Addition of vitamins and minerals
There is a wide range of nutrients and other ingredients that might be used in food manufacturing, including (but not limited to) vitamins, minerals including trace elements, amino acids, essential fatty acids, fibre, various plants and herbal extracts.
Regulation 1925/2006 harmonises the provisions laid down in Member States which relate to the addition of vitamins and minerals and of certain other substances to foods. The aim is to ensure the effective functioning of the internal market whilst providing a high level of consumer protection.
Annex I of the Regulation is a list of vitamins and minerals which may be added to foods. Annex II is a list of the sources of vitamins and minerals which may be added to foods. Annex I and Annex II have been amended by Commission Regulation (EC) 1170/2009, Commission Regulation (EU) No 1161/2011 and Commission Regulation (EU) No 119/2014 to include additional substances. Annex III is a list of substances whose use in foods is prohibited, restricted or under Community scrutiny.
At the end of a transitional period, only vitamins and/or minerals listed in Annex I, in the forms listed in Annex II, may be added to foods.
Regulation 1925/2006 has been aligned with the new Regulatory Committee procedure with Scrutiny by
Regulation (EC) 108/2008
Inclusion of nutrients 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 Authority (EFSA).
Member States may provide derogations for vitamins and minerals and their forms not included in the Directive 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.
Petitioners should contact the competent authorities in the individual Member States if they wish to obtain such derogations.
Information on the relevant contact points within the meaning of Article 17(1) of Regulation (EC) 1925/2006 has been provided by some Member States. Updated 29-05-2013
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.
Conditions for the addition of vitamins and minerals to foods
The Regulation provides for the setting of maximum amounts of vitamins and minerals in these products via the procedure of the Standing Committee on the Food Chain and Animal Health.
Minimum amounts are linked to the notion of significant amount, where this is defined according to the Annex to Directive 90/496/EEC.
Directorate General Health and Consumer Protection 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.
The consultation closed on 30 September 2006.
Responses to the Discussion Paper on the setting of maximum and minimum amounts for vitamins and minerals in foodstuffs.
Guidance document for competent authorities, tolerances for the control of compliance of nutrient values declared on a label with EU legislation
- 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
Addition of certain other substances
Article 8 of the Regulation gives the possibility to put under scrutiny and, if necessary, to restrict the use of substances added to foods or used in the manufacture of foods under conditions that would result in the ingestion of amounts greatly exceeding those reasonably expected to be ingested under normal conditions of consumption of a balanced and varied diet and/or would otherwise represent a potential risk to consumers.
Commission Implementing Regulation (EU) No 307/2012 of 11 April 2012 establishing implementing rules for the application of Article 8 of Regulation (EC) No 1925/2006 of the European Parliament and of the Council on the addition of vitamins and minerals and of certain other substances to foods establishes the implementing rules for application of Article 8 of Regulation (EC) No 1925/2006.
The Commission has received a request from a Member State to initiate the procedure under Article 8 of the Regulation for Ephedra species (Ephedra spp.) and for yohimbe (Pausinystalia yohimbe). The following available information has been submitted to the European Food Safety Authority (EFSA) for a safety assessment:
Article 16 of the Regulation provides for the submission by the Commission to the European Parliament and the Council of a report that evaluates the effects of implementation of the Regulation. Commission Implementing Regulation (EU) No 489/2012 establishes implementing rules for the application of Article 16 of Regulation (EC) No 1925/2006.
The Commission establishes and maintains a Community Register on the addition of vitamins and minerals and of certain other substances to foods.Updated 03-04-2014