91999E2576

WRITTEN QUESTION P-2576/99

by Michael Cashman (PSE) to the Commission

(16 December 1999)

Subject: Dietary and natural health products

Could the Commission please indicate whether there is any intention to harmonise legislation with regard to dietary supplements and natural health products?

Could the Commission also outline the differing positions of the Member States regarding the classification of health products as medicines?

Answer given by Mr Liikanen on behalf of the Commission

(12 January 2000)

The Commission had intended to put forward a proposal for a Parliament and Council directive on food supplements containing vitamins and minerals early in the year 2000.

The term natural health product is not defined in Community legislation and the Commission has no intention to propose specific measures regarding these products. Existing Community pharmaceutical legislation makes no distinction between natural or non-natural products. According to Article 1 of 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), any substance or combination of substances presented for treating or preventing disease in human beings or animals shall be regarded as a medicinal product. Likewise, any substance or combination of substances which may be administered to human beings or animals with a view to making a medicinal diagnosis or to restoring, correcting or modifying physiological functions in human beings or animals, has to be considered a medicinal product. The decision whether a natural health product falls under the above definition of medicinal product and therefore needs to be authorised as medicinal product must be taken by the national authorities on a case by case approach, taking into account both the ingredients and the presentation of a concrete health product.

It is up to the regulatory authorities in Member States to apply the above principles of Community pharmaceutical legislation and to take concrete decisions on authorisations and restrictions (e.g. medical prescription) for specific products. The Commission is not considering a proposal to change that approach.

In the context of this question, the attention of the Honourable Member is also drawn to the answer already delivered by the Commission to Written Question P-2317/99 by Mr Fitzsimons(2) on regulatory control on herbal medicinal products in the Community.

(1) OJ 22, 9.2.1965.

(2) See page 97.