Novel and Traditional Food applications and notifications: regulations and guidance

EU legislation and EFSA guidance documents detail how to compile dossiers for submission and the information and studies required for the evaluation. EFSA’s guidance is updated regularly so applicants should check they are using the latest version before applying.

Novel foods

Regulatory framework

• Regulation 2017/2469 on administrative and scientific requirements for novel foods applications
• Regulation 2017/2470 on establishing the Union list of novel foods
• Regulation 2015/2283 on novel foods

Administrative guidance and support initiatives

Applicable to all applications submitted as of 1 February 2025

• Administrative guidance for the preparation of novel food applications in the context of Article 10 of Regulation (EU) 2015/2283
• Administrative guidance for processing of applications for regulated products (update 2021)
• EFSA's Catalogue of support initiatives during the life-cycle of applications for regulated products (update January 2024)

For applications submitted until 31 January 2025, the below versions of the EFSA guidance documents apply, depending on the submission date of the application

Scientific guidance

Applicable as of 1 February 2025

• Guidance on the scientific requirements for an application for authorisation of a novel food in the context of Regulation (EU) 2015/2283
  • EFSA statement on the requirements for WGS analysis of microorganisms intentionally used in the food chain

Until 31 January 2025, the below versions of the EFSA guidance documents apply, depending on the submission date of the application

Other guidance

Guidance on the review, revision and development of EFSA's cross-cutting guidance documents

Traditional Foods

Regulatory framework

• Regulation 2017/2468 on administrative and scientific requirements for novel foods applications
• Regulation 2017/2470 on establishing the Union list of novel foods
• Regulation 2015/2283 on novel foods

Administrative guidance and support initiatives

A new Administrative guidance for the preparation of notifications and applications on traditional foods from third countries in the context of Regulation (EU) 2015/2283 will be published in the coming weeks, to provide a detailed description of the notification and application procedure. You can check the progress of this activity on OpenEFSA: https://open.efsa.europa.eu/question/EFSA-Q-2024-00513 

Scientific guidance

Applicable as of 1 February 2025

• Guidance on the scientific requirements for an application for authorisation of a novel food in the context of Regulation (EU) 2015/2283
  • EFSA statement on the requirements for WGS analysis of microorganisms intentionally used in the food chain

Until 31 January 2025, the below versions of the EFSA guidance documents apply, depending on the submission date of the notification or application

Other guidance

Guidance on the review, revision and development of EFSA's cross-cutting guidance documents