Guidance on biocide application pathways and general requirements: Overview

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• Purpose
• Application pathways
• Fees
• Issuance of a market authorization
• Contact us

Purpose

This guidance document provides information to help biocide applicants comply with the Food and Drugs Act and Biocides Regulations (the regulations).

You must submit an application to obtain a market authorization to import, sell or advertise a biocide. This document provides information on the application process and requirements for a biocide regulated under the regulations.

To receive a market authorization from the Minister of Health (the Minister), you must provide sufficient information to support the safety, efficacy and quality of a biocide when used in accordance with the label's recommended conditions of use.

The Minister will issue a market authorization if all the following conditions are met:

• The application meets the requirements outlined in section 10 or 26 of the regulations.
• You have provided the Minister with any additional information and material requested under subsection 10(4) or 26(5) of the regulations.
• The Minister has sufficient evidence to conclude that the benefits associated with the biocide outweigh the risks associated with it, taking into account any uncertainties relating to the benefits and risks.
• The Minister has reasonable grounds to believe that the biocide will be packaged and labelled in accordance with the:
  • Food and Drugs Act
  • Biocides Regulations

Learn more:

• Food and Drugs Act
• Biocides Regulations
• Guidance for post-authorization changes for biocides

Application pathways

Before you import, sell or advertise a biocide in Canada, you must obtain a market authorization for it from the minister. To obtain a market authorization, you must file an application with us that complies with the requirements set out in the regulations.

The pathways to apply for a new market authorization for a biocide are:

• full review
• full review - novel biocide
• monograph
• applications based on comparison:
  • comparison - administrative application
  • comparison - labelling only
• use of foreign decisions

These application pathways are described in more detail in this guidance to help you determine the appropriate application pathway for your biocide.

Find out what you need to prepare your application

Full review application

Relevant section of the regulations: subsection 10(1) Fee class: Biocide - full review (tier I, II or III)

For a full review application, you must submit evidence to us to support the safety, efficacy, and quality of the biocide when used in accordance with its conditions of use. These applications require a scientific review as part of their market authorization.

The tier you choose on the application form and associated fee depend on the number of reports of tests and studies with respect to efficacy data (for the basic formulation or confirmatory data) contained in the application:

• Tier I: contains 25 or fewer reports of tests and studies
• Tier II: contains 26 to 50 reports of tests and studies
• Tier III: contains at least 51 reports of tests and studies

Use this application pathway if you want to include formulation variations other than differences in fragrances and dyes that are less than or equal to 1.0% of the total formulation.

Learn more:

• Fee classes
• Formulation variations under one market authorization

Full review - novel biocide application

Relevant section of the Regulations: subsection 10(1) Fee class: Biocide full review - novel biocide

This pathway is for biocides with aspects that have never been authorized for a biocide in Canada, such as a novel:

• active ingredient
• combination of active ingredients
• use or purpose (claim)
• physical form
• method of application

Your novel biocide application will need to include additional information compared to a biocide full review, which helps to:

• establish the unique benefits and risks of the biocide
• address uncertainties related to the biocide's novel characteristics

The information that may be requested depends on the specific characteristics of the biocide.

This pathway includes biocides with characteristics that have never been authorized for a biocide in Canada and biocides that meet both of these criteria:

• Have characteristics that we have previously accepted or authorized but are not substantially similar to a previously accepted or authorized product.
• Additional information compared to a full review is necessary to:
  • establish the unique benefits and risks of the biocide
  • address uncertainties related to the biocide's novel characteristics

If applications are concurrently filed for the same novel characteristic of a biocide, they must be filed through this pathway. For example, biocides with substantially similar formulations and conditions of use. These applications would be treated separately, each paying the novel biocide fee even if filed at the same time. You can also file applications for eligible novel biocides through the use of foreign decisions application pathway if all criteria are met.

Novel protocols or test methods to support the efficacy or safety of a biocide should not go through this pathway unless accompanied by at least 1 of the novel characteristics mentioned above. Contact us to request advice or a pre-submission consultation for a novel protocol being used to test your biocide to obtain feedback on its suitability for it.

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

Active ingredients

A biocide containing an active ingredient that has never been accepted or authorized in a biocide in Canada would require a full review - novel biocide application.

A biocide containing an active ingredient that has been previously accepted or authorized in a biocide may also require this type of application if:

• it is not substantially similar to an accepted or authorized biocide and
• additional information compared to a full review application is required

For example, the benefits and risks of a biocide can vary greatly depending on the concentration of the active ingredient in the biocide. The safety and efficacy of a 0.01% concentration of an active ingredient may be substantially different from a 10% concentration (1000x the initial concentration). As such, these products might not be substantially similar.

