16 April 2007 - Traditional knowledge should be equally considered to scientific evidence when evaluating the health effects of botanicals in food supplements, the European Botanical Forum has said.
In a statement on the application of the EU’s Nutrition and Health Claims Regulation (NHCR), the European Botanical Forum (EBF) insisted botanical knowledge accumulated over the years through practice and experience should be accepted as a valid body of evidence when their nutrition and health claims come under scrutiny by European Food Safety Authority (EFSA) for marketing approval.
The regulation – which aims to harmonise the use of nutrition and health claims at European level by pre-marketing approval for all nutrition and health claims – applies to botanicals and foodstuffs containing botanicals, such as enriched foodstuffs, herbal teas and food supplements. But according to the EBF it does not specify how much weight traditional evidence will hold in claims evaluations, and does not include criteria or clarification on how the scientific substantiation should be demonstrated when claims are submitted for approval.
“According to the regulation, claims should be based on generally accepted scientific evidence. But there is no indication what this exactly means, how much evidence and what type of evidence will be needed for a claim to be acceptable,” said Manfred Ruthsatz, chairman of the European Botanical Forum. “It states that the substantiation should take into account all of the available scientific data and weigh up the evidence. That, therefore, is implicit acceptance that other aspects can also be considered, and in the field of botanicals, a substantial part of supporting evidence relates to practice and practical experience which has accumulated over the years.”
Under the NHCR nutrition and health claims made on botanical food supplements must include not only the information about the effect of the product but also its intended use. As the intended use of most botanicals is not based on newly developed scientific evidence and relates to growth, development and bodily functions, the products must seek scientific approval to be allowed on the regulation’s Article 13 positive list to be marketed.
Patrick Coppens, secretary of the European Botanical Forum, said: “Especially in the field of traditional herbal medicinal products, the value of observational evidence and experience is given substantial weight when assessing efficacy of medicinal effects under medicinal law – in such way that it is accepted that proof of traditional use may eliminate the need for clinical efficacy trials. It would be quite disproportionate if requirements for proving efficacy of a health effect would need to be more demanding than for a medicinal therapeutic effect.”
The European Botanical Forum will take this up in constructive discussions with EFSA, European Commission and Members States to build a solid foundation for botanical health products that benefit the consumer.