Biocide monograph

Health Canada published the updated Biocide monograph in May 2025. Updates include the addition of active ingredients to Table 1, addition of a new table with active ingredients and general microorganism claims for surface sanitizers for use in food premises (SSFPs), and updates to the text to provide additional clarity. This updated monograph replaces the previous version released in June 2024.

On this page

• Foreword
• Active ingredients and efficacy parameters
• Use or purpose
• Directions for use
• Formulants
• Safety requirements
• Quality requirements
• References

Foreword

This monograph will replace the monograph on hard-surface disinfectants (2015) when the Biocides Regulations come into force on May 31, 2025. This monograph includes the addition of surface sanitizers for use in food premises (SSFPs) as a new category of biocide eligible for an abbreviated review via the monograph application pathway. These biocides were not previously required to have a market authorization to be sold on the Canadian market. If you market an SSFP, you will need to obtain a biocide market authorization to continue to sell, advertise or import it. You should consult the guidance on the transition of disinfectants and surface sanitizers to the Biocides Regulations and the guidance on biocide application pathways and general requirements for information on transition period requirements and available filing pathways for SSFPs.

This monograph describes the parameters that an application must meet under the biocide monograph pathway. These parameters include the:

• contact times
• permitted active ingredients
• target microorganism classes
• minimum in-use concentrations
• intended settings for use of the biocide

This monograph does not apply to biocides:

• intended for use on porous surfaces
  • such as carpets, fabrics and textiles
• with certain efficacy claims:
  • biofilm
  • residual (long-lasting)
  • specific microorganisms
    • such as Escherichia coli or rhinovirus
  • broad-spectrum virucide
• intended for use at temperatures outside of 18 to 25°C

Biocides that do not meet the parameters specified in this monograph should apply for a market authorization outside of the monograph pathway, as indicated in the application pathways and general requirements guidance document.

You are not required to submit efficacy data through the monograph pathway. However, when conducting efficacy testing for your proposed formulations, you should reference the guidance on efficacy requirements for biocides for recommended efficacy test methods and expected performance criteria.

You are required to submit safety information for your biocide, as this monograph only specifies efficacy parameters. Consult the guidance on safety requirements for biocides to determine the types of safety information to be included in your abbreviated safety summary.

You should consult the guidance on quality requirements for biocides for quality-related requirements (such as product specifications). Consult the guidance on labelling requirements for information on how to develop the labelling for your biocide.

Learn more:

• Guidance on application pathways and general requirements
• Guidance on efficacy requirements for biocides
• Guidance on safety requirements for biocides
• Guidance on quality requirements for biocides
• Guidance on labelling requirements for biocides
• Guidance on the management of biocide applications

Active ingredients and efficacy parameters

Your biocide must:

• contain 1 or more of the permitted active ingredients listed in Tables 1, 2 or 3 and
• meet the specified minimum in-use concentrations, expressed as parts per million (ppm)

Table 1 applies to all biocides except surface sanitizers for use in food premises (SSFPs). Table 2 specifies an additional active ingredient for biocides intended only for use in toilet bowls. Table 3 applies exclusively to SSFP claims, as defined in subsection 70(3) of the Biocides Regulations.

Your biocide must meet the efficacy parameters specified in tables 1, 2 or 3, based on the active ingredient(s) and minimum in-use concentrations. These include:

• contact times
• intended settings for use
• target microorganism classes

Your biocide may combine efficacy parameters specified in tables 1, 2, or 3, provided that the labelling clearly identifies each type of use independently. The exception is hydrogen chloride, which is only acceptable for use in toilet bowls.

Combinations of active ingredients

Combinations of any of the active ingredients from the same category are permitted provided that the total in-use concentration of the combined ingredients meets the minimum stated in Tables 1, 2 or 3. For SSFP claims, the total-in use concentration of the combined ingredients must not exceed the maximum in-use concentration specified in Table 3.

Combinations of any of the active ingredients from the different categories listed in tables 1, 2 or 3 are permitted provided that the:

• ingredient(s) from 1 of the categories is present at the minimal in-use concentration for that category and
• ingredients do not interact in a manner that reduces the biocidal activity

Use or purpose

Your biocide must be intended for 1 or more settings for use as supported in Table 1, Table 2 or Table 3:

• Household
• Commercial:
  • Industrial or institutional
  • Hospital or health care
  • Food premises
  • Animal housing areas

Your biocide label must indicate 1 or more of the following uses or purposes (claims):

• Required, 1 or more:
  • Disinfectant
  • Sanitizer
• Optional disinfectant claims, with percentage reduction claims supported by the performance criteria set out in biocide test methods and protocols published by international standards organizations as referenced in the guidance on efficacy requirements for biocides:
  • Kills bacteria or bactericide or bactericidal
  • Kills viruses or virucide or virucidal
  • Kills fungi or fungicide or fungicidal
  • Kills germs or germicide or germicidal
  • Kills mould and mildew
  • Kills 99.99% of bacteria or fungi
  • Kills 99.9% of viruses
• Optional sanitizer claims for non-food contact surfaces, with a percentage reduction claim supported by the performance criteria set out in biocide test methods and protocols published by international standards organizations as referenced in the guidance on efficacy requirements for biocides:
  • Reduces bacteria
  • Kills 99.9% of bacteria
  • Controls mould and mildew
• Optional SSFP claims, with a percentage reduction claim supported by the performance criteria set out in biocide test methods and protocols published by international standards organizations as referenced in the guidance on efficacy requirements for biocides, and with guidelines in the federal/provincial/territorial Food Safety Committee Food Retail and Food Services Code (FPTFSC 2016):
  • Reduces bacteria
  • Kills 99.999% of bacteria
  • Kills bacteria on food contact surfaces

Refer to the biocides labelling requirements guidance for more information about claims.

