Import and processing of maize Bt11 x MIR604

The present application by Syngenta Seeds S.A.S. (file EFSA/GMO/UK/2007/50) concerns import and processing for use in feed and food of the genetically modified maize line Bt11 x MIR604. Cultivation is not part of this application.
Maize line Bt11 x MIR604 was obtained by conventional cross-breeding of the two parental lines. Previously, COGEM issued positive advices on import and processing, and on cultivation of maize line Bt11. COGEM also advised positively on import and processing of maize line MIR604.
The hybrid maize line Bt11 x MIR604 contains the cry1Ab and mcry3A gene conferring resistance to respectively certain lepidopteran and coleopteran insects. In addition, this maize line contains the pat gene, resulting in tolerance to glufosinate ammonium containing herbicides. Furthermore, Bt11 x MIR604 expresses the pmi gene allowing the plant to utilize mannose as a sole carbon source.
  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 volunteers 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 genes introduced in Bt11 x MIR604 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 x MIR604 poses negligible risks to the environment. Therefore, COGEM considers the risks associated with import and processing of maize line Bt11 x MIR604 negligible. Additionally, COGEM questions some aspects of the general surveillance plan and gives a few comments on the revised information regarding the molecular characterization.