Biocide application form user guide

The primary form for biocide regulatory transactions is the Biocide application form (BAF). It is designed to be completed online and saved at any time to your workstation. Through an active internet connection, the Biocide application form searches and populates data from the Biocides Ingredients Database (BID).

Each page of the form includes links to specific sections of this user guide for information on how to successfully complete the form.

For information on biocide market authorization application requirements and the application submission process please consult the Guidance on biocide application pathways and general requirements and the guidance on the Management of Biocide Applications (MBA).

Prior to submitting a Biocide application, if you are uncertain as to the classification of your product (i.e. whether or not it is a biocide), please consult the "product classification" section of the Guidance on biocides. You will also find instructions on how to submit a product classification request to NNHPD.

To report bugs or request additional information on the BAF, please contact Biocides Online Support.

Recommendations for optimal results

Following the recommendations below will ensure the best possible outcome when using the BAF.

General

Filing of information to Health Canada

Before submitting a biocide application, you will need to understand the electronic filing requirements. You should ensure that your application contains the information needed to satisfy the regulatory requirements of the Regulations.

A company ID and Dossier ID will be required prior to completing the Biocide application form. It will be impossible to complete and submit the form without these. Please consult the Management of Biocide Applications: Pre-submission information for complete information and guidance for filing of information to Health Canada.

Become familiar with the Biocides Ingredients Database

It is highly recommended that you become familiar with the Biocides Ingredients Database (BID) and its terminology prior to starting an application to ensure your ingredient is represented correctly on the application form. The BAF populates information such as active ingredients and formulant ingredients directly from the BID. This feature will ensure consistency in ingredient representation.

Become familiar with the Guidance on Management of Biocide Applications

Before using the BAF, review the application pathways (captured as the submission class on the BAF) to determine which is appropriate for your product (see the Guidance on Management of Biocide Applications and Guidance on biocide application pathways and general requirements). Certain changes such as altering the regulatory activity lead or type on the application information page will result in the loss of any information already entered in the subsequent sections of the form. The form may not function as expected if applicants go back and change the regulatory activity lead or type during an active session. A warning box will appear when navigating to another page to inform the user that data loss will occur. Options will be provided to either proceed with or cancel the changes.

Biocide Application Form specifications

Meet the system requirements and enable JavaScript

While the BAF will function in most browsers, for best results, we recommend using either Firefox 54+ or Chrome 60+. The form also requires you to have JavaScript enabled in your browser. When JavaScript is disabled the form will malfunction, e.g. disabled buttons and missing fields and text.

Click on enable JavaScript to find the instructions specific to your browser.

If you have concerns with making these changes to your security settings, consult with your IT security advisor first.

Use the Help link to access the Biocide application form user guide

Every page of the form will have a Help link. Click on the icon Help to open that section of the user guide corresponding to the section of the webform you are on. To exit the help page and return to the form, you can click anywhere outside the user guide or click the Esc (escape) key on your keyboard.

Save your progress - sessions will timeout

The BAF may be saved at any time on your workstation and resumed at a later time by loading the saved HTML file into the form. During an active session, any data you enter in the form will be temporarily retained. However, if you do not save your progress, any changes will be lost after 2 hours of inactivity. A timeout warning will pop up 5 minutes before the actual timeout. Clicking on "Continue session" will refresh the timer. If you are unable to continue with your session, please remember to save your progress prior to exiting the application by clicking on "Save file".

Allow web pages to refresh before continuing

Depending on your internet speed it might take several seconds for each web page to refresh. To prevent entering the same information twice, allow the web page to fully load before continuing.

Validate as you go

The BAF constantly applies form validation rules for accuracy and completeness. When relevant, click "Save and continue" to validate each page before proceeding.

If information is incorrect or a required field is missing, an error message will appear above the page indicating which field needs correction. A red error message will also display above the problem field(s). Click on the error message or scroll to find the field(s) needing revision. Review and correct all issues before clicking "Save and continue" again. The form cannot be finalized until all fields are completed correctly.

If the page does not have a "Save and Continue" button, then use the "Next" button to move to the next section of the form.

Note: For all NNHPD forms, required fields are indicated by a red asterisk (*) before the field label and the word "(required)", after the field label.

Create templates

When submitting multiple product applications to NNHPD, save templates before finalizing the form. For example, save contact information if it is consistent across applications or for products with the same formulant ingredients. Using a template reduces repetitive data entry and eliminates the potential for errors in data entry.

Use the form's navigation features

The BAF has consistent navigation features across the form. Use these instead of your browser's forward and back buttons to avoid unpredictable behavior during an active session.

Links: Only use bottom page links for navigation. Click "Save and continue" to save your data.

Table of contents: The table of contents can be accessed from the top right of the form. It identifies the main sections of the form and allows you to move directly to a specific section as needed.

Summary: At any time while completing the form, select "Summary" at the top right to review your information.

Save file: To save your progress or create a template, select "Save file" to store a copy in HTML format on your drive. The file may either prompt you for a location or save automatically to your default folder. To continue a saved session, select "Load submission form from file," find the .html file on your drive, and choose "Load data".

