Health Canada has recalled multiple hand sanitizers which contain industrial-grade ethanol. The list of recalled products can be found here.
Industrial-grade ethanol is not authorized for use in the manufacture of hand sanitizers because it contains impurities and chemicals that may not be approved for safe use. Frequent use of these products can cause dry, irritated, or cracked skin.
It is important to ensure hand sanitizers are manufactured according to the guidelines and regulations set out by Health Canada. Health Canada published an interim guide on the use of ethanol as an ingredient in alcohol-based hand sanitizers sold in Canada. Food-grade or pharmaceutical-grade ethanol are typically used in the manufacture of hand sanitizers. Due to the high demands of hand sanitizers during the COVID-19 pandemic, Health Canada has also temporarily approved the use of technical-grade ethanol in hand sanitizers.
Companies proposing to supply technical-grade ethanol for the manufacture of hand sanitizers must be assessed by Health Canada and must receive written authorization prior to proceeding. Health Canada has a list of approved suppliers that are temporarily approved to supply technical-grade ethanol for this purpose. Companies who want to produce hand sanitizers with technical-grade ethanol are subject to additional labeling and information requirements.
Authorized products will have a Natural Product Number (NPN) or a Drug Identification Number (DIN) on the label. Health Canada has an ongoing list of antiseptic/antibacterial skin cleansers or hand sanitizers that meet requirements and are authorized for sales in Canada. There is also a secondary list of hard-surface disinfectants and hand sanitizers that have been approved for sale in Canada but do not have a NPN or DIN number.
Health Canada has also implemented an expedited licencing approach to support companies that intend to manufacture, package, label and/or import alcohol-based hand sanitizers in response to the COVID-19 pandemic.
To see if your hand sanitizers are eligible for the expedited licensing or for more information on selling hand sanitizers in Canada or the US, Contact Nexreg.