EC Parliament to restrict market for herbal medicines

Members of European Parliament support new system for registration of herbal remedies

On 21 November, MEPs voted in favour of creating a new registration and labelling system for traditional herbal medicinal products. The move, welcomed by OTC manufacturers, is seen as a threat to the health foods market.

MEPs have adopted a resolution, drafted by Giuseppe Nistico, with the aim of setting basic quality and safety standards for herbal medicinal products in the EU.

The backgound to the resolution follows an EC proposal in January 2002 for a new directive to establish a harmonised legislative framework covering traditional herbal medicinal products.

The Commission’s principal objectives with the proposal were:

• to guarantee a high level of health protection for European patients;
• to promote the Single Market for herbal medicines: laying down harmonised rules and procedures will facilitate the cross-border trade in herbal medicines;
•  to create a clear and favourable environment for the mainly small and medium-sized companies working in this sector.

The new rules supported by Parliament focus on the following main issues:

• A new registration system has been proposed for traditional herbal medicines. These registered products will be subject to standards on the quantity and quality of their ingredients. The substances will have to prove their safety through "traditional use" which means that they must have been on the market for 30 years, of which, 15 years must have been in Europe.
• A new labelling regime is proposed to clearly state what the products are intended for and what conditions they can treat or cure.
• A new Committee on Herbal Medicinal Products is to take over the tasks of the Committee for Human Medicinal Products with regard to the evaluation of the herbal medicinal products.
• A statement which accompanies the product information is to describe in an appropriate way the product’s nature and main priorities. It is also important that the consumer be informed about the possible occurrence of adverse reactions or possible interactions with food and/or other drugs administered
• The Committee on Herbal Medicinal Products is to establish a classification of herbal medicinal products, taking into account their composition and their pharmacological and toxicological effects.

Greeted by Dr Hubertus Cranz, Director of the Association of the European Self-Medication Industry (AESGP) as a "missing piece of legislation, which will clarify the legal basis for traditional herbal medicinal products in the European Union." the AESGP representing European manufacturers of non-prescription medicines, welcomed the outcome of the vote in Parliament.

Dr. Rob Verkerk, speaking on behalf of an organisation that represents herbal medicine practitioners, the Alliance for Natural Health, expressed disappointment saying he feared "some herbal medicines with a proven safety record would disappear off the shelves of health food stores".

The proposal will be discussed by the Council at its next meeting.

Background document:

EC: Proposal for a Directive of the European Parliament and of the Council amending the Directive 2001/83/EC as regards traditional herbal medicinal products (27 January 2002)

Keywords : Nutraceuticals Traditional herbal medicines EC Directive Harmonised legislation Registration and labelling Committee on Herbal Medicinal Products