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.

Soy leghemoglobin produced from genetically modified Pichia pastoris

Soy leghemoglobin is intended as a ‘meaty taste’ flavouring in meat analogue products such as burgers, meatballs, and sausages.

The P. pastoris strain employed in the production of soy leghemoglobin contains genetic modifications which allow it to express this protein. The soy leghemoglobin is delivered in a liquid preparation (LegH Prep) that is standardised to contain up to 9% soy leghemoglobin on a wet weight basis and a soy leghemoglobin protein purity of at least 65%. The remainder of the protein fraction in the LegH Prep is accounted for by residual proteins from the P. pastoris production strain.

In accordance with the assignment by NFSA and NEA, the VKM GMO Panel assessed the application EFSA-GMO-NL-2019-162 during the EFSA public hearing. 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 microorganisms for use in food. Further, the VKM GMO panel concluded that the use of soy leghemoglobin from genetically modified Pichia pastoris 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-2019-162 during the EFSA hearing.

Previous assessments

Not previously assessed by VKM.

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.