In Canada, infant formulas and human milk fortifiers are regulated under the Food and Drug Regulations, Part B, Division 25 (B.25.019). Health Canada defines infant foods as food to be consumed by persons under the age of one year of age. There are two categories of infant food according to Health Canada: human milk substitutes and human milk fortifiers. Both products need to be comprehensively evaluated by Health Canada before they can enter the Canadian market to ensure they meet safety and nutritional adequacy standards set out by the regulations.

In April 2021, Health Canada published a finalized regulatory framework amending the requirements for human milk fortifiers. The amendment details new definitions, as well as substitutions and some exemptions and considerations in the regulations, see details in the link. Health Canada outlined transitional provisions in the regulations, to which manufacturers can still submit pre-market approvals during the interim period.

All submissions must go through the Food Directorate’s Pre-Market Submission Management Process for Food Additives, Infant Formulas, and Novel Foods. To get your infant food onto the Canadian market during the transition period, there are a few key steps to follow. Below is a summary of the steps to follow for success.

New Infant Formula Submissions

1. It is optional to arrange a pre-submission consultation meeting with Health Canada in preparation for application.
2. Ensure all administrative activities are finalized. Including a written cover letter, a submission title, contact information, electronic copies of the submission and applicable reference numbers are documented.
3. A finalized application dossier should be assembled including the following information:
   • Product name, name and address of the principal place of business of the manufacturer, list of ingredients and quantities.
   • Specifications for nutrient, microbiological, and physical quality for the ingredients and the new infant formula.
   • Details of quality control procedures respecting the testing of the ingredients and the new infant formula.
   • Details of the manufacturing process and quality control procedures used throughout the process.
   • Results of tests carried out to determine the expiration date of the new infant formula.
   • Evidence is relied on to establish that the new infant formula is nutritionally adequate to promote acceptable growth and development in infants when consumed in accordance with the directions for use.
   • Description of the type of packaging to be used.
   • Directions for use.
   • The written text of all labels (bilingual-coloured mockups are preferred), including package inserts, is to be used in connection with the new infant formula.
   • Name and title of the person who signed the submission and the date of signature.
4. Submit the application through the Food Directorate’s Pre-Market Submission Management Process for Food Additives, Infant Formulas, and Novel Foods. This is an online portal.
5. Health Canada will then make acknowledgements and perform an application screening. Following that Health Canada will communicate any gaps, if applicable.
6. Once any gaps have been dealt with, Health Canada will begin the safety and efficacy review.
7. The deficiencies response period begins, where any additional questions are answered, and any further information is provided.
8. Health Canada then issues a Letter of No Further Questions and the product can be sold in Canada.

The difference between the submission for infant formula and human milk fortifiers is that for human milk fortifiers, a scientific rationale for the formulation must also be submitted in the dossier.

Major changes to already approved infant formulas or human milk fortifiers must also be submitted for approval by Health Canada.

Additional steps and approvals are considered when trying to introduce a new ingredient (novel or non-novel) in infant formulas or human milk fortifiers.

For personalized assistance and further guidance on getting your infant formula or human milk fortifier on the Canadian market, contact us today. Explore a tailor-made solution to navigating the regulatory pathways and securing approval for your product.