Health Canada’s notice of modification to enable the use of L-alpha-glycerylphosphorylcholine in supplemented foods
Notice of modification – List of permitted supplemental ingredients
Reference Number: [NOM/ADM SI-006]
September 20, 2023
On this page
- Summary
- 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 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 L-alpha-glycerylphosphorylcholine (also called alpha GPC or choline alfoscerate) supports its safe use in supplemented foods, as a source of supplemental choline, provided the levels of use do not exceed the previously established maximum levels for choline, and that other labelling requirements are met.
Since this is a source of choline that was not previously permitted for use in Canada, Health Canada published a Notice of proposal to enable the use of L-alpha-glycerylphosphorylcholine as a supplemental ingredient in foods on April 17, 2023, 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 L-alpha-glycerylphosphorylcholine as a source of supplemental choline in supplemented foods by revising the entry for choline as shown in the table below 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: Vitamins | |||||
| 2 | Choline | (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) 1171 mg | (1) (a) If the amount of choline declared on the label is more than 122 mg per serving, the following cautionary statement is required: "Not recommended for those under 14 years old" (b) If the amount of choline declared on the label is more than 234 mg 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) 478 mg | (2) None specified | (2) None specified | ||
Rationale
Health Canada's Food Directorate completed a safety assessment of L-alpha-glycerylphosphorylcholine. The assessment concluded that information related to chemistry, nutrition, microbiology, toxicology, and allergenicity supports the safety of L-alpha-glycerylphosphorylcholine for its use as a source of supplemental choline in supplemented foods.
Notification – Summary of comments and Health Canada's responses
Health Canada did not receive any comments in response to the Notice of proposal to enable the use of L-alpha-glycerylphosphorylcholine as a supplemental ingredient in foods published on April 17, 2023.
Implementation and enforcement
The above modification came into force September 20, 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 L-alpha-glycerylphosphorylcholine. 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 "Alpha GPC (NOM SI-006)" 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
Page details
- Date modified: