ensured by the EU’s general rules on food safety, existing national rules and, where applicable, the Commission’s use of Article 8 of Regulation 1925/2006 assessing the safety of substances added to food that may pose a potential risk to consumers. It is not consistent to have harmonised standards for health claims in the EU, while the use of botanicals in food is governed by national rules. The absence of a harmonised regulation in the EU on the use of plants in food has a predominantly negative impact on food business operators, in par- ticular on product innovation and often on the possibility of marketing the same product simultaneously in several Member States. Although the classification of «food» towards «drug» remains a preroga- tive of the Member States, harmonisation in the EU of the use of botani- cals in food through a positive or negative list would improve the safety situation and facilitate the functioning of the EU market; The current situation with a list of claims at EU level, even though their assessment has been suspended, has nevertheless helped to improve consumer protection compared to the situation prior to the adoption of the Claim Regulation. Actif’s Mag: What is EHPM proposing ? Antonino Santoro: The EHPM proposal for a graded approach to health claims. The Commission, in the conclusions of the REFIT evaluation, recognizes the possibility of assessing also the «traditional use» for the substantiation of health claims. EHPM has always asked EFSA and the Commission to consider the tradition of use when assessing claims for botanicals. And recently, through the botanicals working group, EHPM has analysed a new «graded model» (1)of claims substantiation that could be a solution for the evaluation of more than 2000 claims pending and for a better regulation for the sector. The model proposed by EHPM goes beyond the recognition of the only tradition of use and would allow to have for consumers truthful and well-substantiated claims formulated in relation to the available evi- dence and for companies to have the opportunity to invest in long-term projects, make innovation and make available to consumers new pro- ducts with well-documented claims. EHPM proposes a substantiation of claims according to three levels of available evidence and documenta- tion: claims «scientifically documented» based on conclusive clinical trials conducted according to criteria recognised by EFSA; «well-substantiated» claims that reflect more recent developments than a claim that boasts a tradition of use and availability of supporting documentation; and claims «traditional use», in analogy to health indications recognized as plausible for traditional herbal medicines products (THMP). The different types of studies and evidence necessary to validate the three types of claims en- sure the reliability of the claims made. Each level of evidence would be associated with a claim for the consumer, formulated with terminology in accordance with the degree of substantiation. Finally, preparations clai- ming claims must be adequately characterised in terms of quality and safety. This approach has a number of advantages: it resolves the legal anomaly with regard to the treatment of THMP, while benefiting from the legal so- lidity of the THMP approach. It provides an incentive for small and me- dium-sized enterprises (SMEs) that are predominant in the food sector; encourages all companies to engage in research and development, provi- ding a practical solution from which they can benefit. And finally, it provi- des consumers with controlled information on foods, and in particular on food supplements, which they buy and consume. In conclusion, a harmo- nisation of the regulation on botanicals in the community could initially #76 - 57 -GAM s’fitcA