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PFASs 限制提案意见——ECHA 的附件 XV 限制报告,限制提案,2023 年 3 月。

PFASs-restriction proposal commentary on ECHA's Annex XV restriction report, proposal for a restriction, March 2023.

机构信息

Formerly Public Health Agency of Lower Saxony, Hannover, Germany.

University of Applied Sciences Hochschule Emden/Leer, Emden, Germany.

出版信息

Arch Toxicol. 2023 Dec;97(12):3305-3312. doi: 10.1007/s00204-023-03597-y. Epub 2023 Oct 6.

DOI:10.1007/s00204-023-03597-y
PMID:37801158
Abstract

PFASs are defined as substances that contain at least one fully fluorinated methyl (CF-) or methylene (-CF-) carbon atom. The excellent technical properties of members of the PFAS group have led to their use in a wide range of applications. The substance group comprises more than 10,000 individual compounds. A variety of adverse effects has been described for single substances. For the majority of the PFASs, neither toxicokinetic data nor effect data is available. Hence, because of the small number of PFASs for which a full toxicological profile is available, grouping based on the existing data is not feasible. A critical problem of PFASs and their degradation products is the very high persistence, which clearly fulfils the criterion for the substance property Very Persistent (vP) according to Annex XIII of the REACH Regulation. Because of this property the European Commission is planning to take action. Defining suitable subgroups appears to be a scientifically based approach. However, to reach this goal, large data gaps would have to be closed which would take up to centuries, a time-frame, which is not defendable with respect to potential irreversible harm. Because of the time pressure resulting from the potential irreversible harm, the precautionary principle has been selected as an appropriate tool to handle PFASs and in the restriction proposal PFASs are treated as one group. This approach is justified in the view of the advisory committee of the German Society for Toxicology. ECHA's proposal received a lot of attention in the public. However, communication so far has obviously led to the misunderstanding of a proven health hazard for all PFASs. Communication should explain the justification of the broad inclusion of substances as being based on the precautionary principle. Data gaps versus current knowledge need to be clearly communicated; communication should also include the possibility for derogation of essential use. It should address the issue of suitable substitutes to avoid unintended health consequences; and it should mention that existing persistent environmental contamination calls for developing innovation in remediation techniques.

摘要

全氟和多氟化合物 (PFAS) 被定义为至少含有一个全氟化甲基 (CF-) 或亚甲基 (-CF-) 碳原子的物质。PFAS 组的成员具有出色的技术特性,因此被广泛应用于各种领域。该物质组包含超过 10,000 种不同的化合物。已经描述了单一物质的多种不良影响。对于大多数 PFAS,既没有毒代动力学数据,也没有效应数据。因此,由于只有少数 PFAS 具有完整的毒理学概况,基于现有数据进行分组是不可行的。PFAS 及其降解产物的一个关键问题是它们具有非常高的持久性,这显然符合 REACH 法规附件 XIII 中物质特性“非常持久 (vP)”的标准。由于这一特性,欧盟委员会正计划采取行动。确定合适的亚组似乎是一种基于科学的方法。然而,要实现这一目标,必须填补大量的数据空白,这可能需要几个世纪的时间,从潜在的不可逆转损害的角度来看,这个时间框架是不可接受的。由于潜在的不可逆转损害带来的时间压力,预防原则已被选为处理 PFAS 的合适工具,在限制提案中,PFAS 被视为一个整体。德国毒理学学会咨询委员会认为,这种方法是合理的。ECHA 的提案在公众中引起了广泛关注。然而,迄今为止的沟通显然导致了对所有 PFAS 都存在已证实的健康危害的误解。沟通应该解释将物质广泛纳入的理由是基于预防原则。需要明确传达数据空白与当前知识之间的关系;沟通还应包括对基本用途豁免的可能性。它应该解决合适替代品的问题,以避免意外的健康后果;并提到现有的持久性环境污染需要开发修复技术的创新。

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