Genetically Modified Organisms - Food and Feed
Scientific hearing of application GMFF-2022-10651/EFSA-Q-2023-00106 (application 182) for authorisation of the genetically mRegulation 1829/2003/EC on genetically modified food and feed
Report no: Comments to EFSA
The Norwegian Scientific Committee for Food and Environment (VKM) has assessed an application for approval of the genetically modified maize MON 94804 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.
Maize MON 94804
MON 94804 is a genetically modified maize developed via Agrobacterium tumefaciens -mediated transformation of maize tissue. Maize MON 94804 expresses a micro-RNA (miRNA) transcript, that inhibits translation of the mRNA from the two genes ZmGA20ox3 and ZmGA20ox5 that control the biosynthesis of the plant hormone gibberellin. Gibberellin is involved in i.a., plant stem elongation. The resulting reduction in levels of Gibberellin leads to reduced hight of maize MON 94804 plants.
VKM concludes that the applicant's scientific documentation for the genetically modified maize MON 94804 is sufficient for risk assessment, and in accordance with EFSA guidance for risk assessment of genetically modified plants for use in food or feed.
VKM has not identified specific Norwegian conditions that indicate follow-up. 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.