E.U. Natural Products Regulatory Update
July 30, 2007
BRUSSELS—As the European Union tackles various dietary supplement and food issues, European trade associations continue to analyze proposed and final regulations, providing stakeholders a summary and review. Among the latest happenings: The European Federation of Health Product Manufacturers (EHPM) and the European Responsible Nutrition Alliance (ERNA) have spent the last year working together with other industry associations to create a credible list of scientifically substantiated dossiers for substances other than vitamins and minerals, for amino acids, proteins and botanicals, all of which are subject to Article 13 in the E.U. Nutrition and Health Claims Regulation. Claims under Article 13 must be substantiated on the basis of generally accepted scientific evidence, and well understood by the average consumer.
The European Botanical Forum (EBF)—a creation of ERNA (www.Erna.org) and EHPM (www.Ehpm.org)—blasted the European Food Safety Authority (EFSA) draft health claim document for ignoring “traditional use” or ”history of use” for botanicals in food and food supplements, despite the fact that the EU’s Traditional Herbal Medicinal Products Directive allows certain traditional medicines to be registered based on traditional use, safety and quality with no requirement for proof of efficacy for claims.
EU Food Law Unit administrator Fabio d’Atri reported in May on a proposal being drafted to set up special conditions in the Novel Foods Regulation for new ingredients with a proven safe history of food use outside the European Union. Welcoming this news, the European Advisory Services (EAS) noted some factors in the current Novel Food Regulation could create hurdles for the marketing of bio-diverse products and have a negative impact on EU trade and innovation.
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