Technical Grade Ethanol – Hand Sanitizer

In response to the increasing demand for hand sanitizers in Canada during the current COVID-19 pandemic, Health Canada has implemented an interim expedited licensing procedure to help businesses obtain the required authorizations to produce and distribute hand sanitizers.

An unprecedented demand for hand sanitizer products has created global shortages for USP and food grade ethanol. The resultant shortages have led to Health Canada’s consideration of other types of ethanol for the manufacture of hand sanitizers. After conducting a risk assessment of the benefits and risks of technical grade ethanol-based hand sanitizers Health Canada has determined that, when used as directed and for a limited period of time, the public health benefit of hand sanitizers containing technical grade ethanol to limit the spread of COVID-19 outweighs the risk.

Health Canada will impose certain conditions for companies that temporarily produce technical grade ethanol for use in hand sanitizers. Manufacturers will be required to demonstrate that they have sufficient quality control measures in place to support product compliance with the USP monograph testing requirements. These requirements must be met by all lots of sanitizer released for sale.

Manufacturers are also required to inform customers (such as manufacturers of hand sanitizer using technical grade ethanol for their products) of the necessary adjustments required for product labels in order for labels to be compliant in Canada. Customers must be notified that ethanol quality is of technical grade, containing some impurities. Manufacturers will be required to provide Health Canada with a full customer distribution list which will be treated in a confidential manner.

By allowing the use of technical grade ethanol in hand sanitizers Health Canada can increase the supply of these products while minimizing the potential risks. Once the COVID-19 pandemic comes to an end, or upon a reduction in the demand of ethanol, any time-limited conditional approvals granted by Health Canada will cease to be valid. At that time suppliers of technical grade ethanol will be provided with two weeks notice to discontinue sales.