Administrative guidance for the preparation of applications for the authorisation of individual recycling processes to produce recycled plastics materials and articles intended to come into contact with food1

Abstract

This document provides guidance to applicants submitting applications for the authorisation of individual recycling processes that use a suitable technology to produce recycled plastic materials and articles intended to come into contact with food, which are to be evaluated by EFSA. Currently post-consumer mechanical PET recycling is the only suitable technology listed in Annex I to Commission Regulation (EU) 2022/1616 that requires individual authorisation. Consequently, this guidance describes the administrative requirements for the preparation and online submission of the dossier to support applications, submitted to the competent authority of a Member State for a new authorisation or for the modification of an authorisation of an individual recycling process based on post-consumer mechanical PET recycling as technology. It does not apply to novel technologies developed in accordance with Chapter IV of Commission Regulation (EU) 2022/1616. 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 individual recycling processes that use a suitable technology, 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.