WRITTEN QUESTION E-2816/98

by Carmen Díez de Rivera Icaza (PSE) to the Commission

(17 September 1998)

Subject: Sun screens

In view of the various reports published in August in various sections of the media concerning the ineffectiveness of sun screens in cases such as melanoma, can the Commission say:

1. whether it has any information on the effectiveness or ineffectiveness of such products, and

2. if not, what steps will it take to clarify the matter?

Answer given by Mr Bangemann on behalf of the Commission

(16 October 1998)

The safety of cosmetic products marketed in the Community is ensured by the provisions of Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products, otherwise known as the Cosmetics Directive. The safety of sunscreens is closely examined and regulated through the provisions of Annex VII which lists the ultra violet (UV) filters that can be used in cosmetic products in the Community.

Article 7a of the Directive states that the manufacturer must make information on the efficacy of the product available to the authorities. The efficacy of sunscreens is demonstrated through the determination of the sun protection factor (SPF) for a material or product. This is the universal means by which the effectiveness of a sunscreen is assessed. It compares the UV dose required to introduce skin reaction with and without the protective product under examination. This method (for which a standard protocol is available) is widely accepted by dermatologists and health workers and has demonstrated the positive benefits of the protection provided by UV filters.

However, the Commission is responsive to the concerns over the safety and efficacy of sun products that have recently been reported. The Commission has convened, in the framework of the activities of the scientific committee on cosmetic products and non-food products intended for consumers, an expert panel on the safety of sunscreens. The expert panel will convene its first meeting in early 1999 and will advise the Commission on the consumer safety implications of the use of sunscreens and UV protectors. The scientific committee will examine the safety of sunscreens, their ability to block the harmful effects of UV exposure, consumer habits and the suitability of SPF for giving consumer information. The Commission will review the opinions of the expert panel and propose legislative or technical actions as appropriate.