Norway, which is not a member of the European Union, regulates cisgenic gene-editing and other New Breeding Techniques (NBTs) in the highly restrictive way Europe has regulated transgenically modified crops (GMOs). Many scientists are pressing to modify regulations when no “foreign genes” are involved, but so far, as in the EU, restrictions remain in place. In addition to the health and environmental safety criteria followed by the EU, Norwegian law further demands the assessment of three non-safety categories: societal benefit, sustainable, and ethically sound products.
Although there are no NBT crops in the approval pipeline, the Institute of Marine Research (HI) in Norway has been experimenting with CRISPR since 2013 in the hope of developing a sterile farmed salmon. “We are in particular focused on using the technology to address challenging problems associated with photosynthesis and nutrient responses of marine algae as well as lipid metabolism in Atlantic salmon,” said the Norwegian University of Science and Technology.
Norway has a history of fierce opposition to all forms of crop genetic engineering dating to the early 2000s. The government classifies any modification to the plant or animal genome, including gene editing, as described under the 1993 Gene Technology Act. It has approved only two genetically modified products: a single species of GMO ornamental purple carnation and a high Omega-3 GM rapeseed oil for use as a renewable, plant-based aquaculture feed. The government also has granted the fishing industry an exemption from GMO-related permit requirements.
The historical, cultural and political suspicion of crop biotechnology has been among the most intense in Europe, but there are signs of a thaw in attitudes. In 2018, the Norwegian Biotechnology Advisory Board proposed a tiered regulatory system in which genetic changes that could arise naturally without “foreign genes” (the argument for NBTs) or by using conventional breeding methods would be regulated as conventional plants after a notification is submitted to the government. Crops developed with other within-species genetic changes would require expedited but limited assessment and approval. Genetic changes that cross species barriers (transgenesis) or involve synthetic DNA sequences would require assessment and approval under prevailing strict GMO regulations.
In 2019, a group of Norwegian scientists recommended that the government review its staunch opposition to crop biotechnology. That led to the creation of the Norwegian Public Committee (NPC) to investigate a new overview of gene technologies. In June 2023 the committee came with a statement. A majority of 7 of the 11 NPC members recommended a relaxation of GMO regulations for precision breeding, which if enacted would effectively exempt CRISPR from restrictive GMO regulations.
Public opposition against crop biotechnology appears to have softened in recent years. A 2020 survey conducted by GENEinnovate, a collaboration of private Norwegian companies, research institutes and the Norwegian Biotechnology Advisory Board, found 70% of those interviewed supported approval of a gene-edited potato resistant to fire blight, a disease caused by the pathogenic bacteria that kills shoots and flowers; and 60% supported modifications of animal genomes to prevent diseases.
In a June 2023 proposal, the Norwegian Gene Technology Committee stated that ‘’gene technology can play a significant role in meeting future challenges related to food production, climate change and health.’’ The committee proposed a case-by-case product-risk based assessment, departing from the process-based assessment standard now in effect. Consideration is also being given to harmonizing upcoming legislation with any changes the EU might institute to stimulate cooperation and socially beneficial innovation.
Products/Research
Gamete less salmon, 2022: Norwegian Institute of Marine Research developed salmon without gametes (no eggs and sperm) using gene-editing. The salmon would therefore be unable to reproduce.
Regulatory Timeline
2023: The Norwegian Gene Technology Committee submits a proposal to the Norwegian government. The committee proposes case-by-case assessment and harmonization with EU legislation.
2023: The Norwegian Public Committee recommends a relaxation of GMO legislation. This would exempt gene-editing from GMO legislation.
2020: The Norwegian government establishes a public committee to give an overview of advances in gene technologies. This committee will assess whether the current definition of GMOs is still up to date, and ‘to compare the advantages and disadvantages of product-based GMO regulation with a technology-based regulation’. This committee will then make any proposed change to the current policy of the Norwegian government.
2019: A group of Norwegian scientists recommends the Norwegian government to review its opposition towards new breeding techniques in agriculture. The report offers a tiered regulatory framework, in which organisms with ‘’temporary and non-heritable changes’’ would be exempted from GMO regulation.
2018: Norwegian Biotechnology Advisory Board proposes final recommendations for how GMOs and gene-edited organisms should be regulated, including allowing gene-edited crops to be regulated as conventional as long as a notification is submitted to the government.
2016: The Norwegian Biotechnology Advisory Board initiates a comprehensive process to formulate a proposal for a relaxation of the regulation of GMOs, which included a review of gene-edited crops.
2003: Matloven Food Act finalized, which requires GMO food to be labeled.
2001: Cartagena Protocol (an international agreement) ratified, which protects the transport and use of organisms modified by biotechnology.
1993: Gene Technology Act finalized, which states products should be ethically justified, sustainable and provide societal benefits.
1992: Bioteknologirådet (Biotechnology Council) established. It has since been a consultative body for the government and parliament on both ethical and environmental concerns related to genetically engineered crops for import. Bioteknologirådet has developed close relationships with anti-biotech activists and has yet to recommend importing even a single genetically engineered food crop.
NGO Reaction
The Norwegian Institute of Gene Ecology (GenØk) has spearheaded opposition to crop biotechnology in Norway. In 2006, GenØk, under authorization by the Norwegian Biotechnology Council, produced a series of studies purporting to demonstrate the dangers of insect-resistant Bt corn. That study was a factor in the suspension of the cultivation of Bt corn in Europe, leading to widespread criticism by mainstream scientists. GenØk played a key role in blocking all innovation in the crop biotechnology sector. It has also consistently promoted the work of anti-GMO scientists including the discredited findings of French scientist Gilles-Éric Séralini. It also has promoted activist propaganda, such as the docu-fiction OMG GMO, which was scathingly criticized by scientists and reviewers.
A consortium of 18 Norwegian organizations known as GMO-Nettverket (GMO-Network) and including Greenpeace Norway and Friends of the Earth Norway, are fierce detractors of biotechnology. The GMO-Network calls for a “precautionary approach to GMOs”, claiming that GM crops have led to “adverse effects on the ecological system and cause unacceptable trouble for conventional and organic farming.” Although the group claims that it is “not against GMOs in general,” they maintain, after more than 35 years and thousands of studies, that there has not been sufficient “research on long-term consequences for the environment and human health”.
Additional Resources
- USDA Biotechnology Annual 2020: Sweden and Nordic Countries
- Scandinavian perspectives on plant gene technology: applications, policies and progress
updated: 08/03/2023