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Health Canada publishes new biocides regulations

July 12, 2024

Health Canada has published new Biocides Regulations under the Foods & Drug Act, creating a single regulatory framework for the approval of disinfectants and sanitizers. Entering into force on May 31, 2025, Health Canada says the move will streamline the regulatory requirements for most biocides, helping lower costs to industry, and expediting authorisation procedures without compromising the health and safety of Canadians.

Existing Canadian regulations

Currently, a biocide may fall under one or more of three different regulations and agencies:

  1. Disinfectants (6 log/99.9999% reduction of microorganisms) – regulated as drugs under the Food & Drug Regulations (DIN#)
  2. Sanitizers (3 log/99.9% reduction of microorganisms and or biostatic claims) – regulated as pesticides under the Pest Control Products Regulations (PCP#)
  3. Food contact surface sanitizers used in food preparation premises – these products currently receive a Letter of No Objection (LONO) from the Bureau of Chemical Safety. They are not currently subject to an efficacy review and are not registered

New Canadian biocides regulations

On June 19, 2024, Health Canada published final Biocides Regulations, bringing all three product types under a single regulatory framework.

These new regulations will:

  • Come into force on May 31 , 2025
  • Apply to all biocides used on hard and soft surfaces. They do not apply to air or water sanitizers or material preservatives
  • Introduce a new “Use of Foreign Decision” (UFD) pathway to allow products that are registered with a trusted Foreign regulatory authority an administrative pathway to be registered in Canada. The first trusted Foreign Regulatory is the US EPA, though the framework is set up to recognize others such as the EU BPR
  • Introduce a new Food Contact Surface Sanitizer Monograph
  • Allow alternate brand names for a product under one registration
  • Allow multiple formulations under one registration
  • Afford a 4-year timeline for existing disinfectants (DIN#) and Sanitizers (PCP#) to transition registrations to the new Biocides Regulations
  • Afford a 6-year timeline for food contact surface sanitizers with a LONO to transition to registration to the new Biocides Regulations

How can TSG help?

Joe McCarthy, TSG’s Principal Regulatory Consultant, Canada, is ready to assist you in understanding how your existing or new products can transition to the new regulations. As Chair of the Canadian Consumer Specialty Products Association, Registered Products Committee, Joe is involved in supporting industry in implementing the new regulations and guidance. Joe can guide you on the timing of the transition, the necessary supporting documentation, and the required changes for your labels. Get in touch at [email protected] if you’d like to schedule an informal chat with Joe.