New Genomic Techniques (the European Union term for “New Breeding Techniques”— NBTs), including gene editing, are banned for cultivation and human consumption across the European Union based on legislation known as the 2001 GMO Directive. That law was formulated to restrict seeds of crops created using genes from another species (e.g., transgenic crops). Almost all of the transgenic GMOs authorized for sale in the EU are imported from the United States and South America, and are used to feed farm animals; limited amounts of imported food contains them.
With the discovery of CRISPR to edit plants and the subsequent research boom in gene editing that it touched off, scientists and agri-businesses across Europe pushed for revisions in the outdated GMO rules. In 2018, following a request by France to determine how to regulate NGTs, the European Court of Justice (ECJ) ruled that they fall under the 2001 GMO Directive. The ECJ ruled that even if gene editing applications do not result in the introduction of “foreign” genes (e.g., cisgenic crops), they should still be strictly regulated.
The 2018 ruling classified gene editing as a form of mutation breeding (e.g., exposing seeds to chemicals or radiation to generate mutant plants with desirable traits), a practice begun in the 1930s and still used today). The ruling exempted from regulation more than 3,000 plant varieties that had already been, but did not exempt new varieties created using NGTs. That decision stunned scientists who viewed it as nonsensical. Consequently, many research programs were put on hold and some large companies moved their biotechnology programs out of the EU.
The ECJ cited the “precautionary principle”, an artifact of the 1980s and 1990s applied to plant biotechnology innovation. Under EU law, “The precautionary principle is an approach to risk management, where, if it is possible that a given policy or action might cause harm to the public or the environment and if there is still no scientific agreement on the issue, the policy or action in question should not be carried out. However, the policy or action may be reviewed when more scientific information becomes available.”
As specified in Article 4 of Directive 2001/18, the justices concluded: “Member States shall, in accordance with the precautionary principle, ensure that all appropriate measures are taken to avoid adverse effects on human health and the environment which might arise from the deliberate release or the placing on the market of GMOs.” That ruling placed NGTs in the same restrictive regulatory category as GMOs.
That court decision was eagerly greeted by many Green politicians and environmental groups opposed to agricultural genetic engineering. But there was a simmering backlash against the restrictions by individual member states, independent institutions, agriculture ministers and scientists. Scientists cited mounting evidence that crop gene editing does not threaten human health or the environment; in fact it makes agriculture more efficient, furthering EU’s sustainability goals. The Ethics Council of the Max Planck society argued in a discussion paper in 2019 that gene-edited crops should not be regulated as GMOs if the changes are indistinguishable from natural mutations.
Even liberal factions in the media challenged the court ruling. As The Observer/The Guardian wrote: “This absurd ruling restricts highly targeted plant breeding but allows random changes caused by carcinogenic chemicals”.
In response to global criticism and fear of falling behind much of the rest of the world, the EU launched a reassessment of the regulations. Released in April 2021, a 117-page study concluded that the 2001/2018 rules were “not fit for purpose.” The document stated that NGTs had the potential to contribute to sustainable agriculture while acknowledging there were concerns about safety, the environmental impact and the issue of labeling. It concluded that the “applicable legislation is not fit for purpose for some New Genomic Techniques (NGTs) and their products, and that it needs to be adapted to scientific and technological progress.”
Two years later, in July 2023, the EC released new recommendations, calling for an overhaul of the regulations and effectively separating gene editing and other NGTs from the restrictions on GMOs. Under the proposal, the EU’s restrictive rules on GMOs would no longer apply to plants created using NGTs as long as the modifications were comparable to those that could be achieved using conventional breeding.
The recommendations, which still need approval by the EU and could be changed substantially, separate NGT plants into two categories:
Category I reflects new plants in which changes made using a NGT are similar to what could result from conventional breeding, in which plant characteristics are crossed and selected, but where using gene editing speeds up the process and with more precision. That should accelerate the development of crops that are more resilient, pest-resistant, require less pesticides, produce higher yields and are more nutritious. It would set a limit of 20 modifications. “I think it’s conservative, but at this stage we prefer to take a precautionary approach and exclude more complex modifications. The number is backed up by scientific literature,” said one senior EU official.
