Notice of Intent regarding the Minister of Health's intention to publish a Marketing Authorization to permit increased vitamin D levels in milks and margarine

The purpose of this Notice of Intent is to inform Canadians of the Minister of Health's intention to publish a Marketing Authorization (MA) to permit increased vitamin D levels in cow's milk, goat's milk and margarine. The MA will come into force upon its publication in early fall 2021, and is an interim measure until amendments are made to the Food and Drug Regulations (FDR).

The MA will allow manufacturers to voluntarily increase vitamin D in cow's milk, goat's milk and margarine to the levels outlined in Table 1 by creating an exemption to certain prohibitions found in the Food and Drugs Act (FDA) and provisions of the FDR. As a condition of the MA, manufacturers adopting the new vitamin D levels must use the new daily value (DV) for the vitamin when calculating the "% DV" to be displayed on the Nutrition Facts table (NFt). The DV for vitamin D, which is set out in the Table of Daily Values, was increased as part of the Regulations Amending the Food and Drug Regulations (Nutrition Labelling, Other Labelling Provisions and Food Colours) (2016 NL regulations).

Consultation summary:

On February 10, 2018, the Department published in Canada Gazette, Part I its proposed regulations to increase vitamin D in cow's milk, goat's milk and margarine, to the levels outlined in Table 1, for a 75-day consultation period as part of the Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Nutrition Symbols, Other Labelling Provisions, Partially Hydrogenated Oils and Vitamin D) (FOP regulations).

There were 32 comments received in response to the vitamin D component of the consultation. Almost all respondents supported the proposal to increase vitamin D levels in milks and margarine. A small number of respondents expressed concern with the approach and/or posed questions regarding timelines, scope, technical aspects and consumer education. Four comments expressing support for the vitamin D proposal were also received through the World Trade Organization (WTO) Technical Barriers to Trade (TBT) notification process.

Rationale:

Vitamin D is a nutrient that helps the body use calcium and phosphorus to maintain strong bones and teeth. It is obtained from food and supplements and can be made by the body after exposure to sunlight.

Based on blood status data from the Canadian Health Measures Survey up to 2017, collected on a biennial basis, approximately 20% of Canadians are at risk of vitamin D inadequacy, while about 8% are at risk of deficiency. Vitamin D deficiency can lead to rickets in children and osteomalacia (softening of the bones) in adults.

Fortified foods, primarily milk and margarine, are the major dietary source of vitamin D for Canadians. The FDR prescribes vitamin D levels required in cow's milk and margarine and permitted in goat's milk. Health Canada recognizes that it is challenging for Canadians to meet vitamin D intake recommendations given that there are currently insufficient amounts in the food supply.

To address this issue, we have been working toward an updated vitamin D fortification strategy, part of which is an increase to the vitamin D levels of milks and margarine by way of the front-of-package (FOP) nutrition labelling regulations. Due to Health Canada's efforts to support the government response to the COVID-19 pandemic, publication of the final FOP regulations has been delayed. Therefore, the Department is taking steps to advance the vitamin D fortification element of the proposal as expediently as possible via an MA.

The 2016 NL regulations provided for an increase in the DV for vitamin D to account for updated dietary intake recommendations. The transition period for the 2016 nutrition labelling changes is currently set to end on December 14, 2021. However, given the challenges imposed by COVID-19, the Canadian Food Inspection Agency (CFIA) will focus its efforts on education and compliance promotion for the first year, until December 14, 2022. After that date, regulated parties must comply with the new requirements. The CFIA will verify compliance and apply enforcement discretion in cases of non-compliance when regulated parties have a detailed plan that shows how they intend to comply at the earliest possible time, and no later than December 14, 2023.

The MA will allow manufacturers who have not already updated their product labels to transition to the new vitamin D levels and the new DV simultaneously, avoiding multiple label changes and minimizing costs. This measure will also prevent sharp fluctuations to the "% DV" declared on the NFt and allow milks to maintain the "excellent source" claim^{Footnote 1} to ensure continued consumer confidence in these foods as a source of vitamin D. Permitting increased vitamin D levels in these foods will bring us closer to attaining our public health goal, which is to promote adequate bone health among Canadians without creating the risk of excessive intakes.

Next steps:

The MA will come into force on the day it is published in the Canada Gazette, Part II in early fall 2021. Industry is not required to submit a premarket notification or a Temporary Marketing Authorization application in order to apply the increased vitamin D levels.