Authorization of Surface Disinfectants in the United States and Canada

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?

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

Authorization of Surface Disinfectants in Canada

Surface disinfectants require pre-market authorization in Canada. They are regulated by Health Canada under the Biocides Regulations and require market authorization prior to sale in Canada.

Surface Disinfectants in Canada

In Canada, surface disinfectants intended for use on environmental surfaces, inanimate objects, and non-critical medical devices require pre-market authorization from Health Canada before they can be sold. Historically, these products were regulated as disinfectant drugs and required a Drug Identification Number (DIN). Under the Biocides Regulations, which came into force on May 31, 2025, surface disinfectants are transitioning to Health Canada's new biocides framework.

The applicable regulatory pathway depends on the product's intended use, claims, formulation, and target surfaces. Health Canada evaluates safety, efficacy, quality, and labelling information as part of the authorization process.

Products may qualify for streamlined review pathways where they meet the requirements of applicable monographs. Products with novel active ingredients, unique claims, or specialized uses generally require a more comprehensive review.

How Can Intertek Help?

Canada

Intertek can:

• Conduct regulatory feasibility assessments and gap analyses.
• Determine the applicable regulatory pathway for surface disinfectants and biocides.
• Review product formulations, efficacy data, and supporting documentation.
• Review product labels for Canadian regulatory compliance.
• Prepare and submit applications to Health Canada.
• Act as liaison with Health Canada during the review process.
• Support responses to Health Canada information requests.
• Provide post-authorization regulatory support, including change management and compliance obligations.
• Assist with transition activities under the Canadian Biocides Regulations.