It is no surprise that disinfectants and hand sanitizers have been in the public eye recently due to the COVID-19 pandemic.
Although they do not claim to kill viruses, hand sanitizers can help reduce the risk of infection by spread of microorganisms. As a result, Health Canada has introduced new measures to expedite the regulatory review of COVID-19 related health products without compromising safety, efficacy and quality standards.
The quality of ethanol used in manufacturing hand sanitizers must be fit for the purpose and meet safety, efficacy and quality requirements. Health Canada recommends the purity of ethanol used for fabricating those products to be of pharmacopoeia grade. For any products containing ethanol with specifications that deviate from the recommended standards, such as those with higher than permitted level of impurities compared to the standard, a risk assessment must be conducted and submitted to Health Canada for review. Each risk assessment will be evaluated on a case-by-case basis to determine if the ethanol is safe for use in hand sanitizer production.
Due to the worldwide shortages of pharmacopoeia and food-grade ethanol since the start of the pandemic, Health Canada has allowed the temporary use of technical-grade ethanol in alcohol-based hand sanitizers and has approved specific sources of technical-grade ethanol for their fabrication. The companies proposing to supply technical-grade ethanol for use in hand sanitizers or hard-surface disinfectants must have received written authorization from Health Canada before proceeding.
Part of Health Canada’s process of technical-grade ethanol risk mitigation consists of additional information that must be added on both the product container and the external packaging.
After spot-inspections of various hand sanitizers for regulatory compliance, Health Canada considered to go as far as to recall certain products from the market. A published list of recalled products is available, and updated frequently, on their website.
Still unsure if your product label is compliant?
Reach out to us and our regulatory team will be able to review your label to ensure your product is safe for consumers!
Uncertain if your product formula is compliant for a product license?
Contact us today and our regulatory team will be able to review your formula and provide informed consulting!