Notice of modification to the list of permitted supplemental ingredients to enable the use of iodine in supplemented foods

Notice of modification – List of permitted supplemental ingredients
Reference number: NOM/ADM SI-005
September 8, 2023

On this page

• Summary
  • Rationale
• Notification – Summary of comments and Health Canada’s responses
• Implementation and enforcement
• Contact information

Summary

The Food and Drugs Act provides the authority to set out requirements and conditions for foods sold in Canada. The Regulations amending the Food and Drug Regulations and the Cannabis Regulations (Supplemented Foods), hereinafter referred to as the “Supplemented Foods Regulations”, came into force on July 21, 2022, and set out the regulatory requirements specific to supplemented foods. These regulations are found in the Food and Drug Regulations (FDR) (Part B, Division 29 and other applicable provisions); four documents are incorporated by reference into the FDR; and Subsection 102(2) of the Cannabis Regulations.

Permitted supplemented food categories and permitted supplemental ingredients along with their conditions of use are set out in the List of Permitted Supplemented Food Categories and List of Permitted Supplemental Ingredients, respectively, incorporated by reference into the FDR, as amended from time to time and published on the Canada.ca website.

Health Canada has concluded that information related to the safety of iodine supports its use in supplemented foods provided the label declared amount does not exceed 76 µg per serving of stated size for caffeinated energy drinks and 189 µg per serving of stated size for supplemented foods other than caffeinated energy drinks, and all other labelling requirements are met.

Since this is a supplemental ingredient that was not previously permitted for use in Canada, Health Canada published a Notice of proposal to enable the use of iodine as a supplemental ingredient in foods on November 9, 2022, which was open for public comment for 75 days. No new scientific information was submitted to the Department in response to this notice. Since the conclusions of the evaluation remain as described in the publication, Health Canada has enabled the use of iodine as a supplemental ingredient in foods by adding the entry shown in the table below to the List of Permitted Supplemental Ingredients.

Modification to the List of permitted supplemental ingredients

Supplemental Ingredient		Conditions of Use
Item No.	Column 1 Description	Column 2 Permitted in	Column 3 Maximum Amounts and Units Per Serving of Stated Size	Column 4 Cautionary Statements Required on the Label	Column 5 Other
Part II: Mineral Nutrients
4	Iodine	(1) Foods belonging to a category listed in the List of Permitted Supplemented Food Categories, excluding foods belonging to the category listed in item 1 that contain added caffeine and a total amount of caffeine from all sources of more than 150 p.p.m.	(1) 189 µg	(1) (a) If the amount of iodine declared on the label is more than 6 µg per serving, the following cautionary statement is required: “Not recommended for those under 14 years old” (b) If the amount of iodine declared on the label is more than 37 µg per serving, the following additional cautionary statements are required: Do not [eat/drink] on the same day as any other supplemented foods with [the same supplemental ingredients/ (name specific ingredients)]; and “Do not [eat/drink] more than X serving(s) per day”, where X is a number of servings that provides a daily amount of iodine, based on the amount declared on the label, that does not exceed the maximum amount	(1) None Specified
		(2) Foods belonging to the category listed in item 1 of the List of Permitted Supplemented Food Categories that contain added caffeine and a total amount of caffeine from all sources of more than 150 p.p.m.	(2) 76 µg	(2) None Specified	(2) None Specified

Rationale

Health Canada’s Food Directorate completed a safety assessment of iodine. The Department concluded that information on dietary and nutritional exposure supports the safety of iodine for its use as a supplemental ingredient. Therefore, the Department has enabled the use of iodine as a supplemental ingredient in accordance with the conditions of use outlined in the table above.

Notification – Summary of comments and Health Canada’s responses

Health Canada received two (2) comments in response to the Notice of proposal to enable the use of iodine as a supplemental ingredient in foods published on November 9, 2022.

The comments provided pertained to the caution statements that are required with the addition of iodine as a supplemental ingredient in supplemented foods. The stakeholder agreed with the position of Health Canada with respect to cautionary labelling; therefore, no response was required.

Implementation and enforcement

The above modification came into force September 8, 2023, the day it was published in the List of Permitted Supplemental Ingredients.

The Canadian Food Inspection Agency is responsible for the enforcement of the Food and Drugs Act and its associated regulations with respect to foods.

Contact information

Health Canada's Food Directorate is committed to reviewing new scientific information regarding the safety of permitted supplemental ingredients, including iodine. Anyone wishing to submit an inquiry or new scientific information on the use of this supplemental ingredient may do so in writing, by regular mail or electronically. If you wish to contact the Food Directorate electronically, please use the words "Iodine (NOM SI-005)” in the subject line of your e-mail.

For additional information, please contact:

Supplemented Foods:
Bureau of Nutritional Sciences, Food Directorate
251 Sir Frederick Banting Driveway
Tunney’s Pasture, A.L.: 2203E
Ottawa, Ontario  K1A 0K9
E-mail: supplementedfoods-alimentssupplementes@hc-sc.gc.ca