Europe’s Evolving Landscape for New Genomic Techniques and Precision Breeding Technologies

Europe's stance on genetically modified organisms (GMOs) is complex and characterized by a strict regulatory framework based on the precautionary principle. This principle prioritizes caution when scientific evidence about potential environmental or health risks is uncertain or incomplete.

In the European Union, member states have the right to restrict or ban the cultivation of approved GMOs within their territories based on environmental or health concerns. Many EU countries have chosen to opt out of growing GMO crops. Currently, only one GM maize (MON810) is cultivated in the EU on a limited scale.

The stance on genome editing in other parts of Europe, however, is evolving. While currently regulated under strict GMO rules following the 2018 ECJ ruling, the European Commission has proposed a reform for plants that would introduce a more differentiated approach based on the comparability of the genetic changes to conventional breeding. This proposal is currently under debate among EU member states and institutions, with the final regulatory framework still to be determined. The outcome will significantly impact the future of agricultural innovation and the use of genome-edited crops in Europe. In the United Kingdom, the Precision Breeding Act is in the implementation phase for plants, with the secondary legislation detailing the authorization process currently in Parliament. In Switzerland, a new proposal aimed at easing the restrictions on plants developed through New Genomic Techniques (NGTs) has been released and is currently under a consultation period.

European Union

The Proposal on New Genomic Techniques and Plant Reproductive Material (EU Proposal), suggested by the Council of the European Union in 2019, aims to boost innovation and sustainability within the EU's agrifood sector while contributing to food security and reducing external dependencies. The regulation is set to ensure robust protection for human, animal, and environmental health while guaranteeing that the plant breeding sector is safe, transparent, and competitive.

On March 14, 2025, the Committee of the Permanent Representatives of the Governments of the Member States to the European Union (Coreper) endorsed the Council's negotiating mandate on regulating NGT plants.

The new EU legislation adapts rules to recent technological advancements. Key changes include: member states' option to prohibit category 2 NGT plant cultivation and implement measures against unintended presence (for both category 1 in organic farming and category 2 in other products); mandatory submission of patent information for category 1 NGT plants to a public database; required labeling of category 2 NGT plants indicating their status and relevant traits; and a prohibition of herbicide tolerance as a trait for category 1 NGT plants.

The partners ask EU policymakers to support the Commission and Council proposal that allows freedom of choice for breeders, farmers, supply chain operators, and consumers in relation to the use of plants and food, feed, and non-food products obtained by NGTs. They reject mandatory traceability and labeling due to potential costs, enforcement issues, and trade disruptions. Instead, they emphasize the importance of increasing public understanding of NGTs and their potential benefits to create an informed and engaged consumer base.

United Kingdom

In the United Kingdom, the Genetic Technology (Precision Breeding) Act 2023 is a major step in unlocking growth and innovation in new breeding technologies (NBTs), ensuring that England becomes a world leader in agri-food innovation while reinforcing food security and sustainability.

In January 2025, Secretary Steve Reed of the UK's Department for Environment, Food, and Rural Affairs (Defra) confirmed the timetable for the Precision Breeding Act 2023 at the Oxford Farming Conference, declaring that secondary legislation will be presented to Parliament by the end of March 2025. This legislation will provide detailed rules for implementing the Precision Breeding Act, particularly for plants.

Genetic Technology (Precision Breeding) Regulations 2025 is based on a two-tier approach. Businesses first apply to Defra for a "marketing notice" to market the precision-bred organism (PBO). Subsequently, they apply to the Food Standards Agency (FSA) for food and feed marketing authorization. All applicants conduct a "Tier 1" safety assessment, evaluating the PBO's history of safe food use, compositional changes (nutrition, toxicity, allergenicity), and other safety concerns.

If any Tier 1 criteria raise concerns, a more rigorous "Tier 2" safety assessment is required by the FSA. However, if the PBO has a history of safe food use and doesn't negatively impact nutrition, toxicity, allergenicity, or general food safety, the lighter-touch Tier 1 assessment applies. For Tier 1, the FSA aims to provide recommendations to Defra within 60 days of application receipt. Tier 2 applications will take longer.The 2025 Regulation is accompanied by a draft guidance from the FSA and Defra, outlining the requirements for obtaining food and feed marketing authorisation for PBOs. Only precision-bred plants are covered by these regulations.

In a recent survey conducted by British Sugar, 69% of UK adults strongly support gene editing to create a sustainable and resilient future for British farming. The survey also found that Gen Zs lead the call for gene editing to be used, with a staggering 80% supporting the technology. All age groups in the survey viewed sustainability as the leading motivator, with 44% citing green credentials as a key reason for backing gene editing. Affordability is also a key motivator, with 50% of survey respondents emphasizing the crippling food costs in recent years as a key factor.

Switzerland

On April 2, 2025, Switzerland's Federal Council released the Breeding Technologies Act (BTA), a proposal aimed at easing the restrictions on plants developed through NGTs such as CRISPR. The bill also aims to strengthen Switzerland's position as a hub for agricultural innovation and cultivation.

Under the current law, these plants are treated identically to those developed through conventional genetic engineering and are subject to the strict provisions of the Genetic Engineering Act, including the ongoing moratorium on cultivation in Switzerland. The new proposal marks a shift in the country's regulatory landscape and introduces a risk-based authorization system that reflects the potential of NBTs and the need for appropriate safeguards.

The draft BTA proposes a simplified regulatory framework for plants developed through NBTs across agriculture, forestry, and horticulture. It outlines a three-step process: controlled closed-system handling for initial research and risk assessment (requiring notification or authorization based on risk), authorized release trials in controlled outdoor settings (only if necessary data can't be obtained indoors), and market authorization for commercialization (requiring proof of benefits and comparative data).

The draft BTA also mandates clear labeling of NBT plants as "from new breeding technologies" or "from new genomic processes" upon market placement. Currently in a consultation period until July 8, 2025, the BTA will undergo a full legislative process.


For Further Reading:

• EU Governments Agree on Negotiating Mandate for NGTs 
• EU Council Agrees Negotiating Mandate for NGTs 
• Defra Secretary Confirms Timetable for Precision Breeding Act 
• UK Pushes for Precision Breeding to Boost Food Security 
• Gen Zs Lead Strong Support for Gene Editing in the UK 
• Genetic Technology (Precision Breeding) Regulations 2025 
• Food Standards Agency Technical guidance to applicants for the authorisation of Precision Bred Organisms for food and feed 
• Department for Environment, Food and Rural Affairs Guidance 
• Switzerland Drafts New Law on NBTs 

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