Notice of Modification to the List of Permitted Supplemental Ingredients to Permit the Use of Green Tea Extract (EGCG/catechins) as a Supplemental Ingredient in Foods

Notice of Modification – List of Permitted Supplemental Ingredients

Reference Number: NOM/ADM SI-007

January 11, 2024

Summary

Supplemented foods, including supplemental ingredients, are regulated in Canada under Part B of the Food and Drug Regulations (Regulations). Ingredients that are permitted for use as supplemental ingredients are set out in the List of Permitted Supplemental Ingredients, which is incorporated by reference in the Regulations. This list sets out the conditions of use for each supplemental ingredient such that the supplemented food may be sold in Canada.

Health Canada's Food Directorate has assessed green tea extract for safety as a supplemental ingredient. The Food Directorate identified green tea extract for further assessment as it was an ingredient that was present in product(s) that were previously eligible for sale as food under Temporary Marketing Authorizations.

The Notice of Health Canada's proposal to enable the use of green tea extract (EGCG/catechins) as a supplemental ingredient in foods was published on July 28, 2022, and was open to the public for comment for 75 days. No new scientific information that changes the outcome of the safety assessment was submitted in response to this Notice of Proposal. Since the conclusions of the assessment remain as described in the Notice of Proposal, Health Canada has permitted the supplemental use of green tea extract (EGCG/catechins)^{Footnote 1} by adding the entry shown in the table below to Part IV of the List of Permitted Supplemental Ingredients.

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
2	Green tea extract (EGCG/catechins)	Foods belonging to a category set out in the List of Permitted Supplemented Food Categories	100 mg epigallocatechin gallate (EGCG) and 200 mg total catechins	(a) All products 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 EGCG in a serving exceeds 60 mg or the amount of total catechins in a serving exceeds 120 mg, the following additional cautionary statement is required: "Do not eat/drink more than X container(s)/serving(s) daily", where X is a number of servings that provides a daily amount of EGCG or catechins that does not exceed 300 mg or 600 mg, respectively.	Green tea extract (EGCG/catechins) is a dry extract, fluid extract, tincture, decoction or infusion of Camellia sinensis and: must be obtained using an extraction solvent used in accordance with the List of Permitted Carrier or Extraction Solvents or water; and must contain at least 40% epigallocatechin gallate (EGCG) and 70% total catechins; and must not contain more than 50% EGCG, 80% total catechins, and 5% caffeine The amount in milligrams of EGCG and total catechins from green tea extract must be declared, each separately, under the "Supplemented with" heading in the Supplemented Food Facts table.

Rationale

Health Canada's Food Directorate completed a safety assessment of green tea extract. The assessment concluded that information related to chemistry, nutrition, microbiology, toxicology, and allergenicity supports the safety of green tea extract (EGCG/catechins) for its use as a supplemental ingredient.

Green tea extract is derived from the dried leaves and buds of a tea herb, Camellia sinensis (L.) Kuntze (Family Theaceae), and is standardized according to the content of total catechins, including the primary catechin EGCG. Green tea extract is associated with liver damage; however, this adverse effect is observed at high intakes and under certain conditions of use. Adverse effects are not expected as a result of the use of supplemental green tea extract when used per the conditions that are set out for such use (as described in the table above). These conditions are based on the available toxicological and clinical evidence that supports that standardized green tea extract can be safely consumed as a supplemental ingredient, on a daily basis, at single-serving levels consistent with a cup of brewed green tea, and up to three cups of brewed green tea (daily maximum), and is in consideration of background consumption patterns. Under the conditions set out, consumption of green tea extract (EGCG/catechins) as a supplemental ingredient does not pose any toxicological or nutritional concerns, and is not associated with reports of allergic reactions.

Therefore, Health Canada has authorized the use of green tea extract (EGCG/catechins) as a supplemental ingredient by adding to the List of Permitted Supplemental Ingredients the new item shown in the above table.

