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Norway: Crops / Food

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Proposed: No Unique Regulations

Proposed regulations support regulating gene-edited crops as conventional unless they are transgenic (contain "foreign" DNA).

Norway has a history of fierce opposition to transgenic crop biotechnology (GMOs) dating to the early 2000s. Proposed regulations state that gene-edited crops without foreign genes do not fulfill the definition of transgenic GMOs and should be regulated as conventional crops. In 2018, the Norwegian Biotechnology Advisory Board proposed a tiered regulatory system in which genetic changes that can arise naturally or can be achieved 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 strict GMO regulations. Although these regulations appear to pave the way for the introduction of gene-edited crops, the historical, cultural and political suspicion and opposition to crop biotechnology in general remains among the most intense in Europe, raising questions about whether these relaxed guidelines will lead to any innovation in this sector.

Biotechnology in Norway is regulated by the Ministry of Agriculture, the Ministry of Environment and the Ministry of Health. The Directorate for Nature Management is responsible for feed and seed and Norwegian Food Safety Authority is responsible for biotech food. Genetically engineered food is regulated by the Matloven Food Act and the Gene Technology Act, one of the world’s strictest, which requires that genetically modified products contribute to sustainable development in order to be approved. 

So far, the Food Safety Authority has not approved any genetically engineered crops in food or feed. It has, however, granted the fishing industry an exemption from GMO-related permit requirements. All products containing GMOs require a label.

Products

None

Regulatory Timeline

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.

2003: Matloven Food Act finalized, which requires GMO food to be labelled.

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 original opposition to crop biotechnology in Norway was spearheaded by the Norwegian Institute of Gene Ecology (GenØk) whose purported vision is the safe use biotechnology. In 2006, GenØk obtained status from the coalition government as the National Center for Biosecurity. It produced a series of studies purporting to demonstrate the dangers of insect-resistant Bt corn, which was used as a pretext to suspend the cultivation of Bt corn in Europe, leading to widespread criticism by mainstream scientists. GenØk became tied very closely to the Biotechnology Council, even exchanging board members, in effect blocking all innovation in the crop biotechnology sector. GenØk has consistently promoted the work of anti-GMO scientists including the discredited findings of French scientist Gilles-Éric Séralini. It also promotes activist documentaries, such as OMG GMO, scathingly criticized by scientists and reviewers.

Many environmental advocacy groups led by a consortium of 18 organizations known as GMO-Nettverket (GMO-Network) are also active detractors of biotechnology in Norway. The organization includes Greenpeace Norway, Friends of the Earth Norway and numerous organic groups The GMO-Network calls for a “precautionary approach to GMOs” and claims they have “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 there has not been sufficient “research on long-term consequences for the environment and human health”.

 

Resources

Click on a country (eg. Brazil, US) or region (eg. European Union) below to find which agriculture products and processes are approved or in development and their regulatory status. The regulations on genetically engineered crops and animals are emerging out of the regulatory landscape developed for transgenic GMOs.

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Agriculture Gene Editing Index
Compare Regulatory Restrictions Country-to-Country

Gene editing regulations worldwide are evolving. The Gene Editing Index ratings below represent the current status of gene editing regulations and will be updated as new regulations are passed.

Colors and ratings guide
 

Regulation StatusRating
Determined: No Unique Regulations*10
Lightly Regulated8
Proposed: No Unique Regulations†6
Ongoing Research, Regulations In Development5
Highly Regulated4
Mostly Prohibited2
Limited Research, No Clear Regulations1
Prohibited0
Lightly Regulated: Some or all types of gene editing are regulated more strictly than conventional agriculture, but not as strictly as transgenic GMOs.
*Determined: No Unique Regulations: Gene-edited crops that do not incorporate DNA from another species are regulated as conventional plants with no additional restrictions.

†Proposed: No Unique Regulations: Decrees under consideration for gene-edited crops that do not incorporate DNA from another species would no require unique regulations beyond current what is imposed on conventional breeding.

Crops/Food:
Gene editing of plants and food products. Research and development has mostly focused on disease resistance, drought resistance, and increasing yield, but more recent advances have produced low trans-fat oils and high-fiber grains.
Animals:
Gene editing of animals, not including animal research for human drugs and therapies. Fewer gene edited animals have been developed than gene edited crops, but scientists have developed hornless and heat-tolerant cattle and fast-growing tilapia may soon be the first gene edited animal to be consumed.

Rating by Country / Region
Click each column header and arrow to sort the countries / regions

Swipe right/left if all columns aren't visible

Country / RegionFood / CropsAnimalsAg Rating
Japan888
Brazil101010
Canada888
Russia555
Argentina101010
Israel1057.5
Australia888
China555
US1047
Chile1015.5
New Zealand444
Ukraine111
Central America666
Paraguay101010
Uruguay666
India666
UK222
Mexico111
EU222
Colombia1015.5

Global gene editing regulatory landscape

The regulations on genetically engineered crops and animals are emerging out of the regulatory landscape developed for transgenic GMOs. Regulations across 34 countries where transgenic or gene edited crops and animals are commercially allowed (as of 12/19) are guided in part by two factors:
 
 
Whether the country has ratified the international agreement that took effect in 2003 that aims to ensure the safe handling, transport and use of living modified organisms (LMOs) resulting from biotechnology that may impact biological diversity, also taking into account potential risks to human health. It entered into force for those nations that signed it in 2003. It applies the ‘precautionary approach as contained in the Rio Declaration on Environment and Development. The US, Canada, Australia and Chile and the Russian Federation have not signed the treaty.
 
 
Whether regulations are based on the genetic process used to create the trait (conventional, mutagenesis, transgenesis, gene editing, etc.) or the final product.Transgenic crops and animals (aka GMOs) are product regulated in many countries including the US and Canada, while the EU, India, China and others regulate based on how the product is made. There is almost an equal number of countries with product- and process-based regulations. It’s not clear how much this distinction matters. It’s somewhat true that countries with product-based regulation have more crops approved and the approval process is more streamlined, but there are contradictions. For example, Brazil and Argentina have emerged as GMO super powers using different regulatory concepts, while there is no GMO commercial cultivation in Japan, North Korea, and the Russian Federation, which employ product-based regulations. How this will effect gene editing regulations is also unclear. For example, Japan, which has no commercialized GMOs, is emerging as a leader in the introduction of gene edited crops.
Agricultural Landscape
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Gene editing is a set of techniques that can be used to precisely modify the DNA of almost any organism. It is being used for applications in human health, gene drives and agriculture. There are numerous gene-editing tools besides CRISPR-Cas 9, which gets most of the attention because it is a comparatively easy tool to use.

Gene editing does not usually involve transgenics – moving ‘foreign’ genes between species. It also refers to a specific technique in contrast to the general term GMO, which is scientifically ambiguous, as genetic modification is a process not a product. Most gene editing involves creating new products by deleting very small segments of DNA (sometimes in agriculture called Site-Directed Nuclease 1 or SDN-1 techniques), which can silence a gene or change a gene’s activity. Countries are evaluating whether or not to regulate this type of gene editing, since it is so similar to natural mutations. The GLP’s Gene Editing Index ratings reflect the regulatory status of SDN-1 techniques, which are the most liberally regulated and will generate most products in the near term.

To develop different products, gene editing can change larger segments of DNA or add DNA from other species (a form of transgenics sometimes in agriculture called SDN-2 or SDN-3 techniques). While many countries are not regulating or lightly regulating SDN-1 techniques, most are moving toward tightly regulating or even restricting SDN-2 and SDN-3.

For more background on the various gene editing SDN techniques, read background articles here and here.

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