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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

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

CHAPTER I SUBJECT MATTER, SCOPE AND DEFINITIONS

Article 1 Subject matter and scope

1.

This Regulation harmonises the provisions laid down by law, regulation or administrative action in Member States which relate to the addition of vitamins and minerals and of certain other substances to foods, with the purpose of ensuring the effective functioning of the internal market, whilst providing a high level of consumer protection.

2.

The provisions of this Regulation regarding vitamins and minerals shall not apply to food supplements covered by Directive 2002/46/EC.

3.

This Regulation shall apply without prejudice to specific provisions laid down in Community legislation concerning:

  1. 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;

  2. novel foods and novel food ingredients;

  3. genetically modified food;

  4. food additives and flavourings;

  5. authorised oenological practices and processes.

Article 2 Definitions

For the purposes of this Regulation:

  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(1);

  2. ‘other substance’ means a substance other than a vitamin or a mineral that has a nutritional or physiological effect.

CHAPTER II ADDITION OF VITAMINS AND MINERALS

Article 3 Requirements for the addition of vitamins and minerals

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:

  1. 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

  2. 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

  3. evolving generally acceptable scientific knowledge on the role of vitamins and minerals in nutrition and consequent effects on health.

3.

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.

Article 4 Restrictions on the addition of vitamins and minerals

Article 5 Purity criteria

Article 6 Conditions for the addition of vitamins and minerals

Article 7 Labelling, presentation and advertising

CHAPTER III ADDITION OF CERTAIN OTHER SUBSTANCES

Article 8 Substances prohibited, restricted or under Community scrutiny

CHAPTER IV GENERAL AND FINAL PROVISIONS

Article 9 Community Register

Article 10 Free movement of goods

Article 11 National provisions

Article 12 Notification procedure

Article 13 Safeguard measures

Article 14 Committee procedure

Article 15 Monitoring

Article 16 Evaluation

Article 17 Transitional measures

Article 18 Entry into force

ANNEX IVITAMINS AND MINERALS WHICH MAY BE ADDED TO FOODS

ANNEX II

ANNEX IIISUBSTANCES WHOSE USE IN FOODS IS PROHIBITED, RESTRICTED OR UNDER COMMUNITY SCRUTINY