Import and processing of genetically modified maize Bt11xMIR162xMIR604xGA21

The present application by Syngenta Crop Protection AG (file EFSA/GMO/DE/2009/66) concerns import and processing for use in feed and food of the genetically modified maize line Bt11xMIR162xMIR604xGA21. Cultivation is not part of this application.
Maize line Bt11xMIR162xMIR604xGA21 expresses the cry1Ab, mcry3A and vip3Aa20 genes conferring resistance to certain lepidopteran and coleopteran insects. In addition, this maize line contains the genes mepsps and pat resulting in tolerance to glufosinate-ammonium and glyphosate containing herbicides. Finally, Bt11xMIR162xMIR604xGA21 contains two copies of the pmi gene which acts as a selectable marker enabling transformed plant cells to utilize mannose as a carbon source.

  Bt11xMIR162xMIR604xGA21 was produced by conventional cross-breeding of four genetically modified maize lines. Previously, COGEM issued positive advices on import and processing of maize lines Bt11, MIR604, GA21, Bt11xMIR604, Bt11xGA21, MIR604xGA21 and Bt11xMIR604xGA21. In addition, COGEM issued positive advices on cultivation of Bt11 and GA21. Maize line MIR162 has never been evaluated by COGEM but was evaluated in the current application.
 The molecular characterization of maize line Bt11xMIR162xMIR604xGA21 and its individual parental lines (including MIR162) meets the criteria of COGEM.

 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 or interactions between the transgenic proteins 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 the risks for humans and the environment associated with import and processing of maize line Bt11xMIR162xMIR604xGA21 are negligible. A food/feed safety assessment is carried out by other organizations. Therefore, COGEM abstained from advice on the potential risks of incidental consumption.