Scientific hearing of application GMFF-2024-29150/AP195 for authorisation of the genetically modified soybean 305423xDAS-44406-6 under EU Regulation 1829/2003/EC on genetically modified food and feed

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. The assignment is divided into three stages.

Genetically modified soybean 305423xDAS-44406-6

Soybean 305423xDAS-44406-6 was produced by traditional breeding to combine the genetically modified soybeans 305423 and DAS-44406-6. Soybean 305423xDAS-44406-6 expresses the gm-fad2-1 gene fragment from 305423 soybean. Transcription of the gm-fad2-1 gene fragment in 305423 soybean seeds results in gene silencing and suppression of transcription of the endogenous fad2-1 gene, that encodes the soybean microsomal omega-6 desaturase, FAD2-1. Suppression of transcription of the endogenous fad2-1 gene resulting in a modified fatty acid profile in seed (high-oleic phenotype) with an increased level of oleic acid and decreased levels of linoleic and linolenic acids, and to a lesser extent, palmitic acid.

Soybean 35423-1xDAS-44406-6 also expresses the 2mepsps, aad-12, pat and gm-hra genes. 2mEPSPS, AAD12 and PAT proteins from DAS-44406-6 soybean confer tolerance to glyphosate, 2,4-dichlorophenoxyacetic acid (2,4-D) and glufosinate herbicides respectively; as well as the GM-HRA protein from 305423 that confers tolerance to ALS inhibiting herbicides and was used as a selectable marker during the event development.

VKM has provided comments to application GMFF-2024-29150/AP195 during EFSA's scientific hearing in accordance with the assignment from NSFA and NEA. Comments regarding requirements of the Implementing Regulation 503/2013.

VKM has not identified specific Norwegian conditions that indicate follow-up.

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.