Health Canada warns about certain hand sanitizers that may pose health risks (Part 2 – March 31, 2021 to present)

The COVID-19 outbreak has created a high demand for hand sanitizers. To increase the supply, Health Canada has taken several measures, including permitting the temporary use of technical-grade ethanol in alcohol-based hand sanitizers.

Manufacturers wishing to use technical-grade ethanol must choose from a list of Health Canada-authorized suppliers. They must receive a No Objection Letter from us before they can manufacture or distribute the product.

Technical-grade ethanol contains more impurities than pharmaceutical- and food-grade ethanol. Therefore, manufacturers must include the following risk statements on their product labels if the ethanol impurities exceed a certain level:

• Under Medicinal Ingredients: "Ethanol XX% (technical-grade)"
• Under Directions: "Adults only"
• Under Warnings: "Do not use on broken or damaged skin," "Not recommended if you are pregnant or breastfeeding" and "Do not inhale"
• Include a statement for consumers: "Report any incident to Health Canada"
• Under Questions: "Call 1-866-234-2345 to report any adverse reaction"

Hand sanitizers that contain unacceptable grades of ethanol, undeclared impurities at elevated levels, or unauthorized denaturants have not been reviewed for safety or efficacy. Denaturants are added to ethanol to make it taste bad to discourage the unintentional ingestion of hand sanitizers, especially by children.

Two unauthorized denaturants have been found in hand sanitizers sold in Canada:

• Ethyl acetate: Frequent use of hand sanitizer containing ethyl acetate may cause dry skin, leading to irritation or cracking
• Methanol: Frequent use of hand sanitizer containing methanol may cause dermatitis, eye irritation, upper respiratory system irritation and headaches. If swallowed, methanol can cause severe adverse reactions, including death.

An unauthorized medicinal ingredient has been found in hand sanitizers sold in Canada:

• 1-Propanol: Frequent use of hand sanitizer containing 1-propanol may cause eye, nose and throat irritation, as well as dry cracking skin, drowsiness and headache
• Benzalkonium chloride (BZK): BZK is permitted at a concentration of up to 0.15% in non-alcohol-based hand sanitizers. Frequent use of an alcohol-based hand sanitizer containing undeclared BZK above a 0.15% concentration may cause irritation or an allergic reaction (ranging from rash and hives to trouble breathing), especially in vulnerable people like children and individuals allergic to this ingredient.

Two undeclared impurities at elevated levels have been found in hand sanitizers sold in Canada:

• Acetaldehyde: Hand sanitizer containing elevated levels of the impurity acetaldehyde may increase the risk of cancer. This risk is assumed to increase with use (e.g., frequent applications over a long period of time)
• Benzene: Hand sanitizer containing elevated levels of the impurity benzene may increase the risk of cancer. In addition, exposure (e.g. through inhalation or applying to the skin) to elevated levels of benzene may cause drowsiness, dizziness, rapid or irregular heartbeat, and headaches. These risks are assumed to increase with use (e.g., frequent applications over a long period of time).

Potential bacterial contamination has been found in hand sanitizers sold in Canada:

• Burkholderia stabilis is a member of a group of bacterial organisms called Burkholderia cepacia complex (Bcc) that are potentially highly virulent and multi-drug resistant. The effects of Bcc vary widely, ranging from no symptoms at all to serious infections. Bcc bloodstream infections may result in sepsis and death in some cases.

All health products, including hand sanitizers, must be tested before they can be sold in Canada. Testing is done to ensure the product meets Health Canada's required safety, quality and efficacy standards.

Counterfeit products may contain ingredients not listed on the label, dangerous additives or other contaminants. In addition, they may not contain the active ingredients consumers would expect them to contain. Since counterfeit products are unauthorized and made with an unknown formulation, they may not be effective at killing bacteria and viruses, and may pose serious risks to health.

For more information

• Natural health products
• Licensed Natural Health Products Database
• Hard-surface disinfectants and hand sanitizers (COVID-19)
• Health Canada is temporarily authorizing the use of technical-grade ethanol in hand sanitizer products
• Technical-grade ethanol risk assessment summary report
• Health Canada's decision on technical-grade ethanol for the manufacture of hand sanitizers: Notice to industry
• Policy on counterfeit health products (POL-0048)