Technical-grade ethanol for use in hand sanitizers and hard-surface disinfectants: Notice to industry
Date published: April 17, 2020
Updated: July 09, 2020
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- Authorization for technical-grade ethanol in hand sanitizers
- Use of technical grade ethanol in hard-surface disinfectants
- Conditions for producing technical-grade ethanol
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The COVID-19 pandemic has created a huge demand for hand sanitizers in Canada. To meet the demand, Health Canada has implemented an interim expedited licensing approach. This will help businesses obtain the required authorizations to produce and distribute hand sanitizers.
Because of the demand, there are worldwide shortages of USP and food-grade ethanol.
Data released by Statistics Canada shows that retail sales of hand sanitizer continues to trend much higher compared to the same timeframe in 2019. In May and early June 2020, demand was on average 12 times higher compared to the previous year.
Health Canada conducted a risk assessment on these other sources. As a result, we have approved specific sources of technical-grade ethanol for use in the manufacture of hand sanitizers. We announced this temporary decision on April 15, 2020 and we updated it in June 2020.
We also published an interim guide on the use of ethanol in alcohol-based hand sanitizers sold in Canada.
Authorization for technical-grade ethanol in hand sanitizers
A number of companies have expressed interest in supplying technical-grade ethanol for use in hand sanitizers.
In response, we conducted an assessment of the risks and benefits of the use of specific sources of technical-grade ethanol in hand sanitizers. When used as directed and for a limited time, the benefit of helping to limit the spread of COVID-19 outweighs the risk.
Companies proposing to supply technical-grade ethanol for use in hand sanitizers or hard-surface disinfectants must receive written authorization from Health Canada before proceeding.
With our authorization, there are no restrictions for distributing hand sanitizers containing technical-grade ethanol. Under the interim measure for alcohol-based hand sanitizers, these products can be distributed in health care and commercial settings, although must be labelled for personal use.
As for any other health product, we will take the necessary measures to protect the health and safety of Canadians. These measures include:
- stopping the sale of technical-grade ethanol
- stopping the sale of a finished product
- conducting on-site visits
- recalling a product
- issuing public communications
- seizing a product
Use of technical grade ethanol in hard-surface disinfectants
The Natural and Non-prescription Health Products Directorate received questions from industry about the use of technical-grade ethanol in hard-surface disinfectant products. Health Canada conducted an assessment for this specific use. In the absence of an identifiable new or increased risk, the use of technical-grade ethanol in these products is allowed under the same conditions that exist for hand sanitizers.
The temporary use of technical-grade ethanol will no longer be valid when the regular supply of higher-quality ethanol stabilizes. Suppliers, distributors and manufacturers will have 2 weeks' notice to stop distributing and selling hand sanitizers and hard-surface disinfectants with technical-grade ethanol.
We have made available a list of approved suppliers for technical-grade ethanol and a list of manufacturers of hand sanitizers and hard-surface disinfectants.
Conditions for producing technical-grade ethanol
Companies that want to temporarily produce technical-grade ethanol for use in hand sanitizers or hard-surface disinfectants must meet these conditions:
- have quality assurance and quality control measures in place to ensure the consistent quality of the product
- certificates of analysis for all lots, which list the impurity levels of the ethanol
- inform their manufacturers of the bilingual labelling requirements for the main container (for example, bottle) and external package (for example, box), if applicable as follows:
- under Medicinal Ingredients: "Ethanol XX% (technical grade)"
- under Directions: "Adults only"
- under Warnings: "Do not use on broken or damaged skin"; "Not recommended for use by women who are pregnant or breastfeeding"; "Do not inhale"
- 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"
- notify all customers that the ethanol is technical-grade quality and contains impurities
- prioritize deliveries of USP-grade ethanol to customers that must use this product (if they produce USP-grade ethanol)
- update us every day by providing a list of customers receiving technical-grade ethanol to produce hand sanitizers or hard-surface disinfectants, and report regularly on the level of impurities in their technical-grade ethanol
- these lists will be kept confidential
- ensure their customers contractually agree to not resell the product (unless they are on the list of approved distributors) or blend approved technical-grade ethanol
These measures support traceability of the ethanol, proper labelling and future compliance.
To manufacture hand sanitizers with technical-grade ethanol, manufacturers must:
Companies may not manufacture their hand sanitizer or hard-surface disinfectant product made with technical-grade ethanol until they have received a No Objection Letter (NOL) from us.
Manufacturers that receive an NOL must only:
- use technical-grade ethanol products from the list of approved suppliers for technical-grade ethanol
- purchase from an approved supplier or distributor
We will verify each label proposal to ensure it aligns with the technical-grade ethanol risk statements and that there are no false or misleading claims.
Companies must receive temporary authorization to further distribute or resell an approved technical-grade ethanol for use in the production of hand sanitizers or hard-surface disinfectants. Companies will be added to the list of authorized distributors for this specific purpose.
Distributors and resellers may only distribute or resell approved technical-grade ethanol between authorized suppliers and manufacturers that have received an NOL. Unauthorized companies that resell or distribute may be subject to enforcement action.
These conditions are designed to minimize potential risks, while ensuring a sufficient supply of hand sanitizers and hard-surface disinfectants during this public health crisis.
For more information, you may contact Health Canada's Natural and Non-prescription Health Products Directorate at firstname.lastname@example.org.
- Technical-grade ethanol for the manufacture of hand sanitizers during the COVID-19 pandemic: Risk assessment summary report (updated June 2020)
- 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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