Health Canada Updates Food Fortification Policy: What Changed in August 2026

August 24, 2026

Policy revised August 2026

On August 20, 2026, Health Canada has revised its Interim Policy on the Use of Expired Interim Marketing Authorizations Related to Food Fortification, introducing two changes that may affect the formulation and Canadian market strategy of certain fortified foods.

The August 2026 update:

extends the existing corn meal fortification framework to corn masa flour; and
increases the acceptable maximum level of vitamin A in term infant formula from 500 IU to 600 IU per 100 kcal, including overage.

Although these changes are narrow in scope, they are particularly relevant to manufacturers, importers, and brands operating in infant nutrition, plant-based beverages, grain products, bakery products, juices, and other fortified food categories.

More broadly, the update highlights an unusual feature of Canadian food regulation. Several fortification permissions, still relied upon by industry, originate from Interim Marketing Authorizations (IMAs) that have expired and were never formally incorporated into the Food and Drug Regulations.

Understanding the latest revision, therefore, requires some context on how these authorizations came to exist and why they continue to influence product compliance today.

What Is an Interim Marketing Authorization (IMA)?

Before 2012, Health Canada used IMAs to permit the sale of certain fortified foods while corresponding amendments to the Food and Drug Regulations were being finalized. In this way, an IMA allowed qualifying products to enter the Canadian market following Health Canada’s scientific assessment, without waiting for completion of the official regulatory amendment process.

Between 1997 and 2011, Health Canada issued ten IMAs covering several fortified food categories, including:

fortified plant-based beverages;
fortified corn meal;
folic acid-fortified goat’s milk;
fortified products resembling cheese;
certain infant formulas and formulated liquid diets;
calcium and vitamin D-fortified orange and orange-tangerine juice; and
vitamin D2 yeast in yeast-leavened bakery products.

In October 2012, amendments to the Food and Drugs Act replaced the IMA authority with the Minister’s authority to issue Marketing Authorizations (MA) for foods. However, the ten existing fortification IMAs had not yet been incorporated into the FDR and subsequently expired before the corresponding regulatory amendments were finalized.

Why Do Expired Interim Marketing Authorizations (IMAs) Still Matter?

Although the IMAs expired, Health Canada had already completed scientific evaluations of the ten fortification proposals and concluded that they were safe and appropriate. Each proposal was also published for consultation, with no stakeholder objections reported. However, because the corresponding amendments were never finalized, foods relying on these expired IMAs are not technically compliant with the FDR as currently written.

To address this regulatory gap, Health Canada established an interim compliance and enforcement policy. Products that fully comply with an applicable expired IMA, including any relevant appendix, may continue to be marketed under Health Canada’s interim enforcement approach while permanent regulatory amendments are developed.

The policy therefore provides a defined pathway for affected products, provided all applicable specifications and conditions are met.

Against this backdrop, the August 2026 revision introduces two notable changes.

What Changed in August 2026 Interim Marketing Authorization (IMA) Update?

Corn Masa Flour Is Now Covered

Health Canada has clarified that the fortification framework established under the expired corn meal IMA also applies to corn masa flour, commonly used to produce tortillas and other corn-based foods.

The change responds to a November 2025 request concerning folic acid fortification and supports greater alignment with the United States, where folic acid may already be added to corn masa flour.

Under Appendix C, manufacturers must comply with the applicable conditions of the original corn meal IMA, including established nutrient levels and requirements for products represented as “enriched.” For folic acid, the permitted range is 0.15 mg to 0.22 mg per 100 g.

For companies marketing products in both Canada and the U.S., the update may support greater formulation alignment. However, products sold in Canada must still meet the applicable Canadian IMA conditions and other relevant regulatory requirements.

Vitamin A Maximum Increased for Term Infant Formula

The second change applies to term infant formula, with Health Canada increasing the acceptable maximum vitamin A level from 500 IU to 600 IU per 100 kcal, including overage.

Health Canada concluded that the higher level is safe and nutritionally adequate following a safety assessment. The revised maximum also aligns with the Codex Alimentarius Infant Formula Standard and the Australia New Zealand Food Standards Code.

The change is an interim measure while Health Canada continues to modernize Divisions 24 and 25 of the FDR, including requirements for foods for infants. Infant formula manufacturers should therefore account for both the revised vitamin A limit and future changes to the broader regulatory framework.

Vitamin D in Plant-Based Beverages Remains Relevant

While the August 2026 update focuses on corn masa flour and infant formula, Appendix B remains important for manufacturers of fortified plant-based beverages.

Health Canada previously revised the policy to allow qualifying fortified plant-based beverages to contain up to 2 µg of vitamin D per 100 mL ready-to-serve, provided they meet all other conditions of the applicable expired IMA.

