Authorization of Surface Disinfectants in Canada and in the United States

Surface Disinfectants in Canada

In Canada, surface disinfectants can fall under two Acts:

1. Food and Drugs Act

• Regulated by the Natural and Non-prescription Health Products Directorate (NNHPD)
  • “Disinfection” claims for hard surfaces, non-porous environmental surfaces, and inanimate objects are regulated by Health Canada as disinfectant drugs.
    • Disinfectant drugs require a pre-market assessment and issuance of a Drug Identification Number (DIN) prior to being sold in Canada.

2. Pest Control Products Act (PCPA)

• Regulated by the Pest Management Regulatory Agency (PMRA)
  • “Sanitization” claims and other “kill” claims related to microbes are regulated as pesticides
    • Pesticide registration requires the submission of efficacy data, physical/chemical product data, and toxicological data to support safety.

Surface Disinfectants in the United States

Surface disinfectants that are not intended to be used on medical devices, or are intended for use on or in living humans or animals, are considered pesticides in the U.S. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) regulates the distribution, sale, and use of antimicrobials including surface disinfectants.

How Can Intertek Help?

Canada

Intertek can:

• Identify the appropriate regulatory route for disinfectant products based on efficacy claims and ingredients.
• Prepare and submit the appropriate regulatory application (DIN application for a disinfectant drug product, or PMRA application for products considered an antimicrobial pesticide).
• Review product labels against the applicable regulation(s).
• Act as a liaison between the PMRA and clients during the application review.
• Provide Canadian Agent Services.

United States

Intertek can:

• Obtain a company and/or establishment number.
• Provide feasibility assessments and gap analyses.
• Review product labels.
• Prepare and submit appropriate applications based on the Pesticides Registration Improvement Act (PRIA) category.
• Act as a liaison between the EPA and clients during the application review.
• Provide U.S. Agent Services.
• Facilitate state agency registration.
• Monitor annual federal and state-level registrant obligations