Pharmaceutical-grade ethanol, a key ingredient in hand sanitizer, has been hard to source with an increased demand for hand sanitizer in recent months. Statistics Canada shows a seven-fold increase in hand sanitizer sales in March alone.

In response to the increased demand, Health Canada temporarily approved using technical-grade ethanol to manufacture hand sanitizer products.

With this change, Health Canada released a new risk assessment and new labelling requirements, including warnings for who should not use it.

Hand sanitizer made with technical-grade ethanol should not be used by:

  • children
  • those with broken or damaged skin, and
  • pregnant or breastfeeding women.

In this post, we highlight risks laid out in Health Canada’s risk assessment and considerations individuals should take before using hand sanitizer made with technical-grade ethanol.

What is ethanol?

Ethanol, or ethyl alcohol, is a chemical compound used in a variety of applications including antiseptic, chemical solvents and in manufacturing alcoholic beverages. Its disinfectant properties make it a common choice for use in hand sanitizers and other disinfectant products.

What is pharmaceutical-grade or USP-grade ethanol?

‘USP’ stands for United States Pharmacopeia, an organization that develops quality and safety standards for medicine, food, and dietary supplements. Pharmaceutical-grade ethanol is sometimes called USP-grade ethanol to denote it meets the standards of the USP organization. This grade of ethanol must meet certain purity standards. For example, a maximum allowable level for acetaldehyde of 10 parts per million (ppm).

What is technical-grade ethanol?

The purity standards of technical-grade ethanol are not as strict as USP-grade ethanol. This grade of ethanol may contain acetaldehyde in concentrations between 800 and 1000 ppm.

What is acetaldehyde?

Acetaldehyde is an organic chemical compound that occurs naturally in a wide variety of foods including meat, seafood, eggs, nuts, bread, coffee and ripe fruit. It is also a byproduct produced in the human body from drinking alcoholic beverages. The average adult is estimated to consume between 35 mg and 200 mg of acetaldehyde every day from food and beverages.

The carcinogenicity of acetaldehyde:

Carcinogenicity is the tendency of a chemical to induce tumors, whether benign or malignant.

“Acetaldehyde is considered to be possibly carcinogenic to humans according to the International Agency for Research on Cancer (IARC),” states the summary report. Evidence on carcinogenicity of the substance is mainly via inhalation.

Health Canada’s task force used a “worst case scenario” of 1000 ppm acetaldehyde concentration and focused on a healthcare setting where there could be as many as 109 applications per day for nurses in the Intensive Care Unit (ICU).

The task force determined an increased cancer risk from dermal and inhalation exposure when applying hand sanitizers “would not be considered negligible.”

The summary report went on to state the risk is “considered to be tolerable for the short-term, under the current COVID-19 circumstances.”

It should be noted that in industrial settings the number of applications per day will be significantly lower.

Why use technical-grade ethanol if it has a higher risk of exposure?

The task force examined the risk of not having alcohol-based hand sanitizer available in situations where individuals may be unable to routinely wash their hands with soap and water. It was determined in the summary report 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 risk assessment concluded that acetaldehyde exposure from ethanol-based hand sanitizers is not expected to result in acute toxicity, high irritation or sensitization. However, concerns remain 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 use of, or exposure to, a product may cause temporary adverse health consequences or where the probability of serious adverse health consequences is remote.

Final thoughts:

The safety of our customers is Levitt-Safety’s main focus and keeping you informed about products on the market is one way we can do that.

Most of the hand sanitizer we carry uses USP-grade ethanol, however two of our current manufacturing partners through our Emergency Supply Sourcing use technical-grade ethanol in producing their hand sanitizers. We have updated the sourcing page with that information to keep customers informed.

Hand sanitizers made with technical-grade ethanol should be labelled as such as per Health Canada regulations.

It is up to the individual to weigh the risks of using it versus not. Exceptions to this are pregnant or breastfeeding women, those with broken or damaged skin and children — these individuals should not use hand sanitizer made with technical-grade alcohol.

Health Canada stated in the summary report that they will continue to monitor the situation and consider additional risk mitigation strategies if the shortages of higher quality ethanol persist beyond the time-limited approval period.

Bruce Levitt

President

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