Assessment of the technical dossier submitted under EFSA/GMO/DE/2011/103 for approval of Bt11xMIR162xMIR604x1507x5307xGA21 maize.

Overall recommendation
From our analysis, we find that the deficiencies in the dossier do not support claims of safe use, social utility and contribution to sustainable development of Bt11xMIR162xMIR604x1507x5307xGA21 maize. Critically, the Applicant has not included any of the required information to assess social utility and sustainability as required in Appendix 4 of the Norwegian Gene Technology Act, which would be necessary for consideration of approval in Norway. Hence at minimum, the dossier is deficient in information required under Norwegian law. A new application or reapplication should only be reconsidered with the delivery of the information requests recommended here, including any additional information deemed significant by the Norwegian authorities.

Therefore, in our assessment of Bt11xMIR162xMIR604x1507x5307xGA21 maize, we conclude that based on the available data supplied by the Applicant, the Applicant has not substantiated claims of environmental safety satisfactorily or provide the required information under Norwegian law to warrant approval in Norway at this time.

Lise Nordgård, Frøydis Gillund, Idun M. Grønsberg, Marianne Iversen, Hermoine J. Venter and Rosa A. Binimelis A.

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