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 assessment of product safety and corresponding impact assessment of event MON87403 maize, setting out the risk of adverse effects on the environment and health, including other consequences of proposed release under the pertinent Norwegian regulations.
Overall recommendation
In our assessment of maize event MON87403, we find that the information provided in the summary of the technical dossier does not provide enough data to support claims of safe use, social utility and sustainable development.
We therefore conclude that the Applicant has not provided the information required under Norwegian law to warrant approval in Norway at this time.
Especially, the Applicant has not included information which is required to assess social utility and sustainability as required by the Norwegian Gene Technology Act (Appendix 4) 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.
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