Notice of proposal to enable the use of phosphatidylserine (soy) as a supplemental ingredient in foods

Notice of proposal – List of Permitted Supplemental Ingredients

Reference Number: NOP/ADP SI-003

September 7, 2022

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Summary

Supplemental ingredients are regulated in Canada under the Supplemented Foods Regulations, which are set out in Division 29, Part B of the Food and Drug Regulations (Regulations).  The “List of Permitted Supplemental Ingredients” is incorporated by reference in the 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 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. 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.

Health Canada’s Food Directorate has assessed phosphatidylserine for use 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 under Temporary Marketing Authorizations.

The Food Directorate concluded that information related to the safety of phosphatidylserine derived from soy supports its safe use in supplemented foods provided levels of use do not exceed intakes of 300 mg per day, do not exceed 300 mg per serving, and that certain other compositional and labelling requirements are met; as set out in the table below. Therefore, Health Canada proposes to enable the use of phosphatidylserine (soy)Footnote 1 by adding the entry shown in the table below to the List of Permitted Supplemental Ingredients.

Proposed 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 IV: Other Supplemental Ingredients

1.2

Phosphatidylserine (soy)

Foods belonging to a category listed in the List of Permitted Supplemented Food Categories

300 mg

  1. All products containing phosphatidylserine (soy) require the cautionary statements:
    1. “For Adults only (18 years of age or older)”;
    2. “Not recommended for pregnant or breastfeeding women”; and
    3. “Do not [eat/drink] on the same day as any other supplemented foods or supplements with [the same supplemental ingredients/(name specific ingredients)]”.
  2. If the amount of phosphatidylserine (soy) declared on the label is more than 60 mg per serving, the following cautionary statement is required:
    1. “Do not [eat/drink] more than X serving(s) per day”, where X is a number of servings that provides a daily amount of phosphatidylserine (soy), based on the amount declared on the label, that does not exceed 300 mg.

Phosphatidylserine made from food grade soy lecithin

Rationale

Health Canada’s Food Directorate completed a premarket safety assessment of phosphatidylserine.  The assessment concluded that information related to chemistry, nutrition, microbiology, toxicology, and allergenicity supports the safety of phosphatidylserine (soy) for its use as a supplemental ingredient. 

Phosphatidylserine is a glycerophospholipid that is naturally present in a wide variety of commonly consumed foods. It is composed of the amino acid serine, as well as phosphate, two fatty acids, and glycerol. When phosphatidylserine is produced from soy lecithin, the fatty acids composing phosphatidylserine will mainly be linoleic and palmitic fatty acids. Phosphatidylserine (soy) 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 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 phosphatidylserine as a supplemental ingredient, please contact our publications office or send an e-mail to publications-publications@hc-sc.gc.ca  with the subject heading "HPFB BNS Phosphatidylserine (soy) EN- 2022".

Other relevant information

Part B of the Regulations do not set out specifications for the use of phosphatidylserine (soy) as a supplemental ingredient; however, the proposed conditions of use as set out in Column 5 of the table above identify compositional requirements that must be met and which, in part, form the basis of Health Canada's determination that phosphatidylserine (soy) is safe for use as a supplemental ingredient.

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 will be 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 “Phosphatidylserine (soy) (NOP SI-003)” in the subject line of your e-mail.  Health Canada is able to consider information received by November 20, 2022, 75 days from the date of this posting.

Footnote 1

This naming convention denotes that phosphatidylserine used as a supplemental ingredient must be derived from soy.

Return to footnote 1 referrer

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