How to Complete the Online Application and Transport Form for Pre-Market Submissions to the Food Directorate

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Application Form for Pre-Market Submissions to the Food Directorate (Online Application Form)

Background

Health Canada's Food Directorate has prepared this document to outline the steps to complete the Application Form for Pre-Market Submissions to the Food Directorate (Online Application Form) for the submission of novel food, infant formula, and food additive notifications. The Online Application Form replaces all existing methods (i.e. email, hard copy, and courier) of filing novel food, infant formula and food additive submissions to the Food Directorate.

Please send all other submission types and requests (Temporary Marketing Authorization (TMA), Novelty Determination Information Form (NDIF), Human Milk Fortifier (HMF), New Infant Formula Ingredient (NIFI), Food Fortifications, Novel Fibre and Health Claims) electronically to the Submission Management and Information Unit (SMIU) inbox at smiu-ugdi@hc-sc.gc.ca.

The Online Application Form has seven sections and can be saved at any time. Refer to Section 6 for instructions on how to save the information in the form. The cumulative total size of attached documents should not exceed 70 megabytes (mb). Some file types such as Zip (.zip) and executable (.exe) files cannot be attached.

It is recommended to complete the sections of the form in chronological order and save the form at least twice. First, save after the completion of Section 2, as saving at this point will save all of the contact information, which can be used as a base for future submissions to the Food Directorate. The form should also be saved after the completion of Section 5, when the information has successfully been submitted to the Food Directorate and a case number has been assigned.

To complete the Online Application Form, all fields marked with an asterisk (*) are required. All required fields must be populated to submit the form to the Food Directorate.

Issues – Contact Information

For any issues or questions about the form, please contact the SMIU via email at smiu-ugdi@hc-sc.gc.ca

Completing the Online Application Form

Type of Food Product – Section 1

Select the food type, followed by the food sub-type. The food types and sub-types are listed in Table 1:

Table 1:Food sub-types that will appear in the drop-down list for each food type
Food Type Relevant Food Sub-Type
Food Additives
  • New Food Additive
  • Extension of Use
  • Level of Use Change
Infant Formula
  • New Infant Formula
  • Major Change
  • Minor Change
Novel Food
  • New Novel Food
  • Novel Process
  • GMO

Contact – Section 2

Identify the contact information of the petitioner and/or consultant of the submission. Health Canada will directly correspond with this official submission contact.

The petitioner is the legal authorization holder. The consultant is a third party authorized by the petitioner to act on their behalf. If a consultant is submitting on behalf of the petitioner, the Designated Party Authorization (DPA) Form must be included in the submission.

If Consultant is selected as the primary contact, the form will generate additional fields for the petitioner contact.

The Country field will generate additional fields to complete. If Canada is selected, a Province field will be generated. If United States is selected, a State field will be generated. If Other is selected, Other Country and Region fields will be generated.

Additional Contacts

Complete this section only if there are additional contacts to whom Health Canada should directly correspond with about the subject submission. Leave this section blank if the official submission contact is listed above.

Complete the fields in the box for Contact 1.

To add another contact, press the Add Contact button. To remove additional contacts, press the "Remove Contact #" button.

Tip: If the applicant intends on submitting multiple or future applications to the Food Directorate, it is recommended to save the form after the completion of the contact section (Section 2). This saved form can be uploaded on a blank web page and completed at a future date. See Sections 6 and 7 for instructions on how to save and reopen the form.

Substance or Product – Section 3

Provide the name and a summary of the product or substance being submitted.

In the first field, input the name of the substance or product being submitted for review. This field will become the title of the submission. Follow the submission title naming convention as per Table 2.

In the second field, input additional information for the product or substance (e.g. the purpose of use or a summary description of the application).

