Interim guidance for producing ethanol for use in alcohol-based hand sanitizers: Background

Date published: May 9, 2020
Updated: October 8, 2020

This interim guidance gives information on the use of ethanol in alcohol-based hand sanitizers sold in Canada. Many companies not currently regulated by Health Canada are interested in providing other sources of ethanol, such as anhydrous alcohol, ethyl alcohol or grain alcohol, for use in the production of hand sanitizers. They want to help address the shortage of hand sanitizers during the COVID-19 pandemic.

To help reduce the risk of infection or spread infection to others, both the Public Health Agency of Canada and the World Health Organization (WHO) recommend that people:

• wash hands often with soap and water or
• use an alcohol-based hand sanitizer if soap and water are not available

Health Canada produced a guidance document for the production and distribution of alcohol-based hand sanitizers on March 27, 2020. We updated it on July 13, 2020. The guidance:

• outlines the licensing approach for companies that want to manufacture, package, label or import alcohol-based hand sanitizers for the COVID-19 pandemic
• explains the application and review process for both site and product licences
• outlines the quality requirements for ethanol to be used in the production of hand sanitizers
• highlights key formulation aspects
• lists other flexibilities that can be leveraged

Health Canada is committed to protecting the health and safety of Canadians while balancing the need for exceptional measures during the COVID-19 pandemic. The quality of ethanol used to manufacture hand sanitizers must meet safety, efficacy and quality requirements.

For this interim measure, we have taken into account:

• the current policies and best practices of foreign regulatory partners, such as the U.S. Food and Drug Administration
• the recommendations of the WHO and the U.S. Pharmacopeia

Health Canada will lift this interim measure when the regular supply of ethanol stabilizes.

If you have questions about this guide or the licensing of alcohol-based hand sanitizers, please contact our Natural and Non-prescription Health Products Directorate at nnhpd.consultation-dpsnso@hc-sc.gc.ca.