Genetically Modified Organisms
Assessment of the genetically modified soybean SYHT0H2 under EU Regulation 1829/2003/EC on genetically modified food and feed (application EFSA-GMO-DE-2021-111)
Report no: 2022:20
The Norwegian Scientific Committee for Food and Environment (VKM) has assessed an application for approval of the genetically modified soybean SYHT0H2 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 soybean SYHT0H2
Genetically modified soybean SYHT0H2 (application EFSA‐GMO‐DE-2012-111) was developed by transforming plant cells with the bacterium Agrobacterium tumefaciens. The soybean expresses the transgenes avhppd-03 and pat. The proteins AvHPPD-03 and PAT provides tolerance to HPPD-inhibiting herbicides, such as mesotrione, and herbicides containing glufosinate ammonium, respectively.
VKM has assessed the documentation in application EFSA-GMO-DE-2021-111 and EFSA's scientific opinion on genetically modified soybean SYHT0H2. VKM concludes that the applicant's scientific documentation for the genetically modified soybean is satisfactory for risk assessment, and in accordance with EFSA guidelines for risk assessment of genetically modified plants for food or feed uses.
The genetic modifications in soybean SYHT0H2 do not indicate an increased health or environmental risk in Norway compared with EU countries. EFSA's risk assessment is therefore sufficient also for Norwegian conditions. As no specific Norwegian conditions have been identified regarding properties of the genetically modified soybean, VKM's GMO panel has not performed a complete risk assessment of the soybean.
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.