The EU takes a very strict approach to regulating gene-edited crops and food that effectively favors banning their introduction. In opposition to scientific recommendations, the European Court of Justice (ECJ) ruled in 2018 that gene editing shall be regulated under the 2001 GMO Directive that heavily restricts transgenic crops created using genes from another species, even though most gene editing applications do not result in the introduction of “foreign” genes. This ruling reaffirmed the EU’s regulation of the process used to create genetically engineered seeds rather than focusing on the characteristics of the final products, as is typically the case in the US and many other countries. The 2018 ruling classified gene editing as a form of mutation breeding (e.g. exposing seeds to chemicals or radiation to generate mutants with desirable traits), but said gene-edited products should be highly regulated while at the same time exempting from regulation more than 3,000 plant varieties (listed in the IAEA database) that have been created through other forms of mutagenesis. The ECJ ruling brought field trials of gene-edited crops in the UK and Belgium under GM requirements. The court’s decision resulted in some research programs being put on hold and some large companies moving their programs or the focus of their programs out of EU markets.
There remains significant disagreement among EU member states regarding how gene editing should be regulated. The European Commission Group of Chief Scientific Advisors criticized the EU court ruling and some countries are asking the next EU Commission, which will be appointed in 2020, to reform the current regulations. The EU Council requested that the EU Commission conduct a study (to be finalized by April 2021) regarding the ECJ judgment and a proposal for changes to the ruling, if appropriate based on the outcomes of the study. Some member states including the Dutch government issued a policy analysis in October 2019 in which it “analysed 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 that the EU adopt “a more product-based regulatory system based on new traits [that] is more future-proof with respect to the development of new techniques”. Three German scientific societies made recommendations in 2019 for a “scientifically justified regulation” of genome-edited plants in the EU. Among other things, they recommended amending European genetic engineering law.
19 member states have already applied additional special restrictions on genetically engineered organisms, shown in the map below with white and purple stripes. These states have applied for “demands for restriction of the geographical scope of a GMO application or authorisation” which restrict or prohibit the cultivation of genetically modified organisms (GMOs) in their territory. Since the 2018 ECJ ruling, these restrictions would also apply to products of gene editing, even if they would have been approved for cultivation in the EU.
In 2020, France’s top administrative court confirmed the ECJ ruling and also ruled 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”). Depending on this list, France might even regulate plants that have been developed by earlier mutagenesis techniques if the HCB comes to the conclusion that the above mentioned requirement is not met. France is the EU’s largest agricultural producer.
- US agricultural company Corteva Agriscience signed a licensing deal in 2019 to provide the French seed producer Vilmorin & Cie access to gene editing tools for agricultural use.
- Corn that can withstand heat, UV radiation, drought and other environmental stressors: Ongoing field trial in Belgium, using the gene editing technology CRISPR, permitted to continue in 2019, but for research purposes only.
- Fungus-resistant banana: In development in Belgium using CRISPR before the ECJ decision, but lost funding and abandoned.
- Herbicide-resistant canola: Developed in Germany in 2014 through a gene editing technique called oligonucleotide‐directed mutagenesis (ODM), but not commercialized and now unlikely to gain approval.
- Gluten free wheat: Being developed using CRISPR at Wageningen University in the Netherlands.
- Potato with stable starch: Developed in Sweden using CRISPR to contain starch that does not have to be chemically modify the starch before storage, to be used in paper-making, textiles, glues, and other products.
- Camelina with high oleic acid: Rothamsted Research is conducting field trials of CRISPR Camelina plants with higher levels of oleic oil, which is used in food.
- Barley produces its own fertilizer: John Innes Centre in England is developing barley that produces nitrogen fertilizer within the plant itself.
- Beetroot produces medicine to treat Parkinson’s: 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.
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 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 European organizations 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 Advocat 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, labelling 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, labelling and monitoring obligations.
1990: The first Directive on GMOs establishes the definition of a GMO and a legal framework for the development of the biotechnology. The Directive introduces a focus on regulating the process used to create the seed rather than the characteristics of the final product.
Environmental advocacy groups, including Friends of Earth Europe, BUND, GeneWatch Greenpeace, the Association for Food Without Genetic Engineering (VLOG) and Corporate Europe Observatory are active detractors of and lobbyists against biotechnology in Europe.
In 2020, the EU Commission presented recommendations for increasing agricultural sustainability as part of the European Green Deal. Innovative biotechnology was included as part of possible strategies that could increase sustainability and help reduce dependency on pesticides. However, environmental advocacy groups argued that technologies like gene editing are not sustainable and should not be part of the European Green Deal.
VLOG stated 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 advocated for no weakening of the current legal framework for new genetic engineering processes and that “new genetic engineering also needs to be labeled, risk-checked and traced”. Friends of Earth Europe argued that treating gene editing differently than GMOs would weaken EU genetic engineering law and only support agribusiness executives.
Activist groups were heavily involved in the July 2018 ruling by the European Court of Justice which ruled, over the objections of its science advisor, that existing GMO regulations must be applied to all products produced from New Breeding Techniques (NBTs), including various forms of gene editing such as CRISPR. That ruling ended more than two years of legal wrangling.
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. FoE believed that gene editing modifies plants in “unnatural” ways and posed the same risks as earlier genetic modification techniques (even though most do not introduce foreign genes) and therefore should be regulated to the same extent. 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.”
Pushback to the ruling by scientists and even GMO-skeptical journalist organizations has been intense. The Observer/The Guardian wrote: “This absurd ruling restricts highly targeted plant breeding but allows random changes caused by carcinogenic chemicals”. 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 due to gene editing are indistinguishable from natural mutations. Three German scientific societies, the German National Academy of Sciences Leopoldina, the Union of German Academies of Science and the German Research Foundation (DFG), made recommendations in 2019 for a “scientifically justified regulation” of genome-edited plants in the EU. Among other things, they recommended amending European genetic engineering law.
Organic and anti-GMO lobby groups, such as Corporate Europe Observatory, are aggressively campaigning to keep pressure on the public and politicians to avoid any rollback or sunsetting of these anti-CRISPR regulations.
- Genetic Literacy Project’s FAQ on gene editing
- Library of Congress summary of EU gene regulations includes detailed analysis of the country’s evolving biosafety laws and liabilities
- Library of Congress Restrictions on Genetically Modified Organisms: European Union
- No Rose Without Thorns: Implications of a product-based regulatory system for GM crops in the European Union: Netherlands Commission on Genetic Modification (COGEM) Policy Report, October 2019
- Statement by the Group of Chief Scientific Advisors: A scientific perspective on the regulatory status of products derived from gene editing and the implications for the GMO Directive
- An overview of regulatory approaches to genome editing in agriculture
- Regulation of Genome Editing in Plant Biotechnology