Understanding Biocides and Their Regulation in Canada

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09 May 2025

Biocides play a critical role in public health and safety by controlling harmful organisms and preventing the spread of disease.

In Canada, products that sanitize or disinfect hard or soft non‑living, non-liquid surfaces (e.g., countertops, textiles, or equipment) are collectively referred to as biocides. These substances help protect humans and animals from harmful pathogens, making them essential in environments ranging from healthcare facilities to food processing plants and homes. However, because of their potential impact on health and the environment, biocides are regulated under separate regulatory frameworks in Canada. Let’s explore the types of products that fall under the biocides umbrella in Canada and the key regulatory requirements that govern their approval, marketing, and use across the country.

Surface Sanitizers, Disinfectants, and Surface Sanitizers for Use in Food Premises 

Biocides in Canada are subject to various regulatory frameworks. While surface sanitizer and disinfectants for general use, and surface sanitizers for use in food premises share similarities in terms of benefits, risks, uses, and ingredients, they are not regulated the same. Notably, while surface disinfectants and disinfectant-sanitizers with a Drug Identification Number (DIN) are subject to Food and Drug Regulations (FDR), sanitizers for use on non-living and non-liquid surfaces fall under the Pest Control Products Act (PCPA) and disinfectants and surface sanitizers for use in food premises are governed by the Food and Drugs Act (F&DA). This disparate regulatory landscape leads to inconsistent assessments of safety, efficacy, and quality, with varying requirements, fees, and timelines for product approvals.

At present, surface sanitizers for use in food premises do not need mandatory pre‑market review and do not require a license or market authorization to be sold on the Canadian market. Health Canada’s Bureau of Chemical Safety evaluates products voluntarily submitted by manufacturers for their acceptability from a food chemical safety perspective. For products considered acceptable, a “letter of no objection” is issued. This letter does not constitute an approval under the F&DA. Health Canada has limited tools available under the F&DA to effectively protect the health and safety of individuals exposed to surface sanitizers intended for use in food premises. There is no system to effectively identify, and track biocides used in food premises, and they are not subject to any post-market obligations. The current voluntary approach has also led to confusion in determining which biocides would be considered acceptable for use in food premises to address microbial contamination.

For perspective, without pre-market and post-market oversight by Health Canada, there is no assurance that surface sanitizers for use in food premises are effective in eliminating foodborne microbes on the surfaces to which they are applied. The impacts of foodborne illness on public health are known and important, with the Public Health Agency of Canada estimating about 4 million Canadians are affected by foodborne illness each year, which can lead to hospitalization and, in severe cases, death. While the causes of foodborne illness vary, proper sanitization of food contact surfaces can reduce instances of these illnesses. Furthermore, surface sanitizers for use in food premises do not have clear labelling requirements. Users of these products therefore may be unaware of the health risks associated with the products and any safety measures that need to be taken to mitigate those risks (e.g., wearing appropriate personal protective equipment).

The Biocides Regulations: Bridging the Gaps in the Regulatory Landscape for Biocides

The way in which all biocides are regulated in Canada is about to change through the upcoming implementation of the Biocides Regulations. The regulations were registered on May 31, 2024, and published in the Canada Gazette, Part II on June 19, 2024. The regulations will come into force on May 31, 2025.

Under the Biocides Regulations, biocides must undergo a pre-market assessment with the National Microbiology Laboratory, and a market authorization must also be obtained before they can be imported, sold, or advertised in Canada.

To obtain a market authorization, Health Canada requires the filing of a market authorization application, which includes detailed information on the safety, efficacy, and quality of the biocide. The Minister of Health issues the authorization, in accordance with section 11 of the Biocides Regulations, if the following conditions are met:

  • The application meets the relevant requirements set out in section 10 or 26 of the regulations, as applicable;
  • The applicant has provided the Minister of Health with any additional information or materials requested under subsection 10(4) or 26(5) of the regulations;
  • The Minister of Health has sufficient evidence to support the conclusion that the benefits of the biocide outweigh its risks, taking into account any uncertainties relating to its benefits and risks; and
  • The Minister of Health has reasonable grounds to believe that the biocide will be packaged and labelled in accordance with the F&DA and the regulations.

