CHIASMA

The European chemicals market operates under stringent safety regulations (REACH, CLP, Biocidal Products Regulation), yet current risk assessment practices still heavily rely on animal testing to predict long-term health hazards such as cancer, neurodegenerative diseases, or respiratory sensitization. Although ethical and societal pressures have pushed for animal-free alternatives, technical/scientific constraints and the time required for regulatory acceptance have significantly slowed the introduction of New Approach Methodologies (NAMs).

A key challenge lies in proving that NAMs can reliably predict long-term safety endpoints — a gap that regulators, industry, and academia urgently need to close. The project builds upon a rich legacy of EU-funded R&I including NanoHarmony, Gov4Nano, NanoRIGO, PHOENIX, SCENARIOS, MACRAMÉ, and POTENTIAL, consolidating years of knowledge in nanosafety, computational modelling, and regulatory frameworks.

CHIASMA devises and demonstrates a comprehensive set of NAMs integrated into a user-friendly, reliable, and robust framework — the CHIASMA SSbD (Safe & Sustainable by Design) Assessment — enabling human and environmental safety evaluation in a regulatory context .

The framework uniquely combines three complementary pillars:

• Chemocentric approaches (QSAR models, read-across, text mining, knowledge graphs)
• Biocentric approaches (OMICS analyses, Adverse Outcome Pathways – AOPs, Integrated Approaches to Testing and Assessment – IATAs)
• New experimental models (advanced in vitro liver models, inhalation toxicology models)

All data and methods will be FAIR-ified and GLP-ified, ensuring transparency, reproducibility, and regulatory readiness . The framework is accessible through an open, user-friendly software interface, removing technical barriers for regulators and industry alike.

The project is applied to three high-relevance demo cases: 1) PFAS (Per- and polyfluoroalkyl substances), 2) Nano-pesticides, and 3) 2D materials for energy applications — chemicals and materials of high societal, economic, and safety concern.

LIST's role: As project coordinator, LIST leads WP2 (regulatory support & stakeholder outreach) and WP9 (overall project management). LIST contributes to NAM development, in-project validation, framework construction, and bridges the gap between scientific disciplines and regulatory requirements — leveraging its expertise in environmental sciences, IT, and safety assessment.

Key Deliverables include:

• Reports on NAM performance, prediction of long-term health effects, and establishment of experimental NAMs
• CHIASMA Knowledge Graph and analytical module for multi-layer chemocentric modelling
• Regulatory dossiers (GLP-ified protocols) submitted to OECD and EURL ECVAM for formal NAM validation
• Harmonization & Standardization Roadmap for NAMs
• Open SSbD Assessment Framework with a user-friendly software interface

Industry & Regulatory Impact: CHIASMA will provide industry and public authorities with innovative tools for faster, more comprehensive, and more ethical safety assessments, covering a wider range of chemicals and advanced materials. By enabling safety screening in the early phases of R&I, CHIASMA supports Europe's green and digital transitions and contributes to EU industrial leadership in sustainable value chains.

Real-life Applications:

• Accelerated regulatory approval of novel materials and chemicals (supporting REACH/CLP compliance)
• Animal-free toxicology services commercialisable through platforms like PHOENIX-OITB
• Safety screening of PFAS, nanomaterials, and 2D materials for electronics, textiles, and energy sectors
• Decision-support tools for risk assessors, contract research organizations (CROs), and policy makers

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More information on the project