Assessment of the technical dossier submitted under EFSA/GMO/NL/2012/108 for approval of transgenic soy, MON 87708 x MON 89788, filed by Monsanto Company.

Overall recommendation

Based on our detailed assessment, we find that the informational, empirical and deductive deficiencies identified in the dossier do not support claims of safe use, social utility and contribution to sustainable development of MON 87708 × MON 89788. 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.

Therefore, in our assessment of MON 87708 × MON 89788, we conclude that based on the available data, including the safety data supplied by the Applicant, the Applicant has not substantiated claims of safety satisfactorily or provide the required information under Norwegian law to warrant approval in Norway at this time.

Lise Nordgård, Idun M. Grønsberg, Marek Cuhra, Marianne Iversen and Rosa Binimelis.

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