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1.Only vitamins and/or minerals listed in Annex I, in the forms listed in Annex II, may be added to foods, subject to the rules laid down in this Regulation.
2.Vitamins and minerals in a form that is bio-available to the human body may be added to foods, whether or not they are usually contained therein, in order to take into account, in particular:
(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.
[F13. Modifications to the lists referred to in paragraph 1 of this Article shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(3), taking account of the opinion of the Authority.
On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 14(4) in order to remove a vitamin or a mineral from the lists referred to in paragraph 1 of this Article.
Prior to making these modifications, the Commission shall carry out consultations with interested parties, in particular food business operators and consumer groups.]
Textual Amendments
Vitamins and minerals may not be added to:
unprocessed foodstuffs, including, but not limited to, fruit, vegetables, meat, poultry and fish;
beverages containing more than 1,2 % by volume of alcohol, except and by way of derogation from Article 3(2), to products:
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(1); and
which were marketed prior to the adoption of this Regulation; and
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.
[F1Measures determining the additional foods or categories of foods to which particular vitamins and minerals may not be added and designed to amend non-essential elements of this Regulation may be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(3) in the light of scientific evidence and taking into account their nutritional value.]
Textual Amendments
[F11. Measures determining the purity criteria for vitamin formulations and mineral substances listed in Annex II and designed to amend non-essential elements of this Regulation by supplementing it shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(3), except where they apply pursuant to paragraph 2 of this Article.]
2.Purity criteria for vitamin formulations and mineral substances listed in Annex II, specified by Community legislation for their use in the manufacture of foodstuffs for purposes other than those covered by this Regulation, shall apply.
3.For those vitamin formulations and mineral substances listed in Annex II for which purity criteria are not specified by Community legislation, and until such specifications are adopted, generally acceptable purity criteria recommended by international bodies shall be applicable and national rules setting stricter purity criteria may be maintained.
Textual Amendments
[F11. When a vitamin or a mineral is added to foods, the total amount of the vitamin or mineral present, for whatever purpose, in the food as sold shall not exceed maximum amounts. Measures setting that amount and designed to amend non-essential elements of this Regulation by supplementing it shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(3). The Commission may, to this end, submit a draft of measures for the maximum amounts by 19 January 2009 . For concentrated and dehydrated products, the maximum amounts set shall be those present in the foods when prepared for consumption according to the manufacturer's instructions.]
[F12. Any conditions restricting or prohibiting the addition of a specific vitamin or mineral to a food or a category of foods and designed to amend non-essential elements of this Regulation, inter alia , by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(3).]
3.The maximum amounts referred to in paragraph 1 and the conditions referred to in paragraph 2 shall be set taking into account:
(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.
4.When the maximum amounts referred to in paragraph 1 and the conditions referred to in paragraph 2 are set, due account shall also be taken of reference intakes of vitamins and minerals for the population.
5.When the maximum amounts referred to in paragraph 1 and the conditions referred to in paragraph 2 are set for vitamins and minerals whose reference intakes for the population are close to the upper safe levels, the following shall also be taken into account, as necessary:
(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.
[F16. The addition of a vitamin or a mineral to a food shall result in the presence of that vitamin or mineral in the food in at least a significant amount where this is defined according to the Annex to Directive 90/496/EEC. Measures determining the minimum amounts, including any lower amounts, by derogation from the significant amounts mentioned above, for specific foods or categories of foods and designed to amend non-essential elements of this Regulation by supplementing it shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(3) of this Regulation.]
Textual Amendments
[F11. The labelling, presentation and advertising of foods to which vitamins and minerals have been added shall not include any mention stating or implying that a balanced and varied diet cannot provide appropriate quantities of nutrients. Where appropriate, a derogation concerning a specific nutrient and designed to amend non-essential elements of this Regulation by supplementing it may be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(3).]
2.The labelling, presentation and advertising of foods to which vitamins and minerals have been added shall not mislead or deceive the consumer as to the nutritional merit of a food that may result from the addition of these nutrients.
[F23. Nutrition labelling of products to which vitamins and minerals have been added and which are covered by this Regulation shall be compulsory. The information to be provided shall consist of that specified in Article 30(1) of Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers (2) and of the total amounts present of the vitamins and minerals when added to the food.]
4.The labelling of products to which vitamins and minerals have been added may bear a statement indicating such addition under the conditions laid down in Regulation (EC) No 1924/2006.
5.This Article shall apply without prejudice to other provisions of food law applicable to specified categories of foods.
6.Rules for implementing this Article may be specified in accordance with the procedure referred to in Article 14(2).
Textual Amendments
F1 Substituted by Regulation (EC) No 108/2008 of the European Parliament and of the Council of 15 January 2008 amending Regulation (EC) No 1925/2006 on the addition of vitamins and minerals and of certain other substances to foods.
F2 Substituted by Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on 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).
OJ 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).
Textual Amendments
F2 Substituted by Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on 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).