The Food Directorate's Pre-Market Submission Management Process for Food Additives, Infant Formulas and Novel Foods

October 2021

Table of contents

• 1.0 Introduction
  • 1.1 Purpose
  • 1.2 Legislative authorities
  • 1.3 Scope
• 2.0 Pre-market submissions
  • 2.1 Guidance for preparing submissions
  • 2.2 Pre-submission consultation
  • 2.3 Instructions for sending submissions and additional requested information
• 3.0 Submission management process
  • 3.1 Administrative verification
    • 3.1.1 Unacceptable submissions
    • 3.1.2 Acceptable submissions
  • 3.2 Scientific review
  • 3.3 Decision
    • 3.3.1 Unfavourable decisions
    • 3.3.2 Favourable decision - food additives
    • 3.3.3 Favourable decision - infant formula
    • 3.3.4 Favourable decision - novel foods
• 4.0 Withdrawal of a submission
• 5.0 Re-filing a submission
• 6.0 Confidentiality
• 7.0 Dispute resolution
• 8.0 Single window into the Food Directorate submission management process
• 9.0 Performance standards
• Appendix 1: Brief overview of the timelines of a submission

Introduction

1.1 Purpose

Health Canada's Food Directorate has prepared this document to describe the pre-market submission management process for food additives, infant formulas and novel foods pursuant to requirements of the Food and Drug Regulations. This follows consultation with stakeholders in 2014-2015. The document provides information on activities and timelines related to the management of submissions. With the implementation of these business practices, the Food Directorate will be in a position to improve the timeliness, predictability and transparency of the submission process.

1.2 Legislative authorities

The Food and Drugs Act provides the authority to set out various requirements and conditions for foods sold in Canada. Pre-market submission requirements for food additives are set out in Division 16 of the Food and Drug Regulations (Regulations). Pre-market notification requirements for infant formulas and for novel foods are set out in Division 25 and Division 28, respective, of the Regulations.

1.3 Scope

The document outlines the steps and target timelines in the Food Directorate for managing pre-market submissions for food additives, infant formulas and novel foods. The process begins with an optional pre-submission consultation and proceeds through the receipt of a submission to the communication of the Directorate's decision to the applicant.

This document focuses on the steps related to the review and approval of these submissions, but also provides a brief explanation of any additional steps required to sell a food containing a food additive or to sell an infant formula or novel food in Canada.

The steps in the submission management process are: (1) Administrative verification; (2) Scientific review and (3) Decision.

1. Administrative verification - This step validates that the submission package contains the necessary administrative information.
2. Scientific review - The submission is evaluated to determine whether the food additive, infant formula or novel food will pose a risk to human health. Food additives may also be evaluated for efficacy. Where applicable, the evaluation considers other aspects that will inform the Food Directorate's decision (e.g. consultation with industry/public/other government groups, international status).
3. Decision - The outcome of the scientific review and a recommendation based on that outcome are presented to Food Directorate senior management; the Directorate's decision is then communicated to the applicant. For food additives, the appropriate List(s) of Permitted Food Additives must be modified for the additive to be legally sold in Canada. For infant formulas applicants receive a "Letter of No Further Questions", and for novel foods, a "Letter of No Objection."

2.0 Pre-market submissions

2.1 Guidance for preparing submissions

The Food Directorate has developed specific guidance to assist applicants in meeting the scientific and regulatory requirements for food additive, infant formula and novel food submissions. The present document is intended to be used in conjunction with the following documents.

• A Guide for the Preparation of Submissions on Food Additives
• A Guide for the Preparation of Infant Formula (IF) and Human Milk Fortifier (HMF) Premarket Submissions
• Guidelines for the Safety Assessment of Novel Foods Derived from Plants and Microorganisms
• Guidance document: How to Complete the Online Application and Transport Form for Pre-Market Submissions to the Food Directorate

2.2 Pre-submission consultation

If, after reading the relevant guidance, applicants require further assistance, they may request a pre-submission consultation with the Food Directorate. These consultations could be in the form of emails, phone calls or meetings, and are an opportunity to seek further guidance on submission requirements so that a complete submission can be filed at the outset, potentially reducing the number of requests to the applicant for clarification or additional information, or preventing the submission from being rejected as incomplete. For information on requesting a pre-submission consultation with the Food Directorate, please see the Pre-submission meeting guidance: Pre-market mandatory submissions for the Food Directorate. Pre-submission consultation requests may be sent to the SMIU at smiu-ugdi@hc-sc.gc.ca.

2.3 Instructions for sending submissions and additional requested information

Submissions should be sent electronically through the Application Form for Pre-Market Submissions to the Food Directorate (Online Application Form).

