Information on the use of certain ingredients in foods including supplemented foods

Last updated: 2024-08-15

Health Canada published the Regulations amending the Food and Drug Regulations and Cannabis Regulations (Supplemented foods) in Canada Gazette, Part II on July 20, 2022. These regulations, referred to as the "supplemented foods regulations" specify compositional and labelling requirements for supplemented foods. The List of permitted supplemental ingredients (the List), which is incorporated by reference in the Food and Drug Regulations (FDR), specifies the permitted supplemental ingredients and their conditions of use. Only ingredients used in compliance with their maximum amounts and other conditions of use, as described in the List, are permitted for addition to supplemented foods as supplemental ingredients. Modifications to the List can be sought by filing a pre-market submission to Health Canada. When a submission sufficiently supports the safety of the substance under the proposed conditions of use, then a Notice of Proposal is posted for public comment on Health Canada's webpage. If the proposal is supported, the List will be amended, and a Notice of Modification will be posted on the same webpage.

Ingredients can also be added to foods where there is a history of safe use as a food (e.g., when an ingredient is used in a manner consistent with flavouring use, typically at lower levels). Safety may not have been established for other uses in foods, and thus the same ingredient may require pre-market assessment by Health Canada as a novel food (Division 28. Part B, FDR) or supplemental ingredient (Division 29, Part B, FDR) (e.g., when intended for use at higher levels and/or for representation as a supplemental ingredient).

Prior to the coming into force of the supplemented foods regulations, temporary marketing authorizations (TMAs) were issued by Health Canada for individual products. These temporary authorizations were based on product-specific assessments that considered the use of ingredients in accordance with established conditions of use or existing provisions of the FDR. Now, under the supplemented foods regulations, a successful pre-market assessment will result in a rule of general application, and thus must consider the background dietary exposure to the ingredient and whether the proposed conditions of use would permit its safe consumption in one or more supplemented food categories.

Health Canada wishes to provide clarity on some of the ingredients that were permitted on a product-specific basis under the TMAs. Table 1 provides information relevant to the use of these ingredients as conventional food ingredients, including in supplemented foods, along with any data gaps that exist to establish their safety as proposed supplemental ingredients. Some of these ingredients may be used as food additives or flavourings. When they are not being used as supplemental ingredients, their use will continue to be permitted under the relevant provisions in the FDR, and would be acceptable for use in foods, including supplemented foods, provided they are compliant with the applicable regulatory provisions. The food seller is responsible for ensuring that the sale of a food containing any ingredient does not contravene section 4 of the Food and Drugs Act.

Certain ingredients in Table 1 have been assessed by Health Canada's Food and Nutrition Directorate for use as supplemental ingredients and are in the process of being permitted for use as such. Once these ingredients are added in the List, they may be used as supplemental ingredients under the conditions set out in the List. For certain other ingredients, the publicly available data were found to be insufficient to establish acceptable conditions for use. Consequently, Health Canada has not permitted their use as supplemental ingredients, and additional data must be submitted with a pre-market request to add them to the List.

In addition, Health Canada's List of Contaminants and Other Adulterating Substances and the List of Maximum Levels for Chemical Contaminants in Foods set out the prohibitions and maximum levels for certain substances. Other substances, such as controlled substancesFootnote 1, prescription drugsFootnote 2, and cannabisFootnote 3, are also inappropriate for consumption in food, including supplemented foods.

For more information on a specific ingredient, contact the Food and Nutrition Directorate's Submission Management and Information Unit at smiu-ugdi@hc-sc.gc.ca.

Table 1: Ingredients permitted on a case-by-case basis during the TMA period and information on their use in foods, including supplemented foods, following the coming into force of the supplemented foods regulations
Ingredient History of use as a food ingredient? Permitted as a supplemental ingredient? Comments
Acetyl-L-carnitine/L-carnitine No No

While L-carnitine is naturally present in a variety of foods consumed as part of the diet, and acetyl-L-carnitine is synthesized in the body, neither have a history of use as ingredients added to foods.

Data required for further consideration as a supplemental ingredient, as described in the "Decision on acetyl-L-carnitine/L-carnitine".

