Food Additives - Submission Preparation

Food additive submission

Food additives that can be used in foods sold in Canada are set out in the Lists of Permitted Food Additives. The lists show which foods each additive may be used in, the maximum level of use in each food, and in some cases other conditions of use.

To ask Health Canada to permit a new food additive or to change a condition of use for a food additive that is already permitted, you need to file a food additive submission with Health Canada's Food Directorate.

Anyone can file a food additive submission. The person, company or organization who files the submission is referred to as the "petitioner".

This webpage explains the three types of food additive submission. It also summarizes what to include in a submission and outlines what happens once a submission is filed (the premarket authorization process).

Types of food additive submission

In general, there are three types of food additive submission.

1. Submission for a "new" food additive (other than a food enzyme)

   File this type of submission if the food additive is not currently permitted in Canada.

2. Submission to extend the use of an "already permitted" food additive (other than a food enzyme)

   File this type of submission if the food additive is already permitted in Canada and you want to request one or more of the following changes:

   • New source for the food additive
   • Use the food additive in a food it is not already permitted in
   • New purpose of use for the food additive
   • Change in the maximum level of use for the food additive
   • Change in a condition of use for the food additive

3. Submission for a food enzyme

   File this type of submission if the food enzyme is not already permitted in Canada or if the food enzyme is already permitted and you want to request one or more of the following changes:

   • New source for the food enzyme
   • Use the food enzyme in a food it is not already permitted in
   • Change in a condition of use for the food enzyme

Information to include in a food additive submission

The information to include in a food additive submission is summarized below. Additional details are in "A Guide for the Preparation of Submissions on Food Additives".

There is a checklist for each of the three types of food additive submission to help you ensure your submission is complete. The filled-out checklist must be included with the submission.

If you do not include certain information in the submission, provide a rationale explaining why it is not included. The submission will not be accepted if information is missing and there is no rationale.

If the rationale is insufficient, the Food Directorate may ask you for additional information. If there is a significant deficiency in information the Food Directorate may close the submission. The submission could be closed, for example, if a new toxicology study is needed to obtain the data to address the deficiency.

Premarket authorization process for food additives

Filing a food additive submission starts the premarket authorization process for food additives. There are two main stages to this process:

1. Evaluation of the food additive submission and decision

   A food additive submission that meets the minimum requirements undergoes an evaluation. The evaluation focuses on whether the additive will be safe for use as requested by the petitioner.

   In some cases, the Food Directorate may send a deficiency email to the petitioner regarding potential changes to the requested use of the food additive. For example, if the potential dietary exposure to the food additive would exceed the Acceptable Daily Intake (ADI) for that food additive, the Directorate might ask the petitioner to eliminate one or more food categories from the request or reduce a maximum level of use.

   If the submission passes the evaluation, the Food Directorate decides whether to authorize the use of the food additive. Typically, the Directorate's primary consideration is the result of the safety evaluation.

2. Authorization

   To authorize the use of the food additive, the Food Directorate follows an administrative process to add the new food additive use(s) to the applicable List of Permitted Food Additives on the Government of Canada website. The use of the food additive is permitted once it has been placed on the applicable List.

   For an extension of use of an already permitted food additive, including an already permitted food enzyme, the Food Directorate proceeds with having the new use of the food additive added to the List. On the same day the List is modified, the Directorate publishes a Notice of Modification (NoM) to publicly announce the List has been changed. Canada's international trading partners are informed through a notice to the World Trade Organization (WTO).

   For new food additives, including new food enzymes, the Food Directorate first publishes a Notice of Proposal (NoP) announcing Health Canada's intent to enable (authorize) the use of the new food additive. The NoP usually provides 75 days for anyone to comment on the proposal. Canada's international trading partners are informed of the proposed change through a notice to the WTO.

   If no information is received during the public comment period or from an international trading partner that warrants a substantial change to the proposal, the Food Directorate can then proceed with modifying the applicable List to include the new food additive and announcing the modification through an NoM and a second notice to the WTO.

   Details about the premarket authorization process are in The Food Directorate's Pre-Market Submission Management Process for Food Additives, Infant Formulas and Novel Foods.

Filing a food additive submission

Food additive submission packages 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).

Pre-submission consultations

For information on requesting a pre-submission consultation with the Food Directorate, please see the Pre-submission consultation guidance: Pre-market mandatory submissions for the Food Directorate.

Contact information

Questions about the food additive submission process can be sent by e-mail to the Submission Management and Information Unit at smiu-ugdi@hc-sc.gc.ca.