Technical-grade ethanol for the manufacture of hand sanitizers and hard-surface disinfectants during the COVID-19 pandemic: Risk assessment summary report

Published: May 12, 2020
Updated: November 16, 2020

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Overview

The unprecedented demand for hand sanitizer products during the COVID-19 pandemic has created global shortages of pharmaceutical and food-grade ethanol. Pharmaceutical and food-grade ethanol are also known as anhydrous alcohol, ethyl alcohol or grain alcohol. On April 15, 2020, Health Canada published a notice to industry about the time-limited approval of specific sources of technical-grade ethanol for use in the manufacture of hand sanitizers. This approval was originally scheduled to end on June 30, 2020, but was later extended to October 31, 2020.

Other countries are also experiencing shortages of pharmaceutical and food-grade ethanol, and are providing similar flexibilities to suppliers and manufacturers. Risk assessment approaches have been established in the:

This report provides a summary of the technical-grade ethanol risk assessment, including recommendations and risk mitigation measures.

Approvals related to technical-grade ethanol use in 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 sanitizer 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.

This high demand has resulted in shortages of raw materials, such as pharmaceutical or food-grade ethanol, which has led to searches for substitute sources of ingredients.

In April 2020, Health Canada established a government task force to conduct a risk assessment of hand sanitizer containing specific sources of technical-grade ethanol. The task force determined that the public health benefits of using this hand sanitizer outweigh the risk when it is used:

Based on the task force recommendations, Health Canada:

In June, 2020, an updated risk assessment considered persistent supply chain shortages of pharmaceutical and food-grade ethanol, as well as lower impurity levels of technical-grade ethanol than those observed in April 2020. To further inform this work, Health Canada commissioned an independent supply and demand forecasting analysis. Results showed that in the absence of technical-grade ethanol, there would be an ethanol shortage of approximately 1 million litres per week.

The task force recommended:

In September 2020, Health Canada observed ongoing dependence on imported pharmaceutical and food-grade ethanol to meet the demand for ethanol. The task force considered the risk of supply chain disruptions if exports of high-quality ethanol are restricted from countries facing their own surge in demand. Labelling requirements for products containing technical-grade ethanol were also re-evaluated.

The task force made the following recommendations:

Scientific rationale and process for approvals

Numerous Canadian entities and industries not currently regulated by Health Canada expressed interest in providing additional and alternate sources of ethanol for use in the production of hand sanitizers to help alleviate supply shortages during the COVID-19 pandemic.

On April 3, 2020, Health Canada published an interim guide on the use of ethanol as an ingredient in alcohol-based hand sanitizers sold in Canada. The guide:

Health Canada received submissions from producers to allow the temporary supply of technical-grade ethanol for use in alcohol-based hand sanitizers during the COVID-19 pandemic.

Original risk assessment (April 2020)

Health Canada engaged a government task force of experts in toxicology, emergency medicine and dermal absorption. The task force undertook an assessment of the potential health risks posed by hand sanitizers containing technical-grade ethanol with concentrations of up to 1000 ppm of acetaldehyde.

The primary impurity of concern in technical-grade ethanol is acetaldehyde. Acetaldehyde was found in concentrations of 800 to 1000 ppm in the technical-grade ethanol from interested suppliers.

Acetaldehyde limits have been set at 10 ppm in pharmacopoeia such as the:

These pharmacopeia help set acceptable quality standards for drug or medicinal use in many jurisdictions. Acetaldehyde is considered to be "possibly carcinogenic to humans" according to the International Agency for Research on Cancer (IARC). Evidence on carcinogenicity of this substance is mainly by inhalation, leading this substance to be considered "toxic" to human health as defined under section 64(c) of the Canadian Environmental Protection Act, 1999. Acetaldehyde is naturally occurring in many foods that are considered safe to consume. It is also present in cosmetics, products that are expected to be safe when applied to the skin.

On April 13, 2020, the task force completed the risk assessment and provided final recommendations on the use of technical-grade ethanol in alcohol-based hand sanitizers in Canada.

The risk assessment concluded that acetaldehyde exposure from technical-grade ethanol-based hand sanitizers isn't expected to result in:

There are concerns about potential carcinogenicity due to an increase in acetaldehyde exposure, especially if the hand sanitizer is used for a long duration. The risk is considered a type II health hazard, which means that:

The task force compared the relative risk of using hand sanitizer made with technical-grade ethanol to situations where there is no alternative (for instance, neither higher-quality alcohol-based hand sanitizers nor soap and water). It determined that the public health benefit to limit the spread of COVID-19 outweighs the risk associated with exposure to technical-grade ethanol impurities (acetaldehyde) at higher levels than those typically found in these products.

The task force estimated acetaldehyde exposure through the skin (dermally) and by inhalation resulting from hand sanitizer use. Exposure scenarios were based on a variety of factors, including:

Based on these factors, and using a worst case scenario of an acetaldehyde concentration of 1000 ppm (v/v), the increase in cancer risk resulting from both dermal and inhalation exposures when applying hand sanitizers wouldn't be considered negligible.

The task force concluded that there is no duration of use for products containing acetaldehyde levels higher than the USP limit of 10 ppm that would result in a negligible risk.

However, this risk is considered tolerable for the short term, under the current COVID-19 circumstances. Should the level of acetaldehyde decrease, the risk of cancer would decrease as well. Risk is a function of hazard and exposure.

The risk is greater with higher exposure to acetaldehyde in the alcohol-based hand sanitizers, based on:

This risk is expected to decrease with decreasing exposure by:

The task force considered different product use scenarios, including:

The task force determined that the risk related to higher frequency of use and exposure would be tolerable as a short-term solution, given:

Based on the factors and scenarios considered, Health Canada didn't restrict the distribution of hand sanitizer containing technical-grade ethanol.

