Proposal to modify the use of caffeine as a supplemental ingredient

• Notice of Proposal – List of Permitted Supplemental Ingredients
• Reference Number: P-SIS-25-01
• March 7, 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 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

Caffeine is permitted as a supplemental ingredient in products belonging to specific supplemented food categories when used in accordance with the conditions set out in the List of Permitted Supplemental Ingredients (the List). Health Canada has evaluated the safety of caffeine and developed a recommended maximum daily intake (RMDI) for the general adult population of 400 mg per day, a limit that has international concurrence. The acute limit for caffeine consumption by the healthy adult population is generally considered to be 200 mg per serving.

Of particular relevance for this proposal, caffeine is currently permitted for use as a supplemental ingredient in "Chocolate confectioneries, sweet chocolate confectioneries, and milk chocolate confectioneries belonging to the category listed in item 7 of the List of Permitted Supplemented Food Categories", excluding one bite confections sold individually.

When products belonging to this category contain caffeine in amounts not exceeding 56 mg per serving, no cautionary statements are required, provided the product meets labeling and packaging requirements set out in the List, including individually wrapped servings and a "contains caffeine" statement on the principal display panel of the label.

If the caffeine content exceeds 56 mg per serving, the following conditions apply: the product must not be represented for physical performance, the caffeine content must not exceed 100 mg per serving, servings or portions must be individually wrapped, the total amount of caffeine per package must not exceed 400 mg, and the label must include the following statements 1) "high caffeine content", 2) "Not recommended for those under 14 years old, pregnant or breastfeeding women or individuals sensitive to caffeine". If the caffeine content per serving exceeds 79 mg, an additional cautionary statement "Do not [eat/drink] more than X serving(s) per day" must also be included, where X is a number of servings that provides a daily amount of caffeine, based on the amount declared on the label, that does not exceed 400 mg.

Issue

Health Canada's Food and Nutrition Directorate received a pre-market submission seeking modification to the List to allow the use of synthetic caffeine (caffeine anhydrous) in "gummies with a texture spanning from hard to soft", a category currently not permitted to contain caffeine as a supplemental ingredient. The requested food falls under the category of hard, soft, or semi-soft candies (excludes one bite confections that are sold individually), which is the category set out in item 6 of the List of Permitted Supplemented Food Categories.

The petitioner agreed to applying the same conditions for caffeine use as those for foods listed in item 7 of the List of Permitted Supplemented Food Categories (that is, chocolate confectioneries), as described above. Given that the requested foods (that is, candies) and those listed in item 7 (that is, chocolates) are expected to have similar consumption patterns, the same conditions for caffeine use could be applied. However, the RMDI considers caffeine intake from all sources, and there is no current requirement for a recommendation against combining high-caffeine supplemented foods with other caffeine sources.

Therefore, to prevent excessive caffeine intake, it is proposed that the statement "Do not [eat/drink] on the same day as any other source of caffeine" be required for all solid supplemented foods, including candies, but also chocolate confectioneries, protein-isolate- and cereal-based bars, and chewing gums, when the food contains more than 56 mg caffeine per serving (or more than 56 mg per multiple-serving pre-packaged product, in the case of chewing gums).

Rationale

The Food and Nutrition Directorate received a request to modify the List, as described above. No safety concerns were identified regarding the use of caffeine in foods belonging to the category listed in item 6 of the List of Permitted Supplemented Food Categories under the same conditions as already permitted for caffeine as a supplemental ingredient in foods listed in item 7 of the same list, provided that products containing more than 56 mg of caffeine carry the label statement "Do not [eat/drink] on the same day as any other source of caffeine". The additional label statement is meant to caution consumers against consuming these products and other sources of caffeine on the same day, so to prevent excessive caffeine intake in respect of the RMDI.

The same statement should appear on the label of the other high caffeine content solid supplemented foods for the same reason.

Proposed Modification

In light of the Food and Nutrition Directorate's conclusion that information related to the safety of caffeine supports its use as a supplemental ingredient in the foods of interest, Health Canada proposes to enable the use of caffeine as a supplemental ingredient in foods listed in item 6 of the List of Permitted Supplemented Food Categories, and to update the cautionary statements for the already permitted solid supplemented food categories (that is, chocolate confectioneries, protein-isolate- and cereal-based bars, and chewing gums) with high caffeine content by modifying the List of Permitted Supplemental Ingredients as shown in the table below (in bold).

Other relevant information

Labelling considerations

The modifications to items (4), (6), and (7) in Column 4 of the table shown above represent a new labelling requirement for the use of caffeine as a supplemental ingredient in foods set out in Column 2.

Implementation and enforcement

The proposed modification will come into effect the day on which it is published in the List of Permitted Supplemental Ingredients. However, given that the proposed changes related to the addition of the new cautionary statement fall within the scope of the joint Health Canada-Canadian Food Inspection Agency Food Labelling Coordination policy, Health Canada is proposing to give industry until January 1, 2028 to implement the labelling change for products affected by the modification to items (4), (6), and (7).

Stakeholders will be informed of the changes to the List via a Notice of Modification that will be available on the Food and Nutrition Directorate's Notices of Proposal and Notices of Modification webpage. Stakeholders interested in staying informed of Notices of proposals (consultations) and modifications, can also register for Consultation and Stakeholder Information Management System (CSIMS), a stakeholder registry used to communicate Health Canada stakeholder and public engagement activities.

The Canadian Food Inspection Agency is responsible for the enforcement of the Food and Drugs Act and its associated regulations with respect to foods.

Consultation

Anyone wishing to submit comments on the Proposal to modify the use of caffeine as a supplemental ingredient may do so by sending an email to the Food and Nutrition Directorate's Food Incorporation by Reference Unit at food.ibr-ipr.aliments@hc-sc.gc.ca by May 21, 2025, 75 days from the date of this posting. Please use the words "caffeine (P-SIS-25-01)" in the subject line of the email.