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2025

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Abstract

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: (...)

Abstract

• This chapter summarises biodiversity responses to continuous cover forestry (CCF). The comparator throughout this chapter is rotation forestry (RF) and its main harvesting method—clearcutting—unless otherwise stated. • Research on the biodiversity effects of logging methods applied in CCF (mostly selection or gap cutting) mainly concerns the short-term effects of measures taken in mature, originally fairly even-aged forests, at best 10–15 years after cutting. Thus far, no surveys or chronosequences cover the whole rotation period (60–100 years). • Continuous cover forestry is likely to beneft species that suffer when the tree cover is removed, such as bilberry and its associated species. Species requiring spatial continuity in host trees or canopy cover may also benefit. • Selection cutting may preserve the majority of species in the mature forest, but the most sensitive species may decline or even disappear. Gap cutting (diameter 20–50 m) affects forest-interior species relatively little, but species’ abundances in gaps change with increasing gap size. Shelterwood cutting seems to closely resemble selection cutting in terms of species responses. In the long term, however, shelterwood cutting results in an even-aged and sparse overstorey, which does not produce the biodiversity benefits of CCF. • Species that have declined due to forestry mostly require large living and dead trees. The preservation of these species is not ensured by CCF alone, but requires deliberately maintaining these structural features. • A mosaic of different forest-management practices within landscapes may provide complementary ways to maintain rich biodiversity.