Proposed compositional requirements for infant foods and foods currently regulated as foods for special dietary use

Table of contents

• List of abbreviations
• 1.0 Introduction
  • 1.1 Purpose
  • 1.2 Scope
  • 1.3 Guiding principles
• 2.0 Proposed compositional requirements for foods for a special dietary purpose
  • 2.1 Infant formula
  • 2.2 Medical foods for ages one or more
  • 2.3 Medical foods represented as a total diet replacement for weight reduction
• 3.0 Proposed compositional requirements for foods that are not foods for a special dietary purpose
  • 3.1 Conventional infant foods
  • 3.2 Gluten-free food
  • 3.3 Formulated nutritional foods
• 4.0 Conclusion
• Appendix 1: Dietary Reference Intakes
• Appendix 2: References from authoritative bodies other than NASEM
• Appendix 3: List of micronutrients for which a maximum requirement was not established and supporting rationale

List of abbreviations

AI

Adequate Intakes

CCHS

Canadian Community Health Survey

CDRR

Chronic Disease Risk Reduction Intake

Codex

Codex Alimentarius Commission

DFE

Dietary folate equivalents

DRI

Dietary Reference Intakes

EFSA

European Food Safety Authority

EU

European Union

FDR

Food and Drug Regulations

FNF

Formulated nutritional foods

FSANZ

Food Standards Australia New Zealand

FSDU

Foods for special dietary use

FSDP

Food for a special dietary purpose

FVLED

Foods for a very low energy diet

MR

Meal replacements

NASEM

National Academies of Science, Engineering and Medicine

NGO

Non-governmental organization

NE

Niacin equivalents

NS

Nutritional supplements

PDCAAS

Protein Digestibility Corrected Amino Acid Score

PER

Protein Efficiency Ratio

RAE

Retinol activity equivalents

RDA

Recommended Dietary Allowance

TDR

Total diet replacement

UL

Tolerable Upper Intake Level

US

United States

WHO

World Health Organization

1.0 Introduction

Health Canada is proposing to take a comprehensive approach to modernizing Divisions 24 and 25 of the Food and Drug Regulations (FDR). These Divisions govern foods for special dietary use (FSDU) and infant foods in Canada. The current regulations, developed decades ago, are outdated and inflexible, hindering the integration of scientific advancements and updates to recommended intakes. This rigidity poses challenges for industry innovation, limits availability of products approved in other countries and leaves Canada more vulnerable to shortages.

On November 28, 2023, Health Canada pre-published a proposal that envisioned a complete restructuring of the current regulatory framework for FSDU and infant foods including how the modernized framework would align with the 2019 amendment to the Food and Drugs Act, which introduced the term "food for a special dietary purpose (FSDP)". The impact of this restructuring would necessitate removing the term FSDU and creating a framework to regulate FSDP that would integrate updates and flexibilities to improve product access and mitigate supply disruptions. Details of the proposed regulatory modernization and restructuring were provided in the last consultation and are not provided again in this paper but influence how the information is organized and how the proposals are set forth.

The 2023 proposal committed to reviewing and updating the compositional and labelling requirements for infant foods and foods currently regulated as FSDU. Details pertaining to the proposed labelling requirements were outlined, but limited information was shared regarding composition.

This proposal is focused on compositional requirements. To ensure safety and nutritional adequacy, the proposed requirements are underpinned by the latest dietary intake recommendations. Due consideration was also given to approaches applied internationally as well as feedback received from the 2023 consultation relevant to product composition. The updated requirements are proposed to be incorporated by reference in the FDR, allowing a more flexible approach in which future amendments could be made administratively to reflect scientific advancements.

1.1 Purpose

The purpose of this pre-consultation document is to present Health Canada's proposal for the compositional requirements of infant foods and foods currently regulated as FSDU in order to gather input from interested parties. Stakeholder comments to this proposal will inform the drafting of regulations, which are anticipated to be pre-published in the Canada Gazette Part I in spring 2026 for public comment.

Sections 2.0 and 3.0 are organized by food category. For each category, compositional requirements are proposed and a supporting rationale is provided. A summary of the main comments that emerged from the 2023 consultation relevant to the current proposal are also shared along with Health Canada's response.

