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If you are bringing a new infant formula to Canada, or making a major change to one already on the market, Health Canada must review it before it can be sold or advertised. That review starts with an infant formula submission to the Food and Nutrition Directorate. QSS prepares and files these premarket submissions for infant formula manufacturers in Canada and internationally. Since 2007.
Start My Infant Formula Submission
An infant formula premarket submission is the file a manufacturer sends to Health Canada's Food and Nutrition Directorate before selling or advertising an infant formula in Canada. It is required for a new infant formula and for an existing formula that has undergone a major change, such as a new manufacturing facility, a new macronutrient source or a new ingredient. The requirements are set out in Division 25 of the Food and Drug Regulations (FDR) and apply whether the formula is made in Canada or abroad.
In practice, the submission brings together the full ingredient list and quantities, ingredient and finished product specifications, the manufacturing process and HACCP-based control plan, stability data supporting the expiry date, evidence of nutritional adequacy and the proposed label text. Some major changes also call for growth and tolerance study data. Health Canada reviews the file for safety and nutritional adequacy and, when it has no further questions or objections, issues a letter for the sale of the formula in Canada.
Health Canada applies a service standard of 90 days of active review time for most infant formula submissions, counted from receipt of a complete package. Time spent waiting for the manufacturer to answer an information request does not count toward that standard, so gaps in stability data, specifications or nutritional evidence are a common source of delay. QSS helps you go into that review with a complete, well-organized file.
We confirm whether your product needs a submission as a new infant formula or a major change, or whether the change qualifies as minor. Health Canada strongly encourages a pre-submission meeting, and we prepare the briefing materials and questions and support you through it.
We review your formulation, specifications, manufacturing and quality control records, stability data and nutritional adequacy evidence against Division 25 and Health Canada’s submission guide, and identify what needs to be added before filing.
We compile the complete premarket submission, including the cover letter, verification checklist, formulation comparison table for major changes, manufacturing process and HACCP-based plan, and label text, organized the way Health Canada’s guide sets out.
We file the submission with the Food and Nutrition Directorate’s Submission Management and Information Unit as your authorized third party, and manage correspondence with Health Canada through to the decision.
If Health Canada asks for clarification or additional data during the review, we help you prepare a clear, complete response so the file can keep moving.
If your formula contains an ingredient that first needs novel food or new infant food ingredient approval, we flag it early and map the pathway. We also review label text, warnings and directions for use against Canadian requirements, with French translation support.
Health Canada regulatory experience since 2007, with 3,500+ companies supported across 74 countries and 60,000+ projects delivered.
Strategy, data review, compilation and filing handled in one engagement, with information request support if Health Canada needs more.
Gaps identified before filing, when they are easier to address than during an active review.
Support for manufacturers outside Canada, with related services for Canadian labelling, French translation and food import.
A clear view of where your submission stands at each stage, from preparation through Health Canada's decision.
An infant formula submission is the premarket file a manufacturer sends to Health Canada’s Food and Nutrition Directorate before selling or advertising a new infant formula, or a formula with a major change, in Canada. Health Canada reviews it for safety and nutritional adequacy. When it has no further questions or objections, Health Canada issues a letter for the sale of the formula in Canada.
A submission is required before a new infant formula, or a formula that has undergone a major change, is sold or advertised in Canada. A formula is considered new when it is manufactured for the first time, sold in Canada for the first time, or manufactured for the first time by a particular manufacturer. These requirements are set out in Division 25 of the Food and Drug Regulations. Minor changes are not reviewed by Health Canada, but the manufacturer is responsible for confirming that a minor change does not affect the quality or safety of the product.
Major changes include a new manufacturing facility, a change in processing or packaging, a new macronutrient source, a substantial change in protein, fat or carbohydrate, or the addition of a new ingredient. Each of these requires a premarket submission before the changed formula is sold. When it is unclear whether a change is major or minor, a pre-submission meeting with Health Canada can help settle the question before the product reaches the market.
The submission includes the product and manufacturer details, the full ingredient list with quantities, specifications, quality control testing, the manufacturing process and HACCP-based plan, stability data, evidence of nutritional adequacy, packaging information and the proposed label text. Major change submissions also describe the change, usually with a formulation comparison table. Health Canada asks for a dated cover letter and a completed verification checklist, with documents in English or French, sent by email to the Food and Nutrition Directorate’s Submission Management and Information Unit.
Health Canada applies a service standard of 90 days of active review time for most infant formula submissions, counted from receipt of a complete package. Time spent waiting for the manufacturer to respond to an information request is not counted toward the 90 days. A complete submission at the time of filing is the most practical way to keep the review on track.
Yes. Health Canada’s premarket requirements apply whether the infant formula is manufactured in Canada or abroad. International manufacturers can work with a third party to prepare and file the submission, in which case a Designated Authorization Party Form is included. QSS files infant formula submissions on behalf of manufacturers based outside Canada.
No. A formula sold in Canada for the first time is treated as a new infant formula, even if it is already marketed in the United States or elsewhere, so a premarket submission to Health Canada is required. Information from reviews by other regulators can support the file, but it does not replace Health Canada’s own assessment.
A new ingredient needs its own approval under Division 28 of the Food and Drug Regulations, as a novel food or a new infant food ingredient, before the formula submission can rely on it. Identifying that early lets you plan both steps together. QSS can assess whether an ingredient needs this approval and map the pathway alongside your infant formula submission.
Human milk fortifiers have their own premarket requirements under Division 25. QSS supports human milk fortifier submissions alongside your infant formula work.
View Human Milk Fortifier Submission ServicesA new ingredient may need approval before your formula submission can rely on it. QSS helps you request a novelty determination from Health Canada.
View Novel Food Determination Services