Abstract

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.

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