Assessment of the technical dossier for GM cotton 281-24-236×3006-210-23xMON88913


Assessment of the technical dossier submitted under EFSA/GMO/NL/2009/68 for approval of 281-24-236×3006-210-23xMON88913 Cotton from Agrigenetics, Inc. d/b/a Mycogen Seeds.

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 281-24-236×3006-210-23xMON88913. 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 281-24-236×3006-210-23xMON88913, we conclude that based on the available data supplied by the Applicant, the Applicant has not substantiated claims of environmental safety satisfactorily or provided the required information under Norwegian law to warrant approval in Norway at this time.

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Idun M. Grønsberg, Lise Nordgård, Marek Chura og Marianne Iversen.