Exit: Choosing "Exit" will return you to the BAF landing page and erase data from the current session. Use this option only to start a new form without saving or after saving a copy locally.

"Back to" links:Certain subsections, such as "Modify active ingredient," include a link that allows you to return to the table of records instead of using previous and next buttons. For example, a link might say "Back to active ingredients table". Use these links to go back without saving changes. If you want to save changes, click "Save and continue".

Biocide Application Form

New application

From the landing page, select "New application form" to open a new Biocide Application Form (BAF).

Load application form from file

The "Load saved application form from file" option allows you to load a previously saved BAF back into the web application. Only BAF files saved in HTML format will load. Depending on whether the BAF form is finalized or not, different load options will appear.

Non-finalized forms: Load a non-finalized application form from file (i.e. partially completed forms or templates saved to your local drive) to resume your session online. Once a file has been selected, confirm the brand name and market authorization holder, then click "View summary" to load it into the web application. From the summary page, use the table of contents to navigate to any section of the application.

Finalized forms: Load a finalized BAF to view it online and modify it. The control number, brand name, and applicant/market authorization holder will appear in the file information view if a finalized application is loaded.

When a finalized form has been selected, two actions are possible:

• View summary: Select this to view the finalized summary without unlocking the form for editing.
• Modify: Select modify to open and unlock the form for editing. This option is used to revise previously submitted data. Please review all the sections of the form to ensure submitting valid and updated information.

Contact for this regulatory activity

This page contains information regarding the Company to which the product market authorization will be registered. The Company Name and Company Identifier are always required.

Name of market authorization holder

Company Name of market authorization holder

Company Name of market authorization holder must match exactly the Company Name on the Company (CO) template. In case of a discrepancy, the official record will be based on the information provided in the CO template used for Health Canada's tracking systems, databases, documents, including the market authorization. Any changes to the company information must be made using the CO template and not using this form.

Ensure that Health Canada has the most up-to-date REP CO for your company, including all contact information. The REP CO is considered the official record for all information contained within it, which is used for Health Canada's tracking systems, databases, documents, including Market Authorization. In addition, ensure that the applicable importers are identified in the Site Information section of the BAF.

The name of the MAH on the label and BAF will be verified internally. Any discrepancies will be resolved via clarification request to revise the MAH on the BAF to match what we have on record.

Company Identifier

Company Identifier is a 5 digit unique number assigned by Health Canada to the manufacturer/market authorization holder. For information on the Company Identifier refer to the sections 2.3 Company Enrolment/Amendment of the Guidance Document Regulatory enrolment process (REP): Drugs for human/veterinary use, disinfectants and biocides (available upon request Click here to submit an email request to no-reply.ereview.non-reponse@hc-sc.gc.ca). Please ensure the text 'Request for REP Guidance Document Drugs' is in the subject line of the email.

The form will not validate the Company Identifier. Please carefully validate that the Company Identifer is matching the one assigned to your company by Health Canada. Do not use a third party contact's identifier, as this will delay processing and could lead to your application being refused. To obtain a Company Identifier, submit a request via the Company Template: Regulatory Enrolment Process - Canada.ca.

Contact for this regulatory activity

The contact for this regulatory activity section pertains to the contact specific to the regulatory activity, i.e., the person/company to whom Health Canada should direct correspondence about this filling.

If the contact for this regulatory activity is a third party acting on behalf of the applicant, a Third Party Authorization (TPA) letters required for each application contact person. Please consult the Management of Biocide Applications: Additional resources for the Third party authorization template. If the third party contact is filing an application for the first time, the section Address information appears on the form for the applicant to file.

Company representative

Indicate in this section the information for the contact specific to the regulatory activity, i.e., the person/company to whom Health Canada should direct correspondence about the subject regulatory activity.

In addition to the contact information, please provide a routing identifier. The Routing identifier (ID) is a unique identifier within the Electronic Submissions Gateway (ESG) used to identify specific gateway account. For any further questions on the routing identifier, please contact the Food and Drug Administration Help Desk at ESGHelpDesk@fda.hhs.gov.

Key information

Indicate any additional contacts/addresses, in addition to the market authorization holder, to which the market authorization should be sent (when required).

Application information

Regulatory information

Dossier Identifier (ID)

The dossier identifier is a code created by Health Canada to uniquely identify the dossier. If a dossier ID has not yet been assigned, sponsors must request one using the Dossier ID request form for biocide dossiers. The format of a Dossier Identifier is a lowercase 'q' followed by six unique numbers (e.g. q123456) . On the Application information page, the Dossier ID must be the one assigned to the product. The form will not verify that the dossier ID is correct, therefore please be sure to use the correct dossier ID issued by Health Canada.

To obtain a dossier ID, please consult the Management of Biocide Applications: Pre-submission information and the page Filing submissions electronically for detailed information related to filing submissions electronically and the Dossier ID request form.

Primary brand name: This is a free text field. Enter the product's primary brand name.

