Guidance on the transition of disinfectants and surface sanitizers to the Biocides Regulations: Transition of authorized disinfectants and registered sanitizers

On this page

• Options to transition
• Using a transition application
• Using a new application for your biocide
• Changing how your product is marketed
• Discontinuing your biocide

Options to transition

The transition period is from May 31, 2025 to May 31, 2031. If you have a product authorized or registered in Canada that now meets the definition of a biocide, you have 4 options during this transition period:

1. You may transition your biocide to the regulations by submitting a transition application to receive a market authorization as a biocide before May 31, 2029.
   • The guidance on management of biocide applications provides an estimated performance standard for transition applications.
2. You may apply for a new market authorization for your biocide under the regulations by submitting a new application. The only applicable option for surface sanitizers for use in food premises is to obtain a market authorization through the new application pathways.
   • The guidance on management of biocide applications provides an estimated performance standard for new biocide applications.
3. You may remove all biocide claims from your existing product label, authorization and registration. However, your product will need to be compliant with whichever regulatory frameworks apply to the remaining claims as applicable. For example, medical device, pest control product or cleaner claims.
4. You may remove your biocide from the market and request that your DIN or pest control product registration be cancelled.

You will be able to continue to sell your product that is authorized under the FDR or registered under the PCPA:

• before you apply to transition your biocide
• while your transition application is under review with Health Canada

This is because its DIN or pest control product registration is still valid. You may also continue to sell your surface sanitizer for use in food premises:

• before applying
• while an application for a market authorization is under review

At the end of their 4-year transition period, DINs and pest control product registrations for biocides under the FDR and the PCPA, respectively, will no longer be valid. You will require a market authorization issued under the regulations to sell the biocide.

If you market a surface sanitizer for use in food premises, you will need to obtain a biocide market authorization by the end of the 6-year transition period to continue to sell, advertise, or import it.

Using a transition application

The following biocides are eligible to use a transition application:

• disinfectants with an active (approved, marketed or dormant) DIN (not cancelled)
• sanitizers with an active pest control product registration (not cancelled or expired)

If your biocide is eligible, the requirements in the regulations apply to your biocide on the earliest day that any of these situations occur:

• the transition period ends
• your DIN is cancelled under the FDR
• your registration is no longer active under the PCPA (it was not renewed)
• you receive a market authorization under the regulations
• the Minister has refused to issue you a market authorization for your biocide under the regulations
• you withdraw your application for a market authorization for the biocide under the regulations

Your DIN or pest control product registration will no longer be valid when the Minister issues you a market authorization under the regulations. In other words, we will no longer regulate your product under the FDR or PCPA and it will be transitioned to the regulations.

After receiving your market authorization under the regulations, you must provide us with a notification of first sale within 30 days, if the biocide is being sold.

Conditions

If you are transitioning your biocide using a transition application, the following apply:

• The biocide must remain identical to the product authorized or registered under the FDR or PCPA, except for the brand name.
  • You may add alternate brand names and change the primary brand name of the biocide in the transition application, provided it is a unique name.
  • You will not be able to add new formulations, or change or remove previously authorized formulations for your biocide, within a transition application.
• The same 8-digit identification number will be issued as the sequence of numbers used for your DIN under the FDR.
• A new 8-digit identification number will be issued to replace the pest control product registration number.
• No fees or performance standards are associated with the transition application.

When using a transition application, transitioning sanitizers registered under the PCPA must also make the changes to the product labels to comply with the regulations. For example, switch to using a DIN designation before the new 8-digit identification number.

More information on the labelling changes required for sanitizers

Adding or revising brand names in a transition application

If you wish to use a brand name for your biocide in a transition or other application, and it is associated with an already authorized disinfectant or registered sanitizer, you may either:

• first cancel the DIN or pest control product registration with that brand name, or revise the brand name for the already authorized or registered product before requesting to add this brand name to your biocide market authorization
• request in your cover letter and in the biocide application form that the associated DIN(s) or pest control product registration(s) be cancelled at the same time as issuance of the market authorization for the biocide
  • You will only be able to add unique brand names to your biocide market authorization.

Additional information during review

During review of an application, the Minister may request additional information to determine if a market authorization will be issued. For example, additional information may be requested if there are uncertainties:

• related to the benefits and risks of a biocide
• regarding the biocide's ability to be compliant with the packaging or labelling requirements outlined in the regulations

The Minister may also ask for additional information for the transition of authorized disinfectants. For example, those that were last reviewed prior to 2014 to verify the safety labelling meets current standards for authorization.

