Guidance on biocide application pathways and general requirements: Description of information and documents

On this page

• Overview
• Cover letter
• Biocide application form
• Label text
• Letter of confirmation
• Safety and efficacy information
• Quality information
• Summary
• Foreign biocide documents

Overview

Certain information or documents must be included in all applications for a market authorization for biocides. These include:

• a cover letter
• a biocide application form
  • with the completed attestation, as applicable (specific to the application pathway)
• the label text

In addition to these items that are common requirements for all application pathways, each application pathway requires specific information and documentation.

How to prepare your application

Table 1: Specific requirements for each application pathway

Application pathway	Letter of confirmation	Safety and efficacy information	Quality information (Product specifications and stability informationFootnote 1)	Summary	Foreign biocide documents
Full review - novel biocide	Not applicable	Required	Required	Required	Not applicable
Full review	Not applicable	Required	Required	Required	Not applicable
Monograph	Not applicable	RequiredFootnote 2	Required	Required	Not applicable
Use of foreign decisions	Not applicable	Not applicableFootnote 3	Not applicableFootnote 4	Not applicable	Required
Comparison - administrative application	Required	Not applicable	Not applicable	Not applicable	Not applicable
Comparison - labelling only	Required	Not applicable	Not applicableFootnote 4	Recommended	Not applicable
Footnote 1 Stability information is not required for all biocides. Refer to the quality requirements for biocides guidance for more information. Return to footnote 1 referrer Footnote 2 Monograph applications do not require safety or efficacy data but should include other safety information such as: a copy of a Safety Data Sheet, if available rationales to support the determination of risk information and directions for use an explanation of the hazard profile for the biocide Return to footnote 2 referrer Footnote 3 Efficacy or safety information is not required under the use of foreign decisions pathway. However, you must possess or have immediate access to the data that was submitted to the foreign regulatory authority to obtain the authorization to sell the foreign biocide. Return to footnote 3 referrer Footnote 4 If you make a change to the packaging type, refer to the guidance on quality requirements for biocides to determine whether you should include stability information to support the shelf life of the biocide. Return to footnote 4 referrer Guidance for quality requirements

Cover letter

We require certain information to be included in all cover letters for a new application for a biocide market authorization. The cover letter should:

• clearly state the reason for filing
• indicate the:
  • primary brand name
  • application pathway
  • Dossier ID
  • application contact name and role, such as authorization holder or third-party contact
  • include reference to a correspondence or a request letter issued by us, if applicable
• clearly state any referenced application control number (include the date the application was approved)

You should indicate in your cover letter if any associated DIN(s) or pest control product registration(s) should be cancelled at the same time as issuance of the market authorization for the biocide.

Biocide application form

The biocide application form collects information on the:

• applicant
• contact information for the application
• Dossier ID
• type of authorization (new market authorization or post-authorization change)
• application pathway
• fees

You should indicate in the biocide application form if any associated DIN(s) or pest control product registration(s) should be cancelled at the same time as issuance of the market authorization for the biocide.

The biocide application form also collects information related to the biocide such as the:

• shelf life
• physical form
• formulations
  • active ingredients and formulants and their quantities, including:
    • formulants that only a particular version of the biocide contains
    • their Chemical Abstracts Service (CAS) registry numbers
• packaging information
• primary and alternate brand names, if any
• site information:
  • name and contact information of any importers
  • name and contact information of the manufacturers
  • name and contact information of the packagers and labellers, if known
  • the civic addresses of the locations where the biocide will be manufactured and, if known, packaged and labelled (not the administrative office location)
• methods of application
• conditions of use:
  • intended uses or purposes
  • the settings in which it is intended to be used
  • its risk information
  • its directions for use
  • its directions for storage

If certain manufacturing sites are responsible only for specific steps, this should be indicated on the form.

If the name and contact information or civic address of the packagers and labellers are not known at the time of application, they must be provided to us in the notification of first sale.

Where applicable, each biocide application must include the appropriate completed attestation.

Application types and their appropriate attestations

Declaration of formulations

Both active ingredients and formulants can affect the safety, efficacy and quality profile of your biocide. They can affect the benefit-risk profile of your biocide and any associated uncertainties.

For example, any ingredient in a biocide may:

• affect the biocide's shelf life
• change the colour or smell of the biocide
• improve or impair the safety of the biocide

The formulants included in a biocide may:

• indirectly affect the efficacy of the biocide
• act as a solvent, pH adjuster, stabilizer or chelating agent
• improve the ease of application and manufacturing by preventing caking or foaming
• affect the biocide's physical characteristics such as detergency, foaming or volatility

Formulants should not directly contribute to the efficacy of the biocide. All ingredients that are directly responsible for the biocide's efficacy should be listed as active ingredients, not formulants. You may test the ingredients to determine if they directly contribute the efficacy of the biocide at the proposed concentration.

The sum of the percent nominal concentrations of the active ingredients and formulants declared on the biocide application form for each formulation should:

• total 100%
• be expressed as a percentage on a weight-per-weight basis (% w/w)

The Chemical Abstract Service (CAS) registry number, if there is one, must be included for every active ingredient or formulant in the biocide.

