PURPOSE: the conclusion on behalf of the European Union of the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety.

NON-LEGISLATIVE ACT: Council Decision 2013/86/EU on the conclusion on behalf of the European Union of the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety.

CONTENT: according to this Decision, the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety is approved on behalf of the Union.

The objective of the Supplementary Protocol is the conservation of biological diversity, the sustainable use of its components, and the fair and equitable sharing of benefits arising from the use of genetic resources. The text of the Supplementary Protocol is appended to the Decision.

To recap, Article 27 of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity provides that the Conference of the Parties serving as the Meeting of the Parties to the Protocol (COP/MOP) shall adopt, in its first meeting, a process with respect to the elaboration of international rules and procedures in the field of liability and redress for damage resulting from transboundary movements of living modified organisms.

In June 2007, the Council adopted a Decision authorising the Commission to participate in the negotiations concerning liability and redress in this field on behalf of the Union as regards matters falling within Union competence, in accordance with certain negotiating directives. That authorisation was extended in October 2008 to cover the final stages of the negotiations. On 15 October 2010, the final plenary of the fifth COP/MOP adopted the Supplementary Protocol which was then signed by the Union on 11 May 2011, subject to its conclusion at a later date.

The Union and its Member States should endeavour to deposit as soon as possible their instruments of ratification, acceptance or approval of the Supplementary Protocol.

ENTRY INTO FORCE: 12/02/2013.

The European Parliament adopted a legislative resolution on the draft Council decision on the conclusion on behalf of the European Union of the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety.

Parliament gave its consent to the conclusion of the Protocol.

The Committee on the Environment, Public Health and Food Safety adopted the report by Matthias GROOTE (S&D, DE) on the draft Council Decision on the conclusion on behalf of the European Union of the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety.

The committee recommended that the European Parliament give its consent to the conclusion of the Agreement.

The Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety, adopted on 15 October 2010, at the final plenary of the fifth Conference of the Parties serving as the Meeting of the Parties (COP/MOP 5) in Nagoya, was signed by the Union on 11 May 2011.

The request for consent was submitted by the Council in accordance with Article 192 and Article 218(6), second subparagraph, point (a), of the Treaty on the Functioning of the European Union (TFEU).

PURPOSE: to approve, on behalf of the European Union, the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety.

PROPOSED ACT: Council Decision.

BACKGROUND: Article 27 of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity provides that the Conference of the Parties serving as the Meeting of the Parties to the Protocol (COP/MOP) shall adopt, in its first meeting, a process with respect to the elaboration of international rules and procedures in the field of liability and redress for damage resulting from transboundary movements of living modified organisms.

In June 2007, the Council adopted a Decision authorising the Commission to participate in the negotiations concerning liability and redress in this field on behalf of the Union as regards matters falling within Union competence, in accordance with certain negotiating directives. That authorisation was extended in October 2008 to cover the final stages of the negotiations

During the fifth COP/MOP in Nagoya, Japan, the Union supported the final compromise reached on the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety ("the Supplementary Protocol"), following consideration that it was within the limits of the agreed Union positions and negotiating directives addressed to the Commission. On 15 October 2010, the final plenary of the fifth COP/MOP adopted the Supplementary Protocol and it was then signed by the Union on 12 May 2011, subject to its conclusion at a later date.

It is now appropriate to approve the Supplementary Protocol on behalf of the Union.

IMPACT ASSESSMENT: no impact assessment was undertaken.

LEGAL BASIS: Article 192, in conjunction with Article 218(6)(a) of the Treaty on the Functioning of the European Union (TFEU).

CONTENT: with this draft decision, it is proposed to approve on behalf of the European Union, the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety.

The content of the Protocol is identical to that which was the subject of the Commission’s proposal of June 2012 (please refer to the summary dated 5 June 2012).

The draft decision also includes a declaration by the European Union in accordance with Article 34(3) of the Convention ion Biological Diversity in which it confirms that, in accordance with the Treaty on the Functioning of the European Union (Article 191), it is competent for entering into international agreements and for implementing the obligations resulting therefrom, which contribute to the pursuit of the following objectives:

• preserving, protecting and improving the quality of the environment;
• protecting human health;
• prudent and rational utilisation of natural resources;
• promoting measures at international level to deal with regional or worldwide environmental problems, and in particular combating climate change.

