Technical-grade ethanol for use in hand sanitizers and hard-surface disinfectants: Notice to industry
Date published: April 17, 2020
Updated: November 16, 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
- Conditions for manufacturing a hand sanitizer with technical-grade ethanol
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The COVID-19 pandemic has created a huge demand for hand sanitizers in Canada. Because of this demand, there are worldwide shortages of United States Pharmacopeia (USP) and Food-Chemicals Codex (FCC) grade ethanol. These shortages led to searches for other types of ethanol for the manufacture of hand sanitizers.
Data released by Statistics Canada show that retail sales of hand sanitizer in 2020 continue to trend much higher compared to the same timeframe in 2019. In May and early June 2020, retail demand for hand sanitizers was on average 12 times higher compared to the weekly average in 2019. In August and September, it continued to be 6 times higher than in 2019.
Health Canada conducted a risk assessment on these other sources of ethanol if used in hand sanitizers. As a result, we have approved specific sources of technical-grade ethanol (TGE) for use in the manufacture of this product. We announced this temporary decision on April 15, 2020, updated it in June 2020 and again in September 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.
Under the interim measure for alcohol-based hand sanitizers, these products can be distributed in health care and commercial settings, although they 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
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, approved distributors of technical-grade ethanol and a list of manufacturers of hand sanitizers and hard-surface disinfectants.
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 disinfectants. 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.
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
- provide certificates of analysis for all lots, which list the impurity levels of the ethanol
- when acetaldehyde levels exceed 75 ppm, 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"
- "Questions?: Call 1-866-234-2345 to report any adverse reaction"
- remove, cover or omit statements such as "Supervise children when they use this product" and/or "Do not use on children/infants less than 2 years of age"
- 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.
Conditions for manufacturing a hand sanitizer with technical-grade ethanol
To manufacture and distribute hand sanitizers with technical-grade ethanol, product licence holders must submit a TGE notification form and receive authorization from Health Canada through a no objection letter (NOL). Authorization is still required from Health Canada to manufacture products containing any of the approved technical-grade ethanol products, even if the product doesn't require the additional warning statements noted in the licensing guide. Please refer to the TGE notification form for more information on the authorization requirements.
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. All hand sanitizer product labels should comply with the antiseptic skin cleansers monograph and the Natural Health Product Regulations (NHPR).
Companies that have received an NOL will be listed on Health Canada's website to provide transparency to the general public.
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. Distributors 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.
Companies will be added to the list of authorized distributors for this specific purpose.
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 September 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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