Health Canada recently published a notice providing clarity on the use of certain ingredients in supplemented foods.
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Recently, Health Canada published a notice entitled "Information on the use of certain ingredients in foods including supplemented foods" (the "Notice"). The Notice intends to provide clarity on the use of certain ingredients, previously permitted on a product-specific basis under the terms of temporary marketing authorizations ("TMAs"), in food products, including supplemented foods.
Background – Regulations amending the Food and Drugs Regulations and Cannabis Regulations (Supplemented foods)
The Notice follows the enactment of the Regulations amending the Food and Drugs Regulations and Cannabis Regulations (Supplemented foods) on July 21, 2022 (the "Supplemented Foods Regulations"). We reported on the Supplemented Foods Regulations in our previous article, Canada Introduces Regulatory Framework for Supplemented Foods.
Prior to the coming into force of the Supplemented Foods Regulations, TMAs were issued by Health Canada permitting supplementation of individual products with specific ingredients. These TMAs were based on product-specific assessments that considered the use of ingredients, in accordance with established conditions of use or existing provisions of the Food and Drugs Regulations.
Following the enactment of the Supplemented Foods Regulations, ingredients proposed as supplemental ingredients undergo pre-market assessment that, if successful, will result in the listing on the List of Permitted Supplemental Ingredients (the "List") and a rule of general application. In other words, once these ingredients are added to the List, they may be used as supplemental ingredients under the conditions set out in the List for specific supplemented food categories. Because the rule is for general application, the assessments must consider the background dietary exposure to the ingredient and whether the proposed conditions of use would permit its safe consumption in one or more supplemented food categories.
The Notice
Prior to the Notice, the status of ingredients previously authorized under the TMA framework, but not present on the List, was unclear. The Notice addresses this gap by issuing a table which provides information relevant to the use of these ingredients as conventional food ingredients and in supplemented foods, along with any data gaps that must be filled to establish safety as proposed supplemental ingredients.
In some cases, an ingredient has a history of safe use in food and is permitted as an ingredient (including in supplemented foods) on that basis. These ingredients may be used in all foods, including supplemented foods, according to the relevant provisions of the Food and Drug Regulations. Examples include certain food additives and flavourings. If use is proposed at levels higher than those with a history of safe use or if an ingredient has no such history, the ingredient would be considered a supplemental ingredient and require a pre-market assessment by Health Canada.
Some ingredients have already been assessed by Health Canada for use as supplemental ingredients and added to the List. These ingredients may be added to supplemented foods subject to the maximum amounts and other conditions of use set out in the List. As outlined in the Notice, certain ingredients are still undergoing the process of assessment.
Finally, for certain ingredients, Health Canada found that publicly available data were insufficient to establish acceptable conditions for use as supplemental ingredients. Consequently, Health Canada has not permitted their use as such, and noted that additional data must be submitted with a pre-market request to add them to the List.
As a reminder, modifications to the List can be sought by filing a pre-market submission to Health Canada. If the outcome of the assessment supports the proposed change, Health Canada will post a Notice of Proposal for public feedback. If no new scientific information is provided that would require revisions to the proposed change, the List will be amended, and a Notice of Modification reflecting the changes will be published on Health Canada's webpage. The successful pre-market assessment will result in a rule of general application.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
