Botanicals that rely on evidence of traditional use for health claims substantiation face an uncertain future after EFSA’s draft dossier guidelines failed to acknowledge the criteria.
According to the European Botanical Forum (EBF) the European Food Safety Authority (EFSA) guidance document makes no reference whatsoever to ‘traditional use’ or ‘history of use’ for botanicals in food and food supplements, despite the fact that the European Union’s (EU) 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.
The EFSA guidelines, which apply to Article 14 of the EU’s recently adopted Nutrition and Health Claims Regulation, state that data from intervention studies and observational studies in humans and animals must be used as evidence to make a health claim, but appears not to have addressed on the use of evidence based on long-standing use and experience.
“It is disproportionate and incongruous that a product for a therapeutic purpose can be based on traditional use with no evidence of efficacy required, and yet a health claim on a food that is based on traditional use has no opportunity in the EFSA document to be used as supporting evidence,” said Manfred Ruthsatz, Chair of the EBF. “Botanical ingredients are a growing market in terms of both food and food supplements, and traditional use should be taken into account so as not to endanger the use of botanicals in foods, herbal teas and food supplements. This way the market can continue to provide all European consumers with safe and well-established products to enhance their health in a natural way.”
The EBF was created in 2005 by the European Federation of Health Product Manufacturers (EHPM) and the European Responsible Nutrition Alliance (ERNA) as a forum to stimulate discussions amongst all interested stakeholders on the use of botanicals under food law. To date it has developed a model for future regulations on botanicals, which was presented to the Council of Europe in February, and is working in the fields of safety evaluation and claims substantiation for botanical food supplements. It has also compiled a ‘negative’ list of EU-wide botanicals using plant lists from various Member States, which should not be used in food supplements because of safety considerations.
Dr Ruthsatz said: “If you look at the regulatory changes across the world botanicals now top the list, with between 80 to 90 countries making changes. In reality this is not just an EU issue, it is a global concern.”
The European Botanical Forum aims to consolidate the efforts undertaken by national associations and individual companies to work to protect national systems currently in place, contribute to the creation of appropriate national systems where not currently in place, and build a pan-European system for the trade of herbs under food law.
For more information contact Patrick Coppens, European Botanical Forum, 50 Rue de l’Association, 1000 Brussels, tel: (+32) (0)2 209 11 50.