This guidance document is applicable for applications submitted until 26 March 2021.
This document provides guidance to applicants submitting applications for authorisation of substances to be used in plastic food contact materials within the scope of Regulation (EC) No 1935/2004 and according to Commission Regulation (EU) No 10/2011, as amended. This guidance describes the procedures in place in the European Union for handling applications, from submission of an application to the adoption and publication of the EFSA scientific opinion. It provides instructions on how to prepare a dossier for the safety evaluation by EFSA and is supplemented with three appendices downloadable from the EFSA website. The format provided in the appendixes shall be followed by applicants to present data required for the application. The information contained in this guidance is valid for all applications submitted under Articles 9 and 12 of Regulation (EC) No 1935/2004. The document ultimately presents the different possibilities to interact with EFSA staff and the support initiatives available during the different stages of the application life-cycle.