09.01.07
According to the European Botanical Forum (EBF), Brussels, Belgium, the European Food Safety Authority’s (EFSA) most recent guidance document makes no reference 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 long-standing use and experience.