The situation in Europe

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In Europe, dietary supplements account for 15—20 per cent of the herbal market. Although regulations vary from country to country, in Europe, herbal products are generally considered as medicines. Therefore, full registration with a full dossier on quality, safety and efficacy has to be submitted for pre-market approval. Bibliographic documentation can be based on clinical trials, and the monographs of the European Pharmacopoeia (EP), World Health Organization (WHO), German Commission E and the European Scientific Cooperative on Phytotherapy (ESCOP). There is a simplified way of registering a herbal product as medicine with proof of efficacy based on long-term traditional use in countries like Germany, Austria, Belgium and France. In such a case, the medicine has to carry a disclaimer on the label stating that it is 'traditionally used' (Lawson and Bauer, 1998; Stott, 1998; Grunwald, 1999; Steinhoff, 2001).

In short, the EU has, at present, no legislation like in the USA to regulate dietary supplements (Grunwald, 1999).

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