New approach methodologies for next-generation risk assessment of nanomaterials and nano-enabled products

New Approach Methodologies (NAMs) are increasingly promoted for animal-free nanosafety assessment, yet their regulatory use remains constrained by fragmented regulatory criteria and nanomaterial-specific testing complexities. This review comprehensively analyzes the convergence of advanced cell biology, nanotechnology, and information technology in reshaping safety evaluations, with a focus on regulatory translation across global frameworks. We first summarize enabling technologies, including advanced in vitro and ex vivo systems, organoids, microphysiological systems, high-dimensional single-cell multi-omics and label-free hyperspectral imaging, AutoML, generative AI, physiologically based kinetic modeling, and in vitro-to-in vivo extrapolation. We then analyze the regulatory landscape, emphasizing OECD harmonization efforts, the Mutual Acceptance of Data system, and regional developments across Europe, Africa, the Americas, and Asia-Pacific. A central theme is that regulatory acceptance of NAMs for nanomaterials requires not only biological relevance, reproducibility, and context-of-use definition, but also robust physicochemical characterization, exposure control, dosimetry, and data interoperability. Industrial implementation in pharmaceuticals, cosmetics, agrochemicals, antimicrobials, and environmental protection is discussed as a measure of regulatory readiness and scalability. Finally, we outline future directions involving Smart NAMs, digital twins, and Safe and Sustainable by Design (SSbD) frameworks. By integrating technological, regulatory, and implementation perspectives, this review identifies pathways toward harmonized, mechanistic, and human- or target species-relevant next-generation risk assessment (NGRA) for nanotechnology.

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Publication Details

Journal
Nano Convergence
Published
2026-07-22
DOI
https://doi.org/10.1186/s40580-026-00566-w
Primary Topic
Nanoparticles: synthesis and applications
Type
article
Field-Weighted Citation Impact
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New approach methodologies for next-generation risk assessment of nanomaterials and nano-enabled products

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article en

Abstract

New Approach Methodologies (NAMs) are increasingly promoted for animal-free nanosafety assessment, yet their regulatory use remains constrained by fragmented regulatory criteria and nanomaterial-specific testing complexities. This review comprehensively analyzes the convergence of advanced cell biology, nanotechnology, and information technology in reshaping safety evaluations, with a focus on regulatory translation across global frameworks. We first summarize enabling technologies, including advanced in vitro and ex vivo systems, organoids, microphysiological systems, high-dimensional single-cell multi-omics and label-free hyperspectral imaging, AutoML, generative AI, physiologically based kinetic modeling, and in vitro-to-in vivo extrapolation. We then analyze the regulatory landscape, emphasizing OECD harmonization efforts, the Mutual Acceptance of Data system, and regional developments across Europe, Africa, the Americas, and Asia-Pacific. A central theme is that regulatory acceptance of NAMs for nanomaterials requires not only biological relevance, reproducibility, and context-of-use definition, but also robust physicochemical characterization, exposure control, dosimetry, and data interoperability. Industrial implementation in pharmaceuticals, cosmetics, agrochemicals, antimicrobials, and environmental protection is discussed as a measure of regulatory readiness and scalability. Finally, we outline future directions involving Smart NAMs, digital twins, and Safe and Sustainable by Design (SSbD) frameworks. By integrating technological, regulatory, and implementation perspectives, this review identifies pathways toward harmonized, mechanistic, and human- or target species-relevant next-generation risk assessment (NGRA) for nanotechnology.

Nano ConvergenceVol. 13(1)
University of Rome Tor Vergata (IT), Danube Private University (AT), Thorlabs (Germany) (DE), AIT Austrian Institute of Technology GmbH (AT), Innsbruck Medical University (AT), Tampere University (FI), Korea Research Institute of Standards and Science (KR), Joongbu University (KR), Frederick University (CY), KIST Europe (DE), Korea Institute of Toxicology (KR), Leibniz Institute of Environmental Medicine (DE), Acumen (United States) (US), Larnaca College (CY), Institute for In Vitro Sciences (US), Luxembourg Institute of Science and Technology (LU), Institute for Experimental Psychophysiology (Germany) (DE), NovaMechanics (Cyprus) (CY), Brazilian Center for Research in Energy and Materials (BR), Bridge Pharma (United States) (US), Hanyang University (KR), Swiss Federal Laboratories for Materials Science and Technology (CH), University of Birmingham (GB)
Openalex Percentile: Top 19%
Nanoparticles: synthesis and applications
DOIOpen Access PDFOpenAlex
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