1.2 Scope

The scope of this proposal is limited to the compositional requirements pertaining to infant foods as well as foods currently regulated as FSDU. In response to the 2023 consultation, the Department received comments from 84 stakeholders and many of these addressed aspects aside from compositional requirements. These comments continue to be analyzed and will be addressed in a broader regulatory modernization proposal that will be pre-published in the Canada Gazette, Part I.

The current proposal only includes details on the categories of foods that will have prescribed compositional requirements. Section 2.0 pertains to FSDP and compositional requirements are proposed for infant formula and medical foods for ages one or more. Under the medical food category, distinct compositional requirements are proposed for products intended for total diet replacement (TDR) for weight reduction. The compositional requirements for most FSDP would allow for deviations when medically justified.

Although they would be categorized as FSDP, this proposal does not address prepackaged human milk or medical foods for infants. As stated in the 2023 consultation paper, compositional requirements would not be proposed for prepackaged human milk given the natural variation in composition of human milk and the difficulty in meeting a standard set of compositional requirements. Regarding medical foods for infants, while Health Canada intends to permit their fortification, in the 2023 consultation paper it was proposed that compositional requirements would not be prescribed. Instead, premarket authorization would be required for all medical foods for infants, except for non-fortified products like modulars and thickeners. By requiring premarket authorization similar to infant formula, the goal is to establish appropriate safeguards and ensure the production of safe products that meet the specific dietary needs of vulnerable infants.

Section 3.0 provides details on the proposed compositional requirements for foods that are not FSDP. The following categories are addressed: conventional infant foods, gluten-free foods and formulated nutritional foods (FNF) (currently regulated as meal replacements (MR) and nutritional supplements (NS)). The FNF category also includes MR represented for weight reduction.

In the 2023 consultation paper, updated category names were proposed for many product categories. For continuity, the new proposed category names are used throughout the current proposal.

1.3 Guiding principles

Health Canada is responsible for establishing standards for the safety and nutritional quality of all foods sold in Canada. Given that, the primary guiding principle underpinning the proposed compositional requirements was to ensure that foods within the scope of the proposal are safe and nutritionally adequate, which aligns with the objectives of Canada's food fortification policy. This is achieved by anchoring the proposal in the most recent scientific evidence on recommended intakes. In most cases, Health Canada relied on the Dietary Reference Intakes (DRIs)^{Footnote 1} established by the National Academies of Sciences, Engineering and Medicine (NASEM). However, in certain instances, Health Canada used recommendations set out by other authoritative bodies, such as the European Food Safety Authority (EFSA).

Improving alignment with other international jurisdictions and access were also important guiding principles, particularly for infant formulas which are vulnerable to shortages. The proposed compositional requirements for infant formulas largely align with the Codex Alimentarius Commission (Codex) standards, which are globally recognized and strongly influenced by the composition of human milk. This approach will help improve access and mitigate the risk of shortages by facilitating the importation of infant formulas from other jurisdictions.

Where discrepancies existed between international regulations and the latest scientific data, Health Canada prioritized the latter, acknowledging that various jurisdictions undertake updates to their own regulations and standards at different times.

2.0 Proposed compositional requirements for foods for a special dietary purpose

2.1 Infant formula

2.1.1 Background

The proposed category of infant formula would capture products currently regulated as human milk substitutes under Division 25 of the FDR.

The proposal presented below applies to infant formulas intended for healthy term infants (0 to 12 months). Certain exceptions are proposed for infant formulas intended for older infants (6 to 12 months). The proposed approach also applies to both lactose-free formulas and partially hydrolyzed formulas.

The proposed compositional requirements presented below do not take into account the specific needs of preterm infants and/or infants with a medical condition. However, in the 2023 consultation paper it was proposed that an exemption from meeting compositional requirements could be permitted when medically justified. To mitigate potential risks and ensure clarity, it was proposed to require additional product labelling information such as "Free of the essential amino acid phenylalanine for infants with phenylketonuria".

2.1.2 Proposal

The proposed compositional requirements for infant formula are outlined in Table 1. These pertain to term infant formulas made from cow's milk, goat's milk or soy. The requirements apply to the total amount in the product, from all added and naturally occurring sources.

It is proposed that an energy density range of 60 to 70 kcal/100 mL be required. Also, it is proposed that the requirements be prescribed per 100 kcal, with maximum values being inclusive of overages.

