The Biocides Regulations (SOR/2024-110), introduced under the Food and Drugs Act and the Pest Control Products Act, aim to establish a unified regulatory framework for biocides in Canada. These regulations, recommended by the Minister of Health with the goal of providing a more risk-based approach to the regulation of products used to destroy or inactivate microorganisms on non-living surfaces while ensuring safety and efficacy.

Defined in the regulations, a biocide is a drug specifically manufactured to control or eliminate microorganisms on surfaces that are not liquid or living; however, it excludes biocides used on food surfaces, contact lenses, or certain medical devices. Historically, surface sanitizers, disinfectants, and similar products have been regulated under various frameworks, resulting in inconsistencies in safety and efficacy assessments due to the dual oversight of the Food and Drugs Act (FDA) and the Pest Control Products Act (PCPA). This bifurcated system led to duplicate reviews and regulatory delays, particularly evident during the COVID-19 pandemic when the demand for disinfectants surged.

The new Biocides Regulations aim to consolidate the regulation of biocides under the FDA, facilitating easier market access to safe and effective products. By tailoring application requirements specific to biocides, the regulations seek to reduce regulatory burdens while maintaining safety standards. This modernized framework addresses the need for continuous post-market oversight of biocides and introduces a pathway to leverage authorizations from other regulatory bodies, notably the U.S. Environmental Protection Agency (U.S. EPA).

Key features of the regulations include their scope of coverage, which applies to surface sanitizers and disinfectants under the FDA’s definition of drugs, while products like algaecides or water sanitizers will continue to be regulated under the PCPA. The regulations outline a clear market authorization process requiring applicants to provide comprehensive information on product safety, efficacy, and quality, including general product information and specifications to support the product’s claims. There are distinct application pathways for market authorization, including comparison-based applications that allow for authorization of biocides similar to existing products, thus streamlining the approval process. Additionally, applicants can utilize decisions from trusted foreign regulatory authorities for expedited market access.

Health Canada will maintain authority for ongoing oversight of biocides post-authorization, including the ability to request further data or samples if concerns arise regarding a product’s benefits or risks. Each biocide will receive an eight-digit identification number for tracking and transparency on product labels.

By integrating the regulation of biocides into a single framework under the FDA, the government aims to improve public access to safe and effective products while simplifying the complexities of previous regulations.

Canada (SOR/2024-110) June 19, 2024