Health Canada’s proposal to enable the use of green tea extract (EGCG/catechins) as a supplemental ingredient in foods

Notice of Proposal - List of Permitted Supplemental Ingredients
Reference Number: NOP/ADP SI-001
July 28, 2022

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 green tea extract 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.

Green Tea extract has a history of safe use as a flavouring in food. The continued use of green tea extract as a food flavouring ingredient is the responsibility of the food seller to ensure that the sale of a food containing green tea extract does not contravene section 4 of the Food and Drugs Act.

For food sellers who choose to use green tea extract as a supplemental ingredient, the Food Directorate concluded that information related to the safety of standardized green tea extract supports its safe use in supplemented foods provided levels of use do not exceed intakes equivalent to 300 mg epigallocatechin gallate (EGCG) and 600 mg total catechins ^{Footnote 1} per day, do not exceed 100 mg EGCG and 200 mg total catechins 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 green tea extract (EGCG/catechins) ^{Footnote 2} 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	Green tea extract (EGCG/catechins)	Foods belonging to a category listed in the List of Permitted Supplemented Food Categories	100 mg EGCG, 200 mg total catechins	(a) All products containing Green tea extract (EGCG/catechins) 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) Products containing Green tea extract (EGCG/catechins) providing more than 60 mg of EGCG or 120 mg catechins per serving require the additional cautionary statement: "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 an extract of Camellia sinensis, including dry extract, fluid extract, tincture, decoction and infusion obtained via water and/or food grade organic solvent extraction techniques that is standardized to an EGCG content of 40% - 50% and a total catechin content of 70% - 80%, and which contains not more than 5% caffeine. Any organic solvents used must be in accordance with the List of Permitted Carrier or Extraction Solvents. EGCG is epigallocatechin gallate, also known as epigallocatechin-3-gallate. For products containing Green tea extract (EGCG/catechins) as a supplemental ingredient, EGGC and total catechins derived from green tea extract must be declared under the "Supplemented with" heading, with the amount expressed in milligrams separately for both EGCG and total catechins, in the Supplemented Food Facts table.

Rationale

Health Canada's Food Directorate completed a premarket 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 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). Green tea extract is standardized according to the content of EGCG and total catechins. The primary catechin in green tea is EGCG and while EGCG is predominantly found in green tea it is also present in other commonly consumed foods, such as certain fruits and nuts. Green tea extract is associated with liver damage; however, these adverse effects are observed at high intakes and under certain conditions.

Adverse effects would not be expected as a result of the use of green tea extract in supplemented foods based on Health Canada's safety assessment and in consideration of the conditions that are set out for such use (as in the table above). These conditions are based on the available evidence that supports that standardized green tea extract can be safely consumed as a supplemental ingredient on a daily basis at levels consistent with a cup of brewed green tea. Daily intakes of green tea extract (EGCG/catechins) consistent with a cup of brewed tea are well tolerated in clinical studies, are not associated with reports of allergic reactions, and do not pose any toxicological or nutritional concerns. Health Canada is therefore proposing to enable the use of this supplemental ingredient as shown in the table.

Health Canada's summary of the safety assessment for the use of green tea extract as a supplemental ingredient

Other Relevant Information

Part B of the Regulations do not set out specifications for the use of green tea extract (EGCG/catechins) 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 green tea extract (EGCG/catechins) 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, 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 (NOP/ADP SI-001)" in the subject line of your e-mail. Health Canada is able to consider information received by October 3, 2022, 75 days from the date of this posting.