Administrative guidance for the preparation of applications on novel foods pursuant to Article 10 of Regulation (EU) 2015/2283
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Note: This administrative guidance was first published on 12 March 2021 and has been updated on 29 November 2022. A list of changes introduced in November 2022 is provided in Annex A. To avoid confusion, the original version of the guidance has been removed from the EFSA Journal, but is available on request.
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 27 March 2021.
The Transparency Regulation amended the General Food Law by introducing new 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 new 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.
This publication is linked to the following EFSA Supporting Publications articles: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2021.EN-6471/full, http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2021.EN-6472/full