Additional requested information (for example, responses to information requests or deficiencies) should be sent electronically through the Transport Form for Submitting Additional Documents to Health Canada (Transport Form).

3.0 Submission management process

A brief overview of the timelines associated with each step of the submission management process is provided in Appendix 1.

3.1 Administrative verification

A pre-market notification will receive a case number upon receipt and the SMIU will verify the data package within 10 calendar days to ensure it contains the administrative components of a submission and is ready for scientific review.

This includes verification that all the components of the data package are included, that the cover letter describes the submission and clearly states the request to the Food Directorate, and that the applicant's contact information has been provided in the Online Application Form. The administrative verification step does not assess the quality of the data.

3.1.1 Unacceptable submissions

The SMIU makes a reasonable effort to gather any administrative information that is deficient in incoming submissions. In cases where submissions do not contain the necessary components for scientific review, the applicant is notified that the submission has not been accepted for review and asked to refile the submission when the complete necessary information can be provided. When an applicant is notified that their submission has not been accepted for review, a list of the missing and necessary information required to advance to the scientific review phase is included in the letter.

3.1.2 Acceptable submissions

Submissions containing the necessary administrative information are forwarded for scientific review. A Letter of Acknowledgment is sent to the applicant stating that the application is complete and that the submission has been accepted for scientific review.

3.2 Scientific review

The scientific review period begins on the date the Letter of Acknowledgement is issued. Depending on the complexity of the submission, the scientific review could take up to 368 calendar days.^{Footnote 1} In circumstances where it may not be possible to complete the review and reach a decision within 410 days (e.g. such as when policy or regulatory questions must be addressed), the Food Directorate will notify applicants promptly.

The scientific review consists primarily of a safety evaluation although it may consider other factors such as product efficacy, regulatory and/or policy issues, permitted uses in other jurisdictions, and comments from the Canadian Food Inspection Agency (CFIA) and other stakeholders (e.g., particular food industry associations).

Scientific screening has been implemented for novel food and infant formula submissions. Screening is completed in 55 calendar days for novel food submissions and 80 calendar days for infant formula submissions, from the date the letter of acknowledgment is issued. If major gaps are identified, the Food Directorate will request that the applicant promptly submit the missing information within 15 calendar days for novel food submissions and 30 calendar days for infant formula submissions. The applicant is notified of the results of the scientific screening.

If at any point during the scientific review significant deficiencies are noted, or significant safety concerns are identified, the file may be closed and the decision communicated to the applicant. However, in most cases, the Food Directorate will provide an opportunity for the applicant to address deficiencies through a request for information. During the safety review of novel food, infant formula and food additive submissions, the applicant has up to 90 calendar days to provide a satisfactory response to the request. If an adequate response is not provided within the specified timeline, the applicant will be notified that the Directorate has closed the submission. At any time, an applicant may request that a submission be withdrawn (see Section 4.0).

3.3 Decision

Decisions on submissions are made by the Food Directorate's senior management based on the results of the submission evaluation. The Directorate will notify the applicant, in writing, of the decision for the majority of submissions within 410 days of receipt of the submission.

3.3.1 Unfavourable decisions

If the proposed use of the food additive, infant formula or novel food is not acceptable, the decision and its basis will be communicated to the applicant as early in the process as possible and the submission will be closed. A new submission that addresses the reason(s) the submission was closed can then be filed with the SMIU, without prejudice, at which time it will be processed as a new submission.

3.3.2 Favourable decision - food additives

A food additive may be legally used in foods to be sold in Canada once the appropriate List(s) of Permitted Food Additives has(ve) been modified to include the food additive along with its permitted conditions of use (e.g., the specific foods to which it may be added and its maximum level of use). Each of the 15 Lists is incorporated by reference into a Marketing Authorization (MA), which is a Ministerial regulation.

If the decision is favourable, the applicant is notified in writing that the Food Directorate intends to follow its established administrative procedure for modifying the appropriate list. This procedure^{Footnote 2} involves public notifications and the opportunity for public and stakeholder comment. Once the relevant list has been modified, a food containing the food additive of interest may be legally sold in Canada (provided the conditions of use are respected). The applicant is notified in writing when the relevant list has been modified. On rare occasions it may be necessary to modify an existing MA or issue a new MA before the appropriate List(s) of Permitted Food Additives can be modified. Because modifying and issuing MAs are regulatory processes that are subject to the Cabinet Directive on Regulatory Management (CDRM), this will take longer than the usual mechanism for modifying Lists. The applicant will be notified if modification of an MA is required.

