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WIREs Nanomed Nanobiotechnol
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A global view of regulations affecting nanomaterials

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Abstract The 2000s have been characterized by an unprecedented exploration into research and development of nanotechnology and nanomaterials. Despite a slow start, new regulatory initiatives are popping up like mushrooms internationally. Many of these initiatives have yet to materialize themselves or are soft law initiatives, and their impact on the development of more authoritative and prescriptive regulatory measures is most likely to be limited. This is due to a number of transnational regulatory challenges that include: (1) whether to adapt existing legislation or develop a new regulatory framework, (2) whether nanomaterials should be considered as different from their bulk counterparts, (3) how to define nanotechnology and nanomaterials, and (4) how to deal with the profound limitations of risk assessment when it comes to nanomaterials. In this opinion, I discuss these and related issues and conclude that the development of a new authoritative and prescriptive regulatory framework might be the only way to effectively address these challenges while ensuring a transparent and informed decision‐making process. WIREs Nanomed Nanobiotechnol 2010 2 441–449 This article is categorized under: Toxicology and Regulatory Issues in Nanomedicine > Regulatory and Policy Issues in Nanomedicine

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