Assessment of soy leghemoglobin produced from genetically modified Komagataella phaffii under EU Regulation 1829/2003/EC on genetically modified food and feed (application EFSA-GMO-NL-2019-162)

The Norwegian Scientific Committee for Food and Environment (VKM) has assessed an application for approval of soy leghemoglobin produced from genetically modified Komagataella phaffii for food 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 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.

Soy leghemoglobin produced from genetically modified Komagataella phaffii

This application is submitted to gain authorisation for the use of soy leghemoglobin (the liquid preparation is referred to as “LegH Prep”) produced from genetically modified Komagataella phaffii (yeast) as a flavouring (“meaty taste”) in meat analogue products that will be marketed in the European Union (EU). Soy leghemoglobin is intended for addition to meat analogue products that are for use in foods such as burgers, meatballs, and sausages.

Komagataella phaffii-strain employed in the production of soy leghemoglobin contains genetic modifications which allow it to express this protein. Following fermentation, the cells are lysed, and the soy leghemoglobin is concentrated by physical means. 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 Komagataella phaffii production strain. These residual proteins are all endogenous to Komagataella phaffii as the gene coding for the expression of soy leghemoglobin is the only gene from a different organism.

VKM has assessed the documentation in application EFSA-GMO- NL-2019-162 and EFSA's scientific opinion for the use of soy leghemoglobin produced from genetically modified Komagataella phaffii.

The scientific documentation provided in the application is adequate for risk assessment, and in accordance with the EFSA guidance on risk assessment of genetically modified microorganisms for use in food or feed. The VKM GMO Panel does not consider leghemoglobin from genetically modified Komagataella phaffii to imply potential specific health risks in Norway, compared to EU-countries. The EFSA opinion is adequate also for Norwegian considerations. Therefore, a full risk assessment was not performed 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 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.