TORONTO — Health Canada has issued an advisory and asked distributors to recall masks sold with graphene or biographene in them over potential inhalation risks.
Graphene is comprised of a single layer of carbon atoms and is considered a nanomaterial, meaning it is made of tiny particles, and is reported to have “antiviral and antibacterial properties,” the advisory says.
Health Canada said it conducted a preliminary scientific assessment after becoming aware that masks containing graphene were being sold with COVID-19 health claims and used by adults and children in schools and daycares. Health Canada also believes they may have been distributed for use in health care settings.
The products affected are listed as “face masks labelled as containing graphene or biomass graphene,” the advisory states. Health Canada recommends that Canadians not use masks with the substance and to consult their health-care provider if they have used graphene face masks and have health concerns – such as new or unexplained shortness of breath, discomfort or difficulty breathing.
The specific mask model under review, #SNN200642, is the same model for which Health Canada received a complaint from a concerned citizen raising a question about the potential health risks.
The organization said that their preliminary assessment of available research found that inhaled graphene particles had some potential to cause “early lung toxicity” in rats and other animals, but that the potential for people to inhale graphene particles – and the related health risks – are not yet known, and may vary with based on mask design.
The health risk to people of any age is not clear, the advisory says, as there are many variables such as duration of exposure and the type of graphene used. Health Canada has requested data from mask manufacturers to further investigate the potential health risks.
Until the organization has completed a thorough scientific assessment and has “established the safety and effectiveness of graphene-containing face masks,” the advisory states they are taking the precaution of removing them from the market.
Health Canada has also directed all known distributors, importers and manufacturers to stop selling masks containing graphene and to recall affected products, and has written to all provinces and territories advising them to stop the distribution and use of said masks.
In a separate statement to CTV News, Health Canada said the risks associated with the medical devices are “unacceptable.”
“Unless the manufacturers of these masks can provide substantial evidence to support the safe and effective use of graphene-coated masks, Health Canada considers the risk of these medical devices to be unacceptable,” according to the statement.
The department said it is currently reviewing data from two specific manufacturers of graphene-coated face masks to determine the safety and effectiveness of their devices and will take appropriate action pending the review’s outcome.
Health Canada has requested that any health product adverse events or complaints regarding graphene face masks be reported to the organization.
No incidents involving serious harm have been reported to date.