It also declares that it has already adopted legal instruments, binding on its Member States, covering matters governed by this Supplementary Protocol. The exercise of Union competence is by nature subject to continuous development. In order to comply with its obligations, the Union will keep up to date the list of legal instruments already transmitted to the Biosafety Clearing House.

BUDGETARY IMPLICATIONS: the proposal has no implications on the EU’s budget.

PURPOSE: to approve, on behalf of the European Union, the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety.

PROPOSED ACT: Council Decision.

BACKGROUND: Article 27 of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity provides that the Conference of the Parties serving as the Meeting of the Parties to the Protocol (COP/MOP) shall adopt, in its first meeting, a process with respect to the elaboration of international rules and procedures in the field of liability and redress for damage resulting from transboundary movements of living modified organisms.

In June 2007, the Council adopted a Decision authorising the Commission to participate in the negotiations concerning liability and redress in this field on behalf of the Union as regards matters falling within Union competence, in accordance with certain negotiating directives. That authorisation was extended in October 2008 to cover the final stages of the negotiations

During the fifth COP/MOP in Nagoya, Japan, the Union supported the final compromise reached on the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety ("the Supplementary Protocol"), following consideration that it was within the limits of the agreed Union positions and negotiating directives addressed to the Commission. On 15 October 2010, the final plenary of the fifth COP/MOP adopted the Supplementary Protocol and it was then signed by the Union on 12 May 2011, subject to its conclusion at a later date.

It is now appropriate to approve the Supplementary Protocol on behalf of the Union.

IMPACT ASSESSMENT: no impact assessment was undertaken.

LEGAL BASIS: Article 192, in conjunction with Article 218(6)(a) of the Treaty on the Functioning of the European Union (TFEU).

CONTENT: with this draft decision, it is proposed to approve on behalf of the European Union, the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety.

The content of the Protocol is identical to that which was the subject of the Commission’s proposal of June 2012 (please refer to the summary dated 5 June 2012).

The draft decision also includes a declaration by the European Union in accordance with Article 34(3) of the Convention ion Biological Diversity in which it confirms that, in accordance with the Treaty on the Functioning of the European Union (Article 191), it is competent for entering into international agreements and for implementing the obligations resulting therefrom, which contribute to the pursuit of the following objectives:

• preserving, protecting and improving the quality of the environment;
• protecting human health;
• prudent and rational utilisation of natural resources;
• promoting measures at international level to deal with regional or worldwide environmental problems, and in particular combating climate change.

It also declares that it has already adopted legal instruments, binding on its Member States, covering matters governed by this Supplementary Protocol. The exercise of Union competence is by nature subject to continuous development. In order to comply with its obligations, the Union will keep up to date the list of legal instruments already transmitted to the Biosafety Clearing House.

BUDGETARY IMPLICATIONS: the proposal has no implications on the EU’s budget.

PURPOSE: to approve, on behalf of the European Union, the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety.

PROPOSED ACT: Council Decision.

BACKGROUND: the Convention on Biological Diversity (CBD), which entered into force on 29 December 1993, is today's main international instrument for addressing biodiversity issues. The three objectives pursued by the Convention are the conservation of biological diversity, the sustainable use of its components, and the fair and equitable sharing of benefits arising from the use of genetic resources.

The Cartagena Protocol on Biosafety to the Convention on Biological Diversity was adopted on 29 January 2000 as a supplementary agreement to the CBD and entered into force on 11

September 2003. This international treaty provides a framework, based on the precautionary principle, for the safe transfer, handling and use of living modified organisms (LMOs) resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, or pose risks to human health.

In June 2007, the Council adopted a Decision authorising the Commission to participate in the liability and redress negotiations on behalf of the Union as regards matters falling within Union competence, in accordance with certain negotiating directives.