Transaction details

Regulatory activity lead:A drop-down list is generated by the form. Select the appropriate activity lead for this transaction. There are 2 regulatory activity leads:

• Biocide Product
• Post-market Vigilance (for Marketed Health Products Directorate)

The regulatory activity lead selected in the Application Information section determines the layout and behavior of the Biocide application form. It is important not to alter the regulatory activity lead mid-session in order to avoid loss of data.

Regulatory activity type: Identify the appropriate regulatory activity type for your application. A drop-down list of regulatory activity type acceptable per the regulatory activity lead previously selected is generated by the form.

• Biocide product
  • Biocide New Market Authorization (BNMA)
  • Biocide pre-submission Meeting (BPSM)
  • Biocide Post-Authorization Change (BPAC)

• Post-Market Vigilance (for Marketed Health Products Directorate)
  • Risk Communication (RC-PV)
  • Issue Related Report (IRR-PV)
  • Notification of Significant Safety Issue (NSSI-PV)
  • Pre-Submission Meeting Post market (MP-PV)
  • Post Authorization commitments (PA-PV)
  • Post-Authorization Act and Regulations (REG-PV)
  • Advertising Ad-Hoc Post market request (ADVT-PV)

For more information, please refer to the Guidance on biocide application pathways and general requirements , the Guidance on Management of Biocide Applications and the the Guidance for industry on safety monitoring and reporting requirements for marketed biocides.

The type of regulatory activity selected in the Application Information section determines the layout and behavior of the Biocide application form. It is important not to change the regulatory activity type mid-session in order to avoid loss of data.

Regulatory transaction description: The current transaction description should be selected (i.e Initial, Response to E-mail Request, etc.). A drop-down list of acceptable regulatory transactions description based on the activity type selected is generated by the form. Please select regulatory transaction for this submission. For more information, please refer to the Guidance on Management of Biocide Applications or the Health Canada issued correspondence.

Control number: Numerical values only. Enter the control number associated with the Regulatory transaction. The form will not verify that the control number is correct, therefore please be sure to use the correct control number indicated in the Health Canada issued correspondence.

Note: If a control number has not been assigned yet, the field will be locked with the data 000000. Please take note that this is not the control number associated with the transaction. Once a control number has been assigned to the regulatory activity, you must enter it in this field for any subsequent transactions.

Application fees

The Application Fees section appears for activity types under cost recovery, such as New Market Authorizations (BNMA) and Biocide Post-Authorization Changes (BPAC).

Submission class: A drop-down list of submission class acceptable per the activity type selected is generated by the form. The submission classes correspond to the various application pathways for biocides. Please select the appropriate submission class in accordance with the Fees in Respect of Drugs and Medical Devices Order .

All changes are subject to fees except for those addressed in subsection 27(1)(c) of the Order Amending the Fees in Respect of Drugs and Medical Devices Order Biocides. Ensure that you select Minor Change - No Fee when making the following minor changes:

• changing the civic address of the authorization holder as it appears on the market authorization
• changing the name or contact information of
  • a person that manufactures the biocide
  • a person that imports the biocide
• changing the location where the biocide is manufactured

Submission description: The description of the submission class selected will populate in this read only field. For additional information, please refer to the Fees in Respect of Drugs and Medical Devices Order and Guidance on biocide application pathways and general requirements the Guidance on Management of Biocide Applications.

Mitigation measures

When mitigation measures apply, the applicant selects the appropriate measures under Mitigation measures field, the corresponding certifications and attestations will populate with a mandatory checkbox. The user must read and check the box prior to continuing with the form.

If no mitigation measures apply, leave the field on Select.

For additional information on the application fees and mitigation measures, please consult the Guidance on evaluation fees for biocides.

Product information

General information about the product is collected on the Product Information page. This includes references to a Canadian Reference Biocide, a monograph or a Foreign Biocide, the primary brand name, alternate brand name(s), use settings, intended users, physical form, method of application, sterility, shelf-life and temperature range.

Canadian reference biocide

This section is visible when the submission class selected on the Application information page are Comparison '” Labelling Only or Comparison '” Administrative application. The applicant can indicate the identification number (DIN) of the reference product. If the product was authorized based on comparison to another product, an additional field is now available to indicate the identification number of the comparison product.

Monograph Name

This section is visible when the submission class selected on the Application information page is monograph application. The applicant can select the monograph for the product.

Foreign biocide

The section Foreign biocide section will only populate when the submission class Use of Foreign decision (UFD) is selected on the Application information page.

The applicant must select the foreign regulatory authority in the drop down list. List of foreign regulatory authorities for biocides sets out conditions that a foreign biocide must meet in order to be used in a use of foreign decisions application. Health Canada's Natural and Non-prescription Health Products Directorate (NNHPD) manages changes to the list and reviews this list regularly. Please consult the web About the List of Foreign Regulatory Authorities for Biocides incorporated by reference for additional information.

Then the foreign authorization holder, foreign registration number, foreign application category or filing pathway used to obtain authorization to sell and finally the terms and conditions on the authorization must be inputted in the identified field.

