Cartagena Protocol on Biosafety to the Convention on Biological Diversity

The Cartagena Protocol on Biosafety to the Convention on Biological Diversity .

The Cartagena Protocol is the first Protocol to the Convention on Biological Diversity. The purpose of the Protocol is to set out procedures for the safe transfer, handling and use of living modified organisms (LMOs) resulting from biotechnology that may have adverse effects on the conservation and sustainable use of biodiversity, taking into account human health. The elaboration of such procedures was identified in the Convention on Biological Diversity as one of the measures that could contribute to the safe handling of biotechnology and the distribution of its benefits.

An LMO is defined in the Protocol (Article 3) as any biological entity capable of transferring or replicating genetic material that possesses a novel combination of genetic material obtained through the use of modern biotechnology. It encompasses organisms intended for intentional introduction into the environment (such as seeds for planting), research in contained facilities (such as academic laboratories), as well as commodities. Such commodities are likely to be mass-produced, sold, exported and marketed for consumption either in viable form (such as grain, fresh fruit and vegetables) or following processing (such as vegetable oil or tomato-puree).

Although the Protocol is generally concerned with the safe development and use of LMOs, its main operative provisions are focused on securing an adequate level of environmental safety in transboundary movements of LMOs between one country and another. In particular, it establishes two procedures to enable a country to take decisions about whether the import of an LMO may have adverse effects on the conservation and sustainable use of its wildlife and natural habitats, and to take action accordingly.

The first procedure (Articles 7-10 and 12) requires an exporting country to obtain advanced informed agreement (AIA) from an importing country before exporting an LMO intended for intentional introduction into the environment. Certain information (Article 8 and Annex 1), including a risk assessment (Article 15 and Annex III), must be supplied in support of an export notification, and the importing country may accept or refuse the LMO on the basis of this information.

The second procedure (Article 11 and Annex II) applies to LMO commodities intended for direct use as food, feed, or for processing. Although AIA is not required under this procedure, an importing country may obtain from a Biosafety Clearing-House (Article 20) information about LMO products cleared for the domestic market in an exporting country and take a decision about import based on a risk assessment.

An important feature of both these procedures is that the importing country may take action on a precautionary basis in order to avoid adverse effects on biodiversity if, on the basis of the risk assessment information supplied, there is scientific uncertainty about the potential for such adverse effects.

Other provisions in the Protocol set out requirements for the handling, transport, packaging and identification of LMOs (Article 18); enable countries to take into account in their decision-making the socio-economic impact of LMOs on the value of biodiversity to indigenous and local communities (Article 26); and require parties to the Protocol to adopt a process on the options for a regime for liability and redress to be completed within four years of the Protocol’s entry force (Article 27).

The Community has adopted common rules on certain matters covered by the Protocol, namely the deliberate release into the environment of genetically modified organisms and on the marketing of products containing such organisms. It thus has the external competence to become a party to the Protocol. The EC and all EC Member States signed the Protocol in May 2000.

The main impact of the Protocol is to give countries without domestic legislation, particularly developing countries, the right to take decisions about the import of LMOs. This includes the right to refuse entry, as a precautionary measure, where there is scientific uncertainty about the risk of adverse effects on the conservation and sustainable use of biodiversity. The establishment of such a global decision making system for transboundary movements of LMOs, based on principles of mutual supportiveness between environment and trade rules, will contribute towards greater consistency, transparency and certainty in decision-making about exports and imports LMOs that may affect biodiversity.

The main elements of the regime for notifying importing countries of intended transboundary movements of LMOs intended for introduction into the environment and for notifying the Biosafety Clearing House of products cleared for the domestic markets are similar to those under the existing EC regime. Some additional costs to business may, however, arise from the need for exporters to make notifications of proposed exports to non-EC countries.
Implementation

The Cartagena Protocol will enter into force 90 days after it has been ratified by at least 50 Parties to the Convention on Biodiversity.

On 25 June 2002, the Environment Council adopted a Council Decision, under a legal base of Article 175(1) EC in conjunction with Article 300 EC subparagraphs 2 and 3, for EC ratification of the Protocol. A separate Explanatory Memorandum, reference number EM 7222/02, and a Supplementary Explanatory Memorandum with the same reference number, have been laid before Parliament on the subject of EC ratification.

There are already EC rules on matters covered by the Protocol, for example, Directive 2001/18/EC on the deliberate release of genetically modified organisms. In order to implement those aspects of the Protocol not covered by existing EC legislation the Commission put forward a proposal for a Regulation on the Transboundary Movement of GMOs in February 2002 (Document COM (02) 85). A political agreement to a common position was reached by Council on the Proposal in December 2002. This Regulation is mainly concerned with movements of GMOs out of the EC, including exports It is hoped that this legislation will come into force by mid 2003. Separate Explanatory Memoranda , reference numbers EM 6447/02 and EM 13372/02 have been laid before Parliament on the subject of this Regulation.

The EC is able to ratify the Protocol before the new Regulation is in place because of the limited external competence it has in the field covered by the Protocol. This limited external competence, derived from existing Community legislation, is referred to in the declaration of competence accompanying the decision to ratify. This was necessary in order to avoid committing the Community to obligations that it cannot yet perform.

Author: international

Mentioned in these Entries

Convention on Biological Diversity, Explanatory Memoranda, Other provisions, country.