Commission welcomes final adoption of new Regulation on the transboundary movements of genetically modified organisms [links to the texts have been included]

June 16, 2003

Brussels, 13 June 2003

The European Commission welcomed the formal adoption by EU Environment Ministers today of the Regulation on the transboundary movements of genetically modified organisms (GMOs). This agreement marks an important step towards the full implementation into EU legislation of the provisions of the UN Cartagena Protocol on Biosafety, which aims to ensure, on a global scale, the protection of biodiversity and of human health.

Environment Commissioner Margot Wallström said: "The agreement reached today is a very important achievement, which confirms the commitment of the European Union to the objectives of the Biosafety Protocol. I take this opportunity to welcome the upcoming entry into force of this international agreement, most probably in September 2003, and congratulate the Republic of Ghana and the Republic of Palau for their recent ratification, which have triggered the entry into force of the Protocol. Thanks to the agreement reached today, the European Union will be in the position to honour its commitments in a timely manner".

The European Union ratified the Cartagena Protocol on Biosafety on August 2002. The overall purpose of this United Nations agreement is to establish common rules to be followed in transboundary movements of GMOs in order to ensure, on a global scale, the protection of biodiversity and of human health.

In order to fulfil its international obligations, the EU must transpose the provisions of the Biosafety Protocol into its own legal order. This Regulation complements the existing regulatory framework, in particular for exports of GMOs, in order to align it with the provisions of the Biosafety Protocol.

Commissioner Wallström added: "This is a global issue which needs global action. The Biosafety Protocol establishes one set of basic international rules for dealing with GMOs. The Protocol will ensure that countries exporting or importing GMOs can rely on a sound regulatory framework, so that they can make informed choices. This Protocol will be particularly helpful for developing countries, which may lack the resources to properly assess the risks and the benefits of biotechnology. We call on countries to ratify and implement the Biosafety Protocol and we invite those who are not in a position to ratify to contribute to the achievement of its objectives on a voluntary basis."

The main elements of the Regulation are:

The obligation to notify exports of GMOs intended for deliberate release into the environment and secure express consent prior to a first transboundary movement;

The obligation to provide information to the public and to our international partners on EU practices, legislation and decisions on GMOs, as well as on accidental releases of GMOs;

A set of rules for the export of GMOs intended to be used as food, feed or for processing;

Provisions for identifying GMOs for export.

The current Regulation does not foresee new specific EU provisions for imports or for movements of GMOs between Member States. These operations will continue to be covered by existing EU legislation.

In light of the imminent entry into force of the Biosafety Protocol (1) , the Commission endeavoured to facilitate an agreement, which will allow the respect of the international deadlines. The Regulation is broadly in line with the overall approach of the Commission's original position, but includes stricter provisions as regards the explicit consent to be given from importing countries. Today's agreement is based on a close co-operation between the Commission, the Parliament and the Council.

The Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Communities. It shall apply from the day of entry into force of the Protocol, or at the date of entry into force of the Regulation, whichever shall be the later.
(1) 50 countries and the European Union have already ratified the Protocol, which shall enter into force on the ninetieth day after the date of deposit of the fiftieth instrument of ratification.

From the "I/A" item note on the approval of the amendments:

6. The outcome of the vote by the EP is set out in doc. 9900/03 and there are no changes compared to the text previously agreed upon informally between the EP and Council. The Commission expressed its positive opinion on the amendments at the Plenary of the EP.

7. Accordingly, Coreper is invited to confirm that the outcome of the vote by the EP corresponds to the text previously agreed upon (doc. 9900/03 ). Council is invited, on that basis, to approve the amendments adopted by the European Parliament which shall then be deemed to have been adopted in the form of the common position (doc. 15546/1/02 ) thus amended.

DN: IP/03/835 Date: 13/06/2003

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