Genetically Modified Organisms
Assessment of the genetically modified maize DP4114 x MON810 x MIR604 x NK603 under EU Regulation 1829/2003/EC on genetically modified food and feed (application EFSA-GMO-NL-2018-150)
Report no: 2022:19
The Norwegian Scientific Committee for Food and Environment (VKM) has assessed an application for approval of the genetically modified maize DP4114 x MON810 x MIR604 x NK603 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 public 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 DP4114 x MON810 x MIR604 x NK603
Stacked event DP4114 x MON810 x MIR604 x NK603 is a genetically modified maize developed via conventional crossing of the four single maize events DP4114, MON810, MIR604, and NK603.
The stacked event expresses genes for the following proteins and enzymes: Cry1F and Cry1Ab to confer resistance to lepidopteran pests; Cry34Ab1, Cry35Ab1 and mCry3A to confer resistance to coleopteran pests; PAT, CP4 EPSPS and CP4 EPSPS L214P providing tolerance to glufosinate-ammonium and glyphosate containing herbicides, respectively; and finally, the enzyme phosphomannose isomerase (PMI) as a selectable marker.
The scientific documentation provided in the application for genetically modified maize DP4114 x MON810 x MIR604 x NK603 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 concludes that the introduced modifications in maize DP4114 x MON810 x MIR604 x NK603 do not imply potential specific health or environmental risks in Norway, compared to EU-countries. The EFSA scientific opinion (EFSA, 2022) is adequate also for Norwegian considerations. The VKM GMO-panel has therefore not performed a full risk assessment of the maize.
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 public 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.