Assessment of the summary of the dossier under 1829/2003/EU of EFSA/GMO/NL/2013/120 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 event FG72xA5547-127 soy, setting out the risk of adverse effects on the environment and health, including other consequences of proposed release under the pertinent Norwegian regulations. The application from Bayer CropScience AG og M.S. Technologies, LLC, applies to food, feed, import and processing.
As we do not have access to the full technical dossier of FG72xA5547-127 soy we can not give a full assessment of this stacked event. Our assessment is therefore based on the information from the summary of the technical dossier and the data presented there.
Overall recommendation
From our analysis, we find that the information provided in the summary of the technical dossier have deficiencies that do not support claims of safe use, social utility and contribution to sustainable development of FG72xA5547-127 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 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 FG72xA5547-127 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.
Complete list of assessments can be found here: http://genok.com/advising/assessments/
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