Other Relevant Information

Green tea extract is not regulated as a supplemental ingredient if it is used solely as a flavouring in food, is not represented as a supplemental ingredient, and is used in a manner that provides no more EGCG and total catechins, based on per day consumption of the food, than would be provided by one cup of brewed green tea consumed per day (i.e. up to 100 mg EGCG and 200 mg total catechins per day). However, since there is no minimum level of use required for representing green tea extract as a supplemental ingredient,^{Footnote 2} if green tea extract is represented as a supplemental ingredient, then it must be used according to the conditions set out in the List of Permitted Supplemented Ingredients even if it is used in a manner that provides no more than the aforementioned amounts of EGCG and total catechins. It is the responsibility of the food industry to ensure that the continued use of green tea extract as a flavouring in food does not contravene section 4 of the Food and Drugs Act.

Part B of the Regulations does not set out specifications for the use of green tea extract (EGCG/catechins) as a supplemental ingredient; however, the 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 green tea extract (EGCG/catechins) is safe for use as a supplemental ingredient.

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 pre-market approval process to determine whether the scientific data support the safety of supplemental ingredients in supplemented foods sold in Canada. See the Contact Information section below to request information about the premarket submission process for supplemental ingredients.

Stakeholder Consultation

Health Canada received comments from two industry stakeholders and one consultant in response to the Notice of Health Canada's proposal to enable the use of green tea extract (EGCG/catechins) as a supplemental ingredient in foods.

The comments received are summarized below. Health Canada's response follows each comment.

Summary of comments received:

Green tea extract as an ingredient in foods

Stakeholder's comment: There was concern expressed that green tea extract (EGCG/catechins) was being permitted for use in supplemented foods, and not solely in natural health products.

Health Canada's response: Supplemented foods are prepackaged foods containing one or more added supplemental ingredients, such as vitamins, minerals, amino acids and herbal ingredients, which have historically been marketed as providing specific physiological or health effects. The same ingredients may also be found in natural health products; however, the compositional and labelling requirements for natural health products differ from those for supplemented foods/foods. Supplemented foods are subject to specific compositional and labelling requirements, as well as the relevant requirements for foods, per the Food and Drug Regulations.

Green tea extract used as a flavouring

Stakeholder's comment: Request that Health Canada confirm green tea extract can continue to be used in ordinary foods as a food flavouring ingredient without the green tea 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 green tea extract has recognized use as a flavouring. Health Canada is not regulating green tea extract as a supplemental ingredient if (1) it is used solely as a flavouring in food (i.e., to impart a flavour to the food); (2) it is not represented as a supplemental ingredient; and (3) it is used in a manner that provides no more EGCG and total catechins, based on per day consumption of the food, than would be provided by one cup of brewed green tea consumed per day (i.e. up to 100 mg EGCG and 200 mg total catechins per day).

However, since there is no minimum level of use required for representing green tea extract as a supplemental ingredient,^{Footnote 3} if green tea extract is represented as a supplemental ingredient, then it must be used according to the conditions set out in the List of Permitted Supplemented Ingredients even if it is used in a manner that provides no more than the aforementioned amounts of EGCG and total catechins.

It is the responsibility of the food industry to ensure that the continued use of green tea extract as a flavouring in food does not contravene section 4 of the Food and Drugs Act.

Green tea extract used as a source of caffeine

Stakeholder's comment: Request for confirmation that green tea extract containing more than 5% caffeine, less than 70% total catechins, and less than 40% EGCG can continue to be used in ordinary foods to contribute caffeine to the food without the green tea 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: For a green tea extract to be considered the supplemental ingredient green tea extract (EGCG/catechins) that is the subject of this Notice of Modification, it must meet the compositional criteria described in the listing (e.g., not more than 5% caffeine). A green tea extract that does not meet this compositional criteria cannot be considered the supplemental ingredient green tea extract (EGCG/catechins).

Regarding green tea extracts that do not meet the compositional criteria of green tea extract (EGCG/catechins) that is the subject of this Notice of Modification, their use is subject to multiple considerations. For example, green tea extract has recognized use as a flavouring when used in a manner that is consistent with the description in the comment above. However, a green tea extract that is used primarily to add caffeine to a food (e.g., added in high amounts, or selectively enriched for this constituent) is likely to be considered "caffeine", and the requirements for caffeine as a supplemental ingredient would need to be followed.

