Consider traditional knowledge for botanical health claims, EBF asks EFSA

Botanicals - plant and herb-derived ingredients - are presently used in a broad range of dietary supplements and foodstuffs, including herbal teas. Many have a long history of use, and as such there is considerable consumer awareness about their purported benefits. Although the new health and nutrition claims regulation entered into force in January and becomes applicable on July 1, the details of evaluation procedures are still being hammered out. According to EBF, it is not clear at the moment how much weight will be given to traditional evidence - nor are any criteria laid out for how scientific substantiation should be demonstrated in claims submissions. For botanicals, this is an issue since a substantial part of supporting evidence relates to practice and practical experience that has accumulated over the years. Moreover, submissions on botanical supplements must include information on intended use as well as effect. Since the intended use of most of such products relates to growth, development and bodily functions, they must be approved under the regulation's article 13 positive list - yet such intended use does not tend to be based on new scientific evidence. If traditional evidence were to be disregarded, there is a chance that botanicals and botanical-containing products could be left out in the cold by the new regulations, presenting a barrier to the market since botanical companies may not have the budget required to deliver another layer of proof of the traditional knowledge through clinical trails. "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,"​ said EBF secretary Patrick Coppens. "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."​ EBF has said that it will take this up the matter in discussions with EFSA, the European Commission and member states "to build a solid foundation for botanical health products that benefit the consumer".​ EBF chairman Manfred Ruthsatz is positive that there is a place for traditional knowledge in evaluations. He points out that claims substantiation should take into account "all the available scientific data and weight 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 that has accumulated over the years,"​ he said. EBF has already done considerable work towards carving out a place for botanicals in EU regulation. Last year it proposed a model for assessing the safety of botanicals for use in food supplements, including a 'negative list' of botanics that should not be used due to safety concerns that it hopes will be used in the implementation of European food regulations. The model, published in the Annals of Metabolism and Nutrition​ at the end of 2006, was devised in order to give a scientific basis for the use of botanicals in food supplements and to give industry, researchers and legislators guidance on the need for safety evaluation and claims substantiation. In March EFSA published its first guidance to companies wishing to make health claims submissions, but this was preliminary guidance relating only to articles 14 and 19, on applications for risk reduction, children's health and development, and newly-developed scientific evidence or proprietary data (articles 14 and 18). While Owen Warnock, partner and food law expert at international law firm Eversheds, said this preliminary guidance is revealing as it gives in insight into health claims the authority expects to cause the most disruption and uncertainty, a comprehensive document expected by the summer and EFSA is advising companies to hold off from submitting any claims until this document is available.