Notice of intent regarding the Minister of Health’s intention to publish marketing authorizations to permit vitamin D fortification of yogurt and kefir and expand the eligibility for the dairy-related exemption from the front-of-package nutrition labelling requirement

July 28, 2023

On this page

• Purpose
• Vitamin D fortification
  • Background
  • Proposal and rationale
• Front-of package nutrition labelling
  • Background
  • Proposal and rationale
• Public comments and contact information

Purpose

The purpose of this Notice of Intent is to inform Canadians, regulated parties and other stakeholders of the Minister of Health's intention to permit the vitamin D fortification of yogurt and kefir that are made from dairy products and expand the eligibility for the dairy-related exemption from the front-of-package (FOP) nutrition labelling requirement by implementing a lower calcium threshold. The types of foods eligible for the exemption remain the same as those currently set out in the Food and Drug Regulations (FDR) (i.e., prepackaged products that are cheese or yogurt – including drinkable yogurt – that are made from dairy products, kefir or buttermilk).

Vitamin D fortification

Background

Vitamin D is a nutrient that is important for bone health. It is obtained from food and supplements and can be made by the body after exposure to sunlight. Vitamin D deficiency can lead to rickets in children and osteomalacia (bone softening) in adults. It is challenging for Canadians to consume the recommended amounts of vitamin D through the current food supply. Blood status data from the Canadian Health Measures Survey (2012-2019) indicate that one in five people in Canada are not getting enough Vitamin D.

To decrease the risk of vitamin D deficiency and support bone health, the FDR set requirements for the addition of vitamin D to certain foods sold in Canada. On July 20, 2022, Health Canada published the Regulations Amending the Food and Drug Regulations (Nutrition Symbols, Other Labelling Provisions, Vitamin D and Hydrogenated Fats or Oils) in the Canada Gazette, Part II (CGII). These regulations included amendments that increased the amount of vitamin D required in milk and margarine. However, to help Canadians meet their vitamin D requirements, more food sources of vitamin D are needed. For instance, some people consume little or no milk or margarine and would benefit from expanded options for vitamin D-rich foods.

Proposal and rationale

To help Canadians meet their vitamin D requirements, Health Canada intends to create new options for vitamin D fortified foods by permitting its addition to yogurt and kefir (a fermented milk drink similar to a thin yogurt) that are made from dairy products to the levels outlined in Table 1. These quantities are based on total vitamin D per 100 g or 100 mL. This would be accomplished by a ministerial regulation in the form of a Marketing Authorization (MA) made under the authority of s. 30.3 of the Food and Drugs Act.

Table 1: Vitamin D levels for yogurt, drinkable yogurt and kefir

Food	Vitamin D
Yogurt	5 µg/100 g
Drinkable yogurt	5.2 µg/100 mL
Kefir	2.7 µg/100 mL

Yogurt and kefir were identified as foods for vitamin D fortification since they contain calcium, which is also critical to bone health, and intake data from the Canadian Community Health Survey (CCHS 2015) show that the prevalence of consumption is increasing. Health Canada has communicated plans to permit the vitamin D fortification of yogurt and the proposed amendments are supported by a broad range of stakeholders. In July 2022 this initiative was identified in the Regulatory Impact Analysis Statement as the next step of the vitamin D fortification strategy.

Of note, the vitamin D levels for kefir are about half of those set out for yogurt. This is because consumption data indicate that people consume about twice the amount of kefir as compared to yogurt. Setting a lower vitamin D concentration for kefir means that, based on average daily intakes, both yogurt and kefir consumers will get a similar amount of vitamin D from their consumption of these foods.

Health Canada conducted dietary intake modelling to assess the impact of permitting vitamin D addition to yogurt and kefir. The modelling showed improvement to vitamin D intakes without posing a risk of excess. These results support that allowing vitamin D fortification of yogurt and kefir will help bring dietary intakes closer to requirements, thereby decreasing the risk of deficiency and supporting bone health.

