Recommendation for second reading of a draft regulation on transboundary movements of genetically modified organisms

May 20, 2003

Brussels, 19 May 2003

FINAL A5-0154/2003 6 May 2003 Type of Procedure: Codecision procedure (second reading)
RECOMMENDATION FOR SECOND READING on the Council common position for adopting a European Parliament and Council regulation on transboundary movements of genetically modified organisms
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The Council's Common Position accepted almost 70% of the amendments adopted by the Parliament at first reading and thus provides the basis for the speedy accord which must, given our anxiety to see the Biosafety Protocol operational as soon as possible, be the priority for both institutions. To date, 45 countries have ratified the Protocol, which will come into force when that figure reaches 50.

The Council accepted many of the most important of Parliament's amendments. It agreed that no first GMO export should take place without the express consent of the country of import; that Member States should take appropriate measures to prevent unintentional transboundary movements; and that the exporter of GMOs should be the party to which the Regulation gives clear responsibilities and obligations.

There remain, however, a number of points of difference and unresolved issues which I have attempted to address through represented or reworded amendments..

The Council accepted in principle that non-decision by a Party or non-Party of Import should not be taken as "silent consent", though here I believe there are omissions in the Council text which could be construed as allowing exceptions to this important principle and which I have attempted to set right.

Secondly, the Commission proposal excluded ?pharmaceuticals for human use?. In line with the Protocol and Parliament's amendment (AM 10), the common position excludes "pharmaceuticals for humans that are addressed by other relevant international agreements or organisations". However, the Council text does not include the Parliament amendment's additional condition, that only international agreements to which the Community or its Member States are party or organisations of which one or the other is a member would be recognised. This is clearly necessary to avoid abuse and to bring the Regulation into line with Art. 5 of the Biosafety Protocol and I have therefore proposed its reinstatement as part of Art2.2.

Thirdly, Council also rejected Parliament's attempt to clarify what is meant by "deliberate release". It is not always the case that GMOs intended for eventual release are released immediately they reach the territory of the country of import. Instead, the GMOs might first be stored, crossed with other organisms or propagated under contained use conditions and only then released into the environment. EP AM 60 therefore proposed that all GMOs should fall under the export notification procedure if they are intended "directly or indirectly" for deliberate release. I have represented this amendment to Article 4, which was carried by a very large majority at First Reading.

Fourthly, in line with Parliament's AM 60, the Council accepted that no first GMO exports should take place without the express consent of the country of import. However, Art. 5 (3) still states that where a Party or non-Party of Import does not reply to a notification, the exporter may proceed with the movement in accordance with procedure required by the Party or non-party of import. I have therefore attempted to eliminate this confusion through the presentation of a reworded amendment. In addition, I have proposed a further amendment to Art. 4 in an attempt to resolve the confusion over the obligations and rights of Parties and non-Parties of Import in relation to releases of GMOs subsequent to the first release. Finally, I have proposed an amendment which reinstates part of AM 29 and ensures that Article 5's procedures also apply in cases covered by the provisions of Art. 10.2.

The final amendments proposed would reinstate Parliament's attempt to find a balance between the right to confidentiality and the defence of intellectual property and other rights, and the right of the public to be informed of matters touching the general interest. [...]

Committee on the Environment, Public Health and Consumer Policy - Rapporteur: Jonas Sjöstedt

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