Joint Regulatory Risk Assessors Summit in Paris: nanoPASS Partners Advance Animal-Free Safety Testing for Advanced Materials

The Joint Regulatory Risk Assessors Summit at OECD Conference Centre in Paris (19–20 June 2025) brought together nearly 100 participants from 23 countries to address challenges in safety and sustainability assessments of advanced materials. Co-organised by EU Horizon Europe projects MACRAMÉ, iCARE, nanoPASS, and ACCORDs, the event strengthened dialogue between science and regulation, focusing on test method development, harmonisation, and uptake of New Approach Methodologies across the lifecycle of advanced materials.

Event Overview

The summit gathered diverse stakeholders including policy makers, regulators, industry representatives, academia, contract research organisations, and NGOs. Sessions covered stakeholder panels on regulatory testing challenges, advanced material characterisation in complex matrices, human health models for safety prediction, environmental fate and ecotoxicity testing, and industrial lifecycle testing approaches.

Key challenges identified included regulatory uncertainty and fragmentation, test method gaps requiring OECD Test Guideline updates, timeline misalignment between research projects and regulatory adoption cycles, limited laboratory capacity for new method uptake, lifecycle perspective requirements, SME scalability needs, and communication linking safety with innovation and competitiveness.

nanoPASS Contributions

nanoPASS partners showcased innovative animal-free testing methodologies and quantitative Adverse Outcome Pathway (AOP) development through strategic presentations and posters:

• [Presentation] Validating animal-free in-vitro-learned digital twin for quantitative inflammation predictionfrom acute to chronic condition addressing 4 OECD Test Guidelines (Janez Štrancar, Infinite Biotech)
• [Poster] OP237: Particle-Induced Acute Phase Response Leading to Atherosclerosis (Ulla Vogel, NFA)
• [Poster] AOP302: Lung surfactant inhibition as a predictor for lung toxicity (Jorid Sørli, NFA)
• [Presentation] Sampling and testing industrially relevant materials: Possibilities and Pitfalls (Christina Isaxon, Lund University)

Key Outcomes and Future Directions

The summit highlighted the transformative potential of digital tools, FAIR data, and AI-based analyses while acknowledging validation and regulatory acceptance challenges. A critical barrier identified was the lack of sustained, strategically coordinated funding to bridge research, validation, and regulatory uptake.

The summit's emphasis on cost-efficient, high-throughput screening approaches directly supports nanoPASS's mission of shifting testing from late endpoints to early key events leading to adverse outcomes. The project's work on four critical adverse outcomes—reduced lung function (AOP302), chronic inflammation, cardiovascular disease (AOP237), and neurodegeneration—demonstrates practical applications of New Approach Methodologies that can replace animal testing while providing more mechanistic insights into material safety.

These advances align with regulatory needs for validated, standardised protocols that can be widely adopted. The upcoming 3rd Joint Workshop on Harmonisation and Standardisation of Test Methods for Nanomaterials and Advanced Materials (3-4 November 2025, online) will continue building on these collaborative efforts. Keep an eye our website for registrations details and the agenda.

Through its focus on animal-free prediction models and quantitative Adverse Outcome Pathways, nanoPASS advances the regulatory science needed for faster, more ethical assessment of advanced materials across their lifecycle.