Table 2: Submission Title Naming Convention
Submission Type Submission Sub-type Submission Title Example(s)

Food Additive

"food(s)" = type of food (a specific one or generic category)

New food additive [FA name] (from [source] when applicable) in [food(s)] as a [function] OR to [briefly describe purpose]

Potassium polyaspartate in wine to inhibit crystal formation

Ground limestone in confectionery as a colouring agent

Extension of use [FA name] (from [source] when applicable) in [food(s)] as a [function] OR to [briefly describe purpose]

Steviol glycosides from Saccharomyces cerevisiae Y63348 in various foods as a sweetener

Lycopene extract from tomato in non-carbonated sweetened flavoured water-based beverages to which vitamins and minerals nutrients have been added and in sports drinks as a colouring agent

Level of use change [FA name] (from [source] when applicable) in [food(s)] as a [function] OR to [briefly describe purpose]

Sucralose in chewing gum and breath freshener products as a

Potassium sorbate in roti as a preservative

Novel Food

use "HPP" for high pressure processing

New Novel Food (no history of safe use) [Name of novel food]

Ahiflower Oil

Lactospore

GMO GM [novel trait][crop] [event#

GM Simplot Innate Potato Event Gen1-V11

GM Herbicide Tolerant Maize Event MON 87419

Novel process [Food] treated with [Novel process]

Fruit and Vegetable-based Juices Treated with HPP

Egg Salad, Egg Dips, and Egg Spreads Treated with HPP

Infant Formula (IF)

FORMAT:

Use "RTF" for ready to feed/ready to use

Use "PDR" for powder

Use "CONC" for concentrate

New Infant Formula [Abbreviated Company Name - Brand Name of product] (FORMAT, container size and container type, when applicable)

AYD - Onpoint Milk-Based IF with Iron and Omega 6 for Babies Sensitive to Lactose (PDR 640g Can)

LJX - Pentax EPA+DHA (CONC 500mL Plastic Bottle)

Major Change [MAJOR CHANGE- Brief Description of Change] for [Abbreviated Company Name - Brand name of product] (FORMAT, container size and type, when applicable)

MAJOR CHANGE for new source of DHA (DHASCO-B) and reduced levels of Arachidonic Acid (ARA) for RBH- Enfamil A+ (CONC 385mL Metal Can)

MAJOR CHANGE for the addition of 2'-fucosyllactose (2'-FL) and lutein for ABB - Similac Alimentum (PDR 400g Metal Can)

Minor Change [MINOR CHANGE- Brief Description of Change] for [Abbreviated Company Name - Brand name of product] (FORMAT, container size and type, when applicable)

MINOR CHANGE in the whey protein concentrate ingredient for ABB - Similac Pro-Advance®Step 1 and 2 (PDR 227g Composite Can, PDR SimplePac Container)

MINOR CHANGE for inclusion of potassium iodide for ABB - Similac Advance Step 1 and 2 (CONC 385mL Metal Can)

Suggested abbreviated company names for IF submissions:

  • Abbott Laboratories: ABB
  • Canada Royal Milk/ Feihe: CRM
  • Dairy Goat Co-Operative: DGC
  • Nestle Canada: NES
  • Nutricia North America: NNA
  • PBM Nutritionals LLC: PBM
  • Prolacta: PRO
  • Mead Johnson (now under Reckitt-Benckiser Health): RBH

Documents – Section 4

To attach a document, press the "Browse/Choose Files" button. Browse to the document location on your computer to select one or multiple documents. The document(s) will be uploaded to the form as Document 1, Document 2, etc. Give each document a title as per the naming conventions in Table 3:

Table 3: Document Title Naming Conventions
Document Document Title
Cover letter Cover letter
Designated Party Authorization Form DPA Form
SubmissionFootnote * Submission Package
Label Inner Label; Outer Label; Draft Label; insert descriptive title
References References
Food Additive Checklist FAS Checklist
Infant Formula Checklist IF Checklist
Other Insert descriptive title

If deleting specific documents, press the "Remove Document" button corresponding to the document to be deleted. Press "Remove All Documents" to delete all documents that have been uploaded.

Zip (.zip) and executable (.exe) files cannot be attached. The cumulative size of all documents cannot exceed 70 megabytes. The form will keep a running tally of the document size as files are attached.

How to Submit the Online Application Form – Section 5

To submit the form, press the "Proceed to Submit" button. The form will validate all information to ensure all required fields have been completed. If information is missing, the form will not be submitted and a prompt is displayed at the top of the form that indicates the required fields that need to be completed prior to submitting.

If all required fields have been completed, the form will generate a pop-up message that confirms the successful transmission of the form to the Food Directorate and generate a case number and submission number. Wait for confirmation. Quote the case number in all future correspondence with the Food Directorate. The form identifier and submission number are internal Health Canada numbers that should be kept for reference in case there are any problems with transmission.

