Food supplements | EFSA

Between 2005 and 2009, EFSA carried out a comprehensive assessment of substances that are permitted to be used as sources of vitamins and minerals in food supplements in the EU. The assessment included both the evaluation of 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. the effectiveness with which the mineral or vitamin is released into the body.

Companies wishing to market a nutrient source not included in the permitted list have to submit an application to the European Commission. Under Directive 2002/46/EC, EFSA then prepares a scientific opinion to support the European Commissions evaluation of the request. Based on EFSAs work, the European Commission reviews and updates the list of vitamin or mineral substances that may be used in food supplements.

If a substance intended to be used in food supplements does not have a history of safe use in the EU before 1997, EFSA is requested to provide a scientific opinion on its safety according to Regulation (EC) No 2015/2283 on novel foods.

Moreover, EFSA has performed a comprehensive evaluation of the possible adverse health effects of individual micronutrients at intakes exceeding the dietary requirements and, where possible, established tolerable upper intake levels (ULs) for different population groups. ULs represent the highest level of chronic daily intake of a nutrient that is not likely to pose a risk of adverse health effects to humans. The ULs defined by EFSA and by the former Scientific Committee on Food (SCF) are used as a reference in EFSAs evaluations of the safety of nutrient sources added to food supplements. Throughout this work EFSA provides support to the European Commission in establishing maximum limits for vitamins and minerals in food supplements and fortified foods.

For all substances added to foods, including food supplements, that are claimed to have an effect on the nutritional or health status of consumers, EFSA carries out an assessment in line with Regulation (EC) No 1924/2006 on nutrition and health claims.

Under the circumstances described in Art. 8 of Regulation 1925/2006, i.e. where a substance other than vitamins or minerals is added to foods under conditions that would result in the ingestion of amounts of this substance greatly exceeding those reasonably expected under normal conditions and/or would otherwise represent a potential risk to consumers, EFSA may be requested by the European Commission to assess the available information to support a decision on the safety of the substance. Based on EFSAs assessment the European Commission may decide to include the specific substance in a list of substances whose use in foods in the EU is prohibited, restricted or under scrutiny (see Annex III of Regulation (EC) No 1925/2006).

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Food supplements | EFSA