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 genetically modified food and feed AMENDING THE PROPOSAL OF THE COMMISSION pursuant to Article 250 (2) of the EC Treaty

2001/0173 (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 genetically modified food and feed

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 9 amendments proposed by the Parliament.

2. Background

- Adoption of the proposal by the Commission on 25 July 2001 and transmission to the Parliament and the Council on 30 July 2001, (COM(2001) 425 final - 2001/0173(COD))

- Opinion of the Committee of the Regions adopted on 16 May 2002

- Opinion of the Economic and Social Committee adopted on 30 May 2002

- Opinion of the European Parliament at first reading adopted on 3 July 2002

- Transmission of Commission amended proposal to Council and Parliament on 9 October 2002, (COM(2002) 559 final - 2001/0173 (COD))

- Adoption of Common Position on 17 March 2003

- Opinion of the European Parliament at second reading adopted on 2 July 2003

3. Purpose of the proposal

The objectives of the proposal, which results from the White Paper on Food Safety, are:

- to provide the basis for ensuring a high level of protection of human life and health, animal health, environment and consumers' interest in relation to genetically modified food and feed, whilst ensuring the effective functioning of the internal market;

- to lay down centralised Community procedures for the assessment (central role of the European Food Safety Authority), authorisation (comitology procedure) and supervision of genetically modified food and feed;

- to lay down comprehensive requirements for the labelling of genetically modified food and feed, with the aim of providing the consumers and users with a real choice. The proposal covers genetically modified organisms for food and feed use as well as food and feed containing, consisting of, or produced from genetically modified organisms. The proposal extends the current labelling provisions to all genetically modified food and feed irrespective of the detectability of DNA and protein. The applicability of this requirement will be ensured through the provisions laid down in the draft Regulation concerning the traceability and labelling of genetically modified organisms and traceability of food and feed products produced from genetically modified organisms. In order to ensure the feasibility and practicability of the proposed Regulation, provisions regarding derogation for adventitious or technically unavoidable presence of genetically modified organisms in food/feed are laid down in the authorisation and in the labelling sections of the proposal. In order to ensure consistency, it is proposed that Directive 2001/18/EC be amended accordingly.

4. Opinion of the Commission on the amendments by the European Parliament

The Parliament adopted 9 amendments (1, 7, 8, 9, 44, 45, 46, 47 and 48) as a compromise package tabled to facilitate the final adoption of the proposal.

Amendments 1 and 9 (deleting Recital 10 and modifying Article 2.13) delete the language specifying that genetically modified organisms for release under part B of Directive 2001/18/EC and genetically modified organisms and genetically modified micro-organisms for contained use activities are excluded from the definition of "placing on the market".

Amendment 8 (modifying Article 2) introduces a definition for traceability by reference to the definition established in the Commission proposal for Regulation concerning the traceability and labelling of genetically modified organisms and traceability of food and feed products produced from genetically modified organisms. This amendment makes little difference, as there are no enacting clauses as regards traceability in Regulation on genetically modified food and feed.

Amendments 7, 46 and 47 delete the definition of risk in Article 2, point 1 and replace the term "unacceptable risk" by the term "adverse effects" in Articles 4 and 16 of the draft Regulation.

Amendments 44 and 45 (introducing a new Article 43a and a new Recital 28a) on co-existence allow Member States to take appropriate measures to avoid the unintended presence of genetically modified organisms in other products and invite the Commission to develop guidelines in order to provide Member States with a framework for putting this into practice.

Amendment 48 (modifying Article 32) provides that the contributions from applicants for authorisation of genetically modified food and feed shall not exceed the costs incurred in carrying out the validation of detection methods.

The Commission can accept all these amendments.

5. Conclusion

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