On March 12, 2026, the Food Standards Agency (FSA) and Food Standards Scotland (FSS) published updated guidance on the authorisation process for novel foods in Great Britain, clarifying regulatory requirements for companies seeking to place novel food products on the market. The update applies to businesses operating across England, Scotland, and Wales and outlines the full procedural pathway from pre-application to final decision-making.
Details of the Update
The revised guidance provides a structured overview of the pre-application process, including how applicants must determine the correct regulatory regime, identify the appropriate product classification, and prepare a comprehensive evidence dossier. Applications must be submitted through the regulated products portal, followed by validation checks, safety assessments conducted by FSA/FSS and independent experts, a public consultation phase, and final ministerial decisions.
The guidance emphasizes that applicants must first confirm whether their product qualifies under the novel foods regime, as certain categories such as genetically modified organisms (GMOs), additives, and enzymes are explicitly excluded from this pathway. It further explains that evidence requirements vary depending on product class, with EFSA technical guidance remaining relevant for dossier preparation.
The update also highlights that incomplete applications will not be accepted, reinforcing stricter validation checks prior to assessment. Companies may request confidentiality and data protection measures for commercially sensitive information included in their submissions. Once validated, applications proceed through public consultation on draft recommendations before a final ministerial decision is made in each nation
Why It Matters
This update introduces greater regulatory clarity by defining pre-application expectations and procedural steps, supporting digital alignment through the regulated products portal, and improving process efficiency with clearer validation requirements. The inclusion of a mandatory public consultation phase enhances transparency while maintaining a neutral compliance burden for industry stakeholders.
Who This Is Relevant For
This update is relevant for regulatory affairs teams, quality assurance professionals, R&D teams, and legal or compliance functions involved in the development, assessment, and commercialization of novel food products in Great Britain.
Next Steps
Organizations should review the updated FSA/FSS guidance to confirm product eligibility under the novel foods framework and ensure that their evidence dossiers align with current technical standards, including those referenced from EFSA. Teams should also prepare data protection considerations when handling commercially sensitive information and coordinate internally across regulatory, R&D, and legal functions before submitting applications via the regulated products portal.
As regulatory processes become more structured and data-driven, leveraging advanced solutions can help streamline compliance efforts. RegASK is a leading agentic AI regulatory intelligence and workflow orchestration platform that empowers global organizations in highly regulated sectors, including consumer products and life sciences, to proactively navigate complex regulatory landscapes. By combining advanced Agentic AI with experts in the loop, RegASK delivers timely predictive actionable insights and end-to-end automation, streamlining compliance processes, mitigating risks, and accelerating market access across more than 160 countries. Learn more or book a demo now.
FAQs
What is the novel foods authorisation process in Great Britain?
It is a regulatory pathway requiring companies to submit a validated application, including a comprehensive evidence dossier, followed by safety assessments, public consultation, and ministerial approval.
Which products are excluded from the novel foods regime?
Products classified as genetically modified organisms (GMOs), additives, enzymes, or other specified categories are not eligible under this pathway.
What are the key requirements for submitting a novel foods application?
Applicants must determine the correct regulatory regime, select the appropriate product class, prepare a complete evidence dossier aligned with FSA/FSS and EFSA guidance, and submit via the regulated products portal.
How can RegASK support novel foods regulatory compliance?
RegASK helps organizations monitor evolving regulatory requirements, prepare compliant dossiers, and streamline submission workflows through AI-driven insights and end-to-end regulatory process automation.
Subscribe to the latest regulatory news
Curated newsletters
Relevant industry info
Access expert insights
