Modification to the List of permitted supplemental ingredients to enable the use of grape seed extract (oligomeric proanthocyanidins)
Notice of modification – List of Permitted Supplemental Ingredients
Reference number: M-SIS-25-01
January 16, 2025
Background
Supplemented foods, including supplemental ingredients, are regulated in Canada under Part B of the Food and Drug Regulations (FDR).
Permitted supplemented food categories, as well as 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 FDR.
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 and Nutrition 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 and Nutrition 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 and Nutrition Directorate identified grape seed extract (oligomeric proanthocyanidins) for further assessment as a supplemental ingredient since it was present in product(s) previously eligible for sale as food under Temporary Marketing Authorizations.
Rationale for action
Health Canada's Food and Nutrition Directorate completed a safety assessment of grape seed extract. The assessment concluded that information related to chemistry, nutrition, toxicology, and allergenicity supports the safety of grape seed extract for use as a supplemental ingredient in supplemented foods.
The grape seed extract that Health Canada has permitted, as a result of the aforementioned safety assessment, is derived from the seeds of grapes, Vitis vinifera L. (family: Vitaceae), and is standardized according to the content of oligomeric proanthocyanidins. The available toxicological and clinical evidence supports the safe consumption of grape seed extract as a supplemental ingredient by the general population of healthy adults, up to the equivalent of 100 mg oligomeric proanthocyanidins on a daily basis. Proanthocyanidins are naturally present in a wide variety of commonly consumed foods, and background consumption patterns of proanthocyanidins were also taken into consideration in establishing the conditions of use.
Health Canada has concluded that grape seed extract (oligomeric proanthocyanidins)Footnote 1, when used as a supplemental ingredient in accordance with the conditions of use outlined in Part IV of the List of Permitted Supplemental Ingredients (and as listed in the table below), does not pose any toxicological, nutritional or allergenic concerns.
For additional information, refer to the Summary of Health Canada's safety assessment of grape seed extract for use as a supplemental ingredient.
Consultation
Health Canada published a Notice of proposal to enable the use of grape seed extract (oligomeric proanthocyanidins) as a supplemental ingredient in foods on August 16, 2022, which was open for public comment for 75 days. Health Canada received comments from one industry stakeholder during the consultation period, which ended on October 29, 2022. These comments are summarized below. Health Canada's response follows each comment.
Summary of stakeholder comments and Health Canada responses
Comment on grape seed extract used as a flavouring
Stakeholder comment: Request that Health Canada confirm grape seed extract can continue to be used in ordinary foods as a food flavouring ingredient, without the grape seed extract automatically being assumed to be added as a supplemental ingredient or the food automatically being regulated as a supplemented food.
Health Canada's response: Health Canada acknowledges that grape seed extract has recognized use as a flavouring. Health Canada is not regulating grape seed extract as a supplemental ingredient if (1) it is used solely as a flavouring in food (that is, to impart a flavour to the food); (2) is used in a manner (for example, level) that is otherwise consistent with a flavouring use; and (3) is not represented as a supplemental ingredient.
However, if grape seed extract is represented as a supplemental ingredientFootnote 2, then it must be used according to the conditions set out in the List of Permitted Supplemental Ingredients even if it is used in a manner consistent with a flavouring.
The food industry is responsible for ensuring that the continued use of grape seed extract as a flavouring does not contravene section 4 of the Food and Drugs Act (FDA).
Outcome: Proposal maintained.
Comment on grape seed extract used as a conventional food ingredient
Stakeholder comment: Based on its Generally Recognized as Safe (GRAS) status in the United States, grape seed extract can be safely used in foods and beverages without requiring any special considerations. Therefore, Health Canada should allow the use of grape seed extract as an ordinary food ingredient/additive, and not designate/regulate it as a supplemental ingredient.
Health Canada's response: The United States Food and Drug Administration has issued a letter indicating the Agency had no further questions about a notifier's conclusion that grape seed extract was GRAS for use as an antioxidant in certain juices, beverages and beverage mixes under the intended conditions of useFootnote 3, and a similar letter about another notifier's conclusion that grape seed extract was GRAS for use in various foods as an antioxidant or antioxidant and emulsifier, depending on the food systemFootnote 4.