Health Canada will assign an 8-digit identification number to a biocide that has been issued a market authorization. This identification number must appear on the label and indicates that it has been authorized for sale in Canada.

Inspectors will monitor and enforce the compliance of biocides with the F&DA and Biocides Regulations through post-market regulatory activities. Health Canada’s Regulatory Operations and Enforcement Branch oversees these activities, while Health Canada’s Marketed Health Products Directorate is involved in the following post-marketing activities:

  • Monitoring and assessing the benefits and risks of marketed health products;
  • Communicating those risks to healthcare providers and the public;
  • Reviewing and analyzing post-market data and information received for biocides to identify any changes to the safety profile of these products; and
  • Developing risk management strategies to mitigate the identified risks when needed.

How Will Health Canada Authorize Biocides Between Now and May 31, 2025?

Between now and May 31, 2025, when the Biocides Regulations come into effect, Health Canada will review all applications for surface disinfectants and sanitizers under the F&DA or PCPA framework, as appropriate. If approved, Health Canada will issue a drug identification number or a pest control product registration number, as appropriate. These biocides will, however, need to comply with the Biocides Regulations by May 31, 2029, which marks the end of the 4-year transition period set by Health Canada. Companies that have registered for a surface sanitizer under the PCPA or those that have obtained an authorization for a disinfectant under the F&DA can file a transition application to meet the requirements of the Biocides Regulations. As of May 31, 2025, all new market authorization applications must adhere to the requirements of the Biocides Regulations.

How Intertek Can Help

Intertek can support companies in navigating the Biocides Regulations in Canada by offering a range of regulatory and compliance services to ensure a smooth transition and market authorization. Here’s how we can assist:

  • Regulatory Gap Analysis: Intertek can evaluate your current biocide registrations under the PCPA or F&DA framework to identify gaps regarding compliance with the Biocides Regulations.
  • Pre-Market Authorization Support: Intertek can prepare and submit applications for Health Canada’s market authorization, ensuring alignment with safety, efficacy, and quality requirements.
  • Labelling & Packaging Compliance: Intertek can review product labels in accordance with the new labelling requirements.
  • Transition Application Assistance: Intertek can guide you through the 4-year transition period (ending May 31, 2029) to secure market authorization under the new framework.

Why Choose Intertek?

Intertek has extensive experience in regulatory consulting and compliance for biocides, disinfectants, and sanitizers. Our team of regulatory experts and toxicologists will provide you with a seamless pathway to market while mitigating compliance risks.

References

Justice Canada. Biocides Regulations. May 31, 2024. Available at: https://laws.justice.gc.ca/eng/regulations/SOR-2024-110/page-1.html

Canada Gazette. Canada Gazette, Part 1, Volume 156, Number 19. May 7, 2022. Available at: https://gazette.gc.ca/rp-pr/p1/2022/2022-05-07/html/reg2-eng.html

Canada Gazette. Canada Gazette, Part 2, Volume 158, Number 13: Biocides Regulations. June 19, 2024. Available at: https://gazette.gc.ca/rp-pr/p2/2024/2024-06-19/html/sor-dors110-eng.html

Justice Canada. Pest Control Products Act. January 14, 2023b. Available at: https://laws.justice.gc.ca/eng/acts/P-9.01/

Health Canada. Biocides - Drugs and Health Products. Retrieved March 27, 2025. Available at: https://www.canada.ca/en/health-canada/services/drugs-health-products/biocides.html  

A professional headshot of Saurabh (Sky) Upadhya.
Saurabh Upadhya

Senior Regulatory Affairs Consultant, Pharmaceuticals & Healthcare, Intertek Assuris

Saurabh Upadhya is a Senior Regulatory Affairs Consultant at Intertek, bringing over a decade of experience across pharmaceutical MNC, start-up and regulatory consultancies. Working with multiple clients, Saurabh specializes in end-to-end management of regulatory submissions for drugs across various therapeutic areas to the Food and Drug Administration (FDA) and Health Canada.

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