Framework on Exposure-Based Adaptation of (human health) REACH hazard information requirements

Report no. 7/25: This report presents a framework for Exposure-Based Adaptation (EBA) of human health hazard information requirements under REACH, developed by Concawe’s Special Task Force on Human Exposure (H/STF-29). It aims to support scientifically justified adaptations (waivers) of information requirements when human exposure is demonstrably low.

The framework outlines key principles for EBA, including scenario definition, exposure estimation, derivation of health-based reference values, and interpretation of margins of exposure. It emphasizes tiered, flexible, and transparent application, aligning with REACH Annex XI provisions.

However, a critical conclusion of the report is that the current framework is not applicable to petroleum UVCBs. Due to the complex and variable composition of these substances, it is not feasible to relate specific hazard endpoints to measurable constituent exposures in a way that meets the scientific and regulatory expectations for EBA. The framework is therefore scoped for discrete substances and not intended for complex UVCBs.

Illustrative examples are provided to demonstrate application of the framework to well-characterized substances under realistic worker exposure conditions. The report concludes with recommendations for further refinement and regulatory engagement to improve clarity and applicability of EBA, while reinforcing its limited current relevance for petroleum-derived UVCBs.