Health Canada resumes sales of disposable graphene masks from the manufacturer Shandong Shengquan New Materials Co., Ltd’s, considering the masks are safe and there is no evidence of any health risk”.

Health Canada previously advised Canadians not to use face masks that contain graphene after a preliminary assessmentidentified some potential for inhaled graphene particles to cause early lung effects in animals (e.g., early signs of inflammation). As a precaution whilea risk assessment was ongoing, Health Canada directed all known importers and distributors of these masks to remove (https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2021/75391r-eng.php) four mask models from one manufacturer, Shandong ShengquanNew Materials Co. Ltd., from the market.

Health Canada has reviewed the available scientific literature along with data provided by Shandong Shengquan New Materials Co. Ltd., related tothe biomass graphene contained within its four models. The review found that biomass graphene particles are not shed from these masks in quantitiesthat are likely to cause adverse lung effects.

Health Canada also determined that the filtration performance of these masks meets the performance standard listed on the label. The Departmentdid not find evidence that biomass graphene provides any added antimicrobial, or antiviral protection.

As a result, given the evidence supporting the safety and effectiveness of these products, Health Canada is permitting the sale of the four ShandongShengquan New Materials Co. Ltd. mask models to resume in Canada (see models listed below).

No other graphene face masks are currently permitted for sale in Canada. Consumers should notify Health Canada by
submitting an online complaintform (https://health.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/problem-reporting/medical-deviceconsumer.html) should they become aware of other graphene masks being sold in Canada.

Companies wishing to sell graphene masks must first provide evidence to Health Canada demonstrating the safety and effectiveness of their models,as the risks with using graphene masks may vary depending on mask design.

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