Botanicals: the three-tiered billiard table Beyond the recognition of the tradition of use of plants, the EHPM proposes a justification of claims according to three levels of evidence and documentation available. This approach has many advantages: support for R&D and innovation in companies, clear claims for consumers. Actif’s Mag: In a long term, are you confident on the future legal status of botanical extracts claims ? Were are we in Europe on this topic? Antonino Santoro: The botanicals topic is very complex and requires a longer and more articulate response. The Claim Regulation was adopted in 2006 to ensure truthful in- formation for consumers and to facilitate the free movement in the EU of foods, including food supplements, which claim nutritional and health claims. The Regulation stipulates that claims of foods, including botanicals, should only be autho- rised after a thorough scientific assessment by the European Food Safety Authority (EFSA). In 2009, no health claim relating to botanicals, received a favourable assessment by EFSA due to the lack of studies deemed suitable according to the Regulation and in 2010 the evaluation procedure was suspended by the Commission, The EHPM proposal pending a solution to the problem. In 2012 the Commission for a graded published a list of 2078 health claims which could still be approach to used on the EU market, pending a final decision and un- der the responsibility of operators ; however, the use of such health claims. The claims was and still is subject to the principles and general Commission, in the conditions of the Rules of Procedure and the related natio- conclusions of the nal provisions. In 2015, the Commission announced its in- REFIT evaluation, tention to apply the Regulatory Fitness and Performance recognizes the Assessment (REFIT) to the Claim Regulation. REFIT aims possibility of to ensure that EU legislation is effective and efficient for ci- tizens and businesses and that the costs of its implementa- assessing also tion are sustainable. The assessment took into account the the «traditional health claims of botanicals, as well as the more general re- use» for the gulatory framework for the use of botanicals in food as it is substantiation of closely linked to claims. health claims. The REFIT evaluation published in May 2020 concluded to several points that I will detailed. Antonino Santoro In the current situation, consumers continue to be exposed EHPM to claims that are not always substantiated and may have been led to believe that such claims had been scientifically documented, which is not always true. The Claim Regulation is consistent with the EU’s general re- gulatory framework; however, for botanicals there is incons- istency in the recognition of «traditional» data for indica- tions made for food and herbal medicines. The safety of food containing botanicals is adequately stneidergnI — stneidérgnI- 47 -