EU heads of food safety agencies identify 117 supplement substances as potential health risks, prioritize 12 for restriction

The Heads of Food Safety Agencies (HoA) Working Group on Food Supplements, comprising 26 European countries and chaired by Germany (BVL) and the Netherlands (NVWA), published its first report on 6 June 2024 in Brussels. The working group collected information on 117 substances used in food supplements, drawing from the DACH-list, member state suggestions, and 1,500 RASFF alerts reviewed between 2017 and mid-2022. Of these, 65 were assessed as likely novel foods (not permitted without authorization), 6 were already regulated or under assessment, and 34 had insufficient data. The remaining 12 substances were prioritized for Article 8 restriction under Regulation (EC) No 1925/2006. In September 2024, Germany and the Netherlands formally submitted these 12 substances to the European Commission to initiate the procedure. The 12 priority substances include ashwagandha (Withania somnifera), curcumin in Curcuma preparations, melatonin, piperine, Hypericum perforatum (St. John's wort), coumarin, p-synephrine, Lepidium meyenii (maca), Ocimum tenuiflorum (holy basil), Melaleuca, Actaea racemosa (black cohosh), and L-tryptophan. Several exhibited possible carcinogenic, mutagenic, or reprotoxic properties. The BfR separately recommended that ashwagandha root be placed in Annex III Part C (substances under Community scrutiny). The report is not a ban but initiates a regulatory process that could lead to prohibition, restriction, or continued scrutiny. EFSA assessment timelines were not specified.

The HoA recommends achieving legal status in EU food law for agreed substances via the Article 8 procedure in Regulation (EC) No 1925/2006 and their addition to Annex III of the Regulation.