[pic] | COMMISSION OF THE EUROPEAN COMMUNITIES |

Brussels, 12.7.2006

COM(2006) 369 final

2003/0262 (COD)

OPINION OF THE COMMISSION pursuant to Article 251 (2), third subparagraph, point (c) of the EC Treaty, on the European Parliament's amendments to the Council's common position regarding the proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the addition of vitamins and minerals and of certain other substances to foods

AMENDING THE PROPOSAL OF THE COMMISSIONpursuant to Article 250 (2) of the EC Treaty

2003/0262 (COD)

OPINION OF THE COMMISSION pursuant to Article 251 (2), third subparagraph, point (c) of the EC Treaty, on the European Parliament's amendments to the Council's common position regarding the proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the addition of vitamins and minerals and of certain other substances to foods

1. Introduction

Article 251(2), third subparagraph, point (c) of the EC Treaty provides that the Commission is to deliver an opinion on the amendments proposed by the European Parliament at second reading. The Commission sets out its opinion below on the amendments proposed by Parliament.

2. Background

Date of transmission of the proposal to the EP and the Council (document COM(2003) 671 final 2003/0262 (COD)): | 10 November 2003. |

Date of the opinion of the European Economic and Social Committee: | 31 March 2004. |

Date of the opinion of the European Parliament, first reading: | 26 May 2005. |

Date of adoption of the common position Date of European Parliament opinion, second reading | 8 December 2005 qualified majority. 16 May 2006 |

3. PURPOSE OF THE PROPOSAL

The proposed Regulation covers the addition of vitamins and minerals and of certain other substances to foods. Different national rules applicable today have led to obstacles to intracommunity trade that the application of the principle of mutual recognition did not succeed in overcoming. It is therefore necessary to adopt Community rules regarding these practices. The White Paper on Food Safety adopted by the Commission on 14 January 2000 announced the adoption by the Commission of this measure (action No 61).

The main objectives of the proposal are:

- to improve the free movement of goods within the internal market

- to contribute to a high level of protection of human health

- to increase legal security for operators and through proportionate measures, promote innovation

- to ensure fair competition in the area of foods.

The proposed Regulation :

- provides for the situations that should be taken into account when considering the voluntary addition of vitamins and minerals to foods.

- lists in Annex I the vitamins and minerals that may be added and in Annex II the vitamin preparations and mineral salts that may be used

- provides for certain restrictions regarding the foods to which vitamins and minerals may be added

- sets the criteria for the establishment of maximum levels of vitamins and minerals in foods through the procedure of the Standing Committee on the Food Chain and Animal Health

- provides for the setting of minimum levels of vitamins and minerals through the procedure of the Standing Committee on the Food Chain and Animal Health

- provides for appropriate specific rules on labelling, presentation and advertising of products to which vitamins and minerals have been added in addition or by derogation to other such horizontal rules applicable to all foods

- enables Member States to require the notification of the marketing of these products in order to facilitate their monitoring

- provides the basis for scrutinising and, where necessary, regulating the addition of certain substances, other than vitamins and minerals, to foods.

4. OPINION OF THE COMMISSION ON THE AMENDMENTS BY THE EUROPEAN PARLIAMENT

4.1. Amendments accepted by the Commission

The Commission can accept all 8 amendments adopted by the European Parliament in full. They are the result of a compromise agreement reached between the European Parliament, Council and Commission during the second reading.

The main modifications introduced by these amendments are the following:

- introduce a definition of other substances in line with the one present in the draft Regulation on nutritional and health claims (COM(2003) 424 final – 2003/0165 (COD)) (amendment 14)

- provide that substances put under scrutiny in accordance with the procedure described in Article 8 and then generally allowed are listed in the Community register (amendment 11)

- underline that vitamins and minerals added to foods have to be bio-available to the human body (amendment 5)

- provide that, prior to making modification to the Annexes, the Commission has to carry out consultations with interested parties (amendment 15)

- foresee that the Commission may submit a proposal for the maximum amounts of vitamins and minerals added to foods by two years from the date of entry into force of the Regulation (amendment 17)

- provide that foods placed on the market or labelled prior to the date of application of the Regulation and which do not comply with it, may be marketed until thirty-fifth months following the date of entry into force of the Regulation (amendment 18)

- give into a recital an example of restrictions regarding the food to which vitamins and minerals can be added and specify that such restrictions should concern particular vitamins and minerals (amendments 1 and 16)

The amendments are in line with the Commission’s objectives for the proposal and maintain the balance of interests achieved in the common position.

5. Conclusion

Pursuant to Article 250(2) of the EC Treaty, the Commission amends its proposal as set out above.