Assessment of the technical dossier for GM oilseed rape MON88302xMS8xRF3


iStock_000006738057LargeAssessment of the technical dossier submitted under EFSA/GMO/NL/2013/119 for approval of MON88302xMS8xRF3 oilseed rape, a joint application from Monsanto and Bayer

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 MON88302xMS8xRF3 oilseed rape. 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 MON88302xMS8xRF3 oilseed rape, 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, Idun M. Grønsberg og Arinze S. Okoli

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