Transition product

This section is visible when the transaction description selected on the Application information page are Transition of authorized disinfectant or Transition of registered sanitizer

• Transition identification number to be canceled:This is a free text field. Indicate the identification number (Drug Identification Number (DIN) or Pest Control Product registration (PCPR) of the product to be cancelled.
  To cancel another identification number, select the "Add Identification number" button. To remove an identification number, select the "Remove" button in the corresponding row.
• DIN number to retain as biocide identification number: Indicate in this field if there is a DIN number you wish to retain as biocide identification number. The cancellation of this number under the Food and Drug Regulations (FDR) will proceed once your new biocide market authorization has been Issued.

For disinfectants authorized under the FDR, you may choose to transition multiple DINs into only 1 biocide market authorization (for example, for products with identical formulations and labels but different product names). In this case, you must clearly identify in this section all of the DINs to be cancelled, and the 1 number you wish to retain for the biocide market authorization.

For information on how to transition products authorized under the FDR, PCPA or FDA, consult the Guidance on the transition of disinfectants and surface sanitizers to the Biocides Regulations: Transition of authorized disinfectants and registered sanitizers .

Primary brand name:This is a free text field. Enter the product's primary brand name.

Alternate brand name(s):This is a free text field. To add more brand names, click on the "Add brand name" button. To remove a brand name, click on the "Remove" button. Enter only one brand name per field.

Use settings:The use setting section is populated from the Biocides Ingredients Database. A complete list of all use settings is provided. More than one use setting may be selected.

Physical form:A drop-down list of physical forms is generated from the Biocides Ingredients Database. Select all the appropriate physical form.

Note: Acceptable synonyms for physical forms can be found in the BID; synonyms can be used on the marketed label.

Method of application:Select all the appropriate methods of application. More than one method may be selected.

Note: The 'Wipe (disposable, sponge)' option in this section of the BAF relates to the method of application for towelette products (with towelette declared as the physical form) and for solutions applied to a surface and wiped with either a sponge, microfiber cloth, etc.

Sterile:Indicate whether or not your product is sterile by selecting either "Yes" or "No".

Shelf-life:This is a free numeric field. Enter the product's shelf-life as packaged for consumers. Only one shelf-life can be identified per product.

• Unit of measure: A drop-down list of time units is generated by the form. Select the appropriate unit.
• Minimum temperature: This is a free numeric field. Enter the product's minimum temperature in degrees Celsius.
• Maximum temperature: This is a free numeric field. Enter the product's maximum temperature in degrees Celsius.

Active ingredients

This page enables you to search and select active ingredients, review active ingredient(s) information, and links to the active ingredient modify page.

Note: Before adding your active ingredients, consult the Biocides Ingredients Database (BID) to confirm ingredient availability.

If the required ingredient is not in the BID, submit a Biocide Ingredients Database Change Request formto add it prior to completing and submitting the BAF. Submit completed forms to ingredient_support@hc-sc.gc.ca for review and inclusion in the BID.

Add active ingredient

The "Add active ingredient" section enables you to search and select active ingredients to be added to the form.

Active ingredient search

The active ingredient search field will appear if you are not attesting to a monograph. To search for an active ingredient, enter the name of the active ingredient in the Active ingredient search field and select the "Search" button.

Search results will appear on the right beginning with the top match followed by the remaining search results in alphabetical order of BID approved name. If many search results are returned, a filter will appear to help narrow the search results even further.

Adding an active ingredient to the active ingredients table

The active ingredient search results will display to the right of the search area. For non-monograph applications, select the active ingredient from the search results to add it to the active ingredients table.

Once selected, click on the corresponding "Add" button to add the active ingredient to the form. Repeat these steps to add more ingredients from the same monograph. When you are done selecting ingredients, click on "Clear search" to refresh the "Add active ingredient" section and start a new search.

Ingredient search: general information

The search field is designed to search and retrieve data from the BID. The following fields are searched:

• BID approved name
• Chemical names
• Common names
• Chemical Abstracts Service (CAS) numbers

Inputting a keyword: Input simple keywords only. Operators such as "and" and "or" are not applied and may cause the search to be unsuccessful. All information that is entered will be treated as a single word.

Using wildcards:Wildcards are acceptable. Use quotation marks "" to search for an exact match (spelling must also be exact). Use '*' or '%' for zero or more continuous characters and '_' for a single character. Example: if you launch a search with 'green*flavour ' or 'green%flavour ', the results will include 'Green Tea Flavour '.

When a search fails: The failure of a search does not always mean the specified ingredient is missing from the database. The following situation may contribute to a failed search:

• Spelling errors
• Improperly using wildcards, and/or
• Using a spelling variant that is different from the spelling used in the database.

This may happen in cases where there are different spellings of a term among American, Canadian, and British English.

The conclusion of "no ingredients found" can only be reached after performing a sufficient and proper search. If you are experiencing difficulty finding ingredients through the search function of the biocide application form, it is best to fully explore the ingredient using the Biocides Ingredients Database.

Note: If any name or term cannot be found from the search tool or from pick lists, the user will need to fill out a Biocide Ingredients Database Change Request form and send it to the NNHPD to request that the missing information be added to the database (see Biocides Ingredients Database issue form guide). An ingredient must appear in the BID with the appropriate ingredient role in order to be added to the biocide application form.

Modify active ingredient

The following fields will include all available data for that ingredient.

