Marketing Authorization for Vitamin D in Yogurt and Kefir: SOR/2024-88
Canada Gazette, Part II, Volume 158, Number 12
Registration
SOR/2024-88 May 15, 2024
FOOD AND DRUGS ACT
The Minister of Health issues the annexed Marketing Authorization for Vitamin D in Yogurt and Kefir under subsection 30.3(1)footnote a of the Food and Drugs Act footnote b.
Ottawa, May 13, 2024
Mark Holland
Minister of Health
Marketing Authorization for Vitamin D in Yogurt and Kefir
Interpretation
Same meaning
1 Words and expressions used in this Marketing Authorization have the same meaning as in the Food and Drug Regulations.
Exemptions
Yogurt
2 (1) Yogurt — except drinkable yogurt — that is made from dairy products is exempt from the application of paragraphs 4(1)(a) and (d) of the Food and Drugs Act and section D.03.002 of the Food and Drug Regulations, in respect of the vitamin D that is present in the food, if the applicable condition in subsection (2) is met.
Condition
(2) The food must contain the following amount of vitamin D:
- (a) in the case of plain yogurt, 5 μg of vitamin D per 100 g; or
- (b) in the case of fruit or flavoured yogurt, not less than 3.8 μg and not more than 5 μg of vitamin D per 100 g.
Drinkable Yogurt
3 (1) Drinkable yogurt that is made from dairy products is exempt from the application of paragraphs 4(1)(a) and (d) of the Food and Drugs Act and section D.03.002 of the Food and Drug Regulations, in respect of the vitamin D that is present in the food, if the applicable condition set out in subsection (2) is met.
Condition
(2) The food must contain the following amount of vitamin D:
- (a) in the case of plain drinkable yogurt, 5.2 μg of vitamin D per 100 mL; or
- (b) in the case of fruit or flavoured drinkable yogurt, not less than 3.9 μg and not more than 5.2 μg of vitamin D per 100 mL.
Kefir
4 (1) Kefir that is made from dairy products is exempt from the application of paragraphs 4(1)(a) and (d) of the Food and Drugs Act and section D.03.002 of the Food and Drug Regulations, in respect of the vitamin D that is present in the food, if the applicable condition set out in subsection (2) is met.
Condition
(2) The food must contain the following amount of vitamin D:
- (a) in the case of plain kefir, 2.7 μg of vitamin D per 100 mL; or
- (b) in the case of fruit or flavoured kefir, not less than 2.3 μg and not more than 2.7 μg of vitamin D per 100 mL.
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
Vitamin D is important for bone health yet many people in Canada are not getting enough. To help address this, a Marketing Authorization (MA) is being introduced to permit manufacturers to voluntarily add vitamin D to yogurt (including drinkable yogurt) and kefir that are made from dairy products. This MA is enacted under subsection 30.3(1) of the Food and Drugs Act (FDA).
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 sufficient 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 (2012–2019), the prevalence of vitamin D inadequacy is 19%. This means that approximately one in five people living in Canada has vitamin D blood values that are generally considered inadequate for bone health. Furthermore, almost half of this group have blood values so low that they are at elevated risk of deficiency symptoms such as weak bones.footnote 1
The Food and Drug Regulations (FDR) control the addition of vitamins, mineral nutrients and amino acids to foods. When vitamin, mineral nutrients or amino acids are added to foods to restore or improve their nutritional quality, this process is called fortification. Grounded in Codex Alimentarius’ principles, Health Canada’s fortification policy helps prevent nutrient deficiencies in the population and maintain or improve the nutritional quality of the food supply, while also protecting against overconsumption. Codex principles make it clear that the food vehicle that delivers the nutrient must reach the intended population and the level of addition must be significant to help prevent or correct the deficiency. To this end, Canada’s fortification policy is informed by Canadian dietary intake and nutrient status data and may differ from the policies of other jurisdictions.footnote 2 To decrease the rates of vitamin D inadequacy and support adequate bone health, the FDR sets out rules for the addition of vitamin D to foods sold in Canada that, depending on the food, can be either voluntary or mandatory. On July 20, 2022, the FDR was amended, increasing the required vitamin D amounts in cow’s milk and margarine, and the permitted vitamin D amount in goat’s milk. Yet, it is still challenging for people in Canada to consume the recommended amounts of vitamin D through the current food supply. More food sources of vitamin D are needed to help people in Canada meet their dietary requirements, especially for those who consume little or no milk or margarine.
