Health Canada’s decision on technical-grade ethanol for the manufacture of hand sanitizers: Notice to industry
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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.
Health Canada imposes the following conditions on the companies who may temporarily produce technical-grade ethanol for use in hand sanitizers:
- They must provide Health Canada with the quality assurance and quality control measures in place to ensure the consistent quality of the product, specifically, certificates of analysis which comply with all applicable USP monographs testing requirement for all lots released.
- They must inform their clients (that is, manufacturers of hand sanitizer using technical-grade ethanol in their production) of the requirement to adjust their product labels before the product enters the Canadian market - considering the tight timeline for this approval, these adjustments could be achieved using an over sticker directly on the product container, on a panel of the external package (for example, box), or an insert in the external package:
- under Medicinal Ingredients: "Ethanol XX% (technical grade)"
- under Directions: "Adults only"
- under Warnings: "Do not use on broken or damaged skin"; "Do not use if you are pregnant or breastfeeding"; "Do not inhale".
- include a statement for consumers: "Report any incident to Canada.ca/drug-device-reporting".
- under Questions?: "Call 1-866-234-2345 to report any adverse reaction".
- Remove or cover up the statement: “Supervise children when they use this product”.
- They must notify all of their customers that the ethanol quality is of technical-grade, containing some impurities.
- If they also produce USP-grade ethanol, they must prioritize deliveries of USP-grade ethanol to their customers who absolutely require this product for use, as determined by Health Canada, for example, neo-natal and pediatric care, formulations that omit fragrances, etc.
- They must provide Health Canada a list of customers that they are distributing technical-grade ethanol to for the production of hand sanitizers before such distribution. Any such lists will be treated as confidential and is for the sole purpose of follow-up in the context of this time-limited approval.
- They must adopt a policy whereby their customers contractually agree to no re-sale or blending of the approved technical-grade ethanol. This measure supports traceability, proper labelling and any potential future compliance action.
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.
You can contact Health Canada's Natural and Non-prescription Health Products Directorate at firstname.lastname@example.org
Manufacturers seeking to use technical-grade ethanol in the production of hand sanitizers must complete the notification form and send it to email@example.com. Manufacturers must then await receipt of a No Objection Letter from us before manufacturing and distributing their hand sanitizer.
- Technical-grade ethanol for the manufacture of hand sanitizers during the COVID-19 pandemic: Risk assessment summary report
- Interim guide on the production of ethanol for use in alcohol-based hand sanitizers
- Guide on Health Canada's interim expedited licensing approach for the production and distribution of alcohol-based hand sanitizers
- Hard surface disinfectants and hand sanitizers (COVID-19)
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