Answer given by Ms Kyriakides on behalf of the European Commission
14.10.2020
Article 8 of Regulation (EC) No 1925/2006[1] aims to address a situation where a substance represents a potential risk to consumers. The procedure for the listing of a substance as prohibited or restricted for use is only launched if a preliminary assessment of the actual conditions of use and of consumption of the substance shows a potential risk to consumers. It is the view of the Commission that this article has been implemented in line with its original intention.
The European Food Safety Authority’s (EFSA) role is to provide independent scientific advice on food-related risks. The Commission takes into account the result of the risk assessment when deciding on risk management measures. Following the publication of a scientific opinion, the Commission may ask for further clarification on the scientific rationale of the opinion, including the methodology used by the Panel, or request EFSA to carry out an additional assessment. The Commission can also hold discussions with interested parties, with the participation of EFSA, to clarify the scientific rationale of the opinion, including the methodology used.
The Commission’s evaluation[2] of Regulation (EC) No 1924/2006[3] has addressed the specificity of botanicals used in food supplements compared to their use in medicines. The evaluation concludes that it could be appropriate to explore the notion of ‘traditional use’ in the efficacy assessment of health claims of botanicals used in foods. It also concludes that there are merits to further study the potential harmonisation of the field of botanicals, including the safety aspect. Based on this evaluation, the Commission may decide on follow up actions.
- [1] Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods, OJ L 404, 30.12.2006, p. 26.
- [2] https://ec.europa.eu/food/safety/labelling_nutrition/claims/refit_en
- [3] Regulation (EC) No 1924/2006 on nutrition and health claims made on foods (OJ L 404, 30.12.2006, p.9).