Canada Gazette, Part I, Volume 155, Number 26: Regulations Amending the Food and Drug Regulations (Supplemented Foods)

June 26, 2021

Statutory authority
Food and Drugs Act

Sponsoring department
Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Executive summary

Issues

Unlike regular food, supplemented foods contain added supplemental ingredients that can pose a risk to health if they are consumed in excess by the general population or if consumed by vulnerable populations such as children and pregnant women. The FDR do not have provisions that permit the sale of supplemented foods in Canada. However, as an interim measure, Health Canada has issued TMAs to allow select supplemented foods on the market on a case-by-case basis.

Under the TMA framework, Health Canada reviews applications for supplemented foods submitted by industry to determine if the supplemental ingredients they contain are safe for consumers. If the safety of the supplemented food can be sufficiently demonstrated, Health Canada issues a TMA letter which includes certain conditions that the manufacturer or distributor must meet in order to sell the product.

As part of the conditions of their TMA, Health Canada requires industry to provide research, sales data, and incident reports on their supplemented foods while they remain on the market. This has allowed the Department to learn more about supplemented foods and to develop specific regulations for them. In the meantime, however, industry has raised concerns that the process to obtain a TMA is unpredictable and time-consuming as the information Health Canada requests may vary from one application to another. Industry has also noted that the TMA requirement to report back regularly to Health Canada on their product is resource-intensive.

In addition, under the TMA framework, Health Canada has permitted only certain categories of food to be eligible as supplemented foods. With a growing interest among industry to introduce different types of supplemented foods to the market, these stakeholders have voiced that the lack of a clear path to market for supplemented foods has been a barrier to innovation.

A new framework in the FDR is needed to provide a predictable regulatory environment for supplemented foods that continues to protect the health and safety of Canadians, while also allowing industry to bring new and innovative products to market.

Background

Supplemented foods are prepackaged foods containing one or more added supplemental ingredients, which are vitamins, mineral nutrients, amino acids, or other ingredients (e.g., caffeine, herbal extracts), which have historically been marketed for the purpose of providing specific physiological or health effects. This includes, for example, beverages with added minerals marketed for hydration, caffeinated energy drinks (CEDs) marketed for temporarily restoring mental alertness, and snack bars with added vitamins marketed for the maintenance of good health.

While there are no safety concerns with consuming regular food as much or as often as desired, consuming supplemented foods may pose a risk because of the supplemental ingredients they contain. Namely, there can be health and safety concerns if the general population overconsumes supplemental ingredients or if vulnerable populations are exposed to them. For example, excess calcium intake has been associated with kidney stones and supplementation with single amino acids may cause an amino acid imbalance which can lead to stunted growth. Because of their potential risks, it is not suitable for supplemental ingredients to be added to food unless this is carried out according to specific safety requirements.

Supplemented foods differ from fortified foods in that fortification involves adding vitamins and mineral nutrients for an established public health purpose, such as mandatory addition of vitamin D to milk to help address bone diseases such as rickets in children. Supplemental ingredients also differ from food additives that are typically used to achieve a technical effect on the food, such as guar gum which is used as a thickening agent. Health Canada has assessed the use of food additives and the addition of nutrients for public health purposes and has set out conditions in regulations under which these ingredients may be safely used in food. However, in the case of foods containing supplemental ingredients, conditions for reducing the risks associated with permitting these foods on the market are yet to be established in the FDR. As a result, the sale of supplemented foods is currently prohibited in Canada except in the cases where Health Canada has issued a TMA.

Supplemented foods were not permitted to be sold under the FDR prior to 2012, leading manufacturers to market their supplemented foods as natural health products (NHPs). In late 2011, the Minister of Health announced the intent to regulate CEDs and other NHPs as foods based on their product format, history of use, representation to consumers and public perception. Subsequently, Health Canada transitioned hundreds of NHPs to the food regulatory framework. Those products containing ingredients at levels considered safe for consumption were allowed to be sold temporarily as foods under a TMA. Since then, manufacturers have also been able to apply for TMAs for new supplemented foods to access the market.

A TMA is a regulatory tool that Health Canada may use to authorize a manufacturer to sell, for a specified period of time, a food that could not otherwise be sold because it does not comply with specific requirements of the FDR. As a condition of the TMA, the manufacturer must generate information related to the product while it is on the market and must provide this information to Health Canada to support future regulatory amendments. In the case of supplemented foods, the research and data obtained from the TMAs since 2012 includes public opinion research, consumption patterns, sales data, and consumption incident reports. This has allowed Health Canada to learn more about these products and their related risks and has informed the development of the proposed regulations.

Industry stakeholders have raised concerns that marketing supplemented foods under the TMA requirements imposes a significant amount of administrative burden and have identified the lack of a predictable framework for these products as a regulatory impediment to bringing products to market. Accordingly, the initiative to establish a new framework for supplemented foods was put forward in the Government of Canada's June 2019 Agri-food and Aquaculture Regulatory Review Roadmap. One of the key issues identified in the Roadmap under the theme of “Clear, Agile, Responsive Regulations” is that food regulations are out of date, thus limiting flexibility and industry's ability to innovate. Health Canada has committed to address this issue by taking the steps necessary to redesign food regulations, including the development of a new regulatory framework for supplemented foods. This commitment can be found in the Department's Forward Regulatory Plan, as part of its initiative to “Modernize food regulations to enable innovative and safe foods for Canadians”.

Objective

The objective of these proposed amendments is to establish a regulatory framework for supplemented foods in Canada. The proposed regulations would help protect the health and safety of Canadians; while providing a clear and predictable regulatory environment for supplemented foods. This objective would be achieved by the development of a risk-based regulatory framework for supplemented foods that:

• Reduces the risks of overconsumption within the general population, as a well as risks of exposure for certain vulnerable groups within it (e.g., children, pregnant women);
• Supports consumers' ability to distinguish supplemented foods from conventional foods, understand the health risks associated with these products, and make more informed choices related to their consumption; and
• Provides flexibility to adapt to new evidence related to supplemented foods and supplemental ingredients, thus supporting innovation in the food industry.

Description

The proposed regulations would amend the FDR to create a new Division 29 in Part B that sets out a regulatory framework for supplemented foods. Numerous related amendments in existing Divisions of Part B and Part D (Vitamins, Minerals and Amino Acids) are also proposed.

Definitions

In Division 1, Part B of the FDR, the proposed regulations would amend the existing definitions of “agricultural chemical” and “food additive” to exclude supplemental ingredients and the existing definition of “specialty food” to exclude supplemented foods. The proposed regulations would also introduce and define the following elements to support the new supplemented foods framework:

• The “List of Permitted Supplemented Food Categories” would be defined and incorporated by reference in the FDR through the definition of “supplemented food”. This list would capture the specific categories of food to which supplemental ingredients may be added.
• The “List of Permitted Supplemental Ingredients” would also be defined and incorporated by reference in the FDR through the definition of “supplemental ingredient”. This list would capture all of the substances that may be added to a specified food as a supplemental ingredient grouped by vitamins, mineral nutrients, amino acids, and other supplemental ingredients (including caffeine). The list would also set out the detailed conditions of use for each supplemental ingredient in order for the supplemented food to be sold in Canada. The conditions include:
  • The food categories in which the supplemental ingredient is permitted (with reference to the List of Permitted Supplemented Food Categories);
  • The maximum level of use of the supplemental ingredient in the product;
  • Cautionary statements that are required on the label of the product, if applicable; and
  • Other conditions of use specific to a supplemental ingredient, if applicable. For example, in order for caffeine to be added to a beverage as a caffeinated energy drink, the product would be subject to additional conditions and restrictions related to its composition, and the information required on its label.
• “Supplemental ingredient” would be defined as a nutrient, including a vitamin, mineral nutrient, amino acid, or any other substance listed in the List of Permitted Supplemental Ingredients and added as an ingredient to a food according to the corresponding conditions set out in that list. A new provision would also clarify that when a supplemented food is used as an ingredient in the manufacturing of another supplemented food, the supplemental ingredient in the first food is also a supplemental ingredient in the second food and subject to the same conditions of use in the List of Permitted Supplemental Ingredients.
• “Supplemented food” would be defined as a prepackaged product belonging to a food category specified in the List of Permitted Supplemented Food Categories to which a supplemental ingredient has been added. The definition would also exclude the following food categories from ever being supplemented foods due to the higher level of risk associated with them, or because they are subject to other regulatory provisions in the FDR:
  • Foods that are fortified for public health purposes (except prepackaged water);
  • Foods labelled and advertised for consumption by infants, children one year of age or older but less than four years of age, or women who are breastfeeding or pregnant;
  • Foods for special dietary use (except gluten-free foods);
  • Foods that have not been processed or have been minimally processed; and
  • Beverages with an alcohol content of more than 0.5%.
• “Supplemented food facts table” would be defined as a facts table that supplemented foods must carry on their label. The Supplemented Food Facts table (SFFt) would replace the Nutrition Facts table (NFt) that is required on the label of prepackaged products for displaying nutritional information about the prepackaged product.

The existing definition of “novel food” in Division 28, Part B would be amended to exclude both supplemental ingredients and supplemented foods.

In addition, the proposed regulations would introduce and define the following elements in Division 29, Part B of the FDR:

• The acceptable formats in which a SFFt may be displayed on a supplemented food (e.g., standard, horizontal, linear, simplified, aggregate, and dual formats) would be prescribed in a “Directory of SFFT Formats” which would also be defined and incorporated by reference. A similar “Directory of NFT Formats” already exists for the NFt and is defined in Division 1.
• Supplemented foods that are required to be labelled with a list of cautionary statements would be required to carry a visual identifier on the principal display panel (PDP) of their label. The term “Directory of Supplemented Food Caution Identifier Specifications” would be defined. This Directory would be incorporated by reference and would outline all of the required specifications, including dimensions and spacing, for the supplemented food caution identifier.

Prohibitions and exemptions

Paragraphs 4(1)(a) and (d) of the Food and Drugs Act (FDA) prohibit the sale of food that contain poisonous or harmful substances or that are adulterated. A new provision in Division 29 would exempt a supplement food from the application of this prohibition by indicating that the addition of a supplemental ingredient to a food would not be considered adding a poisonous or harmful substance or adulterating the food if the ingredient is added according to the conditions set out in the List of Permitted Supplemental Ingredients.

Section 6 and subsection 6.1(2) of the FDA and section B.01.042 of the FDR prohibit activities such as the packaging, advertisement or sale of a standardized food if the standard is not respected. Another provision would be introduced in Division 29 to exempt supplemented foods from the application of these prohibitions specifically regarding any supplemental ingredients that have been added to them.

To prevent supplemental ingredients from being added indirectly to foods without respecting the conditions set out in the List of Permitted Supplemental Ingredients, a new provision would prohibit the use of a supplemented food as an ingredient in manufacturing a prepackaged product that is not a supplemented food.

Lastly, to help prevent consumers from mistaking a supplemented food for a regular food, a new provision in Division 29 would prohibit the sale of a prepackaged product containing an assortment of supplemented foods and regular foods of the same type.

The proposed regulations would also exempt supplemented foods from the requirements and prohibitions in Part D of the FDR on the addition of vitamins, mineral nutrients and amino acids to food for public health purposes. The addition of supplemental ingredients, including those which are vitamins, mineral nutrients and amino acids, in food would be subject to the conditions established in the List of Permitted Supplemental Ingredients instead.

Changes to the lists

Health Canada is proposing to create a submission process by which a person may request a change to the List of Permitted Supplemented Food Categories or the List of Permitted Supplemental Ingredients. This process would be the first step to a path to market for innovative uses of ingredients or food categories for supplementation when supporting information can be provided to demonstrate that they would be safe for Canadians. It would also provide an opportunity for a person to request a removal of a substance or change in the conditions of use in respect of a substance, when information can be provided to support the proposed change.

New provisions in Division 29 of the FDR are proposed to outline the information that would need to be submitted in a form and manner established by the Minister of Health to request a change to either list, including:

• Administrative information to identify the submitter of the request;
• A description and a rationale for the proposed change, including any supporting information;
• In the case of a request to add or modify a supplemental ingredient, information about its method of manufacture, its chemical and physical properties, its composition, its specifications, its proposed conditions of use; and information used to establish the safety of the substance under its proposed conditions of use; and
• Information on the estimated level of consumption of the substance or of food belonging to the food category, if applicable.

A new provision is also proposed to allow the Minister of Health to request additional information from the person who submitted the request, if considered necessary, to properly assess whether the proposed change to either list should be made.

Labelling

The proposed framework intends to leverage existing labelling provisions in the FDR for prepackaged products. As all supplemented foods are prepackaged products, general labelling requirements for prepackaged products in Division 1 would apply to supplemented foods as well. These requirements include: bilingual labelling, common name, country of origin, date markings and storage instructions, name and principal place of business, list of ingredients, allergen labelling, lot numbers, net quantity and the legibility and location of this information. For existing labelling provisions that apply to prepackaged products in Division 1, Health Canada is proposing to amend or expand them, or exempt supplemented foods from them, as needed.

In some cases, different or additional labelling requirements are proposed for supplemented foods as part of the new framework to help consumers distinguish these products from regular food, better understand their associated risks, and make more informed decisions related to consuming them. A supplemental ingredient would always be required to be declared in the list of ingredients, even if it is a component of an ingredient that is not otherwise required to be shown on the label. The following new labelling elements would also be set out in Division 29, Part B:

• SFFt

With the exception of those sold in small packages, supplemented foods would be required to carry a standardized SFFt on their labels, which would take the place of the NFt required on most prepackaged products. This requirement would also be applicable to a prepackaged product that contains an assortment of supplemented foods. The SFFt would be similar to the look and format of the NFt and would require the same information about serving size, the energy value (Calories) and the 13 core nutrients to be declared, as well as the percent Daily Value (% DV) interpretative statement. The SFFt would also require the name and absolute amount of each supplemental ingredient to be declared under a mandatory “Supplemented with” heading. Any vitamin or mineral nutrient that is added as a supplemental ingredient as per the List of Permitted Supplemental Ingredients would have to be declared in the SFFt under the “Supplemented with” heading, and a % DV would not be permitted. Therefore, the placement and manner of declaring a vitamin or mineral nutrient would be dependent on whether any amount of it is added as a supplemental ingredient. An interpretative statement following the “Supplemented with” heading would also be mandatory on supplemented foods or products that contain an assortment of supplemented foods. This statement would explain that the amounts of supplemental ingredients declared in the SFFt includes both naturally occurring and supplemental amounts.

While many of the provisions in the FDR associated with the NFt would also be relevant to the SFFt, a new set of provisions for the SFFt would be prescribed in Division 29. This involves replicating and modifying a majority of the provisions associated with the NFt in Division 1; while also creating new provisions to account for differences with the NFt. Where necessary, specific provisions would also carve out requirements for vitamin A and beta-carotene, which when added as supplemental ingredients would have different manners of expression than in regular foods. In addition to requiring the declaration about the nutrients and supplemental ingredients as mentioned above, other specified nutrients would also be permitted to be declared in the SFFt on a voluntary basis (e.g., starch, polyunsaturated fatty acids) in the same manner as in the NFt. The new provisions in Division 29 would also include requirements on: the presentation, location and orientation of the SFFt on the label; options on various formats of the SFFt (e.g., when a supplemented food is to be prepared according to directions provided on the package or combined with other ingredients, or sold as an assortment of similar kinds of supplemented foods); alternative methods of presentation and exceptions for small packages.

A hierarchy of SFFt formats and sizes would be set out in the regulations, with the choice of format based on the same rule as the NFt; that is, no more than 15% of the available display surface needs to be used for the SFFt. If it is not possible to display the SFFt on 15% or less of the available display surface of the package, the regulations would permit alternative methods of presentation of the SFFt, allowing it to be placed on a tag, package insert, the inner side of a label, a fold-out label or an outer sleeve, overwrap or collar. However, as a new rule specific to supplemented foods, including assortments of supplemented foods, the SFFt would not be permitted on a package insert or on the inner side of a label if a list of cautionary statements is required on the product.

With respect to small packages, supplemented foods which have less than 100 cm^{footnote 2} of available display surface would not be required to display a SFFt, except when the label is required to carry a list of cautionary statements or when the label or advertisement carries a representation. However, an indication of how purchasers or consumers may obtain the information would need to be provided on the label.

Specific requirements would be prescribed for supplemented foods that are intended solely to be used as an ingredient in the manufacturing of other supplemented foods intended to be sold to a consumer at the retail level. The proposed regulations would require that written information accompany such a product rather than be attached directly to it, and to be provided in absolute amounts with a degree of precision that corresponds to the accuracy of the analytical methodology. This information would not be provided directly to the consumer but rather to the purchaser (e.g., a manufacturer) and therefore does not need to be in the form of a SFFt or include % DVs. These provisions build on existing requirements for prepackaged products and are intended to capture information about supplemental ingredients.

• Cautionary statements

As part of the conditions that would be prescribed in the List of Permitted Supplemental Ingredients, the addition of certain supplemental ingredients or certain levels of supplemental ingredients would trigger a requirement for the supplemented food to carry cautionary statements on the label. A new provision in Division 29 would require these cautionary statements to be grouped together in a list under a standardized “Caution” heading adjacent to the SFFt. Other provisions related to the appearance of the cautionary statements are proposed and would be based on the existing requirements for the list of ingredients and allergen statements on the labels of prepackaged products. In particular, the cautionary statements must be listed in both English and French, must appear clearly separated from other information on the label, and must be shown according to font and type size requirements to ensure legibility of the information.

• Supplemented food caution identifier (SFCI)

When a supplemented food is required to be labelled with a list of cautionary statements, the proposed regulations would also require the product to carry a SFCI on the label. Prepackaged products would be prohibited from carrying a SFCI, or any representation that may be mistaken for a SFCI, unless they are a supplemented food that is required to carry a list of cautionary statements.

Health Canada is proposing that the SFCI be black and white, include an exclamation mark in addition to the text “Supplemented” and an attribution to Health Canada, and be placed in a prominent, clutter-free space on the upper half of the PDP of the label of the supplemented food, or on the right half of the PDP where the height of the PDP is less than its width. The SFCI would be a visual cue for consumers to examine the cautionary statements for warnings and guidance about consuming the product. New provisions would be prescribed in Division 29 related to the description, appearance/format, legibility and placement of the SFCI. The permitted SFCI format designs would be set out in the FDR in a new Schedule (Schedule K.2). The size of the SFCI would be proportional to the area of the principal display surface (PDS) of the package, with the SFCI size decreasing as the area of the PDS decreases. The hierarchy of formats and sizes would be set out in the Directory of Supplemented Food Caution Identifier Specifications.

Representations

The proposed framework intends to leverage existing provisions in the FDR for prepackaged products with respect to representations. As with labelling, general requirements in Division 1 of the FDR for making representations on a prepackaged product's label would generally apply to supplemented foods as well.

In addition, Health Canada would introduce new provisions in Division 29 that would impose new conditions on the use of representations on the label of a supplemented food:

• For supplemented foods that would be required to carry a list of cautionary statements, representations about the supplemental ingredient that triggered a cautionary statement would be prohibited;
• When a supplemented food is required to carry cautionary statements, any permitted representation on the PDP would be subject to size restrictions compared to the size of the SFCI and any permitted representation elsewhere on the label would be subject to size restrictions compared to the size of the cautionary statements; and
• In the case of supplemented foods that carry the statement “high caffeine content” on their PDP, representations related to the vitamin and mineral nutrient content in the food, physical performance, hydration, or electrolyte replacement would also be prohibited.

The goal of these additional prohibitions is to prevent representations from overshadowing the risks of a supplemented food, to prevent the use of representations that may be vague or misleading, to avoid conflicting messaging for consumers, and overall to help Canadians make informed choices about consuming supplemented foods.

Transition

Existing supplemented foods on the market with TMAs would be provided a transition period of three years to come into compliance with the proposed regulations once they come into force. Although the TMAs would be expired, the proposed regulations would allow these products to remain on the market for the duration of the transition period as long as specific conditions previously applicable under their TMA continue to be met. To benefit from the transition period, these foods could not be subject of a request to be withdrawn and would have to appear in Table 1 of the document entitled Lists of Foods That Have Received Temporary Marketing Authorization Letters (TMALs) on the day the proposed regulations come into force.

Health Canada would continue to accept TMA applications up until the coming into force date of the new regulations and would continue to process these applications following the coming into force date. In the case of applications approved after the coming into force date, the manufacturer would receive written notification from the Minister that their product is authorized to be sold under conditions set out in the transitional provisions and based on existing requirements under the TMA framework. These products would also be provided the remainder of the three-year transition period for complying with the new regulations, as long as they remain in compliance with the conditions in the transitional provisions.

As for new supplemented foods coming to market following the coming into force of the new regulations, they would be required to comply immediately with the new regulations.

Regulatory development

Consultation

Health Canada has conducted the following preliminary research and consultation activities to obtain early feedback from consumers and impacted stakeholders on the policy elements of the proposal. Health Canada took into account the combined findings as it developed and refined the regulatory proposal in preparation for pre-publication in the Canada Gazette, Part I.

Consumer research

Health Canada collaborated with an academic institution to conduct food environment and consumer research on supplemented foods. The initial series of consumer studies used interviews and discussion groups with Canadians of varying health literacy levels for subjective feedback on proposed labelling options for supplemented foods. Refinements to the proposed labelling requirements were objectively tested with over 4000 Canadians of varying health literacy levels using a randomly controlled, online mock package trial. The consumer research found that:

• A front-of-package text-based identifier or a symbol-based identifier beside the common name of the food when placed in a prominent, clutter-free space on the front of a food package are equally useful formats for identifying a supplemented food;
• Replacement of the NFT with a SFFt designed with a similar look and feel to the NFt responds to consumer feedback concerning trust and credibility;
• Quantitative listing of all supplemental ingredients in the SFFT in combination with listing of each supplemental ingredient in the list of ingredients helps consumers access information about the detailed contents of the SF;
• A distinct and consistent “Caution” heading that stands out from other information on a label makes the cautionary information more noticeable to consumers; and
• Placement of cautionary statements in proximity to the list of supplemental ingredients helps consumers link the cautionary labelling to specific ingredients in the product.

Pre-consultations

In fall 2020, Health Canada held targeted pre-consultation meetings with stakeholders to provide an overview of the proposed approach to regulating supplemented foods. The purpose was to obtain initial feedback on key policy elements and to inform the development of the regulatory proposal. Three separate sessions were held virtually with industry associations, key health stakeholders, and small businesses. Health Canada also held several follow-up meetings with industry associations to receive feedback and to answer additional questions related to the proposal.

During the pre-consultation meetings, health and industry stakeholders mainly asked questions to obtain a better understanding of the proposal and its implications. Health stakeholders were in favour of the restrictions to representations on supplemented foods and expressed that they would like to see more done to inform consumers about the higher sugar content in many of the supplemented foods, especially beverages.

