Genetically Modified Organisms - Food and Feed
Assessment of the genetically modified maize MIR162 under EU Regulation 1829/2003/EC on genetically modified food and feed (renewal application EFSA-GMO-RX-025)
Report no: 2023:04
The Norwegian Scientific Committee for Food and Environment (VKM) has assessed an application for approval of the genetically modified maize MIR162 for food and feed uses, import and processing in the EU. June 2023 update.
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 maize MIR162
Maize MIR162 was developed via transformation of maize embryos mediated by the plant pathogen Agrobacterium tumefaciens. MIR162 plants contain the transgenes vip3Aa20, a modified version of the native vip3Aa1 from the bacterium Bacillus thuringiensis, and the pmi gene from the bacterium Escherichia coli. Vip3Aa20 encodes the insecticidal Vip3Aa20-protein, conferring MIR162 with resistance to several species of Lepidopteran (order of butterflies and moths) insect pests. Pmi encodes the enzyme phosphomannose isomerase (PMI) which catalyses the isomerization of mannose-6-phosphate to fructose-6-phosphate. PMI was used as a selectable marker during development of MIR162.
The scientific documentation provided in the renewal application (EFSA-GMO-RX-025) for maize MIR162 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 event MIR162 to imply potential specific health or environmental risks in Norway, compared to EU-countries. The EFSA opinion is adequate also for Norwegian considerations. Therefore, a full risk assessment of maize event MIR162 was not performed by the VKM GMO Panel in connection with the renewal application EFSA-GMO-RX-025.
A full risk assessment of maize MIR162 was previously conducted by VKM in connection with the initial application EFSA-GMO-DE-2010-82. In addition, VKM has assessed maize MIR162 on several occasions as a component in several hybrid maize varieties.
June 2023 update. Assessment of new information
VKM has assessed new information on maize MIR162 to determine whether the conclusions on the safety of maize MIR162 as a single event and as a part of stacked events remain valid. The new information is included in a European patent that reports a decrease in male fertility in some MIR162 inbred lines, pointing to a potential link between such decrease and the Vip3 protein expressed by maize MIR162.
The EFSA GMO Panel has published an evaluation of the data provided by the patent owner. EFSA found scarce support for a causal link between Vip3 and decreased fertility. The general hypothesis of an association between event MIR162 and altered fertility could not be confirmed. The EFSA GMO Panel conducted the safety assessment based on the conservative assumption that such an association exists. The EFSA GMO Panel concluded that a decrease in male fertility would have no impact on the previous conclusions on maize MIR162 and stacked events containing MIR162. The updated EFSA opinion is adequate also for Norwegian considerations.
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.