Canadian biocide regulations
Expert guidance through Health Canada’s evolving biocides regulatory framework
Canada’s new Biocides Regulations, which came into effect on May 31, 2025, mark a significant shift in how surface disinfectants and sanitizers are regulated. At Sagentia Regulatory, we help you navigate this transition with clarity and confidence – so you can bring your biocidal products to market efficiently, compliantly, and cost-effectively
Understanding the Canadian biocides regulatory landscape
Until recently, biocidal products in Canada were regulated under multiple frameworks depending on their intended use – either as drugs, pesticides, or incidental food ingredients. The new Biocides Regulations, introduced under the Food and Drugs Act, unify these pathways under a single, streamlined system.
As of May 31, 2025, the following product types are now regulated under the Biocides Regulations:
- Disinfectants – previously regulated under the Food and Drug Regulations with a Drug Identification Number (DIN)
- Sanitizers – previously regulated under the Pest Control Products Regulations with a Pest Control Product (PCP) number
- Food contact surface sanitizers – previously unregulated or issued a Letter of No Objection (LONO)
Under the new framework, a biocide is defined as any drug used to destroy, inactivate, reduce, or control micro-organisms on non-living, non-liquid surfaces.
Canadian biocides registration
To be sold in Canada, biocides must now undergo market authorization under one of several pathways:
- Transition application – a fee-free option for existing products with a DIN or PCP number
- Registration application – a paid route offering more flexibility, including multiple brand names and formulas under one registration
- Use of Foreign Decision (UFD) – a new pathway allowing faster registration of products already approved by the US EPA
- Biocide monograph – a simplified route for well-characterized products, offering the fastest and most cost-effective approval
Each pathway has specific requirements for safety, efficacy, quality, and labeling. Food contact surface sanitizers, which were previously exempt, must now be registered under the new framework. Companies must submit applications through the Common Electronic Submissions Gateway (CESG), which requires a separate registration process. Sagentia Regulatory is already registered and ready to submit through CESG on our client’s behalf.
Sagentia Regulatory can help you with biocide registrations
Whether you’re transitioning an existing product or registering a new one, our team provides tailored support at every stage:
- Strategic planning aligned with the Biocides Regulations
- Preparation and submission of transition or registration applications
- Guidance on the Use of Foreign Decision (UFD) pathway
- Label development and compliance with the biocide monograph
- Data review for safety, efficacy, and quality
- Support during Health Canada consultations
- Post-market compliance, including adverse event reporting and label updates
- Representation as a Canadian regulatory agent for foreign companies
Why choose Sagentia Regulatory?
We work closely with your internal teams to ensure your product strategy aligns with Canadian requirements, minimizing delays and maximizing compliance. From global healthcare brands to specialty manufacturers, companies trust Sagentia Regulatory for science-led, practical regulatory solutions that support successful market access in Canada.
Your Canadian biocides regulatory experts
Joe McCarthy leads our Canadian regulatory services with deep expertise in biocide compliance. From evaluating transition options to preparing full registration applications, Joe and his team provide hands-on support to help you navigate the new regulatory landscape with confidence.