When fortified to contain the vitamin D levels in Table 1, the great majority of yogurts and kefirs will contain at least 25% of the daily value (DV). Products containing this quantity of vitamin D are permitted to make an "excellent source" claim.

Health Canada will assess the effectiveness of these measures through ongoing monitoring of vitamin D intakes and blood status.

Front-of-package nutrition labelling

Background

In July 2022, the FDR were amended to add a requirement for FOP nutrition symbol labelling for most prepackaged products containing nutrients of public health concern (saturated fat, sugars and/or sodium) at or above specified thresholds. The nutrition symbol will help Canadians to more easily identify foods high in these nutrients. Avoiding excess consumption of these nutrients can help reduce associated health risks. Regulated parties have until January 1, 2026, to comply with the regulations.

For technical, nutritional or practical reasons, some products are exempt from the requirement to display a nutrition symbol. These exemptions maintain consistency with the Nutrition Facts table, recognize that a nutrition symbol would be redundant on some foods, support health protection for the general population or for vulnerable populations, and mitigate unintended nutritional consequences.

While many dairy products are significant contributors of saturated fat and sodium in Canadian diets, many are also important sources of calcium, which is considered a shortfall nutrient due to inadequate intakes in Canada. Adequate calcium intakes are necessary for bone health, and consequently, to reduce the risk of osteoporosis which is prevalent in Canada. At a national level, the prevalence of inadequate calcium intake varies widely, but tends to increase with age and is higher in women than in men.

To mitigate the concern that the FOP nutrition symbol could negatively impact calcium intakes, the regulations include an exemption for cheese or yogurt – including drinkable yogurt – that are made from dairy products, buttermilk and kefir. To be eligible for the exemption, products with a small reference amount (e.g., cheddar cheese) must contain ≥ 10% of the calcium daily value (DV). For nutrients such as calcium, the DV is the recommended amount that people in a specific age group should try to consume each day. Products with a larger reference amount (e.g., cottage cheese, yogurt) must contain ≥ 15% of the calcium DV to be eligible for the exemption. This approach is consistent with the conditions for making a "good source of calcium" claim on the label as per the FDR.

Following the publication of the regulations in the CGII, Health Canada received feedback from an industry association regarding the current use of a calcium threshold to determine which dairy-based cheese are eligible for the exemption from FOP nutrition labelling. They expressed concern that many fine and fresh cheeses ^{Footnote 1} will require a nutrition symbol because their calcium content does not meet the threshold.

Proposal and rationale

Although fine and fresh cheeses are generally lower contributors to calcium intakes compared to some other cheeses, Health Canada acknowledges that they may serve as a source of calcium. To address concerns regarding the calcium threshold, Health Canada intends to expand the eligibility for the existing dairy-related FOP labelling exemption by implementing a lower calcium threshold of 5% of the DV, regardless of the reference amount. The exemption and threshold will continue to apply to cheese or yogurt – including drinkable yogurt – that are made from dairy products, buttermilk and kefir. This approach is consistent with the conditions for making a "source of calcium" claim on the label. This would be accomplished by a ministerial regulation in the form of a Marketing Authorization made under the authority of s.30.3 of the Food and Drugs Act.

Public comments and contact information

Comments on the Minister of Health's proposals to permit vitamin D fortification of yogurt and kefir and to implement a lower calcium threshold for the dairy-related exemption from the FOP nutrition labelling requirement, as described in this Notice of Intent, can be provided until August 28, 2023. The proposals may be revised prior to the final Marketing Authorizations being published in the CGII. Comments can be submitted by email or in paper format to Health Canada's Bureau of Nutritional Sciences at the coordinates below. Please cite the title and the date of publication of this Notice of Intent in the subject line of your correspondence

Bureau of Nutritional Sciences, Food Directorate
Health Products and Food Branch, Health Canada
251 Sir Frederick Banting Driveway
Tunney's Pasture, PL: 2203E
Ottawa, ON K1A 0K9
Email: bns-bsn@hc-sc.gc.ca