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

On this page

• Purpose
• Overview
• Prior to the coming into force
• Coming into force
• Transition period
• Compliance and enforcement for transitioning biocides
• Contact us

Purpose

This guidance applies to products that meet the definition of a biocide and will be transitioning to the Biocides Regulations (the regulations). These biocides include:

• surface disinfectants and disinfectant-sanitizers with a Drug Identification Number (DIN) authorized for sale under the Food and Drug Regulations (FDR)
• sanitizers for use on non-living and non-liquid surfaces that are registered as pest control products under the:
  • Pest Control Products Act (PCPA)
  • Pest Control Products Regulations (PCPR)
• surface sanitizers for use in food premises that are subject to the Food and Drugs Act (FDA)

This guidance includes information for:

• applications for a DIN or pest control product registration for a new biocide, but without a final decision before the coming into force date
• existing biocides that are authorized or registered under the FDR or PCPA before the coming into force of the regulations
• surface sanitizers for use in food premises coming into compliance with the regulations

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

• compliance and enforcement considerations
• transition period requirements
• labelling requirements
• post-market requirements

Definition of a biocide

Overview

On May 31, 2024, the governor-in-council registered stand-alone regulations for biocides under the FDA that contain:

• regulatory requirements tailored to the unique nature of biocides, such as:
  • record retention
  • packaging and labelling
  • post-authorization changes
  • post-market safety monitoring and incident reporting
• a modern, single authorization framework that provides oversight for biocides that were previously regulated under different regulatory frameworks with different requirements, despite similarities
• a transition period that:
  • minimizes market disruptions by allowing time to exhaust existing stock and reduce costs associated with updating labels
  • provides time for applicants and market authorization holders to learn new or revised requirements and start implementing them
  • provides surface sanitizers for use in food premises additional time to obtain a market authorization and come into compliance with the regulations

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

• the applicable application requirements are met
• you have provided the Minister with any additional information that is requested
• the Minister has sufficient evidence to support the conclusion that the benefits outweigh the risks, taking into account any related uncertainties
• the Minister has reasonable grounds to believe that the biocide will be packaged and labelled in accordance with the FDA and the regulations

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:

• a coming into force date of 1 year from the date of registration of the regulations
• a 4-year period (starting from the coming into force date) for the transition of already authorized disinfectants and registered sanitizers
• transition application pathways to facilitate the transition for biocides that are authorized or registered under the FDR or PCPA before the coming into force of the regulations
• a 6-year period (starting from the coming into force date) for surface sanitizers for use in food premises to obtain a market authorization
• the ability for the Minister to issue a DIN (under the FDR) or pest control product registration (under the PCPA) after the coming into force date of the Biocides Regulations for biocides (either a drug or pest control product) with pending applications that do not receive a final decision by this time

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

• before and after the coming into force of the regulations
• during and after the transition periods described in the regulations

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

• comprehensive information on authorized biocides, except for:
  • CAS registry numbers
  • the biocide's shelf life
  • the quantities of formulants
  • comparison biocide or foreign biocide details
• any changes to the status of the authorization
• how the authorization was granted (application pathway used when based on comparison or the use of foreign decisions)

Prior to the coming into force

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

• DIN
• pest control product registration number
• letter of no objection (LONO)

Coming into force

When the regulations come into force:

• we will begin accepting transition applications to transition existing biocides to the regulations
• we will continue to review any remaining applications for a biocide submitted under the FDA, FDR or PCPR (as applicable)
• applicants for new biocides seeking market authorization must follow the requirements in the regulations instead of the FDR and the PCPA/PCPR
• post-authorization changes must:
  • continue to be filed under the FDR and PCPR for products with DINs or pest control product registrations until they are subject to the regulations
  • be filed under the regulations for biocides that have transitioned to the regulations

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 least 135 days before the end of the transition period (by January 16, 2029). 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:

• a requirement to pay a fee for examination of a new application for a market authorization
• inability to import, sell or advertise your biocide until a market authorization is obtained.

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

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:

• labelling requirements
• record keeping requirements
• post-market surveillance requirements

A decision for your transition application could mean:

• the Minister has granted a market authorization for your biocide
• you have withdrawn your transition application
• the Minister has refused to issue a market authorization for your biocide

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:

• selling, advertising, or importing:
  • a biocide without a valid market authorization
  • a biocide that is not compliant with the terms of its market authorization or registration
  • a disinfectant during the transition period without a valid DIN under the FDR
  • a sanitizer during the transition period without a valid pest control product registration number under the PCPA
  • a surface sanitizer for use in food premises without a valid market authorization after the end of the 6 year transition period
• not meeting the requirements of the regulations for a biocide once it is subject to the regulations, for example:
  • quality control
  • record keeping
  • safety monitoring
  • reporting
• not meeting the requirements under the FDA or FDR for a product with a DIN
• not meeting the requirements under the PCPA or PCPR for a product with a pest control product registration

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

• Biocides Regulations
• Food and Drugs Act (FDA)
• Food and Drugs Regulations (FDR)
• Pest Control Products Act (PCPA)
• Pest Control Products Regulations (PCPR)

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

• Compliance and Enforcement Policy for Health Products (POL-0001)
• Pesticides Compliance and Enforcement Policy

Contact us

Contact us if you have any questions about the information in this guidance document.

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