91999E0477

WRITTEN QUESTION E-0477/99

by Susan Waddington (PSE) to the Commission

(5 March 1999)

Subject: Regulatory framework for natural cosmeceutical products

Manufacturers of cosmeceutical products - i.e. products which are neither a medical nor purely cosmetic product - are facing difficulties in gaining licences for their products as no regulatory structure exists at European level. Is the Commission aware of this problem, and what action would it consider taking to introduce a regulatory framework to enable such products to be sold across the single market?

Answer given by Mr Bangemann on behalf of the Commission

(19 April 1999)

The concept of "cosmeceutical" products is not recognised in Community law; the Commission considers that this type of product should be classified within the framework of existing regulations, whether as a medicinal product, under Council Directive 65/65/EEC of 26 January 1965, on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products(1), or as a cosmetic product under Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products(2).

A product is classified as a medicinal product on the basis of its actual function (possessing therapeutic or curative properties) or on the basis of its presentation (the consumer believes that the product in question is a medicinal product, or the manufacturer presents it as such). In this case, authorisation must be obtained prior to placing on the market. On the other hand, curative or therapeutic properties must not be ascribed to a cosmetic product the function of which is exclusively or mainly to clean the various external parts of the human body, the teeth and mucous membranes of the oral cavity, to perfume them, to change their appearance, to protect them or to keep them in good condition, or to correct body odour. No authorisation prior to placing on the market is required for cosmetic products.

(1) OJ L 22, 9.2.1965.

(2) OJ L 262, 27.9.1976.