In addition to the components that are already required to be present in infant formula under the FDR, it is proposed to mandate the inclusion of alpha-linolenic acid, selenium, inositol and carnitine. Remaining optional under the proposal would be the addition of docosahexaenoic acid, nucleotides and taurine. However, if docosahexaenoic acid is added, it is proposed that arachidonic acid contents should reach at least the same level as docosahexaenoic acid. Finally, it is proposed that erucic acid be limited to 1% of total fatty acids.

Note that exceptions proposed for infant formula intended for older infants are highlighted with an asterisk.

2.1.3 Rationale

a) Term infant formula (0 to 12 months)

The proposed values largely align with those set out in the Codex Standard for Infant Formula and Formulas for Special Medical Purposes Intended for Infants (Codex Standard 72-1981)^{Footnote 3}, a globally recognized standard that considered the composition of human milk in its development. Consequently, in alignment with this standard, it is proposed to introduce energy density requirements and to mandate the inclusion of alpha-linolenic acid, selenium, inositol and carnitine.

Deviations from Codex Standard 72-1981 are proposed for protein, iron, docosahexaenoic acid and nucleotides. The proposed deviations help to support optimal health and growth outcomes while mitigating safety concerns. In most cases, they also improve alignment with international jurisdictions who have more recently updated their regulatory approaches or standards, such as Food Standards Australia New Zealand (FSANZ) and the European Union (EU).

To account for protein quality, it is proposed to align with Codex Standard 72-1981 and set out minimum protein amounts for cow's and goat's milk-based infant formulas that are distinct from soy-based formulas. Two options are proposed for achieving protein quality requirements. The first option is to demonstrate equivalence to casein which is consistent with one of the current requirements under the FDR. The second option aligns with Codex Standard 72-1981 and requires at least the same amount of each essential and semi-essential amino acid as found in the reference protein (human milk) while also accounting for digestibility of the protein source. Health Canada is mindful that NASEM has convened a committee of experts to review methodologies for assessing protein quality in infant formula. The committee recommendations will be considered when they become available^{Footnote 4}.

For iron, separate minimum levels are proposed for milk-based (0.6 mg/100 kcal) and soy-based (0.9 mg/100 kcal) infant formula whereas Codex Standard 72-1981 sets out one minimum of 0.45 mg/100 kcal, applying to either type. For milk-based infant formula, the proposed minimum level aligns with the FSANZ regulatory approach^{Footnote 5}, the EU's regulations^{Footnote 6} for infant formula intended for older infants and recommendations from the European Society for Paediatric Gastroenterology Hepatology and Nutrition^{Footnote 7}. For soy-based infant formula, the same higher minimum level is proposed for iron as applied in the EU regulations. This accounts for the presence of phytate in soy which can negatively affect iron absorption^{Footnote 8}.

In addition, a maximum level of 2 mg/100 kcal is proposed for iron, while Codex Standard 72-1981 does not set out a maximum. Setting a maximum is important to prevent excessive iron intakes which have been associated with adverse cognitive effects^{Footnote 9} and impaired absorption of other minerals^{Footnote 10}. The proposed maximum level aligns with the FSANZ regulatory approach as well as the maximum set out for iron in infant formulas intended for older infants as per the Codex Standard for Follow-up Formula for Older Infants and Product for Young Children (Codex Standard 156-1987)^{Footnote 11} and the EU regulations.

For docosahexaenoic acid, a maximum level of 50 mg/100 kcal is proposed, equivalent to approximately 1% of total fatty acids, which is higher than Codex Standard 72-1981's maximum of 0.5% of total fatty acids. The proposed deviation recognizes that docosahexaenoic acid levels up to this higher limit support the normal physical development of the brain and eyes^{Footnote 12Footnote 13}, with no known risks. It also aligns with the EU regulations and FSANZ's regulatory approach, offering manufacturers greater flexibility. If docosahexaenoic acid is added, it is proposed that arachidonic acid contents should reach at least the same level as docosahexaenoic acid to mimic the natural balance found in human milk.

For nucleotides, a maximum level of 16 mg/100 kcal is proposed whereas Codex Standard 72-1981 does not set out limits, leaving it to the discretion of national authorities. The proposed maximum aligns with FSANZ's regulatory approach for total nucleotides as well as the Life Sciences Research Office recommendations which are based on documented levels of nucleotides in human milk^{Footnote 14}. Unlike the EU regulations which set limits for individual nucleotides and FSANZ's regulatory approach which sets limits for both individual and total nucleotides, the current proposal sets a single limit for total nucleotides to provide greater flexibility.

b) Infant formula intended for older infants (6 to 12 months)

For infant formula intended for infants 6 months and older, the proposal considered Codex Standard 156-1987. This standard applies to infant formula for older infants and, in terms of composition, largely aligns with Codex Standard 72-1981, with the exception of five nutrients: calcium, vitamin D, vitamin A, iron and selenium.

