April 23, 2020 – Health Canada is temporarily authorizing the use of technical-grade ethanol in hand sanitizer products: Always follow the label directions when using alcohol-based hand sanitizers.
Health Canada has assessed the risks and benefits of hand sanitizers containing technical-grade ethanol and has concluded that, when used as directed and for a short period, the public health benefit to limit the spread of COVID-19 outweighs the risks. Based on its risk assessment, Health Canada is taking action immediately to ensure the safety of these products.
Specifically, Health Canada is limiting the period during which technical-grade ethanol can be used to produce hand sanitizers and is strengthening the labelling requirements for these products.
Publication on the interim guide on the production of ethanol for use in alcohol-based hand sanitizers is available on Health Canada’s website.
This document provides information on the use of ethanol as an ingredient in alcohol-based hand sanitizers sold in Canada. Numerous Canadian entities and industries not currently regulated by Health Canada have expressed interest in providing additional and/or alternate sources of ethanol (also known as anhydrous alcohol, ethyl alcohol, or grain alcohol) for use in the production of hand sanitizers to support the national response to the supply shortage during the COVID-19 pandemic.
The document provides information on:
- Acceptable quality grades
- Recommended formulation
- Records
- Non-medicinal ingredients (NMIs)
- Formula substitutions
- Use of non-USP grade alcohol
- Excise tax implications
- Obtaining a licence, registration and/or approved formulation under the Excise Act, 2001
- End of interim approach
If you have questions in relation to this Guide or the licensing of alcohol-based hand sanitizers, please contact Health Canada’s Natural and Non-prescription Health Products Directorate at hc.nnhpd-dpsnso.sc@canada.ca.