Modification to the List of permitted supplemental ingredients to enable the use of phosphatidylserine (soy)

Notice of modification – List of Permitted Supplemental Ingredients

Reference number: M-SIS-24-01
April 18, 2024

Background

Supplemented foods, including supplemental ingredients, are regulated in Canada under Part B of the Food and Drug Regulations (Regulations).

Permitted supplemental 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, which are incorporated by reference into the Regulations.

A petitioner can request that Health Canada approve a new supplemental ingredient, a new condition of use for an already approved supplemental ingredient, or a change to the approved supplemented food categories by filing a supplemental premarket submission with the department's Food Directorate. Health Canada uses this premarket approval process to determine whether the scientific data supports the safety of supplemental ingredients in supplemented foods sold in Canada or supports the safety of the proposed change to the supplemented food categories. Ongoing monitoring by the Food Directorate may also prompt modifications to the Lists based on emerging health risks, new scientific data, or outcomes of health risk assessments.

Issue

The Food Directorate identified phosphatidylserine for further assessment as a supplemental ingredient since it was an ingredient that was present in product(s) that were previously eligible for sale as food under Temporary Marketing Authorizations.

Rationale for action

Health Canada's Food Directorate completed a safety assessment of phosphatidylserine. The assessment concluded that information related to chemistry, nutrition, microbiology, toxicology, and allergenicity supports the safety of phosphatidylserine (soy) in supplemented foods.

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 Part IV of the List of Permitted Supplemental Ingredients.

Health Canada has concluded that information related to the safety of phosphatidylserine made from food grade soy lecithin 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.

For additional information, refer to the Summary of Health Canada's safety assessment of phosphatidylserine for use as a supplemental ingredient.

Consultation

Since food grade soy lecithin is a source of phosphatidylserine that was not previously permitted for use in Canada, Health Canada published a Notice of proposal to enable the use of phosphatidylserine (soy) as a supplemental ingredient in foods on September 7, 2022, which was open for public comment for 75 days. Comments from one industry stakeholder and one member of the public were received during the consultation period, which ended on January 23, 2023. These comments are summarized below. Health Canada's response follows each comment. No new scientific information was submitted to the department resulting from this Notice of proposal. Since the conclusions of the evaluation remain as described in the publication, Health Canada has permitted the use of phosphatidylserine (soy)^{Footnote 1} in supplemented foods by adding the entry as showing in Part IV of the List of Permitted Supplemental Ingredients.

Comment on health claims

Stakeholder comment: A stakeholder requested clarification regarding the acceptability of health claims for products supplemented with phosphatidylserine (soy).

Health Canada's response: Health Canada's Food Directorate assessed the safety of the ingredient for use in supplemented foods. The ingredient's efficacy for any purported health benefit was not evaluated. Thus, no food health claims, including function claims, related to the use of phosphatidylserine (soy) in foods were assessed.

Manufacturers who intend to make health claims related to the use of phosphatidylserine (soy) in food must be aware of the appropriate regulatory requirements. Learn more about food health claims and their regulatory requirements.

Outcome: Proposal maintained.

Comments on overconsumption, maximum amounts, and mandatory cautionary statements

Stakeholder comment: A stakeholder noted that Health Canada's proposed approach is for an ingredient used in foods, not a prescription drug where overconsumption can pose a substantive health risk, and added that the approach needs to recognize that good manufacturing practices can be used to ensure consumers get the food products they are seeking without undue health risk.

Health Canada's response: The conditions Health Canada set for phosphatidylserine (soy) regarding maximum amounts and cautionary statements related to consumption, when used as a supplemental ingredient, are supported by the publicly available/identified safety data and standard risk assessment practices. The stakeholder comment does not specify which good manufacturing practices industry would use that would be effective at mitigating the risk of overconsumption, explain how these practices would be effective in mitigating the risk, nor indicate how Canadian consumers could be assured that all companies would follow such practices.

Outcome: Proposal maintained.

Stakeholder comment: A stakeholder stated that the cautionary statements "For adults only (18 years of age or older)", "Not recommended for pregnant or breastfeeding women", and "Do not [eat/drink] on the same day as any other supplemented foods or supplements with phosphatidylserine (soy)" are overly conservative, and requested that Health Canada remove the proposed labelling requirements, or – in the case of the age-related cautionary statement – modify it to "Not recommended for those under 14 years old", consistent with the statement for other supplemental ingredients.