Post-authorization changes

If you wish to file a post-authorization change for your transitioning biocide you may either:

• transition your biocide to the regulations first and then file for a post-authorization change
• file the post-authorization change under the FDR or PCPA (as applicable) before filing a transition application under the regulations
• file a new application for a biocide under the regulations and:
  • the same 8-digit identification number will be issued as the sequence of numbers used for your DIN under the FDR, as applicable
  • a new 8-digit identification number will be issued to replace the pest control product registration number

You will not be able to submit both a transition application and a post-authorization change application or notification at the same time. Once your biocide has transitioned, you may file for a post-authorization change. Examples of post-authorization changes include:

• adding or revising claims
• directions for use
• risk information
• consolidating additional formulation variations

If a post-authorization change is acceptable, we will update your market authorization as applicable. You may cancel any separately authorized products that have been incorporated into the revised market authorization if you wish.

Your biocide may have been authorized based on comparison to another biocide under the FDR or PCPA that has transitioned to the regulations. If so, you may make major and minor changes using the comparison post-authorization pathways available under the regulations. To do so, you must ensure your biocide fully aligns with the comparison biocide under the FDR or the PCPA (such as ingredients, risk information and conditions of use). Your application must include:

• the DIN or registration number and brand name of the comparison biocide
• a letter of confirmation (if you are not the DIN or registration holder of the comparison biocide) that indicates:
  • the amended master formula of the comparison biocide has been provided to you, if the major change to the comparison biocide resulted in a change to the master formula, or
  • the major change did not result in a change to the master formula
• an attestation that the biocide will:
  • be manufactured in accordance with the updated master formula of the comparison biocide
  • have the same specifications as the comparison biocide, other than in respect of the:
    • net quantity of the biocide in the package and type of package
    • properties and qualities of the packaging material

How to submit a post-authorization change and associated requirements

To file a post-authorization change under the FDR or PCPA/PCPR (as applicable) before filing a transition application under Biocides Regulations:

• existing drug identification number (DIN) holders seeking to file applications to change their authorized surface disinfectant in accordance with the FDR during the 4-year transition period should consult the management of drug submissions and applications (MDSA) guidance.
• existing registrants intending to submit applications under the PCPA/PCPR to amend the registration of their surface sanitizer during the 4-year transition, refer to the Pest Management Regulatory Agency's Category C Application Guidance Document for further details, or contact the PMRA at pesticides-info@hc-sc.gc.ca.

Application requirements

Products with a DIN

Your transition application using the transition pathway for a disinfectant should include a:

• cover letter, which identifies the associated DIN(s) to be cancelled at the same time as issuance of the market authorization for the biocide
• completed biocide application form, including the:
  • biocide's DIN and any associated DIN(s) to be cancelled
  • the name and contact information for all manufacturers of your biocide
  • the name and contact information of all packagers and labelers of your biocide, if known
  • the name and contact information for any importers of your biocide
  • the civic addresses of the locations where the biocide will be manufactured and, if known, packaged and labelled

If you do not know the name, contact information or civic address of the packagers and labellers at the time of application, you must tell us in the notification of first sale.

The label text for your biocide should not be included in your transition application. You should only provide the label text if the Minister asks for additional information for the transition of authorized disinfectants. For example, the label text for those that were last reviewed prior to 2014, to verify the labelling meets current standards for authorization.

Products with pest control product registration

Your transition application using the transition pathway for a sanitizer should include:

• the proposed label text
• the biocide's approved pest control product label
• a cover letter, which identifies the associated pest control product registrations to be cancelled at the same time as issuance of the market authorization for the biocide
• completed biocide application form, including the:
  • biocide's pest control product registration number and any associated registration numbers to be cancelled
  • the name and contact information for all manufacturers of your biocide
  • the name and contact information of all packagers and labelers for your biocide, if known
  • the name and contact information for any importers of your biocide
  • the civic addresses of the locations where the biocide will be manufactured and, if known, packaged and labelled

If you do not know the name, contact information or civic address of the packagers and labellers at the time of application, you must tell us in the notification of first sale.

Transition applications for products authorized or registered based on comparison

If your product was authorized based on a comparison under the FDR or PCPA, you must also include, as applicable within the biocide application form:

• confirmation that the transitioning biocide was authorized based on comparison to another product (either under the FDR, PCPA or the regulations)
• the DIN, pest control product registration number, or identification number of the comparison product

If you receive a market authorization for a biocide under the regulations, the market authorization will include the DIN, pest control product registration number, or identification number of the comparison product referenced.

You may transition your biocide before the comparison product; however, it is recommended that the comparison transition first.

