Considering the severity of the on-going Covid-19 global pandemic, Health Canada (HC) is consistently warning hand sanitizer manufacturers about the use of the right formulation and ingredients in their products. Recently, the Agency halted 12 hand sanitizer companies from selling their unsanctioned products in the Canada due to the presence of unapproved ingredients. The step was taken by the HC to ensure that only safe and effective products reach the market.

In accordance with this, in mid-April, the HC made a temporary update in the hand sanitizer regulations and relaxed the Regulatory requirements for the ingredients used in the sanitizers. The update allowed manufacturers to use technical-grade ethanol in formulations to meet the rising demand of hand sanitizers. However, once the supply of hand sanitizers is stabilized, the temporary regulations will be ceased.

The update in regulations comes with a temporary change in hand sanitizer labeling regulations. According to the update, the manufacturers will have to comply with additional labeling guidelines to ensure that the consumers can make the right buying decision. The additional guidelines that manufacturer using technical-grade ethanol in their products are required to:

1. Clearly indicate on their products that technical-grade ethanol is used as an ingredient
2. Mention specific warnings and precautions regarding the product and its ingredients on the packaging and label of the product
3. Manufacturers must mention clear information on how to report any adverse reactions to Health Canada

During these challenging times it is the responsibility of both health authorities and the manufacturers to ensure that safe and effective products are available to consumers for use. Therefore, for products like hand sanitizers, manufacturers must focus on the formulation of the product and its related regulations to ensure zero-recalls. In such cases, manufacturers are advised to have clarity in target country’s regulations and product formulations. Consult Regulatory experts with an expertise in Canada cosmetics regulations to achieve overall compliance. Stay safe. Stay informed.