This document provides guidance on the submission of applications for authorisation of a novel food in the European Union within the scope of Article 10 of Regulation (EU) 2015/2283 and according to Commission Implementing Regulation (EU) 2017/2469. The guidance is currently composed of a completeness checklist which reflects the data requirements for applications on novel foods, as outlined in the EFSA ‘Guidance on the preparation and presentation of an authorisation of a novel food in the context of Regulation (EU) 2015/2283’ and four tables on the scientific studies provided in the technical dossier. EFSA recommends applicants to use the completeness checklist and the summary tables during the preparation of a technical dossier on novel foods to ensure that the criteria for the completeness of the data for risk assessment are met. The information contained in this document only applies to applications submitted under Article 10 of Regulation (EU) 2015/2283.
Administrative guidance on the submission of applications for authorisation of a novel food pursuant to Article 10 of Regulation (EU) 2015/2283
First published in EFSA Supporting Publications:
15 febbraio 2018
7 febbraio 2018