For green tea extract (EGCG/catechins) that is the subject of this Notice of Modification, Health Canada also established conditions of use related to polyphenol content for safety reasons. These restrictions should also be considered for the use of green tea extract as a source of the supplemental ingredient caffeine. It is the responsibility of the food industry to ensure that the use of green tea extract as a source of the supplemental ingredient caffeine does not contravene section 4 of the Food and Drugs Act.

Characterization of green tea extract (EGCG/catechins)

Stakeholder's comment: Suggest expanding the description in column 1 to make it explicitly clear that the List entry only applies to green tea extract containing 5% or less caffeine, 70% or more total catechin content, and 40% or more total EGCG content.

Health Canada's response: The requirements for caffeine content and polyphenol content are specifications for green tea extract (EGCG/catechins) as a supplemental ingredient. Column 5 of the List of Permitted Supplemental Ingredients, which is for other conditions of use, is the appropriate column of the List to set out specifications as a condition of use. Column 1 is for identifying the supplemental ingredient.

Entries in the List of Permitted Supplemented Ingredients should be read from left to right. In this manner, the List functions to allow green tea extract as a supplemental ingredient in the supplemented food(s) set out in column 2, provided the conditions set out in columns 3, 4 and 5 are met.

Stakeholder's comment: Clarify whether the comment in "Column 5 Other" means that the EGCG content of green tea extract subject to the List entry must be within a 40‐50% range (i.e., minimum 40% EGCG content and maximum 50% EGCG content).

Health Canada's response: The lower (40%) and upper (50%) limit for EGCG content set out in Column 5 of the List entry is a specification for green tea extract (EGCG/catechins) that is a condition of its use. It must be met for the green tea extract to be used as a supplemental ingredient in supplemented foods.

Stakeholder's comment: Clarify whether the comment in "Column 5 Other" means that the total catechin content of green tea extract subject to the List entry must be within a 70‐80% range (i.e., minimum 70% catechin content and maximum 80% catechin content).

Health Canada's response: The lower (70%) and upper (80%) limit for total catechins content set out in Column 5 of the List entry is a specification for green tea extract (EGCG/catechins) that is a condition of its use. It must be met for the green tea extract to be used as a supplemental ingredient in supplemented foods.

Overconsumption, Maximum use levels, Mandatory cautionary statements

Stakeholder's 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: Health Canada's safety assessment identified a health risk (i.e., liver injury) associated with overconsumption of green tea extract. The conditions Health Canada set for green tea extract (EGCG/catechins) regarding maximum use levels and cautionary statements related to consumption, when used as a supplemental ingredient, are to mitigate this health concern. The stakeholder comment does not specify which good manufacturing practices industry would use that would be effective at mitigating this health concern, 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.

Stakeholder's comment: The cautionary statements "Do not [eat/drink] on the same day as any other supplemented foods or supplements with green tea extract (EGCG/catechins)", "For adults only (18 years of age or older)", and "Not recommended for pregnant or breastfeeding women" are overly conservative. Request 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 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, per the approach for supplemented foods.

The cautionary statement "Do not [eat/drink] on the same day as any other supplemented foods or supplements with green tea extract (EGCG/catechins)" is to prevent excessive intake when used as a supplemental ingredient (i.e., beyond dietary background levels), which is necessary to reduce the risk of liver injury – a major safety concern for green tea extract (and its constituents), based on the available scientific literature.

The cautionary statements "For Adults only (18 years of age or older)" and "Not recommended for pregnant or breastfeeding women" are necessary because of the following:

• the results of an animal study that suggest sensitivity to EGCG during development;
• the possibility of developmental effects related to iron absorption following consumption of polyphenols;
• a clinical study of children and adolescents that did not provide the evidence needed to refute the effects observed in the animal study, nor support that green tea extract used as a supplemental ingredient would be safe for children or adolescents; and
• no clinical studies addressing whether green tea extract as a supplemental ingredient would be safe for consumption while pregnant or breastfeeding.

