Administrative guidance for the preparation of applications on smoke flavouring primary products
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Note: This administrative guidance was first published on 5 March 2021 and has been updated on 3 August 2022 and on 13 December 2022. A List of changes introduced in August and in December 2022 is provided in Annex A. To avoid confusion, the previous versions of the guidance have been removed from the EFSA Journal, but are available on request.
Abstract
This document provides guidance to applicants submitting applications on smoke flavouring primary products, 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, for the modification or the renewal of an existing authorisation of smoke flavouring primary products, for applications submitted as of 27 March 2021 to the competent authority of a Member State, or to the European Commission in case of renewal applications.
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, specific aspects for intended applications for renewal (notification of intended studies, including their design, public consultation on the intended studies, renewal pre‐submission advice by EFSA), 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 smoke flavouring primary products, 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.