Chemical name: Ingredient's chemical name. If there is only one applicable chemical name, it will be pre-selected, otherwise select one from the pick list. All chemical names are pre-populated from the Biocides Ingredients Database and are based on the Biocide Regulation.

Common name: Ingredient's common name. If there is only one applicable common name, it will be pre-selected, otherwise select one from the pick list. All common names in the pick list are pre-populated from the Biocides Ingredients Database and are derived from authorized references.

CAS Number: The CAS number will pre-populated from the Biocides Ingredients Database and are derived from authorized references.

Quantity: Amount of the ingredient. Numerical values only.

Unit of measure: Unit for the quantity in percent (weight/weight).

Lower limit:Lowest amount of the ingredient. Numerical values only. This field is optional in the BAF. Refer to the section on tolerance limits within the guidance on quality requirements for biocides.

Upper limit: Highest amount of the ingredient. Numerical values only. This field is optional in the BAF. Refer to the section on tolerance limits within the guidance on quality requirements for biocides.

Standard or grade: If the ingredient conforms to a particular standard or grade (such as United States Pharmacopoeia, British Pharmacopoeia, etc.), it can be stated here. The pick list of pharmacopoeias presents pharmacopeial grades acceptable to the NNHPD. This field is optional.

Is it a nanomaterial? If you are unsure, please consult the Interim Policy Statement on Health Canada's Working Definition for Nanomaterials for more information. A "Yes" or "No" response is required. If the answer is "Yes", the nanomaterial is added to the list of nanomaterial ingredients on the summary page. Please note that nanomaterials are not permitted in the monograph application stream, and biocides using nano-technology may be considered novel.

Active ingredients table

To complete the active ingredient entry, click the "Modify" button corresponding to that ingredient. This action will take you to the Modify active ingredient page. Once the required information has been entered for that ingredient, it will appear in the Active ingredients table and the row will no longer be highlighted. All required active ingredient entries must be complete in order to finalize the form.

Formulant ingredients

Formulant ingredients are selected by searching the Biocides Ingredients Database. For all application pathways, the BID is used to search formulant ingredients.

Add a basic formulation

• Basic formulation name: This is a free text field. The applicant indicates the basic formulation name.
• Click on the button Add to add the basic formulation name to the formulation table.

Add an alternate formulation

• Click on the "Add alternate formulation" button. In the Formulation table, under action, select modify. On the Modify formulation page, input all required information with regards to this product formulation (see Formulation ingredient section below) and select the "Save and continue" button to save the information and return to the formulation table. To add a new formulation, select the "Add formulation" button. To remove a formulation, select the "Remove" button in the corresponding row.

Delete an alternate formulation

• For each alternate formulation, a delete formulation button will appear at the top right of the formulation section to delete the selected formulation. A warning message will appear to ask user if they are sure they want to delete the formulation. If you want to keep the product formulation, click on Cancel.

Add formulant ingredient

Type of formulant: This is a radial button. Please select if the formulant is an ingredient or a proprietary blend.

Search: In the formulant ingredient search field, enter the full name of the formulant ingredient to be added. The search field will search and retrieve data from the Biocides Ingredients Database. The following fields are searched:

• BID approved name
• Chemical names
• Common names
• Synonym
• Chemical Abstracts Service (CAS) numbers

See section Ingredient search: General information for information on how to use the search function and what to do if a search returns no results

Add to formulant ingredients table: Select the desired ingredient from the search results to add it to the formulant ingredients table.

Add ingredient not in list: If no search results is appropriate for the ingredient, click on Add ingredient not in list.

Modify formulant ingredient

On the Modify formulant ingredient page, some fields will be pre-populated based on information found in the Biocides Ingredients Database. If only one value is available, this value will be pre-selected.

Chemical name: Select the chemical name of the ingredient from the drop-down list. If the ingredient is not listed in the database, indicate the chemical name if available.

Common name: Select the common name of the ingredient from the drop-down list. If the ingredient is not listed in the database, this is a free text field. Indicate the common name of the ingredient.

CAS number: The CAS number will pre-populated from the Biocides Ingredients Database and are derived from authorized references.

Purpose: Select a purpose from the drop-down list of valid formulant ingredient purposes. Please see the BID for the controlled list of acceptable formulant ingredient purposes. If the required purpose is not found, complete a Biocides Ingredients Database Request Form to add the desired purpose to the ingredient.

Standard or grade: Pharmacopoeia or other grade or standard with which the ingredient will comply. The drop-down list of standards and grades represents pharmacopoeia grades acceptable to the NNHPD. This field only needs to be completed as required or if applicable to the ingredient.

Quantity: Enter the amount of the ingredient used in the product formulation.

Unit of measure: Unit for the quantity in percent (weight/weight).

Lower limit: Lowest amount of the ingredient. Numerical values only. This field is optional in the BAF. Refer to the section on tolerance limits within the guidance on quality requirements for biocides.

Upper limit: Highest amount of the ingredient. Numerical values only. This field is optional in the BAF. Refer to the section on tolerance limits within the guidance on quality requirements for biocides.