Alpha GPC, Choline alfoscerate No Yes A Notice of Modification was published in September 2023 for use of "L-alpha-glycerylphosphorylcholine" as a source of supplemental choline in supplemented foods.
Alpha-lipoic acid No No

While alpha-lipoic acid is synthesized in the body, and it occurs naturally in foods, levels are relatively low and there is no history of use as an ingredient added to foods.

Data required for further consideration as a supplemental ingredient, as described in the "Decision on alpha-lipoic acid".

Ashwagandha root extract, Winter cherry No No Data required for further consideration as a supplemental ingredient, as described in the "Decision on ashwagandha root extract".
Astragalus root extract No No Data required for further consideration as a supplemental ingredient, as described in the "Decision on astragalus root extract".
Calcium fructoborate No No Calcium fructoborate hydrolyzes into boric acid. In 2016, a draft screening assessment was published in Canada Gazette, Part 1 that proposed that boric acid, including its salts and precursors, meets the criteria under paragraphs 64(a) and (c) of the Canadian Environmental Protection Act. Therefore, calcium fructoborate is not appropriate for addition to foods, as described in the "Decision on calcium fructoborate".
Cha de Bugre leaf powder No No This ingredient did not undergo evaluation for use as a supplemental ingredient. A pre-market submission can be made for its consideration as a supplemental ingredient.
Chamomile extract Yes No Aqueous preparations of whole or minimally processed Chamomilla recutita (syn. Matricaria recutita, Matricaria chamomilla) flower consistent with herbal tea have a history of use as food. Extracts of chamomile flower, when prepared and used in a manner consistent with that of a flavouring, have a history of use in foods. However, Health Canada has not determined a maximum level for its safe use as a food ingredient. A product providing more than 1500 mg per day of the equivalent crude quantity of dried chamomile flower may result in a potentially therapeutic level.
Coffee fruit extract (low caffeine) * **

More information is required for Health Canada to make a determination on whether a specific coffee fruit extract has a history of use as a food ingredient.

Coffee fruit extract did not undergo evaluation for use as a supplemental ingredient. A pre-market submission can be made for consideration as a supplemental ingredient.

Damiana leaves Yes No

This ingredient has a history of use in foods when prepared and used in a manner consistent with that of a flavouring. However, Health Canada has not determined a maximum level for its safe use as a food ingredient.

This ingredient did not undergo evaluation for use as a supplemental ingredient. A pre-market submission can be made for its consideration as a supplemental ingredient.

Dandelion extract Yes No Whole or minimally processed dandelion flower, leaf or root have a history of use as food; however, its extracts cannot be considered equivalent. Extracts of the dandelion root, when prepared and used in a manner consistent with that of a flavouring, have a history of use in foods. However, Health Canada has not determined a maximum level for its safe use as a food ingredient.
Glucuronolactone Yes No Generally, levels up to 1200 mg per serving are considered consistent with food use (La Vielle et. al., 2021). However, Health Canada has not determined a maximum level for its safe use as a food ingredient.
Glucosamine hydrochloride (& Glucosamine sulfate) No No Data required for further consideration as a supplemental ingredient, as described in the "Decision on glucosamine hydrochloride and glucosamine sulfate".
Grape seed extract Yes Proposed

This ingredient has a history of use in foods when prepared and used in a manner consistent with that of a flavouring. However, Health Canada has not determined a maximum level for its use as a food ingredient, outside of its use as a supplemental ingredient with corresponding conditions of use.

A Notice of Proposal was published in August 2022 for use of "Grape seed extract (oligomeric proanthocyanidins)" as a supplemental ingredient in supplemented foods under the conditions of use set out in the listing.

Green coffee bean extract (polyphenols) * **

More information is required for Health Canada to make a determination on whether a specific extract has a history of use as a food ingredient.

Green coffee bean extract did not undergo evaluation for use as a supplemental ingredient. A pre-market submission can be made for its consideration as a supplemental ingredient.

Green tea extract Yes Yes

Camellia sinensis, when prepared and used in a manner consistent with that of a flavouring, has a history of use in foods. One cup of green tea may provide approximately 100 mg of epigallocatechin gallate (EGCG) and 200 mg of total catechins (primary constituents of green tea extract). However, Health Canada has not determined a maximum level for its safe use as a food ingredient, outside of its use as a supplemental ingredient with corresponding conditions of use.