Currently, the FDR does not permit the addition of vitamin D to yogurt or kefir (a fermented milk drink similar to a thin yogurt). However, both yogurt and kefir made from dairy products were identified as new vehicles for vitamin D fortification because they contain calcium, which is also critical to bone health. Furthermore, intake data from the Canadian Community Health Survey-Nutrition (CCHS) shows that the prevalence of their consumption is increasing. Between 2004 and 2015, CCHS data show that yogurt consumption increased by about 45%. By 2015, one in five people in Canada reported consuming yogurt or kefir made from dairy products the previous day and, on average, one serving was consumed. The selection of these vehicles aligns with Codex food fortification principles which state that the food(s) selected for nutrient addition should be habitually consumed in sufficient amounts by the target population.
When setting a nutrient amount for food fortification, Codex principles state that the amount should not result in either an insignificant or excessive intake of the added nutrient. With this in mind, Health Canada established vitamin D amounts for yogurt and kefir as outlined in the Description section below. Dietary intake modelling was conducted to assess the impact of permitting the addition of vitamin D to yogurt and kefir on the vitamin D intakes of people in Canada. Results showed that fortification of these foods would lead to an improvement to vitamin D intakes without posing a risk of excess consumption. These results suggest that enabling the addition of vitamin D to yogurt and kefir will help bring the vitamin D intakes of the population closer to dietary requirements, thereby decreasing the rates of vitamin D inadequacy and supporting bone health.
Objective
The objective of the MA is to expand the food sources that may be eligible to contain vitamin D to help people in Canada meet their dietary requirements and promote adequate bone health without creating the risk of excessive intakes. Permitting manufacturers to voluntarily add vitamin D to yogurt (including drinkable yogurt) and kefir that are made from dairy products will achieve this objective.
Description
The MA will enable manufacturers to voluntarily fortify yogurt, drinkable yogurt and kefir made from dairy products with vitamin D by creating an exemption to certain prohibitions found in the FDA and FDR. The sale of yogurt, drinkable yogurt and kefir containing added vitamin D is prohibited under paragraphs 4(1)(a) and (d) of the FDA and section D.03.002 of the FDR; however, the MA will exempt these products from the application of these prohibitions, only in respect of vitamin D that is present in these products, as long as the levels of vitamin D are within the amounts indicated in the table below.
For plain yogurts and kefirs, the amounts were set to ensure that one serving of most products contains at least 25% of the daily value (DV) for vitamin D; products containing this quantity of vitamin D are permitted to make an “excellent source” claim. It should be noted that, for kefir, the amount of vitamin D fortification per 100 mL is set at a lower level because consumption data indicates 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, consumers will get a similar amount of vitamin D from their consumption of either yogurt or kefir.
For fruit or flavoured yogurts and kefirs, a range of vitamin D levels is set out. This approach accommodates the practical nuances of the yogurt and kefir production process by allowing manufacturers to fortify the plain batch that is then combined with other ingredients to make fruit or flavoured yogurt or kefir. This will confer a number of advantages such as maintaining production efficiencies, ensuring homogeneity of vitamins, and reducing waste. The ranges set out were informed by data provided by the dairy industry on the proportion of plain yogurt and kefir used to make fruit and flavoured yogurts. For example, fruit and flavoured yogurt contain 75% to 95% plain yogurt and could, therefore, achieve a minimum vitamin D level of 3.8 micrograms (μg)/100 grams if made using plain yogurt fortified to contain 5 μg/100 g.
Food | Vitamin D |
Yogurt made from dairy products | |
---|---|
Plain | 5 μg/100 g |
Fruit or flavoured | 3.8 to 5 μg/100 g |
Drinkable yogurt made from dairy products | |
Plain | 5.2 μg/100 mL |
Fruit or flavoured | 3.9 to 5.2 μg/100 mL |
Kefir made from dairy products | |
Plain | 2.7 μg/100 mL |
Fruit or flavoured | 2.3 to 2.7 μg/100 mL |
Coming into force and transitional provisions
This MA will come into force upon registration.
