The Addition of Vitamins and Minerals to Foods
Regulation 1925/2006/EC on the addition of vitamins and minerals and of certain other substances to foods came into force in July 2007. The legislation seeks to harmonise food fortification across Member States and sets out specific rules for the addition of vitamins, minerals and certain other foodstuffs to food. It aims to ensure the effective functioning of the internal market whilst providing a high level of consumer protection.
Annex I of Regulation 1925/2006/EC lists the vitamins and minerals which may be added to foods. These may only be added in the formats listed in Annex II. However, Member States may provide derogations for vitamins and minerals and their forms not included in the legislation until 19 January 2014, as long as the following conditions are fulfilled:
(a) the substance in question was used for addition to foods marketed in the Community prior to 19 January 2007;
(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 on the basis of a dossier supporting use of the substance that has to be submitted to the Commission by the Member State by 19 January 2010.
In view of this the FSAI would like to advise the food industry that dossiers supporting the use of a vitamin or mineral substance in food can be submitted to the FSAI for derogation (provided the above conditions and the general principles of the legislation are fulfilled). These dossiers will be forwarded to the European Food Safety Authority for evaluation. The FSAI will accept dossiers until 1 January 2010.
Guidance on Dossier Submissions
The European Commission has published administrative guidance on submissions for safety evaluation of substances added for specific nutritional purposes in the manufacture of foods, which 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.
Access guidance document on dossier submissions
Last reviewed: 26/3/2009