Anyone interested in using grape seed extract as either an antioxidant (preservative) or an emulsifier in foods sold in Canada should contact the Food and Nutrition Directorate's Bureau of Chemical Safety (bcs-bipc@hc-sc.gc.ca) for further information. Grape seed extract used for such technical functions in a food may be regulated as a food additive, and there currently are no food additive provisions for grape seed extract.
Regarding the use of grape seed extract as an "ordinary food ingredient", the main constituent of grape seed extract (that is, proanthocyanidins) is already consumed regularly in the diet as part of many foods. The publicly available safety data and the application of standard risk assessment practices do not support additional consumption – on top of what is consumed in the diet – other than as a supplemental ingredient, which requires conditions of use (as put forth in the List of Permitted Supplemental Ingredients) to ensure safety and to prevent overconsumption.
Outcome: Proposal maintained.
Comments on overconsumption, maximum use levels, mandatory cautionary statements
Stakeholder comment: Health Canada's proposed approach is for an ingredient used in foods, not a prescription drug where overconsumption can pose a substantive health risk. 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 grape seed extract (oligomeric proanthocyanidins) regarding maximum use levels and cautionary statements related to consumption, when used as a supplemental ingredient, are based on the outcome of an evaluation that reviewed publicly available safety data and applied standard risk assessment practices. This stakeholder comment did not specify which good manufacturing practices the food 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: The cautionary statements "Do not [eat/drink] on the same day as any other supplemented foods or supplements with grape seed extract (oligomeric proanthocyanidins)", "For adults only (18 years of age or older)", and "Not recommended for pregnant or breastfeeding women" are overly conservative. Health Canada should 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 food products of interest to industry while mitigating the health concern about certain ingredients being overconsumed or consumed by sensitive subpopulations, consistent with the approach the Department uses for supplemented foods.
The cautionary statement "Do not [eat/drink] on the same day as any other supplemented foods or supplements with grape seed extract (oligomeric proanthocyanidins)" is intended to prevent excessive intake of proanthocyanidins as a result of grape seed extract having been added to food as a supplemental ingredient, given proanthocyanidins naturally occur in the diet and could also be consumed from supplements (that is, natural health products).
The cautionary statements "For Adults only (18 years of age or older)" and "Not recommended for pregnant or breastfeeding women" are intended to prevent consumption of grape seed extract (oligomeric proanthocyanidins) by these sensitive subpopulations when it has been added to food as a supplemental ingredient, and are necessary because of the following:
- No developmental toxicology studies meeting international standards for toxicological testing were identified in the publicly available literature to support the safety of grape seed extract, used as a supplemental ingredient, for consumption by children, adolescents under 18 years of age, or pregnant or breastfeeding individuals;
- No clinical studies were identified in the publicly available literature to support the safety of grape seed extract, used as a supplemental ingredient, for consumption by children, adolescents under 18 years of age, or pregnant or breastfeeding individuals; and
- The concern relates to polyphenol (for example, proanthocyanidin) consumption by children, adolescents and pregnant individuals because these sensitive subpopulations are especially susceptible to developing iron deficiency, and polyphenols can interfere with iron absorption.
The paucity of toxicological and clinical data in children, adolescents under the age of 18, and pregnant or breastfeeding individuals – in addition to known concerns related to polyphenol consumption in these sensitive subpopulations – supports the requirement of the aforementioned cautionary statements for the use of grape seed extract (oligomeric proanthocyanidins) as a supplemental ingredient.
Outcome: Proposal maintained.
Stakeholder comment: If Health Canada persists in regulating grape seed extract as a supplemental ingredient, there should be a base range of use allowed (that is, up to a certain level) before any of the proposed "Cautionary Statements Required on the Label" outlined in column 4 of the "Conditions of Use" are required. Comprehensive consultations with the food industry should occur before finalizing what such a base range and cautionary statement trigger threshold should be.