Regulatory development
Consultation
Health Canada has consistently communicated with stakeholders regarding plans to permit vitamin D fortification of yogurt. External communications regarding the vitamin D fortification strategy began in 2015 when Health Canada shared its proposed approach with academic stakeholders at a Best Brains Exchange, an event co-hosted by the Canadian Institutes of Health Research and Health Canada that was attended by vitamin D experts, as well as other health stakeholders such as Dietitians of Canada and Osteoporosis Canada. The proposal put forth was to increase the mandatory level of vitamin D in milk, fortified plant-based beverages, and margarine, and to permit the voluntary addition of vitamin D to yogurt. With regards to yogurt, the attendees strongly supported the proposal.
In 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. Although the focus of the meeting was on milk and margarine, there was also discussion regarding yogurt. Stakeholders supported the proposal to allow vitamin D addition to yogurt.
In 2018, Health Canada prepublished its proposal to increase vitamin D levels in milk and margarine in the Canada Gazette, Part I, for a 75-day consultation period. In response, Health Canada received several comments related to expanding the proposed policy beyond milk and margarine. A range of stakeholders (health, consumers, academics and industry) expressed support for the addition of vitamin D to yogurt and other cultured dairy products such as kefir to benefit people whose dietary patterns regularly include such foods and who may not consume milk.
In January 2022, an MA was published to permit increased vitamin D levels in milk and margarine, thus implementing the first step of the vitamin D fortification strategy. This MA was an interim measure until the FDR were amended in July 2022 to increase the amount of vitamin D required in milk and margarine, and to permit vitamin D addition to goat’s milk. At that time, Health Canada communicated, through the Regulatory Impact Analysis Statement, that the final planned step of its strategy would be to allow the vitamin D fortification of yogurt.
In fall 2022, Health Canada sent a survey via the Dairy Processors Association of Canada to the top three yogurt manufacturers in Canada to gauge their interest in adding vitamin D to their products. All three manufacturers confirmed their strong support for and interest in adding vitamin D to many of their yogurts as soon as it could be permitted.
Notice of Intent
On July 26, 2023, Health Canada met with targeted industry and health stakeholders to raise awareness of the planned publication of a notice of intent (NOI) regarding the MA to permit the voluntary fortification of vitamin D in yogurt and kefir made from dairy products, as well as the MA to expand the eligibility for the dairy-related exemptions from front-of-package nutrition labelling. Health Canada officials provided a brief overview of both proposals. Twenty-five participants joined the meeting, including representatives from four industry associations and four health associations.
On July 28, 2023, Health Canada published an NOI online and sent an email to over 7 100 accounts registered with the Department’s Consultation and Stakeholder Information Management System (CSIMS) informing recipients of the Minister of Health’s intention to permit the vitamin D fortification of yogurt and kefir made from dairy products (via enactment of one MA) as well as to expand the eligibility for the dairy-related exemptions from FOP nutrition labelling (via the enactment of another MA).
Stakeholder comments relating to the MA for Vitamin D in Yogurt and Kefir
Health Canada received 66 submissions in support of the proposal to permit vitamin D fortification of yogurt and kefir made from dairy products. An additional three comments were received where it was unclear whether the respondent supported the proposal. A range of stakeholders provided feedback, including 27 dairy farms, 20 industry associations, 11 manufacturers, three non-government organizations (NGOs), two academics, two consumers, one health professional organization, one health professional, one government representative and one consultant. Fourteen of the 66 supportive submissions were unique (i.e. non-template letters) and the remainder were template letters submitted by dairy farmers and manufacturers. There were a few technical comments submitted, mainly from industry, that are summarized below.
Three industry associations requested that Health Canada consider permitting a range of vitamin D levels rather than a single level. The main argument supporting this request was that enabling a range of levels would help to accommodate the practical nuances of yogurt and kefir production by allowing fortification of the plain batch that is used as an ingredient in fruit and flavoured products. In this manner, fortification could occur during manufacturing of the plain batch rather than at the finished product stage. This would confer a number of benefits including maintaining production efficiencies, ensuring homogeneity of vitamins and reducing waste. Another rationale presented to support the request for a vitamin D range was that it would allow manufacturers to market products with varying vitamin D amounts.
