Proposal to modify the List of Permitted Supplemental Ingredients to permit 30% juice in certain caffeinated beverages

Notice of Proposal – List of Permitted Supplemental Ingredients
Reference Number: P-SIS-25-02
July 25, 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 the 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 modification to the conditions of use for an already approved supplemental ingredient, or a modification to the permitted supplemented food categories by filing a pre-market submission for supplemented foods with the Food and Nutrition Directorate. Health Canada uses this pre-market approval process to determine whether the scientific data support the safety of the proposed change to the relevant list. 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.

Current status

As set out in item 1 of the List of Permitted Supplemented Food Categories, carbonated or non-carbonated water-based beverages (and their concentrates and mixes to be reconstituted, if applicable) are permitted to contain supplemental ingredients. The use of caffeine in this food category is permitted when it is used in accordance with the conditions of use set out in columns 2 to 5 of item C.1 in Part IV of the List of Permitted Supplemental Ingredients (List).

Of relevance to this proposal are two caffeine entries for foods belonging to the category listed in item 1, with the following applicable conditions of use:

1. Caffeine entry (1):
   • A maximum amount of 150 p.p.m. (equivalent to 150 mg/L) caffeine in non-carbonated water-based beverages ^{Endnote 1}.
   • Products must not contain, singly or in combination, 25% or more juice, purée, pulp or nectar, as consumed.
   • Products must not include the word “juice”, “purée”, “pulp” or “nectar” on the label other than as required in the list of ingredients.
2. Caffeine entry (2):
   • A maximum amount of 400 p.p.m. (that is, 400 mg/L) caffeine, with no more than 180 mg caffeine per serving, in carbonated and non-carbonated water-based beverages containing added caffeine and a total amount of caffeine from all sources of more than 150 p.p.m ^{Endnote 2}.
   • Products must not contain, singly or in combination, 25% or more fruit and/or vegetable juice ^{Endnote 3}, purée, pulp or nectar, as consumed.
   • Products must not include the word “juice”, “purée”, “pulp” or “nectar” on the label other than as required in the list of ingredients.

Issue

Health Canada's Food and Nutrition Directorate received a pre-market submission to modify the List of Permitted Supplemental Ingredients to permit no more than 30% juice in foods belonging to the category listed in item 1 of the List of Permitted Supplemented Food Categories, permitted to contain added caffeine as a supplemental ingredient and a total caffeine content from all sources of more than 150 p.p.m.

The Food and Nutrition Directorate also identified that specific terminology used in column 5 of caffeine entry (1) (Part IV: Other Supplemental Ingredients, C.1) in the List of Permitted Supplemental Ingredients does not align with the phrasing in column 5 for caffeine entry (2). Additionally, in the French version of the List, the wording for the corresponding entry for caffeine (2) is not an accurate translation of the English version. As a result, minor inconsistencies in the indicated caffeine entries are present in the English and French versions of the List.

Rationale

Health Canada's Food and Nutrition Directorate has assessed the impact of the requested change to the condition of use, as described above, on the overall safety of supplemented foods permitted to contain caffeine. No concerns were identified regarding a limit of no more than 30% juice content in foods belonging to the category listed in item 1 of the List of Permitted Supplemented Food Categories, containing added caffeine and a total amount of caffeine from all sources of more than 150 p.p.m.

The proposal to permit no more than 30% juice content will not affect other conditions of use, including the prohibition of juice-related terms on the label (except when required in the list of ingredients). This condition of use continues to restrict beverages with added caffeine from displaying the terms “juice”, “purée”, “pulp” or “nectar” on the product label, including in the common name. This measure maintains the intent to prevent these products from being represented as foods that may be perceived as healthier.

The proposed modification to the percentage of juice content would be applied to caffeine entry (2) as requested, and extended to caffeine entry (1). This prevents discrepancies in applying different limits and ensures that beverages with lower caffeine content are not subject to more stringent conditions of use than beverages with high caffeine content.
While the above proposed change to the percentage of juice content does not modify the other caffeine conditions of use, Health Canada is proposing revisions to the wording of the condition of use statement in column 5, paragraph (b) to address inconsistencies in the original caffeine entries and to ensure alignment between the English and French versions in the List of Permitted Supplemental Ingredients (as described in the Proposed modification section below).

The proposed modifications to the indicated caffeine entries do not introduce new regulatory requirements and therefore do not require product reformulation or labelling changes. The proposal to modify the condition of use for caffeine to permit no more than 30% juice in the applicable foods from item 1 of the List of Permitted Food Categories is a permissive change. Regulated parties may choose to adopt the new maximum limit or to continue to comply with the original limit of less than 25% juice content. Manufacturers that opt for the new limit must ensure that any resulting changes to their product, such as changes in the nutrient composition, are reflected in corresponding changes to the Supplemented Food Facts table.

Proposed modification

Based on the rationale outlined above, Health Canada proposes to modify the List of Permitted Supplemental Ingredients to permit a total juice content of no more than 30% in the corresponding products described in column 2 for caffeine entries (1) and (2).

Additionally, Health Canada proposes addressing the identified inconsistencies and translation discrepancy in column 5 for caffeine entries (1) and (2) as follows:

• Correction to the French translation of the condition of use statement in caffeine entry (2) to include “…jus de fruits et/ou de légumes…”.
• Revised wording for the condition of use statement in caffeine entry (1) to include “…fruit and/or vegetable juice, …” for consistency with caffeine entry (2). This change would also be reflected in the French version of the List.

The proposed modifications to the English List are shown in the table below (in bold). The proposed modifications to the French List are shown in the corresponding “Avis de proposition”.