Overall, industry stakeholders viewed the proposed framework for supplemented foods as a positive change from the current challenges under the TMAs. In particular, industry was supportive of no longer having to submit annual reports to Health Canada as they consider this TMA requirement to be a significant administrative burden. They also took the opportunity to raise some initial concerns based on the preliminary information shared:

• Industry associations expressed concerns about not being allowed to make representations for a supplemental ingredient that triggers a cautionary statement. Industry found that this would have a negative impact on their business as these representations are used to help market the benefits of their products. Health Canada's response was that it is to avoid conflicting messaging for consumers and helping them make informed decisions related to their health.
• Industry associations also questioned the need for a SFCI, particularly for CEDs, indicating that consumers are familiar with CEDs and can easily distinguish them from other beverages. In response, Health Canada noted that for health and safety reasons, it is important to have consistent labelling across all supplemented foods to help consumers identify supplemented foods with cautionary statements.
• Small businesses raised some concerns that supplemented foods containing added caffeine would be subject to additional labelling requirements and would be disadvantaged compared to foods containing caffeine that is naturally present and not added (e.g., coffee, tea). Health Canada explained that the scope of the proposed framework is limited to foods with added supplemental ingredients but noted that a broader strategy to regulate caffeine is currently being considered.
• Industry stakeholders requested a reasonable transition period to help minimize costs as it relates to label changes and reformulation for existing products on the market. They also indicated that it would be important for their business planning for Health Canada to continue reviewing TMA applications submitted up until the final publication of a new framework. Health Canada confirmed that it would consider these concerns as it develops its transition approach. Subsequently, Health Canada committed to continue accepting TMA applications until the coming into force of the new regulations and to provide an adequate transition period.

Cost-benefit analysis survey

In the fall of 2020, Health Canada sent industry stakeholders a cost-benefit analysis (CBA) survey requesting feedback on the proposed framework. The survey was sent to 60 members of industry, including four associations, which currently have a supplemented food TMA. The response rate for the survey was roughly 12%, with responses received from two associations that represent approximately 70% of the supplemented food industry, one larger business and four small businesses.

Overall, the survey responses indicated that industry was generally in support of the implementation of the new framework, as it would eliminate the existing TMA process for all supplemented foods, which is cumbersome and complex.

Many of the same concerns that were heard during the pre-consultations were also raised in their responses to the CBA survey. However, industry emphasized some additional concerns with certain aspects of the proposed approach, the major ones being:

• The potential for fewer innovative products if certain supplemental ingredients or certain levels of supplemental ingredients which are currently allowed on the market would no longer be permitted;
• The potential to not be able to introduce new kinds of products if the products were limited to certain product categories;
• The potential incremental cost resulting from new labelling requirements;
• The potential impacts of a transition period that may be too short; and
• The potential impact on small businesses, especially if the product affected is core to the business.

Survey responses highlighted specific concerns around the new labelling requirements, some of which were also raised during the pre-consultation:

• The new SFFt could be costly for existing products and could potentially require a complete redesign of the physical product package if a label-only redesign is not possible;
• The restriction on making representations about a supplemental ingredient that triggers a cautionary statement could challenge industries' ability to market to consumers on the benefit of adding these ingredients;
• The use of absolute amounts only instead of % DV for supplemental ingredients in the new SFFt may confuse consumers; and
• The requirement to display a SFCI when other classes of foods could have similar or even higher levels of similar ingredients would be inconsistent.

Health Canada acknowledged these concerns, however, research conducted by Health Canada on labelling of supplemented foods supports a multi-component labelling approach that can be applied consistently across all supplemented foods.

In some cases, the survey respondents suggested that Canada should consider the labelling requirements for supplemented foods used in New Zealand, which requires supplemented food products^{footnote 1} to include “supplemented food” prominently displayed on the label and all advertising materials, and “a name or description of the food sufficient to indicate the true nature of the food”.^{footnote 2} Consistent with the New Zealand approach, Health Canada is proposing a text-based supplemented food identifier.

The respondents had concerns regarding how existing supplemented foods would be transitioned to the new framework. In addition to what was already heard during the pre-consultation, respondents indicated a strong preference for Health Canada to provide a minimum transition period of four years for existing supplemented foods to comply with the new requirements and to align the transition compliance date with that of new food labelling requirements resulting from other regulatory proposals. As such, Health Canada is proposing to continue accepting TMA applications until the coming into force of the new regulations and to provide an adequate transition period of three years after the coming into force to help alleviate burden on all businesses.

Survey respondents also highlighted concerns for impacts on small businesses, indicating a higher cost to small businesses to comply with the proposed regulations. Respondents indicated that updating product labels as a result of the new requirements could be more expensive for small businesses as they lack economies of scale, and could be disproportionately impacted with requiring certain existing products to be reformulated. As small businesses are likely to have fewer products on the market, they could be more significantly impacted if one of their products is affected. Health Canada considered the concerns of small businesses and concluded that a transition period of three years would help alleviate some of the burden for both large and small/medium size enterprises.

Modern treaty obligations and Indigenous engagement and consultation

No impacts on the Government's modern treaty obligations have been identified for this proposal.

Instrument choice

Option 1: Temporary Marketing Authorizations (Status Quo)

There are no provisions in the FDR that specifically permit the sale of supplemented foods in Canada. As a temporary measure, Health Canada has been issuing TMAs following case-by-case safety assessments to allow supplemented foods on the market as the Department gathers information from manufacturers to support amendments to the FDR.

Health Canada has gathered data on supplemented foods over the past decade to support the development of a regulatory framework for these foods. The proposed framework would respond to industry's requests for a predictable regulatory environment for supplemented foods and would address their ongoing concerns that operating under the TMA requirements imposes a significant amount of administrative burden.

Option 2: Non-regulatory approach

The sale of supplemented foods is not permitted by the FDR unless a TMA has been issued. Any non-regulatory approach aimed at permitting their sale would not be viable because it would be inconsistent with the FDR.

Option 3: Regulatory approach (recommended option)

In order to provide transparency for stakeholders and a predictable regulatory environment for supplemented foods to be sold in Canada, amendments to the FDR are recommended. A new regulatory framework for supplemented foods would provide predictability for manufacturers to introduce new and innovative supplemented foods to the market. The proposed regulatory amendments were identified as a Health Canada commitment in the Government of Canada's Agri-food and Aquaculture Regulatory Review Roadmap of June 2019 within the theme of developing clear, agile and responsive regulations. At the same time, the new framework would establish consistent requirements for the sale of supplemented foods to help protect the health and safety of consumers, particularly those belonging to vulnerable groups.

Internationally, there is no consistent regulatory approach to managing supplemented foods. New Zealand is the only country identified that has a specific framework for regulating supplemented foods; its approach was closely considered by Health Canada.

In view of the principles of outcome-based regulations, Health Canada is proposing a risk-based approach for supplemented foods to access the market. The Department would identify supplemental ingredients that may be considered safe when used under specific conditions and in certain food categories, and would capture these in a List of Permitted Supplemental Ingredients and a List of Permitted Supplemented Food Categories. Industry would then have the flexibility to create new products in accordance with the lists and their respective conditions.

At the same time, the proposed framework itself would be responsive and adaptable to requests from individuals, including industry. As Health Canada would manage the lists administratively, it could consider changes to the lists following an appropriate safety assessment without having to go through a regulatory amendment process. This would provide a streamlined path to market for innovative uses of food categories or supplemental ingredients that have not previously been reviewed and assessed to be safe by Health Canada.

Regulatory analysis

Benefits and costs

The full cost-benefit analysis (CBA) report is available upon request. The CBA aims to quantify the proposed benefits and costs of making amendments to the FDR with the introduction of a proposed framework for the regulation of supplemented foods. The analysis describes and quantifies the potential cost savings to both industry and Health Canada by comparing the costs incurred under the current TMA process with the incremental impacts resulting from the proposed regulatory framework. The analysis also quantifies the costs for supplemented foods to transition over to the new regulatory framework by updating labels and product formulations. All calculations for the costs and benefits are projected over a 10-year period, and the net present value is discounted by 7% as required by the Treasury Board Secretariat.

Baseline versus Regulatory Scenario

As an interim measure, Health Canada has issued TMAs to allow select supplemented foods on the market on a case-by-case basis and under certain conditions. Under the TMA framework, manufacturers are required to submit an application for a TMA and once approved, to provide research, sales data, and incident reports to Health Canada on their supplemented food throughout their time on the market. TMAs have allowed Health Canada to collect market data while permitting industry to sell new supplemented foods into the marketplace on a temporary basis. However, with the use of TMAs as a temporary tool, this arrangement creates a burden for both manufacturers to maintain the post-market requirements (i.e., annual consumption incident (CI) reports, annual market sales data and conducting market research) and have Health Canada review this information. In addition, only certain categories of food are eligible as supplemented foods (i.e., beverages and beverage mixes, bars, and confectionaries) under the TMAs.

A new, risk-based approach for regulating supplemented foods would allow products with levels of certain ingredients established as safe to access the market without having to submit a TMA application for review. This approach would be consistent with what is already in place for regular food. At the same time, there is an opportunity for Health Canada to establish a framework that is flexible and can be updated on an ongoing basis. This would allow Health Canada to remain responsive to new evidence related to supplemented foods and to be agile in accepting new food categories or new supplemental ingredients when they become established as safe. The proposed regulatory framework for supplemented foods would provide the opportunity to establish new requirements with respect to labelling, including representations, and to address certain limitations of the TMA framework.

Key Assumptions

• i. All costs and benefits are presented in 2020 dollars.
• ii. A discount rate of 7% is used in the analysis.
• iii. The analysis evaluates the costs and benefits over a 10-year period, thus the study period is presented from 2022 to 2031.
• iv. The regulatory proposal would replace the existing TMA process to permit the sale of supplemented foods on the Canadian market with a risk-based approach.
• v. As of August 2020, there are 611 authorized supplemented food products (equivalent to 611 stock keeping units (SKU)) permitted on the Canadian market through the use of TMAs manufactured by 90 different firms^{footnote 3}. It is unclear how many of these firms hold operations in Canada; therefore, it is assumed that all 90 firms are within scope.
• vi. Based on Health Canada's internal database on TMAs for supplemented foods, this analysis assumes, within the baseline, an average annual growth rate of 10% for the number of firms with supplemented foods and an average annual growth rate of 6% for the number of supplemented foods on the market;
• vii. With the proposed framework in place, it is unclear how these growth rates for the number of firms and supplemented foods on the market would be impacted. Therefore, Health Canada assumes they would remain unchanged from the baseline and would continue to apply going forward;
• viii. Canadian Food Inspection Agency (CFIA) would begin conducting ongoing compliance and enforcement activities in year one, since it is assumed that new supplemented foods entering the market during the transition period are expected to be in compliance with the new framework. Health Canada would support CFIA in conducting one-time implementation activities for the duration of the three-year transition period. Resource requirements for CFIA are assumed to remain constant over the 10-year period;
• ix. Manufacturers of supplemented foods would most likely opt to wait until year three of the three-year transition period to update labels and reformulate products in order to exhaust their current stock of labels and products. This would allow them to reduce product and label waste and have more time to plan and design their new labels.

Costs

The total direct cost to industry for updating labels and reformulating products and to the Government of Canada for implementing compliance and enforcement activities is estimated to be $2.7 million annualized or $19.2 million PV over a 10-year time period.

Costs to Industry

The total direct cost to industry with the proposed supplemented food framework includes the one-time cost of updating labels and product reformulation, which are estimated to be $19.4 million or $15.8 million present value (PV) over a 10-year time period, based on a three-year transition period using a 7% discount rate. These costs are strictly for existing supplemented foods that are currently on the Canadian market to effectively transition from the current TMA framework to the proposed regulatory framework. New products are assumed to incorporate these new requirements in their product design and development, thus they are excluded from the incremental costs to industry in the CBA.

i. Labelling Costs to Industry

Under the current TMA approach, supplemented foods are subject to most of the same food labelling requirements as other prepackaged foods. This includes displaying an NFt as well as a list of ingredients on the label. In addition, the name of the supplemented food on the label must indicate how it is different from a regular food (e.g., “nutrient enhanced water beverage”) and cautionary statements must be shown when certain supplemental ingredients are used or when higher quantities of certain supplemental ingredients are used.

As mentioned above, as of August 2020, there were 611 supplemented foods permitted on the market through the use of TMAs. The proposed labelling requirements under the new regulatory framework for supplemented foods would include the introduction of a new SFFt for all supplemented foods, which would replace the current NFt. The SFFt would be similar to the NFt but would also clearly specify the name and amount of each supplemental ingredient added to the product. A list of ingredients would continue to be required on the label of a supplemented food, including any supplemental ingredient. In addition to the SFFt, the use of certain ingredients or certain levels of ingredients must be accompanied with cautionary statements adjacent to the SFFt, along with a black and white, text-based SFCI on the principal display panel. These two additional labelling requirements would only be required for those products that pose any potential risk in connection to the individual supplemental ingredient; approximately 88% of products currently on the market would require these additional labelling requirements.

Industry stakeholders would be provided a three-year transition period to be able to exhaust their existing product and label stocks in order to eliminate product waste, all while updating their labels to include the appropriate labelling requirements.

Industry provided cost estimates, which were presented for low, medium, and high cost scenarios reflecting the varying level of complexity of the label change (e.g., printing on a paper box versus on an aluminum can and the inclusion of various labelling components) and can range from $19,200-$26,000 per SKU. For the purposes of the CBA, Health Canada assumes that the higher-bound cost estimate of $26,000 per SKU captures the complexity of including the SFFt, the SFCI, and the list of cautionary statements. However, it is acknowledged that this may overstate the cost impact as not all SKUs would require the complete label change. Therefore, the Department estimates that it would cost approximately $26,000 per SKU to incorporate the new labelling requirements. With approximately 611 supplemented foods on the market required to implement these changes, Health Canada assumes it would cost industry stakeholders a one-time cost of $15.9 million. However, these costs are assumed to be incurred within year three of the three-year transition period, resulting in a total one-time cost of approximately $13.0 million PV using a 7% discount rate. Some industry stakeholders indicated that the lifecycle for supplemented foods and their labels are typically every four to five years unless otherwise required by regulations, indicating that some industry members may be able to incorporate the required label changes into their lifecycle, if the timing aligns appropriately. Although the typical lifecycle raised by industry is considered longer than the transition period, the CBA assumes the full label costs as incremental.

ii. Reformulation Costs to Industry

To reduce the potential risks associated with supplemented foods and to inform consumers of their differentiation from regular food, Health Canada consulted with stakeholders between 2012-2016 in order to develop guidance documents outlining requirements on composition, labelling and marketing, and CI reporting under the TMA framework. The Department has been monitoring these compositional requirements on a case-by-case basis for supplemented foods, and has generally permitted up to the maximum levels in order to help ensure the supplemented food is safe for consumption. Health Canada has published these maximum levels for most vitamins and mineral nutrients in a guidance document. However, by requiring manufacturers to submit research, evidence and CI reports under the TMAs, Health Canada has now gathered enough information to update these maximum levels, where warranted, and established new ones for amino acids and other supplemental ingredients.

Under the proposed framework, these updated maximum levels would be prescribed in the List of Permitted Supplemental Ingredients and incorporated by reference in the FDR. This approach would provide Health Canada with flexibility to update levels on an administrative basis as new evidence becomes available and is presented by stakeholders seeking changes. Based on data collected from the TMAs and the number of products considered to be within scope, it is estimated that approximately 6.5% or 40 supplemented foods would have to be reformulated in order to comply with the proposed updated maximum levels.^{footnote 4}

Industry stakeholders provided cost estimates for reformulating on a per SKU basis. These costs were estimated to potentially range from $75,000-$100,000 per SKU with an average of $87,500 per SKU. With approximately 40 supplemented foods that may require reformulation, it would cost industry stakeholders $3.5 million to reformulate the impacted supplemented foods based on the new maximum levels proposed. However, these costs are assumed to be incurred within year three of the three-year transition period, resulting in a total one-time cost of $2.9 million PV using a 7% discount rate.

Cost to the Government of Canada

The total direct cost to the Government of Canada with the proposed supplemented food framework includes a one-time implementation cost to Health Canada and the ongoing cost of compliance and enforcement activities for CFIA once the framework is in place, which are estimated to be $479,301 annualized or $3.4 million PV over a 10-year time period, based on a three-year transition period using a 7% discount rate..

Under the current TMA framework, supplemented foods are subject to the same food safety compliance activities used for regular food in Canada. In addition, Health Canada monitors and authorizes supplemented foods to verify that they are complying with the various conditions established as part of their respective TMAs. This includes reviewing specific labelling and compositional requirements as well as reviewing annual CI reports for specific supplemented foods, annual sales data, and one-time market research for each new supplemented food once they are on the market. Failure to provide this information to Health Canada or to comply with the other TMA conditions can result in revocation of the TMA and withdrawal of the supplemented food from the market.

Under the proposed framework, CFIA would be responsible for the enforcement of the provisions of the FDA and the FDR as they relate to supplemented foods. Based on the strict risk-based compositional, labelling and claims requirements, supplemented foods are considered to be low-risk products and would be subject to CFIA's existing risk-based compliance and enforcement activities. Supplemented food inspections would only be conducted in response to complaints. As required, they would be integrated into the tasks performed by inspectors knowledgeable with manufactured foods and would vary from region to region, depending on where these products are being manufactured and marketed. This would require undertaking investigations and potentially recall activities and possibly other reactive inspection activities (sampling, Preventive Control Inspection etc.) as required.

Once the proposed framework is in place, CFIA would incur an incremental ongoing cost of $369,001 with 2.5 full-time equivalents (FTEs), which would need to be reallocated within CFIA, starting in the first year for the potential increase in number of sample collection, commodity inspections, preventive control inspections, and other reactive activities, such as incident response (complaints, investigation, effectiveness check and recalls), regulatory response (compliance and enforcement activity) and permission activities. The cost estimate for CFIA is based on the current number of firms in the market and past experience with regard to resource requirements for reactive investigation activities. The actual resource requirements may be higher depending on the number of complaints, investigations and recalls, and changes in the volume of products and the number of manufacturers in this area. In such instances where the resource requirements are beyond what CFIA can absorb internally, the Health Portfolio commits to assess and determine an appropriate response including realignment of its existing resources to support the Agency.

For the duration of the three-year transition period, Health Canada would support CFIA in developing guidance material for industry, responding to enquiries, developing training material and operational tools for CFIA inspectors, and providing historical compliance data and program information. Conducting these one-time implementation activities would require the support of two FTEs, which would be derived from existing resources expected to become available once the proposed regulations are in place and are no longer needed to review TMA applications. The opportunity cost of Health Canada reallocating these resources would be approximately $295,201 each year during the three-year transition period. Once the transition period is over, all compliance and enforcement activities would be conducted under CFIA.

Qualitative Costs

i. Potentially limit industry's ability to communicate the intended benefit or purpose of the supplemental ingredients to consumers

The proposed restrictions on representations for supplemental ingredients that trigger cautionary statements could potentially limit industry's ability to communicate the intended benefit of the supplemental ingredient being added to a product and the physiological function it provides to consumers. Health Canada would however allow representations about other nutrients or ingredients that do not trigger any cautionary statements in the product to be made unless the product is high in caffeine.

Benefits

The total direct benefit to both industry and Health Canada from the removal of the TMA application process and eliminating annual post-market reporting requirements is estimated to be an $7.8 million annualized or $54.8 million PV over a 10-year time period. The benefits calculated in the CBA would be recognized immediately after the new regulatory framework comes into force.

Cost Savings to Industry

The proposed regulatory framework for supplemented foods is estimated to result in a significant reduction in burden on industry with the removal of requiring industry to submit a TMA application on a case-by-case basis for all new supplemented foods and the elimination of post-market requirements to submit data to Health Canada. Industry stakeholders would save approximately $6.2 million annualized or $43.5 million PV over a 10-year time period using a 7% discount rate.

Pre-market Cost-Savings

Under the current framework, supplemented foods, including CEDs, are required to submit a TMA application to Health Canada on a product-by-product basis, with specific conditions set out for each approved product. Based on industry stakeholder feedback, it costs TMA holders an average cost of $7,961 to submit a TMA application. It is unclear how this cost estimate would vary depending on the level of complexity associated with the supplemented food in question, therefore, this cost estimate is assumed to apply to all submission types. Industry submits an average of 242 TMA applications for supplemented foods despite only a 70% issuance rate for receiving TMAs. This indicates that industry stakeholders are spending approximately $1,926,539 a year on average attempting to obtain TMAs for their products. This is anticipated to increase each year within the baseline based on Health Canada's internal database on supplemented foods, which illustrates a 6% average annual growth rate for the number of supplemented foods on the market.

Eliminating the use of TMAs for supplemented foods under the proposed framework, and therefore removing the requirement for manufacturers to submit a TMA application for their product, would significantly reduce this burden for new industry stakeholders entering the market or existing stakeholders seeking approvals for new products. Industry would only be able to sell their supplemented food if all the conditions set out in the List of Permitted Supplemental Ingredients are met. However, Health Canada is also proposing to create a submission process for, but is not limited to, industry to request a change to either list. Other stakeholders may also seek to request a change to either list if they choose to; however, it is unclear which stakeholders outside of industry, would choose to seek an assessment at this time. This assessment would be a more efficient review process for Health Canada compared to the current TMA application process and would be similar to a review conducted for a new food additive use as it would be industry's responsibility, in this case, to gather the data and supporting evidence to support a change to the respective list. This may lead to additional costs prior to filing the request for a change, however these costs cannot be estimated by Health Canada. It is unclear how this would impact the cost to industry specifically prior to entering the market, therefore, it is assumed that the cost of requesting to amend the lists would remain the same at a cost of $7,961 per submission. It is expected that industry would continue to submit 2.6 requests on average for supplemented foods that are considered complex (i.e. new use of a supplemental ingredient or new food category) each year under the new framework. It is assumed that the number of complex supplemented foods would continue to increase by 6% each year, based on Health Canada's internal database on supplemented foods. The costs to industry to request a change to the lists would be reduced to approximately $20,689 a year. Overall, industry is expected to save $1,905,841 annually. However, assuming the number of supplemented foods on the market continues to apply for complex supplemented foods under the proposed framework, this would result in an average annualized cost savings of $2.4 million or $17.1 million PV over a 10-year period using a 7% discount rate.

Post-Market Cost-Savings

As a condition of the current TMA framework, TMA holders of supplemented foods are currently required to submit three post-market data requirements: (i) annual CI reports, (ii) annual sales reporting data, and (iii) additional in-market research as a one-time requirement following TMA approval.

i. Submitting Annual CI Reports

One condition of the TMA framework includes an obligation for some TMA holders of some categories of products (e.g., CEDs and those that are required to carry cautionary statements) to provide Health Canada with annual CI reports. These reports are related to suspected or established relationships between the consumption of a supplemented food and the occurrence of an adverse health effect.

