Health Canada’s decision on technical-grade ethanol for the manufacture of hand sanitizers: Notice to industry

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Overview

In response to the increasing demand for hand sanitizers in Canada during the current COVID-19 pandemic, Health Canada has implemented an interim expedited licensing approach to help businesses obtain the required authorizations to produce and distribute hand sanitizer.

An unprecedented demand for hand sanitizer products has created global shortages for USP and food-grade ethanol. Statistics Canada recently reported a seven-fold increase in the sales of hand sanitizer in mid-March compared to the same period last year. These shortages have led to searches of other types of ethanol for the manufacture of hand sanitizers.

Health Canada published an interim guide on the use of ethanol as an ingredient in alcohol-based hand sanitizers sold in Canada. In situations where the ethanol does not meet the established quality standards, a case-by-case risk assessment is undertaken by Health Canada to determine if the ethanol is safe for use in hand sanitizers in the context of the COVID-19 pandemic, with particular attention given to the types and level of impurities.

Review and authorization for technical-grade ethanol

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 received a number of submissions from proponents interested in temporarily supplying technical-grade ethanol for use in hand sanitizers.

Health Canada conducted an assessment of the risks and benefits of the use of specific sources of technical-grade ethanol in hand sanitizers. Health Canada has determined that, when used as directed and for a limited period of time, the public health benefit of hand sanitizers containing these approved sources of technical-grade ethanol to limit the spread of COVID-19 outweighs the risk. Refer to the list of approved suppliers for technical-grade ethanol for use in the production of hand sanitizers.

In cases where Health Canada has provided its authorization, no restrictions are being imposed on suppliers of technical-grade ethanol or their clients with respect to the distribution of hand sanitizer containing technical-grade ethanol. Consistent with the interim measure for alcohol-based hand sanitizers currently in place, these products can be distributed to healthcare and commercial settings.

Production conditions

Health Canada imposes the following conditions on the companies who may temporarily produce technical-grade ethanol for use in hand sanitizers:

Health Canada has put these specific conditions in place to minimize potential risks, while continuing to ensure sufficient supply of hand sanitizer during this public health crisis. Once the COVID-19 pandemic comes to an end, or should the increased demand during the pandemic no longer necessitate production of technical-grade ethanol, all time-limited conditional approvals granted by Health Canada will cease to be valid. Health Canada will provide authorized suppliers of technical-grade ethanol two weeks notice to discontinue sales.

As for any other health product, Health Canada will take measures such as give notice to stop sales of technical-grade ethanol and/or the finished product, conducting on-site visits, requesting recalls, issuing public communications, and/or conducting product seizures, if deemed necessary.

Contact us

You can contact Health Canada's Natural and Non-prescription Health Products Directorate at hc.nnhpd-dpsnso.sc@canada.ca

Manufacturers seeking to use technical-grade ethanol in the production of hand sanitizers must complete the notification form and send it to hc.rmd.coordination-dgr.sc@canada.ca. Manufacturers must then await receipt of a No Objection Letter from us before manufacturing and distributing their hand sanitizer.

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