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Advisory reports 23.05.2008

Renewal of authorization for import and processing of maize Bt11

(080523-02)

The present application by Syngenta Seeds S.A.S. (file EFSA/GMO/RX/Bt11) concerns the renewal of the authorization for import and processing of the genetically modified maize line Bt11. Cultivation is not part of this application.
Previously, COGEM issued positive advices on import and processing, and on cultivation of maize line Bt11. The maize line contains the cry1Ab gene conferring resistance to certain lepidopteran insects. In addition, Bt11 contains the pat gene, resulting in tolerance to glufosinate ammonium containing herbicides.

During its long domestication process, maize has lost its ability to survive in the wild. In the Netherlands, the appearance of maize volunteers is rare and establishment of maize plants in the wild has never been reported. There are no reasons to assume that the introduced traits will increase the potential of maize to establish feral populations. The introduced genes cannot spread to closely related species since wild relatives of maize are not present in Europe.

In view of the above, COGEM is of the opinion that incidental spillage of Bt11 poses negligible risks to the environment. Therefore, COGEM considers the risks associated with import and processing of maize line Bt11 negligible. However, COGEM questions some aspects of the provided general surveillance plan. Furthermore, COGEM has some remarks on the fact that the sequence data in the current application differs from the information present in previous applications.