Developing a Tiered Safety Assessment Strategy for Safe and Sustainable by Design Applications

The Safe and Sustainable by Design (SSbD) framework supports the development of chemicals and materials by embedding safety and sustainability considerations throughout the innovation process. While the framework is applicable across sectors, its implementation in the plastics value chain remains limited. In this context, the Horizon Europe project ANALYST is developing a tiered and iterative SSbD assessment strategy aligned with technology readiness levels (TRLs), following the Joint Research Centre SSbD methodological guidance.

Across all assessment levels, the ANALYST approach starts with systematic data collection and curation, supported by natural language processing (NLP) tools to extract and organize existing information from diverse sources. Building on this foundation, the safety strategy is structured into three progressive levels addressing human and environmental health. At early innovation stages (TRL 1–3), where data are limited, the assessment relies on New Approach Methodologies (NAMs), with a strong emphasis on the use of in silico tools for hazard identification, and conservative exposure and risk considerations. At intermediate stages (TRL 4–6), in vitro NAMs and more advanced exposure models are integrated, enabling preliminary risk characterization. At later stages (TRL 7–9), the strategy supports comprehensive safety assessment in line with regulatory requirements, covering the full life cycle and value chain of plastic-based materials.

Beyond safety, the ANALYST framework integrates environmental, social, and economic dimensions within the SSbD concept, supported by a digital decision-support tool for multicriteria evaluation. The overall framework is being tested and validated through case studies in the plastics sector, to demonstrate how a tiered, NAM-based safety strategy can inform safer and more sustainable innovation pathways.