Cultivation of maize line MON89034xNK603

This notification concerns the cultivation of the genetically modified maize line MON89034xNK603. This maize line expresses the cp4 epsps and cp4 epsps L214P genes conferring tolerance to glyphosate containing herbicides. In addition, MON89034xNK603 contains the cry1A.105 and cry2Ab2 genes and is therefore resistant to certain lepidopteran insects.
Previously, COGEM advised positively on import of maize line MON89034xNK603 and on cultivation of maize line NK603.
In Europe, no wild relatives of maize are present and establishment of maize plants in the wild has never been observed. There are no reasons to assume that the inserted traits will increase the potential of the maize line to establish feral populations. In addition, in Europe the appearance of volunteers is very rare.
COGEM is of the opinion that the molecular characterization of MON89034xNK603 is adequate.
The applicant conducted several laboratory experiments to study whether maize MON89034xNK603 affects non-target organisms (NTOs) adversely. None of the laboratory experiments have been carried out with MON89034xNK603. In most cases either Cry1Ab.105 or Cry2Ab2 pure protein was used. COGEM is of the opinion that the applicant did not sufficiently demonstrate that the Cry1A.105 and Cry2Ab2 proteins do not interact. Five of the nine NTOs that were studied do not occur in the European Union and the applicant did not explain why these organisms are relevant to European maize fields. In addition, although the applicant did not show that Cry2Ab2.820 is biologically identical to Cry2Ab2 some of the experiments have been carried out with Cry2Ab2.820. The laboratory experiments also exhibit other shortcomings: the statistical power of the experiments and the obtained P value are not given, the choice for the statistical test is not explained and the applicant did not provide an explanation for the high mortality (over 15%) in certain control groups.
The applicant presented three studies that describe MON89034xNK603 field trials. However, none of these field trials investigated the effect of MON89034xNK603 on NTOs in Europe. COGEM is of the opinion that the provided data are insufficient to allow a conclusion that cultivation of MON89034xNK603 exerts negligible effects on NTOs.

Based on these considerations, COGEM cannot advise positively on cultivation of maize line MON89034xNK603. COGEM is of the opinion that additional data from laboratory experiments and field trials have to be supplied to be able to make a reliable environmental risk analysis on cultivation of maize line MON89034xNK603.