The Commission's proposal contains detailed rules for the implementation of the Protocol's provisions. It is an integrated part of the EU legal framework on Biotechnology. It complements existing EU legislation on biotechnology, mainly in the field of exporter obligations and information sharing at international level. It will not entail any modification of the existing legal framework on GMOs, which has been proven consistent with the provisions of the Protocol.
The main elements of the proposal are:
As an Importer of GMOs, the Protocol allows the European Union to utilise existing EU legislation on the basis that it is consistent with the requirements of the Protocol, which has been proven to be the case after careful assessment. To this extend, this Proposal does not cover imports and intra-EU movements of GMOs as such, but only refers to the relevant EU legislation. The only exception concerns unintentional transboundary movements of GMOs, where the Protocol's rules for information apply.
The Cartagena Protocol
The Cartagena Protocol on Biosafety was adopted on 29 January 2000. It is a supplementary agreement to the United Nation Convention on Biological Diversity. The overall objective of the Biosafety Protocol is to contribute to ensuring an adequate level of protection in the field of safe transfer, handling and use of genetically modified organisms (GMOs) resulting from modern biotechnology that may have adverse effects on the biological diversity, taking also into account risks to human health, and specifically focussing on so-called 'transboundary movements', i.e. movements across national boundaries.
The Biosafety Protocol has been signed by 107 parties and so far been ratified by 11 (50 ratifications are needed for the Protocol to enter into force). The EU and its Member States signed up to the Protocol on 24 May 2000. The Protocol is based on the precautionary approach and it establishes an information procedure to ensure that countries are provided with the information necessary to make informed decisions before agreeing to the import of GMOs into their territory.
Countries participating in the Biosafety Protocol have the right to submit imports of GMOs intended for deliberate release into their environment to an authorisation procedure based on a notification, prior to a first transboundary movement, and a scientific risk assessment. Exports of such GMOs can only take place after a green light ('advanced informed agreement' or AIA) from the importing country. In addition, the Protocol establishes a system of information exchange about GMOs intended for use as food, feed or processing, as well as a very broad range of relevant information on GMOs (national legislation, national decisions on the use of GMOs…). It establishes a Biosafety Clearing-House to facilitate the exchange of information on living modified organisms and to assist countries in the implementation of the Protocol. The Protocol is of particular benefit to developing countries, since it gives them the necessary information and the power to decide which GMOs they want to receive.