Marketing Authorization for Vitamin D in Milk, Goat’s Milk and Margarine: SOR/2021-278

Canada Gazette, Part II, Volume 156, Number 2

Registration
SOR/2021-278 December 29, 2021

FOOD AND DRUGS ACT

The Minister of Health, pursuant to subsection 30.3(1) ^{footnote a} of the Food and Drugs Act ^{footnote b}, issues the annexed Marketing Authorization for Vitamin D in Milk, Goat’s Milk and Margarine.

Ottawa, December 17, 2021

Jean-Yves Duclos
Minister of Health

Marketing Authorization for Vitamin D in Milk, Goat’s Milk and Margarine

Interpretation

Same meaning

1 Words and expressions used in this Marketing Authorization have the same meaning as in the Food and Drug Regulations.

Exemptions

Milk

2 (1) The following foods are exempt from the application of paragraphs 4(1)(a) and (d) and sections 6 and 6.1 of the Food and Drugs Act and sections B.01.042 and D.01.011 of the Food and Drug Regulations, in respect of the vitamin D that is present in each of those foods, if the applicable condition set out in subsection (2) is met:

• (a) milk or whole milk;
• (b) skim milk;
• (c) partly skimmed milk or partially skimmed milk;
• (d) sterilized milk;
• (e) (naming the flavour) milk;
• (f) (naming the flavour) skim milk;
• (g) (naming the flavour) partly (partially) skimmed milk;
• (h) skim milk with added milk solids;
• (i) partly skimmed milk with added milk solids or partially skimmed milk with added milk solids;
• (j) (naming the flavour) skim milk with added milk solids;
• (k) (naming the flavour) partly (partially) skimmed milk with added milk solids;
• (l) evaporated milk;
• (m) evaporated skim milk or concentrated skim milk;
• (n) evaporated partly skimmed milk or concentrated partly skimmed milk;
• (o) milk powder, whole milk powder, dry whole milk or powdered whole milk; and
• (p) skim milk powder or dry skim milk.

Condition

(2) The food must contain the following amount of vitamin D:

• (a) in the case of a food referred to in any of paragraphs (1)(a) to (k), 2 μg of vitamin D per 100 mL;
• (b) in the case of a food referred to in any of paragraphs (1)(l) to (n), 2 μg of vitamin D per 100 mL when reconstituted to its original volume; and
• (c) in the case of a food referred to in paragraph (1)(o) or (p), 2 μg of vitamin D per 100 mL when reconstituted and ready-to-serve.

Goat’s milk

3 (1) The following foods are exempt from the application of paragraphs 4(1)(a) and (d) of the Food and Drugs Act and sections B.08.029 and D.01.011 of the Food and Drug Regulations, in respect of the vitamin D that is present in each of those foods, if the applicable condition set out in subsection (2) is met:

• (a) goat’s milk;
• (b) partly skimmed goat’s milk or skimmed goat’s milk;
• (c) evaporated goat’s milk;
• (d) evaporated partly skimmed goat’s milk or evaporated skimmed goat’s milk;
• (e) goat’s milk powder; and
• (f) partly skimmed goat’s milk powder or skimmed goat’s milk powder.

Condition

(2) The food must contain the following amount of vitamin D:

• (a) in the case of a food referred to in paragraph (1)(a) or (b), 2 μg of vitamin D per 100 mL;
• (b) in the case of a food referred to in paragraph (1)(c) or (d), 2 μg of vitamin D per 100 mL when reconstituted according to directions for use; and
• (c) in the case of a food referred to in paragraph (1)(e) or (f), 2 μg of vitamin D per 100 mL when reconstituted and ready-to-serve.

Margarine

4 (1) Margarine and calorie-reduced margarine are exempt from the application of paragraphs 4(1)(a) and (d) and sections 6 and 6.1 of the Food and Drugs Act and sections B.01.042 and D.01.011 of the Food and Drug Regulations, in respect of the vitamin D that is present in each of those foods, if the condition set out in subsection (2) is met.

Condition

(2) The food must contain 26 μg of vitamin D per 100 g.

