摘要:
1993年欧盟议会首次通过了已有物质的健康风险评估和危险物质对人类健康危害的风险评估2个指令,继而发布了技术指导文件并沿用至今,欧盟还据此颁布了以《化学品的注册、评估、授权和限制》(Regulation Concerning the Registration, Evaluation, Authorization and Restriction of Chemicals, REACH)为代表的一系列化学品管控法规,促进了化学生产、使用与管控技术的革新。本文综述了欧盟健康风险评估的发展历程、主要步骤方法及其应用进展。欧盟的健康风险评估主要从化学品的释放源和全生命周期入手,对化学品进行综合全面管控。其风险评估技术指导手册架构完整、内容详尽,整体上从危害识别、剂量-效应关系、暴露评估和风险表征4个部分进行了介绍,对健康风险评估中的标准方法、数据来源、参数选择与模型应用做出规定。并以此导则中的办法为基础,对141种化学品进行评估,推出一系列化学品管理办法,实现了优先控制化学品的筛选,值得我国化学品研究与管理工作者借鉴。
Abstract:
In 1993, the European Parliament adopted two original directives, to provide reference for the risk assessment of existing substances and the human health risk assessment for dangerous substance, and then issued the Technical Guidance Document, which has been using until now. The European Union (EU) has also promulgated a chemical control regulations named “Regulation Concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH)”, which has promoted the innovation of chemical production, using and control technologies. This paper reviews the development history, main steps of the EU health risk assessment, and its applications. The EU’s human health risk assessment mainly focuses on the release source and the whole life cycle of chemicals, which carries out comprehensive control of chemicals. The guidance manual on risk assessment is complete in structure and detailed in content. As a whole, it contains four parts: hazard identification, dose-effect relationship, exposure assessment and risk characterization, in which the document defined the standard methods, data sources, parameter selection and model application in health risk assessment. The methods in these guidelines were successfully applied for 141 chemicals to identify the priority controlled chemicals, which is worthwhile for the control and management of chemicals in China.
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