Based on industry stakeholder feedback, TMA holders are currently spending an average of $22,606 each year per firm compiling information to draft and submit CI reports. There are currently 79 out of the 90 firms with supplemented foods that are required to provide Health Canada with annual CI reports as they hold TMAs for CEDs or supplemented foods that carry cautionary statements. Therefore, industry stakeholders are currently spending an average of $1.8 million a year to provide CI reports to Health Canada. This is anticipated to increase each year within the baseline based on Health Canada's internal database on supplemented foods, which illustrates a 10% average annual growth rate for the number of firms with supplemented foods on the market.

With the proposed regulatory framework in place, TMA holders for supplemented foods would no longer be required to submit annual CI reports, resulting in a cost savings to industry. No reporting requirements would be set under the new framework for supplemented foods, however the manufacturers that are licence holders under the Safe Food for Canadians Act will remain responsible for notifying CFIA if an investigation establishes that their supplemented food presents a risk of injury to human health. This would result in an annualized cost savings of $2.7 million or $19.0 million PV over a 10-year period.

ii. Submitting Sales Reporting Data

Another condition of TMAs for all supplemented foods includes an obligation to submit an annual sales report to Health Canada. Based on industry stakeholder feedback, TMA holders are currently spending an average of $5,595 per firm compiling annual sales data, drafting the required report and submitting the information to Health Canada. With 90 firms on the Canadian market currently holding TMAs for supplemented foods, industry is currently spending approximately $503,587 a year to provide Health Canada with sales reporting data in order to be compliant with the current requirements set out by the TMA process. This is anticipated to increase each year within the baseline based on Health Canada's internal database on supplemented foods, which illustrates a 10% average annual growth rate for the number of firms with supplemented foods on the market.

Under the proposed regulatory framework, this requirement to provide an annual sales report would no longer apply, resulting in an annualized cost savings to industry stakeholders of $761,274 or $5.3 million PV over a 10-year period.

iii. In-Market Research

A third reporting condition of TMAs for all supplemented foods includes a one-time obligation for TMA holders to submit in-market research to Health Canada on their supplemented food, which is typically conducted within its first six months on the market. Health Canada works with the firm to refine their initial proposal to address if any additional market research is required.

Based on industry stakeholder feedback, TMA holders are currently spending $1,400 per TMA to submit the necessary information to Heath Canada; however, more complex files can be significantly higher. Since firms are being issued an average of 169 TMAs a year for supplemented foods to enter the market, industry stakeholders are currently spending $236,600 a year on average. However, this is anticipated to increase each year within the baseline based on Health Canada's internal database on supplemented foods, which illustrates a 6% average annual growth rate for the number of supplemented foods on the market.

Under the proposed framework, existing TMA holders would no longer be required to submit in-market research, resulting in an annualized cost savings to industry stakeholders of $301,912 or $2.1 million PV over a 10-year period.

Cost Savings to the Government of Canada

Implementing the proposed regulatory framework would eliminate the need to review TMA applications for supplemented foods and their associated post-market reporting requirements, and would introduce a new submission process for requests to change the List of Permitted Supplemented Food Categories or the List of Permitted Supplemental Ingredients. It is estimated that Health Canada would save an annualized average of approximately $1.6 million or $11.3 million PV over a 10-year time period using a 7% discount rate.

i. Reduction in Pre-Market Review for Supplemented Foods

Since certain supplemented foods were transferred to the FDR in 2012, Health Canada has received over 2,174 applications for supplemented foods from both domestic and international firms, with an average of 242 applications per year, each requiring some level of review. After conducting a full review on each submission, Health Canada has issued a TMA to an average of 169 products each year, generating a 70% issue rate. However, the total number of supplemented foods on the market is anticipated to increase each year within the baseline as illustrated by a 6% average annual growth rate based on Health Canada's internal database on supplemented foods.

A complete review of a TMA application submitted to Health Canada resulting in the issuance of a TMA currently takes an average of 60 hours to complete per application. Applying the appropriate rate of pay for the public service employees involved in reviewing each application,^{footnote 5} it is estimated that it costs the Department approximately $3,150 to review and approve each application submitted for supplemented foods that are deemed safe. With an average of 169 applications receiving a TMA annually, this process is estimated to cost Health Canada $532,424 a year.^{footnote 6} This would a cost savings to Health Canada under the proposed framework.

For the remaining 73 TMA applications, on average, that Health Canada reviews each year but does not issue a TMA, these applications still involve some level of effort by the Department. Reasons for applicants not receiving a TMA include providing insufficient data, the product was not deemed safe, or the application was withdrawn. Reviewing an incomplete TMA application takes an average of 53 hours in comparison to the average of 60 for a successful application. Applying the appropriate rate of pay for the public service employees that process these applications,^{footnote 5} it is estimated that it currently costs Health Canada approximately $2,747 to review one of these applications despite not issuing a TMA. With an average of 70.4 applications not receiving a TMA each year, this process is estimated to cost Health Canada approximately $193,399 a year.^{footnote 7} This would a cost savings to Health Canada under the proposed framework.

Of the 73 non-authorized TMA applications received by Health Canada annually, 2.6 represent more complex products that include innovative uses of supplemental ingredients or new food categories. These applications have been put on hold or denied because Health Canada requires additional safety evidence to approve them. These applications take an average of 960 hours of review based on six months of full-time work and have not resulted in the issuance of a TMA. The approximate resources are considered an underestimate, as other bureaus and evaluators are likely consulted in addition to the standard review process. Applying the appropriate rate of pay for public service employees involved with reviewing each application,^{footnote 5} it is estimated that it costs Health Canada approximately $58,305 to review each application for an innovative product. With an average of 2.6 applications being submitted for complex supplemented foods not receiving a TMA each year, this process is estimated to cost Health Canada approximately $151,592 a year.^{footnote 8} Therefore, it costs Health Canada approximately $877,415 annually to review an average of 169 TMA applications received in a given year.

Under the proposed framework, Health Canada would no longer be required to receive and review TMA applications for supplemented foods. However, Health Canada would allow industry, as well as other stakeholders, to submit a request to change the List of Permitted Supplemented Food Categories or the List of Permitted Supplemental Ingredients if they can provide supporting evidence to demonstrate that the change would be safe for Canadians and that the change is warranted. This would provide a first step on the path to market for products involving innovative uses of ingredients or food categories for supplementation that would otherwise not be permitted under the supplemented foods framework. These new submissions are expected to be similar in nature to the 2.6 complex applications Health Canada currently receives annually. Using this new pathway to assess these requests would be a more predictable and efficient review process requiring approximately 170 hours of review time at a cost of $14,000 per submission. If the request is endorsed, the two lists would then follow an administrative process using a notice of proposal and a notice of modification to allow for comments before they could be officially amended; however, this would not be considered incremental as it is an already established process used by Health Canada. Assuming Health Canada continues to receive 2.6 complex applications each year, the total cost to the Department would be reduced to $36,400 a year, resulting in a cost savings of $841,015.

Therefore, with Health Canada no longer required to review TMA applications and with the introduction of a new process to amending either the List of Permitted Supplemented Food Categories or the List of Permitted Supplemental Ingredients, the proposed framework would result in a total direct cost savings to Health Canada. It is unclear whether the proposed framework would result in a higher or lower growth rate for the number of complex supplemented foods seeking to request a change to the lists; therefore, it is assumed that an average annual growth rate of 6% would continue to apply under the new framework, resulting in an annualized cost savings of $1.1 million or $7.5 million PV over a 10-year period.

ii. Reduction in Post-Market Review of Industry Data

As part of the current TMA requirements for supplemented foods, TMA holders are obliged to submit post-market data and information to Health Canada for review, including a one-time review of market research, annual sales data, and annual CI reports for some products.

Internal data indicates that Health Canada spends 137 hours annually to review all CI reporting information collected for certain supplemented foods on the market. By applying the appropriate rate of pay for public service employees involved by their time requirement, reviewing these reports costs approximately $5,900 a year on average. Annual CI reports are collected and reviewed on a per-firm bases; therefore, it is assumed that the cost to review all CI reports submitted by industry are anticipated to increase within the baseline since the number of firms with supplemented foods on the market is expected to grow by 10% each year.

Health Canada also reviews the submission of sales data provided by industry annually. The Department currently spends approximately 56 hours each year reviewing all annual sales data for supplemented foods on the market, costing approximately $2,016 based on the appropriate rate of pay for public service employees involved by their time requirement. Annual sales data for supplemented foods is also collected and reviewed on a per-firm basis; therefore, it is assumed that the cost to review this information is anticipated to increase within the baseline as the number of firms with supplemented foods on the market is expected to grow by 10% each year.

Health Canada currently reviews the one-time submission of market research, which is typically conducted within the first year of being on the market. Based on internal data, reviewing and analyzing the one-time submission of market research for supplemented foods is estimated to take 40 hours per new TMA. Health Canada is currently spending approximately $2,452 per supplemented food based the appropriate rate of pay for public service employees. Since there are approximately 169 supplemented foods receiving a TMA each year, completing this step alone is estimated to cost Health Canada approximately $414,303.^{footnote 9} Based on an average annual growth rate of 6% for the number of supplemented foods on the market, the costs to review the one-time submission of market research is anticipated to increase annually within the baseline.

Under the proposed regulatory framework, Health Canada would no longer review post-market data from industry, resulting in an annualized cost savings of $538,769 or $3.8 million PV over a 10-year period using a 7% discount rate.

Overall, when accounting for all monetized costs and benefits, an annualized net benefit of $5.1 million or $35.7 million PV is anticipated over the next 10 years applying a 7% discount rate.

Qualitative Benefits

i. Reduces the potential risk associated with overconsumption by the general population and vulnerable groups within it (e.g., children, pregnant women)

With the SFCI located on the front of the package, as well as the SFFt and cautionary statements displayed elsewhere on the label, consumers will be able to inform themselves more easily of the supplemental ingredients added to a supplemented food. This will in turn help in reducing potential risks related to the consumption of these products as certain supplemental ingredients, such as caffeine, can have different effects on different segments of the population. For example, consuming amounts above 300 mg of caffeine per day may adversely effect pregnant and breastfeeding women.

ii. Improves consumer ability to access information, distinguish supplemented foods from regular food, identify products of higher risk, thereby allowing consumers to make more informed choices

With the proposed labelling requirements, consumers can make more informed decisions with the inclusion of cautionary statements in connection to any risks with certain supplemental ingredients, the SFFt detailing the certain supplemental ingredients being added and a SFCI distinguishing which products are supplemented. Consumers can access information about whether the product is a risk if overconsumed and the amount of the supplemental ingredient they are consuming. It also provides time savings for consumers when having to search for nutrient and supplemental ingredient information by making it directly accessible and consistent across products.

iii. Provides flexibility for change, thus enabling industry to take advantage of new evidence related to supplemented foods and supplemental ingredients

With the proposed framework, industry, as well as other stakeholders, are given the flexibility to request a change related to either the category, supplemental ingredient, and/or any of the conditions of use of the supplemental ingredients, if sufficient health and safety data is provided.

iv. Allows for innovation in the food industry

With the proposed framework and set compositional requirements, industry can be flexible in creating new products that will fit those requirements and experiment with different combinations of new food categories and supplemental ingredients.

Cost-Benefit Statement

• Number of years: 10 years (2022-2031)
• Base year for costing: 2020
• Present value base year: 2022
• Discount rate: 7%

Monetized costs ^{footnote 10}

Impacted stakeholder	Description of cost	Base year (2022)	Other relevant years (2024)footnote 11	Final year (2031)	Total (present value)	Annualized valuefootnote 12
Industry	Labelling Costs	$0	$15,886,000	$0	$12,967,708	$1,846,310
Industry	Reformulation Costs	$0	$3,500,000	$0	$2,857,043	$406,779
Government	Compliance and Enforcement Costs	$664,202	$664,202	$369,001	$3,366,409	$479,301
All stakeholders	Total costs	$664,202	$20,050,202	$369,001	$19,191,159	$2,732,389

Monetized benefits

Impacted stakeholder	Description of benefit	Base year (2022)	Other relevant years (2024)	Final year (2031)	Total (present value)	Annualized value
Industry	Cost Savings – Removing TMA application requirements	$1,905,841	$2,141,403	$3,219,878	$17,080,876	$2,431,932
Industry	Cost Savings – Removing post-market requirements	$2,526,061	$3,036,091	$5,798,159	$26,429,013	$3,762,897
Government	Cost Savings – Removing TMA application review requirements	$841,015	$944,964	$1,420,877	$7,537,497	$1,073,170
Government	Cost Savings – Removing post-market review requirements	$422,219	$475,089	$718,621	$3,797,190	$540,634
All stakeholders	Total benefits	$5,695,135	$6,597,547	$11,157,535	$54,844,576	$7,808,634

Summary of monetized costs and benefits

Impacts	Base year (2022)	Other relevant years (2024)	Final year (2031)	Total (present value)	Annualized value
Total costs	$664,202	$20,050,202	$369,001	$19,191,159	$2,732,389
Total benefits	$5,695,135	$6,597,547	$11,157,535	$54,844,576	$7,808,634
NET IMPACT	$5,030,933	-$13,452,655	$10,788,534	$35,653,416	$5,076,244

Quantified (non-$) and qualitative impacts

Positive impacts:

• Reduces the potential risk of overconsumption by the general population, and vulnerable groups within it (e.g., children, pregnant women);
• Improves consumer access to information, distinguishes supplemented foods from conventional foods, identifying products of higher risk and making more informed choices;
• Significantly reduces administrative burden for new entrants as well as existing stakeholders who wish to bring new products to market;
• Provides flexibility for change, thus enabling industry to adapt to new evidence related to supplemented foods and supplemental ingredients; and
• Allows for innovation in the food industry.

Negative impacts:

• Potentially limit industry's ability to communicate the intended benefit or purpose of the supplemental ingredients to consumers when certain products are required to carry a cautionary statement.

Small business lens

The Policy on Limiting Regulatory Burden on Business defines a small business as any business, including its affiliates, that has fewer than 100 employees or less than $5 million in annual gross revenues. Approximately 67 of all businesses in Canada with supplemented food products that could be affected by the proposed regulatory framework are considered small businesses. This includes two that manufacture products in the bars or confectioneries category, 37 that manufacture in the CEDs category and 28 that manufacture in the beverages category. Supplemented foods sold by small businesses in Canada represent approximately 21% of all supplemented foods on the market, totaling 126 products.

Industry, including small businesses, would be given the flexibility to request a change related to either the category, supplemental ingredient, and/or any of the conditions of use of the supplemental ingredients, if sufficient health and safety data is provided. Providing small businesses with the flexibility to adapt to new evidence related to supplemented foods and supplemental ingredients, would support innovation in the food industry. Responses provided by small businesses through CBA survey indicated that the costs with complying with the current TMA requirements can be disproportionately higher for small businesses with a much larger variation in costs to conduct pre-market activities in particular. In removing the burden of seeking a TMA for supplemented foods and providing a more efficient process for requesting a change to the lists, small businesses are assumed to benefit significantly from the proposed framework. In addition to the removal of seeking approvals for a TMA, small businesses would also benefit from the removal of post-market requirements of holding TMAs for supplemented foods as these on-going costs likely represent a higher percentage of their revenue streams. Small businesses are estimated to save an annualized average of approximately $2.7 million or $22 million PV over a 10-year period; which represents a significant percentage of the market. These cost savings to industry are outlined in further detail below under the One-for-One rule.

This proposed regulatory framework is expected to have a disproportional impact on small businesses when it comes to updating labels and reformulating their supplemented foods; however, it is uncertain at this time to what extent. For example, it is currently unclear how many of the products that are anticipated to require reformulation would be for products sold by small businesses. Health Canada considered the concerns of small businesses and concluded that a transition period of three years would help alleviate some of the burden for both large and small/medium size enterprises.

Small business lens summary

• Number of small businesses impacted: 67
• Number of years: 10 (2022-2031)
• Base year for costing: 2020
• Present value base year: 2022
• Discount rate: 7%

Compliance costs^{footnote 13}

Activity	Annualized valuefootnote 14	Present value
Updating Labels	$380,745	$2,674,192
Reformulating Products (new max levels)footnote 15	$81,356	$571,409
Total compliance cost	$462,100	$3,245,600

Total compliance and administrative costs

Totals	Annualized value	Present value
Total cost (all impacted small businesses)	$462,100	$3,245,600
Cost per impacted small businessfootnote 16	$6,897	$48,442

One-for-one rule

The one-for-one rule applies since there is an incremental decrease in administrative burden on businesses, and the proposal is considered an “out” under the rule. The proposed regulatory framework is expected to significantly decrease administrative burden on industry as it introduces a more efficient risk-based approach. Manufacturers of certain supplemented foods would no longer be required to submit annual consumption incident reports, annual sales data as well as conduct and submit any research (e.g., market studies, consumer research, etc.) on their products post-market as a one-time administrative cost. Removing these requirements under the proposed framework would result in a reduction in administrative burden for businesses once the regulations come into force, after which there would not be any ongoing administrative costs.

“One-for-One” Rule using The Regulatory Costing Calculator

	One-for-One Rule Results
Annualized administrative cost savings (constant $2012)	$1,851,312
Annualized Administrative Cost savings Per Business ($2012)	$10,285

Constant 2012 dollars, Present Value Base Year 2012; discounted using a 7% discount rate.

These cost savings are estimated based on responses provided by some industry stakeholders through the CBA survey for the removal of the following post-market elements required to be submitted by industry^{footnote 17}

• i. Annual CI Reporting

Industry is currently spending an average of $22,606 (2020 CAD) annually per firm to compile and submit their CI reports. Out of the 90 firms with supplemented foods in Canada, 79 of those firms are required to provide these reports for CEDs or supplemented foods that carry cautionary statements costing industry a total of $1.8 million annually. With the proposed framework, these firms would no longer be required to submit CI reports for their supplemented foods, resulting in a cost savings. This is anticipated to increase each year based on Health Canada's internal database on supplemented foods, which illustrates a 10% average annual growth rate for the number of firms with supplemented foods on the market.

• ii. Annual Sales Data

Industry is also currently spending an average of $5,595 per firm compiling annual sales data to submit to Health Canada for review. With 90 firms with supplemented foods on the Canadian market, industry is spending approximately $503,587 a year to provide Health Canada with sales reporting data in order to be compliant. With the proposed framework in place, these firms would no longer be required to submit annual sales data for their supplemented foods, resulting in a cost savings. This is anticipated to increase each year based on Health Canada's internal database on supplemented foods, which illustrates a 10% average annual growth rate for the number of firms with supplemented foods on the market

• iii. One-time Market Research

In addition, industry is currently required to submit in-market research to Health Canada on their supplemented food, typically within the first six months on the market. TMA holders are spending $1,400 per TMA to submit the necessary information to Health Canada. Since 169 TMAs are issued on average each year, industry is currently spending $236,600 a year. With the proposed framework in place, industry would no longer be required to submit in-market research, which would indicate a cost savings. This is anticipated to increase each year based on Health Canada's internal database on supplemented foods, which illustrates a 6% average annual growth rate for the number of supplemented foods on the market.

Regulatory cooperation and alignment

In developing a proposed regulatory framework, Canada considered models from various international regulatory authorities including those in Australia and New Zealand, the European Union, Japan, and the United States. There is no global standard for the regulation of supplemented foods.

With regard to Canada's key trading partners, Europe and the United States consider the addition of substances to food more broadly and do not have separate requirements for supplemented foods. In Europe, there is some oversight in terms of the specific vitamins, minerals and amino acids that are approved to be added to foods. However, the use of these ingredients is mostly discretionary where the majority of countries have not set maximum levels. Canada is seeking to permit the discretionary use of supplemental ingredients within specific levels and conditions based on what evidence has shown to be safe.

In the United States, substances added to a food which have been established as safe are categorized as generally recognized as safe (GRAS) substances. Within the category of GRAS substances, a specific framework for supplemental ingredients does not exist. Due to the added risk associated with products containing supplemental ingredients, Canada does not intend to regulate supplemental ingredients using GRAS principles. Instead, it intends to differentiate supplemental ingredients from other substances that may be safely added to foods by providing specific requirements and conditions for the use of the former including maximum levels and cautionary statements.

New Zealand is the only country that was identified as having a specific regulatory framework for supplemented foods. Labels on these products must carry the words “supplemented food”. Cautionary statements are also required under identified conditions including when there is a risk of overconsumption, in the presence of certain ingredients, or when caffeine amounts are above a certain level. As New Zealand categorizes supplemented foods separately and establishes specific requirements for these products, it was found to have the most similar approach to Canada and was closely considered for the proposed framework.

Strategic environmental assessment

In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a preliminary scan concluded that a strategic environmental assessment is not required.

Gender-based analysis plus

Gender, age and socio-economic factors were taken into account during the development of these amendments to the FDR.

Women

Compared to the general population, pregnant and breastfeeding women are more vulnerable to health risks related to excessive nutrient intake. Many herbal ingredients have also never been assessed or do not have data available to support their safety as food ingredients in foods targeted to pregnant or breastfeeding women. To help mitigate these additional risks for pregnant or breastfeeding women, Health Canada would not be permitting foods intended solely for these groups to be supplemented foods.

As pregnant or breastfeeding women may be particularly vulnerable to supplementation with amino acids,^{footnote 18} cautionary labelling would be required to indicate that supplemented foods containing amino acids are not recommended for pregnant or breastfeeding women.

Caffeine consumption may present additional risks to pregnant or breastfeeding women, as well as women trying to get pregnant. Research has shown that overconsumption of caffeine may significantly reduce fertility, may increase the risk of miscarriage and may interfere with fetal growth.^{footnote 19,footnote 20,footnote 21} As a specific mitigation to these risks, Health Canada is proposing that a relevant cautionary statement directed at pregnant or breastfeeding women would have to be included on supplemented foods that contain high caffeine levels.

Children and youth

Young children are more vulnerable to risks related to nutrient imbalances compared to older children and adults. For this reason, Health Canada would not be permitting foods intended solely for infants and children over one year of age but under the age of four to be supplemented foods.

Recognizing that children are more at risk of adverse outcomes from misusing supplemented foods compared to adults, two different sets of maximum levels have been prescribed for vitamins and mineral nutrients—one for the population four years and older, and one for the population 14 years and older. If using supplemental ingredients up to the maximum levels considered safe for the population 14 years of age and older, proposed risk mitigation measures would require the product to carry cautionary statements. In contrast, if using the maximum levels considered safe for the population four years and older, which have been set more conservatively, cautionary statements may not be required.

When a supplemented food contains ingredients that may pose a risk to health, it would be required to carry cautionary statements regarding the maximum amount that should be consumed (e.g. “Do not consume more than X servings”). As children under 14 would not be expected to interpret this type of caution effectively, products containing higher-risk ingredients would be required to indicate instead that they are not recommended for those under 14 years old.