That change helped align plant-based beverages with Canada’s increased vitamin D fortification requirements for cow’s milk and corresponding permissions for goat’s milk.

However, the higher vitamin D level cannot be considered in isolation. Manufacturers must assess the complete formulation and ensure that the product continues to satisfy all other applicable IMA requirements.

Which Companies Should Review the Updated Interim Marketing Authorization (IMA)?

Given the breadth of the underlying IMAs, the policy is relevant to more than corn masa flour and infant formula manufacturers.

Companies should review the framework if they manufacture, import, reformulate, or launch:

term or preterm infant formula;
corn masa flour and fortified corn meal;
tortillas and related corn-based foods;
fortified soy, oat, almond, rice, and other plant-based beverages;
fortified goat's milk;
formulated liquid diets;
calcium or vitamin D-fortified orange and orange-tangerine juice; or
vitamin D-fortified yeast-leavened bakery products.

The policy is also particularly relevant to U.S. and international brands entering Canada. Although a product may already comply with U.S., European, or other international fortification requirements, those permissions do not automatically carry over to Canada. Nutrient levels, food category, common name, labelling conditions, product representation, and intended population must all be assessed under the Canadian framework prior to market entry.

The Compliance Detail of the Interim Marketing Authorization (IMA) Update Brands Should Not Overlook

Health Canada’s interim policy should not be interpreted as general flexibility to add vitamins or minerals to conventional foods. To fall within the policy, a product must comply with the applicable expired IMA and any relevant appendix.

Depending on the category, requirements may include

minimum and maximum nutrient concentrations;
permitted nutrient sources;
composition requirements;
prescribed common names;
mandatory label statements;
Nutrition Facts table (NFt) requirements;
ingredient declaration requirements; and
restrictions relating to intended consumers or product representation.

For example, the plant-based beverage IMA establishes compositional criteria and prescribes the common name “fortified (naming the plant) beverage.” Certain products may also require the statement “Not a source of protein.”

If a product does not meet all of the conditions set out in the applicable expired IMA and relevant appendix, it may no longer fall within Health Canada’s interim compliance and enforcement approach. In practical terms, this means that even a seemingly minor change to the formulation, nutrient levels, ingredient source, labelling, or product positioning could affect whether the product remains covered by the policy.

For this reason, the applicable requirements should be reassessed whenever a product is reformulated, suppliers or ingredient specifications change, a foreign product is adapted for the Canadian market, labels are redesigned, or a company is considering a harmonized North American SKU.

What Should Brands Do Following the Interim Marketing Authorization (IMA) Update?

Companies relying on these fortification pathways should review the complete regulatory position.

Key considerations include:

Confirm Product Elegibility

Determine whether the product falls under an existing FDR provision, an expired IMA, or one of the policy appendices.

Review the Complete Formulation

Verify that added vitamins and minerals, including applicable overages, remain within permitted levels.

Assess Canadian Labelling

Confirm the common name, NFt, ingredient list, nutrient declarations, mandatory statements, and claims.

Review Cross-Border Formulations

Identify differences between Canadian and foreign-market requirements before adopting a harmonized formulation.

Monitor Regulatory Modernization

Health Canada's current approach remains interim and may continue to evolve as permanent fortification requirements are developed.

Final Remarks

The August 2026 update is targeted, but its practical implications are broader. It reinforces the need for brands to assess fortified foods against the full Canadian regulatory framework, not only against foreign-market standards or isolated nutrient permissions. For companies manufacturing, importing, reformulating, or launching fortified products in Canada, a careful review of formulation, labelling, product representation, and category-specific conditions remains essential to maintaining compliance while Health Canada continues to modernize the applicable rules.

How SNI Supports Food Compliance in Canada

Canadian food fortification can involve several overlapping layers of regulation, including historical IMAs, current FDR provisions, Health Canada policies, and category-specific labelling requirements. For products developed for multiple markets, navigating these requirements can become particularly complex.

Source Nutraceutical, Inc. (SNI) supports food and beverage companies with:

vitamin and mineral fortification assessments;
reviews against applicable FDR provisions, IMAs, MAs, and Health Canada policies;
formulation and ingredient compliance assessments;
Canadian food classification and market-entry strategy;
NFt and ingredient list development
common name, claims, and label compliance reviews; and
regulatory support for U.S. and international brands entering Canada

By confirming the applicable regulatory pathway early, companies can reduce the risk of reformulation, relabelling, import complications, and avoidable launch delays.

If you are developing a fortified food or beverage for Canada, reformulating an existing product, or assessing whether a foreign-market formulation can be sold in Canada, SNI can help determine the applicable requirements, ensuring a compliant and streamlined launch

Book an introductory call using the following form:

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