Is it a nanomaterial? If you are unsure, please consult the Interim Policy Statement on Health Canada's Working Definition for Nanomaterials for more information. A "Yes" or "No" response is required. If the answer is "Yes", the nanomaterial is added to the list of nanomaterial ingredients on the summary page. Please note that nanomaterials are not permitted in the compendial monograph stream, and biocides using nano-technology may be considered novel.

Add proprietary blend formulant

By selecting Proprietary blend as formulant type, the form will populate the section Modify proprietary blend. Please enter the information.

Modify blend formulant

Proprietary blend name: This is a free text field. Indicate the proprietary blend name.

CAS number: Numeric field. Indicate the CAS number if applicable.

Quantity: Enter the amount of the blend used in the product formulation.

Unit of measure: Unit for the quantity in percent (weight/weight).

Lower limit: Lowest amount of the ingredient. Numerical values only. This field is optional in the BAF. Refer to the section on tolerance limits within the guidance on quality requirements for biocides.

Upper limit: Highest amount of the ingredient. Numerical values only. This field is optional in the BAF. Refer to the section on tolerance limits within the guidance on quality requirements for biocides.

Purpose: Select a purpose from the drop-down list of valid formulant ingredient purposes. Please see the BID for the controlled list of acceptable formulant ingredient purposes. If the required purpose is not found, complete a Biocide ingredient issue form to add the desired purpose to the ingredient.

Are the details of this proprietary blend known? A "Yes" or "No" response is required. If "Yes" is selected, the applicant can continue to the next page. If "No" is selected, the section Proprietary blend manufacturer contact information will appear for the applicant to file.

If you do not know the chemical identity or chemical composition of an ingredient because it's proprietary or trade secret information, you must ensure the supplier or producer of the ingredient provides this information. For example, if the biocide formulation includes a pre-blended antifoaming agent and the complete composition of this blend is proprietary to the manufacturer/supplier. NNHPD will contact the supplier as needed, to obtain this information for the purpose of review, and it will remain confidential.

Formulant ingredients table

Ingredients and proprietary blend formulant that have been added to a formulation can be modified or removed in the formulant table. To modify the formulant ingredient entry, click the "Modify" button corresponding to that ingredient

To remove an ingredient, click on the 'Delete' button corresponding to that ingredient.

Container information table

General information about the container is collected on the Container information page. This includes type, material and net contents.

Container information

Click on Add container to add a container to the container information table. To complete the container information, click the corresponding "Modify" button. This action will take you to the Modify container information page (see below). Once the required information has been entered, the information will appear in the container information table. All container information must be completed in order to complete the application.

Modify container

Container type: A drop-down list of container type is generated from the Biocides Ingredients Database. Select the appropriate container type.

Specify other container type: This is an open text field available when the container type selected is Other. Indicate the type of container.

Container material: The container material section is populated from the Biocides Ingredients Database. Select the appropriate container material.

Net contents: This is a free numeric field. Enter the container net contents.

Unit of measure: A drop-down list of measure units is generated by the form. Select the appropriate unit.

Recommended conditions of use

Recommended use(s) or purpose(s)

For all applications, at least one use or purpose statement must be indicated.

The application form will pre-populate the recommended use or purpose statement(s) from the BID. Select the statement(s) to be added by clicking on the corresponding checkbox(es). Statements with a checkmark next to them will be added to form and visible on the summary page. To deselect a statement, simply click on the corresponding checkbox to remove the checkmark.

Formulation type: This is a check box. Select all the formulation type appropriate for the recommended use or purpose. When the formulation type selected is Dilutable, the field Dilution(s) will populate for the applicant to file.

Dilution(s): This is a free text field. Enter the dilution(s) for the recommended use and purpose. There may be multiple use dilutions for each recommended use or purpose, such as a dilution for hard surface disinfection against bacteria, and a different dilution for hard surface disinfection against viruses. All dilutions should be indicated within the BAF.

Cross-promotion or co-packaged product(s)

Is this product being cross-promoted or co-packaged with another product?: A "Yes" or "No" response is required. If Yes, is selected, please fill the Cross-promotion or co-packaged product(s) field (see below).

Cross-promoted or co-packaged product(s): Indicate the product name(s) of the cross promoted or co-packaged product.

The following section will populate in the form if you previously selected transition of authorized disinfectant in the Application information page.

Directions for use: This is a free-text field. Indicate the directions for use of the product.

Directions for storage: This is a free-text field. Indicate the direction for storage of the product.

Risk information

Precautionary statements: Select the precautionary statements that will appear on the biocide label. More than one statement can be selected.

Note: The precautionary statement 'Keep out of reach of children' must appear on the principal display panel (PDP) of your inner and outer (if there's an outer) biocide label.

Other precautionary statements: A free text field is available in order to add your own risk statements.

First aid instructions A free text field is available in order to add your own first aid information.

Site information

The site information section allows you to capture all of the sites used in the manufacturing, labelling, packaging, and if applicable the importer. The applicant should provide the name and address of each company. For each company name and address provided, the associated activity/activities must also be indicated (such as manufacturer, packager, labeler, and/or importer).

To input site information, select the "Add site information" button. In the Site information table select modify next to the corresponding site.

