Evidence mapPaperPMID 42484809Full record

ReviewNano convergence2026

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

Eunseo Lee, Aline Chary, Zayakhuu Gerelkhuu, Pamina Weber, Ishita Virmani, Beatrice A Brugger, Iris Renata Sousa Ribeiro, Emilie Brun, Valentina Lacconi, Hyojoo Bang and 30 more

Abstract readReview
In one paragraph

Review in Nano convergence, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

40 authors.

Eunseo LeeDepartment of Chemistry, Hanyang University, Seoul, 04763, Republic of Korea.
Aline CharyEnvironmental Health group - SUSTAIN Unit, Luxembourg Institute of Science and Technology, L4422, Belvaux, Esch-sur-Alzette, Luxembourg.
Zayakhuu GerelkhuuDepartment of Chemistry, Hanyang University, Seoul, 04763, Republic of Korea.
Pamina WeberEnvironmental Health group - SUSTAIN Unit, Luxembourg Institute of Science and Technology, L4422, Belvaux, Esch-sur-Alzette, Luxembourg.
Ishita VirmaniInstitute of Medical Biochemistry, Medical University Innsbruck, 6020, Innsbruck, Austria.
Beatrice A BruggerNanomaterials in Health Lab, Swiss Federal Laboratories for Materials Science and Technology (Empa), 9014, St. Gallen, Switzerland.
Iris Renata Sousa RibeiroBrazilian Nanotechnology National Laboratory (LNNano), Brazilian Center for Research in Energy and Materials (CNPEM), Campinas, São Paulo, Brazil.
Emilie BrunSchool of Geography, Earth and Environmental Sciences, University of Birmingham, Birmingham, B15 2TT, UK.
Valentina LacconiDepartment of Biomedicine and Prevention, University of Rome Tor Vergata, 00133, Rome, Italy.
Hyojoo BangDepartment of Chemistry, Hanyang University, Seoul, 04763, Republic of Korea.
Ik Hwan KwonNanobio Measurement Group, Division of Biomedical Metrology, Korea Research Institute of Standards and Science, Daejeon, 34113, Republic of Korea.
Anna PohlAcumenIST SRL, 1040, Brussels, Belgium.
Juyong YoonKorea Institute of Science and Technology (KIST) Europe Forschungsgesellschaft mbH, Campus E7.1, 66123, Saarbrücken, Germany.
Shin Woong KimCenter for Ecotoxicology and Environmental Future Research, Korea Institute of Toxicology (KIT), Jinju, 52834, Republic of Korea.
Anastasios Tassos PapadiamantisDepartment of Cheminformatics, NovaMechanics Ltd., 1070, Nicosia, Cyprus.
Riju Roy ChowdhuryIUF - Leibniz Research Institute for Environmental Medicine, 40225, Düsseldorf, Germany.
Dong-Youn HwangOrganoidsciences, Ltd., Osong, Chungbuk, 28160, Republic of Korea.
Lara LamonESQlabs GmbH, 26683, Saterland, Germany.
Melanie-Jasmin OrtInstitute of Medical Biochemistry, Medical University Innsbruck, 6020, Innsbruck, Austria.
Martin PaparellaInstitute of Medical Biochemistry, Medical University Innsbruck, 6020, Innsbruck, Austria.
Ekaterina A SosninaInstitute of Medical Biochemistry, Medical University Innsbruck, 6020, Innsbruck, Austria.
Angela SerraFinnish Hub for Development and Validation of Integrated Approaches (FHAIVE), Faculty of Medicine and Health Technology, Tampere University, 33100, Tampere, Finland.
Jack MorikkaFinnish Hub for Development and Validation of Integrated Approaches (FHAIVE), Faculty of Medicine and Health Technology, Tampere University, 33100, Tampere, Finland.
Lorenzo CampiniFinnish Hub for Development and Validation of Integrated Approaches (FHAIVE), Faculty of Medicine and Health Technology, Tampere University, 33100, Tampere, Finland.
Katharina KochIUF - Leibniz Research Institute for Environmental Medicine, 40225, Düsseldorf, Germany.
Antreas AfantitisDepartment of Cheminformatics, NovaMechanics Ltd., 1070, Nicosia, Cyprus.
Dario GrecoFinnish Hub for Development and Validation of Integrated Approaches (FHAIVE), Faculty of Medicine and Health Technology, Tampere University, 33100, Tampere, Finland.
Iseult LynchSchool of Geography, Earth and Environmental Sciences, University of Birmingham, Birmingham, B15 2TT, UK.
Kristie SullivanInstitute for In Vitro Sciences, Inc. (IIVS), Gaithersburg, MD, 20878, USA.
Seokjoo YoonCenter for Biomimetic Research, Korea Institute of Toxicology (KIT), Daejeon, 34114, Republic of Korea.
Tae Geol LeeNanobio Measurement Group, Division of Biomedical Metrology, Korea Research Institute of Standards and Science, Daejeon, 34113, Republic of Korea.
June-Woo ParkCenter for Ecotoxicology and Environmental Future Research, Korea Institute of Toxicology (KIT), Jinju, 52834, Republic of Korea.
Diego Stéfani Teodoro MartinezBrazilian Nanotechnology National Laboratory (LNNano), Brazilian Center for Research in Energy and Materials (CNPEM), Campinas, São Paulo, Brazil.
Vivekkumar P DadhaniaSciQra LLC, Old Bridge, NJ, 08857, USA.
Luisa CampagnoloDepartment of Biomedicine and Prevention, University of Rome Tor Vergata, 00133, Rome, Italy.
Winfried NeuhausCompetence Unit Molecular Diagnostics, AIT Austrian Institute of Technology GmbH, 1210, Vienna, Austria.
Steffi FriedrichsAcumenIST SRL, 1040, Brussels, Belgium.
Tina Buerki-ThurnherrNanomaterials in Health Lab, Swiss Federal Laboratories for Materials Science and Technology (Empa), 9014, St. Gallen, Switzerland.
Tae Hyun YoonDepartment of Chemistry, Hanyang University, Seoul, 04763, Republic of Korea. taeyoon@hanyang.ac.kr.ORCID http://orcid.org/0000-0002-2743-6360
Tommaso SerchiEnvironmental Health group - SUSTAIN Unit, Luxembourg Institute of Science and Technology, L4422, Belvaux, Esch-sur-Alzette, Luxembourg. tommaso.serchi@list.lu.ORCID http://orcid.org/0000-0003-2386-3514

Funding

Conselho Nacional de Desenvolvimento Científico e Tecnológico 443735/2023-9Fundação de Amparo à Pesquisa do Estado de São Paulo 2024/00989-7Fundação de Amparo à Pesquisa do Estado de São Paulo 2025/22280-2HORIZON EUROPE Digital, Industry and Space 101092686HORIZON EUROPE Digital, Industry and Space 101137613HORIZON EUROPE Digital, Industry and Space 101178074National Research Foundation of Korea RS-2024-00452934National Research Foundation of Korea RS-2025-25458852Swiss State Secretariat for Education, Research and Innovation 23.00141Swiss State Secretariat for Education, Research and Innovation 24.00029
6 · The paper itself

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.

Indexed as

NanomaterialsNanotechnologyNew approach methodologies (NAMs)Next-generation risk assessment (NGRA)Regulatory acceptanceSafe and sustainable by design (SSbD)

Identifiers

PMID42484809
PMCPMC13391997

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.