One industry association and a health professional recommended expanding the scope of the policy to include plant-based alternatives to yogurt and kefir. There were several reasons to support this recommendation including that people following a plant-based diet may face greater challenges consuming adequate vitamin D and that such an approach would align with evolving dietary preferences and the recommendation in Canada’s food guide to choose protein foods that come from plant sources more often.
Some industry stakeholders pointed out that certain provinces, including Quebec, Manitoba and Nova Scotia, have standards of identity for yogurt which could pose challenges, especially regarding compliance, when applying federal fortification rules. This means that some products recognized as yogurt outside of these provinces may need alternative designations (e.g. “yogurt-like products”) when sold within these provinces. One industry stakeholder asked for clarification on how to address contradictions between provincial standards and federal rules for dairy products in Quebec.
Other comments from industry were that the use of fortified milk as an ingredient in yogurt manufacturing should continue to be permitted without the need to also add vitamin D to the product; the scope of the MA should be expanded to include organic yogurt; and the overage and rounding rules should be provided by Health Canada. One industry association and one industry representative recommended that Health Canada should prioritize other amendments related to vitamin D and specifically referred to the fortification of breakfast cereals that has been permitted under Temporary Marketing Authorizations since 2012. The industry association also recommended that the Department prioritize the modernization of its fortification regulations such as addressing the expired interim marketing authorizations. Finally, an NGO encouraged the Department to commit to ongoing monitoring to ensure vitamin D intakes remain within safe limits.
Health Canada’s response to comments relating to the MA for vitamin D in yogurt and kefir
To account for practical concerns raised by industry, Health Canada has adjusted the policy to permit a vitamin D range for fruit or flavoured yogurts and kefirs that are made from dairy products. The range is set on the basis that the plain batch of yogurt or kefir used to manufacture these products would be fortified to contain the levels proposed in the NOI. The lower end of the range was informed by data provided by industry on the proportion of plain yogurt used in fruit or flavoured yogurts and kefirs. The range was not decreased to the extent requested by industry to accommodate marketing purposes since enabling the addition of vitamin D to yogurt and kefir is to address a public health need. The revised approach will ensure that most plain yogurts and kefirs contain at least 25% of the DV for vitamin D, while most fruit or flavoured yogurts and kefirs contain at least 20% of the DV.
Health Canada recognizes that some people do not consume animal-based foods such as dairy-based yogurt and kefir and instead choose alternative foods. When permitting fortification of alternative foods, it is important that the alternative food contains the same key micronutrients (i.e. vitamin and mineral nutrients) as the food it is intended to replace. Dairy-based yogurts and kefirs contribute many important micronutrients to the diets of people in Canada such as calcium and vitamin B12. When fortification regulations are modernized in the future, Health Canada will consider enabling the fortification of plant-based alternatives to dairy yogurts and kefirs with all of the important micronutrients contained in dairy-based yogurts; this would include vitamin D. In the meantime, the Department has authorized the sale of some fortified plant-based alternatives to dairy yogurt through Temporary Marketing Authorizations.
Health Canada met with one industry association to discuss the provincial standard of identity issues. The stakeholder explained that they plan to work on resolving this issue at the provincial level and requested that the Department formally notify the provinces and territories of their intent to permit the voluntary addition of vitamin D to yogurt and kefir that are made from dairy products. On November 7, 2023, Health Canada sent a letter to its provincial and territorial partners to notify them of this intent.
Health Canada wishes to clarify that the use of fortified milk as an ingredient in yogurt and kefir manufacturing will continue to be permitted without the need to fortify these products with vitamin D to achieve the levels in the MA.
Another point to clarify is that the MA enables the addition of vitamin D to all dairy-based yogurts and kefirs, regardless of claims such as “organic.” In addition, it is the responsibility of the manufacturer to determine the appropriate levels of overage required, for all nutrients, in accordance with good manufacturing practices. Rounding rules for presenting vitamin D on the product label are published online.