With respect to calcium and vitamin D in formulas intended for older infants, it is proposed to align the maximum levels, 180 mg/100 kcal and 3 µg/100 kcal, respectively, with Codex Standard 156-1987. This approach is appropriate since older infants have a greater tolerability for these nutrients as compared to younger infants as reflected in the higher Tolerable Upper Intake Levels (ULs) set out by NASEM for older infants. In addition, older infants have higher requirements for calcium as compared to younger infants^{Footnote 15}.

For vitamin A, iron and selenium, Codex Standard 156-1987 sets out higher minimums for formulas intended for older infants. However, this approach was not adopted since the proposed minimums for term infant formula, aligning with Codex Standard 72-1981 (vitamin A and selenium) and with the FSANZ regulatory approach (iron), are adequate for all infants 0 to 12 months.

2.1.4 Consultation

During the pre-consultation period, Health Canada received 14 comments from a range of stakeholders regarding the proposal to update the compositional requirements for infant formula, including seven indicating strong support.

Comments on international alignment

Many stakeholders emphasized the importance of aligning the compositional requirements for infant formula with other international jurisdictions. Three regional health authority representatives and one health professional voiced support for Health Canada's proposal to align compositional requirements with the Codex standards while two industry stakeholders stressed the importance of aligning compositional requirements with regulations in the United States (US), as Canada's biggest trading partner. One of these industry stakeholders also recommended allowing deviations from compositional requirements to enable sharing of formulations with key trading partners.

Health Canada's response

In developing its proposed approach for setting compositional requirements for infant formula, Health Canada considered various international standards to maximize international alignment and trade opportunities. The proposal set forth is largely based on the Codex standards. The US regulations were also considered to verify that most products imported from the US would comply with the proposal. Where discrepancies existed, Health Canada's proposal prioritized alignment with the latest scientific data, acknowledging that various jurisdictions undertake updates of their own standards at different times.

As noted in the 2023 proposal, Health Canada would permit exemptions from meeting compositional requirements when medically justified to ensure the framework remains flexible and inclusive.

Comments on maximum levels for vitamins A and D

One industry stakeholder recommended increasing the maximum level of vitamin A to 225 µg RAE /100 kcal to align with Codex Standard 156-1987 and the US regulations. The stakeholder also recommended increasing the maximum level of vitamin D to 2.5 µg/100 kcal for infant formula meeting standard compositional requirements while allowing deviations up to 3 µg/100 kcal for hypoallergenic and amino acid-based formulas to allow for harmonizing formulations developed to meet the EU regulations for foods for special medical purposes.

Health Canada's response

Regarding vitamin A, Health Canada proposes to increase the maximum level from 150 µg to 180 µg RAE/100 kcal. This level is consistent with the maximum set out in the two Codex standards. Health Canada notes that Codex Standard 156-1987 previously set out a maximum amount of 225 µg RAE/100 kcal. However, due to concerns raised by the EU, Norway and Switzerland that this level was too high and might lead to the UL being exceeded, the amount in Codex Standard 156-1987 was recently revised downward to 180 µg RAE/100 kcal^{Footnote 16}.

Regarding vitamin D, Health Canada's proposed maximum of 2.5 µg/100 kcal for term infant formula aligns with Codex Standard 72-1981. No deviations are proposed for term infant formulas due to concerns regarding the potential for excessive intake among younger infants who have a lower tolerability for vitamin D. However, since older infants have a higher tolerability for vitamin D, a higher maximum level of 3 µg/100 kcal is proposed for infant formulas intended for ages 6 to 12 months, in alignment with Codex Standard 156-1987.

2.1.5 Questions for stakeholders

• Do you support the proposal to align the infant formula compositional requirements for most nutrients with Codex Standard 72-1981?
• Do you support the proposed deviations from Codex Standard 72-1981 and Codex Standard 156-1987 for protein?
• Do you support the proposed deviations from Codex Standard 72-1981 for iron, docosahexaenoic acid, and nucleotides for term infant formulas (0 to 12 months)?
• Do you support the proposed maximum levels for calcium and vitamin D in infant formulas targeted to infants 6 months and older?

