Precision Breeding: Navigating Regulation and Unlocking Innovation with Confidence

At Fera Science Ltd, we are driven by a clear mission: to protect people, food, and the environment. This means staying ahead of emerging technologies that are shaping the future of food and farming and helping our partners bring them to market responsibly.

With the introduction of the Genetic Technology (Precision Breeding) Act (2023) and its accompanying 2025 Regulations, the UK has opened the door to a new wave of agri-food innovation. Precision breeding offers game-changing potential for developing more resilient, sustainable crops. But alongside opportunity comes the challenge of navigating a complex and evolving regulatory landscape.

What is precision breeding? 

Precision breeding is a collective term for novel technologies that allow you to manipulate and develop desired traits within an organism. Historically, plant or animal breeding has relied on these desired characteristics arising naturally over time and breeders working to establish these as stable traits in a variety.

Precision breeding represents a major leap forward in how we develop crops for the future. Enabling targeted genetic changes that mimic natural processes offers a faster, more precise route to creating varieties that are more resistant to pests and diseases, better adapted to climate change, and less reliant on chemical inputs. These innovations could have a key role to play in improving sustainability and resilience across the food chain.

However, bringing a precision-bred organism (PBO) to market is more than just a scientific discovery. It requires a clear regulatory pathway, robust data, and evidence, not only to protect brand reputation and earn public trust, but to give innovators the confidence to bring forward new solutions that meet both environmental and commercial goals.

How can this be achieved? 

The updated UK framework separates oversight between two key regulators:

• Defra: Oversees environmental safety and classification. PBOs must pass an assessment by the Advisory Committee on Releases to the Environment (ACRE) to confirm they meet the definition of “precision bred”.
• FSA: Evaluates the safety of PBOs used in food and feed. A two-tier system is being proposed to reflect different levels of risk associated with the novelty of organism and effects resulting from the genetic changes that have been introduced, with a ‘light touch’ self-assessment for Tier 1 crops that are effectively the same as conventionally bred crops and pose no additional risks.

To succeed in this environment, developers must have:

• A clearly documented breeding programme
• Robust molecular characterisation data
• A compositional and safety assessment for food/feed uses
• A strong understanding of the PBO’s risk profile
• The ability to defend claims about benefits (e.g. nutritional or environmental)

Although the PBO application and Tier 1 marketing applications themselves will be light touch, companies will require high confidence in their underlying data and understanding of the PBO they are bringing to market.

Fera’s role

Fera supports organisations across the full innovation lifecycle, from early-stage development, preparing for field trials, to commercial launch and registration. Our deep scientific expertise and regulatory insight ensure your innovation is not only credible but market-ready.

We help you:

• Understand your obligations under Defra and FSA
• Build and review the evidence base needed to demonstrate regulatory compliance
• Prepare regulator-ready submissions aligned with both environmental and food/feed safety requirements
• Validate claims and traceability through independent analytical testing
• Strengthen retailer and consumer confidence with science-backed assurance

Fera offers end-to-end support to help bring your precision-bred organism (PBO) to market. From tailored regulatory advice and accredited analytical testing to risk assessment guidance and claim substantiation, we ensure your innovation meets all Defra, ACRE, and FSA requirements. With our expertise, you can move forward with confidence, knowing your product is credible, compliant, and ready for market.

Whether you’re preparing for field trials, entering the retail supply chain, or exploring upstream applications, we ensure your product is built on a foundation of scientific rigour and regulatory compliance.