Genetically Modified Organisms - Food and Feed
Scientific consultation of genetically modified oilseed rape NS-B5ØØ27-4 under EU Regulation 1829/2003/EC on genetically modified food and feed (application EFSA-GMO-NL-2019-160)
Report no: Comments to EFSA
The Norwegian Scientific Committee for Food and Environment (VKM) has assessed an application for approval of the genetically modified oilseed rape NS-B5ØØ27-4 for food and feed uses 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 consultations 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.
Oilseed rape NS-B5ØØ27-4
NS-B5ØØ27-4 is a genetically modified oilseed rape developed to produce ω3 long-chain polyunsaturated fatty acids (ω3 LC-PUFAs) not normally present in the crop. The resulting phenotype is an oilseed rape that contains the ω3 LC-PUFAs docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) in the seed oil fraction. The DHA and EPA produced from DHA canola aim to provide an alternative for these fatty acids from fish or algae for human consumption as well as for feed, especially in aquaculture. NS-B5ØØ27-4 also contains the gene pat which encodes the enzyme phosphinothricin acetyltransferase (PAT), conferring tolerance to glufosinate ammonium-based herbicides. Pat was used as a selectable marker during the transformation process with the bacterium Agrobacterium tumefaciens.
In accordance with the assignment by NFSA and NEA, the VKM GMO Panel assessed the application EFSA-GMO-NL-2019-160 during the EFSA scientific consultation. The Panel concluded that the scientific documentation provided in the application is adequate for risk assessment, and in accordance with EFSA guidance on risk assessment of genetically modified plants for use in food and feed. Further, the VKM GMO panel concluded that the use of genetically modified oilseed rape NS-B5ØØ27-4 does not imply potential specific health risks in Norway compared to EU-countries. Therefore, the VKM GMO Panel had no comments to EFSA regarding application EFSA-GMO-NL-2019-160 during the EFSA scientific consultation.
Not previously assessed by VKM.
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 consultation 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.