Pre-submission consultation guidance: Mandatory Pre-market submissions for the Food Directorate

You must send a pre-market submission to Health Canada if you want to market a food additive, novel food, infant formula, supplemental ingredient or supplemented food category in Canada. This page explains how to ask questions about pre-market submissions and how to request and prepare for a pre-submission consultation.

On this page

• Purpose of pre-submission consultations
• Types of pre-market submissions for which a consultation is often requested
• Requesting a pre-submission consultation
• Information required in your pre-submission consultation package
• The pre-submission consultation process
• Pre-submission consultation on the products that require novelty determination
• Contact us

Purpose of pre-submission consultations

The main purpose of a consultation is to discuss the information that should be included in a pre-market submission. Such consultations also:

• explain the submission process
• give you an opportunity to discuss details of your submission with us
• familiarize our evaluators with your submission before it officially arrives
• allow us to provide feedback to you on any areas of concern, based on our current experience and regulatory requirements
• discuss any major, unresolved issues early in the submission process

You may also want to discuss:

• preliminary issues that may affect the preparation of a submission
  • For example, you may need help in determining if the food or process is novel or not, and thus to know if a novel food submission is required.
• the clinical protocol for any planned clinical studies required to support the safety and nutritional adequacy of a new or changed infant formula

Types of pre-market submissions for which a consultation is often requested

We typically meet with members of the food industry to consider pre-market submissions for:

• novel foods
• infant formula
• food additives
• supplemental ingredient and supplemented food category
• human milk fortifiers (HMFs)
• new infant formula ingredients (NIFI)

Requesting a pre-submission consultation

Please send a formal request by email to the Submission Management and Information Unit (SMIU) at smiu-ugdi@hc-sc.gc.ca to find out if a pre-submission consultation is necessary.

Your email must clearly identify:

• the purpose of the consultation
• the food product, food ingredient, novel process or food category that is the subject of the potential pre-market submission
• details about the food product, ingredient, process or category, how it will be used or applied and, where relevant, details about the product formulations
• a list of specific issues and questions you would like to discuss or have addressed
• 3 proposed dates for the pre-submission consultation

Send your email at least 8 weeks before the proposed consultation dates.

We will share these details with the appropriate review bureau. They may be able to determine whether a pre-submission consultation is indeed needed. In some cases, you won't need a pre-submission consultation and we may be able to respond to your concerns via email.

The information disclosed for the consultation is confidential business information that will not be shared with individuals outside of the Government of Canada.

If we confirm a pre-submission consultation, SMIU will send you an email with:

• a case number
• details about time and location for the consultation

Once you receive a case number, please use it on all future correspondence regarding the pre-submission consultation.

Consultations are typically 1 hour in length.

Information required in your pre-submission consultation package

Once we have determined that a pre-submission consultation is needed and before we meet, you must send us a pre-submission consultation package. This package should be sent:

• 4 weeks before the consultation
• electronically to SMIU

The package should include all of the information listed in the administrative information and technical information sections. Your package must be complete, even if you already submitted some of the information with the initial consultation request. This will allow us to be well informed and contribute to the overall efficiency of the consultation. Note that you must share with us, for our records, any updates to the consultation documents, including the presentation. We may require additional information before a consultation. The package will help us set up the consultation and identify the appropriate subject matter experts.

We reserve the right to re-schedule consultations to a later date if we don't receive your package early enough to allow us time to review it carefully.

We will need 2 types of information for this pre-submission consultation package:

Administrative information

• a cover letter stating the:
  • purpose of the consultation
  • agenda for the consultation
  • list of participants, such as the petitioner and others participating on behalf of the petitioner
    • include name, title and company for each
  • contact information for the primary contact
    • include name, title, phone number and email
  • technical equipment needs for the consultation, such as video conference details, etc.
• brief presentation slides

Technical information

This may include:

• a description of the product
• a list of specific issues/questions you would like to discuss or have addressed
• background material on the food product, ingredient or category
• a written discussion of the product/ingredient/category's compliance with the Food and Drugs Act and Regulations
• an overview of the market history of the food product, ingredient or category, including:
  • the regulatory status of the food product, ingredient or category in other jurisdictions
• a summary of the development of the food product or ingredient, including:
  • any changes to the manufacturing process
  • a description of the manufacturing process for the product to be marketed
• brief summaries of the safety data relating to the food product, food ingredient or food category

It's important to note that we may still identify data deficiencies or information gaps later, during the scientific screening or safety evaluation of the submission.

The pre-submission consultation process

The pre-submission consultation process has a number of stages.

Before the consultation

In the weeks before the pre-submission consultation, the SMIU may contact you to request additional information or clarification regarding your pre-submission consultation package.

During and after the consultation

For all consultations, you will:

• deliver a brief presentation to us about your food product, ingredient or category
• prepare the first draft of the minutes (with the exception of genetically modified (GM) novel food consultations)

During the meeting, we will provide feedback. After the consultation, we will email a list of the consultation participants to you.

You must submit the draft consultation minutes in Microsoft Word to your SMIU contact within 2 weeks of the date of the consultation. For GM-novel food consultations, we will draft the minutes within 4 weeks of the date of the consultation due to the complexity of the material.

We will circulate the minutes to Health Canada participants, as well as those from other government agencies that may be present. Revisions may be required before the minutes are final. We will coordinate the merging of comments from Health Canada and all participating agencies and send them back to you.

When submitting your pre-market submission, include the final minutes of the consultation(s).

Additional consultations

For some submissions, you may need several pre-submission consultations before your formal pre-market submission.

If this is the case, please:

• follow the same processes above each time
• keep the SMIU as your point of contact

Pre-submission consultation on the products that require novelty determination

If you want to find out if your product is novel before sending in a novel food submission, please send an email to the SMIU with:

• the scientific or common name of the ingredient
• a thorough description of the ingredient

You can request a copy of the novelty determination information form by email at smiu-ugdi@hc-sc.gc.ca.

Depending on the type of product, we will conduct a joint pre-submission consultation with the Canadian Food Inspection Agency (CFIA).

You can get more information about pre-submission consultation procedures for novel foods, novel feeds and plants with novel traits.

Contact us

If you have any questions about the pre-submission consultation process, please contact the SMIU by email at smiu-ugdi@hc-sc.gc.ca.