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.

(1 )OJ C 151 E , 25.6.2002 , p.121.
(2 )OJ C 241 , 7.10.2002 , p.62.
(3 )OJ C 278 , 14.11.2002 , p.31.
(4 )Opinion of the European Parliament of 24 September 2002 ( not yet published in the Official Journal) , Council Common Position of 4 March 2003 ( OJ C 107 E , 6.5.2003 , p.1 ) , Decision of the European Parliament of 4 June 2003 ( not yet published in the Official Journal ) and Council Decision of 16 June 2003.
(5 )OJ L 201 , 31.7.2002 , p.48.(6 )OJ L 106 , 17.4.2001 , p.1.

(16)It is necessary to ensure the identification of GMOs

HAVE ADOPTED THIS REGULATION:
CHAPTER I
OBJECTIVES , SCOPE AND DEFINITIONS
Article 1
Objectives
In accordance with the precautionary principle , and without prejudice to the provisions of Directive 2001/18/EC , the objectives of this Regulation are to establish a common system of notification and information for transboundary movements of genetically modified organisms ( GMOs ) and to ensure coherent implementation of the provisions of the Protocol on behalf of the Community in order to 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 sustainable use of biological diversity , taking also into account risks to human health.

Article 2 Scope
1. This Regulation shall apply to the transboundary move- ments of all GMOs that may have adverse effects on the conser- vation and sustainable use of biological diversity , also taking into account risks to human health .
2. Pharmaceuticals for humans that are addressed by other relevant international agreements or organisations are excluded from the scope of this Regulation .

Article 3
Definitions
For the purpose of this Regulation , the following definitions shall apply:
1.'organism 'means organism as defined in Article 2 ( 1 ) of Directive 2001/18/EC;
2.'genetically modified organism ' , or 'GMO ' , means geneti- cally modified organism as defined in Article 2 ( 2 ) of Direc- tive 2001/18/EC , excluding organisms obtained through the techniques of genetic modification listed in Annex IB to Directive 2001/18/EC;
3.'deliberate release 'means deliberate release as defined in Article 2 ( 3 ) of Directive 2001/18/EC;
4.'placing on the market 'means placing on the market as defined in Article 2 ( 4 ) of Directive 2001/18/EC;
5.'contained use 'means: ( a ) activities defined in Article 2 ( c ) of Directive 90/219/ EEC ( 1 ) ; ( b ) activities in which organisms other than micro-organ- isms are genetically modified or in which such GMOs are cultured , stored , transported , destroyed , disposed of or used in any other way , and for which specific containment measures , based on the same principles of containment as in Directive 90/219/EEC , are used appropriately to limit their contact with the general population and the environment; 6.'food 'means food as defined in Article 2 of Regulation ( EC ) No 178/2002 ( 2 ) ;
7.'feed 'means feed as defined in Article 3 ( 4 ) of Regulation ( EC ) No 178/2002;
8.'notification 'means the submission of the information required from the exporter under this Regulation to the competent authority of a Party to the Protocol or to the competent authority of a non-Party;
9.'the Biosafety Clearing-House 'or 'the BCH 'means the Biosafety Clearing-House established under Article 20 of the Protocol; 10 .
'export 'means: ( a ) the permanent or temporary leaving of the customs territory of the Community of GMOs meeting the conditions of Article 23 ( 2 ) of the Treaty; ( b ) the re-export of GMOs not meeting the conditions referred to in ( a ) which are placed under a customs procedure other than transit procedure; 11 .
'import 'means the placing under a customs procedure , other than transit procedure , of GMOs introduced into the customs territory of a Party or non-Party outside the Community from a Party within the Community; 12 .
'exporter 'means any natural or legal person by whom or on whose behalf a notification is made , that is to say the person who , at the time when the notification is sent , holds the contract with the consignee in the third country and has the power to determine that the GMO is to be sent out of the customs territory of the Community .
If no export contract has been concluded or if the holder of the contract does not act on its own behalf , the power to determine that the GMO is to be sent out of the customs territory of the Community shall be decisive; 13 .
'importer 'means any natural or legal person , under the jurisdiction of the Party or non-Party of Import , who arranges for a GMO to be imported; ( 1 ) Council Directive 90/219/EEC of 23 April 1990 on the contained use of genetically modified micro-organisms ( OJ L 117 , 8 .
5 .
1990 , p .
1 ) .
Directive as last amended by Decision 2001/204/EC ( OJ L 73 , 15 .
3 .
2001 , p .
32 ) .
( 2 ) 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 ( OJ L 31 , 1 .
2 .
2002 , p .
1 ) .

21.'Secretariat 'means the Secretariat to the Protocol.