Notice - Release of Draft Guidance Document: Disinfectant Drugs (2013) for Consultation

April 2, 2013
Our file number: 13-105060-229

Health Canada is pleased to announce the release of Draft Guidance Document: Disinfectant Drugs (2013) for a 60-day stakeholder consultation. Once finalized, this guidance will supersede Guidance Document: Disinfectant Drugs (2007).

This guidance document has been developed in response to the withdrawal of the Canadian General Standards Board (CGSB) guideline CAN/CGSB 2.161-97 "Assessment of Efficacy of Antimicrobial Agents for Use on Environmental Surfaces and Medical Devices". This standard was heavily referenced in Guidance Document: Disinfectant Drugs (2007).

Features of the Draft Guidance Document

This document has been created to provide a more user friendly and comprehensive overview of the safety and efficacy requirements considered necessary to obtain market authorization of disinfectants and disinfectant-sanitizers regulated under the Food and Drugs Act and Food and Drug Regulations. The proposed revisions to this guidance document draw upon the long standing regulatory and scientific basis for the evaluation of disinfectant products by other regulators, most notably the United States Environmental Protection Agency (U.S. EPA) and the United States Food and Drug Administration (FDA), the guidance for North American Free Trade Agreement (NAFTA) labelling of hard surface disinfectants, and ongoing Organization for Economic Cooperation and Development (OECD) harmonization goals. Features of this guidance document include:

• well established test methods [for example (e.g.) Association of Analytical Communities standard methods) and more recent test methods (e.g. towelette protocols];
• the inclusion of more detailed efficacy requirements to specify the recommended criteria for assessing disinfectant drugs, in tables based on microorganism type;
• the expansion of safety requirements to specify the recommended criteria for assessing disinfectant drugs;
• the expansion of efficacy and safety data requirements for high-level disinfectants and chemosterilants intended for use on semi-critical and critical medical devices to specify the recommended criteria for assessing higher-risk disinfectants;
• the expansion and updating of efficacy and safety data requirements for contact lens disinfectants to specify the recommended criteria for assessing these higher-risk disinfectants;
• the addition and expansion of definitions;
• the addition of an appendix describing the regulation of products containing antimicrobial ingredients in Canada with reference to the various regulatory frameworks for cleaners, sanitizers, disinfectants, incidental additives, and non-food chemical requirements; and,
• the removal of the Category IV Monographs, Labelling Standard, and Labelling Guide: Food Processing Plant Sanitizers/Cleaners from the body of the document. These documents will be published separately on the Health Canada website.

In addition to the safety and efficacy features described above, this guidance document proposes flexibility in the application of certain aspects of Division 1 of the Food and Drug Regulations for selected categories of hard surface disinfectants. This flexibility will help reduce unnecessary regulatory burden for low-risk disinfectant products and will achieve greater alignment with the U.S. EPA. The areas of increased alignment include lot numbering designation; expiry date labelling; permissible colouring agents; highest degree of purity for active ingredients; and the maximum upper limit for the active ingredient. These proposals reflect the Health Product and Food Branch (HPFB)'s risk-based approach of applying a level of oversight that is proportional to the risks associated with the use of the product. They will also be addressed in the context of a new regulatory framework for disinfectant drugs, to be developed as part of HPFB's Regulatory Roadmap for Health Products and Food Modernization.

Comments on the draft guidance document should be provided to Health Canada, preferably in electronic format using the attached template, within 60 days of the date of this notice. All comments will be considered in the finalization of the draft guidance.

Comments should be directed to: Bureau of Gastroenterology, Infection and Viral Diseases

Therapeutic Products Directorate
Health Products and Food Branch
Health Canada
Finance Building, Address Locator 0202D1
101 Tunney's Pasture Driveway
Ottawa, Ontario
K1A 0K9
Telephone: 613-941-2566
Fax: 613-941-1183
E-Mail: BGIVD_Enquiries@hc-sc.gc.ca