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REACH 计划寻求解决方案:对欧盟化学品法规进行必要修订,以实现安全评估现代化。

REACHing for solutions: Essential revisions to the EU chemicals regulation to modernise safety assessment.

机构信息

Humane Society International/Europe, Research & Toxicology, Av. des Arts 50, 1000, Brussels, Belgium.

Humane Society International/Europe, Research & Toxicology, Av. des Arts 50, 1000, Brussels, Belgium.

出版信息

Regul Toxicol Pharmacol. 2022 Dec;136:105278. doi: 10.1016/j.yrtph.2022.105278. Epub 2022 Oct 21.

Abstract

The Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation was created to protect human health and the environment through the better and earlier identification of harmful intrinsic properties of chemical substances on the European market. One of its central aims was the promotion of alternatives to animal testing, yet it has instead become a long tick-box list of in vivo experiments questionable relevance to human health outcomes despite a global trend towards new approach methods (NAMs) in chemical safety assessment. The Chemicals Strategy for Sustainability (CSS), proposed by the European Commission in 2020, is a golden opportunity to revise REACH in a significant and impactful way, yet proposals presented so far have significant negative animal welfare consequences. There is still time to correct the course of the ongoing REACH revision - proposals made herein offer a path towards the promising future intended by the CSS. These proposals are anchored in three vectors of action, varying in level of complexity - from changes that ECHA can implement to improve existing processes, through technical changes aimed at minimizing animal testing and increasing NAM acceptance, to deeper structural changes to establish non-animal testing strategies as the basis for risk assessment.

摘要

《化学品注册、评估、授权和限制法规》(REACH)的制定是为了通过更好地和更早地识别欧洲市场上化学物质的有害固有特性,来保护人类健康和环境。其主要目标之一是推广替代动物测试的方法,但它却成为了一份冗长的、需要进行大量体内实验的清单,这些实验与人类健康结果的相关性值得怀疑,尽管全球化学品安全评估领域都在朝着新方法(NAMs)的方向发展。2020 年,欧盟委员会提出了《化学品可持续战略》(CSS),这是一个以重大和有影响力的方式修订 REACH 的绝佳机会,但迄今为止提出的提案对动物福利产生了重大负面影响。现在仍有时间纠正正在进行的 REACH 修订的方向——本文提出的提案为 CSS 所期望的美好未来提供了一条途径。这些提案基于三个行动向量,其复杂性各不相同——从 ECHA 可以实施的改进现有流程的变更,到旨在最小化动物测试和增加 NAM 接受度的技术变更,再到更深入的结构变更,以建立非动物测试策略作为风险评估的基础。

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