The Department is developing plans to modernize Canada’s food regulations. When fortification-related regulations are modernized, Health Canada plans to address any outstanding issues. This may include updating the FDR to permit the addition of vitamin D to all breakfast cereals and incorporating elements of the expired interim marketing authorizations. Specific timelines have not been identified for this work.
Health Canada will continue to monitor the vitamin D intakes and status of people in Canada through tools such as the Canadian Health Measures Survey. Monitoring will help the Department determine if further changes to the vitamin D fortification strategy are needed.
Modern treaty obligations and Indigenous engagement and consultation
As required by the Cabinet Directive on the Federal Approach to Modern Treaty Implementation, an assessment of modern treaty implications was conducted. The assessment did not identify any modern treaty implications or obligations.
Instrument choice
The MA was selected as a tool for advancing the voluntary addition of vitamin D to yogurt and kefir made from dairy products since it is the most immediate method for enabling increased vitamin D amounts in the food supply to help address inadequate vitamin D status among people in Canada and support bone health.
Regulatory analysis
This section provides a brief description of the potential impacts of the MA on industry stakeholders involved in the manufacturing and/or importation of kefir and yogurt in Canada; consumers of these products; and Health Canada and the Canadian Food Inspection Agency (CFIA).
As the MA is permissive in nature, industry stakeholders can decide if they would add vitamin D to yogurt and kefir made from dairy products, or continue with supplying existing products in the Canadian market.
In response to a targeted survey by Health Canada, the three largest yogurt manufacturers in Canada reported interest in adding vitamin D to a combined total of 300 to 400 stock-keeping units (SKUs) of yogurt once permitted to do so. These estimates will be used in this cost-benefit analysis.
The revenue of the yogurt market is reported at $2.9 billion (CAD) in 2022.footnote 3 Annual growth rates were seen in the revenue of the yogurt industry in Canada between 2018 and 2022, and it is expected that the revenue will continue to grow in coming years. Canada imported $5.75 million worth of yogurt and exported $75.6 millionfootnote 4 in 2022.footnote 3, footnote 5The compound annual worldwide revenue growth rate for kefir between 2017 and 2021 was 2.9% and it is expected to reach 3.5% in the period between 2022 and 2032.footnote 6 This suggests that the consumption of yogurt and kefir in Canada is likely to increase in the future.
Due to the permissive nature of the MA, this cost-benefit analysis will not quantify these impacts.
Costs
The top three yogurt manufacturers in Canada have indicated that they intend to add vitamin D to up to 50–75% of their SKUs (approximately 300 to 400 SKUs in total).footnote 7 This suggests that some industry stakeholders may take this opportunity to increase their market shares and to expand the market segments of yogurt and kefir by diversifying the range of their products. As this is a permissive rule, Health Canada believes that these stakeholders will decide to add vitamin D to their yogurts or kefirs based on the potential benefits to their businesses (such as to maximize profit by capturing a bigger market share through these initiatives). Therefore, no incremental cost is estimated since these actions are considered to be voluntary business decisions.
Health Canada believes that this regulation will not result in any price effect on the supplies of yogurt and kefir in the Canadian market due to the competitive nature of the food market in Canada. If more people in Canada decide to consume yogurts and kefirs as a source of vitamin D following the amendments, it is believed that manufacturers would match the increase in demand of these foods. Due to the voluntary nature of the MA, Health Canada also assumes that this regulation will not cause any domestic or international manufacturers to discontinue supplying existing products in Canada. Moreover, different brand names of yogurts and kefirs are available in Canada. If the MA results in any product discontinuation, it is anticipated that these discontinued products would be easily substituted. Therefore, it is assumed that the regulations will not lead to significant inconvenience to consumers of yogurts and kefirs in Canada due to product accessibility.
There are no anticipated additional operational costs for Health Canada with respect to this MA as it will enable the Department to permit the vitamin D fortification of yogurt, drinkable yogurt and kefir made from dairy products. As Health Canada is not establishing any additional regulatory requirements for industry under this MA, it does not expect a change in compliance and enforcement activities for the CFIA. It is assumed that any potential incremental efforts would be minimal and manageable within existing government resources and that any incremental change in costs would be negligible.