Research has indicated that male children and young adults (12-30 years) represent the largest proportion of CED users.^{footnote 22,footnote 23} It has also been noted that CEDs may affect children and adolescents more than adults because they weigh less and thus experience greater exposure to stimulant ingredients such as caffeine per kilogram of body weight.^{footnote 24}

Health Canada is proposing that high caffeine containing supplemented foods and all CEDs would require cautionary statements indicating that these products are not recommended for those under 14 years of age. In addition, all caffeine containing supplemented foods would be required to include a statement indicating that the product contains caffeine on the PDP. This would help adolescents 14 years of age and over to understand their caffeine consumption and manage within their recommended limits.

The combined consumption of CEDs and alcohol has also been identified as a public health concern in Canada.^{footnote 25} To help mitigate this risk, a cautionary statement informing consumers not to mix with alcohol would be required on all CEDs.

Individuals with low literacy

Canadians with lower health literacy levels may be disadvantaged in their ability to identify and distinguish supplemented foods from conventional foods, identify the type and amount of supplemental ingredients a product contains, and most importantly, identify any cautions associated with the use of a particular product.

To support the development of these regulatory amendments, Health Canada implemented a consumer research protocol to test the efficacy of the proposed labelling requirements for supplemented foods and assess their usefulness for all Canadians, including those with limited health literacy.

Health Canada subsequently developed the risk-based approach for labelling of supplemented foods as set out in these proposed amendments to help ensure that Canadians at varying literacy levels would have access to the labelling tools that they would need to safely and appropriately use these products.

Implementation, compliance and enforcement, and service standards

Implementation

The proposed regulations would come into force upon publication in the Canada Gazette, Part II. Existing supplemented foods on the market under a TMA and those that submitted a TMA application prior to publication of the regulations and subsequently received a Health Canada authorization would have three-years following the coming into force date to become compliant with the new proposed framework.

Information on the implementation of this regulatory proposal would be posted on the Government of Canada website. In addition, Health Canada is planning to conduct education and awareness campaigns to help consumers understand the new SFFt and SFCI labelling elements on supplemented foods.

Compliance and enforcement

CFIA is responsible for the enforcement of the provisions of the FDA and the FDR as they relate to food. As supplemented foods are a subset of prepackaged products, they would be subject to CFIA's existing risk-based compliance and enforcement activities. In this regard, CFIA would use a complaint-based approach to enforce the proposed regulations based on the level of risk of supplemented foods. This would include undertaking investigations, recalls, and other compliance activities as required.

CFIA would deliver its compliance and enforcement program for supplemented foods with existing operational resources. However, for the duration of the transition period, Health Canada would support CFIA in developing guidance material for industry, responding to enquiries, developing training material and operational tools for CFIA inspectors, and providing historical compliance data and program information. In addition, Health Canada laboratories, or third party laboratories contracted by Health Canada, would carry out testing for CFIA where there may be gaps in CFIA's ability to assess regulatory compliance of supplemental foods on a priority basis. This process is documented in Canada's Foodborne Illness Outbreak Response Protocol (FIORP): A guide to multi-jurisdictional enteric outbreak response, which will be amended to reflect these responsibilities for supplemented foods.

Service standards

Service standards would be provided in a Health Canada guidance document.

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 14
11 Holland Avenue
Address Locator: 3000A
Ottawa ON
K1A 0K9
Email: hc.lrm.consultations-mlr.sc@canada.ca

PROPOSED REGULATORY TEXT

Notice is given that the Administrator in Council, pursuant to subsection 30(1)^{footnote a} and section 30.5^{footnote b} of the Food and Drugs Act^{footnote c}, proposes to make the annexed Regulations Amending the Food and Drug Regulations (Supplemented Foods).

Interested persons may make representations concerning the proposed Regulations within 60 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice, and be addressed to Bruno Rodrigue, Office of Legislative and Regulatory Modernization, Policy, Planning and International Affairs Directorate, Health Products and Food Branch, Department of Health, postal locator 3000A, 11 Holland Avenue, Suite 14, Ottawa, Ontario K1A 0K9 (email: hc.lrm.consultations-mlr.sc@canada.ca).

Ottawa, June 16, 2021

Julie Adair
Assistant Clerk of the Privy Council

Regulations amending the Food and Drug Regulations (Supplemented Foods)

Amendments

1 (1) The definition agricultural chemical in subsection B.01.001(1) of the Food and Drug Regulations^{footnote 26} is amended by adding the following after paragraph (c):

• (c.1) supplemental ingredient,

(2) The definition food additive in subsection B.01.001(1) of the Regulations is amended by adding the following after paragraph (b):

• (b.1) supplemental ingredients;

(3) Subsection B.01.001(1) of the Regulations is amended by adding the following in alphabetical order:

List of Permitted Supplemental Ingredients

means the List of Permitted Supplemental Ingredients, published by the Government of Canada on its website, as amended from time to time; (Liste des ingrédients supplémentaires autorisés)

List of Permitted Supplemented Food Categories

means the List of Permitted Supplemented Food Categories, published by the Government of Canada on its website, as amended from time to time; (Liste des catégories d'aliments supplémentés autorisées)

supplemental ingredient

means a nutrient — including a vitamin, mineral nutrient or amino acid — or any other substance listed in column 1 of the List of Permitted Supplemental Ingredients and added as an ingredient to a food in accordance with the applicable conditions of use set out in columns 2 to 5; (ingrédient supplémentaire)

supplemented food

means a prepackaged product that belongs to a food category specified in column 1 of the List of Permitted Supplemented Food Categories and to which a supplemental ingredient has been added, but does not include

• (a) a food for special dietary use as defined in section B.24.001 and referred to in any of paragraphs B.24.003(1)(f) to (f.2) and (h) to (j), even if the food for special dietary use is also a gluten-free food referred to in paragraph B.24.003(1)(g);
• (b) a food that is labelled or advertised for consumption by
  • (i) infants as defined in section B.25.001,
  • (ii) children one year of age or older but less than four years of age, or
  • (iii) women who are pregnant or breastfeeding;
• (c) any of the following foods set out in column I of the table to section D.03.002:
  • (i) a food referred to in any of items 1, 2.1, 2.2, 4, 5, 7, 8, 9.1, 10 to 13, 15, 17 to 19, 21 to 25 and 27, and
  • (ii) prepackaged ice referred to in item 26;
• (d) a food that has not been, or has been minimally, processed; or
• (e) a beverage with an alcohol content of more than 0.5%; (aliment supplémenté)

supplemented food facts table

means the supplemented food facts table required by subsection B.29.002(1) to be carried on the label of a supplemented food or required by subsection B.29.002(2) to be carried on the label of a prepackaged product containing an assortment of supplemented foods; (tableau des renseignements sur les aliments supplémentés)

(4) Section B.01.001 of the Regulations is amended by adding the following after subsection (3):

(4) For the purposes of the definition supplemented food in subsection (1), if one supplemented food is used as an ingredient in the manufacture of a second supplemented food, the supplemental ingredient in the first supplemented food is deemed to also have been added to the second supplemented food as a supplemental ingredient if it is contained in the second supplemented food in accordance with the applicable conditions of use set out in columns 2 to 5 of the List of Permitted Supplemental Ingredients.

2 Subsection B.01.005(5) of the Regulations is replaced by the following:

(5) Despite subsection (2), the nutrition facts table — or, in the case of a supplemented food or prepackaged product containing an assortment of supplemented foods, the supplemented food facts table and, if any, the list of cautionary statements referred to in subsection B.29.020(1) — may be shown on that part of the label that is applied to the bottom of the food or container if the available display surface includes the bottom.

3 Paragraph B.01.008(1)(a) of the Regulations is replaced by the following:

• (a) any information required by these Regulations, other than the information required to appear on the principal display panel, the nutrition facts table or supplemented food facts table and the information required by sections B.01.007, B.01.301, B.01.305, B.01.311, B.01.503, B.01.513 and B.01.601, paragraphs B.25.020(1)(e) and (f) and section B.29.020; and

4 (1) The portion of subsection B.01.008.1(1) of the Regulations before paragraph (a) is replaced by the following:

B.01.008.1 (1) Information appearing on the label of a prepackaged product according to sections B.01.008.2 to B.01.010.4 and B.29.020 shall be shown

(2) Paragraphs B.01.008.1(1)(c) and (d) of the Regulations are replaced by the following:

• (c) in type of normal or condensed width that is not scaled down so that the characters take up less space horizontally and, if a nutrition facts table or supplemented food facts table appears on the label, the width of type must be the same as that required for the type used to show the nutrients that appear in the nutrition facts table or the supplemental ingredients that appear in the supplemented food facts table, as the case may be;
• (d) in regular type, subject to paragraph B.01.008.2(1)(b), subparagraph B.01.010.3(1)(a)(ii) and paragraphs B.01.010.3(1)(c), B.01.010.4(1)(c) and (d) and B.29.020(1)(b) and (d); and

(3) Subsections B.01.008.1(3) and (4) of the Regulations are replaced by the following:

(3) Despite paragraph (1)(e), if a nutrition facts table or supplemented food facts table appears on the label of a prepackaged product and the type size of the nutrients shown in the nutrition facts table or the supplemental ingredients shown in the supplemented food facts table is not less than 8 points, the information appearing on the label must appear in type that is the same height that is not less than 1.4 mm with identical leading of not less than 3.2 mm.

(4) Despite paragraph (1)(e), a title that introduces a list of ingredients, a food allergen source, gluten source and added sulphites statement as defined in subsection B.01.010.1(1), a declaration referred to in subsection B.01.010.4(1) or a list of cautionary statements referred to in subsection B.29.020(1) may be shown in type that is of a height that is greater than the height of the type used to show the ingredients in the list of ingredients, the information in the statement, the information in the declaration or the cautionary statements in the list of cautionary statements, as the case may be.

5 (1) Paragraph B.01.008.2(2)(b) of the Regulations is replaced by the following:

• (b) a background colour that creates a contrast between the background colour of the list and the background colour used on the adjacent area of the label, other than the area used to display a food allergen source, gluten source and added sulphites statement as defined in subsection B.01.010.1(1), a declaration referred to in subsection B.01.010.4(1), a list of cautionary statements referred to in subsection B.29.020(1) and, as the case may be, a nutrition facts table or supplemented food facts table.

(2) Subparagraphs B.01.008.2(3)(b)(i) and (ii) of the Regulations are replaced by the following:

• (i) the first letter of each ingredient or, in the case of a food additive or supplemental ingredient shown in whole or in part by an acronym, the entire acronym, and
• (ii) the alpha-descriptor that forms a part of the common name for a food additive, vitamin, supplemental ingredient or micro-organism; and

(3) Subsection B.01.008.2(4) of the Regulations is amended by striking out “and” at the end of paragraph (g), by adding “and” at the end of paragraph (h) and by adding the following after paragraph (h):

• (i) supplemental ingredients.

(4) Subparagraphs B.01.008.2(5)(c)(i) and (ii) of the Regulations are replaced by the following:

• (i) in the case of a food additive or supplemental ingredient shown in whole or in part by an acronym, the entire acronym, and
• (ii) the alpha-descriptor that forms a part of the common name for a food additive, vitamin, supplemental ingredient or micro-organism; and

6 Subsection B.01.009(4) of the Regulations is amended by striking out “and” at the end of paragraph (b), by adding “and” at the end of paragraph (c) and adding the following after paragraph (c):

• (d) supplemental ingredients.

7 The portion of the definition specialty food in subsection B.01.012(1) of the Regulations before paragraph (a) is replaced by the following:

specialty food

means a food — other than a human milk fortifier or supplemented food — that

8 (1) The portion of subsection B.01.301(1) of the Regulations before paragraph (a) is replaced by the following:

B.01.301 (1) No person shall, on the label of or in any advertisement for a food, other than in the nutrition facts table or supplemented food facts table, if any, include a declaration of the food's energy value or the amount of a nutrient or supplemental ingredient contained in the food unless it is declared in the following manner, per serving of stated size:

(2) Paragraph B.01.301(1)(b) of the Regulations is replaced by the following:

• (b) in the case of a vitamin referred to in subsection D.01.002(1), other than vitamin A that is a supplemental ingredient, in the applicable unit set out in subsection D.01.003(1);
• (b.01) in the case of vitamin A or beta-carotene that is a supplemental ingredient, in the applicable unit referred to in column 3 of the List of Permitted Supplemental Ingredients;

(3) Subsection B.01.301(1) of the Regulations is amended by striking out “and” at the end of paragraph (d) and by adding the following after that paragraph:

• (d.1) in the case of a supplemental ingredient other than a vitamin or mineral nutrient referred to in this subsection, in the applicable unit referred to in column 3 of the List of Permitted Supplemental Ingredients; and

(4) The portion of subsection B.01.301(2) before paragraph (c) of the Regulations is replaced by the following:

(2) Despite subsection (1), a person may, on the label of or in any advertisement for a food, other than in the nutrition facts table or supplemented food facts table, if any, include a declaration of the percentage of the daily value of a nutrient contained in the food if

• (a) in the case of a food that is not a supplemented food, the nutrient is listed in column 1 of the tables to section B.01.401 or B.01.402 and the percentage of the daily value of the nutrient is required or permitted to be declared in the nutrition facts table;
• (b) in the case of a supplemented food, the nutrient is listed in column 1 of the tables to section B.29.002 or B.29.003 and the percentage of the daily value of the nutrient is required or permitted to be declared in the supplemented food facts table; and

9 Section B.01.302 of the Regulations is replaced by the following:

B.01.302 If the label of a multiple-serving prepackaged product indicates that the product contains or, if prepared as directed in or on the package, provides a specified number of servings or portions, that information must be based on the serving of stated size set out in the nutrition facts table or supplemented food facts table, as the case may be.

10 (1) The portion of subsection B.01.305(2) of the Regulations before paragraph (a) is replaced by the following:

(2) No person shall, on the label of or in any advertisement for a food, other than a supplemented food, make a representation, express or implied, respecting an amino acid unless

(2) Paragraph B.01.305(3)(i) of the Regulations is replaced by the following:

• (i) a declaration of the amount of protein in the nutrition facts table or supplemented food facts table, as the case may be;

11 Subsection B.01.311(4) of the Regulations is replaced by the following:

(4) If a statement or claim described in subsection (3) concerns a nutrient not listed in column 1 of the tables to sections B.01.401 and B.01.402 — or, as the case may be, column 1 of the tables to sections B.29.002 and B.29.003 — the amount of the nutrient contained in the food must be expressed on any part of the label in grams per serving of stated size.

12 Subsections B.01.401(4) and (5) of the Regulations are replaced by the following:

(4) Subsection (1) does not apply to a formulated liquid diet, human milk fortifier, human milk substitute, food represented as containing a human milk substitute, meal replacement, nutritional supplement, food represented for use in a very low energy diet, supplemented food or prepackaged product containing an assortment of supplemented foods.

(5) The label of, or an advertisement for, a formulated liquid diet, human milk substitute, food represented as containing a human milk substitute, meal replacement, nutritional supplement, food represented for use in a very low energy diet, supplemented food or prepackaged product containing an assortment of supplemented foods shall not contain a nutrition facts table or the phrase “nutrition facts”, “valeur nutritive” or “valeurs nutritives”.

13 Subsection B.01.404(1) of the Regulations is replaced by the following:

B.01.404 (1) Subject to section B.29.004, this section applies to a prepackaged product intended solely for use as an ingredient in the manufacture of other prepackaged products intended for sale to a consumer at the retail level or as an ingredient in the preparation of food by a commercial or industrial enterprise or an institution.

14 (1) The portion of subitem 2(1) of the table following section B.01.603 of the Regulations in column 3 is replaced by the following:

Item

Column 3 Conditions — Label or Advertisement

2

(1) If the statement or claim is made on the label of a prepackaged product, or in any advertisement for the prepackaged product that is made or placed by or on the direction of the manufacturer of the product, the amount of vitamin D and phosphorus shall be included in, as the case may be, (a) the nutrition facts table in accordance with subsection B.01.402(2); or (b) the supplemented food facts table in accordance with subsection B.29.002(1) or (2), in respect of the description set out in column 2, the unit set out in column 3 and the manner of expression set out in column 4 of the table to section B.29.002, or with subsection B.29.003(3), or with both, as the case may be.

(2) The portion of item 5 of the table following subsection B.01.603 of the Regulations in column 3 is replaced by the following:

Item

Column 3 Conditions — Label or Advertisement

5

If the statement or claim is made on the label of a prepackaged product, or in any advertisement for the prepackaged product that is made or placed by or on the direction of the manufacturer of the product, the amount of sugar alcohols, if present, shall be included in, as the case may be, (a) the nutrition facts table, in accordance with subsection B.01.402(2); or (b) the supplemented food facts table, in accordance with subsection B.29.003(3).

15 Subsection B.15.001(4) of the Regulations is amended by adding the following after paragraph (a):

• (a.1) a supplemental ingredient;

16 The portion of the definition novel food in section B.28.001 of the Regulations before paragraph (a) is replaced by the following:

novel food

means any of the following substances and foods, other than a supplemental ingredient as defined in subsection B.01.001(1) or a supplemented food as defined in B.01.001:

17 The Regulations are amended by adding the following after section B.28.003:

DIVISION 29

Supplemented Foods

Interpretation

B.29.001 (1) The following definitions apply in this Division.

Directory of SFFT Formats

means the Directory of Supplemented Food Facts Table Formats, published by the Government of Canada on its website, as amended from time to time. (Répertoire des modèles de TRAS)

Directory of Supplemented Food Caution Identifier Specifications

means the Directory of Supplemented Food Caution Identifier Specifications, published by the Government of Canada on its website, as amended from time to time. (Répertoire des spécifications sur l'identifiant des aliments supplémentés avec mise en garde)

supplemented food caution identifier

means the identifier set out in Schedule K.2 and required under subsection B.29.021(1). (identifiant des aliments supplémentés avec mise en garde)

(2) For the purpose of this Division, fat means all fatty acids expressed as triglycerides.

(3) For the purpose of this Division, the amount of vitamins shall be determined

• (a) in the case of a vitamin referred to in subsection D.01.002(1), other than vitamin A that is a supplemental ingredient, in accordance with section D.01.003; and
• (b) in the case of vitamin A or beta-carotene that is a supplemental ingredient, in terms of its content, expressed in the applicable unit set out in column 3 of the List of Permitted Supplemental Ingredients.

Nutrition Labelling

Core Information

B.29.002 (1) Except as otherwise provided in this section and sections B.29.003 to B.29.005, B.29.018 and B.29.019, the label of a supplemented food shall carry a supplemented food facts table that contains only the information set out in column 1 of the table to this section, expressed using a description set out in column 2, in the unit set out in column 3 and in the manner set out in column 4.

(2) Subject to sections B.29.003 to B.29.005, the label of a prepackaged product containing an assortment of supplemented foods shall carry a supplemented food facts table that contains only the information set out in column 1 of the table to this section, expressed using a description set out in column 2, in the unit set out in column 3 and in the manner set out in column 4, and subsections (3), (4), (9) and (10) apply to the supplemented foods in the assortment.

(3) For the purpose of subsection (1), the serving of stated size set out in a supplemented food facts table, as expressed in a metric unit, shall be used as the basis for determining the information appearing in the supplemented food facts table in respect of the energy value and the amounts of nutrients and supplemental ingredients in the supplemented food.

(4) The percentage of the daily value for a mineral nutrient shown in the supplemented food facts table in accordance with subsection (1) shall be established on the basis of the amount, by weight, of the mineral nutrient per serving of stated size for the supplemented food, rounded off in the applicable manner set out in column 4 of the table to this section.

(5) If, for a supplemented food, the information in respect of six or more of the energy value and nutrients referred to in column 1 of items 2 to 5 and 7 to 15 of the table to this section may be expressed as “0” in the supplemented food facts table in accordance with this section, the supplemented food facts table need only include the following information:

• (a) the serving of stated size;
• (b) the energy value;
• (c) the amount of fat;
• (d) the amount of carbohydrate;
• (e) the amount of protein;
• (f) the amount of any nutrient that is the subject of a representation on the label of the supplemented food, or in any advertisement for the supplemented food that is made or placed by or on the direction of the manufacturer of the supplemented food, if the representation expressly or implicitly indicates that the supplemented food has particular nutritional or health-related properties, including any statement or claim set out in column 4 of the table following section B.01.513 or column 1 of the table following section B.01.603 or referred to in section B.01.311, D.01.006 or D.02.004;
• (g) the amount of any added sugar alcohol;
• (h) the amount of any supplemental ingredient;
• (i) the amount of any vitamin or mineral nutrient — other than a vitamin or mineral nutrient that is a supplemental ingredient — that is declared as a component of one of the supplemented food's ingredients, other than flour;
• (j) the amount of any nutrient referred to in column 1 of any of items 4, 5, 7, 8, 10, 11 and 13 to 15 of the table to this section that may not be expressed as “0” in the supplemented food facts table;
• (k) the statement “Not a significant source of (naming each nutrient that is omitted from the supplemented food facts table in accordance with this subsection)” or, if the supplemented food meets the condition specified in subsection B.29.010(3), the statement “Not a significant source of other nutrients”;
• (l) the % Daily Value interpretative statement; and
• (m) the “Supplemented with” interpretative statement.

(6) The supplemented food facts table of a supplemented food that is a single-serving prepackaged product need only include the following information:

• (a) the serving of stated size;
• (b) the energy value;
• (c) the amount of fat;
• (d) the amount of carbohydrate;
• (e) the amount of protein;
• (f) the amount of any nutrient that is the subject of a representation on the label of the supplemented food, or in any advertisement for the supplemented food that is made or placed by or on the direction of the manufacturer of the supplemented food, if the representation expressly or implicitly indicates that the supplemented food has particular nutritional or health-related properties, including any statement or claim set out in column 4 of the table following section B.01.513 or column 1 of the table following section B.01.603 or referred to in section B.01.311, D.01.006 or D.02.004;
• (g) the amount of any added sugar alcohol;
• (h) the amount of any supplemental ingredient;
• (i) the amounts of saturated fatty acids and trans fatty acids and the sum of saturated fatty acids and trans fatty acids, if any of the amounts or the sum may not be expressed as “0” in the supplemented food facts table;
• (j) the amount of any nutrient referred to in column 1 of item 8 or 11 of the table to this section that may not be expressed as “0” in the supplemented food facts table;
• (k) the % Daily Value interpretative statement; and
• (l) the “Supplemented with” interpretative statement.

(7) Subsection (1) does not apply to a supplemented food intended solely for use as an ingredient in the manufacture of other supplemented foods intended for sale to a consumer at the retail level.

(8) If the supplemented food facts table on the label of a supplemented food corresponds to Figure 6.5(B), 6.6(B), 6.5.1(B), 6.6.1(B), 7.3(B), 7.4(B), 7.3.1(B), 7.4.1(B), 17.2(E) and (F) or 17.2.1(E) and (F) of the Directory of SFFT Formats, the supplemented food facts table is not required to show the % Daily Value interpretative statement or the “Supplemented with” interpretative statement referred to in items 16 and 17, respectively, of the table to this section.