Non-therapeutic (marketing) claims should not be included on the label text submitted in the application. We do not evaluate the accuracy of non-therapeutic claims for biocides unless they are expected to pose health and safety risks, even if they are present on the label text submitted in the application. Approval of the label text is not an endorsement of any non-therapeutic (marketing) claims that might be present.

Directions for use

Your biocide label must include adequate directions for all intended uses or purposes, consistent with the labelling recommendations provided within the guidance on biocides labelling.

Many biocide ingredients have the potential to remain on surfaces after their contact time, forming residues that may:

• contaminate food or drink
• be a concern for surfaces or objects that come into contact with young children

To determine if a rinse step is necessary following use of a biocide, consult the guidance on safety requirements for biocides. As specified in the safety guidance section on residues, if you do not wish to include a statement on the label to rinse with potable water after using the biocide, you should explain why in your application. Biocides with SSFP claims compliant with Table 3 generally do not require a rinse statement, provided that their formulants are also acceptable for use in food premises. To support your decision, you may reference an incidental additive "letter of no objection" (LONO) if the Food and Nutrition Directorate had previously issued one for the biocide's formulation.

An SSFP label should include the following additional directions for use:

• food contact surfaces must be cleaned and rinsed with potable water prior to sanitizing
• prior to application (spraying) of the product in food handling areas, all food should either be removed from the vicinity or otherwise protected from the spray
• the surfaces must be thoroughly drained prior to re-use

Check the labelling recommendations for your biocide.

Formulants

Your biocide's formulants must be listed in the Biocides Ingredients Database before filing a monograph application. The biocides application pathways and general requirements guidance specifies the process to request:

• the addition of a new ingredient
• modifications to the information found within the database

The formulants within your biocide should not adversely affect the efficacy, safety or quality of the biocide. As specified in the biocides application pathways and general requirements guidance, all ingredients that are directly responsible for the biocide's efficacy should be listed as active ingredients, not formulants.

Formulation variations for biocides authorized through the monograph pathway are limited to differences in fragrances and dyes that do not exceed 1.0% expressed as a percentage on a weight-per-weight basis (% w/w). No other differences in formulation are allowed through the monograph pathway because any other variation requires a review of the scientific rationale and confirmatory data.

Learn more:

• Guidance on application pathways and general requirements

Safety requirements

Your biocide must comply with the safety requirements outlined in the Biocides Regulations, including that a biocide label must include:

• adequate risk information
• directions for use that minimize unintentional residues on treated surfaces

For more information on safety requirements for biocides, and the types of safety information to be included in your abbreviated safety summary, consult the guidance on:

• Safety requirements for biocides
• Labelling requirements for biocides
• Biocide application pathways and general requirements

Quality requirements

Compliance with the quality requirements outlined in the Biocides Regulations, including that a biocide must have a master formula, which includes specifications, is mandatory for:

• applicants
• market authorization holders
• manufacturers
• packagers
• labellers
• importers

For more information on quality-related requirements, consult the guidance on:

• Quality requirements for biocides
• Biocide application pathways and general requirements

References

• Federal/Provincial/Territorial Food Safety Committee (FPTFSC). Food Retail and Food Services Code, February 2016.
• Government of Alberta, Alberta Health. Food Retail & Food Services Code, June 2020.
• Government of Northwest Territories. Food Establishment Safety Regulations, Public Health Act, August 2019.
• Government of Nova Scotia, Department of Agriculture. Food Retail & Food Services Code, March 2016.
• Government of Ontario. Ontario Regulation 493-17, Health Protection and Promotion Act, Food Premises, December 2024.
• Government of Ontario. Ontario Food Premises Reference Document, 2019, Ministry of Health and Long-Term Care, February 2019.
• Government of Prince Edward Island. Public Health Act Food Premises Regulations, Public Health Act, Chapter P-30.1,, October 2024.
• Government of Saskatchewan. Food Processing Facility Standards, September 2023.
• Health Canada. Drug Product Database [accessed 2025-02-07].
• Rutala, W.A., Gergen, M.F., and Weber, D.J. 2012. Efficacy of improved hydrogen peroxide against important healthcare-associated pathogens. Infection Control and Hospital Epidemiology, 33(11): 1159-1161.
• Rutala, W.A., and Weber, D.J. 2013. Disinfectants used for environmental disinfection and new room decontamination technology. American Journal of Infection Control, 41 (2013) S36-S41.
• Russell, Hugo & Ayliffe's Principles and Practice of Disinfection, Preservation and Sterilization, 5th Edition, December 2012.
• United States Centers for Disease Control and Prevention. 2008. Healthcare Infection Control Practices Advisory Committee (HICPAC) Guideline for Disinfection and Sterilization in Healthcare Facilities.
• United States Environmental Protection Agency. Pesticide Product and Label System [accessed 2025-02-07].