If you are transitioning a surface sanitizer that was used as a comparison product under the PCPR, include a list of products relying on your product in your application. This will enable us to update relevant information in the market authorizations of all biocides that have already transitioned relying on your surface sanitizer. For example, the other biocide's identification number.

Obtaining a biocide market authorization based on comparison under the regulations will allow you to make any post-authorization changes, if required, to match the master formula or label of the other biocide.

More information on post-authorization changes

Using a new application for your biocide

Any biocide is eligible to use a new application to transition to the regulations. This includes:

• disinfectants or disinfectant-sanitizers with a DIN
• sanitizers with pest control product registration
• surface sanitizers for use in food premises

Any application pathway could be used to transition your biocide if the eligibility criteria and conditions are met. This includes the following pathways:

• Full review - novel biocide
• Full review (tier I, II and III)
• Use of foreign decisions
• Monograph
• Comparison - labelling only
• Comparison - administrative application

Conditions

Using a new application to transition your biocide will allow you to:

• add or consolidate formulation variations
• make other post-authorization changes (for example, change the conditions of use of the biocide with supporting evidence, as applicable)
• have either:
  • the same 8-digit identification number as the sequence of numbers used for your DIN under the FDR, as applicable
    • a new 8-digit identification number will be issued if changes that create a new biocide are made (for instance, change to active ingredient, active ingredient quantity, or physical form)
  • a new 8-digit identification number to replace the pest control product registration number

You will be required to pay a fee and Health Canada will review the application according to the set performance standards. For the applicable fee for your biocide application, refer to the fees for the evaluation of an application - biocides.

To use a new application to transition your biocide, your application must include, as applicable, the existing:

• DIN
• pest control product registration number

You should also provide a letter of no objection or a letter of acceptance (if you have one) if the product is a surface sanitizer for use in food premises.

Your DIN or pest control product registration will no longer be valid when the Minister issues you a market authorization under the regulations. In other words, we will no longer regulate your product under the FDR or PCPA and it will be transitioned to the regulations.

After receiving your market authorization under the regulations, you must provide us with a notification of first sale within 30 days if the biocide is being sold.

Learn more:

• Formulation variations section of application pathways and general requirements for biocides guidance
• Guidance for post-authorization changes for biocides
• Guidance on application pathways and general requirements for biocides

Changing how your product is marketed

Instead of transitioning your product to the regulations when they come into force, you may instead choose one of the following:

1. Market your product as a cleaner by updating the product label to remove any claims pertaining to use other than cleaning, including biocide claims.

   Notify or submit an application to Health Canada (as applicable) to discontinue and cancel your:

   1. DIN or
   2. pest control product registration
2. Remove all biocide claims from your product labels (if the product has other types of claims). Your product will need to be compliant with the regulatory frameworks that apply to the remaining claims (for example, medical device or pest control product).

If your product has both biocide (surface sanitizer) and pest control product (for example, air or water sanitizer) claims at the coming into force of the regulations, you can choose to maintain your pest control product registration. To do so, you will need to remove all biocide related claims and information from your pest control product label. You must make these changes by submitting a pest control product label amendment to Health Canada's Pest Management Regulatory Agency application by the earliest of:

• before the end of the transition period or
• prior to the expiry of your pest control product registration

Dual-use products

If you wish to market a product as both a biocide and a pest control product (a surface and air sanitizer, for example), the product would need to meet the requirements of the:

• Food and Drugs Act
• Biocides Regulations
• Pest Control Products Act
• Pest Control Products Regulations

These include:

• labelling
• safety monitoring
• record keeping
• quality control
• payment of annual (right to sell) fees

If you are able to meet both sets of regulatory requirements and obtain the necessary authorizations, you may market a dual-use product. These products would be required to:

• file a transition application or a new application to obtain a market authorization for the biocide claims and
• update the pest control product registration to remove the biocide claims.

The assessment under each set of regulatory requirements are independent of each other.

If you do not want to market a dual-use product, you can market your formulation as:

• solely a biocide
• solely a pest control product
• both a biocide and a pest control product separately with separate labels

You can market them by choosing 1 of the following:

1. Applying using a transition application to sell your product as a biocide only (removing all pest control product claims) and discontinue your pest control product registration.
2. Updating your pest control product registration to remove all biocide claims.
3. Proceed with both 1 and 2 to market the same formulation as both a biocide and a pest control product, each with separate labels that reflect the respective regulatory frameworks.

Using a transition application

Discontinuing your biocide

If you choose to discontinue your biocide, you can sell it until (the earliest of):

• the product no longer has a valid pest control product registration (it has not been renewed after 5 years) or
• the transition period for the regulations has ended for your product