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.
Specific environmental release categories (SPERCs) are an instrument for lower-tier environmental emissions assessments. They support chemical safety assessments under the European Union (EU) regulation Registration, Evaluation, Authorisation, and Restriction of Chemicals. SPERCs have been developed by industry and subjected to regulatory review. Within the framework of the Chemical Safety Report/Exposure Scenario Roadmap, the EU Chemicals Agency (ECHA), the EU Member State authorities, and European industry sector associations collaborate to improve the quality of the SPERCs. Following up on the outcome of ECHA's SPERC Best Practice Project, industry, together with ECHA, developed an updated SPERC factsheet template and guidance on how to fill it out. In addition, industry developed 2 sets of SPERC factsheet examples and the corresponding SPERC background documents. These documents were submitted to a multistakeholder review process. The comments from the review were discussed at a workshop in spring 2016. The workshop participants acknowledged the revised factsheet format including the corresponding guidance, the 2 SPERC factsheets, and the 2 SPERC background documents as best practice examples. The package is expected to support further improvement of the quality of the SPERCs. A common understanding was achieved of the need to match the level of detail of the use conditions description with the risk to be controlled (i.e., the emission intensity and hazard profile of the substances) and with the level of conservatism of SPERC release factors. The complete and transparent documentation of the derivation of the release factors and of their conservatism is conceived as crucial for the credibility of the SPERCs, such that they can be trusted by partners in the chemicals supply chain and by regulators. To that end, background documents will include a dedicated section describing the conservatism of SPERCs. The workshop concluded with an outline of the practical way forward for the improvement of SPERC documentation. Integr Environ Assess Manag 2017;13:815-820. © 2017 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals, Inc. on behalf of Society of Environmental Toxicology & Chemistry (SETAC).
The Nordic Product Registers and the future REACH substance databaseComparison of the registration systems and options for future developments Nordic cooperationNordic cooperation is one of the world's most extensive forms of regional collaboration, involving Denmark, Finland, Iceland, Norway, Sweden, and three autonomous areas: the Faroe Islands, Greenland, and Åland.Nordic cooperation has firm traditions in politics, the economy, and culture. It plays an important role in European and international collaboration, and aims at creating a strong Nordic community in a strong Europe.Nordic cooperation seeks to safeguard Nordic and regional interests and principles in the global community. (Denmark, Norway, Finland, Sweden) are already today obliged to register to the Nordic Product Registers (NPRs). With REACH entering into force it may be felt that reporting to the Nordic Product Registers and to Chemicals Agency is duplication of work and hence reporting under the NPRs should be ceased. In order to clarify the extent of overlap between the two systems and characterise the potential added value of the NPRs, the Nordic Product Register Group initiated a study to Oekopol.There are significant differences between the two systems with regard to both, the purpose of the system and the information content of the related data bases. The REACH registration process will not generate information on volumes and uses of substances similar to what is available from the Nordic Product Registers. Thus replacing the NPRs with a future REACH substance register would lead to a significant loss of information essential for targeting and balancing chemicals policy.While REACH is a system to register single substances only, in the NPRs substances and preparations are registered. Hence, the overlap between the information being available in the NPRs and the future REACH data base is limited to the identity of substances, the identity of companies manufacturing or importing substances and to the generic use of a substance as anticipated by the substance manufacturer. Information related to single preparations on the market or single preparation makers like available in the NPRs will not be part of the REACH substance data base. Also, it will hardly be possible to obtain relevant time trend information on market volumes and shifts in the use patterns of substances from the future REACH data base.The added value of the NPRs during the implementation phase of REACH and after REACH has entered into full operation can be summarized in three items: 12The Nordic Product Registers and the future REACH substance database• Product registers of the NPRs-type can be used as a tool to support and enforce the implementation of REACH at the level of preparation makers and preparation importers. The functioning of the REACH system very much depends on whether the downstream user requirements will really work in practice. Based on the NPRs information the inspectorates can directly follow up the response of formulators receiving the extended Safety D...
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