Canada’s New Biocides Regulation: What Manufacturers Need To Know

Biocides—products used to sanitize or disinfect surfaces to prevent disease—are now subject to a new regulatory framework in Canada. These updates affect manufacturers, importers, and regulatory consultants.

At Maven Regulatory Solutions, we help companies navigate the complexities of regulatory affairs, compliance consulting, global regulatory intelligence, and regulatory submissions for biocides and other health-product categories.

What Are Biocides?

According to Health Canada, biocides are products that sanitize or disinfect hard or soft non-living, non-liquid surfaces to prevent disease in humans or animals.

These are distinct from products intended to treat living tissue, and they exclude medical devices, water/air sanitization, and direct food surface sanitization.

Canada’s Previous Regulatory Framework

Prior to the changes:

• Disinfectants were regulated under the Food and Drugs Act (FDR).
• Surface sanitizers were regulated under the Pest Control Products Act (PCPA).

This dual framework created confusion for industry because:

• Different rules and fees applied depending on product classification
• Registration and market-access pathways were inconsistent

What’s Changing: The Biocides Regulations

In May 2022, Health Canada published the proposed Biocides Regulations in the Canada Gazette, Part I.

The final regulations were registered June 19, 2024, and come into force May 31, 2025.

Key Features of the New Framework

• A single regulatory regime for biocides under the Food and Drugs Act.
• A pre-market assessment & market authorization requirement for surface disinfectants and sanitizers.
• A Use of Foreign Decisions (UFD) pathway allowing recognition of trusted foreign regulatory authority decisions (e.g., U.S. EPA).

Scope and Exclusions

Included Products

• Disinfectants and surface sanitizers for hard or soft non-liquid surfaces in commercial or household settings.

Excluded Products

• Sanitizers not meeting the “drug” definition (e.g., algaecides, odor control)
• Sanitizers/disinfectants for air or water treatment
• High-level sterilant or medical-device disinfectants
• Products applied directly to food surfaces
• Drugs for human/animal antiseptic use

Transition & Implementation Timeline

• As of May 31, 2025, all new biocide market-authorization applications must follow the Biocides Regulations.
• Existing products under FDR or PCPA have up to a 4-year transition period (to May 31, 2029) to convert to the new framework.
• Transition applications may be simplified for products already authorized.

Regulatory Pathways & Submission Options

Comparison of Existing Authorized Biocides

Applicants can expedite entry if they demonstrate:

• Same active ingredients and quantity as a previously authorized biocide
• Same formulants and manufacturing process
• Same label claims, risk management, storage/disposal instructions
• Same master formula

Use of Foreign Decisions (UFD) Pathway

Allows reliance on a trusted foreign regulator’s decision (initially U.S. EPA) to support Canadian authorization.

What Maven Regulatory Solutions Offers

We support clients through:

• Regulatory gap assessments and compliance strategy development
• Submission preparation for market authorization under the new biocides' framework
• Label and packaging review to meet Canadian requirements
• Monitoring of global regulatory intelligence—keeping you ahead in 2025 and beyond

Conclusion: Preparing for the Biocides Era

The Biocides Regulations mark a major shift toward a harmonized, risk-based regulatory model in Canada. Products not aligned with this framework risk market delays, increased cost, and compliance issues.

With Maven Regulatory Solutions, manufacturers and importers gain the expertise needed to navigate these regulations, streamline regulatory submissions, and maintain global compliance confidence.