Genetically Modified Organisms - Food and Feed
Scientific hearing of application GMFF-2021-0071/EFSA-Q-2023-00051 (application 179) for authorisation of the genetically modified maizeDP51291 under EU Regulation 18
The Norwegian Scientific Committee for Food and Environment (VKM) has assessed an application for approval of the genetically modified maize DP51291 for food and feed uses, import and processing in the EU.
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.
DP51291 is a genetically modified maize developed via Agrobacterium tumefaciens mediated transformation. DP51291 plants contain the transgenes ipd072Aa and pat which encode the protein IPD072Aa and the enzyme phosphinothricin acetyltransferase (PAT), respectively. IPD072Aa confers protection against susceptible corn rootworm pests, and PAT confers tolerance to glufosinate-ammonium based herbicides.
A third transgene, pmi, encoding the enzyme phosphomannose isomerase (PMI) was used as a selectable marker.
The scientific documentation provided in the application for genetically modified maize DP51291 is adequate for risk assessment, and in accordance with the 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 event maize DP51291 to imply potential specific health or environmental risks in Norway, compared to EU-countries. Therefore, VKM had no comments to EFSA regarding the application.
About the assignment
The assignment is divided into three stages.
In stage 1, VKM shall assess the health and environmental risks of the genetically modified organism and derived products in connection with the EFSA scientific hearing of GMO applications. VKM shall review the scientific documentation that the applicant has submitted and possibly provide comments to EFSA.
VKM must also consider: i) whether there are specific Norwegian conditions that could give other risks in Norway than those mentioned in the application, ii) whether the Norwegian diet presents a different health risk for the Norwegian population should the GMO be approved, compared to the European population, and iii) risks associated with co-existence with conventional and/or ecologic production of plants for GMOs seeking approval for cultivation. Relevant measures to ensure co-existence must also be considered.
In stage 2, VKM shall assess whether comments from Norway have been satisfactorily answered by EFSA. In addition, VKM shall assess whether comments from other countries imply need for further follow-up.
If EFSAs response to Norwegian comments is not satisfactory, or comments by other countries imply the need for further follow-up, VKM shall in stage 3 perform a risk assessment of these conditions, including conditions specific to Norway.