WRITTEN QUESTION E-1983/96 by Hiltrud Breyer (V) to the Commission (17 July 1996)

Subject: Cosmetic products and BSE

1. Are the raw materials used safe throughout the EU?

2. What weight do official recommendations carry? To what extent are cosmetics manufacturers bound by them?

3. In which cosmetic products is beef tallow used?

4. What other beef substances are used in the production of cosmetics, and in which products are they used?

5. How high is the risk of infection in the case of damaged skin?

6. Are the same safety measures taken when cattle-derived substances are used in the UK as in Germany/other EU States? Have appropriate guarantees been issued by British cosmetics manufacturers?

7. When raw materials are shown in lists of ingredients, can it be seen which parts of cattle have been used and from what countries they came?

Answer given by Mrs Bonino on behalf of the Commission (4 October 1996)

1. Within the Community, the safety of cosmetic products and of their ingredients is governed by Council Directive 76/768/EEC ((OJ L 262, 27.9.1976 )), known as the 'cosmetics' directive, which has been amended on several occasions. This directive lays down the conditions under which cosmetic products may be placed on the market with all due safety for consumers.

Council Directive 93/35/EEC ((OJ L 151, 23.6.1993. )), amending for the sixth time the 'cosmetics' directive, strengthened the guarantees concerning the safety of cosmetic products. This directive obliges producers or importers into the Community of cosmetic products to keep available for the national authorities, for control purposes, a dossier containing certain information, notably on the qualitative and quantitative composition of the product, the physico-chemical and microbiological specifications of the raw materials and the finished product, the purity and microbiological control criteria of the cosmetic product, the method of manufacture, and the assessment of the safety for human health of the finished product.

2. Regarding bovine spongiform encephalopathy (BSE), at the start of the 1990s the World Health Organisation and the various national and Community committees concerned, including the Scientific Committee on Cosmetology, recommended industrial producers to use ingredients of bovine origin sourced from countries where there was no bovine spongiform encephalopathy. The European cosmetic toiletry and perfumery association (COLIPA) states that it has followed these recommendations ever since.

Thus, bovine extracts of specific organs supplied to producers must be accompanied by a certificate of origin. In addition, COLIPA has stated that bovine extracts likely to present a high risk of contamination, such as the brain, the spinal cord and the eyes, were not used in the manufacture of cosmetic products in the Community.

At Community level, regulatory measures, essentially of a veterinary nature, have been taken since the beginning of the endemic. These were recently supplemented by Commission Decision 96/239/EC of 27 March 1996 ((OJ L 78, 28.3.1996. )), prohibiting the United Kingdom from exporting products obtained from bovine animals slaughtered in the United Kingdom for use in medicinal products, cosmetics or pharmaceutical products.

Decision 96/362/EC ((OJ L 139, 12.6.1996. )) of 11 June 1996 stipulated that the United Kingdom may not authorise the production of the above-mentioned products except in establishments under official veterinary control which have been shown to be operating in accordance with the conditions set out. This provision indicates that the rules laid down for products originating from the United Kingdom apply also to the production of these products for national use. In the same Decision the Commission also authorised a partial lifting of the embargo on gelatin and tallow, to be implemented progressively so long as the strict conditions specified are applied.

The United Kingdom has itself also taken a number of measures since 1988, including the elimination of the bovine offal specified.

3. - 4. Tallow is essentially used in the manufacture of soap. Of the other bovine extracts employed in cosmetic products, some, such as gelatin, are extracted from various tissues (bone, skin) and are used in different types of products (shampoos, soaps, hair products). Others are extracted from specific organs such as the placenta or the thymus and are used in a very small number of cosmetic products.

Concerning the use of bovine extracts in cosmetic products, it is important to point out that:

* bovine extracts are not incorporated in cosmetic products in their raw state but undergo various chemical treatments;

* in most cases, the ingredients of animal origin represent only a very small proportion of the composition of the finished cosmetic product.

5. The Commission has no knowledge of any research into the risk of infection through the application of cosmetics to damaged skin.

6. British manufacturers must comply with the relevant Community and national legislation. As already pointed out, the provisions of Decision 96/362/EC apply also to the production of the products mentioned in the Decision for use in the United Kingdom.

7. Pursuant to the sixth amending Directive mentioned earlier (Directive 93/35/EEC), the ingredients incorporated in cosmetic products must be listed on the label. As regards the extracts of bovine origin mentioned in the recently-published inventory of ingredients employed in cosmetic products ((Commission Decision 96/335/EC of 8.5.1996 - OJ L 132, 1.6.1996. )), the organ from which they have been extracted will be specified when this is a very specific organ such as the spleen or the placenta.