Administrative guidance for the preparation of applications on new nutrient sources

Abstract

This document provides guidance to applicants submitting applications on new nutrient sources 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 for a new authorisation of substances proposed as source of nutrients which may be added to food, including food supplements, foods for general population or foods for specific groups, pertaining to 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 a non-confidential version of all information submitted in support of the application and related confidentiality decision-making process, and 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 new nutrient sources, 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.