The role of EFSA
Between 2005 and 2009, EFSA carried out a comprehensive assessment of substances authorized for use as a source of vitamins and minerals in food supplements in the EU. The assessment included both assessing the safety of a nutrient source at the intake levels suggested by the applicant and the bioavailability of the nutrient from the source, i.e. effectiveness with which the mineral or vitamin is released into the body.
Companies wishing to market a nutrient source not on the authorized list must submit an application to the European Commission. Below Directive 2002/46/ECEFSA then prepares a scientific opinion Opinions include risk assessments on general scientific issues, assessments of an application for authorization of a product, substance or claim, or an evaluation of a risk assessment. to support the assessment of the application by the European Commission. Based on the work of EFSA, the European Commission reviews and updates the list of vitamins or mineral substances that can be used in food supplements.
If a substance intended for use in food supplements does not have a history of safe use in the EU before 1997, EFSA is asked to provide a scientific opinion on its safety in accordance with the Regulation (EC) No. 2015/2283 on new foods.
In addition, EFSA has carried out a comprehensive assessment of the possible adverse health effects of certain micronutrients whose intakes exceed dietary requirements and, where possible, established tolerable upper intake levels (ULs) for different groups. of population. ULs represent the highest level of chronic daily intake of a nutrient that is not likely to pose a risk of adverse effects on human health. The ULs defined by EFSA and the former Scientific Committee on Food (SCF) are used as a reference in EFSA assessments of the safety of nutrient sources added to food supplements. Throughout this work, EFSA supports the European Commission in establishing maximum limits for vitamins and minerals in food supplements and fortified foods.
For all substances added to food, including food supplements, which are expected to have an effect on the nutritional status or health of consumers, EFSA carries out an assessment in accordance with the Regulation (EC) No. 1924/2006 on nutritional and health claims.
In the circumstances described in art. 8 of Regulation 1925/2006, i.e. “…when a substance other than vitamins or minerals…is added to food…under conditions which would result in the ingestion of quantities of that substance well in excess of those reasonably expected…under normal conditions …and/or would otherwise represent a potential risk to consumers…”, the European Commission may request EFSA to assess the information available to support a decision on the safety of the substance. Based on the EFSA assessment, the European Commission may decide to include the specific substance in a list of substances whose use in food in the EU is prohibited, restricted or under surveillance (see annex III of Regulation (EC) No. 1925/2006).
