Assessment of renewal of the current approval in EU for 1507 maize


Assessment of the renewal of the current approval in EU under 1829/2003/EF of EFSA/GMO/RX-001 1507 maize. Application filed by Pioneer Hi-Bred International, Inc. and Dow AgroSciences LLC

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 re-evaluation of product safety and corresponding impact assessment of event 1507 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
From our analysis, we find that the information provided in the summary of the renewal of the current application has deficiencies that do not support claims of safe use, social utility and contribution to sustainable development of 1507 maize. 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 1507 maize, 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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