Presentation
This guide, published by EFSA, provides guidance to applicants who wish to submit applications for the evaluation of substances that may be used in the manufacture of plastic materials and articles intended for food contact (MCDA) under Regulation (EU) 10/2011.
This document describes the administrative requirements for the preparation and online submission of the application dossier for a new substance authorization or modification of an existing authorization from March 27, 2021. This administrative guide replaces the previous 2017 version (Administrative Guidance for the preparation of applications for the safety assessment of substances to be used in plastic Food Contact Materials). The 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 plastic MCDAs:
- 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 Commission Regulation (EU) No. 10/2011, substances must be included in the Union list of substances authorized and intended for intentional use in the manufacture of plastic materials and articles.
For applications submitted before March 27, 2021, the previous version of the EFSA guidance applies (EFSA, 2017).