Modification to correct the French version of the List of permitted supplemental ingredients for green tea extract and vitamin A
Notice of modification – List of Permitted Supplemental Ingredients
Reference number: M-SIS-24-02
July 12, 2024
Background
Supplemented foods, including supplemental ingredients, are regulated in Canada under Part B of the Food and Drug Regulations (FDR).
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 FDR.
The above lists may be modified following a petitioner's 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. In addition, Health Canada may also make minor modifications to the above lists, such as changes to correct errors, improve clarity, achieve consistency in terms used in the lists, or to align the lists with amendments of Part B of the FDR. These minor changes do not alter the permitted uses of supplemental food categories or supplemental ingredients.
Issue
Health Canada's Food and Nutrition Directorate identified that certain terms and wording used in the green tea extract entry (Part IV: Other supplemental ingredients, G.1) published in the French version of the List of Permitted Supplemental Ingredients on January 11, 2024, are not an accurate translation of the English version and do not align with French terminology in similar entries. One minor editorial error was also identified for the vitamin A (beta-carotene, retinol) entries.
Rationale for action
Some of these translation discrepancies pertain to cautionary statements required on the labels of supplemented foods containing green tea extract (EGCG/catechins) as a supplemental ingredient. As manufacturers rely on the cautionary statements published in the list to prepare their product labels, Health Canada has promptly addressed the translation inconsistencies in French. These revisions are intended to reduce the risk of consumers encountering incorrect label information, and to prevent manufacturers from printing labels with inconsistent wording for cautionary statements and other supplemented food terminology.
Therefore, Health Canada has modified the French version of the List of Permitted Supplemental Ingredients by:
- Correcting the French reference to the List of Permitted Supplemented Food Categories to Liste des catégories autorisées d'aliments supplémentés
- Revising the wording for the caution statements in column 4 to align with the French text used in similar entries
- Revising "…sous la rubrique 'Supplémenté par' du tableau des compléments alimentaires" to "…sous la rubrique 'Supplémenté en' du tableau des renseignements sur les aliments supplémentés"
These changes aim to better align with the French used in similar entries and to more clearly convey the intended conditions of use for green tea extract. Note that the revisions apply only to the French version of the green tea extract entry, as shown below (in bold in this Notice to illustrate the revisions).
| Ingrédient supplémentaire | Conditions d'utilisation | ||||
|---|---|---|---|---|---|
| N° d'article | Colonne 1 Description |
Colonne 2 Autorisé dans |
Colonne 3 Teneur maximale et unités par portion indiquée |
Colonne 4 Mises en garde qui doivent figurer sur l'étiquette |
Colonne 5 Autre |
| Partie IV : Autres ingrédients supplémentaires | |||||
| G.1 | Extrait de thé vert (EGCG/catéchines) | Aliments appartenant à une catégorie figurant dans la Liste des catégories autorisées d'aliments supplémentés | 100 mg d'épigallocatéchine gallate (EGCG) et 200 mg de catéchines au total | (a) Tous les produits doivent comporter les mises en garde suivantes :
(b) Si la quantité dépasse 60 mg d'EGCG ou 120 mg de catéchines par portion, la mise en garde supplémentaire suivante est requise :
|
L'extrait de thé vert (EGCG/catéchines) est un extrait sec, un extrait liquide, une teinture, une décoction et une infusion de Camellia sinensis et : (a). doit être obtenu à l'aide d'un solvant d'extraction utilisé conformément à la Liste des solvants de support ou d'extraction autorisés ou de l'eau; et (b). doit contenir au moins 40 % d'épigallocatéchine gallate (EGCG) et 70 % de catéchines au total; et (c). ne doit pas contenir plus de 50 % d'EGCG, 80 % de catéchines au total et 5 % de caféine. La quantité en milligrammes d'EGCG et la quantité totale de catéchines dérivées de l'extrait de thé vert doivent être déclarées, chacune séparément, sous la rubrique « Supplémenté en » du tableau des renseignements sur les aliments supplémentés. |
Editorial Modifications
One minor grammatical correction has also been made throughout the French version of Part I, column 5, in both entry 7 (vitamin A, beta-carotene), and entry 8 (vitamin A, retinol) of the List of Permitted Supplemental Ingredients. "Supplémentée en" has been revised to "Supplémenté en" in all instances it appears in column 5 for both entries.
Implementation and enforcement
The above modification came into force July 12, 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.
On July 21, 2022, the regulations for supplemented foods came into force. Manufacturers or distributors of supplemented foods with a valid market authorization were provided a transition period until December 31, 2025. This transition period allows them to maintain market access while making the necessary changes to comply with the requirements of the new regulations.
A transition period until December 31, 2025, is also provided to manufacturers and distributors that printed labels for supplemented foods containing green tea extract (EGCG/catechins) before this modification to the List of Permitted Supplemental Ingredients came into force. However, supplemented foods having entered the market after July 20, 2022, without a valid market authorization, must continue to immediately comply with all other applicable requirements of the regulations for supplemented 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 green tea extract and vitamin A. Anyone wishing to submit an inquiry or new scientific information on the use of these supplemental ingredients may do so by regular mail or email. If you wish to contact the Food and Nutrition Directorate by email about green tea extract (EGCG/catechins) and/or vitamin A, please use the words "Green tea extract (EGCG/catechins)/vitamin A [M-SIS-24-02]" 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
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