Health Canada food fortification rules changed on August 20, 2026, with two additions to the Interim Policy on the Use of Expired Interim Marketing Authorizations Related to Food Fortification. A new Appendix D raises the maximum permitted level of vitamin A in term infant formula from 500 International Units per 100 kilocalories to 600 IU per 100 kcal, including overage. A new Appendix C confirms that the corn meal fortification provisions extend to corn masa flour.
Both changes are permissive. Neither creates a new obligation, and neither amends the Food and Drug Regulations. They affect infant formula manufacturers and importers supplying the Canadian market, and producers of tortillas, tortilla chips, and other corn-based foods.
How the interim policy works
Interim marketing authorizations were instruments Health Canada used between 1997 and 2011 to permit nutrient additions that fell outside the Food and Drug Regulations while formal rulemaking proceeded. Ten were issued. The authority to issue them was removed in October 2012 when the Food and Drugs Act was amended to allow the Minister to issue Marketing Authorizations instead.
All ten IMAs expired before final publication in the Canada Gazette, Part II. Health Canada’s position is that the underlying science remains valid and that pulling these products from the market would harm Canadians, including vulnerable subpopulations. The interim policy, first published in March 2017, sets out how that position operates in practice.
The distinction that matters most is this. Foods fortified under the expired IMAs are not in compliance with the FDR. The interim policy does not make them compliant. What it does is direct how the Canadian Food Inspection Agency weighs relative risk when setting compliance and enforcement priorities. Companies are operating under enforcement discretion, not a legal permission.
Vitamin A maximum increased in term infant formula
Health Canada received a submission to raise the maximum level of vitamin A in term infant formula to 600 IU per 100 kcal, completed a safety assessment, and concluded that the available data support the adequacy and safety of the higher level.
Two international references are named in the appendix. The new maximum is consistent with the Codex Alimentarius Infant Formula Standard, CODEX STAN 72-1981, and with the Australia New Zealand Food Standards Code for infant formula products as updated in 2025.
The position holds while Health Canada undertakes regulatory changes to Division 25 of the Food and Drug Regulations, part of a broader modernization of the rules governing foods for special dietary use and foods for infants. Preterm infant formula is not affected, as it falls under a separate expired IMA that already permits up to 1,420 IU of vitamin A per 100 kcal.
Corn masa flour brought under the corn meal IMA
Health Canada received a request in November 2025 to permit folic acid fortification of corn masa flour and has now confirmed that the corn meal provisions extend to it. The rationale is neural tube defect prevention. Folic acid fortification of grain products is an established public health measure in Canada, and mandatory fortification of white flour and enriched cereal grain products has been associated with significant reductions in NTD prevalence. Corn masa flour is used in tortillas and other corn-based foods consumed as staples by some population groups.
Regulatory alignment is the second driver. Folic acid addition to corn masa flour is permitted under United States federal law and became mandatory in California on January 1, 2026. Health Canada states that supporting voluntary fortification in Canada contributes to alignment and reduces the potential for trade disruptions.
Manufacturers taking up the option must meet every other condition in the corn meal IMA, which sets minimum and maximum amounts per 100 g for thiamine, riboflavin, niacin, folic acid, iron, and calcium. Representing a product as enriched requires added thiamine, riboflavin, niacin, folic acid, and iron together.
What this means for your business
For infant formula companies, the practical question is whether to use the additional formulation range. Anyone moving toward 600 IU per 100 kcal should confirm that specifications, stability data, and labelling account for overage within the ceiling, since the maximum includes it. The position should also be treated as provisional, because Division 25 modernization will eventually replace it with prescribed limits that may differ.
For corn masa flour producers and importers, fortification is now available but not required. Companies choosing to fortify should document against the full nutrient table rather than adding folic acid alone, and should confirm supplier specifications match. Quality Smart Solutions supports manufacturers through this kind of review under its Health Canada food compliance services, covering formulation assessment, labelling, and ongoing monitoring of policy changes.
More broadly, any company formulating under an expired IMA is operating in a framework that remains active and revisable. That is worth building into regulatory monitoring rather than treating as settled.
Frequently asked questions
Does the 600 IU maximum apply to all infant formula?
No, and the distinction is easy to miss. Appendix D applies specifically to term infant formula, described in the regulations as human milk substitutes. Preterm infant formula is covered by a separate expired IMA that already permits up to 1,420 IU of vitamin A and 300 IU of vitamin D per 100 kcal.
Is folic acid fortification of corn masa flour now mandatory in Canada?
It is voluntary. The corn meal IMA permits the optional addition of vitamins and mineral nutrients, and Appendix C extends that permission rather than creating a requirement. This differs from California, where corn masa flour fortification became a legal requirement on January 1, 2026.
If products under expired IMAs are not FDR-compliant, what is the actual risk?
The interim policy directs CFIA to account for relative risk when setting enforcement priorities for products meeting the conditions of the expired IMAs. Health Canada has stated it intends to amend the regulatory framework to permit legal sale. Until that happens, companies should document compliance against the IMA conditions carefully, since the conditions themselves are what the policy rests on.
Key Takeaways
- Health Canada revised its fortification interim policy on August 20, 2026, adding Appendix C for corn masa flour and Appendix D for vitamin A in term infant formula.
- The vitamin A maximum in term infant formula rises from 500 IU to 600 IU per 100 kcal, including overage, consistent with Codex STAN 72-1981.
- Corn masa flour may now be fortified under the corn meal IMA on a voluntary basis, subject to all other conditions in that authorization.
- Both positions rest on CFIA enforcement discretion, not on an amendment to the Food and Drug Regulations.
- The vitamin A measure holds while Division 25 of the FDR is modernized. The corn masa clarification is separate and not tied to that work.
Next Steps
This revision to the Health Canada food fortification policy gives two product categories additional formulation range without imposing new obligations. The practical work is confirming that specifications, labelling, and supplier documentation line up with the conditions the policy actually rests on, and tracking the Division 25 modernization that will eventually replace the infant formula position. To review how these changes apply to your formulations, contact Quality Smart Solutions to speak with a regulatory specialist.
