Copernicus Institute of Sustainable Development, Utrecht University, Princetonlaan 8a, CB, Utrecht, 3584, the Netherlands.
Department of Mathematical Sciences, Chalmers University of Technology, Gothenburg, SE-412 96, Sweden.
J Environ Manage. 2021 Feb 15;280:111692. doi: 10.1016/j.jenvman.2020.111692. Epub 2020 Dec 6.
With the Green Deal the EU aims to achieve a circular economy, restore biodiversity and reduce environmental pollution. As a part of the Green Deal a 'one-substance one-assessment' (OS-OA) approach for chemicals has been proposed. The registration and risk assessment of chemicals on the European market is currently fragmented across different legal frameworks, dependent on the chemical's use. In this review, we analysed the five main European chemical registration frameworks and their risk assessment procedures for the freshwater environment, covering 1) medicines for human use, 2) veterinary medicines, 3) pesticides, 4) biocides and 5) industrial chemicals. Overall, the function of the current frameworks is similar, but important differences exist between the frameworks' environmental protection goals and risk assessment strategies. These differences result in inconsistent assessment outcomes for similar chemicals. Chemicals are also registered under multiple frameworks due to their multiple uses, and chemicals which are not approved under one framework are in some instances allowed on the market under other frameworks. In contrast, an OS-OA will require a uniform hazard assessment between all different frameworks. In addition, we show that across frameworks the industrial chemicals are the least hazardous for the freshwater environment (median PNEC of 2.60E-2 mg/L), whilst biocides are the most toxic following current regulatory assessment schemes (median PNEC of 1.82E-4 mg/L). Finally, in order to facilitate a successful move towards a OS-OA approach we recommend a) harmonisation of environmental protection goals and risk assessment strategies, b) that emission, use and production data should be made publicly available and that data sharing becomes a priority, and c) an alignment of the criteria used to classify problematic substances.
欧盟通过《绿色协议》旨在实现循环经济、恢复生物多样性并减少环境污染。作为《绿色协议》的一部分，提议采用一种针对化学品的“一种物质一种评估”（OS-OA）方法。目前，欧洲市场上化学品的注册和风险评估分散在不同的法律框架中，取决于化学品的用途。在这项研究中，我们分析了欧洲五个主要的化学品注册框架及其针对淡水环境的风险评估程序，涵盖了 1）人用药品、2）兽用药品、3）农药、4）生物杀灭剂和 5）工业化学品。总体而言，当前框架的功能相似，但在环境保护目标和风险评估策略方面存在重要差异。这些差异导致对类似化学品的评估结果不一致。由于化学品的多种用途，它们也在多个框架下进行注册，而在一个框架下未获得批准的化学品，在某些情况下可能会在其他框架下获准上市。相比之下，OS-OA 将要求在所有不同框架之间进行统一的危害评估。此外，我们还表明，在各个框架下，工业化学品对淡水环境的危害性最小（PNEC 中位数为 2.60E-2 mg/L），而生物杀灭剂在现行监管评估方案下毒性最大（PNEC 中位数为 1.82E-4 mg/L）。最后，为了促进向 OS-OA 方法的成功过渡，我们建议：a）协调环境保护目标和风险评估策略，b）公开排放、使用和生产数据，并将数据共享作为优先事项，以及 c）统一用于分类有问题物质的标准。
