Administrative guidance for the preparation of novel food applications in the context of Article 10 of Regulation (EU) 2015/2283

Abstract

This document provides guidance to applicants submitting applications on novel foods in the European Union, which are to be evaluated by EFSA. It describes the administrative requirements for the preparation and online submission of the dossier to support an application pursuant to Article 10 of Regulation (EU) 2015/2283 for a new authorisation or for the modification of an existing authorisation of a novel food for applications submitted to the European Commission as of 1 February 2025. The Transparency Regulation amended the General Food Law by introducing provisions in the pre-submission phase and in the application procedure: general pre-submission advice, notification of information related to studies commissioned or carried out to support an application, public disclosure of non-confidential version of all information submitted in support of the application and related confidentiality decision-making process, public consultation on submitted applications. These requirements, as implemented by the Practical Arrangements laid down by EFSA, are reflected in this guidance. The guidance describes the procedure and the associated timelines for handling applications on novel foods, 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. It also takes into account the updated Guidance on the scientific requirements for an application for authorisation of a novel food in the context of Regulation (EU) 2015/2283, which provides advice on the scientific information needed to be submitted by the applicant towards demonstrating the safety of the novel food.