EHPM : now and tomorrow In February 2021 Antonino Santoro was elected chairman of EHPM and succeeds Michel Horn in this role. The new president of the EHPM agreed to present the roadmap for the coming years.* Actif’s Mag: What are the main challenges to be applied for carrying out such studies. This leads to shift- that awaits you? ing the burden of proof of ingredient’s safety completely from Antonino Santoro: There are several issues that EHPM will the Authority to companies. In addition, due to the lack of ade- have to face, indicated in the Manifesto «Food Supplements quate methodologies applied to the evaluation of the safety of for healthier citizens & a stronger economy in the EU» (Editor’sbotanicals, EFSA’s scientific assessment tends to result in a neg- note : this document was adopted in February 2020 dur- ative evaluation for the ingredients under consideration. ing a round table organised by EHPM held in Brussels at the This is in fact a problem not only when it comes to safety, but European Parliament, attended by MEPs, representatives of also in relation to the evaluation of the efficacy of these sub- EFSA, the European Commission and industrial experts), in- stances. In fact, botanicals are complex natural substances that cluding the situation of EC Regulation 1924/2006 for botani- differ from isolated compounds and would therefore need a cals (Claims Regulation), the real and more uniform specific approach for their evaluation. implementation of the mutual recognition prin- EHPM is working in collaboration with academ- ciple in the EU, in compliance with Regulation ics from multiple EU Member States to devel- 2019/515, the use of the term probiotic and op appropriate guidelines for botanical safety in particular the application of Article 8 of assessment and will share these guidelines Regulation 1925/2006 and the assessment with the European Commission and EFSA. of product safety of botanicals for which EHPM calls for a proportionate approach Actif’s Mag: What roads could be by the Commission. followed to reach these goals? Products containing botanicals account for Antonino Santoro: EHPM is trying to raise more than 60% of the food supplement mar- the awareness of consumers and Institutions ket in Europe and botanicals fall into the catego- at EU level on the value of the food supplements ry of ingredients that are not yet harmonised in the as a support for maintaining and enhancing health. EU from a legislative point of view. As a result of the lack Therefore, healthy lifestyles and health products that can re- of a harmonised framework, Article 8 of Regulation 1925/2006 duce the risk factors of certain diseases and improve health and has become the legislative instrument used by the Commission quality of life play an important role in modern society; food sup- to assess the safety of these ingredients often after a request toplements can play a strategic support role. In order to maintain do so by a Member State. This procedure can lead to the ban- ishing of an ingredient, already safely used for decades, from the market. Unfortunately, the sector is experiencing an increasing use of this procedure, under pressure from some Member States, « Products containing botanicals sometimes guided by the intention to reclassify products, rath- account for more than 60% of the food er than by concrete safety problems. supplement market in Europe» In addition, the lack of implementing rules requires econom- Antonino Santoro ic operators, mainly SMEs, to provide data on carcinogenicity EHPM’s Chairman or genotoxicity studies on substances in an unrealistic period of time without giving specific indications on the methodology stekraM — séhcraM- 23 -