In answering these questions, please provide supporting rationale.

2.2 Medical foods for ages one or more

2.2.1 Background

The proposed category of medical foods for ages one year or more aims to capture some of the products that are currently regulated as FSDU under Division 24 of the FDR, including formulated liquid diets and foods represented for protein-restricted or low amino acid diets. In addition, the category intends to capture a wide range of existing and future innovative products for various medical conditions or diseases.

In the 2023 consultation paper, the following definition was proposed:

• medical food for ages one or more means a food that has been specially processed or formulated and is intended for the dietary management of individuals ages one or more, to be used under medical supervision. It is intended for the exclusive or partial feeding of those individuals:
  1. with a limited, or impaired capacity to take, digest, absorb, metabolize, or excrete ordinary food or certain nutrients contained therein, or metabolites, or
  2. with other medically determined nutrient requirements
• whose dietary management cannot be reasonably achieved by modification of the normal diet alone

Two categories of medical foods for ages one or more were also proposed:

• Nutritionally complete foods, which are represented for use as primary or sole source of nourishment.
• Nutritionally incomplete foods, which are not represented for use as primary or sole source of nourishment.

The proposed compositional requirements presented below for medical foods prioritize patient health and safety through alignment with updated DRIs. However, since the DRIs were developed for the general population, in some instances, they may not be appropriate for those with a medical condition. As such, an exemption from meeting compositional requirements when medically justified was proposed in the 2023 consultation paper to ensure that the formulation of these products can meet the specific dietary requirements of individuals with medical conditions. For example, medical foods intended for individuals with chronic kidney disease are specifically formulated to provide a lower level of protein and specific mineral nutrients. In such cases, there would be a well-recognized medical basis for deviating from the minimum compositional requirements for these specific nutrients. It would be the responsibility of the manufacturer to determine whether the formulation of a medical food should deviate from prescribed compositional requirements to meet the nutritional needs of the target population for whom the product is intended based on well-recognized scientific data such as clinical guidelines from authoritative bodies (for example, the American Society for Parenteral and Enteral Nutrition). Manufacturers would be responsible to provide documentation supporting deviations if requested. To further mitigate potential risks and ensure clarity, it was proposed to require additional product labelling information including a statement describing the deviation(s), for example, "formulated with lower protein, phosphorus and potassium for people with chronic kidney disease". Nutrients that do not require adjustment based on medical needs would still have to meet the compositional requirements proposed below.

2.2.2 Proposal

It is proposed that the compositional requirements for medical foods for ages one or more be prescribed per 100 kcal of the food, regardless of the recommended intake of the food. It is also proposed to separate the nutrient requirements into two categories based on the age of the intended user:

• 1 to 8 years
• 9 years or more

Table 2 provides the proposed compositional requirements for medical foods intended for ages 1 to 8 years and 9 years or more, including protein quality requirements. These requirements apply to the total nutrient amount in the product, from all added and naturally occurring sources, when prepared. The proposed maximum amounts for micronutrients would not include overage.

For medical foods represented as nutritionally complete, it is proposed that all nutrients in Table 2 be required within the ranges set out. However, for fluoride, amino acids, and taurine, it is proposed that their addition be voluntary.

For medical foods represented as nutritionally incomplete, it is proposed that the addition of all nutrients be voluntary. When adding nutrients, it is proposed that there would be no minimum requirements and that the maximum requirements in Table 2 be applied.

2.2.3 Rationale

Distinct compositional requirements are proposed for medical foods for ages 1 to 8 versus ages 9 and up. This is because the DRIs differ significantly for these age groups, especially for ages 1 to 3 compared to ages 19 to 70. In some cases, the recommended intakes (Recommended Dietary Allowance (RDA)/Adequate Intake (AI)) for adults are higher than the safe upper limits (UL/ Chronic Disease Risk Reduction Intake (CDRR)) for younger age groups.