A biocide containing a formulant that has never been accepted or authorized in a biocide in Canada does not require a full review - novel biocide application.

Combination of active ingredients

A biocide containing a combination of active ingredients that has never been accepted or authorized in a biocide in Canada would be considered novel. A novel combination of active ingredients could include:

• a novel active ingredient being combined with a non-novel active ingredient
• a novel active ingredient being combined with another novel active ingredient
• a non-novel active ingredient being combined with another non-novel active ingredient and that combination is considered novel

A biocide containing a combination of active ingredients that has been previously accepted or authorized in a biocide may require a full review - novel biocide application if:

• it is not substantially similar to an accepted or authorized biocide and
• additional information compared to a full review application is required

For example, the benefits and risks of a biocide can vary greatly depending on the:

• concentrations of active ingredients in the biocide
• combination of active ingredients in the biocide

Use or purpose, physical form or method of application

A biocide is considered novel if it has a characteristic that has never been accepted or authorized for a biocide in Canada, such as a:

• use or purpose (claim)
• physical form
• method of application

A novel characteristic could include innovative technologies that:

• present unique uncertainties for the biocide
• impact the establishment of the benefits and risks of the biocide, such as:
  • prion-related claims
  • extended residual claims (greater than 24 hours)
  • generation of a biocide on site using a generating device
  • application by methods that increase the exposure profile to the user
  • activation of biocide requires UV light exposure

A biocide with a characteristic that has been previously accepted for a previously accepted or authorized biocide may require a full review - novel biocide application if:

• it is not substantially similar to an accepted biocide and
• additional information compared to a full review application is required

For example, the benefits and risks of a biocide can vary greatly depending on:

• the novel characteristics of the biocide
• how the novel characteristics relate to the concentrations and combinations of the active ingredients in the biocide

Therefore, the safety and efficacy of a biocide with a novel characteristic may be substantially different from one biocide composition to another. As such, these products might not be substantially similar.

How to determine if your biocide is novel

A biocide is not always considered novel just because it has a characteristic that has never been accepted or authorized for a biocide in Canada before, such as its:

• active ingredient
• combination of active ingredients
• use or purpose (claim)
• physical form
• method of application

Contact us to submit a biocide classification request if you:

• think your biocide may have a novel characteristic
• are unsure what type of application to file

In support of your biocide classification request, include:

• a summary of your substantial similarity search results
• your evidence-based justification to support comparability of your biocide to other already accepted biocides with market history in Canada

Once you have confirmed that your biocide is a novel biocide, request a pre-submission meeting to confirm application requirements.

How to request a meeting

Substantial similarity search

Before submitting a biocide classification request, you should determine if your biocide has novel characteristics by:

• conducting a search for substantially similar biocides which could include searches in the:
  • biocides market authorization database
  • drug product database
  • pesticide label search
• compiling an evidence-based justification to support comparability of your biocide to one or more already accepted or authorized biocides with market history in Canada

When establishing substantial similarity for characteristics of your biocide, you may reference characteristics of other biocides, including those with 1 of the following:

• A biocide market authorization under the Biocide Regulations, including through the use of foreign decisions application pathway.
• A drug identification number (DIN) under the Food and Drug Regulations.
• A pest control product registration number under the Pest Control Products Act.
• A market history as a food-contact surface sanitizer in Canada, supported by a Letter of No Objection from Health Canada's Food Directorate.

Learn more:

• Search for a surface sanitizer label
• Search the drug product database for information about disinfectants

Evidence-based justification

An evidence-based justification to support comparability of your biocide could include references to one or multiple products to support your rationale.

You should consider in your justification the comparability of their:

• formulations, that is:
  • active ingredients and their concentrations
  • formulants and their concentrations
• conditions of use, that is:
  • efficacy and safety profiles,
  • whether the novel characteristic would increase the level of exposure or change the route of exposure in humans or animals
• physical and chemical characteristics, such as:
  • physical form
  • pH
  • nanomaterials
• methods of application, such as:
  • certification of any devices used in combination with the biocide
  • the durability of long-term residual applications
• manufacturing processes, such as:
  • the in-process controls for biocides with innovative technologies that are:
    • biologically-derived
    • created on site using generating devices

Pre-submission meeting

For biocides that are confirmed to be novel through the biocide classification request, you should request a voluntary pre-submission meeting to:

