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The Council adopted on 15 May 2000 by written procedure a decision on the signing of the Cartagena Protocol on Biosafety on behalf of the European Community( 1). The Protocol provides for a framework for the safe transfer, handling and use of living modified organisms (LMOs) resulting from modern biotechnology. Agreement on the text of the Protocol was reached by more than 130 delegations on 29 January 2000 in Montreal after almost four years of negotiation.

The European Community will thus be able to sign the Protocol on 24 May 2000 in Nairobi at the official ceremony during the 5^th meeting of the Conference of the Parties to the Convention on Biological Diversity (15 to 26 May 2000). The Portuguese State Secretary for the Environment,

Mr. Rui Gonçalves, and Mr. Fernand Thurmes, Director in the Environment Directorate General of the European Commission will sign the Protocol on behalf of the European Community.

As far as the implementation of the Protocol is concerned, the extraordinary Conference in January decided to set up an ad hoc Intergovernmental Committee for the Cartagena Protocol on Biosafety (ICCP), chaired by Ambassador Yang (Cameroon), which should prepare the 1^st meeting of the Parties to the Protocol. A work programme for the ICCP will also be considered and approved by the 5^th Conference of the Parties to the Convention on Biological Diversity.

There are references to the precautionary principle at four levels in the text of the Protocol: in the Preamble, in the Objective (Art. 1), in operational terms as regards the decision-making (Art. 10 (6) and 11 (8)) and as one of the general principles to be followed when conducting a risk assessment (Annex II, § 4).

The scope includes all LMOs that may have adverse effects on the conservation and sustainable use of biodiversity, taking into account risks to human health. It excludes however pharmaceuticals for humans that are addressed by international agreements or other organisations.

The "Advanced Informed Agreement" (AIA) procedure (Art. 7-10 and 12) ensures that the Party of import is notified and can take a decision or give its consent before the first movement actually takes place. This procedure applies to LMOs intended for direct introduction into the environment (e.g. seeds and plants).

As regards LMOs which are not intended for direct introduction into the environment but intended for food, feed or for processing (so-called LMO commodities), the exporting countries will in advance share information on domestic approvals with potential importing countries via a Biosafety Clearing House, which needs to be established. In response, a Party will decide on such imports either under its domestic regulatory framework or following a risk assessment (e.g. in the case of the developing countries and countries with an economy in transition).

Shipments of LMOs will be indicated as such through labelling or accompanying documentation. This does however not amount to an obligation for consumer labelling, which would remain a domestic matter.

Documentation requirements differentiate as far as the categories of LMOs are concerned. For LMOs intended for direct introduction into the environment, accompanying documentation shall clearly identify LMOs as such and provide detailed information. Documentation accompanying movements of LMO-commodities shall identify them as "may contain LMOs". Detailed requirements on how to ensure identification will have to be worked out by the Parties in the two years following the entry into force of the Protocol.

It is stated that the Protocol and other international agreements, including WTO-based agreements, are to be mutually supportive. There is no binding provision in the text whereby some form of subordination, e.g. to a WTO-based instrument, would be imposed on the Protocol.

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