April 2020

Health Canada temporarily relaxes hand sanitizer ingredient regulations

Now allowing technical grade ethanol

Proper hygiene and disinfection is essential during the COVID-19 outbreak to reduce the risk of infection. Washing your hands frequently with soap and water for at least 20 seconds remains the most effective way to limit the spread of COVID-19. If soap and water are not available, a hand sanitizer, with at least 60% alcohol, that has been approved by Health Canada should be used.

There are a variety of hand sanitizers that meet Health Canada’s requirements for safety, efficacy and quality and have been approved. They are listed on Health Canada’s website.

Recent data released by Statistics Canada shows that there was a sevenfold increase in sales of hand sanitizer in mid-March compared to sales during the same one-week period last year. This high demand has led to shortages of raw materials, such as ethanol, which has led to searches for substitute ingredients.

Hand sanitizers are normally made with United States Pharmacopeia (USP) or food grade ethanol. However, in light of the current shortage of hand sanitizers, Health Canada recently temporarily modified its rules to allow manufacturers to use other types of ethanol for hand sanitizer without compromising safety, efficacy and quality. Health Canada is temporarily authorizing the use of technical-grade ethanol on a short-term and case-by-case basis, under specific conditions. This authorization is based on a thorough analysis of the benefits and risks to Canadians and will end as soon as USP- or food-grade ethanol can once again be produced in sufficient quantities to meet increased demand.

Technical-grade ethanol has more impurities than USP- and food-grade ethanol. One of these impurities is acetaldehyde, which is also found in alcohol and food we consume as well as products we use on our skin, such as cosmetics. Like most health products, hand sanitizers containing acetaldehyde can pose health risks if used more frequently and for a longer period than directed.

Health Canada has assessed the risks and benefits of hand sanitizers containing technical-grade ethanol and has concluded that, when used as directed and for a short period, the public health benefit to limit the spread of COVID-19 outweighs the risks. Based on its risk assessment, Health Canada is taking action immediately to ensure the safety of these products.

Specifically, Health Canada is limiting the period during which technical-grade ethanol can be used to produce hand sanitizers and is strengthening the labelling requirements for these products as follows:

Manufacturers that use technical-grade ethanol in their hand sanitizers must provide additional information on their product labels to support the safe use of these products. This includes:

clearly indicating that technical-grade ethanol is included as an ingredient;
specific directions for use and warnings that these products are intended for adult use only, that they should not be used on broken or damaged skin, that they should not be used by women who are pregnant or breastfeeding, and that they should not be inhaled; and,
information on how to report any adverse reactions to Health Canada.