Additional information concerning the application for cultivation of genetically modified MON89034xNK603 maize

This advice concerns the application for cultivation, import and processing of genetically modified MON89034xNK603 maize. This maize line expresses the cp4 epsps, cp4 epsps L214P, cry1A.105 and cry2Ab2 genes conferring tolerance to glyphosate containing herbicides and resistance to certain lepidopteran insects.
In its previous opinions concerning this application, COGEM concluded that insufficient data were provided to draw conclusions on the effect of MON89034xNK603 on non-target organisms (NTOs). COGEM was of the opinion that additional data from laboratory experiments and field trials had to be provided. The applicant recently provided additional information on the studies that assess the effect of MON89034xNK603 on NTOs. Although several of COGEMs questions are answered by this information, other questions were not sufficiently addressed.
The provided information does not substantiate the claim that the data obtained from laboratory experiments on target organisms can be extrapolated to exposure to NTOs. In addition, COGEM asks the applicant to determine the ‘maximum expected environmental concentration’ for the NTO Orius insidiosus using information of the maize line of concern i.e. MON89034xNK603, and to take into account the potential exposure of O. insidiosus to Cry1A.105 via exposure routes, such as prey or plant tissues other than pollen. Furthermore, COGEM asks the applicant to examine the effect of MON89034xNK604 on non-target lepidopteran species. The report on the Spanish field trial appears to contain inconsistencies and obscurities, which have to be addressed by the applicant.
A revised general surveillance plan, as requested, has not been submitted yet.
In conclusion, COGEM is of the opinion that the above mentioned questions need to be addressed to allow conclusions on the effect of cultivation of MON89034xNK603 on NTOs.