Prescribing compositional requirements for medical foods for ages 1 or more per 100 kcal of the food, regardless of the recommended intake of the food is consistent with international jurisdictions. It is also simpler than Canada's current regulatory approach which prescribes different nutrient requirements for formulated liquid diets based on the recommended daily energy intake of the food.

a) Mandatory and voluntary nutrient requirements

Medical foods are designed for the exclusive or partial feeding of individuals for an indefinite period, ranging from a few days to a lifetime. Individuals who consume medical foods as a sole or primary source of nutrition rely on these foods to meet all their nutrient requirements for the duration of use. Therefore, medical foods represented as nutritionally complete must contain all nutrients within an acceptable range to meet the minimum requirements of an individual (RDA/AI) without exceeding safe levels of intake (UL/CDRR). However, the addition of carbohydrates, including fibre, is proposed to be voluntary to allow for flexibility in product composition. As well, the addition of fluoride is proposed to be voluntary since only trace amounts are found in most foods.

Medical foods that are not intended for use as a sole source of nutrition are consumed alongside other foods in the diet, which reduces the risk of inadequate intake. Therefore, voluntary nutrient addition is proposed for these foods. However, there may still be a risk of excessive nutrient intakes if nutritionally incomplete foods are fortified with high levels of nutrients. To mitigate this risk, maximum requirements are proposed in Columns III and V of Table 2.

b) Minimum requirements

Nutrients with RDAs

As presented in Table 2, it is proposed to set out minimum requirements for macronutrients and micronutrients with established RDAs.

For nutritionally complete medical foods, minimum protein quality requirements are proposed to ensure that vulnerable individuals with medical conditions or diseases who rely on these foods as a sole source of nourishment meet protein requirements. This is important to help prevent undesired loss of lean body mass and promote healing.

It is proposed that minimum requirements prescribed per 100 kcal provide daily nutrient intakes that meet the RDA for all groups within the targeted age category based on their respective median daily energy intakes obtained from the Canadian Community Health Survey-Nutrition 2015 (CCHS 2015). For example, for nutritionally complete medical foods for ages 1 to 8, the proposed minimum requirement for vitamin A (24 µg RAE per 100 kcal) in Column II was derived by identifying the most vulnerable group (ages 4 to 8 have the highest RDA) and ensuring that this group would meet their RDA (400 µg RAE) if consuming their median caloric intake (1650 kcal per day). The same approach was used for setting proposed minimum nutrient amounts for ages 9 or more (Column IV in Table 2).

Nutrients with AIs

As presented in Table 2, it is proposed to set out minimum requirements for macronutrients and micronutrients with established AIs, with the exception of fluoride. Since AIs were established by NASEM when there was insufficient scientific evidence to establish an RDA, it is challenging to draw conclusions about the adequacy of nutrient intakes below these levels. Therefore, for these nutrients, it is proposed to adjust minimum requirements downward to align with the minimums set out for nutritionally complete foods for special medical purposes in the EU^{Footnote 17} and Australia/New Zealand^{Footnote 18}, when AI values are higher. This would provide greater flexibility for manufacturers when formulating their products and would help mitigate potential trade barriers.

c) Maximum requirements

For macronutrients, no maximum amounts are proposed for protein, carbohydrates, fat, or linoleic and alpha-linolenic fatty acids as there are no upper limits set by NASEM or other authoritative bodies for these. For amino acids, it is proposed that they may be added to medical foods only to meet protein quality requirements.

For micronutrients, maximum requirements are proposed for 16 vitamin and mineral nutrients where NASEM or another authoritative body established a UL or CDRR based on the potential of serious irreversible adverse effects (refer to Appendix 2 for references for ULs established by other authoritative bodies). Since these ULs and CDRR do not include overage, it is proposed that the maximum amounts would not include overage. It is proposed that no maximum requirements be set for vitamins and minerals with the potential of acute adverse effects (Appendix 3) as these can be easily detected and reversed through close monitoring by a healthcare professional.

It is proposed that maximum requirements prescribed per 100 kcal provide daily nutrient intakes that would not exceed the UL or CDRR for all groups within the targeted age category based on their respective median total energy intakes obtained from the CCHS 2015. For example, for medical foods for ages 1 to 8, the proposed maximum requirement in Column III for preformed vitamin A (46 µg per 100 kcal) was derived by identifying the most vulnerable group (ages 1 to 3 have the lowest UL) and ensuring that this group would not exceed the UL (600 µg) if consuming their median caloric intake (1300 kcal per day). The same approach was used for setting proposed maximum nutrient amounts for ages 9 or more (Column V in Table 2).

2.2.4 Consultation

Health Canada received comments from six stakeholders on the proposed compositional requirements for medical foods for ages one or more. A range of stakeholders provided feedback including two non-governmental organizations (NGOs), one health professional organization, one industry association, and two industry stakeholders.

