New regulations on biocidal products strengthen supervision

Canada’s new biocides regulations will consolidate oversight of a range of surface disinfectants that are currently regulated through different regulatory channels, sometimes requiring redundant authorization processes. When the regulations go into effect on May 31, 2025, almost all disinfectants used on inanimate and nonliquid surfaces will be regulated under the federal Food and Drug Act.

This involves new packaging and labeling requirements and increased vigilance for biocides used on food preparation surfaces, but there will be a multi-year transition period for products that are already available on the Canadian market. The new regulations will also introduce streamlining solutions.

In particular, registrants will only need to obtain single market authorization for multiple brands containing similar ingredients within their product suite – a policy already in place in the US, UK and European Union. Canadian officials also recognize marketing authorizations from the U.S. Environmental Protection Agency and other potentially designated “trusted foreign regulators.”

Currently, approximately 60 surface disinfectants, including those used in institutional, commercial, industrial and residential settings, are regulated by the Pest Control and Products Act (PCPA), which requires them to be reviewed and recertified every five years. Additionally, products with substantially the same composition are regulated by the Food and Drug Administration (FDA) when used in a healthcare or food handling facility, requiring a separate approval process.

Government officials have concluded that it is more appropriate to reclassify biocides as “drugs” because their primary purpose is to prevent disease in humans and/or animals and they generally require different methods and frequencies of application than other types of pest control products. The new rules on biocidal products aim to better match the “nature of these products”, while eliminating redundant processes, reducing industry costs and bringing effective products to market faster.

“Many industry stakeholders have consistently identified opportunities for reduced administrative burdens, increased international alignment, and the need for consistent requirements for the use of these similar products as priorities in regulatory modernization efforts. These problems can be solved by implementing a single regulatory framework with requirements specific to biocidal products,” states the attached regulatory analysis.

Meanwhile, 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, there has been something of a regulatory vacuum regarding surface disinfectants in food-handling establishments. The regulatory analysis shows that Health Canada has assessed about 8 per cent of food facility surface disinfectants that are currently on the market under a voluntary program, but found that the rest “have never been reviewed for food safety by Health Canada.” While provincial/territorial governments are responsible for health and safety in food processing establishments, regulatory analysis shows that the new regulations will provide paramount certainty and vigilance in the face of microbial contamination.

“Surface disinfectants used in food establishments are currently not required to undergo mandatory pre-market review or be licensed or authorized for sale in the Canadian market,” it states. “Creating a regulatory framework for surface disinfectants for use in food establishments will help ensure they are safe, effective and of high quality.”

Some other biocides related to property/facility management will not be covered by the new regulations. Pool and spa disinfectants, water and air disinfectants, anti-algae agents, mucus killers and odor control products will continue to be regulated under the Pest Control and Products Act. Cleaning products containing biocides will continue to be regulated by the Canadian Consumer Product Safety Act and the Hazardous Products Act.