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: July 9, 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.

Other countries are also experiencing shortages and are providing similar flexibilities to suppliers and manufacturers. Risk assessment approaches have been established in the United States for ethanol in hand sanitizers (March 2020, updated June 2020), and in the United Kingdom for isopropyl alcohol-based handrubs (May 2020).

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 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.

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:

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 various 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 convened to undertake 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 - 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 via 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, which 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 is not expected to result in:

There are concerns about potential carcinogenicity due to an increase in acetaldehyde exposure, particularly if the hand sanitizer is used for a longer 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 in which there is no alternative (i.e., neither higher quality alcohol-based hand sanitizers nor soap and water). The task force 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 would not 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 to be 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 outlined factors, Health Canada does not need to impose restrictions on suppliers of technical-grade ethanol or their clients with respect to the distribution of hand sanitizer containing technical-grade ethanol.

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 to maintain the label statements established in April with one exception.

The task force confirmed that the precautionary warning for pregnant and breastfeeding women remains appropriate. However, they recommended changing it 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 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 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.

Use of technical-grade ethanol for hard-surface disinfectants 

Health Canada received questions from industry regarding 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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