Food Supplements

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.

Fortified Foods

On December 30, 2006, the EU published Regulation 1925/2006, 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.

The regulation allows Member States to provide derogations - until January 2014 - for vitamins and minerals not included in the positive list on condition that the substance was used in the EU before January 19, 2007, a dossier supporting the use of the substance is submitted to the Commission by January 19, 2010, and EFSA has not given an unfavorable opinion on the use of the substance.

Some Member States require the addition of vitamins and minerals to certain food products, e.g. in the U.K. the fortification of flour is mandatory.  Regulation 1925/2006 will not affect such provisions in national legislation.  By July 19, 2007, Member States must inform the European Commission of existing national provisions, which will be included in a Community Register.

The Community Register, published on DG Sanco's website, will include:

- the list of permitted vitamins and minerals (Annex I)
- the list of permitted vitamin and mineral formulations (Annex II)
- maximum and minimum levels
- information on national provisions
- restrictions (unprocessed foodstuffs and alcoholic beverages)
- the list of substances for which a dossier has been submitted
- information on prohibited and restricted substances
 

Maximum Levels

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.

Reports

French Market for Food Supplements (GAIN report FR7039)

Maximum Levels for Vitamins and Minerals (GAIN report E36147)
European Parliament passes new EU rules on fortified foods  (GAIN report E36087)
Adding vitamins and minerals to foods - EU proposal (GAIN report E23225)