On 11 October 2010, during the fifth Conference of the Parties serving as the Meeting of the Parties to the Protocol in Nagoya, Japan, the EU unanimously supported the final compromise reached on the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress. On 15 October 2010, the final plenary of COP/MOP5 successfully adopted the

Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety. In accordance with Council Decision of 6 May 2011, the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety was signed by the Union on 11 May 2011, subject to its conclusion at a later date.

The Supplementary Protocol contributes to the achievement of the objectives of the environmental policy of the Union. It is therefore appropriate that this Protocol be concluded on behalf of the Union as soon as possible.

IMPACT ASSESSMENT: no impact assessment was carried out.

LEGAL BASIS: Article 192 (1) TFEU, in conjunction with Article 218(6)(a) of the Treaty on the Functioning of the European Union (TFEU).

CONTENT: the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety contributes to the conservation and sustainable use of biological diversity, or pose risks to human health by establishing international rules and procedures in the field of liability and redress for damage resulting from transboundary movements of living modified organisms.

Any protocol to the Convention on Biological Diversity, pursuant to Article 34 thereof, is open for ratification, acceptance or approval by Member States and by regional economic integration organisations. In view of the above the Commission proposes that the Council authorizes the President to designate the person(s) empowered to deposit the instrument of approval of the Nagoya-Kuala Lumpur Supplementary Protocol on behalf of the Union and to confer on them the necessary powers thereto.

In accordance with Article 34, paragraph 3, of the Convention, regional economic integration organisations must declare the extent of their competence with respect to the matters governed by the relevant protocol. To fulfill this obligation, the Commission has prepared the Declaration annexed to the present proposal.

PURPOSE: to approve, on behalf of the European Union, the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety.

PROPOSED ACT: Council Decision.

BACKGROUND: the Convention on Biological Diversity (CBD), which entered into force on 29 December 1993, is today's main international instrument for addressing biodiversity issues. The three objectives pursued by the Convention are the conservation of biological diversity, the sustainable use of its components, and the fair and equitable sharing of benefits arising from the use of genetic resources.

The Cartagena Protocol on Biosafety to the Convention on Biological Diversity was adopted on 29 January 2000 as a supplementary agreement to the CBD and entered into force on 11

September 2003. This international treaty provides a framework, based on the precautionary principle, for the safe transfer, handling and use of living modified organisms (LMOs) resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, or pose risks to human health.

In June 2007, the Council adopted a Decision authorising the Commission to participate in the liability and redress negotiations on behalf of the Union as regards matters falling within Union competence, in accordance with certain negotiating directives.

On 11 October 2010, during the fifth Conference of the Parties serving as the Meeting of the Parties to the Protocol in Nagoya, Japan, the EU unanimously supported the final compromise reached on the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress. On 15 October 2010, the final plenary of COP/MOP5 successfully adopted the

Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety. In accordance with Council Decision of 6 May 2011, the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety was signed by the Union on 11 May 2011, subject to its conclusion at a later date.

The Supplementary Protocol contributes to the achievement of the objectives of the environmental policy of the Union. It is therefore appropriate that this Protocol be concluded on behalf of the Union as soon as possible.

IMPACT ASSESSMENT: no impact assessment was carried out.

LEGAL BASIS: Article 192 (1) TFEU, in conjunction with Article 218(6)(a) of the Treaty on the Functioning of the European Union (TFEU).

CONTENT: the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety contributes to the conservation and sustainable use of biological diversity, or pose risks to human health by establishing international rules and procedures in the field of liability and redress for damage resulting from transboundary movements of living modified organisms.

Any protocol to the Convention on Biological Diversity, pursuant to Article 34 thereof, is open for ratification, acceptance or approval by Member States and by regional economic integration organisations. In view of the above the Commission proposes that the Council authorizes the President to designate the person(s) empowered to deposit the instrument of approval of the Nagoya-Kuala Lumpur Supplementary Protocol on behalf of the Union and to confer on them the necessary powers thereto.

In accordance with Article 34, paragraph 3, of the Convention, regional economic integration organisations must declare the extent of their competence with respect to the matters governed by the relevant protocol. To fulfill this obligation, the Commission has prepared the Declaration annexed to the present proposal.