• familiarize our review staff with the proposed application prior to its arrival, and to identify potential uncertainties early
• determine the additional information considered necessary to establish the benefits and risks of the novel biocide
  • For example, a novel combination of active ingredients that on their own have well established safety and efficacy profiles may not require the same information in the application as an entirely novel active ingredient.
• obtain guidance on how to satisfy specific safety, efficacy and quality requirements that would apply to your biocide

Once a market authorization has been issued for an application for a novel biocide (including through the use of foreign decisions application pathway), a subsequent application for a market authorization may be eligible to be filed through the full review application pathway if:

• the biocide is substantially similar to a previously accepted or authorized biocide and
• additional information compared to a biocide full review is not required

Additional information for biocides that are not required to file a full review - novel biocide application may be requested during a full review application. This will help us to better understand the impacts of the formerly novel characteristic within the context of the data provided to support the biocide.

Monograph application

Relevant section of the regulations: subsection 10(1) Fee class: Biocide monograph

This application pathway applies to biocides with a use or purpose (claim) that meet the parameters outlined in the Biocide monograph. This pathway allows for an abbreviated review process for biocides that have well-characterized benefits and risks under specific conditions of use and labelling requirements.

You can submit a monograph application if your biocide is completely in accordance with the Biocide monograph including its:

• claims
• active ingredients
• conditions of use

Your application must comply with all the parameters specified within a monograph. For aspects not specified within the monograph, you will need to include supporting information. For example, if the monograph does not specify the:

• product specifications, you will need to include product specifications in your application
• risk information, you will need to include information to support the determination of the risk information for the biocide

When a biocide goes beyond the parameters outlined in the monograph, you must submit evidence to support its safety, efficacy and quality through either a:

• full review - novel biocide application or
• full review application

Refer to the efficacy requirements guidance for more information on the data requirements to support biocide claims and to the safety requirements guidance and quality requirements guidance for information on what to include in a monograph application.

Learn more:

• Guidance on efficacy requirements for biocides
• Biocide monograph

Application based on comparison

Relevant section of the regulations: subsection 10(2)

You can apply for a market authorization for a biocide based on a comparison to an authorized biocide. This is typically demonstrated through a licensing agreement. In these agreements, the licensor provides access to information about the comparison biocide to the licensee for sale under the second party's name and a different brand name.

The Biocides Regulations do not permit a comparison to be made to a biocide that was already authorized based on comparison. Licensees may not act as licensors for other applications based on comparison.

Market authorization holders of biocides that received a market authorization using one of the following pathways are eligible to be a comparison biocide (licensor) for applications based on comparison:

• use of foreign decisions (UFD) application pathway
  • Only if the holder of the market authorization of the UFD-authorized biocide is also the holder of the authorization to sell the foreign biocide.
• full review - novel biocide application pathway
• monograph application pathway
• full review application pathway

To compare to a biocide authorized through the UFD pathway, these names should be the same:

• The holder of the foreign biocide authorization.
• The holder of the biocide UFD market authorization.

If they are not the same, you will need to provide information in your application to demonstrate that they are affiliated. This means they must fit one of the following criteria:

• One of them is the subsidiary of the other.
• Both are subsidiaries of the same parent company.
• Each of them is controlled by the same parent company.

This information can be included in the letter of confirmation from the licensor (holder of the biocide UFD market authorization that is being compared to).

There are 2 application pathways based on comparison:

• Comparison - administrative application
• Comparison - labelling only

They apply to biocides that don't require data review before market authorization as they are based on comparison to an authorized biocide. More differences are permitted between your biocide and the comparison biocide in the comparison – labelling only pathway, as outlined in the sections below.

Applications filed under both of these pathways must meet the requirements outlined in subsection 10(2) of the regulations:

• The application is based on a comparison between the biocide and another biocide with a market authorization that has not been suspended or revoked.
• The application contains information that demonstrates that:
  • for a given quantity of biocide:
    • the biocide contains the same active ingredients in the same quantities as the other biocide
    • the quantity of each formulant that the biocide contains is the same as the quantity of that formulant that the other biocide may contain under its market authorization
  • the formulants that the biocide contains are among the formulants that the other biocide may contain under its market authorization
  • the conditions of use of the biocide fall within the conditions of use of the other biocide
    • However, its risk information and directions for storage which must be the same as the other biocide.
• If the applicant is not the holder of the market authorization for the other biocide, the application contains an attestation, by an individual who has the authority to bind the holder, that:
  • confirms the holder has provided you (the applicant), with the master formula for the other biocide
  • mentions the other biocide's brand names and identification number (letter of confirmation)
• The application contains an attestation, by an individual who has the authority to bind you (the applicant), that confirms that:
  • the biocide will be manufactured in accordance with the master formula for the other biocide
  • the biocide's specifications are the same as those of the other biocide, other than package description
• The market authorization for the other biocide was not issued on the basis of a comparison to a third biocide
  • The exceptions are certain biocides authorized based on the biocide UFD pathway as noted previously.

