Genetically Modified Organisms - Food and Feed
Scientific hearing of application EFSA-GMO-NL-2022-173 for authorisation of the genetically modified maize MON 95275 under EU Regulation 1829/2003/EC on genetically modified food and feed
Report no: Hearing
The Norwegian Scientific Committee for Food and Environment (VKM) has assessed an application for approval of the genetically modified maize MON 95275 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.
Genetically modified MON 95275
Genetically modified maize MON 95275(application EFSA‐GMO‐NL-2022-173) was developed by transforming plant cells with the bacterium Agrobacterium tumefaciens. MON 95275 plants contain the transgenes mpp75Aa1.1 and vpb4Da2 which encode the proteins Mpp75Aa1.1 and Vpb4Da2, and a double-stranded RNA transcript DvSnf7.
The proteins Mpp75Aa1.1 and Vpb4Da2, and the double-stranded RNA transcript DvSnf7, provide protection against feeding damage caused by targeted coleopteran insect pests.
VKM concludes that the applicant's scientific documentation for the genetically modified maize 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.
However, VKM has provided comments to application EFSA-GMO-NL-2022-173 during EFSA's scientific hearing. Maize MON 95275 contains a double-stranded RNA transcript (RNAi). In general, VKM finds bioinformatic evaluations necessary for the risk assessment of GMPs containing RNAi. VKM has therefore recommended EFSA to include specific considerations in the guidance regarding different properties of GMPs containing RNAi, e.g., sequence screening for off-targets in the modified plant. This would be beneficial to ensure a common understanding between product developers and risk assessors regarding the type and extent of data needed to perform a risk assessment.
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.