If your biocide includes a proprietary blend of formulants, the biocide application form will allow you to indicate this.

Label text

You are required to include the text of every label to be used for the biocide, including any:

• inner label
• outer label
• package insert
• any supplementary information on the use of the biocide that is to be provided to users on request (for example, leaflets and package inserts)
  • the exception is marketing or other information not required by the regulations

We recommend that applications filed through the comparison – administrative application, comparison – labelling only, or use of foreign decisions pathways include:

• annotated label text that clearly highlights all the proposed changes from the comparison biocide or foreign biocide label text, as applicable
• a clean version of the label text that incorporates the changes

The label text should indicate the circumstances in which each statement would appear on a final label if it includes multiple statements that apply to different:

• uses or purposes
• settings
• methods of application

For example, a label may indicate that one section of the directions for use applies to the biocide's use in animal housing areas, such as:

• barns
• kennels
• veterinary clinics

We will review the proposed label text and approve it if acceptable.

The label text included in the application should specify the location of the information on the marketed label (on the principal display panel or other parts of the label). You can do this by using headings. The layout of information on the label text submitted for review should be representative of the marketed label.

If there are multiple brand names or formulation variations included in 1 application, we will only authorize 1 label text. Separate draft label text for each formulation should not be included in the application. The label text provided in the application may:

• contain only the primary brand name of the biocide or
• list all brand name options for the biocide

All brand names must be included on the biocide application form in the appropriate field and will be listed in the online database, if authorized.

The label text that we authorize through an application for a biocide market authorization must meet the requirements of the Biocides Regulations (the regulations). Biocide label text approved under the regulations may not be compliant with labelling requirements in another set of regulations for a comparably formulated product, such as a cleaner regulated by the:

• Hazardous Products Regulations
• Consumer Chemicals and Containers Regulations, 2001

Non-therapeutic (marketing) claims should not be included on the label text submitted in the application for a biocide market authorization. It's the responsibility of the applicant/market authorization holder to make sure that non-therapeutic claims do not imply any therapeutic use. Advertising preclearance agencies are also available to review advertising for biocides to confirm that therapeutic claims and their depiction of use align with a biocide's market authorization.

We do not evaluate the accuracy of non-therapeutic claims for biocides unless they're expected to pose health and safety risks, even if they're present on the label text submitted in the application. Approval of the label text is not an endorsement of any non-therapeutic (marketing) claims that might be present.

Refer to the guidance on labelling requirements for biocides when developing the label text to submit in your application.

Learn more:

• Non-therapeutic marketing claims
• Guidance on labelling requirements for biocides

Letter of confirmation

You must include a letter of confirmation in an application based on comparison, unless:

• you are also the holder of the market authorization for the other biocide or
• you and the holder of the market authorization for the other biocide are affiliated, which means:
  • one of them is the subsidiary of the other
  • both are subsidiaries of the same entity (parent company)
  • each of them is controlled by the same entity (parent company)

The letter of confirmation must:

• attest that the comparison biocide market authorization holder has provided you with the master formula for the other biocide
• mention the other biocide's brand names and identification number

It should also:

• confirm the market authorization holder has provided you with up-to-date label text for the biocide
• be on the official letterhead of the comparison biocide market authorization holder
• be dated and signed by the appropriate contact person for the comparison biocide application
• include
  • the name of the applicant
  • the primary brand name of the biocide in the application

Sample letter of confirmation

Safety and efficacy information

For the Minister to issue a market authorization for a biocide, the Minister must have sufficient information to conclude that the benefits associated with the biocide outweigh the risks associated with it. This decision must take into account any uncertainties relating to the benefits and risks. For an application filed through the full review - novel biocide or full review pathways, this includes reports of any tests and studies conducted to support the safety and efficacy of the biocide that should be included in the application.

Reports of tests and studies are not required for a biocide monograph application. This is because the application relies on an attestation that the biocide meets the information established in the monograph.

The guidance on management of biocide applications outlines the mechanisms that we can use to request additional information from you during our assessment of your biocide application.

Quality information

Applications for a biocide market authorization must include information about the quality of the biocide, as applicable. This information includes:

• specifications
• stability information

The guidance on management of biocide applications outlines the mechanisms that we can use to request additional information from you during our assessment of your biocide application.

Specifications

Each batch or lot of a biocide in finished form should be tested to ensure it meets its specifications before it is sold. This is to ensure that the biocide has been manufactured according to its market authorization and meets the requirements of:

• the regulations, which prohibit the sale of a biocide unless it is manufactured, packaged, labelled, and stored in accordance with its master formula
• paragraph 8(b) of the Food and Drugs Act (prohibiting the sale of products that are adulterated)

Learn more:

• Food and Drugs Act
• Guidance on quality requirements for biocides

Stability information

Certain biocides with greater uncertainty with respect to their shelf life should include stability data in their application for a market authorization. Stability data or information to support the shelf life may also be needed for applications filed through the:

• comparison - labelling only pathway if you make a change to the packaging type from the comparison biocide
• use of foreign decisions pathway if you make a change to the packaging type from the foreign biocide

Read the guidance on quality requirements for biocides to determine whether stability data or information is required.

