Within the European regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH, EC No 1907/2006) specific provisions for nanomaterials were included, which have become effective on 1 January 2020. Although knowledge on the peculiarities of testing and assessing fate and effects of nanomaterials in the environment strongly increased in the last years, uncertainties about how to perform a reliable and robust environmental risk assessment for nanomaterials still remain. These uncertainties are of special relevance in a regulatory context, challenging both industry and regulators. The present paper presents current challenges in regulatory hazard and exposure assessment under REACH, as well as classification of nanomaterials, and makes proposals to address them. Still, the nanospecific considerations made here are expected to also be valid for environmental risk assessment approaches in other regulations of chemical safety. Inter alia, these proposals include a way forward to account for exposure concentrations in aquatic toxicity test systems, a discussion of how to account for availability of dissolving nanomaterials in aquatic test systems, and a pragmatic proposal to deduce effect data for soil organisms. Furthermore, it specifies how to potentially deal with nanoforms under the European regulation on Classification, Labelling and Packaging of substances and mixtures (CLP) and outlines the needs for proper exposure assessments of nanomaterials from a regulatory perspective. Integr Environ Assess Manag 2020;16:706–717. © 2020 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals LLC on behalf of Society of Environmental Toxicology & Chemistry (SETAC)

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根据REACH法规，根据新的义务对纳米材料的环境风险评估：哪些挑战仍然存在，以及如何应对？

在《欧洲化学品注册，评估，授权和限制法规》（REACH，EC No 1907/2006）中，包括了有关纳米材料的特定规定，该规定已于2020年1月1日生效。尽管有关测试和评估命运的特殊性的知识近年来，纳米材料在环境中的作用大大增加，如何对纳米材料进行可靠而可靠的环境风险评估仍然存在不确定性。这些不确定性在监管环境中具有特殊意义，对行业和监管机构均构成挑战。本文介绍了目前在REACH法规监管危害和暴露评估以及纳米材料分类方面的挑战，并提出了应对这些挑战的建议。仍然，在其他化学安全法规中，预期此处进行的纳米特定考虑对于环境风险评估方法也将有效。除其他外，这些建议包括解决水生毒性测试系统中暴露浓度的方法，讨论如何考虑在水生测试系统中溶解纳米材料的可用性以及实用的建议以推论土壤生物的影响数据。此外，它规定了如何根据欧洲物质和混合物的分类，标签和包装法规（CLP）处理纳米形态，并从法规角度概述了对纳米材料进行适当暴露评估的需求。这些建议包括解决水生毒性测试系统中暴露浓度的方法，讨论如何考虑水生测试系统中可溶性纳米材料的可用性以及推论土壤生物效应数据的实用建议。此外，它规定了如何根据欧洲物质和混合物的分类，标签和包装法规（CLP）处理纳米形态，并从法规角度概述了对纳米材料进行适当暴露评估的需求。这些建议包括解决水生毒性测试系统中暴露浓度的方法，讨论如何考虑水生测试系统中可溶性纳米材料的可用性以及推论土壤生物效应数据的实用建议。此外，它规定了如何根据欧洲物质和混合物的分类，标签和包装法规（CLP）处理纳米形态，并从法规角度概述了对纳米材料进行适当暴露评估的需求。Integr环境评估管理2020； 16：706–717。©2020作者。Wiley Periodicals LLC代表环境毒理化学协会（SETAC）发布的《综合环境评估与管理》