(9) The supplemented food facts table shall not contain the percentage daily value of a vitamin or mineral nutrient if any amount of that vitamin or mineral nutrient has been added as a supplemental ingredient.

(10) If a substance has been added as a supplemental ingredient, the amount referred to in item 18 of the table to this section includes the total amount of the substance in the supplemented food, unless otherwise provided for in column 3 of the List of Permitted Supplemental Ingredients.

Core Information

TABLE

Item	Column 1 Information	Column 2 Description	Column 3 Unit	Column 4 Manner of expression
1	Serving of stated size	"Serving Size (naming the serving size)", "Serving (naming the serving size)" or "Per (naming the serving size)"	The size is expressed (a) in the case of a supplemented food that is a single-serving prepackaged product, (i) per package, and (ii) in grams or millilitres, in accordance with subparagraph B.01.002A(2)(a)(i) or (ii); and (b) in the case of a supplemented food, or an assortment of supplemented foods, that is a multiple-serving prepackaged product, in the following units set out in column 3B of the Table of Reference Amounts: (i) the household measure that applies to the supplemented food, and (ii) the metric measure that applies to the supplemented food.	(1) The size when expressed in a metric unit is rounded off (a) if it is less than 10 g or 10 mL, to the nearest multiple of 0.1 g or 0.1 mL; and (b) if it is 10 g or more or 10 mL or more, to the nearest multiple of 1 g or 1 mL. (2) The size when expressed as a fraction is represented by a numerator and a denominator separated by a line. (3) The size shall include the word "assorted" if the information in the supplemented food facts table of a prepackaged product containing an assortment of supplemented foods is set out as a composite value.
2	Energy value	"Calories", "Total Calories" or "Calories, Total"	The value is expressed in Calories per serving of stated size.	The value is rounded off (a) if it is less than 5 Calories (i) if the supplemented food meets the conditions set out in column 2 of item 1 of the table following section B.01.513 for the subject "free of energy" set out in column 1, to "0" Calorie, and (ii) in all other cases, to the nearest multiple of 1 Calorie; (b) if it is 5 Calories or more but not more than 50 Calories, to the nearest multiple of 5 Calories; and (c) if it is more than 50 Calories, to the nearest multiple of 10 Calories.
3	Amount of fat	"Fat", "Total Fat" or "Fat, Total"	The amount is expressed (a) in grams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.	(1) The amount is rounded off (a) if it is less than 0.5 g (i) if the supplemented food meets the conditions set out in column 2 of item 11 of the table following section B.01.513 for the subject "free of fat" set out in column 1 and the amounts of saturated fatty acids and trans fatty acids are declared as "0 g" in the supplemented food facts table or are omitted from that table in accordance with subsection B.29.002(5) and no other fatty acids are declared in an amount greater than 0 g, to "0 g", and (ii) in all other cases, to the nearest multiple of 0.1 g; (b) if it is 0.5 g or more but not more than 5 g, to the nearest multiple of 0.5 g; and (c) if it is more than 5 g, to the nearest multiple of 1 g. (2) The percentage is rounded off (a) if the amount is declared as "0 g", to 0%; and (b) in all other cases, to the nearest multiple of 1%.
4	Amount of saturated fatty acids	"Saturated Fat", "Saturated Fatty Acids", "Saturated" or "Saturates"	The amount is expressed in grams per serving of stated size.	The amount is rounded off (a) if it is less than 0.5 g (i) if the supplemented food meets the conditions set out in column 2 of item 18 of the table following section B.01.513 for the subject "free of saturated fatty acids" set out in column 1, to "0 g", and (ii) in all other cases, to the nearest multiple of 0.1 g; (b) if it is 0.5 g or more but not more than 5 g, to the nearest multiple of 0.5 g; and (c) if it is more than 5 g, to the nearest multiple of 1 g.
5	Amount of trans fatty acids	"Trans Fat", "Trans Fatty Acids" or "Trans"	The amount is expressed in grams per serving of stated size.	The amount is rounded off (a) if it is less than 0.5 g (i) if the supplemented food meets the conditions set out in column 2 of item 22 of the table following section B.01.513 for the subject "free of trans fatty acids" set out in column 1, to "0 g", and (ii) in all other cases, to the nearest multiple of 0.1 g; (b) if it is 0.5 g or more but not more than 5 g, to the nearest multiple of 0.5 g; and (c) if it is more than 5 g, to the nearest multiple of 1 g.
6	The sum of saturated fatty acids and trans fatty acids	"Saturated Fat + Trans Fat", "Saturated Fatty Acids + Trans Fatty Acids", "Saturated + Trans" or "Saturates + Trans"	The sum is expressed as a percentage of the daily value per serving of stated size.	The percentage is rounded off (a) if the amounts of saturated fatty acids and trans fatty acids are declared as "0 g", to 0%; and (b) in all other cases, to the nearest multiple of 1%.
7	Amount of cholesterol	"Cholesterol"	The amount (a) is expressed in milligrams per serving of stated size; and (b) may also be expressed as a percentage of the daily value per serving of stated size.	(1) The amount is rounded off (a) if the supplemented food meets the conditions set out in column 2 of item 27 of the table following section B.01.513 for the subject "free of cholesterol" set out in column 1, to "0 mg"; and (b) in all other cases, to the nearest multiple of 5 mg. (2) The percentage is rounded off (a) if the amount is declared as "0 mg", to 0%; and (b) in all other cases, to the nearest multiple of 1%.
8	Amount of sodium	"Sodium"	The amount is expressed (a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.	(1) The amount is rounded off (a) if it is less than 5 mg (i) if the supplemented food meets the conditions set out in column 2 of item 31 of the table following section B.01.513 for the subject "free of sodium or salt" set out in column 1, to "0 mg", and (ii) in all other cases, to the nearest multiple of 1 mg; (b) if it is 5 mg or more but not more than 140 mg, to the nearest multiple of 5 mg; and (c) if it is more than 140 mg, to the nearest multiple of 10 mg. (2) The percentage is rounded off (a) if the amount is declared as "0 mg", to 0%; and (b) in all other cases, to the nearest multiple of 1%.
9	Amount of carbohydrate	"Carbohydrate", "Total Carbohydrate" or "Carbohydrate, Total"	The amount is expressed in grams per serving of stated size.	The amount is rounded off (a) if it is less than 0.5 g, to "0 g"; and (b) if it is 0.5 g or more, to the nearest multiple of 1 g.
10	Amount of fibre	"Fibre", "Fiber", "Dietary Fibre" or "Dietary Fiber"	The amount is expressed (a) in grams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.	(1) The amount is rounded off (a) if it is less than 0.5 g, to "0 g"; and (b) if it is 0.5 g or more, to the nearest multiple of 1 g. (2) The percentage is rounded off (a) if the amount is declared as "0 g", to 0%; and (b) in all other cases, to the nearest multiple of 1%.
11	Amount of sugars	"Sugars"	The amount is expressed (a) in grams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.	(1) The amount is rounded off (a) if it is less than 0.5 g, to "0 g"; and (b) if it is 0.5 g or more, to the nearest multiple of 1 g. (2) The percentage is rounded off (a) if the amount is declared as "0 g", to 0%; and (b) in all other cases, to the nearest multiple of 1%.
12	Amount of protein	"Protein"	The amount is expressed in grams per serving of stated size.	The amount is rounded off (a) if it is less than 0.5 g, to the nearest multiple of 0.1 g; and (b) if it is 0.5 g or more, to the nearest multiple of 1 g.
13	Amount of potassium	"Potassium"	The amount is expressed (a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.	(1) The amount is rounded off (a) if it is less than 5 mg, to "0 mg"; (b) if it is 5 mg or more but less than 50 mg, to the nearest multiple of 10 mg; (c) if it is 50 mg or more but less than 250 mg, to the nearest multiple of 25 mg; and (d) if it is 250 mg or more, to the nearest multiple of 50 mg. (2) The percentage is rounded off (a) if the amount is declared as "0 mg", to 0%; and (b) in all other cases, to the nearest multiple of 1%.
14	Amount of calcium	"Calcium"	The amount is expressed (a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.	(1) The amount is rounded off (a) if it is less than 5 mg, to "0 mg"; (b) if it is 5 mg or more but less than 50 mg, to the nearest multiple of 10 mg; (c) if it is 50 mg or more but less than 250 mg, to the nearest multiple of 25 mg; and (d) if it is 250 mg or more, to the nearest multiple of 50 mg. (2) The percentage is rounded off (a) if the amount is declared as "0 mg", to 0%; and (b) in all other cases, to the nearest multiple of 1%.
15	Amount of iron	"Iron"	The amount is expressed (a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.	(1) The amount is rounded off (a) if it is less than 0.05 mg, to "0 mg"; (b) if it is 0.05 mg or more but less than 0.5 mg, to the nearest multiple of 0.1 mg; (c) if it is 0.5 mg or more but less than 2.5 mg, to the nearest multiple of 0.25 mg; and (d) if it is 2.5 mg or more, to the nearest multiple of 0.5 mg. (2) The percentage is rounded off (a) if the amount is declared as "0 mg", to 0%; and (b) in all other cases, to the nearest multiple of 1%.
16	% Daily Value interpretative statement	"*5% or less is a little, 15% or more is a lot"	[not applicable]	The "% Daily Value" or "% DV" subheading is followed by an asterisk in order to reference the % Daily Value interpretative statement shown in the supplemented food facts table.
17	"Supplemented with" interpretative statement	"† Includes naturally occurring and supplemental amounts"	[not applicable]	The "Supplemented with" subheading is followed by a dagger in order to reference the "Supplemented with" interpretative statement shown in the supplemented food facts table.
18	Amount of supplemental ingredient	The supplemental ingredient is described in accordance with column 1 of the List of Permitted Supplemental Ingredients.	The amount is expressed in the applicable unit referred to in column 3 of the List of Permitted Supplemental Ingredients.	The amount is rounded off to the nearest whole number and expressed in the manner set out in column 3 of the List of Permitted Supplemental Ingredients.

Additional Information

B.29.003 (1) Subject to subsection (2), the supplemented food facts table may also contain information set out in column 1 of the table to this section.

(2) This section does not apply in respect of a vitamin or mineral nutrient that is set out in the supplemented food facts table in accordance with subsection B.29.002(1) or (2) if any amount of that vitamin or mineral nutrient has been added as a supplemental ingredient.

(3) If information set out in column 1 of the table to this section is included in the supplemented food facts table, it shall be expressed using a description set out in column 2, in the unit set out in column 3 and in the manner set out in column 4.

(4) For the purpose of subsection (3), the serving of stated size set out in a supplemented food facts table for a supplemented food, expressed in the metric unit, shall be used as the basis for determining the information appearing in the supplemented food facts table in respect of the energy value and nutrient content of the supplemented food.

(5) The percentage of the daily value for a vitamin or mineral nutrient shown in the supplemented food facts table for a supplemented food in accordance with subsection (3) shall be established on the basis of the amount, by weight, of the vitamin or mineral nutrient per serving of stated size for the supplemented food, rounded off in the applicable manner set out in column 4 of the table to this section.

(6) The amount of omega-6 polyunsaturated fatty acids, omega-3 polyunsaturated fatty acids and monounsaturated fatty acids shall be in the supplemented food facts table if

• (a) the amount of any of those groups of fatty acids or the amount of polyunsaturated fatty acids is in the supplemented food facts table or is shown on the label of or in any advertisement for the supplemented food — or the prepackaged product containing an assortment of supplemented foods — that is made or placed by or on the direction of the manufacturer; or
• (b) the amount of any specific fatty acid is shown on the label of or in any advertisement for the supplemented food — or the prepackaged product containing an assortment of supplemented foods — that is made or placed by or on the direction of the manufacturer.

(7) If the label of or any advertisement for the supplemented food — or the prepackaged product containing an assortment of supplemented foods — that is made or placed by or on the direction of the manufacturer, contains a representation, express or implied, that includes information that is set out in column 1 of the table to this section, that information shall also be in the supplemented food facts table.

(8) The supplemented food facts table shall show the amount of any added sugar alcohol.

(9) The supplemented food facts table shall show the amount of any vitamin or mineral nutrient — other than a vitamin or mineral nutrient that is a supplemental ingredient — that is declared as a component of an ingredient, other than flour.

(10) If information set out in column 1 of the table to this section is included in the supplemented food facts table, it shall be shown

• (a) in English and French; or
• (b) in one of those languages, if, in accordance with subsection B.01.012(3), the information that is required by these Regulations to be shown on the label may be shown in that language only and is shown on the label in that language.

TABLE

Additional Information

Item	Column 1 Information	Column 2 Description	Column 3 Unit	Column 4 Manner of expression
1	Servings per package	"Servings per Container", "(number of units) per Container", "Servings per Package", "(number of units) per Package", "Servings per (naming the package type)", or "(number of units) per (naming the package type)"	The quantity is expressed in number of servings.	(1) The quantity is rounded off (a) if it is less than 2, to the nearest multiple of 1; (b) if it is between 2 and 5, to the nearest multiple of 0.5; and (c) if it is more than 5, to the nearest multiple of 1. (2) If a quantity is rounded off, it shall be preceded by the word "about". (3) If the product is of a random weight, the quantity may be declared as "varied".
2	Energy value	"kilojoules" or "kJ"	The value is expressed in kilojoules per serving of stated size.	The value is rounded off to the nearest multiple of 10 kilojoules.
3	Amount of polyunsaturated fatty acids	"Polyunsaturated Fat", "Polyunsaturated Fatty Acids", "Polyunsaturated" or "Polyunsaturates"	The amount is expressed in grams per serving of stated size.	The amount is rounded off (a) if it is less than 1 g, to the nearest multiple of 0.1 g; (b) if it is 1 g or more but not more than 5 g, to the nearest multiple of 0.5 g; and (c) if it is more than 5 g, to the nearest multiple of 1 g.
4	Amount of omega-6 polyunsaturated fatty acids	(1) If the supplemented food facts table includes the amount of polyunsaturated fatty acids: "Omega-6", "Omega-6 Polyunsaturated Fat", "Omega-6 Polyunsaturated Fatty Acids", "Omega-6 Polyunsaturates" or "Omega-6 Polyunsaturated" (2) In all other cases: "Omega-6 Polyunsaturated Fat", "Omega-6 Polyunsaturated Fatty Acids", "Omega-6 Polyunsaturates" or "Omega-6 Polyunsaturated"	The amount is expressed in grams per serving of stated size.	The amount is rounded off (a) if it is less than 1 g, to the nearest multiple of 0.1 g; (b) if it is 1 g or more but not more than 5 g, to the nearest multiple of 0.5 g; and (c) if it is more than 5 g, to the nearest multiple of 1 g.
5	Amount of omega-3 polyunsaturated fatty acids	(1) If the supplemented food facts table includes the amount of polyunsaturated fatty acids: "Omega-3", "Omega-3 Polyunsaturated Fat", "Omega-3 Polyunsaturated Fatty Acids", "Omega-3 Polyunsaturates" or "Omega-3 Polyunsaturated" (2) In all other cases: "Omega-3 Polyunsaturated Fat", "Omega-3 Polyunsaturated Fatty Acids", "Omega-3 Polyunsaturates" or "Omega-3 Polyunsaturated"	The amount is expressed in grams per serving of stated size.	The amount is rounded off (a) if it is less than 1 g, to the nearest multiple of 0.1 g; (b) if it is 1 g or more but not more than 5 g, to the nearest multiple of 0.5 g; and (c) if it is more than 5 g, to the nearest multiple of 1 g.
6	Amount of monounsaturated fatty acids	"Monounsaturated Fat", "Monounsaturated Fatty Acids", "Monounsaturates" or "Monounsaturated"	The amount is expressed in grams per serving of stated size.	The amount is rounded off (a) if it is less than 1 g, to the nearest multiple of 0.1 g; (b) if it is 1 g or more but not more than 5 g, to the nearest multiple of 0.5 g; and (c) if it is more than 5 g, to the nearest multiple of 1 g.
7	Amount of soluble fibre	"Soluble Fibre" or "Soluble Fiber"	The amount is expressed as grams per serving of stated size.	The amount is rounded off (a) if it is less than 0.5 g, to "0 g"; and (b) if it is 0.5 g or more, to the nearest multiple of 1 g.
8	Amount of insoluble fibre	"Insoluble Fibre" or "Insoluble Fiber"	The amount is expressed as grams per serving of stated size.	The amount is rounded off (a) if it is less than 0.5 g, to "0 g"; and (b) if it is 0.5 g or more, to the nearest multiple of 1 g.
9	Amount of sugar alcohol	(1) If the supplemented food contains only one type of sugar alcohol: "Sugar Alcohol", "Polyol" or "(naming the sugar alcohol)" (2) In all other cases: "Sugar Alcohols" or "Polyols"	The amount is expressed as grams per serving of stated size.	The amount is rounded off (a) if it is less than 0.5 g, to "0 g"; and (b) if it is 0.5 g or more, to the nearest multiple of 1 g.
10	Amount of starch	"Starch"	The amount is expressed as grams per serving of stated size.	The amount is rounded off (a) if it is less than 0.5 g, to "0 g"; and (b) if it is 0.5 g or more, to the nearest multiple of 1 g.
11	Amount of vitamin A	"Vitamin A" or "Vit A"	The amount is expressed (a) in micrograms per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.	(1) The amount is rounded off (a) if it is less than 5 µg, to "0 µg"; (b) if it is 5 µg or more but less than 50 µg, to the nearest multiple of 10 µg; (c) if it is 50 µg or more but less than 250 µg, to the nearest multiple of 50 µg; and (d) if it is 250 µg or more, to the nearest multiple of 100 µg. (2) The percentage is rounded off (a) if the amount is declared as "0 µg", to 0%; and (b) in all other cases, to the nearest multiple of 1%.
12	Amount of vitamin C	"Vitamin C" or "Vit C"	The amount is expressed (a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.	(1) The amount is rounded off (a) if it is less than 0.1 mg, to "0 mg"; (b) if it is 0.1 mg or more but less than 1 mg, to the nearest multiple of 0.2 mg; (c) if it is 1 mg or more but less than 5 mg, to the nearest multiple of 0.5 mg; and (d) if it is 5 mg or more, to the nearest multiple of 1 mg. (2) The percentage is rounded off (a) if the amount is declared as "0 mg", to 0%; and (b) in all other cases, to the nearest multiple of 1%.
13	Amount of vitamin D	"Vitamin D" or "Vit D"	The amount is expressed (a) in micrograms per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.	(1) The amount is rounded off (a) if it is less than 0.1 µg, to "0 µg"; (b) if it is 0.1 µg or more but less than 1 µg, to the nearest multiple of 0.2 µg; (c) if it is 1 µg or more but less than 5 µg, to the nearest multiple of 0.5 µg; and (d) if it is 5 µg or more, to the nearest multiple of 1 µg. (2) The percentage is rounded off (a) if the amount is declared as "0 µg", to 0%; and (b) in all other cases, to the nearest multiple of 1%.
14	Amount of vitamin E	"Vitamin E" or "Vit E"	The amount is expressed (a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.	(1) The amount is rounded off (a) if it is less than 0.05 mg, to "0 mg"; (b) if it is 0.05 mg or more but less than 0.5 mg, to the nearest multiple of 0.1 mg; (c) if it is 0.5 mg or more but less than 2.5 mg, to the nearest multiple of 0.25 mg; and (d) if it is 2.5 mg or more, to the nearest multiple of 0.5 mg. (2) The percentage is rounded off (a) if the amount is declared as "0 mg", to 0%; and (b) in all other cases, to the nearest multiple of 1%.
15	Amount of vitamin K	"Vitamin K" or "Vit K"	The amount is expressed (a) in micrograms per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.	(1) The amount is rounded off (a) if it is less than 0.05 µg, to "0 µg"; (b) if it is 0.05 µg or more but less than 0.5 µg, to the nearest multiple of 0.1 µg; (c) if it is 0.5 µg or more but less than 2.5 µg, to the nearest multiple of 0.25 µg; and (d) if it is 2.5 µg or more, to the nearest multiple of 0.5 µg. (2) The percentage is rounded off (a) if the amount is declared as "0 µg", to 0%; and (b) in all other cases, to the nearest multiple of 1%.
16	Amount of thiamine	"Thiamine", "Thiamin", "Thiamine (Vitamin B1)", "Thiamine (Vit B1)", "Thiamin (Vitamin B1)" or "Thiamin (Vit B1)"	The amount is expressed (a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.	(1) The amount is rounded off (a) if it is less than 0.005 mg, to "0 mg"; (b) if it is 0.005 mg or more but less than 0.05 mg, to the nearest multiple of 0.01 mg; (c) if it is 0.05 mg or more but less than 0.25 mg, to the nearest multiple of 0.025 mg; and (d) if it is 0.25 mg or more, to the nearest multiple of 0.05 mg. (2) The percentage is rounded off (a) if the amount is declared as "0 mg", to 0%; and (b) in all other cases, to the nearest multiple of 1%.
17	Amount of riboflavin	"Riboflavin", "Riboflavin (Vitamin B2)" or "Riboflavin (Vit B2)"	The amount is expressed (a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.	(1) The amount is rounded off (a) if it is less than 0.005 mg, to "0 mg"; (b) if it is 0.005 mg or more but less than 0.05 mg, to the nearest multiple of 0.01 mg; (c) if it is 0.05 mg or more but less than 0.25 mg, to the nearest multiple of 0.025 mg; and (d) if it is 0.25 mg or more, to the nearest multiple of 0.05 mg. (2) The percentage is rounded off (a) if the amount is declared as "0 mg", to 0%; and (b) in all other cases, to the nearest multiple of 1%.
18	Amount of niacin	"Niacin"	The amount is expressed (a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.	(1) The amount is rounded off (a) if it is less than 0.05 mg, to "0 mg"; (b) if it is 0.05 mg or more but less than 0.5 mg, to the nearest multiple of 0.1 mg; (c) if it is 0.5 mg or more but less than 2.5 mg, to the nearest multiple of 0.25 mg; and (d) if it is 2.5 mg or more, to the nearest multiple of 0.5 mg. (2) The percentage is rounded off (a) if the amount is declared as "0 mg", to 0%; and (b) in all other cases, to the nearest multiple of 1%.
19	Amount of vitamin B6	"Vitamin B6" or "Vit B6"	The amount is expressed (a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.	(1) The amount is rounded off (a) if it is less than 0.005 mg, to "0 mg"; (b) if it is 0.005 mg or more but less than 0.05 mg, to the nearest multiple of 0.01 mg; (c) if it is 0.05 mg or more but less than 0.25 mg, to the nearest multiple of 0.025 mg; and (d) if it is 0.25 mg or more, to the nearest multiple of 0.05 mg. (2) The percentage is rounded off (a) if the amount is declared as "0 mg", to 0%; and (b) in all other cases, to the nearest multiple of 1%.
20	Amount of folate	"Folate"	The amount is expressed (a) in micrograms of dietary folate equivalents (DFE) per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.	(1) The amount is rounded off (a) if it is less than 1 µg DFE, to "0 µg DFE"; (b) if it is 1 µg DFE or more but less than 10 µg DFE, to the nearest multiple of 2 µg DFE; (c) if it is 10 µg DFE or more but less than 50 µg DFE, to the nearest multiple of 5 µg DFE; and (d) if it is 50 µg DFE or more, to the nearest multiple of 10 µg DFE. (2) The percentage is rounded off (a) if the amount is declared as "0 µg DFE", to 0%; and (b) in all other cases, to the nearest multiple of 1%.
21	Amount of vitamin B12	"Vitamin B12" or "Vit B12"	The amount is expressed (a) in micrograms per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.	(1) The amount is rounded off (a) if it is less than 0.005 µg, to "0 µg"; (b) if it is 0.005 µg or more but less than 0.05 µg, to the nearest multiple of 0.01 µg; (c) if it is 0.05 µg or more but less than 0.25 µg, to the nearest multiple of 0.025 µg; and (d) if it is 0.25 µg or more, to the nearest multiple of 0.05 µg. (2) The percentage is rounded off (a) if the amount is declared as "0 µg", to 0%; and (b) in all other cases, to the nearest multiple of 1%.
22	Amount of biotin	"Biotin"	The amount is expressed (a) in micrograms per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.	(1) The amount is rounded off (a) if it is less than 0.05 µg, to "0 µg"; (b) if it is 0.05 µg or more but less than 0.5 µg, to the nearest multiple of 0.1 µg; (c) if it is 0.5 µg or more but less than 2.5 µg, to the nearest multiple of 0.25 µg; and (d) if it is 2.5 µg or more, to the nearest multiple of 0.5 µg. (2) The percentage is rounded off (a) if the amount is declared as "0 µg", to 0%; and (b) in all other cases, to the nearest multiple of 1%.
23	Amount of pantothenic acid	"Pantothenic Acid" or "Pantothenate"	The amount is expressed (a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.	(1) The amount is rounded off (a) if it is less than 0.01 mg, to "0 mg"; (b) if it is 0.01 mg or more but less than 0.1 mg, to the nearest multiple of 0.02 mg; (c) if it is 0.1 mg or more but less than 0.5 mg, to the nearest multiple of 0.05 mg; and (d) if it is 0.5 mg or more, to the nearest multiple of 0.1 mg. (2) The percentage is rounded off (a) if the amount is declared as "0 mg", to 0%; and (b) in all other cases, to the nearest multiple of 1%.
24	Amount of choline	"Choline"	The amount is expressed (a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.	(1) The amount is rounded off (a) if it is less than 1 mg, to "0 mg"; (b) if it is 1 mg or more but less than 10 mg, to the nearest multiple of 2 mg; (c) if it is 10 mg or more but less than 50 mg, to the nearest multiple of 5 mg; and (d) if it is 50 mg or more, to the nearest multiple of 10 mg. (2) The percentage is rounded off (a) if the amount is declared as "0 mg", to 0%; and (b) in all other cases, to the nearest multiple of 1%.
25	Amount of phosphorous	"Phosphorus"	The amount is expressed (a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.	(1) The amount is rounded off (a) if it is less than 5 mg, to "0 mg"; (b) if it is 5 mg or more but less than 50 mg, to the nearest multiple of 10 mg; (c) if it is 50 mg or more but less than 250 mg, to the nearest multiple of 25 mg; and (d) if it is 250 mg or more, to the nearest multiple of 50 mg. (2) The percentage is rounded off (a) if the amount is declared as "0 mg", to 0%; and (b) in all other cases, to the nearest multiple of 1%.
26	Amount of iodide	"Iodide" or "Iodine"	The amount is expressed (a) in micrograms per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.	(1) The amount is rounded off (a) if it is less than 1 µg, to "0 µg"; (b) if it is 1 µg or more but less than 10 µg, to the nearest multiple of 2 µg; (c) if it is 10 µg or more but less than 50 µg, to the nearest multiple of 5 µg; and (d) if it is 50 µg or more, to the nearest multiple of 10 µg. (2) The percentage is rounded off (a) if the amount is declared as "0 µg", to 0%; and (b) in all other cases, to the nearest multiple of 1%.
27	Amount of magnesium	"Magnesium"	The amount is expressed (a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.	(1) The amount is rounded off (a) if it is less than 1 mg, to "0 mg"; (b) if it is 1 mg or more but less than 10 mg, to the nearest multiple of 2 mg; (c) if it is 10 mg or more but less than 50 mg, to the nearest multiple of 5 mg; and (d) if it is 50 mg or more, to the nearest multiple of 10 mg. (2) The percentage is rounded off (a) if the amount is declared as "0 mg", to 0%; and (b) in all other cases, to the nearest multiple of 1%.
28	Amount of zinc	"Zinc"	The amount is expressed (a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.	(1) The amount is rounded off (a) if it is less than 0.05 mg, to "0 mg"; (b) if it is 0.05 mg or more but less than 0.5 mg, to the nearest multiple of 0.1 mg; (c) if it is 0.5 mg or more but less than 2.5 mg, to the nearest multiple of 0.25 mg; and (d) if it is 2.5 mg or more, to the nearest multiple of 0.5 mg. (2) The percentage is rounded off (a) if the amount is declared as "0 mg", to 0%; and (b) in all other cases, to the nearest multiple of 1%.
29	Amount of selenium	"Selenium"	The amount is expressed (a) in micrograms per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.	(1) The amount is rounded off (a) if it is less than 0.1 µg, to "0 µg"; (b) if it is 0.1 µg or more but less than 1 µg, to the nearest multiple of 0.2 µg; (c) if it is 1 µg or more but less than 5 µg, to the nearest multiple of 0.5 µg; and (d) if it is 5 µg or more, to the nearest multiple of 1 µg. (2) The percentage is rounded off (a) if the amount is declared as "0 µg", to 0%; and (b) in all other cases, to the nearest multiple of 1%.
30	Amount of copper	"Copper"	The amount is expressed (a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.	(1) The amount is rounded off (a) if it is less than 0.0015 mg, to "0 mg"; (b) if it is 0.0015 mg or more but less than 0.025 mg, to the nearest multiple of 0.002 mg; (c) if it is 0.025 mg or more but less than 0.05 mg, to the nearest multiple of 0.005 mg; and (d) if it is 0.05 mg or more, to the nearest multiple of 0.01 mg. (2) The percentage is rounded off (a) if the amount is declared as "0 mg", to 0%; and (b) in all other cases, to the nearest multiple of 1%.
31	Amount of manganese	"Manganese"	The amount is expressed (a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.	(1) The amount is rounded off (a) if it is less than 0.005 mg, to "0 mg"; (b) if it is 0.005 mg or more but less than 0.05 mg, to the nearest multiple of 0.01 mg; (c) if it is 0.05 mg or more but less than 0.25 mg, to the nearest multiple of 0.025 mg; and (d) if it is 0.25 mg or more, to the nearest multiple of 0.05 mg. (2) The percentage is rounded off (a) if the amount is declared as "0 mg", to 0%; and (b) in all other cases, to the nearest multiple of 1%.
32	Amount of chromium	"Chromium"	The amount is expressed (a) in micrograms per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.	(1) The amount is rounded off (a) if it is less than 0.05 µg, to "0 µg"; (b) if it is 0.05 µg or more but less than 0.5 µg, to the nearest multiple of 0.1 µg; (c) if it is 0.5 µg or more but less than 2.5 µg, to the nearest multiple of 0.25 µg; and (d) if it is 2.5 µg or more, to the nearest multiple of 0.5 µg. (2) The percentage is rounded off (a) if the amount is declared as "0 µg", to 0%; and (b) in all other cases, to the nearest multiple of 1%.
33	Amount of molybdenum	"Molybdenum"	The amount is expressed (a) in micrograms per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.	(1) The amount is rounded off (a) if it is less than 0.05 µg, to "0 µg"; (b) if it is 0.05 µg or more but less than 0.5 µg, to the nearest multiple of 0.1 µg; (c) if it is 0.5 µg or more but less than 2.5 µg, to the nearest multiple of 0.25 µg; and (d) if it is 2.5 µg or more, to the nearest multiple of 0.5 µg. (2) The percentage is rounded off (a) if the amount is declared as "0 µg", to 0%; and (b) in all other cases, to the nearest multiple of 1%.
34	Amount of chloride	"Chloride"	The amount is expressed (a) in milligrams per serving of stated size; and (b) as a percentage of the daily value per serving of stated size.	(1) The amount is rounded off (a) if it is less than 5 mg, to "0 mg"; (b) if it is 5 mg or more but less than 50 mg, to the nearest multiple of 10 mg; (c) if it is 50 mg or more but less than 250 mg, to the nearest multiple of 25 mg; and (d) if it is 250 mg or more, to the nearest multiple of 50 mg. (2) The percentage is rounded off (a) if the amount is declared as "0 mg", to 0%; and (b) in all other cases, to the nearest multiple of 1%.