Category II encompasses plants with more than 20 modifications obtained through the use of NGTs, which would continue to fall under GMO rules.
NGO critics are already lobbying for mandatory traceability and labeling, challenging the EC conclusion that most NGTs are so similar to conventional foods they need not be traced or labeled.
The revamped proposed regulations appear to have wide support from the European public. A fall 2022 survey backed more relaxed restrictions on crops developed using gene editing or other NGTs. According to the poll, ‘’the majority of academia/research, breeders, farmers (except organic and GM-free), other agri-food chain operators and public authorities called for the adaptation of the current legislation to a more enabling framework.’’
Individual EU Member States
Numerous EU countries are interested in relaxing regulations, pursuing controlled trials, and commercializing foods made using NGTs. Even before the release of the EC recommendations, 20 member states were reportedly in favor of relaxing the 2018 regulations while six countries wanted to hew to a severely precautionary approach. Conscious of the previous outcry against GMOs, six agriculture ministers pointed to the necessity of providing more information to the public.
France: In France, EU’s largest agricultural producer, an administrative court reconfirmed the ECJ ruling in 2020. But in 2021, Agriculture Minister Julien Denormandie said that France sees crops developed using new breeding techniques as different from GMOs. “This technology allows much quicker development of a variety that could have emerged naturally at some point, and that is a very good thing,” he said, calling for NBTs not to be regulated like GMOs.
Germany: In 2020, the European Academies’ Science Advisory Council published a commentary supporting the recommendations produced in 2019 by three German scientific societies—German National Academy of Sciences Leopoldina, Union of German Academies of Science and German Research Foundation (DFG). They jointly recommended “scientifically justified regulation” of genome-edited plants and amending Europe’s restrictive genetic engineering law.
The Netherlands: The Dutch government issued a policy statement in October 2019 analyzing the “possible consequences of switching from the current process-based regulatory system to a product-based system for GM crops in the EU”. It argued for the EU to adopt “a … regulatory system based on new traits [that] is more future-proof”. Twelve other EU member states supported the policy statement, agreeing there needs to be a “unified approach” to regulating new breeding techniques.
Spain: Spain remains one of only two countries (the other being Portugal) in the EU to cultivate the one GMO crop approved for cultivation, a corn variety. Spain is expected to hold a ‘’pivotal role’’ in Europe’s future regulatory framework for GE crops, as the country is set to hold the presidential role of the EU Council of Ministers beginning in late 2023. Agriculture minister Luis Planas has asked the EU to temporarily lift its import ban on GE crops for human consumption as a response to the crisis brought on by the ongoing war in Ukraine.
Products/Research (partial list as many products are in development)
- Fungus-resistant tomato, 2022: Researchers in the Netherlands used CRISPR to develop a tomato resistant to powdery mildew.
- Salinity and salt resistant broccoli, 2022: Field trials on genetically altered broccoli in Spain. Evaluation of salinity and salt resistance without commercial repercussions, to ultimately evaluate the acronomic suitability.
- Disease-resistant tomato, 2019: Researchers in Spain and France used CRISPR to develop a tomato resistant to bacterial speck disease.
- Broad-spectrum blight resistant rice, 2019: Researchers in France, Germany, and elsewhere used CRISPR to develop rice with broad-spectrum resistance to bacterial blight.
- Gluten free wheat, 2019: Being developed using CRISPR at Wageningen University in the Netherlands.
- Disease-resistant rice, 2017: Researchers in France and Germany used TALENs to begin developing rice resistant to bacterial leaf blight.
- Potato with stable starch, 2016: Developed in Sweden using CRISPR to contain starch that does not have to be chemically modified before storage, to be used in paper-making, textiles, glues, and other products.
