Biocide monograph

(PDF version - 107 K)

June 19, 2024

This monograph takes effect when the Biocides Regulations come into force. Until then, use the 2015 monograph for hard-surface disinfectants.

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 revised monograph on hard-surface disinfectants (2015) when the Biocides Regulations come into force.

It describes the parameters for a biocide that must be met to be eligible to file an application for a market authorization 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

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 document 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

Active ingredients and efficacy parameters

Your biocide must:

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

Table 1 applies to all biocides. Table 2 specifies an additional active ingredient for biocides intended only for use in toilet bowls.

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

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

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 Table 1.

Combinations of any of the active ingredients from the different categories listed in tables 1 and 2 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 or Table 2:

• 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:
  • 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 or viruses
• Optional sanitizer claims:
  • Reduces bacteria
  • Kills 99.9% of bacteria
  • Controls mould and mildew

Refer to the biocides labelling requirements guidance for more information about claims, including non-therapeutic claims (for example, "cleaner").

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.

Check the labelling recommendations for your biocide.

Formulants

Your biocide's formulants should be listed in the Biocides Ingredients Database before filing an 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% of the total formulation. 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
• distributors
• importers

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

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

References

• Centers for Disease Control and Prevention 2008. Healthcare Infection Control Practices Advisory Committee (HICPAC) Guideline for Disinfection and Sterilization in Healthcare Facilities [accessed 2014-11-27].
• Health Canada 2014. Drug Product Database (online and in-house [accessed 2014-11-27].
• United States Environmental Protection Agency 2014. National Pesticide Information Retrieval System [accessed 2014-11-27].
• 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.