Supplemented Food for Use in Manufacturing Other Supplemented Foods

B.29.004 (1) This section applies to a supplemented food that is intended solely for use as an ingredient in the manufacture of other supplemented foods intended for sale to a consumer at the retail level.

(2) No person shall sell the supplemented food unless the information referred to in subsection (3) in respect of the supplemented food is provided in writing and accompanies the supplemented food when it is delivered to the purchaser.

(3) The information

• (a) shall include the information that would, but for subsection B.29.002(7), be required by sections B.29.002 and B.29.003 to be included in a supplemented food facts table;
• (b) may include other information that is permitted by section B.29.003 to be included in that supplemented food facts table; and
• (c) shall be expressed in accordance with sections B.29.002 and B.29.003, subject to the following modifications, namely,
  • (i) information about supplemental ingredients shall be expressed according to the applicable unit referred to in column 3 of the List of Permitted Supplemental Ingredients,
    • (A) per gram or 100 g of the supplemented food, if the net quantity of the supplemented food is declared on the label by weight or by count, or
    • (B) per millilitre or 100 mL of the supplemented food, if the net quantity of the supplemented food is declared on the label by volume,
  • (ii) information — other than in respect of supplemental ingredients — for vitamins referred to in subsection D.01.002(1) shall be expressed in the applicable unit referred to in subsection D.01.003(1) and for mineral nutrients referred to in paragraphs D.02.001(1)(a) to (j), (l) to (n) and (p) shall be expressed in milligrams for sodium, potassium, calcium, phosphorus, magnesium, iron, zinc, chloride, copper and manganese and in micrograms for iodide, chromium, selenium and molybdenum,
    • (A) per gram or 100 g of the supplemented food, if the net quantity of the supplemented food is declared on the label by weight or by count, or
    • (B) per millilitre or 100 mL of the supplemented food, if the net quantity of the supplemented food is declared on the label by volume,
  • (iii) information for other nutrients and the energy value set out in column 1 of the tables to section B.29.002 or B.29.003 shall be expressed in the units referred to in column 3,
    • (A) per gram or 100 g of the supplemented food, if the net quantity of the supplemented food is declared on the label by weight or by count, or
    • (B) per millilitre or 100 mL of the supplemented food, if the net quantity of the supplemented food is declared on the label by volume,
  • (iv) percentages of daily values and information on servings of stated size may be omitted, and
  • (v) the information shall be stated with a degree of precision that corresponds to the accuracy of the analytical methodology used to produce the information.

Basis of Information

B.29.005 (1) Subject to subsections (2) to (5), the information in the supplemented food facts table shall be set out only on the basis of the supplemented food as offered for sale, or, in the case of a prepackaged product containing an assortment of supplemented foods, on the basis of the prepackaged product as offered for sale.

(2) If a prepackaged product contains an assortment of supplemented foods of the same type and the typical serving consists of only one of those supplemented foods, the information in the supplemented food facts table shall be set out

• (a) on the basis of each of the supplemented foods contained in the prepackaged product, if the information set out in column 1 of the table to section B.29.002 for each of those supplemented foods is different; or
• (b) on the basis of one of the supplemented foods contained in the prepackaged product, if the information set out in column 1 of the table to section B.29.002 for each of those supplemented foods is the same.

(3) If a prepackaged product contains an assortment of supplemented foods of the same type and the typical serving consists of more than one of those supplemented foods, the information in the supplemented food facts table shall be set out for each of the supplemented foods contained in the prepackaged product or as a composite value.

(4) If a prepackaged product contains a supplemented food that is to be prepared in accordance with directions provided in or on the package or that is commonly combined with other ingredients or another food or cooked before being consumed, the supplemented food facts table may also set out information for the supplemented food as prepared, in which case

• (a) the supplemented food facts table shall set out the following information for the supplemented food as prepared, namely,
  • (i) except in the case described in subparagraph (ii), the amount of the supplemented food expressed using the unit referred to in column 3 of subparagraph 1(b)(i) of the table to section B.29.002 as “about (naming the serving size)” or “about (naming the serving size) prepared” and, if applicable, in the manner specified in column 4 of subitems 1(1) and (2),
  • (ii) if the supplemented food is commonly served combined with another food, the amount of the other food expressed using the unit referred to in column 3 of subparagraph 1(b)(i) of the table to section B.29.002,
  • (iii) the energy value, expressed using a description set out in column 2 of item 2 of the table to section B.29.002, in the unit set out in column 3 and in the manner set out in column 4,
  • (iv) subject to subparagraph (v), the information set out in column 1 of items 3, 6 to 8, 11 and 13 to 15 of the table to section B.29.002 and in column 1 of items 11 to 34 of the table to section B.29.003 that is declared as a percentage of the daily value in the supplemented food facts table for the supplemented food as sold, expressed using a description set out in column 2 of those tables, as a percentage of the daily value per serving of stated size and in the manner specified in column 4 of those tables, and
  • (v) the information referred to in column 1 of item 18 of the table to section B.29.002, expressed using the description referred to in column 2, the unit referred to in column 3 and in the manner referred to in column 4; and
• (b) the supplemented food facts table may also set out the following information for the added ingredients or the other food, if it is declared in the supplemented food facts table for the supplemented food as sold, namely,
  • (i) the information set out in column 1 of items 3 to 5 and 7 to 12 of the table to section B.29.002, expressed using a description set out in column 2, in milligrams for the information set out in column 1 of items 7 and 8 and in grams for the information set out in column 1 of items 3 to 5 and 9 to 12 and in the manner specified in column 4,
  • (ii) the information set out in column 1 of items 3 to 10 of the table to section B.29.003, expressed using a description set out in column 2, in grams and in the manner specified in column 4, and
  • (iii) the information set out in column 1 of item 2 of the table to section B.29.002, expressed using a description set out in column 2, in the unit set out in column 3 per serving of stated size of the supplemented food as prepared, and in the manner specified in column 4.

(5) The information in the supplemented food facts table may also be set out on the basis of other amounts of the supplemented food that reflect different uses or different units of measurement of the supplemented food, in which case

• (a) the supplemented food facts table shall set out the following information for each of the other amounts of the supplemented food, namely,
  • (i) the amount of the supplemented food expressed in a household measure and a metric measure and in the manner specified in column 4 of subitems 1(1) and (2) of the table to section B.29.002,
  • (ii) the energy value, expressed using a description set out in column 2 of item 2 of the table to section B.29.002, in the unit set out in column 3 and in the manner set out in column 4,
  • (iii) subject to subparagraph (iv), the information set out in column 1 of items 3, 6 to 8, 11 and 13 to 15 of the table to section B.29.002 and in column 1 of items 11 to 34 of the table to section B.29.003 that is declared as a percentage of the daily value in the supplemented food facts table for the first amount of the supplemented food for which information is declared, expressed using a description set out in column 2 of those tables, as a percentage of the daily value per serving of stated size and in the manner specified in column 4 of those tables, and
  • (iv) the information referred to in column 1 of item 18 of the table to section B.29.002, expressed using the description referred to in column 2, the unit referred to in column 3 and in the manner referred to in column 4; and
• (b) if the supplemented food facts table is set out in a version of the aggregate format specified in section B.29.015, it shall also set out the following information for each of the other amounts of the supplemented food, if that information is declared in the supplemented food facts table for the first amount of the supplemented food for which information is declared, namely,
  • (i) the information set out in column 1 of items 3 to 5 and 7 to 15 of the table to section B.29.002, expressed using a description set out in column 2, in milligrams for the information set out in column 1 of items 7, 8, and 13 to 15, and in grams for the information set out in column 1 of items 3 to 5 and 9 to 12 and in the manner specified in column 4, and
  • (ii) the information set out in column 1 of items 3 to 34 of the table to section B.29.003, expressed using a description set out in column 2, in micrograms for the information set out in column 1 of items 11, 13, 15, 21, 22, 26, 29, 32 and 33, in micrograms of dietary folate equivalents for the information set out in column 1 of item 20, in milligrams for the information set out in column 1 of items 12, 14, 16 to 19, 23 to 25, 27, 28, 30, 31 and 34, and in grams for the information set out in column 1 of items 3 to 10 and in the manner specified in column 4.

Presentation of Supplemented Food Facts Table

B.29.006 (1) Subject to subsections (2) to (7), the supplemented food facts table shall be presented in accordance with the format specified in the applicable figure in the Directory of SFFT Formats, having regard to matters such as order of presentation, dimensions, spacing and the use of upper and lower case letters and bold type.

(2) The characters and rules in the supplemented food facts table shall be displayed in a single colour that is a visual equivalent of 100% solid black type on a white background or on a uniform neutral background with a maximum 5% tint of colour.

(3) The characters in the supplemented food facts table

• (a) shall be displayed in a single standard sans serif font that is not decorative and in such a manner that the characters never touch each other or the rules; and
• (b) may be displayed with larger dimensions than those specified in the applicable figure in the Directory of SFFT Formats if all the characters in the table are enlarged in a uniform manner.

(4) The type size shown in parentheses for a version referred to in a table to sections B.29.009 to B.29.015 is the minimum type size that may be used in a supplemented food facts table to show nutrients and supplemental ingredients set out in the tables to sections B.29.002 and B.29.003 in accordance with that version.

(5) A rule that is specified in the applicable figure in the Directory of SFFT Formats as being a 1 point rule or a 2 point rule may be displayed with larger dimensions in the supplemented food facts table.

(6) The information in the supplemented food facts table shall be in accordance with subsections B.29.001(2) and (3) and sections B.29.002, B.29.003 and B.29.005.

(7) In a supplemented food facts table consisting of a table in both English and French, the order of languages may be reversed from the order shown in the applicable figure in the Directory of SFFT Formats.

Location of Supplemented Food Facts Table

B.29.007 (1) Subject to subsection (2), the supplemented food facts table shall be displayed

• (a) in a table in English and a table in French on the same continuous surface of the available display surface;
• (b) in a table in both English and French on a continuous surface of the available display surface; or
• (c) in a table in English on a continuous surface of the available display surface and a table in French on another continuous surface of the available display surface that is of the same size and prominence as the first surface.

(2) If, in accordance with subsection B.01.012(3), the information required by these Regulations may be shown on the label of a supplemented food — or a prepackaged product containing an assortment of supplemented foods — in English only or in French only and is shown in that language, the supplemented food facts table may be displayed on the label in a table in that language only on a continuous surface of the available display surface.

Orientation of Supplemented Food Facts Table

B.29.008 (1) Subject to subsection (2), the supplemented food facts table shall be oriented in the same manner as other information appearing on the label of a supplemented food or a prepackaged product containing an assortment of supplemented foods.

(2) If a version of a supplemented food facts table cannot be oriented in the same manner as other information appearing on the label, it shall be oriented in another manner if there is sufficient space to do so and the food contained in the package does not leak out and is not damaged when the package is turned over.

(3) Subsection (1) does not apply in respect of a supplemented food facts table that is set out on the top or bottom of a package.

Standard and Horizontal Formats

B.29.009 (1) This section applies to a supplemented food unless any of sections B.29.010 to B.29.015 applies to it.

(2) Subject to subsection (3), the supplemented food facts table of the supplemented food shall be set out in a version listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.

(3) If it is not possible to display, in accordance with these Regulations on 15% or less of the available display surface of the supplemented food, a supplemented food facts table in any of the versions that is listed in column 1 of the table to this section, the supplemented food facts table shall be set out in

• (a) the bilingual standard format in accordance with Figure 3.5(B), 3.6(B) or 3.7(B) of the Directory of SFFT Formats;
• (b) the bilingual horizontal format in accordance with Figure 4.3(B), 4.4(B) or 4.5(B) of the Directory of SFFT Formats;
• (c) the linear format in accordance with Figures 16.1(E) and (F) or 16.2(E) and (F) of the Directory of SFFT Formats;
• (d) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the supplemented food facts table; or
• (e) a manner described in section B.29.017.

(4) For the purpose of this section, in determining whether a version of a supplemented food facts table cannot be displayed in accordance with these Regulations on 15% or less of the available display surface of the supplemented food, the supplemented food facts table shall include only the information that is required by these Regulations to be included in that table.

(5) Despite subsections (2) and (3), if the supplemented food facts table of the supplemented food is set out on a tag attached to an ornamental container or a tag attached to a package to which a label cannot be physically applied or on which information cannot be legibly set out and easily viewed by the purchaser or consumer under the customary conditions of purchase, it shall be set out in a version that is described in paragraph (3)(a), (b) or (c) or that is listed in column 1 of the table to this section, without regard to any condition specified in column 2.

TABLE

Standard Format

PART 1

Item	Column 1 Figure in Directory of SFFT Formats (Version)	Column 2 Condition of use
1	1.1(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 8 points)
2	1.2(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points)	The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
3	1.3(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed))	The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
4	1.4(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed))	The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
5	1.5(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed))	The versions in items 1 to 4 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
6	1.6(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed))	The versions in items 1 to 5 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.

Narrow Standard Format

PART 2

Item	Column 1 Figure in Directory of SFFT Formats (Version)	Column 2 Condition of use
1	2.1(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 8 points)
2	2.2(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points)	The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
3	2.3(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed))	The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
4	2.4(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed))	The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.

Bilingual Standard Format

PART 3

Item	Column 1 Figure in Directory of SFFT Formats (Version)	Column 2 Condition of use
1	3.1(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 8 points)
2	3.2(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points)	The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
3	3.3(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed))	The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
4	3.4(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed))	The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.

Bilingual Horizontal Format

PART 4

Item	Column 1 Figure in Directory of SFFT Formats (Version)	Column 2 Condition of use
1	4.1(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed))	The versions in Parts 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
2	4.2(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed))	The versions in Parts 1 to 3 and in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.

Simplified Formats

B.29.010 (1) This section applies to a supplemented food if it satisfies the condition set out in subsection B.29.002(5) and its supplemented food facts table includes only the information referred to in paragraphs B.29.002(5)(a) to (m).