- Beetroot produces medicine to treat Parkinson’s, 2016: Researchers at John Innes Centre in England are developing a type of beetroot using CRISPR to accumulate an amino acid that can be used to treat Parkinson’s disease.
Regulatory Timeline
2023: The expected European Commission proposal on a new legal framework for plant modification is leaked. The proposal recommends softening EU regulations of gene edited crops and other products of New Genomic Techniques.
2021: Following the European green deal, the European Commision has presented a new legal framework for plant modification. The deal includes the possibility to breed plants that have been developed using CRISPR. This is done to allow for “adapting the genetic engineering laws to scientific and technical progress” and therefore “enabling innovations in agriculture”. The proposal is expected to be finished in 2023.
2020: Based on the 2018 ruling by the European Court of Justice (ECJ), France’s top administrative court rules that the French High Council for Biotechnology (HCB) needs to set up, within 6 months, a specific list of mutagenesis techniques or methods that will be exempted from GMO restrictions (technologies that fulfill the requirement of “having been conventionally used in a number of applications and have a long safety record”).
2019: EU Agriculture and Fisheries Council requests a study from the European Commission to clarify how to “ensure compliance when products obtained by means of New Breeding Techniques (NBTs) cannot be distinguished, using current methods, from products resulting from natural mutation”. The study will be submitted to the Council by the end of April 2021.
2019: Netherlands Commission on Genetic Modification (COGEM) holds International Symposium on gene-editing of crops, including suggesting a product-based regulatory system.
2019: Dutch Government calls for a review of the adequacy of the current EU legislation to cover the rapidly progressing technical developments in the plant breeding sector.
2019: Over 100 European research institutes and universities release an open letter, calling for the newly elected European Parliament and European Commission to deregulate gene editing techniques to achieve a more sustainable agriculture, arguing that existing regulations do not reflect the current state of science.
2019: 14 member states call on the next European Commission (appointed in 2020) to update regulations for gene editing, arguing that it could lead to more sustainable agriculture.
2019: A group of 117 research facilities sign an open letter arguing that the 2018 ECJ ruling that all gene editing techniques would be regulated as genetic modification hinders the development of products that would benefit European consumers and increase agricultural sustainability.
2018: The EU’s Group of Chief Scientific Advisors warns that the 2018 ECJ ruling is likely to block the development of “plants….which have the potential to provide immediate direct benefits to the consumer.”
2018: European Court of Justice (ECJ) rules that crops developed through gene editing are genetically modified organisms (GMOs) and are subject to the same regulations as transgenic crops, rejecting a regulatory exemption or the issuance of a revised directive.
2017: European Advocate General, who leads the European Court of Justice case assessing gene editing, releases a statement suggesting that while crops that have undergone gene editing should be considered GMOs, they could be exempted from strict regulation if no foreign DNA was inserted.
2017: Dutch Cabinet states that the Netherlands will continue to support the approval and application of innovative plant biotechnologies if no genes are transferred between species.
2016: Conseil d’Etat (the Supreme Court of France) asks the ECJ to interpret the 2001 GMO Directive in light of gene editing techniques, including New Breeding Techniques (NBTs) that have since been developed.
2015: Swedish Board of Agriculture issues interpretation that gene-edited plants which do not contain foreign DNA should be exempted from the EU GMO legislation.
2015: Directive 2015 amends Directive 2001 and allows member states to restrict or prohibit the cultivation of GMOs in their territory without requiring new scientific evidence.
2003: Regulation No 1829/2003 establishes strict regulations for genetically modified food and feed, including environmental risk assessment, safety assessment, as well as tracing, labeling and monitoring requirements.
2001: European GMO Directive replaces the 1990 GMO directive. The process of developing organisms altered through genetic modification is strictly regulated. Requirements include environmental risk assessment as well as traceability, labeling and monitoring obligations.
