Genetically Modified Organisms

Assessment of application EFSA-GMO-NL-2022-173 (GMFF-2022-5890)/EFSA-Q-2022-00330 for authorisation of the genetically modified maize MON 95275 under EU Regulation 1829/2003/EC on genetically modified food and feed

Commissioned:

Report no: VKM Bulletin 2024: 22

Published: 12.09.2024

Hovedbudskap:

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. The assignment is divided into three stages. (link)

Maize MON 95275

MON 95275 is a genetically modified maize developed via Agrobacterium tumefaciens transformation. MON 95275 plants contain the transgenes mpp75Aa1.1 and vpb4Da2 which encode the proteins Mpp75Aa1.1 (Cry) and Vpb4Da2 (Vip), 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.

The scientific documentation provided in the application for maize MON 95275 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 maize MON 95275 to imply potential specific health or environmental risks in Norway, compared to EU-countries. The EFSA scientific Opinion is adequate also for Norwegian conditions.

Therefore, a full risk assessment of maize MON 95275 was not performed by the VKM GMO Panel.

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