By: Joanna Chudyk, SENIOR REGULATORY AFFAIRS SPECIALIST, email
On November 28, 2023, Health Canada opened a consultation for the proposed changes to modernize Divisions 24 and 25 of the Food and Drug Regulations.
These Divisions have been long overdue for an update. The last major update to Division 24 was in 1995; the addition of Human Milk Fortifiers to Division 25 took place in 2021.
These newest revisions will bring a more flexible and modern approach to regulating these product types.
Divisions 24 and 25 encompass Foods for Special Dietary Use (low-energy diets, formulated liquid diets, and meal replacements/nutritional supplements) and infant formulas. The most notable updates include:
- Compositional requirement changes that are incorporated by reference and reflect the most recent Dietary Reference Intakes (DRI)
- Restructuring of Divisions 24 and 25 to be divided by the risk profile and subpopulation vulnerability, as opposed to the current division by age of the consumers
- Replacement of the term “Foods for Special Dietary Use” with “Foods for a Dietary Purpose”
- Stop-sales provision expansion to all foods under the Foods for Special Dietary Purpose
- Inclusion of foods for dysphagia, fortified beverages for pre- and postoperative recovery, and metabolic products (for example, for galactosemia and dyslipidemia)
- Replace the existing premarket notification process with a premarket authorization before the sale of a new infant formula
- Labelling changes for all products covered under the Foods for Special Dietary Purpose
Currently, Temporary Marketing Authorizations Letters (TMALs) are still being issued for Division 24 products, however, it is unclear how the new regulations will impact the future submissions. The proposed changes are currently open for feedback and no deadline has been set. Compositional requirements for each product type will be available for feedback during Canada Gazette I.
Do you have questions about the consultation? Are you concerned with how these regulations will affect your products? Contact Dell Tech today to help you stay ahead of these changes.
Dell Tech has provided professional, confidential consulting services to the specialty chemical
industry in Canada, the USA, Europe, and Asia for the last 40 years.
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