Notice of proposal to enable the use of iodine as a supplemental ingredient in foods- Reference number: NOP/ADP-005
Notice of proposal – List of permitted supplemental ingredients
November 9, 2022
Supplemental ingredients are regulated in Canada under the Regulations Amending the Food and Drug Regulations and the Cannabis Regulations (Supplemented Foods) (hereinafter referred to as the “Supplemented Foods Regulations”). The List of permitted supplemental ingredients is incorporated by reference in the Supplemented Foods Regulations through the definition of “supplemental ingredient” set out in Division 1, Part B of the Regulations and captures substances that may be added to a specific food as a supplemental ingredient. This list also sets out the conditions of use for each supplemental ingredient such that the supplemented food may be sold in Canada. A petitioner can request that Health Canada approve a new supplemental ingredient or a new condition of use for an already approved supplemental ingredient by filing a Supplemental ingredient submission with the Department's Food Directorate. Health Canada uses this premarket approval process to determine whether the scientific data support the safety of supplemental ingredients in foods sold in Canada.
In 2012, Health Canada started regulating Natural Health Products (NHPs) in food-like format as foods instead of as NHPs through the use of Temporary Marketing Authorizations. For the duration of the TMA period, iodine had not been permitted for addition to supplemented foods as a supplemental ingredient. Therefore, there are currently no supplemented foods, including caffeinated energy drinks, that contain iodine as a supplemental ingredient. Health Canada’s Food Directorate has assessed iodine using more recent intake data and has determined that it can be safely be used as a supplemental ingredient in supplemented foods.
The Food Directorate 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 addition to caffeinated energy drinks and 189 µg per serving of stated size for addition to supplemented foods other than caffeinated energy drinks, and that labelling requirements are met; as set out in the table below. Therefore, Health Canada proposes to enable the use of iodine by adding the entry shown in the table below to the List of permitted supplemental ingredients.
|Supplemental ingredient||Conditions of use|
|Item No.||Column 1
Maximum Amounts and Units Per Serving of Stated Size
Cautionary Statements Required on the Label
|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:
|(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|
Health Canada’s Food Directorate completed a safety assessment of iodine. The assessment concluded that information on dietary and nutritional exposure supports the safety of iodine for its use as a supplemental ingredient. Iodine does not pose any safety or nutritional concerns when used as a supplemental ingredient in accordance with the conditions of use outlined in the table above.
Health Canada is therefore proposing to enable the use of this supplemental ingredient as shown in the table.
To obtain an electronic copy of Health Canada’s summary of the safety assessment for the use of iodine as a supplemental ingredient, please contact our publications office or send an e-mail to email@example.com with the subject heading "HPFB BNS Iodine-EN".
Other relevant information
A stakeholder can request that Health Canada approve a new supplemental ingredient or condition of use for an already approved supplemental ingredient by filing a Supplemental Ingredient Submission with the Department's Food Directorate. Health Canada uses this pre-market approval process to determine whether the scientific data support the safety of supplemental ingredients in foods sold in Canada.
Implementation and enforcement
The proposed change will be effective the day on which it is published in the List of Permitted Supplemental Ingredients. This will be announced via a Notice of Modification that will be published on the Government of Canada’s website.
The Canadian Food Inspection Agency is responsible for the enforcement of the Food and Drugs Act and its associated Regulations with respect to foods.
For additional information or to submit comments related to this proposal, please contact:
Bureau of Nutritional Sciences, Food Directorate
251 Sir Frederick Banting Driveway
Tunney’s Pasture, A.L.: 2203E
Ottawa, Ontario K1A 0K9
If communicating by e-mail, please use the words “Iodine (NOP-005)” in the subject line of your e-mail. Health Canada is able to consider information received by January 23, 2023, 75 days from the date of this posting.
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