The EU takes a very strict approach to regulating gene-edited animals 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 organisms 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 organisms rather than focusing on the characteristics of the final products, as is typically the case in the US and many other countries. The ECJ ruling brought field trials of gene-edited organisms 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.
- Human disease research in pigs: Technische Universität München in Germany used gene-edited pigs to study human diseases, including cardiovascular diseases, cancers, diabetes mellitus, Alzheimer’s disease, cystic fibrosis and Duchenne muscular dystrophy.
- Sheep with larger muscles: Center for Research in Transplantation and Immunology (ITUN) used gene editing to develop larger sheep with more developed muscles.
- Organs in pigs: Researchers in multiple European countries (Spain, Italy) have studied how to develop humans organs for transplantation in pigs.
- Gene editing research in pigs: Researchers in Germany studied how to silence genes in pigs using a gene editing technique called ZFNs as a first step to gene-edited pigs for agriculture.
- Virus-resistant pigs: Researchers at Edinburgh university’s Roslin Institute and the UK company Genus developed pigs resistant to the virus that causes Porcine Reproductive and Respiratory Syndrome (PRRS), one of the costliest animal diseases.
- Swine fever-resistant pigs: Researchers at the Roslin Institute used ZFNs to develop pigs resistant to African swine fever.
- Influenza-resistant chickens: Researchers at the Roslin Institute and Imperial College London took first steps in developing influenza-resistant chickens to help curb the spread of avian flu to humans.
- Chicken research: Researchers at the Roslin Institute used a gene editing technique called TALENs to begin developing hens that do not produce their own chicks, for use as surrogates to lay eggs from rare breeds, as well as hens that produce human proteins in their eggs for medical purposes.
- Pigs with organs for humans: Researchers at the Center for Innovative Medical Models Facility of Ludwig-Maximilians University used CRISPR to begin developing pigs with organs that are more likely to be accepted when transplanted into a human.
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: 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 European Court of Justice (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: European Court of Justice (ECJ) rules that animals developed through gene editing are genetically modified organisms (GMOs) and are subject to the same regulations as transgenic animals, 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 organisms that have undergone gene editing should be considered GMOs, they could be exempted from strict regulation if no foreign DNA is 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.
2013: European Food Safety Authority issues guidance on how to complete environmental risk assessments of all genetically modified animals.
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.
In 2016, in an attempt to block the deregulation of gene editing, Friends of the Earth (FoE) France led a group of European-based NGOs in filing a court case, referred to the ECJ in 2017, requesting that gene editing should be regulated as GMOs under the 2001 Directive. FoE believes that gene editing modifies organisms in “unnatural” ways and poses 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 decision in 2018, FoE stated that it “welcome[s] this landmark ruling which defeats the biotech industry’s latest attempt to push unwanted genetically-modified products onto our fields and plates.”
- 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