Health Canada's notice of proposal to enable the use of L-alpha-glycerylphosphorylcholine as a supplemental ingredient in foods

Summary

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 Food and Drug Regulations (FDR), and captures substances that may be added to a specified food as a supplemental ingredient. This list also sets out the detailed conditions of use for each supplemental ingredient such that the supplemented food may be sold in Canada.

Health Canada's Food Directorate has assessed L-alpha-glycerylphosphorylcholine (also called alpha GPC or choline alfoscerate) as a supplemental ingredient. This is one of the ingredients the Food Directorate previously identified for further assessment since it was an ingredient that was present in product(s) that were previously eligible to transition to the food regulatory framework from the natural health products regulatory framework under Temporary Marketing Authorizations.

The Food Directorate concluded that information related to the safety of L-alpha-glycerylphosphorylcholine 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 certain other labelling requirements are met; as set out in the table below. Therefore, Health Canada proposes to enable the use of L-alpha-glycerylphosphorylcholine as a source of supplemental choline by modifying the choline entry in the List of permitted supplemental ingredients as shown in the table below (in bold).

Proposed modification to the List of permitted supplemental ingredients

Supplemental Ingredient Conditions of Use
Item No. Column 1 i
Description
Column 2
Permitted in
Column 3 ii
Maximum Amounts and Units Per Serving of Stated Size
Column 4 iii, iv
Cautionary Statements Required on the Label
Column 5
Other
Part I: 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. "Do not [eat/drink] on the same day as any other supplemented foods or supplements with choline, including L-alpha-glycerylphosphorylcholine (alpha GPC)"; and
  2. "Do not [eat/drink] more than X serving(s) per day", where X is a number of servings that provides a daily amount of choline, based on the amount declared on the label, that does not exceed the maximum amount

(1.1) 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

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.

L-alpha-glycerylphosphorylcholine is an esterified form of choline, and once consumed, is converted to choline; therefore, it is considered a source of choline and will be subject to the conditions of use for choline set out in the List of permitted supplemental ingredients. L-alpha-glycerylphosphorylcholine is naturally present in a wide variety of commonly consumed foods, is well tolerated in clinical studies, is not associated with reports of allergic reactions, and does not pose any toxicological or nutritional concerns when used as a source of supplemental choline in accordance with the conditions of use outlined in the table above.

Health Canada is therefore proposing to modify the current choline listing in the List of permitted supplemental ingredients as shown in the table to account for L- alpha-glycerylphosphorylcholine as a source of supplemental choline.

Health Canada has published the summary of the safety assessment for the use of L-alpha-glycerylphosphorylcholine in supplemented foods.

Other relevant information

Part B of the FDR does not set out specifications for the use of L-alpha-glycerylphosphorylcholine as a source of supplemental choline. The sale of all foods is subject to Sections 3 to 7 of the Food and Drugs Act (FDA) and must be in compliance with any applicable divisions under Part B of the FDR, Marketing Authorizations respecting the use of food additives, and regulatory standards administered by the Canadian Food Inspection Agency (CFIA). Manufacturers and distributors of food products are responsible for the safety of their products, and for ensuring that their products are compliant with applicable legislation and regulation.

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 premarket 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.

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.

Under the transitional provisions of the Regulations Amending the Food and Drug Regulations and the Cannabis Regulations (Supplemented Foods), products that have a valid authorization for market access are allowed a transition period after the coming into force of the regulations until December 31, 2025. The transition period allows manufacturers or distributors of supplemented foods continued market access and provides time to make the necessary changes to comply with the requirements of the Supplemented Foods Regulations.

Contact information

For additional information or to submit comments related to this proposal, 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

If communicating by e-mail, please use the words "Alpha GPC (NOP SI-006)" in the subject line of your e-mail. Health Canada is able to consider information received by July 1, 2023, 75 days from the date of this posting.

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