Health Canada's response: Regarding the use of a "base range" of grape seed extract, the main constituent of grape seed extract (that is, oligomeric proanthocyanidins) is already consumed regularly in the diet as part of many foods. The publicly available safety data and the application of standard risk assessment practices do not support additional consumption (that is, a "base range") – on top of what we consume in the diet – other than as a supplemental ingredient, which requires conditions of use (as put forth in the List of Permitted Supplemental Ingredients) to ensure safety and to prevent overconsumption.
Outcome: Proposal maintained.
Comment on labelling declaration
Stakeholder comment: Request for clarification on how to appropriately declare grape seed extract, specifically its constituents, in the Supplemented Food Facts table (SFFt). Would the declaration in the "Supplemented with" section be: "Oligomeric proanthocyanidins XX mg"?
Health Canada's response: The declaration for grape seed extract under the "Supplemented with" heading in the SFFt would appear as follows, and would have a similar look and feel to the declarations of fat and carbohydrates in the upper part of the SFFt. This will help to ensure that consumers are aware that oligomeric proanthocyanidins is the constituent of interest for grape seed extract. Furthermore, as a maximum level has been set for oligomeric proanthocyanidins, the level of this constituent will be clearly labelled.

Figure 1 : Descriptive text
There are 4 lines of text within the figure. Left justified on the first line is the ingredient name in English, Grape seed extract, followed by a forward slash and the ingredient name in French, Extrait de pépins de raisin. The word "raisin" continues on the second line directly beneath "Grape".
Indented on the next line under raisin is the English constituent name, Oligomeric proanthocyanidins, followed by a forward slash. Indented on the next line, directly beneath "Oligomeric proanthocyanidines", is the French constituent name, Proanthocyanidines oligomériques, followed by a placeholder ## to indicate the amount of grape seed extract (in milligrams) and the letters mg in lowercase.
Stakeholder comment: Health Canada should 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: Health Canada's proposal to enable the use of grape seed extract (oligomeric proanthocyanidins) as a supplemental ingredient in foods indicated that products that have a valid authorization for market access will be allowed a transition period, after the coming into force of the regulations, that ends December 31, 2025. This transition period allows market access to continue for these products and provides time for the food industry to make the necessary changes to comply with the regulatory requirements for supplemented foods.
Outcome: Proposal maintained.
Modifications to the List of Permitted Supplemental Ingredients
Since the conclusions of the safety evaluation remain as described in the Notice of Proposal, Health Canada has permitted the use of grape seed extract (oligomeric proanthocyanidins) as a supplemental ingredient in supplemented foods by adding the entry as shown in Part IV of the List of Permitted Supplemental Ingredients. Minor modifications have been made to the grape seed extract listing wording in the Notice of Proposal to align with similar entries in the list. For example, in column 4 (b), the term "daily" has been revised to "per day" in the cautionary statement. These changes do not alter the permitted uses of the supplemented food categories or the supplemental ingredient.
Consequential modifications
As a result of the recent publication of the Modification to the Lists of Permitted Food Additives as part of the modernization of Part B of the Food and Drug Regulations on December 18, 2024, the title of the incorporated by reference document "List of Permitted Carrier or Extraction Solvents" has been updated to "List of Permitted Solvents". Therefore, references to this list title in the List of Permitted Supplemental Ingredients have been updated in the new item G.1 (grape seed extract (oligomeric proanthocyanidins)) as shown below, and in item G.2 (green tea extract (EGCG/catechins)).