3.3.2.1 New food additives

If the Food Directorate determines that the proposed use of a new food additive can be permitted, the Directorate notifies the public of its intent to modify the Lists of Permitted Food Additives via a "Notice of Proposal". The Notice of Proposal is posted on the Food Directorate's website for public consideration. If substantial new scientific or safety evidence is submitted, the Directorate will consider the information and adjust the proposal as necessary. Otherwise a "Notice of Modification" is posted on the website on the same date that the applicable List(s) of Permitted Food Additives is/are modified.

3.3.2.2 Extension of food additive use

Extensions of use for currently permitted food additives are incorporated into the Lists of Permitted Food Additives via a "Notice of Modification". The Notice of Modification is posted on the Food Directorate's website on the same date that the applicable food additive list(s) is/are modified. Interested parties may provide comments on the modification. The Food Directorate will consider any substantial new scientific or safety information that is submitted or that becomes available in the peer-reviewed scientific literature.

Further details on Incorporation by Reference into Marketing Authorizations and the associated timelines can be found in the Food Directorate's Transition Guide: Understanding and Using the Lists of Permitted Food Additives.

3.3.3 Favourable decision - infant formula

For infant formula, if the decision is favourable the applicant receives a Letter of No Further Questions, after which the product can be sold in Canada.

3.3.4 Favourable decision - novel foods

For novel foods, if the decision is favourable the applicant is notified in writing that the Food Directorate has no objection to the sale of the novel food product as a food in Canada. Novel foods are legal for sale in Canada as of the date that the Letter of No Objection is issued. The Food Directorate also publishes on its website a decision document summarizing the food safety assessment and communicating the decision that no objection has been taken to the use of the subject product as food in Canada.^{Footnote 3}

Health Canada shares regulatory oversight of some genetically-modified (GM) foods with the Canadian Food Inspection Agency (CFIA). For these products, the Food Directorate of Health Canada conducts the food safety assessment while the CFIA conducts the animal feed and/or environmental release assessments (as appropriate). The Food Directorate and the CFIA coordinate their respective authorizations to minimize the potential for unapproved GM food or feed products to enter the Canadian marketplace. Should the situation occur where the Food Directorate completes its safety assessment, but is waiting on CFIA to complete the feed and/or environmental release assessments, the file will be considered "on hold" and the time for the CFIA's assessment will not be counted against the performance standard proposed in this document. When the CFIA has confirmed that the relevant feed and/or environmental release assessments have been completed, the file will be considered active and Food Directorate will issue the Letter of No Objection to the applicant in a timely manner.

4.0 Withdrawal of a submission

Applicants may withdraw their submission at any time during the submission management process.

5.0 Re-filing a submission

Any submission that has been withdrawn by the applicant or closed by the Food Directorate may be re-filed at a later date without prejudice. It will be re-entered into the submission management process as a new submission and assigned a new tracking number. When re-filing a submission, the applicant should make reference in the cover letter to the previous submission number and ensure that any previously identified deficiencies have been addressed.

6.0 Confidentiality

The Food Directorate is committed to upholding its obligations with respect to confidentiality in accordance with the Access to Information Act and will keep submitted information confidential to the extent permitted by law. For more information on Access to Information, please visit the website on Access to Information and Privacy published by the Treasury Board of Canada Secretariat.

7.0 Dispute resolution

Staff within the Food Directorate will make every effort to identify, manage, and resolve disputes at the level at which they take place and to be available to discuss concerns regarding submissions before disputes arise.

Stakeholders may also seek assistance from Health Canada's alternate dispute resolution services offered by the Food and Drugs Act Liaison Office (FDALO). The FDALO is available as a neutral and impartial dispute resolution resource for stakeholders when they experience problems with the regulatory process or with the application of policies or procedures related to the Food and Drugs Act.

8.0 Single window into the Food Directorate submission management process

The Submission Management and Information Unit (SMIU) is the single access point for filing food additive, infant formula and novel food submissions with the Food Directorate.

The SMIU ensures that the necessary administrative information has been included in each submission and that all the components of the data package are included, and that the status of pre-market submissions are tracked as they move through the submission management process. This information is used by the SMIU to communicate with applicants regarding non-technical matters, including status updates, and to ensure that the Food Directorate is meeting its performance standards.

9.0 Performance standards

The Food Directorate is committed to providing timeliness, predictability and transparency in the submission management process. The Directorate's performance standard is estimated taking into account evaluation practices by other food regulatory agencies in like-minded jurisdictions and considering the current resourcing of the Directorate. The performance standard is aimed to provide a Decision to the applicant within 410 calendar days of receiving a food additive, infant formula or novel food submission 90 percent of the time.

The Food Directorate will continue to monitor performance against these targets and strive to improve timelines of pre-market assessments.

Appendix 1: Brief overview of the timelines of a submission