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<p>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.</p> Graphical abstract

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

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年7月22日

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  • Eunseo Lee,
  • Aline Chary,
  • Zayakhuu Gerelkhuu,
  • Pamina Weber,
  • Ishita Virmani,
  • Beatrice A. Brugger,
  • Iris Renata Sousa Ribeiro,
  • Emilie Brun,
  • Valentina Lacconi,
  • Hyojoo Bang,
  • Ik Hwan Kwon,
  • Anna Pohl,
  • Juyong Yoon,
  • Shin Woong Kim,
  • Anastasios Tassos Papadiamantis,
  • Riju Roy Chowdhury,
  • Dong-Youn Hwang,
  • Lara Lamon,
  • Melanie-Jasmin Ort,
  • Martin Paparella,
  • Ekaterina A. Sosnina,
  • Angela Serra,
  • Jack Morikka,
  • Lorenzo Campini,
  • Katharina Koch,
  • Antreas Afantitis,
  • Dario Greco,
  • Iseult Lynch,
  • Kristie Sullivan,
  • Seokjoo Yoon,
  • Tae Geol Lee,
  • June-Woo Park,
  • Diego Stéfani Teodoro Martinez,
  • Vivekkumar P. Dadhania,
  • Luisa Campagnolo,
  • Winfried Neuhaus,
  • Steffi Friedrichs,
  • Tina Buerki-Thurnherr,
  • Tae Hyun Yoon,
  • Tommaso Serchi

摘要

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.

Graphical abstract