Canada’s new biocide regulations will consolidate oversight of a range of surface sanitizers that are currently governed through differing regulatory channels, sometimes requiring redundant authorization processes. Once the regulations come into force on May 31, 2025, almost all sanitizers used on non-living, non-liquid surfaces will be regulated under the federal Food and Drug Act.
That will come with new packaging and labelling requirements and added vigilance for biocides used on food preparation surfaces, but there will be a multi-year transition period for formulations that are already on the Canadian market. The new regulations will also introduce streamlining measures.
Notably, registrants will only need to obtain a single market authorization for multiple brand names with similar ingredients within their suite of products — a policy that is already in place in the United States, the United Kingdom and the European Union. Canadian officials will also recognize market authorizations granted by the United States Environmental Protection Agency and other potentially designated “trusted foreign regulatory authorities”.
Currently, about 60 surface sanitizers, including those applied in institutional, commercial, industrial and residential settings are regulated under the Pest Control and Products Act (PCPA), which requires that they be reviewed and re-certified at five-year intervals. As well, products with essentially the same formulation are regulated under the Food and Drug Act (FDA) if they are used in health care or food-handling facilities, requiring a separate approval process.
Government officials have concluded it’s more appropriate to reclassify biocides as “drugs” because their primary purpose is to prevent disease in humans and/or animals and they generally involve different methods and frequencies of application than other types of pest control products. The new biocides regulations are meant to be a better fit with “the nature of these products”, while eliminating redundant processes, reducing the industry’s costs and getting effective products to the market sooner.
“Many industry stakeholders have consistently identified opportunities for reduced administrative burden, increased international alignment, and the need for consistent application requirements for these similar products as priorities for regulatory modernization efforts. These concerns can be addressed through the implementation of a single regulatory framework that has requirements specific to biocides,” the accompanying regulatory analysis states.
Meanwhile, there has been something of a regulatory vacuum surrounding surface sanitizers in food-handling premises since 2014 when the government of the day repealed the Canadian Food Inspection Agency’s authority to set conditions for non-food chemicals in federally registered food establishments. The regulatory analysis estimates that Health Canada has assessed about 8 per cent of surface sanitizers for food premises that are now on the market through a voluntary program, but the remainder are considered to “have never been reviewed for food safety by Health Canada”. Although provincial/territorial governments are responsible for health and safety in food-handling facilities, the regulatory analysis argues that the new regulations will provide overarching assurance and vigilance against microbial contamination.
“Surface sanitizers for use in food premises are currently not required to undergo a mandatory pre-market review nor have a licence or market authorization to be sold on the Canadian market,” it states. “The creation of a regulatory framework for surface sanitizers for use in food premises will help ensure they are safe, effective and of high quality.”
Some other biocides employed in property/facilities management will fall outside the new regulations. Pool and spa disinfectants, water/air sanitizers, algaecides, slimicides and odour control products will continue to be regulated under the Pest Control and Products Act. Cleaners that contain biocides will continue to be regulated under the Canada Consumer Product Safety Act and the Hazardous Product Act.
