Innspill fra GenØk – Senter for Biosikkerhet på høringen av søknad EFSA/GMO/NL/2014/121 fra Monsanto Company som gjelder mat, fòr, import og prosessering av genmodifisert soya MON 87751.
ASSESSMENT OF THE SUMMARY OF THE TECHNICAL DOSSIER RELATED TO EFSA/GMO/NL/2014/121 FOR APPROVAL OF MON 87751 SOY
As a designated National Competence Center for Biosafety, our mission at GenØk in advice giving is to provide independent, holistic and useful analysis of technical and scientific information/reasoning in order to assist authorities in the safety evaluation of biotechnologies proposed for use in the public sphere.
The following information is respectfully submitted for consideration in the evaluation of product safety and corresponding impact assessment of event MON 87751 soy, setting out the risk of adverse effects on the environment and health, including other consequences of proposed release under the pertinent Norwegian regulations.
Recommendation
From our analysis, we find that the deficiencies in the summary of the dossier do not support claims of safe use, social utility and contribution to sustainable development of MON 87751 soy. 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. 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 MON 87751 soy, we conclude that based on the available data, the Applicant has not provided the required information under Norwegian law to warrant approval in Norway at this time.
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