Safe and Sustainable by Design: a paradigm shift in chemical risk assessment and occupational hygiene.

This paper analyses the European Safe and Sustainable by Design paradigm as a prevention-oriented approach to chemical risk assessment, highlighting its integration of hazard reduction, exposure minimisation, life-cycle thinking and occupational hygiene into early-stage innovation governance. The production and use of chemicals are central to modern economies, health technologies, food systems, the energy transition and digital innovation. However, chemical life cycles also contribute to human and environmental exposure, ecosystem degradation and climate-related burdens. Conventional regulatory risk assessment has provided important safeguards, but it is increasingly challenged by the scale of chemical production, complex mixtures, emerging materials, data gaps and the persistence of hazardous substances. Against this background, the European Union has promoted the Safe and Sustainable by Design (SSbD) paradigm as a prevention-oriented approach to chemical and material innovation. This commentary discusses SSbD as a paradigm shift in chemical risk assessment, with particular attention to exposure science and occupational hygiene. The Joint Research Centre initially operationalised SSbD through the 2022 framework, structured around a redesign phase and five assessment steps. Following testing and stakeholder feedback, the framework was revised in 2025 and incorporated into Commission Recommendation (EU) 2026/510, strengthening scoping analysis, integrated safety assessment, process-related risk considerations, socio-economic sustainability, evaluation and documentation. This commentary discusses how SSbD does not replace risk assessment; rather, it extends it by linking hazard-based screening with exposure assessment, life-cycle thinking, New Approach Methodologies (NAMs), biomonitoring and decision-making across innovation stages. Exposure science is therefore a critical component of SSbD, because safe design requires knowledge of real-world exposures in occupational, consumer and environmental contexts. Occupational hygiene provides an additional operational bridge, translating SSbD principles into anticipation, recognition, evaluation and control of workplace exposures, especially for carcinogenic, mutagenic and reprotoxic substances. The implementation of SSbD still faces substantial challenges, including limited data availability, uncertainty, the integration of safety and sustainability metrics, interdisciplinary capacity needs and the risk of superficial “SSbD-washing”. Nevertheless, SSbD offers an important opportunity to reconfigure chemical innovation around prevention, worker protection, environmental sustainability and societal responsibility.