Until the withdrawal of the United Kingdom from the European Union, its gene editing regulations fell under EU jurisdiction [EU Crops]. Since Brexit, England alone has taken steps to establish regulations distinct from the EU’s strict stance, which is based on transgenic GMO regulations promulgated in the early 2000s.
In January 2022, the UK parliament voted to relax restrictions on certain types of gene editing and research and other New Breeding Techniques. The proposed Food Standards Agency rules distinguished between transgenic GMOs in which the seed contains genes from two or more different species versus precision-bred organisms, which could have occurred naturally or through traditional breeding methods.
In March 2023, the UK parliament formally removed restrictions on commercialization of NBTs in England with passage of the Genetic Technology (Precision Breeding) Act 2023. Under the regulations, ‘precision bred’ crops, which have targeted genetic changes which could have arisen through traditional breeding or natural processes would not be regulated or labeled under the.premise that changes from new breeding techniques are akin to what could occur naturally. The chief scientist at the Department for Environment, Food and Rural Affairs (DEFRA) estimates that it would take at least five years, until 2028, for a product to go from research trials to market.
The liberalization does not apply to Scotland, Wales and Northern Ireland, where regulations continue to be based on the EU model. The new regulatory regime does not change restrictions on transgenic GMOs, which will continue to be restricted under the premise that they incorporate “foreign genes”.
Science Media Centre surveyed independent scientists in the UK, finding overwhelming support for the legislation:
- Plant research scientist Prof Jonathan Jones of the Sainsbury Laboratory welcomed the legislation, noting it could pave the way for a host of technologically enhanced products from vitamin D-enriched tomatoes to anti-carcinogenic wheat.
- Dale Sanders, director of the John Innes Centre, said: “This is a genuine opportunity to accelerate access to some innovations that are essential for both human health and for the environment.”
- The Royal Society’s Prof Dame Linda noted that the reforms appropriately focused on regulating the ‘product’ of genetic modification rather than the ‘process’: “The Royal Society has always advocated that regulation of genetic technologies should be based on the outcome of any genetic changes, rather than the current focus on the technology used to make a genetic change. This approach would ensure that safety, welfare, and environmental issues are all considered, and that legislation is future-proofed against new technologies.”
Products/Research (partial list as many products in development)
- Numerous field trials were launched in the wake of the reforms put into place in March 2022, including for pod shatter-resistant oilseed rape, non-browning potatoes, oleic oil rich, omega-3-enriched camelina, tomatoes higher in provitamin B3, and low-asparagine wheat.
- Wheat with reduced cancer risk, 2021: Researchers at Rothamsted Research developed a wheat that has been gene edited to have lower levels of the amino acid asparagine, which could help reduce the risk of acrylamide formation.
- Healthier Wild cabbage, 2021: Researchers at John Innes Centre developed wild cabbage (broccoli, cabbage, sprouts, kale, etc) with increased levels of glucosinolates, which may promote improved blood glucose control and reduce the risk of cardiovascular disease.
- Virus-resistant sugar beet, 2021: The agriculture company British Sugar developed sugar beet resistant to a group of viruses called Virus Yellows and is seeking approval to begin field trials.
- Heat-resistant wheat, 2021: Researchers at the John Innes Centre used gene editing techniques to identify a key gene in wheat responsible for maintaining 50% yield, possibly giving wheat varieties yield resilience to climate change.
- Powdery mildew resistant tomato, 2017: Researchers at Norwich Research Park and other collaborators used CRISPR to develop a tomato resistant to powdery mildew fungus.
- Flowering plant with resistance to virus, 2016 : Researchers at the University of Edinburgh used CRISPR to develop resistance to Turnip mosaic virus in a small flowering plant (thale cress).
Regulatory timeline
2023: The Genetic Technology (Precision Breeding) Act passed into law in March after receiving Royal Assent from the King. This Act enables the development and marketing of gene edited crops in England and is a major step towards modernizing crop breeding.
2022: Genetic Technology (Precision Breeding) Act, proposed to simplify the regulatory regime for gene edited plants and animals, introduced in Parliament.
2021: Government consultation opened to gather views on gene editing so researchers can commence crop trials using gene-editing techniques without consultation.
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.
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
Although their original opposition to agricultural biotechnology was based on a rejection of transgenics because it involved ‘foreign genes’ move between species, almost every anti-GMO NGO has denounced gene-edited crops and animals on entirely different grounds, claiming gene editing is inherently unpredictable and dangerous.
Beyond GM, GM Freeze, GM Watch, Logos Environmental and EcoNexus jointly criticized the 2023 Genetic Technology Bill, claiming that gene edited crops and food will increase the potential for unexpected errors. The organizations expressed concern over the possibility that altered genes could spread from cultivated varieties into wild relatives, presenting risks to the wider environment. They argued that the previous regulatory system of process-based regulation was seen to provide a ‘safety-net’ for new technologies.
Some ethics groups raised issues about the fast-tracking of gene editing approval. Nuffield Council on Bioethics’ Dr Pete Mills argued that earlier experiments that yielded such products as meatier gene-edited “double muscled” pigs had some unexpected health problems. “The legislation doesn’t really have any thought about the purposes for which these technologies are going to be used,” said Mills. “I think that’s problematic.”
Additional Resources
- Genetic Technology Bill
- Expert reaction to the Genetic Technology (Precision Breeding) Bill
- USDA Foreign Agricultural Service Agricultural Biotechnology Report, 2022
Updated: 10/18/2023