Coming into Force

Registration

5 This Marketing Authorization comes into force on the day on which it is registered.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Marketing Authorization.)

Issues

A Marketing Authorization (MA) is being introduced to permit manufacturers to voluntarily increase the amount of vitamin D in cow’s milk, goat’s milk and margarine in order to facilitate alignment and compliance with the Regulations Amending the Food and Drug Regulations (Nutrition Labelling, Other Labelling Provisions and Food Colours) [SOR/2016-305] (2016 nutrition labelling regulations).

Background

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. Vitamin D deficiency can lead to rickets in children and osteomalacia (softening of the bones) in adults. Based on blood status data from the Canadian Health Measures Survey approximately 20% of Canadians are at risk of vitamin D inadequacy (generally considered unsatisfactory for bone health), while about 8% of Canadians are at risk of Vitamin D deficiency.

The Food and Drug Regulations (FDR) set out the daily value (DV) for vitamin D (i.e. a value that would meet the vitamin D requirements of almost all Canadians) as well as the amount of vitamin D required in cow’s milk and margarine, and permitted in goat’s milk. Manufacturers cannot increase the amount of vitamin D in foods beyond what is currently set out in the FDR.

The 2016 nutrition labelling regulations increased the DV for vitamin D in order to address updated dietary intake recommendations. The transition period for the labelling changes ends 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. After December 14, 2022, manufacturers must use the new DV to calculate the percent daily value (% DV) that will appear in the Nutrition Facts table (NFt) on package labels. The % DV gives consumers an indication of the amount of a nutrient in a serving of food to help them make informed food choices.

Health Canada has undertaken a vitamin D fortification strategy with the public health objective of promoting adequate bone health among Canadians without creating the risk of excessive intakes of vitamin D. As a first step, Health Canada proposed in 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] increases to the amount of vitamin D required in cow’s milk and margarine and permitted in goat’s milk. As milk and margarine are the biggest contributors of vitamin D in the Canadian diet, increasing their vitamin D level would have a large impact on the dietary intake of vitamin D of most Canadians.

It was Health Canada’s intention for the changes to the DV for vitamin D and the increased amounts of vitamin D in milks and margarine to coincide in order to avoid manufacturers needing to make multiple label changes. Moreover, if the changes did not coincide, both the sharp decrease in declared % DV and the loss of the “excellent source” claim for cow’s milk and goat’s milk (permitted when a food provides greater than or equal to 25% DV of vitamin D per serving) could negatively affect consumer confidence in these foods as an excellent source of vitamin D. In February 2018, Health Canada prepublished its proposed regulations to increase vitamin D in cow’s milk, goat’s milk and margarine as part of the FOP Regulations in the Canada Gazette, Part I. 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.

Objective

The objectives of this MA are to

• facilitate alignment and compliance with the 2016 nutrition labelling regulations in order to help avoid multiple label changes and potential loss of consumer confidence resulting from a sharp decrease in % DV for cow’s milk, goat’s milk and margarine, and loss of the “excellent source” claim for cow’s milk and goat’s milk; and
• increase vitamin D in the food supply to help promote adequate bone health among Canadians without creating the risk of excessive intakes of vitamin D.

Permitting manufacturers to increase the amount of vitamin D in cow’s milk, goat’s milk and margarine will achieve these objectives. The MA is intended to be an interim measure until amendments are made to the FDR and approved by the Governor in Council.

Description

The MA will enable manufacturers to voluntarily increase the vitamin D level in cow’s milk, goat’s milk and margarine by creating an exemption to certain prohibitions found in the Food and Drugs Act (FDA) and provisions found in the FDR. In the absence of this MA, these higher amounts of vitamin D would be prohibited under the FDA and the FDR. As such, the MA will create exemptions to paragraphs 4(1)(a) and (d) and sections 6 and 6.1 of the FDA, and sections B.01.042 and D.01.011 for cow’s milk and margarine, and paragraphs 4(1)(a) and (d) of the FDA and sections B.08.029 and D.01.011 of the FDR for goat’s milk.