1990: The first Directive on GMOs establishes the definition of a GMO and a legal framework for the development of biotechnology. The Directive introduces a focus on regulating the process used to create the seed rather than the characteristics of the final product.
NGO Reaction
Forty-six NGOs launched a public petition in June 2022 after the release of the EC recommendations opposing any changes in the EU precautionary regulations, writing: “The EU Commission is planning to soften EU genetic engineering law. There is a threat of deregulation and thus a free pass for genetically modified plants. Not with us! Together with 45 other organizations, we have therefore started a new petition and demand that regulation be maintained even for new genetic engineering. This includes: Labeling, risk assessment, authorisation, traceability, transparency, monitoring and liability. … Not behind our backs — No free pass for new genetic engineering in our food.”
Environmental advocacy groups, including BUND, GeneWatch, Greenpeace, Association for Food Without Genetic Engineering (VLOG), Friends of the Earth and Corporate Europe Observatory are among the many active detractors of and lobbyists against crop biotechnology in Europe, and which are now specifically targeting gene editing and gene drives. They campaign to pressure the public and politicians to avoid any rollback or sunsetting of GMO and NGTregulations.
VLOG states that “Europe does not need genetic engineering” and that it is an “unsustainable promise of salvation for those who want to sell genetically modified plants”. BUND advocates against weakening of the current legal framework for new genetic engineering processes and says that “new genetic engineering also needs to be labeled, risk-checked and traced”.
French NGO Demeter shared a petition prepared even before the EC study was released, urging that “new GMOs” (gene edited crops) should continue to be regulated as GMOs. Also in 2022, three German NGOs (the working group on rural agriculture (AbL), Gene-Ethical Network (GeN) and IG Saatgut) published criticism during Bayer’s annual meeting, arguing that plants developed with CRISPR should be regulated at GMOs.
Gene Ethics, a European NGO “working for a GM-free future,” opposes synthetic biology and gene editing, writing: “Synthetic biology (SynBio) is a radical new set of Genetic Manipulation techniques called CRISPR, Talen and ZFN and their living products. They should all be regulated and the Precautionary Principle applied.”
A petition was started in 2022 by an organization called WeMove.eu urging the EC to stand strong against excluding gene editing and other NGTs from the 2001 European GMO directive, amd arguing to keep all genetically engineered food products labeled to ‘’guarantee the safety of our food, as well as to protect nature, the environment and our freedom of choice.’’
Friends of the Earth Europe and the Swiss Alliance for a GMO-free Agriculture (SAG) produced a report in 2021 claiming that “new genetic engineering techniques like gene editing are risky and may result in surprise consequences for people and the planet.” FoE Europe argues that treating gene editing differently than GMOs would weaken EU genetic engineering law and only support agribusiness executives.
Greenpeace issued a report in 2021, New GMOs: Danger Ahead, which claims that the introduction of gene editing techniques would “exacerbate the negative effects of industrial farming on nature, animals and people, but it could effectively turn both nature and ourselves (through the food we eat) into a gigantic genetic engineering experiment with unknown, potentially irrevocable outcomes.”
Dozens of anti-GMO activist groups were heavily involved in lobbying the European Court of Justice which ruled in July 2018 that existing GMO regulations must be applied to all products produced from NBTs, including various forms of gene editing such as CRISPR.
In 2016, in an attempt to block the deregulation of gene editing in crops, Friends of the Earth France and other European-based NGOs had filed a court case, referred to the ECJ in 2017, requesting that gene editing should be regulated as GMOs under the 2001 Directive. After the ECJ ruling, FoE stated that it “welcome[d] this landmark ruling which defeats the biotech industry’s latest attempt to push unwanted genetically-modified products onto our fields and plates.”
Additional Resources
- The regulation of genome-edited plants in the European Union
- Directive 2001/18/EC of the European Parliament and of the Council of 12 March
- Experimental releases of GMO plants in Europe
Updated: 09/12/2023
