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Throughout this work EFSA provides support to the European Commission in establishing maximum limits for vitamins and minerals in food supplements and fortified foods.įor 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. The ULs defined by EFSA and by the former Scientific Committee on Food (SCF) are used as a reference in EFSA’s evaluations of the safety of nutrient sources added to food supplements. 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. 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. 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.
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Based on EFSA’s work, the European Commission reviews and updates the list of vitamin or mineral substances that may be used in food supplements. Under Directive 2002/46/EC, EFSA then prepares a scientific opinion to support the European Commission’s evaluation of the request. the effectiveness with which the mineral or vitamin is released into the body.Ĭompanies wishing to market a nutrient source not included in the permitted list have to submit an application to the European Commission. 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. 8 of Regulation (EC) No 1925/2006.Ģ010 The EFSA NDA Panel publishes an opinion laying down the general principles for establishing Dietary Reference Values ( DRV) and started the review of DRVs for macro and micronutrients established by the Scientific Committee on Food in 1993.Ģ006 EFSA and the Scientific Committee on Food (SCF) compile all opinions identifying possible adverse health effects of individual micronutrients at intakes in excess of dietary requirements and, where possible, establish tolerable upper intake levels (UL) for different population groups.īetween 20, 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. Schum) Pierre ex Beille), Hydroxyanthracene derivatives, Cathechins from green tea, Monacolins from red yeast rice and alpha-lipoic acid (thioctic acid) and the risk of insulin autoimmune syndrome (Hirata’s disease).Ģ018 The mandate of the EFSA NDA Panel is broadened to include the assessment of nutrient sources and requests for safety assessment under Art. For ingredients other than vitamins and minerals, the European Commission has established harmonised rules to protect consumers against potential health risks and maintains a list of substances which are known or suspected to have adverse effects on health and the use of which is therefore controlled.Ģ012-2021 EFSA carries out the safety assessments of six substances used as ingredients in food supplements, for which safety concerns were raised either by the EC or Member States, namely: Ephedra species, Yohimbe (Pausinystalia yohimbe (K. Harmonised legislation regulates the vitamins and minerals, and the substances used as their sources, which can be used in the manufacturing of food supplements. In the EU, food supplements are regulated as foods. Therefore their use is not intended to treat or prevent diseases in humans or to modify physiological functions. They are not medicinal products and as such cannot exert a pharmacological, immunological or metabolic action. A wide range of nutrients and other ingredients might be present in food supplements, including, but not limited to, vitamins, minerals, amino acids, essential fatty acids, fibre and various plants and herbal extracts.įood supplements are intended to correct nutritional deficiencies, maintain an adequate intake of certain nutrients, or to support specific physiological functions. pills, tablets, capsules, liquids in measured doses). mineral and vitamins) or other substances with a nutritional or physiological effect that are marketed in “dose” form (e.g. Food supplements are concentrated sources of nutrients (i.e.