Guidance on biocide application pathways and general requirements: Before you apply

Overview

Before you apply for a biocide market authorization you should ensure that:

your product is a biocide and the ingredients in your biocide are appropriate for inclusion in a biocide
you understand the application requirements for the application pathway you intend to file under

This section will provide you with tools that can help you accomplish these tasks before applying for market authorization for your biocide.

Before you apply, you will also need to understand the application process, including the format for filing an application, the completion of a biocide application form, and how to obtain a:

dossier ID
company ID
electronic submissions gateway (ESG) account

For guidance on navigating the biocide application process, including electronic filing requirements, consult:

Guidance on management of biocide applications

Pre-submission advice and meeting requests

You may request pre-submission advice before filing an application with us. You may also request a pre-submission meeting to discuss the proposed application with us.

The guidance on management of biocide applications outlines the mechanisms that you can use to request pre-submission advice and meeting requests.

Pre-submission consultations are used to:

familiarize our review staff with the application before it is submitted, and discuss the data in the application to enable review
identify potential problems or issues and manage disputes early in the application process
give you an opportunity to obtain feedback on areas of concern identified by us, based on current experience and regulatory requirements, such as:
- cover classification concerns
- whether the proposed supporting data are considered adequate to establish the safety, efficacy, and quality of the biocide
increase the quality of the information included in the application

There are certain biocides for which we strongly recommend you request pre-submission consultation, including:

novel biocides
biocides with fogging or electrostatic spray methods of application
biocides with claims for:
- destroying or controlling biofilms
- reducing the infectivity of prions
- residual self-sanitizing or disinfection
- soft surface sanitization or disinfection
- spore forming bacteria other than Clostridium difficile, Bacillus subtilis and Clostridium sporogenes
biocides relying on test methods other than those recommended within the efficacy requirements guidance document

A pre-submission meeting may not be beneficial for all biocide applicants. In many cases, we can provide written guidance instead. If you're not sure if you should have a pre-submission meeting, contact us with a description of your biocide. We will contact you to discuss the request. If we determine a meeting is warranted, this discussion will include:

possible meeting dates
the overall content of the pre-submission package
confirmation of the number of meeting participants

The available data may be a point of discussion at the meeting, but we will only consider its acceptability during the scientific review of the biocide. That is, within an active biocide application for a market authorization. It's important to understand that the outcome of a pre-submission meeting does not constitute a regulatory decision by the Minister.

Learn more:

Verification of a biocide's ingredients within the Biocides Ingredients Database

Before submitting a biocide application, we recommend that you verify that the ingredients in the proposed product are appropriate for inclusion in a biocide.

The Biocides Ingredients Database (BID) is a repository of active ingredients and formulants for use in biocides that is updated regularly. Ingredients can be verified in this database.

As indicated in the biocide application form user guide, a biocide's active ingredient(s) must be listed in the database before filing your biocide application. A biocide's formulants do not need to be listed in the database before filing an application, except for applications filed through the monograph pathway.

The guidance on management of biocide applications outlines the mechanisms that you can use to request the addition of ingredients within the database.

Note that inclusion of an ingredient and corresponding purpose in the database does not mean that it is safe or effective or guaranteed to be approved for use in a biocide. As outlined in this guidance, depending on the application pathway, you are required to submit evidence to us to support the safety, efficacy and quality of the biocide. This review includes determining whether the ingredients (both active and formulants) meet the requirements for a market authorization to be issued.

Verification of compliance with the Canadian Environmental Protection Act, 1999

You are responsible for ensuring that the substances in your biocide are compliant with:

any relevant risk management measures
the New Substances Notification Regulations of the Canadian Environmental Protection Act, 1999

These are administered by Environment and Climate Change Canada. Substances not on the Domestic Substances List may require notification under the New Substances Notification Regulations prior to import or manufacture beyond regulatory trigger quantities.

For more information, contact the Regulatory Affairs Unit.

Telephone: 1-866-996-9913
Telephone: 613-948-3591
Email: eau-uee@hc-sc.gc.ca

Learn about the new substances program

Filing of information

Before submitting a biocide application, you will need to understand the application process, including the format for filing an application, the completion of a biocide application form, and how to obtain a:

dossier ID
company ID
electronic submissions gateway (ESG) account

The guidance on management of biocide applications outlines the electronic filing requirements and provides additional resources to help you prepare and file information to Health Canada.

You should contact us if you require help filing out the biocide application form.

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2025-08-13

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