You can compare to a biocide that has its market authorization partially suspended but only the versions of the biocide that are not suspended, if there are any. Any such applications would need to be filed through the biocide comparison - labelling only application pathway.

If the application based on comparison does not meet the requirements as outlined in subsection 10(2), use whichever is most appropriate:

• full review application
• full review - novel biocide application

Learn about post-authorization obligations for licensors and licensees for authorizations based on comparison

Comparison - administrative application

Fee class: Biocide comparison - administrative application

This pathway requires a letter of confirmation from the market authorization holder of the comparison biocide (licensor) attesting that they have provided you with the other biocide's:

• master formula
• up to date label text

The letter must confirm that they provided these in support of your application for the same biocide.

All aspects of this application, including labelling materials, need to be identical to those of the comparison biocide, with the exception of the:

• brand names
• applicant's name (unless you hold the market authorization for the comparison biocide)

The biocide in the application must have the same formulations as the comparison biocide.

If there are any differences between your biocide and the comparison biocide other than the name of the applicant and/or biocide, the application will not be eligible for processing under the comparison - administrative pathway. Depending on the differences, any other differences will require you to file either a:

• comparison - labelling only application
• full review application
• full review - novel biocide application

Comparison - labelling only application

Fee class: Biocide comparison - labelling only

This application pathway applies to biocides that require an assessment of their labelling as part of their application for a market authorization. Additional supporting data do not need to be included in the application unless:

• the shelf life or packaging are different and
• stability data is required

In cases where the owner of the comparison biocide is not the same, this pathway also requires a letter of confirmation from the licensor. It must attest that they have provided you with the other biocide's:

• the master formula
• up to date label text

The letter must confirm that they provided these to you to support your application for the same biocide.

Only use this pathway when an existing authorized biocide:

• will be sold under the name of another party (a new market authorization holder) or a new brand name, and
• does not meet the requirements of the comparison - administrative application pathway because of differences in labelling from the comparison biocide

Examples of acceptable differences between the biocide that is subject of the comparison application and the other biocide in this pathway are:

• removing cross-promotion
• change to the packaging material or type
• change to the net quantity of the biocide in the package
• removing intended uses or purposes and associated directions for use
• removing methods of application and associated directions for use
• including only certain alternate formulations in the application, if the comparison biocide has been authorized for more than 1 formulation
• removing settings in which the biocide is intended to be used

Further editorial changes between the comparison biocide label text and the label text included in the application may be acceptable. These types of changes allow you to capture minor variations in the way you present the same information on labels. However, they must not change the meaning or interpretation of a given statement.

The shelf life of the biocide is expected to remain the same as that of the comparison biocide. However, an alternative shelf life can be reviewed within this application pathway if supporting stability information is included in the application. Refer to the quality requirements guidance for information on when stability data should be included in a biocide application to support the benefits, risks and uncertainties.

All other aspects of the biocide in this application must be the same as those of the comparison biocide as outlined in subsection 10(2) of the regulations. If they are not, depending on the differences, you can file either a:

• full review application
• monograph application
• full review - novel biocide application

Learn more about stability data

Use of foreign decisions application

Relevant section of the Regulations: section 26

Fee class: Biocide - use of foreign decisions

This pathway allows you to leverage the decision of a trusted foreign regulatory authority when applying for a market authorization for the same biocide in Canada. By doing so, this pathway helps to reduce:

• authorization time, since the safety, efficacy and quality review has been completed by a trusted regulatory authority
• associated fees to align with the level of effort

Although safety, efficacy and quality data is not required under this pathway, additional information may be requested when necessary to determine whether the market authorization can be issued. For example, we may request additional information if there are concerns about the risks, benefits or uncertainties of the biocide outlined in the application.

