Explanatory Memorandum to COM(2012)236 - Conclusion of the Nagoya-Kuala Lumpur Supplementary protocol on Liability and Redress to the Cartagena Protocol on Biosafety

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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.

Biosafety, one of the issues addressed by the Convention, concerns the need to protect human health and the environment from the potential adverse effects of the products of modern biotechnology.

The Conference of the Parties to the Convention on Biological Diversity (COP), at its second meeting, held in November 1995 pursuant to Article 19, paragraph 3 of the CBD, established an Open-ended Ad Hoc Working Group on Biosafety to develop a draft protocol on biosafety, specifically focusing on transboundary movement of any living modified organism. The Working Group held six meetings between July 1996 and February 1999.

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.

Article 27 of the Cartagena Protocol mandated the Conference of the Parties serving as the Meeting of the Parties (COP/MOP) to establish at its first meeting a formal process with respect to the appropriate elaboration of international rules and procedures on liability and redress for damage resulting from transboundary movements of LMOs, with a view to endeavour to conclude this work within 4 years (i.e. by 2008).

During COP/MOP1, held in Kuala Lumpur from 23 to 27 February 2004, an Ad Hoc Open-ended Working Group of Legal and Technical Experts on Liability and Redress in the context of the Cartagena Protocol on Biosafety was established to analyse issues, elaborate options, and propose international rules and procedures on the subject.

In May 2008, the COP/MOP4, held in Bonn, achieved a political breakthrough in the negotiations, although it did not finalise the drafting of the agreed results. Therefore, the Parties agreed to work on the completion of a legally binding instrument at COP/MOP5 in Nagoya, Japan in October 2010, as well as to develop guidelines on civil liability. This legally binding instrument, largely inspired by the EU Environmental Liability Directive (ELD)[1], would allow national authorities to act on behalf of the collective good and ask operators for remedial measures in case of damage to biodiversity from LMOs, a novelty particularly in many developing countries.

Final negotiations on the legally binding instrument and on the civil liability guidelines took place in a 'Friends of the Co-Chairs' (FoC) group involving 26 of 157 Parties to the Cartagena Protocol, as well as advisors from other Parties. The EU had two seats at the negotiating table. The Commission acted as the EU negotiator for the legally binding instrument on the basis of a formal authorisation adopted by the Council in June 2007 and extended in time after COP/MOP4. The negotiating directives were refined various times and instructed the Commission to ensure that the results of the negotiation are consistent with relevant Union legislation and with the basic principles of Member States' law on liability and redress, and that it could be implemented in the EU without introducing or amending substantive rules on civil liability.

On 15 October 2010, as a result of final negotiations in Nagoya, the plenary of COP/MOP5 successfully adopted an international agreement, known as the 'Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety'[2].

The COP/MOP5 decision adopting the Nagoya-Kuala Lumpur Supplementary Protocol calls upon the Parties to the CBD to sign the Protocol at the earliest opportunity and to deposit instruments of ratification, acceptance or approval or instruments of accession, as appropriate, as soon as possible.

On 20 December 2010, the Council welcomed the adoption of the Nagoya-Kuala Lumpur Protocol i and on 11 May 2011 the European Union signed the Supplementary Protocol.

In the European Union, the provisions of the Cartagena Protocol on Biosafety are covered by the European legislation on Biosafety which is maintaining as a central cornerstone the precautionary principle. The liability provisions of the Nagoya-Kuala Lumpur Supplementary Protocol are covered by the Directive 2004/35/CE of the European Parliament and of the Council of 21 April 2004, on environmental liability with regard to the prevention and remedying of environmental damage, which establishes a framework based on the 'polluter pays' principle, according to which the polluter pays when environmental damage occurs. After the Directive entered into force on 30 April 2004, three years were given to the EU Member States (MS) to transpose the Directive in domestic law. By July 2010, the last MS finalised its transposition. The ELD was already amended twice through Directive 2006/21/EC on the management of waste from extractive industries and through Directive 2009/31/EC on the geological storage of carbon dioxide and amending several directives.

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 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.

In accordance with the advisory opinion of the Court of Justice i, the Decision on the conclusion should be based on Article 192 (1) TFEU, in conjunction with Article 218(6)(a) TFEU (.

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.