In accordance with an assignment specified by the Norwegian Food Safety Authority (NFSA) and the Norwegian Environment Agency (NEA), VKM assesses whether genetically modified organisms (GMOs) intended for the European market can pose risks to human or animal health, or the environment in Norway. VKM assesses the scientific documentation regarding GMO applications seeking approval for use of GMOs as food and feed, processing, or cultivation.

The EU Regulation 1829/2003/EC (Regulation) covers living GMOs that fall under the Norwegian Gene Technology Act, as well as processed food and feed from GMOs (dead material) that fall under the Norwegian Food Act. The regulation is currently not part of the EEA agreement or implemented in Norwegian law.

Norway conducts its own assessments of GMO applications in preparation for the possible implementation of the Regulation.

In accordance with the assignment by NFSA and NEA, VKM assesses GMO applications during scientific hearings initiated by the European Food Safety Authority (EFSA), as well as after EFSA has published its own risk assessment of a GMO, up until EU member countries vote for or against approval in the EU Commission. The assignment is divided into three stages. (link)

Maize DP202216 x NK603 x DAS-40278-9

DP202216 x NK603 x DAS-40278-9 was produced by crossing the GM-maize events DP202216, NK603 and DAS-40278-9 by traditional breeding methods.

DP202216 x NK603 x DAS-40278-9 maize has an increased and extended expression of the zmm28 gene relative to the innate expression of zmm28 in maize, which enhances grain yield potential. DP202216 x NK603 x DAS-40278-9 maize also expresses the genes mo-pat, cp4 epsps and add-1, encoding the enzymes phosphinothricin acetyltransferase (PAT), 5-enolpyruvylshikimate-3-phosphate synthase (CP4 EPSPS) and aryloxyalkanoate dioxygenase (AAD-1), respectively. The enzymes confer tolerance to the herbicides glufosinate-ammonium (via PAT), glyphosate (via CP4 EPSPS), 2,4-dichlorophenoxyacetic acid (2,4-D) (via ADD-1), and aryloxyphenoxypropionate (AOPP) herbicides (also via AAD-1).

The scientific documentation provided in the application for genetically modified maize DP202216 x NK603 x DAS-40278-9 is adequate for risk assessment, and in accordance with EFSA guidance on risk assessment of genetically modified plants for use in food or feed. The VKM GMO panel does not consider the introduced modifications in DP202216 x NK603 x DAS-40278-9 maize to imply potential specific health or environmental risks in Norway, compared to EU-countries. Therefore, VKM had no comments to EFSA regarding the application.