A Notice of Modification was published in January 2024 for use of "Green tea extract (EGCG/catechins)" as a supplemental ingredient in supplemented foods under the conditions of use set out in the listing.Footnote 4

Guarana seed extract * **

More information is required for Health Canada to make a determination on whether a specific extract has a history of use as a food ingredient.

Guarana seed extract did not undergo evaluation for use as a supplemental ingredient. A pre-market submission can be made for its consideration as a supplemental ingredient.

Horny goat weed extract No No This ingredient did not undergo evaluation for use as a supplemental ingredient. A pre-market submission can be made for its consideration as a supplemental ingredient.
5-HTP (5-Hydroxytryptophan) No No

While 5-HTP is synthesized in the body, its natural occurrence in foods is limited and there is no history of use as an ingredient added to foods.

Data required for further consideration as a supplemental ingredient, as described in the "Decision on 5-hydroxytryptophan".

Inositol Yes No Generally, levels up to 200 mg per serving are considered consistent with food use (La Vielle et. al., 2021). However, Health Canada has not determined a maximum level for its safe use as a food ingredient.
Maca root extract No No

Maca root powder has a history of use as food; however, its extracts cannot be considered equivalent.

Data required for further consideration as a supplemental ingredient, as described in the "Decision on maca root extract".

Mangosteen rind extract No No

Whole or minimally processed mangosteen fruit has a history of use as food; however, its rind extracts cannot be considered equivalent.

This ingredient did not undergo evaluation for use as a supplemental ingredient. A pre-market submission can be made for consideration as a supplemental ingredient.

Milk thistle seed extract No Proposed A Notice of Proposal was published in October 2022 for use of "Milk thistle seed extract (silymarin)" as a supplemental ingredient in supplemented foods under the conditions of use set out in the listing.
Panax ginseng root extract Yes No

This ingredient has a history of use in foods when prepared and used in a manner consistent with that of a flavouring, at levels not exceeding 8 mg per day of ginsenosides. However, Health Canada has not determined a maximum level for its safe use as a food ingredient. A product providing more than 8 mg per day of ginsenosides may result in a potentially therapeutic level.

Data required for further consideration as a supplemental ingredient, as described in the "Decision on panax ginseng root extract".

Passionflower extract Yes No

Extracts of aerial parts of passionflower (Passiflora incarnata), when prepared and used in a manner consistent with that of a flavouring, have a history of use in foods. However, Health Canada has not determined a maximum level for its safe use as a food ingredient.

Data required for further consideration as a supplemental ingredient, as described in the "Decision on passionflower extract".

Phosphatidylserine No Yes

While phosphatidylserine is a naturally occurring phospholipid that is part of the diet, significant compositional variations exist based on its source and there is no history of use as an ingredient added to foods.

A Notice of Modification was published in April 2024 for use of "Phosphatidylserine (soy)" as a supplemental ingredient in supplemented foods under the conditions of use set out in the listing.

Pomegranate rind extract No No

Pomegranate fruit arils (seeds) and pomegranate juice have a history of use as foods; however, its rind extracts cannot be considered equivalent.

Data required for further consideration as a supplemental ingredient, as described in the "Decision on pomegranate rind extract".

Quercetin No No

While quercetin is naturally present in a variety of foods that are consumed as part of the diet, it does not have a history of use as an ingredient added to foods.

This ingredient did not undergo evaluation for use as a supplemental ingredient. A pre-market submission can be made for consideration as a supplemental ingredient.

Raspberry seed extract No No This ingredient did not undergo evaluation for use as a supplemental ingredient. A pre-market submission can be made for consideration as a supplemental ingredient.
Resveratrol Yes No

Resveratrol has a history of use as a food ingredient at an intake of less than or equal to 4 mg per day. However, Health Canada has not determined a maximum level for its safe use as a food ingredient.

Data required for further consideration as a supplemental ingredient, as described in the "Decision on resveratrol".

Rhodiola rosea root extract No No Data required for further consideration as a supplemental ingredient, as described in the "Decision on rhodiola rosea root extract".
Schisandra chinensis fruit extract Yes No

Whole or minimally processed schisandra chinensis berries have a history of use as a flavouring in foods. The extract also has a history of use as a food ingredient at levels not exceeding 200 mg per day of the equivalent crude quantity of dried berry. However, Health Canada has not determined a maximum level for its safe use as a food ingredient. Use of the extract that results in an intake of greater than 1200 mg per day of the equivalent crude quantity of dried berry may result in a potentially therapeutic level.

