The European Chemical Industry Guidance on REACH Exposure Assessment Strategies for Substances in Articles

Abstract

Under the European Regulation on Registration, Evaluation and Authorization of Chemicals (REACH) safety assessments of hazardous substances should cover all identified end-uses, including those that lead to the inclusion into articles. Characterization of risks to human health and/or the environment from the subsequent service life cycle stage requires a substantial level of detail on article composition, design, manufacturing process, use patterns under normal reasonably foreseeable conditions, i.e., the information that is not typically available or provided to chemical manufacturers by their downstream users.To overcome this lack of supply chain communication and to ensure consistency in understanding and addressing the problem across all REACH stakeholders, the European Chemical Industry Council (CEFIC) has developed a practical guidance/framework for REACH registrants to help them screen for the necessity of developing exposure scenarios for the service life stage of their substances based on the (limited) information available in the downstream sector use maps. The decision-making framework in the guidance utilizes REACH use description elements such as contributing scenario names, sector of use, and technical function of the substance, as well as the article characteristics known to drive release/exposure potential (e.g. article matrix, shape, intended use pattern).The presentation will outline the decision tree and include introduction to the Release from Articles Potential (RAP) Excel-based tool designed to assist on the determination of a substance’s release/emissions based on its technical function in the article. Application of the workflow will be demonstrated with examples for two substances used in the road construction applications and polymer production.