Supplemental ingredient | Conditions of use | ||||
---|---|---|---|---|---|
Item no. | Column 1 Description i |
Column 2 Permitted in |
Column 3 Maximum amounts and units per serving of stated size ii |
Column 4 Cautionary statements required on the label iii, iv |
Column 5 Other |
Part IV: Other supplemental ingredients | |||||
G.1 | Grape seed extract (oligomeric proanthocyanidins) | Foods belonging to a category listed in the List of Permitted Supplemented Food Categories | 100 mg oligomeric pro-anthocyanidins | (a) All products containing grape seed extract (oligomeric proanthocyanidins) require the cautionary statements:
(b) If the amount of oligomeric proanthocyanidins declared on the label is more than 20 mg per serving, the following additional 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 oligomeric proanthocyanidins, based on the amount declared on the label, that does not exceed 100 mg. |
Grape seed extract (oligomeric proanthocyanidins) is a dry extract, fluid extract, tincture, decoction, or infusion of Vitis vinifera L seeds. and: (a) must be obtained using an extraction solvent used in accordance with the List of Permitted Solvents or water; and (b) must contain at least 70% oligomeric proanthocyanidins; and (c) must not contain more than 90% oligomeric proanthocyanidins. The amount in milligrams of oligomeric proanthocyanidins from grape seed extract must be declared under the "Supplemented with" heading in the Supplemented Food Facts table. |
i, ii, iii, iv The footnote numbers i, ii, iii and iv are included in the column headings to indicate that additional information for each column is available in the List of Permitted Supplemental Ingredients. However, the details are omitted here, as no revisions have been made to the footnotes. |
Other relevant information
Grape seed extract is not regulated as a supplemental ingredient if it is used solely as a flavouring in food (that is, to impart a flavour to the food), is used in a manner (for example, level) that is otherwise consistent with a flavouring use, and is not represented as a supplemental ingredient. However, if grape seed extract is represented as a supplemental ingredientFootnote 2, then it must be used according to the conditions set out in the List of Permitted Supplemental Ingredients even if it is used in a manner consistent with a flavouring. The food industry is responsible for ensuring that the use of grape seed extract as a flavouring in food does not contravene section 4 of the FDA.
Characteristics of the grape seed extract that Health Canada has permitted for use as a supplemental ingredient are set out as conditions in Column 5 of the List of Permitted Supplemental Ingredients (as shown in the table above). Column 5 specifies what grape seed extract is, how it is obtained, and its minimum and maximum oligomeric proanthocyanidin content. These conditions, in part, form the basis of Health Canada's determination that grape seed extract is safe for use as a supplemental ingredient in supplemented foods.
Implementation and enforcement
The above modification came into force January 16, 2025, the day it was published in the List of Permitted Supplemental Ingredients.
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, since the coming into force of the regulations, until December 31, 2025. The transition period allows the food industry continued market access and provides time to make the necessary changes to comply with the requirements of the regulations for supplemented foods (for additional information, refer to Supplemented foods: Regulations and compliance).
The Canadian Food Inspection Agency is responsible for the enforcement of the FDAand its associated regulations with respect to foods.
Contact information
Health Canada's Food and Nutrition Directorate is committed to reviewing new scientific information on the safety of permitted supplemental ingredients, including grape seed extract (oligomeric proanthocyanidins). 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 and Nutrition Directorate by email about grape seed extract (oligomeric proanthocyanidins), please use the words "Grape seed extract (M-SIS-25 -01)" in the subject line of your email.
Supplemented Foods
Bureau of Nutritional Sciences
Food and Nutrition Directorate
251 Sir Frederick Banting Driveway
Postal locator 2203E
Tunney's Pasture
Ottawa ON K1A 0K9
Email: supplementedfoods-alimentssupplementes@hc-sc.gc.ca
Endnotes
- Footnote 1
-
This naming convention denotes that grape seed extracts used as a supplemental ingredient be a standardized preparation of oligomeric proanthocyanidins.
- Footnote 2
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Section 5 of the Food and Drugs Act (in part) prohibits a person from selling or advertising a food in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety.
Available from:
https://laws-lois.justice.gc.ca/eng/acts/f-27/page-2.html - Footnote 3
-
Agency Response Letter GRAS Notice No. GRN 000125. August 18, 2003. From L.M. Tarantino to A.J. Shrikhande.
Available from:
https://wayback.archive-it.org/7993/20171031032510/https:/www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/ucm153942.htm - Footnote 4
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Agency Response Letter GRAS Notice No. GRN 000124. August 1, 2003. From L.M. Tarantino to S.J. Anderson.
Available from:
https://wayback.archive-it.org/7993/20171031022646/https:/www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/ucm153940.htm
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