Analysis of international regulatory requirements for safety of cosmetics with nanotechnology
Vigil Sanit Debate, Rio de Janeiro, 2026, v.14: e02491| Published on: 2026-05-05
DOI:
https://doi.org/10.22239/2317-269x.02491Keywords:
Nanotechnology, Nanomaterial, Cosmetics, Safety, Regulatory ScienceAbstract
Introduction: Cosmetics formulated with nanotechnology (1.0 x 10–⁹ m) have great market potential due to their effectiveness and consumer satisfaction. Objective: To conduct a documentary review of international regulatory requirements related to the safety of cosmetics containing nanomaterials. Method: A systematic documentary analysis was performed using official websites of eight regulatory agencies: the United States, European Union, Canada, Japan, Australia, China, India, and South Korea. The research was structured using the PICOT acronym. Documents were screened based on inclusion and exclusion criteria and evaluated by peer reviewers. Data extraction was conducted using REDCap® software and organized into thematic frameworks. Results: Nine documents were included, with emphasis on those issued by the SCCS (EU), FDA (USA), ICCR, and MHLW (Japan). Regulatory convergence was observed in aspects such as the physicochemical characterization of nanomaterials (including size, morphology, purity, and stability) and the requirement for specific testing related to dermal irritation, inhalation toxicity, genotoxicity, and skin absorption. The analyzed documents highlight that nanomaterials may exhibit physicochemical properties, biological interactions, and toxicological effects distinct from the same ingredients on a conventional scale — with magnetic, optical, structural, electrical, and chemical differences that may impact product performance, safety, and efficacy. Conclusions: There is no international regulatory consensus on mandatory criteria for the use
of nanomaterials in cosmetics. Agencies recommend multiple validated tests, applied to different product batches, and emphasize the importance of detailed physicochemical characterization as well as dose–response assessment as essential requirements. The experience of more established jurisdictions can support the advancement of the Brazilian regulatory framework in this emerging field.
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Author Biographies
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Glécia Virgolino da Silva Luz, Programa de Pós-graduação em Engenharia Biomédica (PPGEB), Faculdade de Ciências e Tecnologias em Engenharia (FCTE), Universidade de Brasília (UnB), Brasília, DF, Brasil | Núcleo de Avaliação de Tecnologias em Saúde (NATS), Universidade de Brasília (UnB), Brasília, DF, Brasil
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Ludmilla Pinto Guiotti Cintra Abreu, Programa de Pós-graduação em Engenharia Biomédica (PPGEB), Faculdade de Ciências e Tecnologias em Engenharia (FCTE), Universidade de Brasília (UnB), Brasília, DF, Brasil
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Nashira Vieira O’Reilly Cabral Posada, Coordenação de Registro de Cosméticos e Saneantes (CRCOS), Gerência-Geral de Cosméticos e Saneantes (GGOCS). Agência Nacional de Vigilância Sanitária (Anvisa). Brasília, DF, Brasil
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Ronaldo Gonçalves Abreu, Programa de Pós-graduação em Engenharia Biomédica (PPGEB), Faculdade de Ciências e Tecnologias em Engenharia (FCTE), Universidade de Brasília (UnB), Brasília, DF, Brasil
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Gleide Célia Virgolino da Silva, Programa de Pós-graduação em Engenharia Biomédica (PPGEB), Faculdade de Ciências e Tecnologias em Engenharia (FCTE), Universidade de Brasília (UnB), Brasília, DF, Brasil
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Graziella Anselmo Joanitti, Programa de Pós-graduação em Engenharia Biomédica (PPGEB), Faculdade de Ciências e Tecnologias em Engenharia (FCTE), Universidade de Brasília (UnB), Brasília, DF, Brasil
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Marcella Lemos Brettas Carneiro, Programa de Pós-graduação em Nanociência e Nanobiotecnologia (PPGNANO), Instituto de Biologia, Universidade de Brasília (UnB), Brasília, DF, Brasil
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