Data required for further consideration as a supplemental ingredient, as described in the "Decision on schisandra chinensis fruit extract".

Siberian ginseng root and/or root extract No No

While siberian ginseng was previously listed as a flavour by the Council of Europe, it was removed from the flavour listing because it was determined to be added for therapeutic purposes only.

Data required for further consideration as a supplemental ingredient, as described in the "Decision on Siberian ginseng root and/or root extract".

L-theanine Yes No

L-theanine has a history of use in foods when used at a level not exceeding 23 mg per day. However, Health Canada has not determined a maximum level for its safe use as a food ingredient. A product providing more than 200 mg per day of L-theanine may result in a potentially therapeutic level.

Data required for further consideration as a supplemental ingredient, as described in the "Information on the use of L-theanine".

Theobromine Yes No

Theobromine occurs naturally in some foods, and has a history of use in foods when prepared and used in a manner consistent with that of a flavouring. However, Health Canada has not determined a maximum level for its safe use as a food ingredient.

Data required for further consideration as a supplemental ingredient, as described in the "Decision on theobromine".

Valerian root extract Yes No

Valerian root extract has a history of use in foods when prepared and used in a manner consistent with that of a flavouring. However, Health Canada has not determined a maximum level for its safe use as a food ingredient.

Data required for further consideration as a supplemental ingredient, as described in the "Decision on valerian root extract".

White tea extract (high caffeine) * **

More information is required for Health Canada to make a determination on whether a specific extract has a history of use as a food ingredient.

An ingredient that has been purified or enriched in a manner that increases its caffeine content compared to the natural ingredient is considered to be "caffeine" as a supplemental ingredient.

White tea extract (polyphenols) * **

More information is required for Health Canada to make a determination on whether a specific extract has a history of use as a food ingredient.

This ingredient did not undergo evaluation for use as a supplemental ingredient. A pre-market submission can be made for consideration as a supplemental ingredient.

White willow bark extract No No

As an ingredient identified for further assessment as set out in Health Canada's Category Specific Guidance for Temporary Marketing Authorization: Supplemented Food, white willow bark extract is currently under evaluation for use a supplemental ingredient. The assessment will consider data available from publicly available information. Results of the assessment will be communicated, when available.

Yerba mate extract * **

More information is required for Health Canada to make a determination on whether a specific extract has a history of use as a food ingredient.

This ingredient did not undergo evaluation for use as a supplemental ingredient. A pre-market submission can be made for its consideration as a supplemental ingredient.

Footnotes

Footnote *

More information is required for Health Canada to make a determination. Certain extracts may have a history of food use as conventional food ingredients (e.g., as a flavouring), depending on how they are prepared and used in the food product. Consultation with Health Canada is recommended for clarification on any specific extract.

Return to footnote * referrer

Footnote **

More information is required for Health Canada to make a determination. These ingredients may be captured/considered as a different ingredient (e.g., caffeine as a supplemental ingredient), depending on how they are prepared and used in the food product. Consultation with Health Canada is recommended for clarification on any specific extract.

Return to footnote ** referrer

Related information

Footnotes

Footnote 1

A substance included in Schedule I, II, III, IV or V of the Controlled Drugs and Substances Act

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**

A drug that is set out in the Prescription Drug List (https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/liste-drogues-ordonnance.html), as amended from time to time, or a drug that is part of a class of drugs that is set out in it

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Footnote 3

As per the Cannabis Act, cannabis means a cannabis plant and anything referred to in Schedule 1 but does not include anything referred to in Schedule 2. As per the Cannabis Regulations, edible cannabis means a substance or mixture of substances that contains or has on it anything referred to in item 1 or 3 of Schedule 1 to the Cannabis Act and that is intended to be consumed in the same manner as food.

Return to footnote 3 referrer

Footnote 4

Modification to correct the French version of the List of permitted supplemental ingredients for green tea extract and vitamin A (https://www.canada.ca/en/health-canada/services/food-nutrition/public-involvement-partnerships/modification-correct-french-version-list-permitted-supplemental-ingredients-green-tea-extract-vitamin-a.html)

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