The European Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation has been in force since 2007 and is intended to ensure a high level of protection for human health and the environment. The REACH regulation is based on the principle that manufacturers, importers, and downstream users take responsibility for their chemicals. Currently about 23 000 single chemicals are registered within the REACH legislation. A large proportion of substances registered under REACH end up in technical mixtures, intentionally manufactured as such, or generated mixtures containing byproducts of processes. Such mixtures that contain a number of different components are, for example, ink, paint, lacquer, mortar, or cleaning agents. However, REACH focuses on single substances and addresses the safe use of substances as such (e.g., bisphenol A) or substances in mixtures (e.g., bisphenol A used as an antioxidant in mixtures) and in articles (e.g., bisphenol A used as a monomer for polycarbonate production from which greenhouse sheets may be made). In contrast to other substance regulations, under REACH the registrants and downstream users of chemicals are responsible for the risk assessment. According to the REACH regulation, they also have the obligation to derive and communicate safe use conditions for their technical mixtures. Currently, no guidance document and no distinct obligations for an assessment of technical mixtures exist. In light of the available evidence for the joint exposures and effects of chemicals due to co‐exposures, the need for approaches for a mixture assessment and improved data communications were highlighted by various stakeholders from industry, European member states, and the European Chemicals Agency (ECHA). The lead component identification (LCID) methodology and the safe use of mixtures information (SUMI) tool were proposed by the European Chemical Industry Council (Cefic) as working tools for the evaluation of the hazard potential, derivation of safe use conditions, and data communication for mixtures along the supply chain. The present paper analyzes the workability and pitfalls of these proposed methodologies from a regulatory perspective, aiming at a safe use of technical mixtures which considers the joint effects and exposures of its components. Integr Environ Assess Manag 2021;17:498–506. © 2021 Umweltbundesamt. Integrated Environmental Assessment and Management published by Wiley Periodicals LLC on behalf of Society of Environmental Toxicology & Chemistry (SETAC)

中文翻译：

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欧洲化学品注册，评估，授权和限制下技术混合物的环境风险评估-监管角度

欧洲化学品注册，评估，授权和限制（REACH）法规自2007年起生效，旨在确保对人类健康和环境的高度保护。REACH法规基于制造商，进口商和下游用户对其化学品负责的原则。目前，REACH法规中注册了约23000种单一化学品。根据REACH法规注册的大部分物质最终成为有意制造的技术混合物或含有工艺副产品的混合物。包含许多不同组分的此类混合物是例如油墨，油漆，清漆，灰浆或清洁剂。但是，REACH侧重于单一物质，并着眼于物质的安全使用（例如，双酚A）或混合物中的物质（例如，双酚A在混合物中用作抗氧化剂）和物品中的物质（例如，双酚A用作聚碳酸酯生产的单体，可制成温室板材）。与其他物质法规相反，根据REACH，化学品的注册人和下游用户应负责风险评估。根据REACH法规，他们还有义务推导出并传达其技术混合物的安全使用条件。目前，没有指导文件，也没有明确的技术混合评估义务。鉴于现有证据表明，由于共同暴露而导致化学品的共同暴露和影响，因此，各行业的利益相关者都强调需要进行混合物评估和改善数据交流的方法，欧洲成员国和欧洲化学品管理局（ECHA）。欧洲化学工业理事会（Cefic）提出了铅成分识别（LCID）方法和混合物安全使用信息（SUMI）工具，作为评估潜在危险，推导安全使用条件和进行数据通讯的工具供应链中的混合物。本文从监管的角度分析了这些提议方法的可操作性和陷阱，旨在安全使用技术混合物，其中考虑了其成分的共同影响和暴露。欧洲化学工业理事会（Cefic）提出了铅成分识别（LCID）方法和混合物安全使用信息（SUMI）工具，作为评估潜在危险，推导安全使用条件和进行数据通讯的工具供应链中的混合物。本文从监管的角度分析了这些提议方法的可操作性和陷阱，旨在安全使用技术混合物，其中考虑了其成分的共同影响和暴露。欧洲化学工业理事会（Cefic）提出了铅成分识别（LCID）方法和混合物安全使用信息（SUMI）工具，作为评估潜在危险，推导安全使用条件和进行数据通讯的工具供应链中的混合物。本文从监管的角度分析了这些提议方法的可操作性和陷阱，旨在安全使用技术混合物，其中考虑了其成分的共同影响和暴露。Integr环境评估管理2021； 17：498-506。版权©2021 Umweltbundesamt。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》