Scientific hearing of application GMFF-2025-35657/AP203 for authorisation of the genetically modified maize MON 87427 × MON 94804 × MON 95379 × MIR162 × MON 88017 under EU Regulation 1829/2003/EC on genetically modified food and feed

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)

Genetically modified maize MON 87427 × MON 94804 × MON 95379 × MIR162 × MON 88017

Maize MON 87427 × MON 94804 × MON 95379 × MIR162 × MON 88017 is obtained by conventional crossing of genetically modified maize plants MON 87427, MON 94804, MON 95379, MIR162 and MON 88017. MON 87427 × MON 94804 × MON 95379 × MIR162 × MON 88017 expresses the proteins CP4 EPSPS from MON 87427 and MON 88017, Cry1B.868 and Cry1Da_7 from MON 95379, Vip3Aa20 and PMI from MIR162 and Cry3Bb1 from MON 88017. It also expresses the inherited GA20ox_SUP miRNA from MON 94804.

MON 87427 produces the CP4 EPSPS protein in vegetative and female reproductive tissues and little to no CP4 EPSPS protein in pollen, thereby providing maize lines with tissue selective glyphosate tolerance to facilitate the production of viable hybrid maize seed.

MON 94804 produces the GA20ox_SUP miRNA that suppresses the expression of the targeted maize endogenous gibberellin 20 oxidase (ZmGA20ox) genes, ZmGA20ox3 and ZmGA20ox5, resulting in the reduction of gibberellic acid/gibberellin (GA) levels predominantly in the stalk, leading to a reduction of internode length and consequently reduced overall plant height compared to conventional maize comparator.

MON 95379 produces the Cry1B.868 and Cry1Da_7 proteins derived from Bacillus thuringiensis. These proteins provide protection against certain lepidopteran insect pests.

MIR162 produces Vip3Aa20 protein providing protection against certain Lepidopteran insect pests and PMI protein which acts as a selectable marker.

MON 88017 produces the CP4 EPSPS derived from Agrobacterium sp., strain CP4, which confers tolerance to the herbicide glyphosate; and the Cry3Bb1 protein derived from Bacillus thuringiensis, which provides protection against certain Coleopteran insect pests.

VKM concludes that the applicant's scientific documentation for the genetically modified maize MON 87427 × MON 94804 × MON 95379 × MIR162 × MON 88017 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:

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.