Regulated as genetically modified, focusing on the process used to genetically engineer the animal rather than the product (animal) created.
The EU takes a very strict approach to regulating gene edited animals that effectively bans their introduction, although research is permitted. In opposition to recommendations from its science advisor, the European Court of Justice (ECJ) ruled in 2018 that gene editing shall be regulated under the 2001 GMO Directive that heavily restricts transgenic animals created using genes from another species, even though most gene editing techniques do not result in the introduction of “foreign” genes. This ruling reaffirmed the EU’s regulation of the process used to create genetically engineered animals rather than the characteristics of the final products, as is the case in the US and many other countries. 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.
- 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.
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.
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