The vitamin D amounts in the food must align with those indicated in the MA and are determined based on the state of the product as indicated in the MA, if one is provided (e.g. when reconstituted and ready-to-serve, reconstituted to original volume, reconstituted according to directions for use). In order to be in compliance with the 2016 nutrition labelling regulations, manufacturers must apply the new DV for vitamin D as per the Table of Daily Values.

For consistency with the new DV for vitamin D set out in the 2016 nutrition labelling regulations, vitamin D quantities in the MA are based on micrograms (µg) rather than international units (I.U.). For clarity and ease of calculation, the MA requires a vitamin D amount per 100 mL of cow’s milk and goat’s milk and a vitamin D amount per 100 g of margarine.

For cow’s milk and goat’s milk, the MA sets out the amount of vitamin D at 2 µg/100 mL, and at 26 µg/100 g for margarine. All other requirements under the FDA and FDR for cow’s milk, goat’s milk and margarine will continue to apply.

If a manufacturer chooses not to increase the amount of vitamin D in these foods to the levels set out in the MA, the current FDR provisions pertaining to vitamin D amounts will continue to apply.

Coming into force and transitional provisions

This MA will come into force upon registration.

Regulatory development

Consultation

Health Canada consulted with stakeholders over a number of years in the development of the policy leading up to this MA.

Early consultations on vitamin D

Health Canada held the following stakeholder engagement activities:

• March 2015: A proposal for a revised vitamin D fortification policy was discussed with experts at a Best Brains Exchange co-hosted by the Canadian Institutes of Health Research (CIHR) and Health Canada.
• February 2017: Health Canada undertook a cost-benefit analysis survey to health and industry stakeholders relating to changes to front-of-package labelling and new vitamin D amounts in cow’s milk, goat’s milk and margarine.
• March 2017: Health Canada engaged with targeted industry and health stakeholders along with provincial and territorial government representatives to discuss proposed changes to its vitamin D fortification policy.

Stakeholder feedback

In March 2015, a proposal for a revised vitamin D fortification policy was discussed with experts (including Dietitians of Canada, academics and health care professionals) at a Best Brains Exchange cohosted by CIHR and Health Canada. The proposal was to increase the mandatory amount of vitamin D in milk, fortified plant-based beverages and margarine, and to permit the optional addition of vitamin D to yogurt. The majority of experts were supportive or neutral toward increasing vitamin D amounts in milk. Supporters of the proposal highlighted that it was important to continue with milk fortification but also to expand to other vehicles. A minority of experts disagreed with increasing vitamin D amounts in milk, the main reason being that it would not reach certain subpopulations at risk. Feedback regarding margarine was divided. Supporters advised that if it is a frequently consumed product, particularly in subpopulations at risk, then it should be considered for fortification. Those with reservations expressed concern regarding the potential for mixed messages, i.e. “limit the food because of its fat content but do not limit the food because of vitamin D.”

Participants at the targeted consultation in 2017 expressed understanding that the proposed increases to vitamin D amounts would not be equivalent to the large increase to the DV since Health Canada plans to extend its fortification policy to other foods in the longer term. However, since the % DV on product labels will consequently drop, health stakeholders highlighted the importance of properly positioning this message through consumer education in order to maintain consumer confidence in these foods, especially milk. Some participants were interested in understanding how the changes to vitamin D amounts would be reflected in dietary guidance. One industry stakeholder expressed concern regarding the volume of changes that were being proposed within a three-to-five-year period [e.g. new NFt and list of ingredient requirements, FOP labelling, vitamin D fortification and the CFIA’s Food Labelling Modernization initiative (now the Food Product Innovation initiative)]. Another industry stakeholder countered this argument with appreciation of the Department’s efforts to align the timelines of the multiple initiatives as much as possible. One health stakeholder added that any delays toward implementation of the various proposals would be quite a disappointment to health care professionals who view the regulatory package as a suite of approaches that will help to move Canada toward a healthier food supply.

