Answer given by Mr Rehn on behalf of the Commission
As already stated by the Commission in 1996, in its reply to the written question E-3629/95(1), ‘tooth whitening products, either used by consumers or by professionals, are cosmetic products according to the definition of a cosmetic product of the Council Directive 76/768/EEC (the Cosmetics Directive)’. Article 1 of the Cosmetics Directive provides that ‘any substance or preparation intended for placing in contact with [...] the teeth [...] with a view exclusively or principally to cleaning them [...] or protecting them in order to keep them in good condition, change their appearance [...]’is a cosmetic product. Moreover, Annex I to the Directive (illustrative list by category of cosmetic products) mentions products for care of the teeth and the mouth. The Commission confirms that tooth whitening products placed on the market for the principal purpose of lightning discoloured teeth, whether or not they contain peroxide and regardless of concentration, cannot be considered as medical devices since they do not meet the definition of ‘medical device’ contained in Council Directive 93/42/EEC of 14 June 1993 concerning medical devices(2).
Hydrogen peroxide is an active substance of tooth whitening products. Its use in oral hygiene products has been regulated by the Fifteenth Commission Directive 92/86/EEC of 21 October 1992 adapting to technical progress Annexes II, III, IV, V, VI and VII of Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products(3), the fifteenth adaptation to technical progress of the Cosmetics Directive. The Cosmetics Directive provides that the maximum concentration of hydrogen peroxide present or released in oral hygiene products is 0.1%.
According to information available to the Commission, tooth whitening products are being marketed in the territory of certain Member States with hydrogen peroxide concentrations of more than 0.1%. The Commission has asked if Member States could provide information about the current situation. The Commission awaits a general overview by autumn.
In September 2002(4) the Scientific Committee on Cosmetic products and Non Food Products intended for consumers (SCCNFP) stated that ‘the content of hydrogen peroxide in tooth whitening products should not exceed 6% (present or released)’ and that ‘the use of tooth bleaching agents containing 0.1 to 6.0% of hydrogen peroxide is safe if used under supervision of a dentist’.
In its opinion of October 2003, the Scientific Committee, on the basis of a Commission request for clarification of the notion ‘used under supervision of a dentist’, mentioned that ‘the tooth whitening products of the type being discussed should only be used under the surveillance of a dentist. These tooth whitening products should not be freely available to the consumers’.
As new scientific data was further submitted, the Commission sent a new mandate to the Scientific Committee in order mainly to clarify whether it supported the safety of up to 6% hydrogen peroxide in tooth whitening products freely and directly available to consumers in various application forms (strips, trays…).
Based on this scientific opinion and following the Comitology procedure the Commission will submit, if appropriate, a proposal to the Standing Committee on Cosmetics and will take the necessary measures in order to update the Cosmetics Directive accordingly.
One of the main objectives of the Cosmetics Directive is the protection of public health. Article 2 of the Directive provides that ‘a cosmetic product put on the market within the Community must not cause damage to human health [...]’. Changes in the Cosmetics Directive are only made following risk assessment of the cosmetic ingredients by a Scientific Committee. Opinions of the Scientific Committee are based on the principles of excellence, independence, impartiality and transparency. Therefore the European Commission considers that the Cosmetics Directive provides full protection for consumers.