Guidance on efficacy requirements for biocides: Overview

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Health Canada updated the Guidance document on efficacy requirements for biocides in May 2025. This new update introduces important changes, including adjustments to the format and order of presentation of information, modifications to texts and tables, and the addition of references. This updated guidance replaces the previous version released in June 2024.

• Purpose
• General
• Good laboratory practice
• Application requirements
  • Efficacy data
  • Efficacy summary
• Alternate efficacy test methods
• Reasons for pre-submission meetings or consultations
• Contact us

Purpose

You are required to provide information in your biocide application so that the Minister of Health (the Minister) can determine if the biocide's benefits outweigh its risks taking into account any uncertainties relating to those benefits and risks. This requirement is set out in both the Food and Drugs Act (act) and Biocides Regulations (regulations).

This guidance document outlines the tools and approaches you can use to meet the efficacy requirements in the regulations. Using these tools and approaches may reduce the number of times we need to clarify an item in an application. It will also help us make a decision on your biocide more quickly.

You're responsible for ensuring that you:

• have scientific evidence to support the efficacy of your biocide

Your application should include:

• sufficient information on the benefits and risks associated with your biocide (including efficacy information) and any uncertainties relating to those benefits and risks
• a summary of this information (including efficacy information) and any uncertainties relating to those benefits and risks

You should contact us if you wish to deviate from the approaches in this guidance.

Studies that were initiated prior to the publication of this guidance document may have relied on a previous efficacy guidance document when undertaking studies. For example, you may have referred to the following 2020 guidance:

• Safety and efficacy requirements for surface disinfectant drugs

We will assess whether these studies are still acceptable for new biocide applications under the updated data requirements. Contact us if you want to verify the acceptability of your efficacy data prior to submitting your application.

Currently, we do not have any re-evaluation requirements for authorized biocides. The supporting data approved for a surface disinfectant under the Food and Drug Regulations or a sanitizer under the Pest Control Products Act will be acceptable under the Biocides Regulations for transition applications. If new scientific information becomes available, we may need to confirm that the benefits of your biocide continue to outweigh the risks taking into account any related uncertainties.

General

If the Minister does not have sufficient information to conclude that the benefits outweigh the risks of your biocide, taking into consideration any related uncertainties, we will either:

• request additional information to support your biocide or
• refuse to issue a market authorization for your biocide

Examples of situations where we may request additional information include:

• when we are aware of an efficacy concern related to the biocide
• when the intended use or purpose (claim) on the label text is inconsistent with the efficacy data submitted for your biocide
  • for example, your biocide is labelled as a fungicide but lacks supporting efficacy data against the representative fungus
• if you have submitted the minimum application requirements, but there is insufficient information in your application for the Minister to make a decision
• when information in your efficacy summary shows there is a specific concern that should be investigated

Examples of additional efficacy information that could be requested to better characterize the benefits and risks of your biocide include:

• data
• literature
• written scientific rationale

For guidance on navigating the biocide application process, consult:

• Guidance on management of biocide applications
• Biocide application form user guide

The guidance on management of biocide applications outlines the mechanisms that we can use to request additional information from you during our assessment of your biocide application.

Good laboratory practice

When testing for efficacy, you should use good laboratory practice (GLP). This will help to ensure that the data you generate is high quality and reliable.

Choose a testing laboratory that complies with our GLP compliance requirements. There are many test laboratories in North America that conduct tests that meet these requirements.

Other types of GLP compliance standards include those published by the:

• Organisation for Economic Co-operation and Development (OECD)
• Environmental Protection Agency in the United States (US EPA)

If you rely on non-GLP compliant data (for example, non-GLP studies or GLP studies with outages), you should confirm that the standard you used to assess compliance is equivalent to GLP certification. For example, certain International Organization for Standardization (ISO) certification standards are equivalent. This scenario is more common for tests done by European laboratories.

Include rationales to demonstrate:

• how the alternate standards differ from GLP standards
• how they meet alternative standards
• your use of non-GLP compliant testing

We will assess whether the deviations from GLP or alternative standards are acceptable. While we will consider all rationales, we cannot guarantee that we will accept the submitted data.

