Mixture toxicity regarding the application for cultivation of MON89034xNK603 maize

This advisory report 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 the data on the combined effect of the two Cry proteins in MON89034xNK603 were insufficient to draw conclusions on non-target organisms (NTOs). COGEM was of the opinion that additional data from laboratory experiments had to be provided. The applicant recently provided additional information on the studies that assess the effect of MON89034xNK603 on NTOs. Although three out of four of COGEMs remaining questions are satisfactorily addressed in this information, one important question was not sufficiently addressed. COGEM questions the rationale of the applicant regarding mixture effects of a combination of Cry proteins. 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 conclusion, COGEM is of the opinion that interaction between Cry proteins in NTOs needs to be addressed in a laboratory experiment to allow conclusions on the effect of cultivation of MON89034xNK603 on NTOs.