Assessment of the genetically modified oilseed rape LBFLFK under EU Regulation 1829/2003/EC on genetically modified food and feed (application EFSA‐GMO‐DE‐2019‐157)

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. (link)

Genetically modified oilseed rape LBFLFK

Oilseed rape LBFLFK was developed by Agrobacterium rhizogenes-mediated transformation. In total the following 13 genes were introduced, which would be expected to result in the expression of 11 new proteins. These proteins impact the content of omega-3 long-chain polyunsaturated fatty acids (LC-PUFAs) in the seeds and also confers tolerance to imidazolinone herbicides. Two gene expression cassettes were introduced twice (O3D(Pir) and D5D(Tc) but have different seed-specific promotors to increase expression during seed maturation. Expression of the ten EPA and DHA biosynthesis genes results in the conversion of oleic acid (OA) to EPA and DHA in LBFLFK canola seeds.

The VKM GMO panel has assessed the documentation in the application EFSA‐GMO‐DE‐2019‐157. The VKM GMO panel has no additional observations regarding the limitations of the scientific documentation when considering the full scope of the application, as pointed out by EFSA: “The GMO Panel is unable to conclude on the adequacy of the PMEM plan proposed by the applicant. The GMO Panel cannot conclude on the safety of oilseed rape LBFLFK when considering the full scope of the application. On the other hand, the GMO Panel concludes that the consumption of RBD LBFLFK oil is safe and does not represent any nutritional concern for humans under the conditions of use proposed by the applicant and considered during the pre-market risk assessment.” As no hazards specific to Norway have been identified, the VKM GMO panel supports EFSAs conclusions with the implied reservations regarding oilseed rape LBFLFK.

The genetic modifications in oilseed rape LBFLFK 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 oilseed rape LBFLFK, VKM's GMO panel has not performed a complete risk assessment of the oilseed rape.

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.