You may submit an application through this pathway if the application and the biocide meet the criteria outlined in section 26 of the regulations, including:

• The product meets the definition of a biocide (all claims that do not meet the definition of a biocide have been removed from the proposed Canadian label text).
• A relevant foreign regulatory authority, as set out in the List of Foreign Regulatory Authorities, has authorized the sale of the foreign biocide and the foreign biocide authorization meets the conditions set out in the list.
• The biocide in the application is the same as the foreign biocide in the following respects:
  • Same physical form and method of application
  • Same active ingredients and quantities.
  • Same conditions of use:
    • intended uses or purposes
    • settings in which it is intended to be used
    • risk information
    • directions for use
    • directions for storage
  • The formulants and their quantities are among the formulants and quantities that the foreign biocide may contain under the foreign authorization.
    • This means that if there are alternate formulations in your biocide application, they must be the same as those authorized for the foreign biocide under the foreign authorization to sell.
    • If there are no alternate formulations, the formulants and quantities are the same as those of the foreign biocide.
  • Same manufacturing process and specifications, except packaging description (manufactured in accordance with the master formula for the foreign biocide).
• The foreign biocide's sale is authorized (no action has been taken by the foreign regulatory authority such that the biocide cannot be sold) and remains authorized throughout the review period.
• You possess or have immediate access to the information that was submitted to the foreign regulatory authority including:
  • information regarding the benefits and risks associated with the foreign biocide and any uncertainties relating to those, including reports of tests and studies to identify and assess those benefits, risks and uncertainties
  • the summary of the information about the benefits and risks and related uncertainties, if one was submitted to the foreign regulatory authority to obtain the foreign biocide authorization
  • the foreign biocide's specifications

A biocide is not eligible for this pathway if the foreign biocide was authorized under the types of applications that are ineligible, as outlined in the List of Foreign Regulatory Authorities.

The List of Foreign Regulatory Authorities includes some types of applications that are ineligible for the foreign biocide. For example, the following pathways from the United States Environmental Protection Agency would not be eligible to apply under this pathway:

• Emergency Exemptions (under Section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA); 40 Code of Federal Regulations (CFR) 166)
• State-specific registration (under Section 24(c) of FIFRA; 40 CFR 162)

Learn more:

• List of Foreign Regulatory Authorities
• Additional post-authorization obligations for holders of a biocide market authorization based on a foreign biocide

Fees

For every application, you must select the appropriate application pathway, which will populate the corresponding fee on the biocide application form.

If your application information and documents do not correspond with the application pathway selected and corresponding fee, your application may be rejected during the screening period.

Do not include advance payment when filing the application. After reviewing your application, we will issue an invoice, typically when we accept the application into review. Payment is due 30 days from the date of invoice issuance.

Fees will be adjusted once a year to keep up with inflation.

You must pay a fee for the right to sell a biocide each year that the biocide is on the Canadian market. This fee applies to the market authorization. Only 1 fee will be required for multiple brand names or formulation variations included in one market authorization.

Issuance of a market authorization

The Minister will issue you a market authorization once the requirements of section 11 of the regulations have been met. These requirements include the Minister having sufficient evidence to determine that the benefits associated with the biocide outweigh the risks associated with it, taking into account any uncertainties relating to the benefits and risks. The market authorization permits you, the applicant, as the market authorization holder, to market the biocide in Canada. The market authorization contains information that is specific to the biocide as authorized by the Minister. A biocide must be labelled, advertised, and sold in accordance with its market authorization.

We will also assign an 8-digit identification number specific to that biocide, which will be included in the market authorization.

If a biocide is authorized to be sold under multiple brand names or formulation variations, these will be included within the market authorization.

Terms and conditions

We may impose terms and conditions on the market authorization in exceptional circumstances. For example, if there are significant uncertainties relating to the benefits or risks associated with the biocide (especially for novel biocides). Exceptional circumstances may include significant uncertainties with the safety, efficacy or quality of a biocide, which cannot be addressed by other means before authorization, such as labelling and test data.

The following are examples of circumstances when terms and conditions may be imposed on a biocide market authorization:

• Uncertainties, such as long-term safety concerns, exist at the time of authorization that could impact safety and efficacy but cannot realistically be resolved during pre-market review.
• New information about the biocide's performance in the real world suggests uncertainties with its safety or effectiveness.

Terms and conditions are not intended to:

• allow you to apply for a biocide market authorization with incomplete or insufficient data
• address deficiencies identified in an application during review

The Minister must have sufficient evidence to support the conclusion that the benefits of a biocide outweigh its risks, taking into account related uncertainties to authorize a biocide for sale.

Before adding or amending terms and conditions, we'll consider if the requirements under the Food and Drugs Act are able to address these significant uncertainties.

These terms and conditions should:

• optimize the benefits and minimize the risks associated with the biocide
• manage the uncertainties relating to the benefits or risks
• involve the collection of information to be able to continuously assess the benefits and risks, identify any changes to them and manage uncertainties

Examples of terms and conditions we may impose in exceptional circumstances include the requirement to conduct:

• long term studies or additional confirmatory testing
• specific stability studies to manage uncertainties with a biocide's stability

Contact us

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

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