Tip: Click on the "Proceed to Submit" button once. It may take up to 10 seconds for the confirmation prompt to display.

How to Save the Online Application Form – Section 6

The information entered in the Online Application Form can be saved as a .hcxs file.

To save the information in the Online Application Form, right click on "Save My Form" and select "Save link as…". Choose a location on your computer and the information and any identified document paths within the form will be saved as a .hcxs file at that location.

Tip: If the form is saved with documents attached, the documents should be in the same file structure location when the form is reopened.

How to View/Edit a Saved Online Application Form – Section 7

To upload the saved .hcxs file to the Online Application Form, ensure the form is blank. Press the "Browse/Choose File" button and browse to the location of the .hcxs file. Ensure documents and attachments are in the same saved location. Select the .hcxs file that contains the information you want to upload into the Online Application Form. Press the "Upload Information" button. If successful, the form will generate a pop-up message to confirm that the information from the saved file was uploaded into the form.

Transport Form for Submitting Additional Documents to Health Canada for Novel Food, Infant Formula and Food Additive Submissions (Transport Form)

Background

Health Canada's Food Directorate has prepared this section to outline the steps to complete the Transport Form for Submitting Additional Documents to Health Canada (Transport Form) to submit any additional requested Health Canada solicited information related to the original submission (i.e. responses to deficiencies) for existing novel food, infant formula and food additive submissions. It may also be used to submit additional supporting documentation that exceeded the total 70 megabyte file size limit in the original Online Application Form.

Completing the Transport Form

Submission – Section 1

Select the programme as "Food Directorate" and input the assigned Case Number.

Who is Submitting – Section 2

Identify the contact information for the person who is submitting the documents (Business name, Address, Name, Email and Telephone).

The Country field will generate additional fields to complete. If Canada is selected, a Province field will be generated. If United States is selected, a State field will be generated. If Other is selected, Other Country and Region fields will be generated.

Privacy Notice: Refer to Food Safety Governance (HC FSN 005) in Info Source for more information about the collection of your personal information.

Documents – Section 3

To attach a document, press the "Browse/Choose Files" button. Browse to the document location on your computer to select one or multiple documents. The document(s) will be identified in the form as Document 1, Document 2, etc.

Select Document Type

Choose "Correspondence" for uploading a response to a Health Canada solicited information request (i.e. response to deficiency request). The document should be presented in a question and answer format.

Choose "Other Documents" to upload any attachments that are referenced in the response or support the Health Canada solicited information request/response to deficiency.

Choose "Other Documents" to upload any attachments that support the initial submission but exceed the 70 megabyte file size limit in the original application form. The types of attachments to submit for each document type are summarized in Table 4.

Table 4: Information to submit for each document type
Document Type What to Submit?
Correspondence Response to deficiency in question and answer format
Other Documents

Attachments that support or are referenced in the response to deficiency

Any documents that support the initial submission but exceed the 70 mb file size limit

Insert Title

A Health Canada solicited information request will have the following naming convention in the email subject line depending on if the request is from the screening or review stage: SENT-1 scr, SENT-2 rev, etc. Table 5 demonstrates the naming convention in the email subject line from Health Canada.

Table 5: Subject line naming convention for Health Canada solicited requests
Health Canada Deficiency or Information Request Email Subject Line Naming Convention
Screening Deficiency Request 1 SENT-1 scr
Screening Deficiency Request 2 SENT-2 scr
Review Deficiency Request 1 SENT-1 rev
Review Deficiency Request 2 SENT-2 rev

For responses to Health Canada solicited information requests/response to deficiencies in the screening or review stage, use the following naming convention format in the title field of the form: RECD-1 scr; RECD-2 rev, etc.

For attachments that support or are referenced in the response to deficiency request, insert a descriptive title (e.g. stability data; exposure assessment, draft label, etc.) in the title field. Table 6 outlines the document title naming convention when submitting attachments through the Transport Form.

