Low Exposures: European collaborative research efforts and future focus areas

In the last two decades, sustainable and safe use of chemicals became a focal point of various international policy efforts and has been addressed through launching of chemical management systems worldwide. In the EU, the regulation on Registration, Evaluation and Authorization of Chemicals (REACH) primarily concentrates on generating substance intrinsic properties data (including hazard) depending on the tonnage being registered. However, using the chemical production/import volume alone as a proxy/indicator of true exposures undermines risk management decision making and deprives exposure information of its real power (e.g. smart studies design, more efficient prioritization). The European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC) together with the European Chemical Industry Council Long Range Initiative program streamline their research efforts towards gaining wider regulatory acceptance of exposure-informed testing and risk management practices. This presentation provides an overview of recent industry-funded research building a knowledgebase on tools and methods for assessment of low exposure. The problem definition of low exposure in various contexts will be discussed, focusing on aspects/factors that make low exposure very important in certain situations. A detailed outline will be provided for multiple projects that consider low exposure from different
perspectives. The examples will cover comparative exposure analysis of alternative exposure sources to the same substance, assessment of intentional and non-intentional exposure, exposure based waiving and workplace risk assessment. The presented material should inform the workshop participants about the ECETOC’s perspective on the importance/weight of (low) exposure in regulatory risk assessment and set the stage for a follow-up panel discussion to help identify remaining knowledge gaps and future focus areas.