Is this site used for importation?: A "Yes" or "No" response is required. If the answer is "No" The Site activity type section will populate,

Site activity type: Select all the applicable activity types for this site. You can select more than one activity type.

Company name of market authorization holder: This is a free text field. Enter the name of the company pursuing the selected activities.

Street address: This is a free text field. Include the civic number and street name.

City or town: This is a free text field. Enter the city or town of the site.

Country: This is a drop down field. Please select the country for the site.

Province or state: This is a drop down field. Please indicate the province or state for the site.

Postal code/zip code: This is a free text field. Please enter the postal code or zip code.

Select the "Save and continue" button to save the information and return to the site information table. To add a new site, select the "Add site information" button. To remove a site, select the "Remove" button in the corresponding row.

Note: 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. You are not required to file changes relating to the packager and labeller information with us. However, you must maintain this information on file and provide it to us, if requested.

Sales-Related Information

As required with all transactions, please remember to include your cover letter with details on the sales related information you are submitting.

The proper use of the cover letter, as instructed below, is a mandatory transitory measure put in place pending future enhancements to the form.

First sale

Within 30 days after the day on which the biocide is first sold in Canada, the market authorization holder must submit a complete biocide application form (an HTML file and an XML file) via the Electronic Submissions Gateway (ESG).

Enter the information in the online biocide application form’s Transaction details section as follows:

• Regulatory activity lead: “Biocide product”.
• Regulatory activity type:
  • Choose the option “Biocide New Market Authorization (BNMA)”, for the first time that a biocide is being sold in Canada after a new market authorization.
  • Choose the option “Biocide Post-Authorization Change (BPAC)”, if the biocide was not sold in Canada under a new market authorization but is now being sold for the first time following post-authorization changes that led to an amendment of the market authorization.
• Regulatory transaction description: “Information-first sale”.
• Control number: Include the most recently approved control number for which a market authorization was issued or amended.

In the cover letter, please include:

• The biocide identification number.
• The date of the first sale.
  • This is the date that the biocide was first sold in Canada either after a new market authorization or after an amended market authorization if the biocide has never been sold in Canada before under the Biocides Regulations.
• The names and contact information of the persons packaging or labelling the biocide in the cover letter filed under module 1.0.1 of the folder structure of the biocide application.
• A copy of all labels used for this biocide under module 1.2.1 of the folder structure of the biocide application.

Permanent discontinuance of sale

Note: The permanent discontinuance of sale affects all biocides authorized under the same market authorization. If, after submitting a permanent discontinuance of sale application, the former holder of a market authorization decides that they want to market one or more of the biocides again, they will need to apply for a new market authorization.

Within 30 days after the day on which the sale of the biocide is discontinued in Canada, the market authorization holder must submit a complete biocide application form (an HTML file and an XML file) via the Electronic Submissions Gateway (ESG).

Enter the information in the online biocide application form’s Transaction details section as follows:

• Regulatory activity lead: “Biocide Product”.
• Regulatory activity type: “Biocide New Market Authorization (BNMA)”.
• Regulatory Transaction Description: “Permanent discontinuance of sale”.
• Control Number: Include the most recently approved control number for which a market authorization was issued or amended.

In the cover letter, please include the following information as is applicable to your product. Please note that your product may have been previously sold under an authorization issued under the Food and Drug Regulations (FDR) and/or the Pest Control Products Act (PCPA):

• If the biocide has been sold under a market authorization issued under the Biocides Regulations, include:
  • The following statement:
    • “The biocide has been sold under a market authorization issued under the Biocides Regulations.”
  • The biocide identification number.
  • The date of permanent discontinuance of sale.
  • The lot number of product last sold under the authorization, and
  • The expiry date* of the last lot sold under the authorization.
• If the product has not been sold under a market authorization issued under the Biocides Regulations but it has been sold under a previous authorization issued under the Food and Drug Regulations (FDR), include:
  • The following statement:
    • “The product has not been sold under a market authorization issued under the Biocides Regulations but it has been sold under a previous authorization issued under the Food and Drug Regulations (FDR).”
  • The biocide identification number.
  • The DIN of the previous authorization.
    • If the biocide market authorization corresponds to multiple market authorizations issued under the FDR, please include each of the previous market authorizations’ DINs, lot numbers and expiry dates.
  • The date of permanent discontinuance of sale.
  • The lot number of product last sold under the previous authorization, and
  • The expiry date* of the last lot sold under the previous authorization.
• If the product has not been sold under a market authorization issued under the Biocides Regulations but it has been sold under a previous authorization issued under the Pest Control Products Act (PCPA), include:
  • The following statement:
    • “The product has not been sold under a market authorization issued under the Biocides Regulations but it has been sold under a previous authorization issued under the Pest Control Products Act (PCPA).”
  • The biocide identification number.
  • The PCPR number of the previous authorization.
    • If the biocide market authorization corresponds to multiple market authorizations issued under the PCPA, please include each of the previous market authorizations’ PCPR numbers, lot numbers and expiry dates.
  • The date of permanent discontinuance of sale.
  • The lot number of product last sold under the previous authorization, and
  • The expiry date* of the last lot sold under the previous authorization.
• If the biocide has never been sold under a market authorization issued under the Biocides Regulations or under a previous authorization issued under the FDR or the PCPA, include:
  • The following statement:
    • “The biocide has never been sold under a market authorization issued under the Biocides Regulations or under a previous authorization issued under the Food and Drug Regulations (FDR) or the Pest Control Products Act (PCPA).”
  • The biocide identification number, and
  • The date of permanent discontinuance of sale.

