The ANALYST project has received funding from the European Union’s Horizon Europe Research and Innovation Programme under the Grant Agreement No 101138548
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NILU
Aug 20, 2025
The findings are closely aligned with the ANALYST Project’s mission to support the operationalisation of SSbD principles across chemicals and materials. Developing and validating new digital and methodological approaches for assessing safety is crucial for building trust and advancing sustainable innovation in Europe.
We are pleased to announce a new publication developed with contributions from the ANALYST Project, recently featured in Frontiers in Toxicology (2025).
📘 Title: New Approach Methods (NAMs) for Genotoxicity Assessment of Nano- and Advanced Materials: Advantages and Challenges
✍️ Authors: Bengt Fadeel, Thomas Exner, Lesley Fletcher, Agnes Oomen, Julia Catalán, Davor Ivanković, and Iseult Lynch
🔗 DOI: https://doi.org/10.1016/j.mrgentox.2025.503867
Research Overview
As nanomaterials and advanced materials become increasingly important in industrial innovation, assessing their genotoxic potential is crucial to ensuring both safety and sustainability. Traditional genotoxicity tests, while widely used, face limitations in sensitivity, reproducibility, and applicability to nano-specific properties.
This paper explores the role of New Approach Methods (NAMs) as a promising way to overcome these gaps. By leveraging in vitro, in silico, and mechanistic approaches, NAMs aim to provide more predictive, efficient, and ethically responsible genotoxicity testing.
Key Contributions of the Study
The publication provides a critical overview of:
The advantages of NAMs: improved mechanistic understanding, reduced reliance on animal testing, and better alignment with regulatory goals.
The challenges ahead: lack of standardisation, the need for validation and regulatory acceptance, and integration of nano-specific considerations.
The role of NAMs in Safe and Sustainable by Design (SSbD): ensuring safety is addressed early in the innovation cycle for chemicals and materials.
Tools and Technical Highlights
In vitro models: advanced cellular and 3D models that mimic biological environments more accurately than traditional assays.
In silico approaches: computational modelling and data integration to predict genotoxic effects.
Mechanistic insights: NAMs allow the identification of pathways and modes of action relevant to nanomaterials.
Together, these methods pave the way for more comprehensive and reliable genotoxicity testing compared to conventional assays.
Implications and Future Outlook
The study highlights how NAMs can contribute to:
Stronger safety assessments for nanomaterials and advanced materials
Accelerated adoption of SSbD principles in research and industry
Improved regulatory decision-making and harmonisation across the EU
Looking ahead, the authors emphasise the need for:
Greater collaboration to standardise and validate NAMs
Integration of NAMs into regulatory frameworks
Expansion of research to close knowledge gaps in nanotoxicology
👉 Read the full open-access article here: https://zenodo.org/records/15722692
This publication is part of the ANALYST Project, funded by the European Union’s Horizon Europe Research and Innovation Programme under Grant Agreement No. 101138548.