(a) foods for particular nutritional uses and, in the absence of specific provisions, compositional requirements of such products rendered necessary by the particular nutritional requirements of the persons for whom they are intended; (b) novel foods and novel food ingredients; (c) genetically modified food; (d) food additives and flavourings; (e) authorised oenological practices and processes.
Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods
Modified by
- Regulation (EC) No 108/2008 of the European Parliament and of the Councilof 15 January 2008amending Regulation (EC) No 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods, 32008R0108, February 13, 2008
- Commission Regulation (EC) No 1170/2009of 30 November 2009amending Directive 2002/46/EC of the European Parliament and of Council and Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards the lists of vitamin and minerals and their forms that can be added to foods, including food supplements(Text with EEA relevance), 32009R1170, December 1, 2009
- Commission Regulation (EU) No 1161/2011of 14 November 2011amending Directive 2002/46/EC of the European Parliament and of the Council, Regulation (EC) No 1925/2006 of the European Parliament and of the Council and Commission Regulation (EC) No 953/2009 as regards the lists of mineral substances that can be added to foods(Text with EEA relevance), 32011R1161, November 15, 2011
- Regulation (EU) No 1169/2011 of the European Parliament and of the Councilof 25 October 2011on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004(Text with EEA relevance), 32011R1169, November 22, 2011
- Commission Regulation (EU) No 119/2014of 7 February 2014amending Directive 2002/46/EC of the European Parliament and of the Council and Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards chromium enriched yeast used for the manufacture of food supplements and chromium(III) lactate tri-hydrate added to foods(Text with EEA relevance), 32014R0119, February 8, 2014
- Commission Regulation (EU) 2015/403of 11 March 2015amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards Ephedra species and Yohimbe (Pausinystalia yohimbe (K. Schum) Pierre ex Beille)(Text with EEA relevance), 32015R0403, March 12, 2015
- Commission Regulation (EU) 2017/1203of 5 July 2017amending Directive 2002/46/EC of the European Parliament and of the Council and Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards organic silicon (monomethylsilanetriol) and calcium phosphoryl oligosaccharides (POs-Ca®) added to foods and used in the manufacture of food supplements(Text with EEA relevance), 32017R1203, July 6, 2017
- Commission Regulation (EU) 2019/649of 24 April 2019amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards trans fat, other than trans fat naturally occurring in fat of animal origin(Text with EEA relevance), 32019R0649, April 25, 2019
- Commission Regulation (EU) 2019/650of 24 April 2019amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards Yohimbe (Pausinystalia yohimbe (K. Schum) Pierre ex Beille)(Text with EEA relevance), 32019R0650, April 25, 2019
- Commission Regulation (EU) 2021/468of 18 March 2021amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards botanical species containing hydroxyanthracene derivatives(Text with EEA relevance), 32021R0468, March 19, 2021
- Commission Regulation (EU) 2022/860of 1 June 2022amending Annex III to Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards monacolins from red yeast rice(Text with EEA relevance), 32022R0860, June 2, 2022
(1) "Authority" means the European Food Safety Authority established by Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety ;OJ L 31, 1.2.2002, p. 1 . Regulation as last amended by Commission Regulation (EC) No 575/2006 (OJ L 100, 8.4.2006, p. 3 ).(2) "other substance" means a substance other than a vitamin or a mineral that has a nutritional or physiological effect.
(a) a deficiency of one or more vitamins and/or minerals in the population or specific population groups that can be demonstrated by clinical or sub-clinical evidence of deficiency or indicated by estimated low levels of intake of nutrients; or (b) the potential to improve the nutritional status of the population or specific population groups and/or correct possible deficiencies in dietary intakes of vitamins or minerals due to changes in dietary habits; or (c) evolving generally acceptable scientific knowledge on the role of vitamins and minerals in nutrition and consequent effects on health.
(a) unprocessed foodstuffs, including, but not limited to, fruit, vegetables, meat, poultry and fish; (b) beverages containing more than 1,2 % by volume of alcohol, except and by way of derogation from Article 3(2), to products: (i) referred to in Article 44(6) and (13) of Council Regulation (EC) No 1493/1999 of 17 May 1999 on the common organisation of the market in wine ; andOJ L 179, 14.7.1999, p. 1 . Regulation as last amended by Regulation (EC) No 2165/2005 (OJ L 345, 28.12.2005, p. 1 ).(ii) which were marketed prior to the adoption of this Regulation; and (iii) which have been notified to the Commission by a Member State in accordance with Article 11,
and provided that no nutrition or health claim is made.
(a) upper safe levels of vitamins and minerals established by scientific risk assessment based on generally acceptable scientific data, taking into account, as appropriate, the varying degrees of sensitivity of different groups of consumers; and (b) intakes of vitamins and minerals from other dietary sources.
(a) the contribution of individual products to the overall diet of the population in general or of sub-groups of the population; (b) the nutrient profile of the product established as provided for by Regulation (EC) No 1924/2006.
(a) if a harmful effect on health has been identified, the substance and/or the ingredient containing the substance shall: (i) be placed in Annex III, Part A, and its addition to foods or its use in the manufacture of foods shall be prohibited; or (ii) be placed in Annex III, Part B, and its addition to foods or its use in the manufacture of foods shall only be allowed under the conditions specified therein;
(b) if the possibility of harmful effects on health is identified but scientific uncertainty persists, the substance shall be placed in Annex III, Part C.
(a) the vitamins and minerals which may be added to foods as listed in Annex I; (b) the vitamin formulations and mineral substances which may be added to foods as listed in Annex II; (c) the maximum and minimum amounts of vitamins and minerals which may be added to foods and any associated conditions set in accordance with Article 6; (d) the information regarding national provisions on the mandatory addition of vitamins and minerals referred to in Article 11; (e) any restrictions on the addition of vitamins and minerals as set out in Article 4; (f) the substances for which dossiers have been submitted as provided for in Article 17(1)(b); (g) information about the substances referred to in Annex III and the reasons for their inclusion therein; (h) information about the substances listed in Annex III, Part C, whose use is generally allowed as referred to in Article 8(5).
(a) on the mandatory addition of vitamins and minerals to specified foods or categories of foods; or (b) on the prohibition or restriction on the use of certain other substances in the manufacture of specified foods,
(a) the substance in question is used for addition to foods marketed in the Community on 19 January 2007 ; and(b) the Authority has not given an unfavourable opinion in respect of the use of that substance, or its use in that form, in the manufacture of food, on the basis of a dossier supporting use of the substance in question to be submitted to the Commission by the Member State not later than 19 January 2010 .
Restricted substance | Conditions of use | Additional requirements |
---|---|---|
Monacolins from red yeast rice | Individual portion of the product for daily consumption shall provide less than 3 mg of monacolins from red yeast rice. | |
Food business operators supplying other food business operators with food not intended for the final consumer or not intended for supply to retail, shall ensure that supplied food business operators are provided with information on the amount of trans fat, other than trans fat naturally occurring in fat of animal origin, where that amount exceeds 2 grams per 100 grams of fat. |