*If the expiry date is presented only as month and year, for the purposes of the Sales-Related Information section, it is understood that the expiry date is the last day of the given month. For instance, the expression “Jan-2024” should be entered into the biocide application form as either “January 31st, 2024” or as “2024-01-31.”

Under exceptional circumstances when the market authorization holder is still unable to provide the expiry date and/or lot number of the last lot sold under the authorization, a rationale must be provided in the cover letter.

For information on sales-related information, contact OSIP at osip-bppi@hc-sc.gc.ca.

Annual Notification

Before October 1st of each year, the market authorization holder for a biocide must inform Health Canada whether or not they are selling the biocide in Canada or have sold it in Canada in the past 12 months.

As of June 2026 and then, every year, in June, Health Canada will send each market authorization holder of a biocide a “Biocide Annual Confirmation of Marketing Status” to be completed and returned to the Department by mid-August to allow Health Canada sufficient time to update information in its regulatory and financial databases to ensure compliance with section 46 of the Regulations and prior to issuing invoices on October 1st.

The market authorization holder must also ensure that:

• All fee mitigation measures that applied, if any, are up to date. For instance, some market authorization holders may be eligible for small business fee mitigation.
• Any information related to their company has been updated.

For information on how to update information related to the company, including the company Identifier, consult the Regulatory enrolment process (REP) webpage to request a copy of the Guidance Document The Regulatory Enrolment Process (REP): Drugs for Human/ Veterinary Use and Disinfectants.

Summary

The Summary page displays the contents of each section of the BAF form in one consolidated view. The summary can be viewed at any time during an active session by clicking on "Summary" in the top right hand corner of the form or by selecting "Summary" in the table of contents.

Completing the form: Once all sections of the form are completed and all required information is entered, click "Complete" at the bottom of the Summary page. Errors will appear if the required information is missing. All errors must be resolved in order to complete the form and move forward with finalizing the form.

Attestation

Before finalizing the form, carefully review the summary and read the attestation at the bottom of the page. To sign the attestation, select the "I agree" checkbox. This will generate an attestation code which acts as your confirmation that you accept the terms of the attestation.

Finalize: Once attestation is complete, the Finalize button will appear. Click on "Finalize" to lock the form and go to the finalized view.

Finalized form

The finalized form includes the control number, complete summary, and a signed attestation. Once finalized, the application is ready to be saved to your local workstation. The save button will download a zip folder containing 2 documents: an HTML file and an XML file. Both of these files are necessary to continue with the Biocide application process. Please note that the zip folder must be unzipped prior to submission.

How to unzip a file

Window

Locate the zipped folder that you want to unzip (extract) files or folders from. Do one of the following:

• Locate the zip file in the File Explorer.
• Right-click the file and select 'Extract All'.
• Choose a destination folder where you want the files to be extracted.
• Click 'extract' to unzip

MAC(macOS)

• Double-click the ZIP file, and it will extract automatically in the same location.
• If it doesn't extract, right-click the file and select Open With''Archive Utility.
• The extracted files will appear in a new folder.

The saved files are then ready to be submitted to NNHPD as part of a complete electronic transaction package.

See the Guidance on Management of Biocide Applications for more information on what consists of a complete submission package.

Note: Only use the "Save file" link provided in the form to download and save a copy of your BAF form to file. Do not save using the browser's save function as this will only save the web page not the form.

Modify finalized form

The "Modify" button is available after a form has been finalized. It must only be used when responding to an information request notice from NNHPD or if you're making any modifications to the form prior to submission. It should not be used to change the content of refused BAFs or to create new applications from previously finalized applications with similar content. The latter actions will result in duplicate tracking numbers at NNHPD which causes serious delays in file processing.

After selecting the "Modify" button and making the desired change(s), be sure to save any modified fields by clicking on the corresponding "Save and continue" button. Proceed to the Summary page in order to finalize the form once again.

Note: See the section "Load application form from file" on the landing page for more information on how to modify the BAF form pre and post finalization.

Submitting to the NNHPD

Both the HTML and XML files must be submitted to the NNHPD within the submission package. The NNHPD accepts completed submission packages via the Electronic Submissions Gateway (ESG). For more information on how to register, connect and submit regulatory transactions using the ESG, please refer to the guidance.

Warning: Do not print and then scan the BAF form. Submitting a scanned BAF form to the NNHPD will result in lengthy processing delays and may result in the refusal of your submission.

Do not provide a PDF copy of the BAF form. This document will not be used for assessment and licensing.

If you require help prior submitting or filling out the BAF, submit questions by e-mail to nnhpd-dpsnso@hc-sc.gc.ca.