Supporting Integrated Chemical Risk Management: Aligning Safe and Sustainable by Design and EU Ecolabel Decision Frameworks.

Abstract

The increasing proliferation of policy-driven frameworks addressing chemical safety and sustainability has intensified the need for coherence and integration in environmental assessment and management. In the European context, Safe and Sustainable by Design (SSbD) and the EU Ecolabel represent influential but conceptually distinct instruments that may yield divergent conclusions when applied to the same product system, potentially challenging transparent and consistent decision-making. This study examines the extent to which such divergences arise from differences in assessment logic rather than from conflicting scientific evidence, using a structured case study of a representative consumer product formulation. An integrated assessment approach was applied, combining exposure-informed regulatory risk characterization with life-cycle-based toxicity prioritization. Occupational and environmental risks were quantified using established regulatory tools (Chesar® and EUSES 2.1.2), while potential human toxicity and freshwater ecotoxicity impacts were evaluated using USEtox® characterization factors. Results indicate that regulatory acceptability thresholds were achieved for nearly all modeled exposure scenarios, with a marginal exceedance of the average dermal risk characterization ratio observed for Cocamidopropyl betaine under conservative occupational exposure assumptions. In contrast, life-cycle toxicity indicators revealed marked differences in relative substance contributions to potential human and ecological impacts, reflecting intrinsic hazard and fate properties rather than exposure-driven risk. The comparative analysis demonstrates that apparent inconsistencies between SSbD and EU Ecolabel outcomes are primarily attributable to differences in decision logic, assessment scope, and the weighting of hazard-, exposure-, and life-cycle-based information. Building on these findings, a conceptual integration model is proposed to support transparent interpretation and reconciliation of assessment results across frameworks. The study contributes to ongoing discourse within the environmental assessment community by illustrating how complementary use of regulatory risk assessment and life-cycle toxicity indicators can enhance chemical risk management, reduce misalignment between policy instruments, and support more informed and consistent sustainability-oriented decisions.