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.
更新详情
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, 安全评估 conducted by FSA/FSS and independent experts, a public consultation phase, 和 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), 添加剂， 和 enzymes are explicitly excluded from this pathway. It further explains that evidence requirements vary depending on product class, ， 和 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
为什么重要
This update introduces greater 监管透明度 by defining pre-application expectations and procedural steps, supporting 数字对准 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 面向行业利益相关者。.
这适用于哪些人群
此更新适用于 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.
下一步
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.
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常见问题解答
What is the novel foods 授权 process in Great Britain?
It is a regulatory pathway requiring companies to 提交 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 提交 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 提交 via the regulated products portal.
如何 RegASK support novel foods regulatory compliance?
RegASK 帮助组织 监视器 evolving regulatory requirements, prepare compliant dossiers, and streamline submission workflows through AI-driven insights and end-to-end regulatory process automation.
