This document provides guidance to applicants submitting applications on substances that may be used in components of active and intelligent materials and articles intended to come into contact with food, 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 or for the modification of an existing authorisation of substances used in components of active and intelligent materials and articles intended to come into contact with food, for applications submitted to the competent authority of a Member State 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 active or intelligent substances present in active and intelligent materials and articles intended to come into contact with food, 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