Guidance documents on disinfectants: Summary

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• Overview
• New guidance documents

Overview

Products that were registered under both the Food and Drugs Act and the Pest Control Products Act are now registered under the Food and Drugs Act. This consolidation took place on April 1, 2020. These products include surface disinfectants and disinfectant-sanitizers.

Health Canada has prepared guidance documents to help stakeholders interpret the legislative and regulatory requirements associated with this new registration process. These 3 new guidance documents are:

1. Disinfectant Drugs
2. Safety and Efficacy Requirements for Surface Disinfectant Drugs
3. Management of Disinfectant Drug Applications

The guidance documents apply to products used as follows:  

• for non-critical medical devices, environmental surfaces, inanimate objects in homes, industrial or institutional settings, hospitals, food processing plants and barns (surface disinfectants)
• for secondary uses, as food and non-food contact surface sanitizers (disinfectant-sanitizers)

New guidance documents

In Canada, chemical products used to clean, sanitize or disinfect environmental surfaces and inanimate objects are regulated under different regulatory frameworks. Regulation is based on their use or purpose, and not solely on their chemical composition. The presence or concentration of a recognized antimicrobial active ingredient as part of a product’s formulation does not dictate how it is regulated. 

In general, 2 key factors determine which regulatory framework applies to a product:

1. the intended use as represented by the expressed or implied claims, including the level of antimicrobial activity on the label
2. the type of surface or object to which the product is intended to be applied 

Chemical products used as disinfectants on environmental surfaces and inanimate objects, or for use on non-critical medical devices are regulated under the Food and Drugs Act and Regulations. Before they can be sold in Canada, they require a pre-market assessment and a drug identification number (DIN). To receive a DIN and market authorization, applicants must provide safety, efficacy and quality evidence that the product performs as indicated by the label.

The Disinfectant Drugs guidance document:

• gives an overview of the regulation of disinfectant drugs and disinfectant-sanitizers in Canada
• outlines the information needed to support their safety, efficacy and quality
• sets out the labelling requirements for these products according to the Act and Regulations

The Safety and Efficacy Requirements for Surface Disinfectant Drugs guidance document outlines the information needed to support the safety and efficacy of chemical products that meet the regulatory definition of “antimicrobial agent.” These are disinfectants represented for use on non-critical medical devices, and on environmental surfaces and inanimate objects.

The Management of Disinfectant Drug Applications guidance document gives an overview of the application streams that apply to disinfectant drugs, including disinfectant-sanitizers.

For a copy of the guidance documents or for help, please email the Stakeholder Engagement Division of the Natural and Non-prescription Health Products Directorate at: hc.nnhpd.consultation-dpsnso.sc@canada.ca