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在化学立法中实施“必要用途”概念的数据要求。

Data Requirements for Implementing the "Essential-Use" Concept in Chemical Legislation.

作者信息

Figuière Romain, Wang Zhanyun, Glüge Juliane, Scheringer Martin, Siegrist Armin, Cousins Ian T

机构信息

Department of Environmental Science, Stockholm University, SE-10691 Stockholm, Sweden.

Empa─Swiss Federal Laboratories for Materials Science and Technology, Technology and Society Laboratory, 9014 St. Gallen, Switzerland.

出版信息

Environ Sci Technol. 2025 Jun 10;59(22):10770-10780. doi: 10.1021/acs.est.4c10866. Epub 2025 Jun 2.

DOI:10.1021/acs.est.4c10866
PMID:40454792
Abstract

The Stockholm Convention and the EU REACH Regulation are two key pieces of legislation on chemicals at the global and European levels, respectively. Discussions have taken place on revising them. For instance, the European Commission is considering implementing the "essential-use" concept in the REACH Regulation to guide decision-making for phasing-out the use of the most harmful chemicals. By assessing 34 existing cases under the Stockholm Convention and 45 restrictions and 544 applications for authorization under the REACH regulation (as of November 2023), this study aims to capture how the essential-use concept may inform decision-making on exemptions and provide insights on its implementation. By conducting a detailed case study of the REACH restriction on intentionally added microplastics, this study also aims to explore how the existing data requirements in regulatory processes could be used in an essentiality assessment. Overall, this study suggests that the Stockholm Convention and the REACH Regulation already consider elements of the concept in their decision-making and that no drastic changes in the data requirements are necessary to apply the concept in decision-making processes.

摘要

《斯德哥尔摩公约》和欧盟《化学品注册、评估、授权和限制法规》(REACH法规)分别是全球和欧洲层面关于化学品的两项关键立法。关于修订这两项法规的讨论已经展开。例如,欧盟委员会正在考虑在REACH法规中实施“必要用途”概念,以指导逐步淘汰最有害化学品使用的决策。通过评估《斯德哥尔摩公约》下的34个现有案例以及REACH法规下的45项限制措施和544项授权申请(截至2023年11月),本研究旨在了解“必要用途”概念如何为豁免决策提供参考,并就其实施提供见解。通过对REACH法规中对有意添加微塑料的限制进行详细案例研究,本研究还旨在探索监管过程中现有的数据要求如何用于必要性评估。总体而言,本研究表明,《斯德哥尔摩公约》和REACH法规在其决策过程中已经考虑了该概念的要素,并且在决策过程中应用该概念无需对数据要求进行大幅更改。

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本文引用的文献

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