Fortified foods: Canada’s approach to fortification
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How Canada regulates fortification
In Canada, food fortification is regulated under the Food and Drug Regulations (regulations).
Section D.03.002 in Part D of the regulations includes a table of the foods that may or must be fortified and the specific nutrients that may or must be added to them. The regulations help to prevent the inappropriate addition of nutrients to foods which could lead to excess nutrients being consumed.
Nutrient levels for many foods listed in this table are found in provisions throughout Part B of the regulations. Some levels are based on a specific amount of a food (for example, nutrient amount per 100 g or 100 mL). Other levels are based on the reasonable daily intake (RDI) for a food. RDIs are found in Schedule K of the regulations.
Some foods in the table do not have nutrient levels specified in Part B of the regulations. For these foods, levels found in the general provisions in Part D of the regulations apply. For example, dehydrated potatoes may be fortified with vitamin C, but the level of vitamin C permitted is not set out in Part B. Therefore, the general provisions in Part D apply (sections D.01.009 to D.01.011 for vitamins and section D.02.009 for mineral nutrients). These provisions set nutrient levels based on a food’s RDI.
To allow fortification at a different nutrient level or for a new food, a regulatory amendment is required. However, Health Canada may also allow this by issuing a product-specific temporary marketing authorization (TMA). Previously, we used interim marketing authorizations (IMAs) for certain food categories.
Expired interim marketing authorizations
The process for amending regulations can be lengthy. Thus, the interim marketing authorization (IMA) process was enacted in 1997 to bridge the time between when a scientific evaluation of a request to amend the regulations was completed and when the amendment was published.
In October 2012, when the Food and Drugs Act (act) was amended to allow the Minister to issue marketing authorizations (MAs) for foods, the authority to issue IMAs was removed. Between 1997 and 2011, we had issued 10 IMAs for the fortification of certain categories of foods. Unfortunately, we were unable to amend the regulations before the IMA periods expired.
Removing these products from the market may have a negative impact on the health of people living in Canada, including certain vulnerable subpopulations. Therefore, until the regulations are amended, we have adopted an interim policy concerning the sale of foods fortified in accordance with the expired IMAs.
Temporary marketing authorization
We may issue a TMA to a manufacturer or distributor for a food that is fortified in a manner that does not comply with the regulations. A requirement of the TMA is to conduct research to support a future regulatory amendment.
We only issue TMAs for foods that are fortified for specific purposes. Information in the TMA submission must show that adding the proposed nutrient addresses a specific purpose and is safe.
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Canada’s vitamin D fortification strategy
Vitamin D is important for bone health. However, about 1 in 5 people living in Canada are not getting enough vitamin D.
To help address this issue, we developed a vitamin D fortification strategy. The strategy is designed to increase or allow vitamin D in certain foods.
Cow’s milk, goat’s milk and margarine
In 2022, we published new regulations to approximately double the amount of vitamin D required in cow’s milk and margarine. The new regulations also roughly doubled the amount of vitamin D permitted in goat’s milk. The food industry must make these changes by December 31, 2025.
Fortified plant-based beverages
We also updated the Interim policy on the use of expired interim marketing authorizations related to food fortification in 2022. The vitamin D level in fortified plant-based beverages can now match the new level required in cow’s milk.
Permitting increased vitamin D in fortified plant-based beverages is important since many people consume them as alternatives to cow’s milk.
Yogurt
In 2024, we published new regulations to permit vitamin D addition to yogurt and kefir made from dairy products. Yogurt and kefir are increasing in popularity. They contain calcium, which is also critical to bone health. These features make yogurt and kefir suitable foods for vitamin D fortification.
Monitoring
We will continue to monitor the vitamin D intakes and status of people living in Canada. Monitoring will help us determine if we need to make other changes to the vitamin D fortification strategy.
Related links
- Fortification of gluten-free foods (Canadian Food Inspection Agency)
- Vitamin D
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