of hydrogen peroxide and other compounds releasing hydrogen peroxide are safe for use in tooth-whitening products. These products are a different category of cosmetic products than oral hygiene products.

In its opinion adopted during the 21st plenary meeting of 17 September 2002, the SCCNFP stated that ‘the content of hydrogen peroxide in tooth whitening products should not exceed 6 % (present or released) with a limitation of maximum 50 mg hydrogen peroxide per day. The use of tooth whitening products is not recommended prior to or immediately after dental restoration. Conditions such as pre-existing tissue injury or concurrent use of tobacco and/or alcohol may exacerbate the toxic effects of hydrogen peroxide. Overall evidence indicates that the proper use of tooth bleaching agents containing 0,1 to 6,0 % hydrogen peroxide (or equivalent for hydrogen peroxide releasing substances) is safe if used under the supervision of a dentist.’

Based on this opinion the Commission intends to take appropriate steps to adapt Annex III to Directive 76/768/EEC, accordingly.

(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.