Comments on energy as the basis for compositional requirements

An industry stakeholder noted that prescribing compositional requirements based on energy content may not be appropriate for some products such as protein substitutes designed to provide appropriate amounts of micronutrients in a given amount of protein.

Health Canada's response

Health Canada is proposing that products such as protein substitutes fall under the "nutritionally incomplete" medical foods category. Nutritionally incomplete medical foods would not have prescribed macronutrient requirements nor prescribed minimum micronutrient levels. However, if medical foods are fortified with micronutrients, the amounts should not exceed prescribed maximum levels unless medically justified. The maximum levels for micronutrients would be prescribed per 100 kcal which is consistent with international jurisdictions as well as Codex.

Comments on alignment with international jurisdictions and recommended dietary intakes

An industry association noted the importance of considering compositional requirements for foods for special medical purpose in the EU and in Australia/New Zealand, and the latest DRIs when developing requirements for medical foods for ages one or more in Canada.

Health Canada's response

The proposed compositional requirements prioritize patient health and safety through alignment with the latest dietary intake recommendations and consider international regulations for similar products. However, where discrepancies existed between international regulations and the latest scientific data, Health Canada prioritized the latter, acknowledging that various jurisdictions undertake updates to their own regulations and standards at different times.

Comments on macronutrient requirements

An industry stakeholder noted that medical foods for ages one or more should not have prescribed macronutrient requirements while a health professional organization requested clarity on acceptable protein sources.

Health Canada's response

Health Canada is proposing that only nutritionally complete medical foods have prescribed protein quantity and quality requirements as well as fat quantity requirements to ensure that individuals who consume these products as a sole source of nutrition meet their nutrient needs. Manufacturers would have the flexibility of using nutrient sources of their choice as long as these are safe, not novel and suitable for the target population.

Comments on exemption from meeting compositional requirements when medically justified

Two industry stakeholders and two industry associations noted the importance of permitting judicious variations from compositional requirements when medically justified. An NGO suggested that deviations from compositional requirements also be permitted to allow the importation of products from other jurisdictions that may be subject to different requirements. Some stakeholders requested guidance regarding acceptable exemptions.

Health Canada's response

To ensure the proposed medical food framework remains flexible and inclusive of the wide range of existing and future innovative products, as well as to accommodate scientific advancements, Health Canada is proposing an exemption from meeting compositional requirements only when medically justified. Acceptable deviations would be based on well-recognized scientific data such as clinical guidelines from authoritative bodies (for example, the American Society for Parenteral and Enteral Nutrition).

2.2.5 Questions for stakeholders

• Do you support the proposal to have distinct compositional requirements for medical foods intended for ages 1 to 8 and 9 or more?
• Do you support the proposal to align the requirements with the updated dietary intake recommendations?
• Do you have concerns with the approach used to establish minimum and maximum nutrient requirements?
• Do you have concerns with the absence of maximum requirements for nutrients that have an established UL based on acute and reversible adverse effects?

In answering these questions, please provide supporting rationale.

2.3 Medical foods represented as a total diet replacement for weight reduction

2.3.1 Background

In the 2023 consultation paper, a distinct subcategory of medical foods was proposed to address the specific needs of individuals aged 19 years or more seeking medically supervised weight reduction through total diet replacement (TDR). Recognizing their unique purpose and the greater risks associated with their use, it was proposed that TDR for weight reduction be subject to distinct compositional requirements from which they would not be able to deviate.

It was proposed that this new category of medical foods, TDR for weight reduction, would replace foods currently regulated as foods for a very low energy diet (FVLED) under Division 24 of the FDR. Under the current regulations, FVLED are intended for weight reduction and must provide less than 900 kcal per day when used as directed. Premarket notification is required prior to the sale of these foods, yet to date, Health Canada has not received any notifications, suggesting that there is no market history for these products.

On the other hand, there are foods being sold in the Canadian marketplace as MR that are represented for weight reduction through TDR and that provide 900 kcal or more. The new proposed category of TDR for weight reduction aims to capture these products to ensure they are nutritionally adequate and safe for consumption.