(2) Subject to subsection (3), the supplemented food facts table of the supplemented food shall be set out in a version that is listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.

(3) If it is not possible to display, in accordance with these Regulations on 15% or less of the available display surface of the supplemented food, a supplemented food facts table containing only the information referred to in paragraphs B.29.002(5)(a) to (m) in any of the versions that is listed in column 1 of the table to this section, the supplemented food facts table shall be set out in

• (a) the bilingual simplified standard format in accordance with Figure 6.5(B) or 6.6(B) of the Directory of SFFT Formats;
• (b) the bilingual simplified horizontal format in accordance with Figure 7.3(B) or 7.4(B) of the Directory of SFFT Formats;
• (c) the simplified linear format in accordance with Figures 17.1(E) and (F) or 17.2(E) and (F) of the Directory of SFFT Formats;
• (d) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the supplemented food facts table; or
• (e) a manner described in section B.29.017.

(4) Despite subsections (2) and (3), if the supplemented food facts table of the supplemented food is set out on a tag attached to an ornamental container or a tag attached to a package to which a label cannot be physically applied or on which information cannot be legibly set out and easily viewed by the purchaser or consumer under the customary conditions of purchase, it shall be set out in a version that is described in paragraph (3)(a), (b) or (c) or that is listed in column 1 of the table to this section, without regard to any condition specified in column 2.

TABLE

Simplified Standard Format

PART 1

Item	Column 1 Figure in Directory of SFFT Formats (Version)	Column 2 Condition of use
1	5.1(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 8 points)
2	5.2(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points)	The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
3	5.3(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed))	The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
4	5.4(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed))	The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
5	5.5(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed))	The versions in items 1 to 4 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
6	5.6(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed))	The versions in items 1 to 5 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.

Bilingual Simplified Standard Format

PART 2

Item	Column 1 Figure in Directory of SFFT Formats (Version)	Column 2 Condition of use
1	6.1(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 8 points)
2	6.2(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points)	The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
3	6.3(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed))	The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
4	6.4(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed))	The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.

Bilingual Simplified Horizontal Format

PART 3

Item	Column 1 Figure in Directory of SFFT Formats (Version)	Column 2 Condition of use
1	7.1(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed))	The versions in Parts 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
2	7.2(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed))	The versions in Parts 1 and 2 and in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.

Simplified Formats — Supplemented Foods that are Single-serving Prepackaged Products

B.29.011 (1) This section applies to a supplemented food that is a single-serving prepackaged product, whose supplemented food facts table includes only the information referred to in paragraphs B.29.002(6)(a) to (l).

(2) Subject to subsection (3), the supplemented food facts table of the supplemented food that is a single-serving prepackaged product shall be set out in a version that is listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.

(3) If it is not possible to display, in accordance with these Regulations, on 15% or less of the available display surface of the supplemented food that is a single-serving prepackaged product a supplemented food facts table containing only the information referred to in paragraphs B.29.002(6)(a) to (l) in any of the versions that is listed in column 1 of the table to this section, the supplemented food facts table shall be set out in

• (a) the bilingual simplified standard format in accordance with Figure 6.5.1(B) or 6.6.1(B) of the Directory of SFFT Formats;
• (b) the bilingual simplified horizontal format in accordance with Figure 7.3.1(B) or 7.4.1(B) of the Directory of SFFT Formats;
• (c) the simplified linear format in accordance with Figures 17.1.1(E) and (F) or 17.2.1(E) and (F) of the Directory of SFFT Formats;
• (d) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the supplemented food facts table; or
• (e) a manner described in section B.29.017.

TABLE

PART 1

Bilingual Simplified Standard Format — Supplemented Foods that are Single-serving Prepackaged Products

Item	Column 1 Figure in Directory of SFFT Formats (Version)	Column 2 Condition of use
1	6.1.1(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 8 points)
2	6.2.1(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points)	The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
3	6.3.1(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed))	The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
4	6.4.1(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed))	The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.

PART 2

Bilingual Simplified Horizontal Format — Supplemented Foods that are Single-serving Prepackaged Products

Item	Column 1 Figure in Directory of SFFT Formats (Version)	Column 2 Condition of use
1	7.1.1(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed))	The versions in Part 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
2	7.2.1(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed))	The versions in Part 1 and in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.

Dual Format — Supplemented Foods Requiring Preparation

B.29.012 (1) Subject to subsection (2), if the supplemented food facts table of a supplemented food includes information referred to in subsection B.29.005(4), the supplemented food facts table shall be set out in a version that is listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.

(2) If it is not possible to display, in accordance with these Regulations on 15% or less of the available display surface of the supplemented food, a supplemented food facts table in any of the versions that is listed in column 1 of the table to this section, the supplemented food facts table shall be set out in

• (a) the bilingual dual format in accordance with Figure 9.5(B) or 9.6(B) of the Directory of SFFT Formats; or
• (b) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the supplemented food facts table.

(3) For the purpose of this section, in determining whether a version of a supplemented food facts table cannot be displayed in accordance with these Regulations on 15% or less of the available display surface of the supplemented food, the supplemented food facts table shall include only the information that is required by these Regulations to be included in the table, together with the information referred to in subsection B.29.005(4).

(4) Despite subsections (1) and (2), if the supplemented food facts table of the supplemented food is set out on a tag attached to an ornamental container or a tag attached to a package to which a label cannot be physically applied or on which information cannot be legibly set out and easily viewed by the purchaser or consumer under the customary conditions of purchase, it shall be set out in a version that is described in paragraph (2)(a) or that is listed in column 1 of the table to this section, without regard to any condition specified in column 2.

TABLE

PART 1

Dual Format — Supplemented Foods Requiring Preparation

Item	Column 1 Figure in Directory of SFFT Formats (Version)	Column 2 Condition of use
1	8.1(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 8 points)
2	8.2(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points)	The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
3	8.3(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed))	The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
4	8.4(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed))	The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
5	8.5(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed))	The versions in items 1 to 4 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
6	8.6(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed))	The versions in items 1 to 5 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.

PART 2

Bilingual Dual Format — Supplemented Foods Requiring Preparation

Item	Column 1 Figure in Directory of SFFT Formats (Version)	Column 2 Condition of use
1	9.1(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 8 points)
2	9.2(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points)	The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
3	9.3(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed))	The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
4	9.4(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed))	The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.

Aggregate Format — Different Kinds of Supplemented Foods

B.29.013 (1) Subject to subsection (2), if the supplemented food facts table of a prepackaged product containing an assortment of supplemented foods includes separate information for each supplemented food as provided in paragraph B.29.005(2)(a) or subsection B.29.005(3), the supplemented food facts table shall be set out in a version that is listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.

(2) If it is not possible to display, in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, a supplemented food facts table in any of the versions that is listed in column 1 of the table to this section, the supplemented food facts table shall be set out

• (a) in the case of a prepackaged product described in paragraph B.29.005(2)(a), in
  • (i) the bilingual aggregate format in accordance with Figure 11.5(B) or 11.6(B) of the Directory of SFFT Formats,
  • (ii) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the supplemented food facts table, or
  • (iii) a manner described in section B.29.017; or
• (b) in the case of a prepackaged product described in subsection B.29.005(3), in
  • (i) the bilingual aggregate format in accordance with Figure 11.5(B) or 11.6(B) of the Directory of SFFT Formats, or
  • (ii) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the supplemented food facts table.

(3) For the purpose of this section, in determining whether a version of a supplemented food facts table cannot be displayed in accordance with these Regulations on 15% or less of the available display surface of the prepackaged product, the supplemented food facts table shall include only the information that is required by these Regulations to be included for each supplemented food for which separate information is set out in the table.

(4) Despite subsections (1) and (2), if the supplemented food facts table of the prepackaged product is set out on a tag attached to an ornamental container or a tag attached to a package to which a label cannot be physically applied or on which information cannot be legibly set out and easily viewed by the purchaser or consumer under the customary conditions of purchase, it shall be set out in a version that is described in subparagraph (2)(b)(i) or that is listed in column 1 of the table to this section, without regard to any condition specified in column 2.

TABLE

PART 1

Aggregate Format — Different Kinds of Supplemented Foods

Item	Column 1 Figure in Directory of SFFT Formats (Version)	Column 2 Condition of use
1	10.1(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 8 points)
2	10.2(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points)	The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
3	10.3(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed))	The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
4	10.4(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed))	The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
5	10.5(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed))	The versions in items 1 to 4 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
6	10.6(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed))	The versions in items 1 to 5 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.

PART 2

Bilingual Aggregate Format — Different Kinds of Supplemented Foods

Item	Column 1 Figure in Directory of SFFT Formats (Version)	Column 2 Condition of use
1	11.1(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 8 points)
2	11.2(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points)	The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
3	11.3(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed))	The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
4	11.4(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed))	The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.

Dual Format — Different Amounts of Supplemented Food

B.29.014 (1) Subject to subsection (2), if the supplemented food facts table of a supplemented food includes separate information for different amounts of the supplemented food as provided in paragraph B.29.005(5)(a) without including the information referred to in paragraph B.29.005(5)(b), the supplemented food facts table shall be set out in a version that is listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.

(2) If it is not possible to display, in accordance with these Regulations on 15% or less of the available display surface of the supplemented food, a supplemented food facts table in any of the versions that is listed in column 1 of the table to this section, the supplemented food facts table shall be set out in

• (a) the bilingual dual format in accordance with Figure 13.5(B) or 13.6(B) of the Directory of SFFT Formats; or
• (b) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the supplemented food facts table.

(3) For the purpose of this section, in determining whether a version of a supplemented food facts table cannot be displayed in accordance with these Regulations on 15% or less of the available display surface of the supplemented food, the supplemented food facts table shall include only the information that is required by these Regulations to be included for each amount of the supplemented food for which separate information is set out in the table.

(4) Despite subsections (1) and (2), if the supplemented food facts table of the supplemented food is set out on a tag attached to an ornamental container or a tag attached to a package to which a label cannot be physically applied or on which information cannot be legibly set out and easily viewed by the purchaser or consumer under the customary conditions of purchase, it shall be set out in a version that is described in paragraph (2)(a) or that is listed in column 1 of the table to this section, without regard to any condition specified in column 2.

TABLE

PART 1

Dual Format — Different Amounts of Supplemented Food

Item	Column 1 Figure in Directory of SFFT Formats (Version)	Column 2 Condition of use
1	12.1(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 8 points)
2	12.2(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points)	The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
3	12.3(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed))	The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
4	12.4(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed))	The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
5	12.5(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed))	The versions in items 1 to 4 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
6	12.6(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed))	The versions in items 1 to 5 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.

PART 2

Bilingual Dual Format — Different Amounts of Supplemented Food

Item	Column 1 Figure in Directory of SFFT Formats (Version)	Column 2 Condition of use
1	13.1(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 8 points)
2	13.2(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points)	The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
3	13.3(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed))	The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
4	13.4(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed))	The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.

Aggregate Format — Different Amounts of Supplemented Food

B.29.015 (1) Subject to subsection (2), if the supplemented food facts table of a supplemented food includes separate information for different amounts of the supplemented food as provided in paragraphs B.29.005(5)(a) and (b), the supplemented food facts table shall be set out in a version that is listed in column 1 of the table to this section and in respect of which the condition specified in column 2 is satisfied.

(2) If it is not possible to display, in accordance with these Regulations on 15% or less of the available display surface of the supplemented food, a supplemented food facts table in any of the versions that is listed in column 1 of the table to this section, the supplemented food facts table shall be set out in

• (a) the bilingual aggregate format in accordance with Figure 15.5(B) or 15.6(B) of the Directory of SFFT Formats; or
• (b) a version that is listed in column 1 of the table to this section, even though more than 15% of the available display surface would be required to display the supplemented food facts table.

(3) For the purpose of this section, in determining whether a version of a supplemented food facts table cannot be displayed in accordance with these Regulations on 15% or less of the available display surface of the supplemented food, the supplemented food facts table shall include only the information that is required by these Regulations to be included for each amount of the supplemented food for which separate information is set out in the table.

(4) Despite subsections (1) and (2), if the supplemented food facts table of the supplemented food is set out on a tag attached to an ornamental container or a tag attached to a package to which a label cannot be physically applied or on which information cannot be legibly set out and easily viewed by the purchaser or consumer under the customary conditions of purchase, it shall be set out in a version that is described in paragraph (2)(a) or that is listed in column 1 of the table to this section, without regard to any condition specified in column 2.

TABLE

PART 1

Aggregate Format — Different Amounts of Supplemented Food

Item	Column 1 Figure in Directory of SFFT Formats (Version)	Column 2 Condition of use
1	14.1(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 8 points)
2	14.2(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points)	The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
3	14.3(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed))	The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
4	14.4(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed))	The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
5	14.5(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed))	The versions in items 1 to 4 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
6	14.6(E) and (F) (nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed))	The versions in items 1 to 5 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.

PART 2

Bilingual Aggregate Format — Different Amounts of Supplemented Food

Item	Column 1 Figure in Directory of SFFT Formats (Version)	Column 2 Condition of use
1	15.1(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 8 points)
2	15.2(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points)	The version in item 1 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
3	15.3(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 7 points (condensed))	The versions in items 1 and 2 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.
4	15.4(B) (nutrients and supplemental ingredients to be shown in a type size of not less than 6 points (condensed))	The versions in items 1 to 3 cannot be displayed in accordance with these Regulations on 15% or less of the available display surface.

Presentation of Additional Information

B.29.016 (1) If information referred to in column 1 of the table to section B.29.003 is included in a supplemented food facts table that is set out in a version consisting of a table in English and a table in French or a table in English or French, that information shall be displayed

• (a) in accordance with the order of presentation, the use of indents and the presentation of footnotes illustrated in Figures 18.1(E) and (F) of the Directory of SFFT Formats; and
• (b) in respect of matters other than those referred to in paragraph (a), in accordance with the format that is specified in the applicable figure in the Directory of SFFT Formats.

(2) If information referred to in column 1 of the table to section B.29.003 is included in a supplemented food facts table that is set out in a version consisting of a table in both English and French, that information shall be displayed

• (a) in accordance with the order of presentation, the use of indents and the presentation of footnotes illustrated in Figure 19.1(B) of the Directory of SFFT Formats; and
• (b) in respect of matters other than those referred to in paragraph (a), in accordance with the format that is specified in the applicable figure in the Directory of SFFT Formats.

(3) Despite paragraph (1)(a), the use of indents illustrated in Figures 18.1(E) and (F) of the Directory of SFFT Formats is not applicable if information referred to in column 1 of the table to section B.29.003 is set out in the linear format referred to in paragraph B.29.009(3)(c) or the simplified linear format referred to in paragraph B.29.010(3)(c).

Alternative Methods of Presentation

B.29.017 (1) Despite section A.01.016 and subject to subsection (2), the supplemented food facts table of a supplemented food that meets the conditions specified in subsection B.29.009(3), B.29.010(3) or B.29.011(3) — or a prepackaged product that contains an assortment of supplemented foods and meets the conditions specified in paragraph B.29.013(2)(a) — may be set out on

• (a) a tag attached to the package;
• (b) a package insert;
• (c) the inner side of a label;
• (d) a fold-out label; or
• (e) an outer sleeve, overwrap or collar.

(2) The supplemented food facts table shall not be set out in a manner described in paragraph (1)(b) or (c) if a list of cautionary statements is required under subsection B.29.020(1).

(3) If the supplemented food facts table is set out in a manner described in paragraph (1)(b) or (c), the outer side of the label of the package shall indicate in a type size of not less than 8 points where the supplemented food facts table is located.

(4) If the supplemented food facts table is set out in a manner described in subsection (1), it shall be set out

• (a) in the case of a supplemented food described in subsection B.29.009(3), in a version that is described in paragraph B.29.009(3)(a), (b) or (c) or that is listed in column 1 of the table to section B.29.009;
• (b) in the case of a supplemented food described in subsection B.29.010(3), in a version that is described in paragraph B.29.010(3)(a), (b) or (c) or that is listed in column 1 of the table to section B.29.010;
• (c) in the case of a supplemented food described in subsection B.29.011(3), in a version that is described in paragraph B.29.011(3)(a), (b) or (c) or that is listed in column 1 of the table to section B.29.011; and
• (d) in the case of a prepackaged product containing an assortment of supplemented foods described in paragraph B.29.013(2)(a), in a version that is described in subparagraph B.29.013(2)(a)(i) or that is listed in column 1 of the table to section B.29.013.

Small Packages

B.29.018 (1) Despite section A.01.016 and subject to subsection (2), if the available display surface of a supplemented food is less than 100 cm^{footnote 2}, the label of the supplemented food need not carry a supplemented food facts table if the outer side of the label contains an indication of how a purchaser or consumer may obtain the information that would otherwise be required to be set out in a supplemented food facts table on the label of the supplemented food.

(2) Subsection (1) does not apply to a supplemented food

• (a) for which a list of cautionary statements is required under subsection B.29.020(1); or
• (b) that contains a nutrient or supplemental ingredient that is the subject of a representation on the label of the supplemented food, or in any advertisement for the supplemented food that is made or placed by or on the direction of the manufacturer of the supplemented food, if the representation expressly or implicitly indicates that the supplemented food has particular nutritional or health-related properties, including any statement or claim set out in column 4 of the table following section B.01.513 or column 1 of the table following section B.01.603 or referred to in section B.01.311, D.01.006 or D.02.004.

(3) An indication referred to in subsection (1)

• (a) shall be set out in a type size of not less than 8 points;
• (b) shall include a postal address, website address or toll-free telephone number; and
• (c) shall be
  • (i) in English and French, or
  • (ii) in one of those languages, if, in accordance with subsection B.01.012(3), the information that is required by these Regulations to be shown on the label of the supplemented food may be shown in that language only and is shown on the label in that language.

(4) The manufacturer of the supplemented food shall provide the information referred to in subsection (1) to a purchaser or consumer on request

• (a) without charge;
• (b) in the following manner, namely,
  • (i) in the official language in which the information is requested or, if specified by the purchaser or consumer, in both official languages, or
  • (ii) in one of the official languages, if, in accordance with subsection B.01.012(3), the information that is required by these Regulations to be shown on the label of the supplemented food may be shown in that language only and is shown on the label in that language; and
• (c) in the form of a supplemented food facts table that is set out
  • (i) in a format, other than a horizontal format, that is specified in any of sections B.29.009 to B.29.015 and that would otherwise be carried on the label of the supplemented food in accordance with these Regulations, and
  • (ii) in a version of that format that is listed in column 1 of item 1 of any Part of the table to the applicable section referred to in subparagraph (i).

B.29.019 If a supplemented food has an available display surface of less than 100 cm^{footnote 2} and has a supplemented food facts table on its label, the supplemented food facts table need only include

• (a) the serving of stated size;
• (b) the information referred to in column 1 of the tables to section B.29.002 or B.29.003 in respect of the energy value of the supplemented food and the amount of any nutrient or supplemental ingredient that is the subject of a representation on the label of the supplemented food, or in any advertisement for the supplemented food that is made or placed by or on the direction of the manufacturer of the supplemented food, if the representation expressly or implicitly indicates that the supplemented food has particular nutritional or health-related properties, including any statement or claim set out in column 4 of the table following section B.01.513 or column 1 of the table following section B.01.603 or referred to in section B.01.311, D.01.006 or D.02.004;
• (c) the amount of any added sugar alcohol; and
• (d) the amount of any supplemental ingredient for which a cautionary statement is required under subsection B.29.020(1).

Cautionary Statements

B.29.020 (1) Any applicable cautionary statements that are set out in column 4 of the List of Permitted Supplemental Ingredients in respect of a supplemental ingredient contained in a supplemented food shall be shown

• (a) in a list on the label of the supplemented food or, in the case of a prepackaged product containing an assortment of supplemented foods, on the label of that prepackaged product;
• (b) grouped together and introduced by the title, in bold type,
  • (i) “Caution” or “Caution:” in the English version, and
  • (ii) “Attention”, “Attention :” or “Attention:” in the French version;
• (c) without any intervening printed, written or graphic material appearing between the title and the first cautionary statement;
• (d) in regular or bold type;
• (e) in lower case letters, except that upper case letters shall be used to show the first letter of each cautionary statement; and
• (f) separated by a bullet point or comma.

(2) The list of cautionary statements shall be shown in a manner that clearly differentiates it on the label by means of one or both of

• (a) graphics in the form of a solid-line border around the list or one or more solid lines appearing immediately above, below or at the sides of the list that are the same colour as that of the type used to show the information referred to in subsection B.01.008.1(1), and
• (b) a background colour that creates a contrast between the background colour of the list and the background colour used on the adjacent area of the label, other than the area used to display a list of ingredients, a food allergen source, gluten source and added sulphites statement, as defined in subsection B.01.010.1(1), a declaration referred to in subsection B.01.010.4(1) and a supplemented food facts table.

(3) The list of cautionary statements shall appear on the label without any intervening printed, written or graphic material,

• (a) in English and French, adjacent to each linguistic version of the supplemented food facts table appearing in the same language, if there are separate English and French versions of the table;
• (b) in English and French, adjacent to a bilingual version of the supplemented food facts table, with one linguistic version of the list following the other linguistic version; or
• (c) in English or French, adjacent to the supplemented food facts table in the same language, if, in accordance with subsection B.01.012(3), the information required by these Regulations to be shown on the label may be shown in that language only and is shown on the label in that language.

(4) If the English and French versions of a list of cautionary statements appear on the label, they shall be displayed on a continuous surface of the label’s available display surface, but need not be on the same continuous surface of the label’s available display surface.

(5) If the English and French versions of a list of cautionary statements appear on the same continuous surface of the label, the version that follows the other version shall not begin on the same line as that on which the other version ends, unless the available display surface is less than 100 cm^{footnote 2}.

Supplemented Food Caution Identifier

Presentation of Supplemented Food Caution Identifier

B.29.021 (1) If the label of a supplemented food — or a prepackaged product containing an assortment of supplemented foods — carries a list of cautionary statements in accordance with subsection B.29.020(1), its principal display panel must carry the supplemented food caution identifier.

(2) The supplemented food caution identifier must be displayed in black and white and include an exclamation mark on the left-hand side and the word or words “Supplemented”, “Supplémenté” or “Supplemented/Supplémenté”, as the case may be, and an attribution of the message to Health Canada, all of which are surrounded by a solid-line border.

(3) Subject to subsection (4), the supplemented food caution identifier must be presented in one of the following formats, in accordance with the applicable specifications in the Directory of Supplemented Food Caution Identifier Specifications:

• (a) the unilingual standard format, which is shown in two separate versions, one in English (ES) and one in French (FS); or
• (b) the bilingual standard format (BS), in which the words in the identifier are shown in both official languages.

