Administrative guidance for the preparation of applications on smoke flavouring primary products

This document provides guidance to applicants submitting applications onsmoke 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 2021to the competent authority of a Member State, or to the European Commission in case of renewal applications.

The Transparency Regulation amended the General Food Lawby introducing new provisionsin 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), notificationof 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 confidentialitydecision‐making process, public consultation on submitted applications. These new requirements, as implemented by the Practical Arrangementslaid downby EFSA, are reflected in this guidance.

The guidance describes the procedure and the associated timelines for handlingapplications onsmoke 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.