Food supplements are concentrated sources of nutrients or other substances with a nutritional or physiological effect, whose purpose is to supplement the normal diet. Food supplements are marketed 'in dose' form, for example as pills, tablets, capsules or liquids in measured doses etc. Supplements may be used to correct nutritional deficiencies or maintain an adequate intake of certain nutrients. However, in some cases excessive intake of vitamins and minerals may be harmful or cause unwanted side effects; therefore, maximum levels are necessary to ensure their safe use in food supplements.
EU regulatory framework
The European Commission has established harmonised rules to help ensure that food supplements are safe and properly labelled. In the EU, food supplements are regulated as foods and the legislation focuses on vitamins and minerals used as ingredients of food supplements.
The main EU legislation is Directive 2002/46/EC related to food supplements containing vitamins and minerals.
The Directive sets out labelling requirements and requires that EU-wide maximum and minimum levels are set for each vitamin and mineral added to supplements. As excessive intake of vitamins and minerals may result in adverse effects, the Directive provides for the setting of maximum amounts of vitamins and minerals added to food supplements. This task has been delegated to the Commission and is currently ongoing.
In addition, its Annex II contains a list of permitted vitamin or mineral substances that may be added for specific nutritional purposes in food supplements. Annex II has been amended by Regulation 1170/2009 of 30 November 2009.
Vitamin and mineral substances may be considered for inclusion in the lists following the evaluation of an appropriate scientific dossier concerning the safety and bioavailability of the individual substance by EFSA. Companies wishing to market a substance not included in the permitted list need to submit an application to the European Commission.
A guidance by the Scientific Committee on Food in 2001 gives information on the data that should be provided in the dossier supporting the application for a new substance.
- Guidance on submission for safety evaluation of sources of nutrients or of other ingredients proposed for use in the manufacture of food.
EFSA’s role and activities
EFSA was asked by the European Commission to evaluate the safety and bioavailability of nutrient sources proposed for addition to the list of permitted substances in Annex II of the food supplements Directive. In July 2009, EFSA completed the first comprehensive assessment of substances used as sources of vitamins and minerals in food supplements, which are currently sold in the EU.
Based on EFSA’s work, the European Commission reviewed the list of permitted vitamin or mineral substances that may be added in food supplements.
Between 2005 and 2009 EFSA examined a total of 533 applications. Of these, 186 applications were withdrawn during the evaluation process, and EFSA received insufficient scientific evidence to be able to assess around half of the remaining applications. Possible safety concerns were identified in relation to 39 applications.
The evaluations were carried out by the Panel on food additives and nutrient sources added to food (ANS). The Panel’s evaluations involved judging the safety of a nutrient substance at the intake levels suggested by the applicant based on best scientific knowledge available. The Panel also assessed the bioavailability of the nutrient from the source, which is the effectiveness with which the mineral or vitamin is released from the source into the tissues of the body. Previously the former Panel on food additives, flavourings, processing aids and materials in contact with food (former AFC) was responsible for this work.
Moreover, EFSA’s NDA Panel has preformed 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 the NDA Panel and by the former Scientific Committee on Food (SCF) are used as a reference by the ANS Panel in its evaluations of the safety of nutrient substances added to food supplements. Throughout this work EFSA will provide support to the European Commission in establishing maximum limits for vitamins and minerals in food supplements and fortified foods.
DG Health and Consumers: Food Supplements
DG Health and Consumers: Addition of vitamins and minerals
DG Health and Consumers: Tolerable upper intake levels for vitamins and minerals