2021
DOI: 10.1016/j.yrtph.2021.104885
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Regulatory landscape of nanotechnology and nanoplastics from a global perspective

Abstract: Nanotechnology and more particularly nanotechnology-based products and materials have provided a huge potential for novel solutions to many of the current challenges society is facing. However, nanotechnology is also an area of product innovation that is sometimes developing faster than regulatory frameworks. This is due to the high complexity of some nanomaterials, the lack of a globally harmonised regulatory definition and the different scopes of regulation at a global level. Research organisations and regul… Show more

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Cited by 141 publications
(74 citation statements)
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“…The safety assessment of medical devices containing or deriving from nanotechnology is carried out by the US-FDA's Centre for Devices and Radiological Health (CDRH), housing a Nanotechnology Regulatory Science Research Programme that is based on three pillars: physicochemical characterization methods, in vitro and in vivo models, and (toxicological) risk assessment [136,137]. The types of devices that incorporate nanotechnology include antimicrobial, dental, orthopaedic, neurological, and combination devices and in vitro diagnostic tools.…”
Section: Regulatory Landscape Of Nanotechnology In Biomedical Applicationsmentioning
confidence: 99%
See 1 more Smart Citation
“…The safety assessment of medical devices containing or deriving from nanotechnology is carried out by the US-FDA's Centre for Devices and Radiological Health (CDRH), housing a Nanotechnology Regulatory Science Research Programme that is based on three pillars: physicochemical characterization methods, in vitro and in vivo models, and (toxicological) risk assessment [136,137]. The types of devices that incorporate nanotechnology include antimicrobial, dental, orthopaedic, neurological, and combination devices and in vitro diagnostic tools.…”
Section: Regulatory Landscape Of Nanotechnology In Biomedical Applicationsmentioning
confidence: 99%
“…It is important to know whether NPs affect the accuracy and/or reliability of standard biocompatibility or toxicity test assays, such as cytotoxicity and genotoxicity. Because of the vast number of sizes, shapes, and chemistry of nanomaterials, there is the need for the development of in vitro models (2D, 3D, organ on a chip, organoids) and in silico models in order to predict human responses and improve in vitro to in vivo extrapolations [137].…”
Section: Regulatory Landscape Of Nanotechnology In Biomedical Applicationsmentioning
confidence: 99%
“…Debido a esta variabilidad basada en los materiales, hoy en día la ciencia se enfrenta a vacíos de conocimiento sobre el destino y el comportamiento de los materiales de nano ingeniería en los sistemas de prueba y el medio ambiente (Gottschalk, Kost y Nowack, 2013). Por tanto, la nanotecnología y los nanomateriales tienen asociadas impredecibles consecuencias, especialmente en lo que se refiere a sus impactos negativos (Allan et al, 2021), plantean un desafío a la ley (Giusti et al, 2019), pues es necesario regular estas nuevas tecnologías a fin de prevenir violaciones de derechos, y aun así, seguirlas según las metas de desarrollo sostenible, propuestos por la Organización de las Naciones Unidas (ONU) hasta 2030.…”
Section: La Nanotecnología Sus Riesgos Y La Cuarta Revolución Industrialunclassified
“…However, plastic end-products include other additives (e.g., stabilizers, pigments) that signi cantly in uence their behavior (sorption, degradation, etc.) (Allan et al 2021;Ateia et al 2020;Saygin and Baysal 2020a-d). As a result, end-product plastics rather than pure material are more representative to understand their actions on human health.…”
Section: Introductionmentioning
confidence: 97%
“…Nowadays, plastics are an emerging global problem because they are considered to be the most widely used industrial products, and they are routinely released into the environment in either direct or indirect ways (Saygin and Baysal 2020a). These plastic particles (or items/debris) are synthetic organic polymer particles and depending on their size, shape, or color, they can be classi ed as micro-(5 mm to 1 µm), submicron-(1 µm to 100 nm), and nano-(< 100 nm) plastics (Bradney et al 2019;Baysal et al 2020;Allan et al 2021). Moreover, these plastic particles are grouped as primary and secondary plastic particles.…”
Section: Introductionmentioning
confidence: 99%