However, the task force recommended additional product labelling requirements to mitigate concerns associated with dermal and inhalation exposure to acetaldehyde. These labelling requirements include:

Health Canada implemented these recommendations and made them a condition for product authorization.

Updated risk assessment (June 2020)

Information provided by authorized suppliers showed that:

A recent analysis conducted for Health Canada indicated that in the absence of a technical-grade ethanol supply, there would be a significant shortage of ethanol to produce hand sanitizers and hard-surface disinfectants.

Based on this new information, Health Canada re-engaged the task force to help determine whether:

In their June 2020 update, the task force recommended maintaining the label statements established in April with one exception.

It confirmed that the precautionary warning for pregnant and breastfeeding women is still appropriate. However, it recommended changing the warning from "Do not use if you are pregnant or breastfeeding" to "Not recommended for use by women who are pregnant or breastfeeding."

The task force felt this change would clarify that this statement is being made in the absence of risk information rather than an identified risk specific to that vulnerable population. This approach is consistent with Health Canada's precautionary approach for labelling health products when there is an absence of scientific evidence supporting safety for vulnerable subpopulations.

Manufacturers of hand sanitizers using technical-grade ethanol in their production must include the following risk information on the product label and in bilingual form:

The task force compared the relative risk of using hand sanitizer made with technical-grade ethanol with unavailability of alcohol-based hand sanitizers in situations where individuals may be unable to routinely access soap and water.

Health Canada supports the task force's conclusion that the public health benefit to limit the spread of COVID-19 outweighs the risk associated with exposure to technical-grade ethanol impurities (acetaldehyde) at higher levels than those typically found in these products.

Updated risk assessment (September 2020)

Supply and demand data forecasted that hand sanitizer use would increase over the next 12 months and that there is still insufficient high-quality domestic ethanol supply to meet demand. If there were disruptions to ethanol imports, there would be significant shortages of ethanol for use in hand sanitizers.

In addition, information provided by authorized suppliers showed that impurity levels of some technical-grade ethanol have continued to decrease since June 2020.

Based on this information, Health Canada re-engaged the task force to help determine if:

In its September 2020 update, the task force maintained its assessment that the public health benefit of using technical-grade ethanol in hand sanitizers to limit the spread of COVID-19 continues to outweigh the risks. It reiterated that the use of technical-grade ethanol should be time-limited, and only while there is a possibility that the supply of pharmaceutical-grade ethanol may not meet demand.

To derive a tolerable acetaldehyde limit for technical-grade ethanol used by all subpopulations over the short term, the task force calculated the tolerable lifetime daily exposure for a person with:

Although the corresponding exposure limit of 75 ppm wouldn't directly apply to vulnerable subpopulations over a lifetime, the approach was determined to justify use of the product due to:

The task force recognized that certain product use scenarios, such as in health care settings, may require more than 100 hand sanitizer applications a day. However, the limited period for using the product as part of the pandemic response is more conservative than lifetime exposure. The calculation was based on constant daily use (700 uses each week). It doesn't take into account non-work days, when exposure is likely lower.

The task force agreed to adopt the following limits for other common technical-grade ethanol impurities for hand sanitizers intended for use by any subpopulation. In general, these limits align with those established in the US FDA's temporary policy.

Impurity Interim Limit
Methanol NMT 200 ppm
Benzene NMT 2 ppm
AcetaldehydeFootnote * NMT 75 ppm
Sum of all other impurities NMT 300 ppm
Footnote *

Includes acetal as per the USP alcohol monograph reporting requirements, which accounts for the potential conversion of acetal into acetaldehyde. Please consult the relevant USP monographs for more information.

Return to footnote * referrer

If the sum of all other impurities exceeds the interim limit of 300 ppm, all individual impurities must be identified and meet the following interim limits. As well, any impurity not included in these tables must be reported to Health Canada for assessment.

Impurity Interim Limit
Acetone NMT 4400 ppm
n-propanol (1-propanol) NMT 1000 ppm
Ethyl acetate NMT 2200 ppm
Sec-butanol (2-butanol) NMT 6200 ppm
Iso-butanol (2-Methyl-1-propanol) NMT 21700 ppm
n-butanol (1-butanol) NMT 1000 ppm
Iso-amyl alcohol (3-Methyl-1-butanol) NMT 4100 ppm
Amyl alcohol NMT 4100 ppm

For authorized products with more than 75 ppm of acetaldehyde, the task force recommended maintaining the existing technical-grade ethanol warnings given the lack of evidence on product safety on vulnerable populations and on the health risks linked to acetaldehyde exposure. For these products, manufacturers of hand sanitizers using technical-grade ethanol must continue to include the following risk information on the product label and in bilingual form:

Health Canada supports the task force conclusions that:

Use of technical-grade ethanol for hard-surface disinfectants

Health Canada received questions from industry on the use of technical-grade ethanol in hard-surface disinfectant products. To evaluate acceptability for this type of use, Health Canada assessed the risk associated with potential exposure to chemical residues on food resulting from use of technical-grade ethanol on food-contact surfaces in establishments where food is handled, as well as a preliminary inhalation exposure assessment. The results of this evaluation indicated that the use of technical-grade ethanol in hard-surface disinfectant products should be authorized under the same conditions that exist for hand sanitizers.

Implementation of technical-grade ethanol approvals

Health Canada is committed to:

To meet this commitment, Health Canada is maintaining:

Health Canada is also providing a notification form for manufacturers to inform us of various aspects of the supply chain associated with these products to facilitate prompt follow-up action as necessary.

This interim policy measure will be lifted as soon as the regular supply of higher-quality ethanol stabilizes.

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