Article | REF: NM4040 V1

Nanotoxicology and nanomedicine regulation

Authors: Elias FATTAL, Hervé HILLAIREAU

Publication date: April 10, 2020

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1. Regulatory definition of a nanomedicine

Nanomedicines are partly composed of nanomaterials. They therefore meet the definitions and standards set by the European Union. The European Commission defines nanomaterials as follows:

"A nanomaterial is a natural, accidentally formed or manufactured material containing free particles or in aggregate or agglomerate form, at least 50% of whose particles, in numerical size distribution, have one or more external dimensions between 1 and 100 nm".

The recommendation adds that "Any material is to be considered as falling within the definition if it has a specific surface area by volume greater than 60 m 2 /cm 3 ". However, any material which, on the basis of its numerical size distribution, constitutes a nanomaterial...

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Regulatory definition of a nanomedicine