Guidance on efficacy requirements for biocides: Overview

On this page

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

Purpose

You're required to provide information so that 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 should contact us if you wish to deviate from the approaches in this guidance.

If the Minister is unable to conclude that the benefits outweigh the risks taking into account any uncertainties relating to those benefits and risks, Health Canada will either:

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

If you relied on a previous guidance document when undertaking studies, we will assess whether these studies are still acceptable under the updated data requirements. For example, you may have referred to the following 2020 guidance:

• Safety and efficacy requirements for surface disinfectant drugs

Currently, we do not have any re-evaluation requirements for authorized biocides. The supporting data that you initially submitted in your application for a biocide market authorization are acceptable. 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.

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 good laboratory practice 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.

Application requirements

Information to support the benefits of your biocide include:

• efficacy data
• an efficacy summary

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

Your application must include a summary of your efficacy data and other related information (such as rationales) for your proposed biocide. This reduces the need for us to ask for an item to be clarified when we are screening your application or conducting a scientific review of your biocide.

You do not have to provide an efficacy summary if you relied on efficacy information that was provided in an application for a previously authorized biocide. This applies to applications filed through the following pathways:

• UFD
• comparison - labelling only
• comparison - administrative application

For these pathways, you must fulfil efficacy information requirements in other ways, such as through a:

• letter of confirmation
• list of tests and studies that have been submitted to the foreign regulatory authority

For information on what to include in the efficacy summary and for a sample template, refer to the page on preparing your benefits package.

Alternate efficacy test methods

All microorganism (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 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, carriers or replicates

Note: Contact us to set up a pre-submission meeting if you want to use an alternate method.

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.

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

• with unconventional method of applications
• 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 tests 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
• biocides with novel ingredients
• 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

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
• discuss the appropriate 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