Novel Foods Regulatory Framework Review: Executive Summary

“Innovation in novel foods is accelerating, creating long‑term challenges for the sustainability, efficiency and adaptability of the current Novel Foods Regulatory Framework. This project was commissioned to strengthen the FSA’s understanding of how effectively the existing framework operates, identify key pain points, and explore credible opportunities for reform that maintain high standards of consumer safety while enabling responsible innovation. The work is intended to inform strategic thinking rather than propose implementable policy without further development and legal advice. Insights were gathered through extensive engagement with food business operators, interest groups, and international and cross‑sector regulators, alongside a critical evaluation of the current framework against five criteria: evidence‑led and safety‑based; collaborative and transparent; user‑centred; efficient; and future‑proofed. Engagement highlighted recurring themes, including the value of early regulatory engagement, clearer application guidance, proportionate and risk‑based authorisation, and greater transparency. The evaluation identified opportunities for both tactical improvements—such as reducing administrative burden and improving application quality—and more strategic reforms, including revisiting definitions, introducing risk‑based triage, lifecycle or conditional authorisation, and strengthening international collaboration. Five illustrative regulatory models were developed, ranging from “no‑regrets” process improvements to more radical, innovation‑centric approaches. Implementation would require careful consideration of legislative complexity, resources, skills, organisational culture and risk appetite. Strong leadership, capability building, and sustained investment are identified as critical enablers of successful reform.”