Regulatory clarification on the use of nanoparticles in masks
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10/06/2021
In a notice to operators, the DGCCRF and ANSM recalled some essential points to be considered before marketing surgical masks. In particular, the risks related to the presence of a biocidal substance or material must be assessed and that this assessment must take into account, among others, the particular risk of exposure to nanoparticles.
If the mask incorporates a nanomaterial, it will fall under Class IIa, IIb, or III with respect to internal exposure potential under Regulation (EU) 2017/745 on medical devices and this will therefore require the involvement of a notified body.
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