Assessment of the genetically modified sugar beet KWS20-1 under EU Regulation 1829/2003/EC on genetically modified food and feed (application GMFF-2023-14732)

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 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. The assignment is divided into three stages. (link)

Genetically modified sugar beet KWS20-1

Genetically modified sugar beet KWS20-1 was developed through Agrobacterium-mediated integration of a single T-DNA from plasmid PV-BVHT527462, containing the dmo gene from Stenotrophomonas maltophiliagenes, pat gene from Streptomyces viridochromogenes and cp4epsps gene from Agrobacterium sp. The genes encode the enzymes DMO, PAT and CP4EPSPS conferring tolerance to dicamba-, glufosinate ammonium- and glyphosate- based herbicides, respectively.

VKM has assessed the documentation in application GMFF-2023-14732 and EFSA's scientific opinion on genetically modified sugar beet KWS20-1. VKM concludes that the applicant's scientific documentation for the genetically modified sugar beet KWS20-1 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 sugar beet KWS20-1 do not indicate an increased health 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 sugar beet, VKM's GMO panel has not performed a complete risk assessment of the sugar beet.

About the assignment

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.