Vitamin D pre-consultation in the Canada Gazette, Part I (February 2018)

On February 10, 2018, Health Canada prepublished its proposed FOP Regulations in the Canada Gazette, Part I, for a 75-day consultation period. There were approximately 32 submissions received in response to the vitamin D component of these proposed regulations from a range of stakeholders, including 11 industry associations, 6 government representatives, 5 industry representatives, 3 consumers, 2 health professional organizations, 2 academics, 2 non-governmental organizations, and 1 health professional. 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. In March 2018, Health Canada also held technical webinars with all interested stakeholders to provide an overview of the proposed regulations that were prepublished in the Canada Gazette, Part I, to facilitate the consultation process.

Stakeholder feedback

Almost all respondents supported the regulatory proposal to increase vitamin D amounts in cow’s milk, goat’s milk and margarine. A small number of respondents expressed concern with the approach and/or posed questions regarding timelines, scope, technical aspects and consumer education.

A few stakeholders raised concerns over the approach to increase vitamin D only in milk and margarine and not in other products. In particular, one industry stakeholder noted that data show that Canadians’ intakes of these products have decreased in recent years and that some ethnic groups do not consume cow’s milk. One health professional organization questioned the overall effectiveness of the approach in helping Canadians meet the increased vitamin D intake recommendations. They expressed concerns over the importance of increasing vitamin D in margarine at this time in relation to the overall public health strategy. They proposed that Health Canada explore modifying dietary guidance to improve vitamin D intakes instead. Finally, some industry stakeholders asked about Health Canada’s plans for educating consumers regarding why the % DV for vitamin D will be lower in the NFt when in fact the amounts are being increased in milks and margarine.

Health Canada response

Milk and margarine are the major contributors to vitamin D in Canadians’ diets. According to dietary intake data collected as part of the Canadian Community Health Survey 2015, milk and margarine are consumed by approximately 81% and approximately 54% of Canadians respectively. Dietary intake modelling of milk and margarine (singly and combined) at the proposed new vitamin D amounts, show that both foods are important to increasing the vitamin D intakes of Canadians and thus bringing intakes closer to requirements. Through consultation with experts at the Best Brains Exchange in March 2015, the Department also learned that margarine is a useful vehicle for reaching certain subpopulations, such as Indigenous peoples, who are particularly vulnerable to vitamin D deficiency and inadequacy.

Health Canada released the updated Canada’s food guide in January 2019, which continues to include foods that provide vitamin D. Health Canada acknowledges the importance of educating consumers and intermediaries on the upcoming changes to the % DV for vitamin D for these foods. With any new policies and regulatory initiatives, Health Canada undertakes educational efforts such as social media messages to encourage Canadians to make informed choices to improve their diets.

Increasing vitamin D amounts in cow’s milk, goat’s milk and margarine will help bring Health Canada closer to attaining the public health goal to promote adequate bone health among Canadians with a particular focus on minimizing risk of deficiency without incurring risk of excessive intakes. Health Canada is aware, however, that increasing vitamin D amounts in these foods will not be sufficient for improving the vitamin D intakes of all Canadians (e.g. some ethnic groups may consume less milk). For this reason, as a next step, the Department plans to increase vitamin D levels of fortified plant-based beverages and to permit the fortification of yogurt. Health Canada will assess the effectiveness of these measures through the ongoing monitoring of the vitamin D intakes and blood status of Canadians. If necessary, the Department will consider permitting the addition of vitamin D to other suitable foods.

Notice of intent

On July 22, 2021, a notice of intent (NOI) was published online and disseminated via email to over 5 300 stakeholders to notify of Health Canada’s intent to publish an MA to enable increased vitamin D levels in milks and margarine. Industry and health stakeholders did not provide feedback on the NOI.

Modern treaty obligations and Indigenous engagement and consultation

No impacts have been identified on modern treaty obligations by this MA. However, during consultation, some vitamin D experts expressed that margarine is a useful vehicle for reaching certain subpopulations, such as Indigenous peoples, who are particularly vulnerable to vitamin D deficiency and inadequacy.

