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
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Disclaimer: This document is subject to the formal agreement of the European Commission as per Article 20(1) of Regulation EU 2022/1616. It is therefore provisional in nature and may be subject to further modifications until the finalised administrative guidance will be published, following receipt of the formal agreement of the European Commission. This provisional document is published for the benefit of the applicants preparing an application under Regulation EU 2022/1616, however it cannot result in any binding obligations and cannot give rise to any legitimate expectations of future conduct. Only the finalised version that will be published in the future can be considered as the applicable administrative guidance document.”
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.