Reihlen Antonia, Bahr Tobias, Bögi Christian, Dobe Christopher, May Thomas, Verdonck Frederik, Wind Thorsten, Zullo Lorenzo, Tolls Johannes
Ökopol GmbH, Hamburg, Germany.
ACEA - European Automobile Manufacturers Association, Brussels, Belgium.
Integr Environ Assess Manag. 2016 Oct;12(4):772-81. doi: 10.1002/ieam.1745. Epub 2016 Mar 9.
The European Union (EU) chemicals regulation Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) requires a hazardous substance registration to identify the uses of a substance and the corresponding conditions of safe use. This requirement includes a human and an environmental safety assessment. Exposure scenarios are developed and employed for estimating emissions resulting from the uses of hazardous substances. To support the environmental assessments, the REACH guidance documents define 22 environmental release categories (ERCs) with conservative release factors (RFs) to water, air, and soil. Several industry associations target the ERCs to more specific uses and respective emission scenarios to enable more realistic emission estimations. They have developed more than 190 specific ERCs (SPERCs) as standardized descriptions of operational conditions (OCs) and risk management measures (RMMs). SPERCs reflect the current good practice and are documented in factsheets. These factsheets contain the information necessary for environmental emission modeling. Key parameters are the substance use rate, the efficiency of the risk management measures (if applicable), and the RFs. These parameters can be based on literature or measured company data or are justified by qualitative arguments. The majority of SPERCs have been implemented as realistic worst-case emission values in screening-level chemical safety assessment (CSA) tools. Three regulatory reviews in Europe have established requirements for documenting the SPERCs and for justifying the RFs. In addition, each of the reviews included recommendations for improving the SPERCs. The latest review proposed a condensed factsheet that focuses on the essentials for exposure assessment and subsequent communication in safety data sheets. It is complemented with a background document for providing details on the emission scenarios and justifications. In the EU the SPERCs will be further progressed in a consensus process using the multi-stakeholder expert network on exposure scenarios. The SPERCs have the potential to be used in environmental risk assessments within other regulatory frameworks or in other geographical regions. Integr Environ Assess Manag 2016;12:772-781. © 2015 SETAC.
欧盟（EU）化学品法规《化学品的注册、评估、授权和限制》（REACH）要求对有害物质进行注册，以确定物质的用途及相应的安全使用条件。该要求包括对人类和环境的安全评估。需制定并采用暴露场景来估算有害物质使用所产生的排放。为支持环境评估，REACH指导文件定义了22种环境释放类别（ERC），并给出了针对水、空气和土壤的保守释放因子（RF）。一些行业协会将ERC针对更具体的用途及相应的排放场景，以实现更现实的排放估算。他们已制定了190多种特定环境释放类别（SPERC），作为操作条件（OC）和风险管理措施（RMM）的标准化描述。SPERC反映了当前的良好做法，并记录在情况说明书中。这些情况说明书包含环境排放建模所需的信息。关键参数包括物质使用率、风险管理措施的效率（如适用）以及释放因子。这些参数可基于文献、公司实测数据或通过定性论证来确定。大多数SPERC已作为现实的最坏情况排放值应用于筛选级化学安全评估（CSA）工具中。欧洲已进行的三项监管审查确立了记录SPERC及证明释放因子合理性的要求。此外，每项审查都包含了改进SPERC的建议。最新审查提出了一份精简的情况说明书，重点关注暴露评估及后续安全数据表中信息交流的要点。并辅以一份背景文件，以提供排放场景及论证的详细信息。在欧盟，SPERC将通过使用多利益相关方暴露场景专家网络，在一个共识过程中进一步推进。SPERC有潜力用于其他监管框架内或其他地理区域的环境风险评估。《综合环境评估与管理》2016年；12：772 - 781。© 2015 SETAC。
