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Abstract：
In the context of entry into force of Regulation (EU) 2022/1616, EFSA updated the scientific guidance to assist applicants in the preparation of applications for the authorisation or for the modification of an existing authorisation of a \'post-consumer mechanical PET\' recycling process (as defined in Annex I of Regulation (EU) 2022/1616) intended to be used for manufacturing materials and articles intended to come into contact with food. This Guidance describes the evaluation criteria and the scientific evaluation approach that EFSA will apply to assess the decontamination capability of recycling processes, as well as the information required to be included in an application dossier. The principle of the scientific evaluation approach is to apply the decontamination efficiency of a recycling process, obtained from a challenge test with surrogate contaminants, to a reference contamination level for post-consumer PET, set at 3 mg/kg PET for a contaminant resulting from possible misuse. The resulting residual concentration of each surrogate in recycled PET is then compared to a modelled concentration in PET that is calculated using generally recognised conservative migration models, such that the related migration does not give rise to a dietary exposure exceeding 0.0025 μg/kg body weight (bw) per day. This is the lowest threshold for toxicological concern (TTC) value, i.e. for potential genotoxicity, below which the risk to human health would be negligible. The information to be provided in the applications relates to: the recycling process (i.e. collection and pre-processing of the input, decontamination process, post-processing and intended use); the determination of the decontamination efficiency by the challenge test; the self-evaluation of the recycling process. On the basis of the submitted data, EFSA will assess the safety of the mechanical PET recycling process.
摘要：
在法规（EU）2022/1616生效的背景下，EFSA更新了科学指南，以协助申请人准备授权或修改现有授权的“消费后机械PET”回收过程（如法规（EU）2022/1616的附件I所定义），旨在用于制造与食品接触的材料和物品。本指南描述了EFSA将用于评估回收过程的去污能力的评估标准和科学评估方法，以及申请档案中需要包含的信息。科学评估方法的原则是应用回收过程的去污效率，从具有替代污染物的挑战测试中获得，到消费后PET的参考污染水平，对于可能误用造成的污染物，将PET设定为3mg/kg。然后，将回收PET中每种替代物的最终残留浓度与使用公认的保守迁移模型计算的PET中的建模浓度进行比较。因此，相关的迁移不会导致饮食暴露超过每天0.0025μg/kg体重（bw）。这是毒理学关注（TTC）值的最低阈值，即潜在的遗传毒性，在此之下，对人类健康的风险可以忽略不计。在应用程序中提供的信息涉及：回收过程（即输入的收集和预处理，净化过程，后处理和预期用途）；通过挑战测试确定去污效率；回收过程的自我评估。根据提交的数据，EFSA将评估机械PET回收工艺的安全性。
