Prompted in part by supply chain challenges emerging during the COVID-19 pandemic, Health Canada is proposing a new regulatory framework under the Food and Drugs Act (FDA) specific to biocides. Biocides are products that sanitize or disinfect hard or soft non-living and non-liquid surfaces to prevent disease in humans or animals. After several rounds of consultation, on May 7, 2022, Health Canada published the proposed Biocides Regulations in the Canada Gazette, which attempt to create a regulatory framework that harmonizes the regulation of biocides under one comprehensive framework.
Biocides are currently regulated under separate regulatory frameworks in Canada: disinfectants are regulated under the FDA, surface sanitizers are regulated under the Pest Control Products Act (PCPA), and products with both disinfectant and sanitizer claims are regulated solely under the FDA.1 As such, despite having similar ingredients and risks and benefits, these products and their safety, efficacy and quality are subject to a myriad of requirements, fees and timelines that confuse (and sometimes deter) applicants, burdening the supply chain.
Under the proposed Biocides Regulations, however, disinfectants currently regulated under the Food and Drug Regulations (FDR) and certain surface sanitizers regulated under the PCPA would instead be regulated together under the new regulations. Health Canada’s hope is that by reducing the application costs and increasing the predictability of the regulatory process for applicants, the Biocides Regulations will attract more industry to the Canadian market and help secure the Canadian supply chain of biocides for future emergency response preparedness.