Genetically Modified Organisms - Food and Feed
Scientific hearing of application GMFF-2022-11530 for authorisation of the genetically modified soybean DBN8002 under EU Regulation 1829/2003/EC on genetically modified food and feed
Report no: Comments to EFSA
The Norwegian Scientific Committee for Food and Environment (VKM) has assessed an application for approval of the genetically modified soybean DBN8002 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.
Genetically modified soybean DBN8002 was developed through transformation of cotyledonary node tissue mediated by Agrobacterium tumefaciens carrying the binary vector pDBN4006. Soybean DBN8002 expresses the two proteins phosphinothricin acetyltransferase (PAT) and Vip3Aa. The PAT protein is an enzyme encoded by the pat gene from Streptomyces viridochromogenes, which confers tolerance to glufosinate-ammonium-based herbicides while the Vip3Aa protein, encoded by the vip3Aa gene derived from Bacillus thuringiensis, confers resistance to certain lepidopteran (order of butterflies and moths) pests of soybean.
The scientific documentation provided in the application for genetically modified soybean DBN8002 is adequate for risk assessment, and in accordance with the 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 soybean DBN8002 to imply potential specific health or environmental risks in Norway, compared to EU-countries.
Therefore, VKM did not submit comments to EFSA during the scientific hearing of application GMFF-2022-11530.
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.