Canada’s New Biocide Regulation

By Dee Wilson, Senior Regulatory Specialist, Supply Chain team, UL Solutions

Currently, biocides are authorized under the Food and Drug Regulations (FDR) or the Pest Control Products Act (PCPA) in Canada. Biocides include surface disinfectants or disinfectant-sanitizers under the FDR (displays an 8-digit DIN number) and surface sanitizers under the PCPA.

The new Canadian Biocides Regulation (registered May 31, 2024) will come into force May 31, 2025. During this 1-year period between the new registration and its coming into force, biocide applicants will proceed with the previous application pathways according to the FDA, FDR or PCPR and if accepted, receive their DIN, PCP registration number or Letter of no Objection (LONO). Once the new biocide regulations have come into force (CIF), product transition applications will now be accepted.

Once the regulation has come into force, biocides must go through a premarket assessment with the NNHPD (Natural and Non-prescription Health Products Directorate) and receive a market authorization before they can be imported, sold or advertised in Canada. For those products that meet biocide safety, efficacy and quality, applicable requirements in section 10 or 26 of the regulation and any subsection 10(4) or 26(5) requests, have sufficient evidence to support its benefits outweigh its risks, and will be packaged and labeled in accordance with the Food and Drugs Act and the regulation will receive an 8-digit number for biocides for those that that are issued market authorization.

Inspectors will monitor and enforce compliance through post-market regulatory activities and the Marketed Health Products Directorate (MHPD) will continue to monitor, assess and communicate risks and develop management strategies where needed.

For now (before May 31, 2025), all biocides will be reviewed according to the FDR or PCPA and will receive their usual respective DIN number or PCP registration number as applicable, however, these products must transition to the new regulation by the end of the 4-year transition period (by May 31, 2029).

These transitional biocides will include:

• Surface disinfectants and disinfectant-sanitizers with a Drug Identification Number (DIN) authorized for sale under the Food and Drug Regulations (FDR) (4-year transition)
• Sanitizers for use on non-living and non-liquid surfaces registered as PCPs under:
  • Pest Control Products Act (PCPA) (4-year transition)
  • Pest Control Products Regulations (PCPR) (4-year transition)
• Surface sanitizers for use in food premises subject to the Food and Drugs Act (FDA)
  • Have 6 years to obtain a market authorization (May 31, 2031)

Those needing to transition a disinfectant or surface sanitizer can consult the following guidance documents:

• Overview
• Transition of Authorized Disinfectants and Registered Sanitizers
• Packaging and Labeling
• Post-Market Requirements

The regulation provides for two types of transition applications and their respective pathways:

1. For sanitizers registered under the PCPA
2. For disinfectants and disinfectant-sanitizers authorized under the FDR

Products will continue to be subject to all FDR or PCPA requirements until the transition application receives a decision. Decisions could include:

• The Minister has granted market authorization of the biocide
• The company has withdrawn its transition application
• The Minister has refused to issue a market authorization for the biocide

All approved transition application biocides:

• Will have their product updated in the respective registered or licensed database
• Must meet new regulations (such as labeling, QC, record keeping, safety monitoring and post-market surveillance, and reporting)
• Maintain compliance with the terms of its market authorization 

Reference

Canada Gazette: Biocide Regulations