Safe management of GMOs: the Cartagena Protocol on Biosafety becomes law

September 12, 2003

Brussels, 11 September 2003

Today, the Cartagena Protocol on Biosafety enters into force. The Protocol is designed to protect biological diversity and human health from the potential risks arising from genetically modified organisms (GMOs) by providing a clear legal framework for their transboundary movement. The Advanced Informed Agreement (AIA) procedure established by the Protocol will ensure that countries can make informed decisions on whether to import GMOs intended for introduction into the environment. Shipments of GMO commodities will have to fulfil specific documentation requirements. The entry into force should be an incentive for more countries to ratify the Protocol, ensuring their participation to the First Meeting of the Parties scheduled for February 2004 in Malaysia.

Environment Commissioner Margot Wallström said: "The Cartagena Protocol establishes one set of basic international rules for dealing with GMOs. It is a fundamental step towards better global governance in the GMO field. This is badly needed to maximise the benefits deriving from biotechnology and minimise the risks for the environment and human health. It will contribute to increasing public confidence in the safe management of GMOs. This Protocol will particularly help developing countries, which often lack the resources to assess the risks of biotechnology and make informed choices about it.

If we want to promote free trade on a global scale we must also ensure that protecting the environment and human health is taken into account by finding multilateral solutions for global problems.

We call on more countries to ratify and implement the Cartagena Protocol and we urge those who are not in a position to ratify to contribute to the achievement of its objectives on a voluntary basis. We also urge the remaining Member States and acceding countries to complete their ratification processes in time to be Parties at the First Conference of the Parties, in February 2004 in Malaysia".

The Cartagena Protocol

The Cartagena Protocol sets out the first international legal framework for the cross-border movement of GMOs on the basis of the 'precautionary principle'.

Countries shipping GMOs for intentional introduction into the environment will have to give prior notification to the importing country that is a Party to the Protocol under the Advance Informed Agreement (AIA) procedure. The notification will have to provide information necessary to enable the importing country to make informed decisions.

The Protocol contains documentation requirements for shipments of GMOs and establishes a Biosafety Clearing House (BCH) to facilitate the exchange of information on GMOs and to assist countries in the implementation of the Protocol.

103 Parties have signed the Cartagena Protocol and 57 have ratified it, including the EU and seven Member States (1) .


The Conference of the Parties to the Convention on Biological Diversity, under the United Nations, adopted a supplementary agreement to the Convention known as the Cartagena Protocol on Biosafety, on 29 January 2000, after more than five years of complex negotiations. The Protocol is legally binding and was the first Multilateral Environmental Agreement (MEA) concluded in the new millennium.

The Protocol's entry into force has been prepared by the Inter-governmental Committee of the Cartagena Protocol (ICCP), created by the Conference of the Parties to the Convention on Biological Diversity. The ICCP has adopted an Action Plan for Building Capacities for the Effective Implementation of the Protocol. It has established a Roster of Experts to provide advice to developing countries, inter alia, on risk assessment, and prepared a compliance mechanism.

The first meeting of the Parties to the Protocol is scheduled for 23- February 2004.

Relevant EU legislation

The EU has already an extensive legislative framework on GMOs. This legal framework has been recently complemented by the Regulation on transboundary movements of GMOs that addresses in particular exports of GMOs, in order to align EU legislation with the provisions of the Biosafety Protocol. The Regulation was finally approved by the Council on 13 June and will enter into force 20 days after its publication in the Official Journal, which should take place by the end of September 2003.

For further information about EU policies on biotechnology, see website:
(1) Spain, The Netherlands, Austria, Denmark, Sweden, Luxembourg, France. The EC ratified on August 2002

DN: IP/03/1236 Date: 11/09/2003

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