Contact us if you want to verify the acceptability of your non-GLP compliant data prior to submitting your application.

Application requirements

Information to support the benefits and any related uncertainties of your biocide include:

• efficacy data (when applicable)
• an efficacy summary (when applicable)

Certain applications must contain efficacy information and/or a summary of the information included in your application about the risks and any related uncertainties of your biocide. Find information below and in the guidance on biocide application pathways and general requirements on when efficacy data and/or a summary are required.

Efficacy data

You must submit efficacy data to support an application for a:

• new biocide market authorization, filed through the full review or full review - novel biocide pathways and
• notice of acceptance for a major change that could reasonably be expected to have a major impact on efficacy of the biocide

You do not have to submit efficacy data to support an application filed through the following pathways:

• monograph
• comparison - administrative application
• comparison - labelling only
• use of foreign decisions (UFD)
• major change - monograph
• major change - quality and risks
• minor change

For these pathways, efficacy data are either not required (those filed through the minor change pathway) or are covered by a:

• Health Canada publication (monograph)
• letter of confirmation and attestation
• list of tests and studies that have been submitted to the foreign regulatory authority

Efficacy summary

Certain applications must contain a summary of the information included in your application about the benefits and any related uncertainties of your biocide. Find information on when an efficacy summary is required and what should be included in the efficacy summary.

As indicated in the summary of information on benefits, risk and related uncertainties of the guidance on biocide application pathways and general requirements, the summary helps us screen and review your application. It may also reduce the number of clarification requests we issue, a mechanism outlined in the guidance on management of biocide applications.

Your summary should explain your biocide's efficacy when used in accordance with the proposed conditions of use. It should include a summary of your efficacy data and other related information (such as rationales) for your proposed biocide.

If possible, you should put the efficacy summary in a table. A sample efficacy summary template is available.

Alternate efficacy test methods

All micro-organism (bacteria, viruses, fungi) claims for your biocide should be tested in similar conditions to how the biocide will be used. If your biocide will not be used in a conventional way, test modifications or alternate test methods may be needed to support its efficacy for the proposed use.

The efficacy test methods outlined in this guidance are examples only.

If you want to use an alternate test method, you may contact us to request pre-submission advice or a pre-submission meeting to verify if the alternate method is acceptable to support your claim.

If you use an alternate method, you should use the test requirements specific to:

• that test method
• the recommendations by other regulators or international organizations

The test requirements should be consistent with:

• test organisms
• microbial counts
• performance criteria
• number of batches
• number of carriers or replicates

Reasons for pre-submission meetings or consultations

Pre-submission meetings or consultations are an opportunity to advise you on the appropriate efficacy data or confirmatory data you may need to support your biocide application.

You should contact us or schedule a meeting before you submit an application for market authorization for certain biocides, including those:

• with an unconventional method of application
• with uncommon or novel claims
  • prion claims, for example
• with unconventional or novel ingredients
  • nanomaterials, for example
• that are to be used with other products or activators

You should also contact us or schedule a meeting to confirm if standard efficacy methods need to be modified to support your claim for your specific biocide and its intended uses if the claims include those for:

• fungi
• residual sanitizing
• residual disinfectants
• vapour or gas biocides seeking a sterilant or spore claim
• soft-surface sanitizing or disinfectants, such as use:
  • in laundry, added in the rinse cycle
  • on carpets
  • sprayed on clothes
• prions
• biocides with novel claims, ingredients, form or methods of application

For instructions on pre-submission meetings or consultations, consult:

• Guidance on biocide application pathways and general requirements
• Guidance on management of biocide applications

Contact us

Contact the Natural and Non-prescription Health Products Directorate to:

• set up a pre-submission meeting
• discuss the appropriate efficacy data you may need to support your biocide
  • for example, the additional efficacy information for a novel biocide
• discuss alternative test methods or modifications for your biocide
• discuss testing requirements, including residual claims against other microbial categories, longer duration or for porous surfaces
• add claims against fungi and viruses for laundry disinfection
• market a biocide with carpet sanitization claims

Email: nnhpd-dpsnso@hc-sc.gc.ca