Food supplements are concentrated sources of nutrients or other substances with a nutritional or physiological effect whose purpose is to supplement the normal diet. They are marketed 'in dose' form i.e. as pills, tablets, capsules, liquids in measured doses etc.
The Directive 2002/46/EC of the European Parliament and Council of 10 June 2002 on the approximation of the laws of Member States relating to food supplements establishes harmonised rules for the labelling of food supplements and introduces specific rules on vitamins and minerals in food supplements. The aim is to harmonise the legislation and to ensure that these products are safe and appropriately labelled so that consumers can make informed choices.
Annex II of Directive 2002/46/EC is a list of permitted vitamin or mineral preparations that may be added for specific nutritional purposes in food supplements. It has been amended by Commission Directive 2006/37/EC, Commission Regulation (EC) 1170/2009, Commission Regulation (EU) No 1161/2011 and Commission Regulation (EU) No 119/2014 to include additional substances. The trade of products containing vitamins and minerals not listed in Annex II has been prohibited from the 1st of August 2005.
Directive 2002/46/EC has been aligned with the Regulatory Procedure with Scrutiny by Regulation (EC) 1137/2008.
Inclusion of substances in the Annexes
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 the European Food Safety Agency (EFSA). For more information, view EFSA’s activities on food supplements.
Guidance for submission
The document Administrative guidance on submissions for safety evaluation of substances added for specific nutritional purposes in the manufacture of foods provides detailed information on the procedure that should be followed for the submission of requests for substances to be considered for inclusion in the permitted list. Updated 03/04/2012
- A simplified summary table gives an overview of the different tolerance values included in the guidance document. In case of doubt the guidance document text should be consulted as the official reference
There is a wide range of vitamin preparations and minerals substances used in the manufacture of food supplements that are currently marketed in Member States and which have not undergone a scientific safety evaluation. In order to allow the necessary time for this safety evaluation, Member States may provide derogations until 31 December 2009, for vitamins and minerals and their forms not included in the Directive, in view of the future addition to the Annexes of the Directive, as long as the following conditions are fulfilled:
(a) the substance in question was used in food supplements marketed in the Community prior to 12 July 2002
(b) the European Food Safety Authority has not given an unfavourable opinion in respect of the use of the substance, or its use in that form, in the manufacture of food supplements, on the basis of a dossier supporting use of the substance that has to be submitted to the Commission by the Member State by 12 July 2005.
Petitioners should contact the competent authorities in the individual Member States if they wish to obtain such derogations.
Levels of vitamins and minerals in food supplements
Directive 2002/46/EC on food supplements provides for the setting of maximum and minimum amounts of vitamins and minerals in these products via the Standing Committee procedure.
Directorate General Health and Consumer Protection has issued a Discussion Paper on the setting of maximum and minimum amounts for vitamins and minerals in foodstuffs, which identified the main issues to be considered in this exercise.
In the frame of the exercise on the establishment of maximum and minimum amounts of vitamins and minerals in foodstuffs and in particular in food supplements, several letters have been addressed to Commissioner Kyprianou.
Directorate General Health and Consumer Protection has prepared a collective answer.
Report to the Council and the European Parliament on the use of substances other than vitamins and minerals in food supplements
Directorate General Health and Consumers has commissioned a study on the use of substances with nutritional or physiological effects other than vitamins and minerals in food supplements.
Taking into account this study and other available information, the Commission, in accordance with the requirement set out in Article 4(8) of Directive 2002/46/EC on food supplements, has prepared a report to the Council and the European Parliament on the use of substances other than vitamins and minerals in food supplements.
The report is accompanied by two Commission staff working documents.