Specific Consumer Exposure Determinants (SCEDs): Refining Default Values in Screening Level REACH Assessments

摘要

The EU Registration, Evaluation and Authorization of Chemicals (REACH) regulation requires that conditions of safe use be specified for all uses EU classified substances are sold into. Meeting this regulation required a significant expansion of traditional hazard based approaches to incorporate exposure and risk elements. Key factors that enabled developing an approach and information to meet the REACH requirements on-time included stakeholder dialogue, common and consistent terminology, and implementation of a tiered and targeted approach to exposure and risk assessment. Within this approach, the European Center for Ecotoxicology and Toxicology of Chemicals Targeted Risk Assessment tool (ECETOC TRA) is a preferred exposure tool for conducting screening level exposure assessments (lower tier) under REACH. Based upon the experiences in developing the initial wave of registrations in 2010, it has been recognized that there are cases where refining default values for consumer exposure scenarios can be an effective way to extend TRA utility. The concept of Specific Consumer Exposure Determinants (SCEDs) as a way to realize this enhanced utility was put forth by ECETOC and subsequently expanded upon by the Downstream Users of Chemicals Coordination Group. The SCEDs concept, template, and underlying principles put forth a consistent and transparent way to utilize more realistic values in place of default parameters for specific consumer exposure scenarios. Within the tiered process, they enable an intermediate step in refinement that can utilize the screening level TRA tool without going to a higher tier more resource intensive model. The SCEDs are based upon basic principles which include transparency and use of common elements. This presentation will discuss the basis of SCEDs and current status of the SCEDs library.