Administrative guidance for the preparation of notifications and applications on traditional foods from third countries in the context of Regulation (EU) 2015/2283

Abstract

This document provides guidance to notifiers or applicants submitting notifications or applications of traditional foods from third countries 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 a notification pursuant to Article 14 of Regulation (EU) 2015/2283 for a new authorisation of a traditional food from third countries, or applications for authorisation of traditional foods from third countries pursuant to Article 16 of Regulation (EU) 2015/2283. The Transparency Regulation amended the General Food Law by introducing provisions in the pre-submission phase and in the notification/application procedure: general pre-submission advice, notification of information related to studies commissioned or carried out to support a notification/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 notifications/applications on traditional foods and the support initiatives available from the preparation of the notification/application (pre-submission phase) to the publication of EFSA's technical report on the notification, or the adoption and publication of EFSA's scientific opinion in case of an application. It also takes into account the updated Guidance on the scientific requirements for a notification and application for authorisation of traditional foods from third countries in the context of Regulation (EU) 2015/2283, which provides advice on the scientific information needed to be provided in a traditional food notification or application.