WRITTEN QUESTION No. 477/99 by Susan WADDINGTON Regulatory framework for natural cosmeceutical products
Date: 1999-03-05
Institutions: European Parliament, WADDINGTON
Subjects: commercial law, cosmetic product, drugs classification, market approval, pharmaceutical legislation, pharmaceutical product, statistical nomenclature, trade licence

C 370/44

Official Journal of the European Communities

EN

21.12.1999

In fact, apart from pigmeat and wholly milled rice, the products to be supplied to the Russian Federation
are already held in the Community’s intervention stores and must therefore have met those minimum
quality requirements when bought into intervention.

The operators involved are responsible only for transporting those products from intervention warehouses
to ports or designated border points, and not for supplying the products. The Commission laid down the
quality criteria for pigmeat and wholly milled rice in the regulations opening the invitations to tender.

The surveillance companies designated by the Commission are responsible, among other things, for
checking that the products from Community intervention stocks still meet the minimum quality required
for intervention products and, on arrival in Russia, have not undergone any significant deterioration in
quality during transport.

The minimum quality required for intervention is accepted for all commercial exports. The quality required
by the Russian operators was far in excess of the quality that the Community could guarantee to supply.

(1)

Parliamentary debates (March 1999).

(1999/C 370/056)

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.