Health Canada's response: By requiring cautionary labelling, Health Canada is able to accommodate the sale of innovative food products, while mitigating the health concern about certain ingredients being overconsumed or consumed by sensitive subpopulations, per the approach for supplemented foods.

The assessment conducted by Health Canada's Food Directorate evaluated the safety of supplemental phosphatidylserine intake (that is, on top of what is consumed in the diet), and so the cautionary statement related to consumption of multiple products is necessary to prevent excessive intake of phosphatidylserine when used as a supplemental ingredient.

Based on publicly available safety data, the Food Directorate concluded that there is sufficient evidence to permit the use of food supplemented with phosphatidylserine (soy) in the general population aged 18 years or older at a maximum limit of 300 mg/day. Regarding the cautionary statements for sensitive subpopulations, insufficient evidence was identified to support the safe use of phosphatidylserine for children or adolescents under the age of 18 – which is consistent with its conditions of use in natural health products – or for pregnant or breastfeeding adult women.

A proposal to remove or modify labelling requirements would need to be supported by sufficient data; however, no data was provided (or previously identified) to support this request. Therefore, the cautionary statements "For adults only (18 years of age or older)", "Not recommended for pregnant or breastfeeding women", and "Do not [eat/drink] on the same day as any other supplemented foods or supplements with phosphatidylserine (soy)" will remain a requirement.

Outcome: Proposal maintained.

Comment on implementation and enforcement

Stakeholder comment: A stakeholder requested that Health Canada provide a minimum of three years as a transition period for manufacturers to bring products into compliance with the final regulatory requirements.

Health Canada's response: This modification to the List is an enabling measure which authorizes the use of phosphatidylserine (soy) as a supplemental ingredient in supplemented foods. This modification took effect on April 18, 2024, the day it was published in the List of Permitted Supplemental Ingredients.   Since no products subject to the transitional provisions of the Supplemented Food Regulations contain phosphatidylserine (soy), there is no need for a transition period to allow manufacturers or distributors to comply with the corresponding conditions of use set out for this ingredient in the List of Permitted Supplemental Ingredients.

Outcome: Proposal maintained.

Modifications to the List of Permitted Supplemental Ingredients

To improve the clarity and ease of reference for Part IV of the List of Permitted Supplemental Ingredients, the item numbers have changed from strictly numerical to alphanumerical ones. Supplemental ingredients in Part IV will now be listed according to the first letter of the ingredient name, accompanied by an assigned number (for example, C.1 for caffeine), ensuring a more precise and consistent presentation of the current and any new ingredients that may be added in the future. This change only affects the organization of Part IV, and doesn't alter the actual ingredients in the List or their conditions of use.

The new entry for phosphatidylserine (soy) as well as the new alphanumerical item numbers (bold font not used in the List) are included in Part IV of the List of Permitted Supplemental Ingredients, as shown below:

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
C.1	Caffeine	(…)	(…)	(…)	(…)
G.1	Green tea extract (EGCG/catechins)	(…)	(…)	(…)	(…)
P.1	Phosphatidylserine (soy)	Foods belonging to a category listed in the List of Permitted Supplemented Food Categories	300 mg	(a) All products containing phosphatidylserine (soy) require the cautionary statements: "For Adults only (18 years of age or older)"; "Not recommended for pregnant or breastfeeding women"; and "Do not [eat/drink] on the same day as any other supplemented foods or supplements with [the same supplemental ingredients/(name specific ingredients)]". (b) If the amount of phosphatidylserine (soy) declared on the label is more than 60 mg per serving, the following cautionary statement is required: "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
T.1	Taurine	(…)	(…)	(…)	(…)

Other relevant information

Part B of the Regulations does not set out specifications for the use of phosphatidylserine (soy) as a supplemental ingredient; however, Column 5 of the table above identifies 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 in supplemented foods.

Implementation and enforcement

The above modification came into force April 18, 2024, 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 on the safety of permitted supplemental ingredients, including phosphatidylserine (soy). 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 by email about phosphatidylserine (soy), please use the words "Phosphatidylserine (soy) (M-SIS-24-01)" in the subject line of your email.

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