Genetically Modified Organisms
Assessment of the genetically modified soybean MON 87705 × MON 87708 × MON 89788 under EU Regulation 1829/2003/EC on genetically modified food and feed (application EFSA-GMO-NL-2015-126)
Report no: 2022:21
The Norwegian Scientific Committee for Food and Environment (VKM) has assessed an application for approval of the genetically modified soybean MON 87705 × MON 87708 × MON 89788 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 MON 87705 × MON 87708 × MON 89788
Stacked event MON87705 × MON87708 × MON89788 is a genetically modified soybean developed via conventional crossing, combining the three single events: MON 87705, MON 87708 and MON 89788. All three single (parental) events were developed through Agrobacterium-mediated transformation of conventional soybean cells. The stacked event MON 87705 × MON 87708 × MON 89788, inherits endogenous soybean gene segments from MON 87705 configured to suppress the genes fatb and fad2. Fatb and fad2 are involved in fatty acid synthesis and regulation of fatty acid composition in the plant, hence the suppression leads to an altered fatty-acid profile in the stacked event. MON 87705 also contributes with the cp4epsps gene from Agrobacterium sp. strain CP4 conferring tolerance to glyphosate-based herbicides. Likewise, the stacked event expresses the dmo-gene (dicamba mono-oxygenase) derived from Stenotrophomonas maltophilia from MON 87708, conferring tolerance to the herbicide Dicamba. Finally, a second cp4epsps gene is inherited by the stack from MON 89788.
The scientific documentation provided in the application for stacked event MON 87705 × MON 87708 × MON 89788 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 MON 87705 × MON 87708 × MON 89788 to imply potential specific health or environmental risks in Norway, compared to EU-countries. The EFSA scientific opinion (EFSA, 2020) is adequate also for Norwegian considerations. Therefore, a full risk assessment of stacked event MON 87705 × MON 87708 × MON 89788 was not performed by the VKM GMO Panel.
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.