Guidance on the transition of disinfectants and surface sanitizers to the Biocides Regulations: Overview

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Purpose

This guidance applies to products that meet the definition of a biocide as of May 31, 2025, and will be transitioning to the Biocides Regulations (the regulations) under the Food and Drugs Act (FDA). These biocides include:

This guidance includes information for:

This guidance contains information to help you transition your biocide to come into compliance with the requirements outlined in the regulations, including:

Definition of a biocide

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

Overview

The way surface disinfectants and surface sanitizers are regulated in Canada has changed. The Biocides Regulations were registered on May 31, 2024, and published in the Canada Gazette, Part II on June 19, 2024. The regulations introduce a single regulatory framework in Canada for biocides under the Food and Drugs Act and came into force on May 31, 2025.

These stand-alone regulations contain:

With the introduction of the regulations, the Minister of Health (the Minister) will issue a market authorization for a biocide (including transitioning biocides) if:

To help the Minister determine if the biocide has benefits that would outweigh the risks, the regulations allow us to request additional information or samples.

To facilitate this transition, the regulations include:

You can find more details in Table 1 regarding how we will treat applications:

Once a biocide has been issued a market authorization, the regulations require the Minister to maintain and publish:

Prior to the coming into force

During the 1-year period between registration and the coming into force of the regulations, applicants could continue to file applications and submissions under the FDA, FDR or PCPR. Health Canada reviewed any applications or submissions received according to the FDA, FDR or PCPR and issued a decision regarding the product's authorization or conditions of use. For example, a:

Coming into force

When the regulations came into force:

Transition period

Existing DIN holders or registrants for biocides authorized or registered under the FDR or PCPA may file a transition application or a new application during the transition period to transition their biocides to the regulations. A transition application is an abbreviated application because you do not need to include all of the information required in a new application for a biocide market authorization.

Surface sanitizers for use in food premises are not eligible to use a transition application unless they also have disinfectant claims and are authorized with a DIN. Surface sanitizers for use in food premises will need to obtain a market authorization under the regulations using the new application pathways before the end of a 6-year transition period to continue to be sold once the 6 years has elapsed.

To allow us enough time to review and issue a decision for your transition application we recommend you submit your application at the latest 135 days before the end of the transition period (by January 16, 2029). The guidance on management of biocide applications provides guidance on navigating the biocide application process and outlines the mechanisms that we can use to request additional information from you during our assessment of your biocide application. Note that the filing date for your biocide application will only be set once it is considered to be administratively complete following the processing period.

Since transition applications are only active during the transition period, we will be unable to issue a market authorization through this transition application pathway after the end of the transition period. After the transition period, any transition applications that have not received a decision must re-apply using a new application pathway under the regulations if you are intending to continue to advertise or sell your biocide.

If we receive your transition application after January 16, 2029, you will receive a letter outlining the risks and consequences if you do not obtain a market authorization for your biocide. These could include:

Once the applicable transition period ends, biocides without a market authorization under the regulations will be non-compliant and must not be sold. Such biocides may be subject to enforcement action. We will no longer accept or process transition applications after the end of the transition period.

Types of transition applications

There are 2 types of transition applications and associated pathways:

  1. Transition application for sanitizers registered under the PCPA
  2. Transition application for disinfectants and disinfectant-sanitizers authorized under the FDR
Table 1: Transition timeline
Timeline Status
May 31, 2024: Registration
  • Existing and new applications in queue reviewed and authorized according to FDR, FDA and PCR
  • No applications accepted under the regulations
May 31, 2025 (1 year after registration): Coming into force (CIF)
  • Applications for a market authorization are available for new products, including surface sanitizers for use in food premises (with an applicable pre-market review fee)
  • Remaining DIN and pest control product applications in queue (at CIF) will continue to be reviewed according to the regulatory framework they were filed under
May 31, 2025 to May 31, 2031 (4 to 6 years, starting at CIF): Transition period

General:

  • Biocides authorized under the FDR or PCPA may submit a transition application (no safety or efficacy data) to transition to the regulations (at no cost)
  • Surface sanitizers for use in food premises have 6 years to obtain a market authorization

Details:

January 16, 2029 (approximately 5 months before transition period ends):

  • Recommended deadline to apply for a market authorization using a transition application

May 31, 2029 (4 years after CIF): End of transition for biocides previously subject to the FDR or PCPA:

  • DINs and pest control product registrations are no longer valid for biocides
  • Transition applications are no longer available

May 31, 2031 (6 years after CIF): Regulations fully in force:

  • Surface sanitizers for use in food premises must have a market authorization to be sold

Compliance and enforcement for transitioning biocides

Existing biocides with a DIN or pest control product registration will continue to be subject to FDR or PCPA requirements until your transition application receives a decision. This includes:

A decision for your transition application could mean:

As the Minister authorizes transitioning biocides under the regulations, we will update their entry in their previous respective registered or licensed database.

You may be subject to compliance and enforcement action if you are:

You will be subject to compliance and enforcement action if you contravene the:

The manner of action will be appropriate to the risks presented by the non-compliant products, in accordance with either the:

Contact us

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

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

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2025-05-29