Summary of information on benefits, risks and related uncertainties

To help in our review of biocide applications, you may be required to submit a summary of its safety, efficacy and quality information including any associated uncertainties. A high quality summary may reduce the need for clarification requests during the screening and scientific review of the application. The summary can be provided in the form of a report (or 3 individual reports for safety, efficacy and quality), depending on the application type.

The summary should:

• capture information relevant to the proposed biocide's safety, efficacy and quality when used according to the label's recommended conditions of use
• reflect and summarize the totality of available information relevant to the proposed biocide
• summarize all safety, efficacy and quality data provided in the application in a table format for ease of review
• provide context on what may otherwise appear as gaps or uncertainties in the information on the biocide's safety, efficacy and quality

Ensure the summary submitted in support of a biocide application includes a description of:

• the biocide's efficacy data and supporting information as outlined in the efficacy requirements for biocides guidance
• the biocide's potential safety hazards and supporting information as outlined in the safety requirements for biocides guidance
• the biocide's regulatory status or approval with foreign regulators
• the biocide's shelf life, along with a rationale on the considerations and stability testing conducted to determine the stability of the formulation as outlined in the biocides quality requirements guidance
• information on whether any pre-submission meetings or discussions were held with us before filing the application

Summary templates for safety, efficacy and quality are available that you can use to summarize information in a tabular format for the biocide. If you choose not to use the templates, you can use a different format that contains the same information.

Learn more:

• Guidance on safety requirements for biocides
• Guidance on quality requirements for biocides
• Guidance on efficacy requirements for biocides

Foreign biocide documents

The application for market authorization of a biocide filed through the use of foreign decisions pathway requires different information and documents from other application pathways. This is because it is based on comparability to a foreign biocide.

You will have to provide us with:

• the common requirements for all applications and
• additional information or documents to fulfill application requirements for the use of foreign decisions pathway

List of common requirements

Table 2: Specific requirements for the use of foreign decisions application pathway

Application requirement	Information or document
An attestation, by an individual who has authority to bind the applicant, confirming that the applicant possesses or has immediate access to the following information that was submitted to the foreign regulatory authority to obtain the authorization to sell the foreign biocide: information on the risks, benefits, and any uncertainties relating to those benefits and risks specifications summary of the information on the risks, benefits and related uncertainties (if one was submitted)	Use of foreign decisions attestation within the biocide application form.
An attestation, by an individual who has authority to bind the applicant, that confirms that: the biocide will be manufactured in accordance with the master formula for the foreign biocide the biocide's specifications are the same as those of the foreign biocide, other than in respect of the: net quantity type of package properties and qualities of the packaging material
An indication of any terms and conditions that the foreign regulatory authority has imposed on the authorization to sell the foreign biocide.	US EPA registration notice for the foreign biocide or other applicable letter outlining terms and conditions imposed on the authorization to sell the foreign biocide
Information that demonstrates all 4 of the following: For a given quantity of biocide, the biocide contains the same active ingredients in the same quantities as the other biocide. The formulants that the biocide contains are among the formulants the foreign biocide may contain under the authorization to sell the foreign biocide. For a given quantity of biocide, the quantity of each formulant that the biocide contains is the same as the quantity of that formulant that the foreign biocide may contain under the authorization to sell the foreign biocide. The biocide has the same conditions of use as the foreign biocide.	US EPA Confidential Statement of Formula (CSF) for the foreign biocide and US EPA Approved Label for the foreign biocide
A list of the tests and studies that have been submitted to the foreign regulatory authority in connection with the authorization to sell the foreign biocide.	US EPA Form 8570-35 Data Matrix for the foreign biocide.
Information that demonstrates that the foreign regulatory authority authorized the sale of the foreign biocide under a statute or other legislative instrument that is set out in that list in connection with the regulatory authority.	US EPA registration notice for the foreign biocide and Evidence that the authorization for the foreign biocide has not been suspended (for example, a screenshot of the foreign biocide registration status in the US EPA Pesticide Product and Label System database)
The text approved by the foreign regulatory authority for every label to be used in connection with the foreign biocide.	US EPA Approved Label for the foreign biocide

If the tests and studies submitted to the foreign regulatory authority are not comparable to those required to support efficacy of a biocide in Canada, we may request additional information such as:

• confirmatory data
• a scientific rationale to justify how efficacy remains supported by the tests and studies in comparison to current domestic standards

For example, we may request additional information for a biocide that was authorized with efficacy test methods that are outdated and no longer accepted.

Additional information may be requested when necessary to determine whether the market authorization must be issued. This may occur where there are concerns about the risks, benefits or uncertainties of the biocide based on the information included in the application.

The guidance on management of biocide applications outlines the mechanisms that we can use to request additional information from you during our assessment of your biocide application.