Benefits
The MA will provide opportunities to industry stakeholders to diversify their supplies of yogurt and kefir in the Canadian market. It is assumed that some yogurt and kefir or related industry stakeholders may benefit from a bigger market through the expansion of the market segment by supplying products containing vitamin D.
The MA will have an important health impact for people in Canada. Permitting the vitamin D fortification of yogurt and kefir will create more options to help people in Canada meet their dietary requirements and in turn will help them improve vitamin D status and support their bone health. It is anticipated that permitting vitamin D fortification of yogurt and kefir made from dairy products will also help to reduce the risk of certain bone diseases and deficiency symptoms, thereby, potentially reducing health care spending on their treatment.
Small business lens
The small business lens does not apply to the MA as it is a permissive proposal in that it creates exemptions from certain prohibitions found in the FDA and the FDR, if certain conditions are met. Similar conditions are applicable to all businesses, without imposing additional administrative or compliance costs on small businesses. Small businesses may benefit from this MA as it may provide an opportunity for them to diversify the range of yogurt and kefir products in the Canadian market. This MA may strengthen the sustainability of small businesses in the Canadian market.
One-for-one rule
The one-for-one rule applies, as these permissive requirements will be introduced as a new MA (which is considered an “IN”). However, Health Canada will be repealing several MAs including the Marketing Authorization for Vitamin D in Milk, Goat’s Milk and Margarine. As the current MA does not introduce any additional reporting requirements, Health Canada considers it to be administratively neutral.
Regulatory cooperation and alignment
Similar to Canada’s approach, in the United States and certain European countries, the addition of vitamin D to yogurt and kefir made from dairy products is voluntary.
Prior to the coming into force of this MA, foreign manufacturers, whether from the U.S. or from other countries, were not allowed to sell fortified yogurt in Canada. This MA will, therefore, allow for greater trade opportunities when compared with the status quo. For example, the United States Food and Drug Administration (U.S. FDA) has a standard of identity for yogurt made from dairy products. Products meeting the U.S. FDA yogurt standard that contain added vitamin D must provide a minimum of 1.2 μgfootnote 8/100 g (10% DV per Reference Amount Commonly Consumed) [21CFR131.200(d)(8)(ii)]. The maximum quantity of vitamin D permitted in yogurt and kefir made from dairy products in the United States is 2.2 µg/100 g [21CFR184.1950; CFR 170.3(n)(31)]. Yogurts and kefirs fortified under U.S. FDA requirements will not achieve the minimum levels of vitamin D required by the MA. However, U.S. manufacturers will now have the opportunity to increase vitamin D amounts in their fortified products to align with the levels established in this MA to sell their products in Canada.
Strategic environmental assessment
In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a preliminary scan was conducted which concluded that there will be no expected important environmental effects, either positive or negative; therefore, a detailed analysis is not required.
Gender-based analysis plus
In Canada, most racialized groups are reported to have an elevated prevalence of vitamin D inadequacy according to blood status data from the Canadian Health Measures Survey.footnote 1 Yogurt and kefir are useful vehicles for vitamin D fortification because they are consumed by a meaningful proportion of people in all racial groups. People of South Asian and Middle Eastern descent may particularly benefit from vitamin D addition to yogurt and kefir as these foods are commonly consumed by these groups (2015 CCHS, unpublished data). They are also among the racialized groups with the largest prevalence of vitamin D inadequacy: 37% and 39% of people of South Asian and Middle Eastern descent have inadequate vitamin D blood status, respectively.footnote 1
Implementation, compliance and enforcement, and service standards
Implementation
Health Canada will post information about this MA on its website and will notify stakeholders accordingly. The requirements associated with this MA are permissive in nature, and manufacturers can decide whether they wish to align with the requirements set out in the MA or whether they wish to continue complying with the requirements set out in the FDR. The new permissive requirements relating to vitamin D fortification of the MA come into force upon its registration and manufacturers are not required to submit a premarket notification or a Temporary Marketing Authorization application.
Compliance and enforcement
Compliance and enforcement of this 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, Suite P2108
11 Holland Avenue
Ottawa, Ontario
K1A 0K9
Address locator: 3000A
Email: lrm.consultations-mlr@hc-sc.gc.ca