EFSA administrative guidance for the preparation of applications for authorization of substances for use in active and intelligent materials

This guide, published by EFSA, provides guidance for applicants wishing to submit applications for the evaluation of substances that may be used in the manufacture of active and intelligent food contact materials and articles under Regulation (EC) 450/2009.

This document describes the administrative requirements for the preparation and online submission of the application dossier for a new authorization of substances or modification of an existing authorization from March 27, 2021. This administrative guide replaces the chapters of the EFSA guidelines published in 2009 (Guidelines on submission of a dossier for safety evaluation by the EFSA of active or intelligent substances present in active and intelligent materials and articles intended to come into contact with food) containing administrative information. These EFSA guidelines have therefore been updated without the administrative information. This new guide takes into account the new provisions introduced into Regulation (EC) No. 178/2002 (General Food Law) and Regulation (EC) No. 1935/2004 by the Transparency Regulation (EU) 2019/1381. The latter amends the general food law by introducing the following new provisions in the pre-submission phase and in the application procedure for the evaluation of substances intended for use in active and intelligent objects and materials:

• General pre-submission advice: potential applicants can request optional submission advice (advice on applicable rules and required content for an application) from EFSA at any time before submitting their application. EFSA recommends submitting this request at least 6 months before the envisaged submission, and provides comments within 15 working days of receipt of the application form. Issues related to hypotheses to be tested, risk management, any information beyond that available in the legislation and guidance in this document will be considered out of scope.
• Notification of information relating to studies commissioned or carried out in support of an application: applicants are required to notify EFSA without delay of information relating to the study (title and scope of the study, testing laboratory carrying out the study, planned start and end dates). The notification must be submitted without delay on the dedicated EFSA website before the study start date. A justification is requested for any study notification submitted after the study start date.
• Public disclosure of the non-confidential version of all information submitted in support of the application and of the confidentiality decision-making process.
• Public consultation on submitted applications: this third-party consultation remains open for a period of 3 weeks.

The guide also describes the procedure and associated deadlines for processing applications concerning the authorization of these substances, the various possibilities for interacting with EFSA and the support initiatives available from the pre-submission phase through to the adoption and publication of EFSA's scientific opinion.

In accordance with Article 5 of Commission Regulation (EC) No 450/2009, substances must be included in the Union list of substances authorized for use in components of active and intelligent materials and articles.

For applications submitted before March 27, 2021, the previous version of the EFSA guide applies (EFSA, 2009).