(4) If the area of the principal display surface is less than or equal to 450 cm^{footnote 2} and, based on that area, it is not possible to present the supplemented food caution identifier in one of the formats set out in subsection (3) because the width of the format exceeds the width of the principal display panel, the identifier may be presented in the bilingual compact format (BC) in which the words in the identifier are shown in both official languages, in accordance with the applicable specifications in the Directory of Supplemented Food Caution Identifier Specifications.

(5) Despite subsections (3) and (4), the supplemented food caution identifier may be displayed with larger dimensions than those specified in column 3 of the applicable table in the Directory of Supplemented Food Caution Identifier Specifications if it is enlarged in a proportional manner vertically and horizontally.

(6) If the supplemented food caution identifier is presented in a bilingual format, the order in which the languages appear in the applicable identifier may be reversed.

(7) The characters and other elements of the supplemented food caution identifier must not touch each other.

Placement of Supplemented Food Caution Identifier

B.29.022 (1) The supplemented food caution identifier must be displayed

• (a) in the case of a supplemented food — or a prepackaged product containing an assortment of supplemented foods — if the height of the principal display panel is less than its width, on that part of the principal display panel that represents the right-most 50% of the area of the principal display panel; and
• (b) in any other case, on that part of the principal display panel that represents the upper 50% of the area of the principal display panel.

(2) If a supplemented food — or a prepackaged product containing an assortment of supplemented foods — is cylindrical in shape, the supplemented food caution identifier must be a minimum distance of 10% of the width of the principal display surface from the edges of the left or right side of the principal display surface.

(3) The supplemented food caution identifier must be clearly visible and distinguishable from all other information appearing on the principal display panel.

(4) The supplemented food caution identifier must be surrounded by a minimum buffer that has a measurement equal to or greater than that specified in column 4 of the applicable table in the Directory of Supplemented Food Caution Identifier Specifications and the buffer must not contain any text.

Orientation of Supplemented Food Caution Identifier

B.29.023 The supplemented food caution identifier must be oriented in such a manner that the words appearing in it are readable from left to right and are parallel with the base of the package.

Prohibitions

B.29.024 No person shall sell a prepackaged product containing an assortment of foods of the same type if the assortment includes both supplemented foods and foods that are not supplemented foods.

B.29.025 (1) No person shall label a prepackaged product with a supplemented food caution identifier or sell a product that is so labelled, unless the label carries a list of cautionary statements in accordance with subsection B.29.020(1).

(2) No person shall label a prepackaged product with any representation — including a word, phrase, illustration, sign, mark, symbol or design — that resembles the supplemented food caution identifier such that it is likely to be mistaken for the supplemented food caution identifier, or to sell a prepackaged product that is so labelled.

Representations

B.29.026 (1) Despite any provision to the contrary in these Regulations, no person shall, on the label of or in any advertisement for a supplemented food — or a prepackaged product containing an assortment of supplemented foods — make a representation, express or implied, if

• (a) the representation is in respect of a supplemental ingredient contained in the supplemented food or, in the case of a prepackaged product containing an assortment of supplemented foods, contained in one of those supplemented foods; and
• (b) that supplemental ingredient is the subject of a cautionary statement required to be carried on the label in accordance with subsection B.29.020(1).

(2) Despite any provision to the contrary in these Regulations, if the principal display panel of a supplemented food — or a prepackaged product containing an assortment of supplemented foods — carries the statement “high caffeine content” in accordance with column 5 of the List of Permitted Supplemental Ingredients, no person shall make a representation, express or implied, on the label of or in any advertisement for that supplemented food or prepackaged product, with respect to any of the following:

• (a) any vitamin or mineral nutrient contained in the supplemented food or in the case of a prepackaged product containing an assortment of supplemented foods, contained in one of those supplemented foods;
• (b) physical performance; and
• (c) hydration or electrolyte replacement.

(3) Subsection (1) does not apply in respect of a declaration of a supplemental ingredient in the list of ingredients or supplemented food facts table.

(4) Paragraph (2)(a) does not apply in respect of a declaration of a vitamin or mineral nutrient in the list of ingredients or supplemented food facts table.

B.29.027 If the label of a supplemented food — or a prepackaged product containing an assortment of supplemented foods — carries a list of cautionary statements in accordance with subsection B.29.020(1), any representation that expressly or implicitly indicates that the supplemented food, or any supplemented food in the assortment, has particular nutritional or health-related properties, including any health-related statement, logo, symbol, seal of approval or mark, must have dimensions that meet the following requirements:

• (a) if the representation is displayed on the principal display panel,
  • (i) the height of the upper case letters in the representation must not exceed two times the height of the upper case letters, excluding any accents, in the supplemented food caution identifier required under subsection B.29.021(1), other than in the words “Health Canada” and “Santé Canada”, and
  • (ii) the height of the tallest ascender of the lower case letters in the representation must not exceed two times the height of the tallest ascender of the lower case letters in the supplemented food caution identifier required under subsection B.29.021(1), other than in the words “Health Canada” and “Santé Canada”; and
• (b) if the representation is displayed on any continuous surface, other than on the principal display panel,
  • (i) the height of the upper case letters in the representation must not exceed two times the height of the upper case letters, excluding any accents, in the cautionary statements, and
  • (ii) the height of the tallest ascender of the lower case letters in the representation must not exceed two times the height of the tallest ascender of the lower case letters in the cautionary statements.

Adulteration and Exemptions

B.29.028 A food, other than a supplemented food, is adulterated if it contains a supplemented food as an ingredient.

B.29.029 (1) A supplemented food does not have a poisonous or harmful substance in or on it for the purposes of paragraph 4(1)(a) of the Act — or is not adulterated for the purposes of paragraph 4(1)(d) of the Act — by reason only that a supplemental ingredient has been added to it.

(2) A supplemented food is exempt from the application of section 6 and subsection 6.1(2) of the Act and section B.01.042 in respect only of a supplemental ingredient that has been added to it.

Changes to the Lists

B.29.030 A request for a change to the List of Permitted Supplemented Food Categories, namely the addition or removal of, or a change to, a supplemented food category, shall be submitted to the Minister in a form and manner established by the Minister and shall include

• (a) the name, title and contact information of the person who signed the submission and the date of signature;
• (b) a description of the proposed change;
• (c) the rationale for the proposed change and the information relied on to support that change; and
• (d) information respecting the estimated levels of consumption of the food belonging to the supplemented food category affected by the proposed change, except in the case of a supplemented food category that is proposed to be removed from the list.

B.29.031 A request for a change to the List of Permitted Supplemental Ingredients, including the addition or removal of a substance or a change in the conditions of use in respect of a substance, shall be submitted to the Minister in a form and manner established by the Minister and shall include

• (a) the name, title and contact information of the person who signed the submission and the date of signature;
• (b) a description of the proposed change, including
  • (i) in the case of a substance that is proposed to be removed from the list, the name of the substance, and
  • (ii) in any other case,
    • (A) the name of the substance,
    • (B) a description of the substance, including its method of manufacture, its chemical and physical properties, its composition, its specifications and, if that information is not available, a detailed explanation, and
    • (C) the proposed conditions of use for the substance;
• (c) the rationale for the proposed change and the information relied on to support that change;
• (d) the information relied on to establish the safety of the substance under the proposed conditions of use, except in the case of a substance that is proposed to be removed from the list; and
• (e) any information respecting the estimated levels of consumption of the substance.

B.29.032 (1) The Minister may request from a person who submitted a request under section B.29.030 or B.29.031 any additional information that the Minister considers necessary to determine whether to make the proposed change.

(2) The information shall be provided in the form and manner established by the Minister.

18 Subsection D.01.001(1) of the Regulations is amended by adding the following in alphabetical order:

supplemental ingredient

has the same meaning as in subsection B.01.001(1); (ingrédient supplémentaire)

supplemented food

has the same meaning as in section B.01.001; (aliment supplémenté)

supplemented food facts table

has the same meaning as in subsection B.01.001(1); (tableau des renseignements sur les aliments supplémentés)

19 (1) Section D.01.004 of the Regulations is amended by adding the following after subsection (1.1):

(1.2) Paragraph (1)(c) does not apply in respect of a supplemented food facts table that does not contain the percentage daily value of the vitamin, in accordance with subsection B.29.002(9), about which the statement or claim is being made.

(2) Subsection D.01.004(4) of the Regulations is replaced by the following:

(4) Paragraph (1)(b) does not apply in respect of a declaration of the vitamin content in a nutrition facts table or supplemented food facts table.

20 The portion of subsection D.01.007(1) of the Regulations before paragraph (a) is replaced by the following:

D.01.007 (1) If a component of an ingredient of a prepackaged product set out in the table to subsection B.01.009(1) is a vitamin, other than a vitamin that is a supplemental ingredient, no person shall, on the label of or in any advertisement for the prepackaged product, make a statement or claim concerning the vitamin as a component of that ingredient unless

21 Section D.01.008 of the Regulations is renumbered as subsection D.01.008(1) and is amended by adding the following:

(2) Sections D.01.009 and D.01.011 do not apply to a supplemented food.

22 (1) Section D.02.002 of the Regulations is amended by adding the following after subsection (1.1):

(1.2) Paragraph (1)(c) does not apply in respect of a supplemented food facts table that does not contain the percentage daily value of the mineral nutrient, in accordance with subsection B.29.002(9), about which the statement or claim is being made.

(2) Subsection D.02.002(6) of the Regulations is replaced by the following:

(6) Paragraph (1)(b) does not apply in respect of a declaration of the mineral nutrient content in a nutrition facts table or supplemented food facts table.

23 The portion of subsection D.02.005(1) of the Regulations before paragraph (a) is replaced by the following:

D.02.005 (1) If a component of an ingredient of a prepackaged product set out in the table to subsection B.01.009(1) is a mineral nutrient, other than a mineral nutrient that is a supplemental ingredient, no person shall, on the label of or in any advertisement for the prepackaged product, make a statement or claim concerning the mineral nutrient as a component of that ingredient unless

24 Subsection D.02.009(2) of the Regulations is replaced by the following:

(2) Subsection (1) does not apply to a human milk fortifier or a supplemented food.

25 Subsection D.03.002(1) of the Regulations is replaced by the following:

D.03.002 (1) Subject to section D.03.003, no person shall sell a food, other than a supplemented food, to which a vitamin, mineral nutrient or amino acid has been added unless the food is listed in Column I of the Table to this section and the vitamin, mineral nutrient or amino acid, as the case may be, is listed opposite that food in Column II.

26 The Regulations are amended by adding, after Schedule K, the Schedule K.2 set out in the schedule to these Regulations.

Transitional Provisions

27 (1) The following definitions apply in sections 28 to 31.

Regulations

means the Food and Drug Regulations. (Règlement)

product

has the same meaning as the definition food in section 2 of the Act. (produit)

Threshold Levels for Cautionary Statements and Other Conditions of Use

means the Threshold Levels for Cautionary Statements and Other Conditions of Use, published by the Government of Canada on its website, as it reads on the day on which these Regulations come into force. (Seuils maximaux relatifs aux mises en garde et autres conditions d’utilisation)

TMAL Lists

means the Lists of foods that have received temporary marketing authorization letters (TMALs), published by the Government of Canada on its website, as it reads on the day on which these Regulations come into force. (Listes LAMT)

(2) Words and expressions used in sections 28 to 31 have the same meaning as in the Regulations.

28 (1) The manufacturer of a product for which a Temporary Marketing Authorization Letter was issued by the Minister in accordance with subsection B.01.054(1) of the Regulations and for which a Temporary Marketing Authorization number is set out in Table 1 of the TMAL Lists, is exempt from the application of the Regulations, if the following conditions are met:

• (a) when the Letter expired, the product was not the subject of an outstanding request that it be withdrawn from the market;
• (b) since the expiration of the Letter,
  • (i) subject to subsection (2), the manufacturer has complied with the Regulations, as they read immediately before the day on which these Regulations come into force, except for section B.01.042 — in respect only of a substance set out in column 1 of the List of Permitted Supplemental Ingredients that has been added to the product — and any provision set out in Appendix 1 to the Letter for which the product does not need to comply,
  • (ii) if any of the following conditions was set out in Appendix 1 to the Letter, the manufacturer has complied with them:
    • (A) there are no marks, statements, labels or advertisements, including product sampling, that promote the product for consumption by children or by pregnant or breastfeeding women,
    • (B) the product contains the ingredients referred to in Appendix 2 to the Letter at the levels specified in that Appendix,
    • (C) the statements set out in Appendix 1 to the Letter, or synonyms with equivalent meaning, are shown on the product label,
    • (D) no claims are made on the product label relating to physical performance or health benefits of the product, and
    • (E) the conditions set out in Appendix 3 to the letter are complied with, and
  • (iii) no substance set out in column 1 of the List of Permitted Supplemental Ingredients has been added to the product as an ingredient, with the exception of
    • (A) a substance set out in Appendix 2 to the Letter, or
    • (B) a substance used as a food additive to which a marketing authorization applies and set out in the Lists of Permitted Food Additives, published by the Government of Canada on its website, as amended from time to time.
      

(2) The manufacturer may comply with the provisions of the Regulations that were amended by sections 1 to 11, 13 to 48, and 57 to 75 of the Regulations Amending the Food and Drug Regulations (Nutrition Labelling, Other Labelling Provisions and Food Colours), as they read on December 13, 2016.

29 (1) If a manufacturer of a product has submitted a request for a Temporary Marketing Authorization Letter for that product before the day on which these Regulations come into force and a Temporary Marketing Authorization Letter has not been issued by the Minister in accordance with subsection B.01.054(1) of the Regulations in respect of that product before that day, the manufacturer is exempt from the application of the Regulations if the following conditions are met:

• (a) the Minister notifies the manufacturer, in writing, in accordance with subsection (2), that the sale of the product is authorized;
• (b) subject to subsections (3) and (4), the manufacturer complies with the Regulations, as they read immediately before the day on which these Regulations come into force;
• (c) the product does not contain a substance that has been added as an ingredient and that is listed in column 1 of the List of Permitted Supplemental Ingredients unless that substance
  • (i) is contained in the product at the level specified in the request for the Temporary Marketing Authorization Letter for which the Minister has issued a notice referred to in paragraph (a), or
  • (ii) is used as a food additive to which a marketing authorization applies and is set out in the Lists of Permitted Food Additives, published by the Government of Canada on its website, as amended from time to time;
• (d) with respect to a product, other than a product referred to in paragraphs (f) and (g), if a substance set out in column 1 of the table to Part I of Threshold Levels for Cautionary Statements and Other Conditions of Use has been added to the product — other than as a food additive to which a marketing authorization applies and that is set out in the Lists of Permitted Food Additives, published by the Government of Canada on its website, as amended from time to time — and the total amount of that substance contained in the product is equal to or above the threshold levels set out in columns 2 to 6 of the table for that substance, the label of the product carries the applicable cautionary statements, or synonyms with equivalent meaning, set out in the headings to columns 2 to 6 of that table with respect to that substance;
• (e) if the cautionary statement “Not intended for children”, “For adults only” or “If you are pregnant or breastfeeding consult a Health Care Practitioner prior to use” is required to appear on the label of the product in accordance with paragraph (d), there are no marks, statements, labels or advertisements, including product sampling, that promote the product for consumption by children or pregnant or breastfeeding women, as the case may be;
• (f) with respect to a product that is a beverage that contains added caffeine and has a total caffeine content of more than 200 parts per million, the label of the product carries the following cautionary statements, or synonyms with equivalent meaning:
  • (i) if a substance set out in column 1 of the table to Part I of Threshold Levels for Cautionary Statements and Other Conditions of Use has been added to the product — other than as a food additive to which a marketing authorization applies and that is set out in the Lists of Permitted Food Additives, published by the Government of Canada on its website, as amended from time to time — and the total amount of that substance contained in the product is equal to or above the threshold level set out in column 8 for that substance, the cautionary statement, or synonyms with equivalent meaning, set out in the heading to column 8 of that table, and
  • (ii) the cautionary statements, or synonyms with equivalent meaning, set out in the headings to columns 2 to 4 of the table to Part II of Threshold Levels for Cautionary Statements and Other Conditions of Use;
• (g) with respect to a product that contains added caffeine, other than a product referred to in paragraph (f), the label of that product carries the following cautionary statements, or synonyms with equivalent meaning:
  • (i) if a substance set out in column 1 of the table to Part I of Threshold Levels for Cautionary Statements and Other Conditions of Use has been added to the product — other than as a food additive to which a marketing authorization applies and that is set out in the Lists of Permitted Food Additives, published by the Government of Canada on its website, as amended from time to time — and the total amount of that substance contained in the product, is equal to or above the threshold levels set out in columns 2 to 6 for that substance, the applicable cautionary statements, or synonyms with equivalent meaning, set out in the headings to columns 2 to 6 of that table with respect to that substance, and
  • (ii) if the total amount of caffeine contained in the product is equal to or above the threshold levels set out in columns 2 to 4 of the table to Part II of Threshold Levels for Cautionary Statements and Other Conditions of Use for the food category set out in column 1 to which the product belongs, the applicable cautionary statements, or synonyms with equivalent meaning, set out in the headings to columns 2 to 4 of the table to Part II;
• (h) the manufacturer of a product referred to in paragraphs (f) or (g) complies with the conditions of use set out in column 6 of the table to Part II of Threshold Levels for Cautionary Statements and Other Conditions of Use for the food category set out in column 1 to which the product belongs; and
• (i) if the cautionary statement “Not recommended for children, pregnant or breastfeeding women and individuals sensitive to caffeine” is required to appear on the label of the product in accordance with subparagraphs (f)(ii) or (g)(ii), there are no marks, statements, labels or advertisements, including product sampling, that promote the product for consumption by children or pregnant or breastfeeding women.

(2) The Minister must provide written notification to the manufacturer that the sale of the product is authorized

• (a) if the manufacturer submits to the Minister
  • (i) the information required under sub-paragraphs B.01.054(1)(a)(i) to (vii) of the Regulations, and
  • (ii) if requested by the Minister, any other information to assess the information provided in subparagraph (i); and
• (b) if the product belongs to a food category specified in column 1 of the List of Permitted Supplemented Food Categories;
• (c) if a substance set out in column 1 of the table to Part I to Threshold Levels for Cautionary Statements and Other Conditions of Use is added to the product, the total amount of that substance contained in the product does not exceed the maximum daily level set out in column 7 of Part I of the table for that substance; and
• (d) if caffeine is added to the product, the total amount of caffeine contained in that product does not exceed the maximum level per serving set out in column 5 of the table to Part II to Threshold Levels for Cautionary Statements and Other Conditions of Use, for the food category to which the product belongs.
  

(3) A manufacturer referred to in subsection (1) need not, in the specified circumstances, comply with the following provisions of the Regulations, as they read immediately before the day on which these Regulations come into force:

• (a) section B.01.042,
  • (i) in respect of a substance set out in column 1 of the List of Permitted Supplemental Ingredients that has been added to the product at the level specified in the request referred to in subsection (1), or
  • (ii) in respect of an extraction solvent that has been used in the manufacturing of an extract that has been added to the product, for a purpose other than as a flavouring;
• (b) section B.01.043,
  • (i) in respect of caffeine that has been added to the product for a use other than an accepted use set out in item C.1, columns 2 to 4, of the List of Permitted Food Additives with Other Accepted Uses (Lists of Permitted Food Additives), published by the Government of Canada on its website, as amended from time to time, or
  • (ii) in respect of an extraction solvent that has been used in the manufacturing of an extract that has been added to the product, for a purpose other than as a flavouring;
• (c) section B.01.045, in respect of caffeine that has been added to the product and that does not meet the specifications set out in the publication referred to in subparagraph B.01.045(b)(i);
• (d) the condition set out in paragraph 37(b), column 2, to the table following section B.01.513, in respect of the subject “free of sugars”, if the product meets the conditions set out in item 2, column 2, of the table with respect to “low in energy”;
• (e) section D.01.009, in respect of the addition of any of the following vitamins to the product if the added vitamin is set out in column 1 of the List of Permitted Supplemental Ingredients and the reasonable daily intake of the product by a person would result in the daily intake by such a person of less than
  • (i) in the case of vitamin A, 1,600 International Units,
  • (ii) in the case of thiamine, 0.6 milligram,
  • (iii) in the case of riboflavin, 1.0 milligram,
  • (iv) in the case of niacin or niacinamide, six milligrams,
  • (v) in the case of ascorbic acid, 20 milligrams, and
  • (vi) in the case of vitamin D, 300 International Units;
• (f) section D.01.011, in respect of the addition of any of the following vitamins to the product if the added vitamin is set out in column 1 of the List of Permitted Supplemental Ingredients and the reasonable daily intake of that product by a person would result in the daily intake by such a person of more than
  • (i) in the case of vitamin A, 2,500 International Units,
  • (ii) in the case of thiamine, two milligrams,
  • (iii) in the case of riboflavin, three milligrams,
  • (iv) in the case of niacin or niacinamide, 20 milligrams,
  • (v) in the case of pyridoxine, 1.5 milligrams,
  • (vi) in the case of ascorbic acid, 60 milligrams,
  • (vii) in the case of vitamin D, 400 International Units, and
  • (viii) in the case of vitamin E, 15 International Units;
• (g) section D.02.009, in respect of the addition of any of the following mineral nutrients to the product if the added nutrient is set out in column 1 of the List of Permitted Supplemental Ingredients and a reasonable daily intake of that product by a person would result in the daily intake by such a person of less than
  • (i) in the case of calcium, 300 milligrams,
  • (ii) in the case of phosphorus, 300 milligrams,
  • (iii) in the case of iron, four milligrams, and
  • (iv) in the case of iodine, 0.10 milligram; and
• (h) section D.03.002.
  

(4) The manufacturer may comply with the provisions of the Regulations that were amended by sections 1 to 11, 13 to 48, and 57 to 75 of the Regulations Amending the Food and Drug Regulations (Nutrition Labelling, Other Labelling Provisions and Food Colours), as they read on December 13, 2016.

(5) The notification referred to in paragraph (1)(a) cannot be a Temporary Marketing Authorization Letter issued under subsection B.01.054(1) of the Regulations.

30 A manufacturer that is exempted under section 28 or subsection 29(1) is also exempt from the application of paragraphs 4(1)(a) and (d), section 6 and subsection 6.1(2) of the Act, in respect only of a substance set out in column 1 of the List of Permitted Supplemental Ingredients that has been added to the product.

31 Sections 28 to 30 cease to have effect on the earliest of:

• (a) the third anniversary of the day on which these Regulations come into force; and
• (b) the day on which the Minister notifies the manufacturer of the product, in writing, that the Minister has reasonable grounds to believe that the use of that product is detrimental to the health of the consumer.

Coming into Force

32 These Regulations come into force on the day on which they are published in the Canada Gazette, Part II.

SCHEDULE

(Section 25)

SCHEDULE K.2

(Section B.29.001)

Supplemented Food Caution Identifier Formats

Unilingual Standard Format

Bilingual Standard Format

Bilingual Compact Format