Regulation 2003/1946 - Transboundary movements of genetically modified organisms - Main contents

official title

 

Legal instrument	Regulation
Number legal act	Regulation 2003/1946
Original proposal	COM(2002)85
CELEX number i	32003R1946

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Regulation (EC) No 1946/2003 of the European Parliament and of the Council of 15 July 2003 on transboundary movements of genetically modified organisms (Text with EEA relevance)

Official Journal L 287 , 05/11/2003 P. 0001 - 0010

Regulation (EC) No 1946/2003 of the European Parliament and of the Council

of 15 July 2003

on transboundary movements of genetically modified organisms

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 175(1) thereof,

Having regard to the proposal from the Commission(1),

Having regard to the opinion of the European Economic and Social Committee(2),

Having regard to the opinion of the Committee of the Regions(3),

Acting in accordance with the procedure laid down in Article 251 of the Treaty(4),

Whereas:

• (1) 

  The Cartagena Protocol on Biosafety to the Convention on Biological Diversity (hereinafter referred to as the Protocol), was signed by the Community and its Member States in 2000 and Council Decision 2002/628/EC(5) to conclude the Protocol, on behalf of the Community, was taken on 25 June 2002.

• (2) 

  Article 1 of the Protocol specifies that, in accordance with the precautionary approach contained in Principle 15 of the Rio Declaration on Environment and Development, the objective of the Protocol is to contribute to ensuring an adequate level of protection in the field of safe transfer, handling and use of genetically modified organisms (GMOs) resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health and specifically focusing on transboundary movements.

• (3) 

  The Protocol requires each Party to take necessary and appropriate legal, administrative and other measures to implement its obligations under the Protocol. Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms(6) invited the Commission to bring forward a legislative proposal for implementing the procedures laid down in the Protocol and, in accordance with the Protocol, requiring Community exporters to ensure that all requirements of the Advance Informed Agreement Procedure, as set out in Articles 7 to 10, 12 and 14 of the Protocol, are fulfilled.

• (4) 

  It is important to organise the supervision and control of transboundary movements of GMOs in order to contribute to ensuring the conservation and sustainable use of biological diversity, taking also into account risks to human health, and so as to enable citizens to make a free and informed choice in regard to GMOs.

• (5) 

  Since Community legislation does not contain specific requirements for exports of GMOs to third countries, and in order to ensure compliance with the obligations in the Protocol regarding transboundary movements of GMOs, a common legal framework should be established for such exports.

• (6) 

  It is necessary to recognise the need to respect the Party or non-Party of import's regulatory biosafety framework, in a manner consistent with the Protocol.

• (7) 

  Pharmaceuticals for humans that are addressed by other international agreements, to which the Community or the relevant Member State is party, or organisations, of which the Community or the relevant Member State is a member, should be excluded from the scope of this Regulation.

• (8) 

  Exports of GMOs intended for deliberate release into the environment should be notified to the Party or non-Party of import, allowing it to make an informed decision, based on a risk assessment carried out in a scientifically sound manner.

• (9) 

  The notification should be ensured by the exporter. The exporter should...

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