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 TRANSBOUNDARY MOVEMENT OF GENETICALLY MODIFIED ORGANISMS AMENDING THE PROPOSAL OF THE COMMISSION pursuant to Article 250 (2) of the EC Treaty

1. BACKGROUND

The Commission forwarded the above proposal for a regulation based on Article 175(1) to the Parliament and to the Council on 18 February 2002.

The Committee of the Regions delivered its opinion on 16 May 2002

The European Economic and Social Committee delivered its opinion on 17 July 2002.

The European Parliament adopted an opinion at first reading on 24 September 2002.

The Commission accepted some of the Parliament's amendments. It submitted an amended proposal to the Council on 16 October 2002 including these amendments.

The Council adopted its common position unanimously on 4 March 2003.

On 4 June 2003, the European Parliament adopted eight amendments to the Council's common position at second reading.

This opinion presents the Commission's position on the European Parliament's amendments pursuant to Article 251(2)(c) of the EC Treaty.

2. PURPOSE OF THE COMMISSION PROPOSAL

The objective of this Proposal is to implement the relevant provisions of the Cartagena Protocol on Biosafety by establishing a common system of notification and information for exports to third countries of genetically modified organisms (GMOs). This system will contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of GMOs that may have adverse effects on the conservation and the sustainable use of biological diversity, taking also into account risks to human health and specifically focussing on transboundary movements.

3. COMMISSION OPINION ON THE PARLIAMENT'S AMENDMENTS

3.1. Summary of the Commission's position

The Commission can accept the European Parliament's eight amendments in full. It considers that the compromise package that these amendments constitutes will enable the Community to implement in due time its obligations pursuant to the ratification of the Cartagena Protocol on Biosafety.

3.2. Parliament amendments at second reading

3.2.1. Amendments accepted

3.2.1.1. Amendment 19 (Respect of the national regulatory framework of the Party of Import)

Amendment 19 does recognise the need to respect the Party or non-Party of Import's regulatory biosafety framework consistent with the Protocol. This is in line with the position taken on numerous occasions by the Commission in international fora, which is to respect the right of counties to a free informed choice with regards to GMOs. So the Commission can accept amendment 19.

3.2.1.2. Amendments 21 and 22 (Obligation to wait for prior written consent before proceeding with the export of a GMO)

Amendments 21 and 22 impose an obligation to wait for prior written consent before proceeding with the export of a GMO. The Commission believes that this goes beyond the Biosafety Protocol. This is actually the only amendment from the package on which the Commission has some reluctance. However, as part of the overall compromise, the Commission can agree on both amendments.

3.2.1.3. Amendments 24 to 26 (Improved public access to information regarding transboundary movements of GMOs)

Amendments 24 to 26 improve public access to information regarding transboundary movements of GMOs, which is in line with the general framework on public access to environmental information and with Directive 2001/18/EC on the deliberate release of GMOs into the environment. So the Commission can accept amendments 24 to 26

3.2.1.4. Amendment 20 (Exemption for pharmaceuticals)

Amendment 20 aims at clarifying the scope of exemptions for pharmaceuticals for humans that are addressed by international agreements or organisations, limiting it to those agreements or organisation to which the EU and its Member States are parties. The compromise amendment can be accepted.

3.2.1.5. Amendment 23 (Articulation of paragraphs one and three of Art. 5 of the Common Position)

Amendment 23 aims at clarifying the articulation of the different paragraphs of Article 5 of the Common Position. The Commission expressed reservation on both paragraphs one and three of Art. 5 for political and technical reasons. However, on a perspective of drafting quality, the EP amendment improves the legal clarity of the text and can be accepted.

4. CONCLUSION

Pursuant to Article 250(2) of the EC Treaty, the Commission is amending its proposal as indicated above.