EFSA's updated guidance on novel food applications

EFSA publishes three updated administrative guidelines on Novel and Traditional Food applications and notifications to reflect the latest developments in food research.

The three guidance documents will be applicable to those applications submitted as of February 2025.

• Administrative guidance for the preparation of novel food applications

This document provides guidance to applicants submitting applications for a new authorisation or for the modification of an existing authorisation of a novel food in the EU, which are to be evaluated by EFSA (art. 10 and 16 of Regulation (EU) 2015/2283 on novel foods).

The guidance describes the administrative requirements for the preparation and online submission of the dossier to support an application, the procedure and the associated timelines, the different possibilities to interact with EFSA and the support initiatives available from the preparation of the application (pre‐submission phase) to the adoption and publication of EFSA's scientific opinion. 

For further information (in English), click on the Link

• Guidance on the scientific requirements for an application for authorisation of a novel food

This document provides guidance on the scientific information needed to demonstrate the safety of the novel food. Requirements pertain to the description of the novel food, production process, compositional data, specifications, proposed uses and use levels and anticipated intake of the novel food. Furthermore, information needed in sections on the history of use of the novel food and/or its source, absorption, distribution, metabolism, excretion, toxicological information, nutritional information and allergenicity is also described. The applicant should integrate and interpret the data presented in the different sections to provide their overall considerations on how the information supports the safety of the novel food under the proposed conditions of use. Where potential health hazards have been identified, they are to be discussed in relation to the anticipated intake of the novel food and the proposed target populations.

For further information (in English), click on the Link

• Guidance on the scientific requirements for a notification and application for authorisation of traditional foods from third countries

This document provides guidance on the scientific information needed when submitting a notification or application for authorization of a traditional food from a third country (art. 14 and 16 of Regulation (EU) 2015/2283 on novel foods). The safety of a traditional food should be substantiated by data on its composition, its experience of continued use and its proposed conditions of use. Its normal consumption should not be nutritionally disadvantageous. Potential health hazards identified on the basis of compositional data and/or data from the experience of continued use should be discussed.

For further information (in English), click on the Link