Regulatory clarification on the use of nanoparticles in masks

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Brief
covid-19 masks biocide regulation

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.

Upcoming Nano Agenda

6
Juin
2024
Managing the risks associated with nanomaterials (CEA, Grenoble)
Grenoble
Training
  • Awareness-raising aimed at personnel in contact with nanomaterials during research, formulation, production, maintenance, cleaning, upkeep, etc., as well as safety coordinators or engineers, facility managers, heads of laboratories where nanoparticles are handled.
  • Organizers: INSTN Grenoble (CEA)
  • On the agenda: potential impact on health; metrology and protection; control of potential risks associated with nanomaterials; consideration of societal aspects.
  • Website: https://instn.cea.fr/formation/maitrise-des-risques-lies-aux-nanomateriaux-sensibilisation
6
Juin
2024
Nanomaterials and Health (ANSES, Maisons-Alfort)
Maisons-Alfort
Dialogue Committee
10
Sep.
2024
Managing the risks associated with nanomaterials (CEA, Grenoble)
Grenoble
Training
  • Awareness-raising aimed at personnel in contact with nanomaterials during research, formulation, production, maintenance, cleaning, upkeep, etc., as well as safety coordinators or engineers, facility managers, heads of laboratories where nanoparticles are handled.
  • Organizers: INSTN Grenoble (CEA)
  • On the agenda: potential impact on health; metrology and protection; control of potential risks associated with nanomaterials; consideration of societal aspects.
  • Website: https://instn.cea.fr/formation/maitrise-des-risques-lies-aux-nanomateriaux-sensibilisation