The developmental sensitivity observed in the animal study, known developmental effects of polyphenols, and insufficient clinical data to refute the concern about sensitivity during development (including in children and adolescents, as well as those who are pregnant or breastfeeding), support the requirement of these cautionary statements for the supplemental use of green tea extract.

Health Claims for green tea extract

Stakeholder's comment: Are health claims allowed for green tea extract? Or would these claims be subject to the regulations for supplemented foods, where one cannot make any health claims due to the presence of a cautionary statement?

Health Canada's response: Regarding the allowance of health claims for supplemented foods when there are cautionary statements present, there are three sections in Part B, Division 29 of the Food and Drug Regulations that are relevant to this topic. These three sections (i.e., B.29.026, B.29.027 and B.29.028) are specifically in respect of nutrient claims; green tea extract (EGCG/catechins) does not meet this criteria.

As with any health claims, they must be substantiated per Health Canada's standards of evidence for health claims for foods, as outlined in the Guidance Documents for Preparing Health Claim Submissions. Consultation with Health Canada's Food Directorate is encouraged to ensure that applicable legislation, regulations and guidelines are followed, or to assist when manufacturers or distributors are uncertain about the status of the claim they are planning to use. Questions regarding health claims can be directed to healthclaims-allegationssante@hc-sc.gc.ca.

Implementation and Enforcement

Stakeholder's comment: Request Health Canada clarify whether the proposal for green tea extract (EGCG/catechins) extends to white tea extract. If it does not, when does Health Canada expect to issue a Notice of Proposal for white tea extract?

Health Canada's response: Health Canada has evaluated the ingredients that were listed in Appendix 2 (List of novel food ingredients eligible for consideration for Temporary Marketing Authorizations) of Health Canada's Category Specific Guidance for Temporary Marketing Authorization: Supplemented Food. White tea extract was not one of the ingredients listed in Appendix 2. Health Canada is prepared to consider a request to evaluate white tea extract as a supplemental ingredient if the request is accompanied by a complete pre-market submission.

Stakeholder's comment: Request for clarification on how to appropriately declare green tea extract, specifically its constituents, in the Supplemented Food Facts table. Would the declaration in the "Supplemented with" section be: "EGCG XX mg; [total] catechins XX mg"?

Health Canada's response: The declaration for green tea extract under the "Supplemented with" heading in the Supplemented Food Facts table (SFFt) would appear as follows, and would have a similar look and feel to those of fat and carbohydrates in the upper part of the SFFt. This will help to ensure that consumers are aware that both EGCG and catechins are constituents of green tea extract. Furthermore, as maximum levels have been set for both EGCG and catechins, the levels for both of these constituents will be clearly labelled.

Green tea extract / Extrait de thé vert
EGCG / GEGC ## mg
Catechins / Catéchines ## mg

Stakeholder's comment: Request 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: The Notice of Health Canada's proposal to enable the use of green tea extract (EGCG/catechins) 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 (refer to the section on "Implementation and Enforcement"). This transition period allows market access to continue for these products and provides time for industry to make the necessary changes to comply with the regulatory requirements for supplemented foods.

Implementation and Enforcement

The above modification came into force January 11, 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.

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 regulations for supplemented foods.

Contact Information

Health Canada's Food Directorate is committed to reviewing new scientific information on the safety in use of any permitted supplemental ingredient, including green tea extract (EGCG/catechins). Anyone wishing to submit an inquiry or new scientific information on the use of any permitted supplemental ingredient may do so in writing, by regular mail or electronically.

Bureau of Nutritional Sciences, Food Directorate
251 Sir Frederick Banting Driveway
Tunney's Pasture, PL: 2203E
Ottawa, Ontario K1A 0K9

E-mail: supplementedfoods-alimentssupplementes@hc-sc.gc.ca

If communicating by e-mail, please use the words "Green Tea Extract (NOM/ADM SI-007)" in the subject line of your e-mail.