FOREIGN AGRICULTURAL SERVICE
European Parliament and Council Directive 2002/46/EC lays down labeling and specific rules for vitamins and minerals used as ingredients in food supplements sold in pre-packaged form. Only vitamins and minerals included in the positive list (Annex II) may be added for specific nutritional purposes in food supplements. Products containing vitamins and minerals not listed in Annex II are prohibited on the EU market. The Directive does not apply to medicinal products.
Vitamins and minerals may be added to the positive list following the European Food Safety Authority ‘s (EFSA) evaluation of scientific information. The European Commission has published a guidance document “Administrative guidance on submissions for safety evaluation of substances added for specific nutritional purposes for the manufacture of foods” that provides information on the procedure that should be followed for submitting requests.
Until December 31, 2009, member states may apply derogations for vitamins and minerals not included in the positive list providing EFSA has not given an unfavorable opinion and the substance in question was used in food supplements marketed in the EU prior to July 12, 2002. Petitioners should contact the competent authorities in the individual member states if they wish to obtain such derogations.
On December 30, 2006, the EU published
which establishes an EU-wide regulatory framework
for the addition of vitamins and minerals and of certain other substances
such as herbal extracts to foods. It lists the vitamins and minerals
that may be added to foods and sets criteria for setting minimum and
maximum levels. The use of vitamins and minerals not included in the
annexes to the new regulation will not be allowed. Vitamins and minerals
may be considered for inclusion in the annexes based on a safety
evaluation by EFSA. Foods not complying with the new rules may be
marketed until December 31, 2009, if they were put on the market or
labeled before July 1, 2007.
Commission Regulation 1170/2009 amending Directive 2002/46/EC (food
supplements) and Regulation 1925/2006 (fortified foods) sets out the
list of vitamins and minerals and their forms which can be added to
foods and food supplements.
Maximum levels for vitamins and minerals have not been set by Directive 2002/46/EC on food supplements but have to be established by the European Commission as an implementing measure. Similar provisions are contained in Regulation 1925/2006 on fortified foods Within two years of this regulation's entry into force, the Commission must submit a proposal on minimum and maximum levels of vitamins and minerals to enrich foods. Proposed levels will have to be adopted by the member states through the Standing Committee procedure (comitology). In June 2006, the Commission published a discussion paper on the setting of such levels as part of a consultation process. A review of the responses to the discussion paper were presented at the November 24 European Conference organized by the European Responsible Nutrition Alliance and the European Federation of Associations of Health Product Manufacturers.
Report from the Commission to the Council and the European Parliament on
the use of substances other than vitamins and minerals in food
supplements (December 2008)