Instrument choice

The MA is an interim measure to accomplish the policy objectives noted above until amendments to the FDR can be made. The MA may serve as an incentive for milk manufacturers to adopt the new NFt during the education and compliance promotion period, as they would be able to retain the “excellent source” claim for vitamin D for their products. Since only one label change will be required, this will minimize costs for industry as well as the potential risk of consumer confusion associated with sharp fluctuations to the % DV.

Regulatory analysis

Benefits and costs

There are no additional operational costs for Health Canada with respect to this MA as it will enable the Department to permit an increased amount of vitamin D in cow’s milk, goat’s milk and margarine. There are also no anticipated incremental cost impacts expected for the CFIA as it relates to compliance and enforcement activities since the MA is permissive, and does not add new or additional regulatory requirements.

This MA will also have the following qualitative benefits:

• helping to promote adequate bone health among Canadians by permitting an increased amount of vitamin D in cow’s milk, goat’s milk and margarine;
• allowing for the possibility of financial savings for manufacturers who have not already updated their product labels to comply with the 2016 nutrition labelling regulations. For these manufacturers, the MA enables a single label change (rather than multiple changes) to account for an increase to vitamin D amounts and meeting the requirements set out in the 2016 nutrition labelling regulations;
• allowing manufacturers to continue to market cow’s milks and goat’s milks as an “excellent source” of vitamin D, thus providing a marketing benefit to manufacturers; and
• helping to reduce the risk of illness related to certain bone diseases and therefore potentially reduce health care spending on the treatment of these diet-related diseases.

Small business lens

The small business lens does not apply to the proposal, since the MA creates an exemption from certain prohibitions found in the FDA and provisions of the FDR, if certain conditions are met, and does not impose additional administrative or compliance costs on small businesses. Additionally, for products that do not yet have updated labels that comply with the 2016 nutrition labelling regulations, the MA will eliminate the need for two label changes, as noted above.

One-for-one rule

The one-for-one rule does not apply to this proposal, since the administrative costs remain the same for businesses, and the impact of the MA is administratively neutral.

Regulatory cooperation and alignment

Canada’s approach to vitamin D amounts in cow’s milk is similar to that of the United States; however, there is a difference when it comes to margarines.

In the United States, the fortification of vitamin D in cow’s milk is mandated at the state level, rather than the federal level. In 2016, the Food and Drug Administration permitted vitamin D fortification above the amount prescribed in milk (~1 µg/100 mL) based on a petition received from industry. It now allows up to 2.1 µg vitamin D/100 mL, which is very close to the amount set out in this MA. Milks that are fortified in excess of the amounts stipulated must be named with a nutrient content claim such as “high vitamin D milk,” similar to the “excellent source” claim in Canada.

Margarine is permitted to be fortified with vitamin D in the United States, but at a lower level than in Canada.

Strategic environmental assessment

In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a SEA preliminary scan was completed and concluded that a detailed analysis was not required because this MA has no environmental impact.

Gender-based analysis plus

Consideration of gender and diversity were taken into account during the development of this MA. No additional sex, gender and/or diversity implications have been identified for this MA.

Implementation and compliance and enforcement

Implementation

Public education efforts to help Canadians understand how best to use nutrition labelling to make informed food choices is ongoing. In addition, Health Canada will post information about the MA on its website and will notify stakeholders about it. Industry is not required to submit a premarket notification or a Temporary Marketing Authorization application in order to apply the increased vitamin D levels for cow’s milk, goat’s milk or margarine.

Compliance and enforcement

Compliance and enforcement of the MA will be incorporated into existing activities carried out by the CFIA under the provisions of the FDA and the FDR, and other applicable food-related legislation enforced by the CFIA.

The CFIA is responsible for the enforcement of the FDA as it relates to food. While it is the responsibility of the industry to comply with regulatory requirements, compliance will be monitored as part of ongoing domestic and import inspection programs, respecting the resources that the CFIA has for enforcement and compliance verification. Appropriate enforcement action will be taken based on risk.

Contact

Bruno Rodrigue
Executive Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada
Holland Cross, Tower A, Suite 14
11 Holland Avenue
Ottawa, Ontario
K1A 0K9
Address locator: 3000A
Email: hc.lrm.consultations-mlr.sc@canada.ca