Table 6: Document Title Naming Conventions
Document being Submitted Document Title
Response to Administrative Deficiency Request Administrative Deficiency Response
Screening Response to Deficiency Request 1 RECD-1 scr
Screening Response to Deficiency Request 2 RECD-2 scr
Review Response to Deficiency Request 1 RECD-1 rev
Review Response to Deficiency Request 2 RECD-2 rev
Exposure Assessment Exposure assessment
Inner Label Inner label
Other Insert descriptive title

If deleting specific documents, press the "Remove Document" button corresponding to the document to be deleted. Press "Remove all documents" to delete all documents that have been uploaded.

Zip (.zip) and executable (.exe) files cannot be attached. The cumulative size of all documents cannot exceed 70 megabytes. The form will keep a running tally of the document size as documents are attached.

How to Submit the Transport Form – Section 4

To submit the Transport Form, press the "Proceed to Submit" button. The form will validate all information to ensure all required fields have been completed. If information is missing, the form will not be submitted and a prompt is displayed at the top of the form that indicates the required fields to be completed prior to submitting.

If all required fields have been completed, the Transport Form will generate a pop-up message that confirms the successful transmission of the Transport Form and generate a case number and submission number. Quote the case number in all future correspondence with the Food Directorate. The form identifier and submission number are internal Health Canada numbers that should be kept for reference in case there are any problems with transmission.

Tip: Verify the information in the form is complete and accurate prior to submitting to the Food Directorate.

How to Save the Transport Form – Section 5

The information entered in the Transport Form can be saved as a .hcxs file.

To save the information in the Transport Form, right click on "Save My Form" and select "Save link as…". Choose a location on your computer and the information and any identified document paths within the form will be saved as a .hcxs file at that location.

How to View/Edit a Saved Transport Form – Section 6

To upload the saved .hcxs file to the Transport Form, ensure the web form is blank. Press the "Browse/Choose File" button and browse to the location of the .hcxs file. Ensure documents and attachments are in the same saved location. Select the .hcxs file that contains the information that you want to upload into the Transport Form. Press the "Upload Information" button. If successful, the form will generate a pop-up message to confirm the information from the saved file was uploaded into the Transport Form.

Frequently Asked Questions: Online Application and Transport Form

Why is the online application form being implemented?

The Online Application Form titled, "Application Form for Pre-Market Submissions to the Food Directorate" supports the transition to an electronic pre-market submission process in the Food Directorate. This initiative aligns with Health Canada's efforts to achieve digital government and allow stakeholders to submit their applications electronically in a secure environment.

What submission types are included in the form?

The Online Application Form is for Food Additive, Infant Formula, and Novel Food submissions.

The table below shows the food type and sub-types that are in scope of the Online Application Form:

Table 7: Food type and sub-types that are in scope of the Online Application Form
Food Type Relevant Food Sub-Type
Food Additives
  • New Food Additive
  • Extension of Use
  • Level of Use Change
Infant Formula
  • New Infant Formula
  • Major Change
  • Minor Change
Novel Food
  • New Novel Food
  • Novel Process
  • GMO

Can I still submit hard copy and electronic submissions through email and courier?

No, the Online Application Form will replace paper submissions and electronic submissions received through courier (USBs, CD-ROMs, etc.) and email for Infant Formula, Novel Food and Food Additive submissions.

What about other submission types (e.g. supplemented foods, novel fibre, health claims, etc.)?

Please send the following submission type and requests electronically to the SMIU email account at smiu-ugdi@hc-sc.gc.ca:

Food packaging submissions can be sent to fpmia-meaai@hc-sc.gc.ca.

Will other submission types be included in the form in the future?

The Food Directorate is evaluating the possibility of expanding the scope of online submissions to other food type requests.

What attachment file types are not supported?
Certain executable files (programs and.exe files) or compressed files (.ZIP files) are not supported.

What is the transport form?

The Transport Form, titled "Transport Form for Submitting Additional Documents to Health Canada", is for the submission of documents to an existing application as in the case of a response to deficiency or Health Canada solicited information request.

The Transport Form may also be used when a submission package exceeds the 70 megabyte file size limit. Documents not submitted with the initial form would be sent using the Transport Form.

How to submit a response to deficiency request and subsequent correspondence?

Use the Transport Form to submit any responses to Health Canada solicited information requests or deficiencies. Responses will not be accepted through email.

What are the requirements to use the forms?

To use the forms you must be connected to the internet with a browser such as:

Contact

Please contact the SMIU via email at smiu-ugdi@hc-sc.gc.ca

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