In the 2023 consultation paper, the following definition was proposed:

• total diet replacement for weight reduction means a medical food specially formulated for use in energy restricted diets for weight reduction and which provides the sole source of nutrition when consumed as directed

2.3.2 Proposal

It is proposed that the compositional requirements for TDR for weight reduction be prescribed per daily energy intake of 800 to 1200 kcal. For macronutrients, it is proposed that there be minimum requirements for protein quantity and quality, carbohydrate quantity and linoleic and alpha-linolenic acid quantities. In addition, it is proposed that all nutrients in Table 3 be required within the ranges set out, with no provision for deviation. However, for fluoride, amino acids, and taurine, it is proposed that their addition be voluntary.

The proposed requirements apply to the total nutrient amounts in the product from all added and naturally occurring sources, when prepared. The proposed maximum amounts for micronutrients would not include overage.

2.3.3 Rationale

a) Energy requirements

The proposed energy requirements are intended to ensure that an individual consuming a medical food represented as a TDR for weight reduction would consume sufficient energy to support metabolic functions and also achieve weight reduction.

The proposed energy requirements for this category align with those in the Codex Standard for Formula Foods for Use in Weight Control Diets (Codex Standard 181-1991)^{Footnote 19} and the proposed maximum energy requirement of 1200 kcal per day aligns with the maximum set out for TDR for weight control in the EU^{Footnote 20}.

b) Nutrient requirements

TDR for weight reduction are designed for the exclusive feeding of individuals for short or longer-term use. It is proposed that these foods contain nutrients within an acceptable range to meet the minimum nutrient requirements of an individual aged 19 or more (RDA/AI) without exceeding safe levels of intake (UL/CDRR) established by NASEM or another authoritative body based on the potential of serious irreversible adverse effects (refer to Appendix 2 for references for ULs established by other authoritative bodies). Since these ULs and CDRR do not include overage, it is proposed that the maximum amounts would not include overage. It is proposed that no maximum requirements be set for vitamins and minerals with the potential of acute adverse effects (Appendix 3) as these can be easily detected and reversed through close monitoring by a healthcare professional.

As sole source products, it is proposed that all nutrients with established RDAs or AIs be mandatory, with the exception of fluoride since only trace amounts are found in most foods. Ensuring sufficient intakes of macronutrients is critical for weight loss. For example, sufficient intakes of high-quality proteins are important to help preserve lean body mass while adequate intakes of carbohydrate are required for proper brain function. For amino acids, it is proposed that they may be added to TDR for weight reduction only to meet protein quality requirements.

It is proposed that all macronutrients and micronutrients in Table 3 be present in amounts that meet the highest RDA/AI without exceeding the lowest UL/CDRR for adults ages 19 and over. However, for fibre, the minimum requirement in Column II of Table 3 is based on the highest median intake of adults aged 19 and over according to intake data from the CCHS 2015 (19 g per day) rather than on the highest AI (38 g per day). Basing the minimum requirement on the AI could pose technological challenges related to achieving products with appropriate consistency and palatability.

2.3.4 Consultation

Health Canada received comments from one expert on the proposed compositional requirements for TDR for weight reduction. The expert noted that the proposed energy requirements would not align with the requirements for similar products in the EU and in Australia/New Zealand, nor with the Codex Standard for Formula Foods for Use in Very Low Energy Diets for Weight Reduction (Codex Standard 203-1995).

Health Canada's response

Health Canada would like to clarify that medical foods represented as TDRs for weight reduction are not intended to be represented for use in very low-calorie diets and therefore the proposed minimum and maximum energy requirements for this category do not align with those for similar very low energy foods in other jurisdictions. In Canada, there is no history of use for FVLED providing less than 900 kcal per day. The proposed energy requirements for this new category align with those in Codex Standard 181-1991 and the proposed maximum requirements in Column III of Table 3 align with those set out for TDR for weight control in the EU.

2.3.5 Questions for stakeholders

• Do you support the proposed energy requirements for TDR for weight reduction (products providing less than 800 kcal per day would not be permitted for sale in Canada)?
• Do you support the proposed minimum and maximum macronutrient and micronutrient requirements?

In answering these questions, please provide supporting rationale.

3.0 Proposed compositional requirements for foods that are not foods for a special dietary purpose

3.1 Conventional infant foods

3.1.1 Background

The proposed category of conventional infant foods aims to capture products currently regulated under Division 25 that would not be considered FSDP such as infant cereal or strained fruit. In the 2023 consultation paper, the following definition was proposed:

• conventional infant food means a food that is labelled or advertised for consumption by infants other than a food for a special dietary purpose

As part of the 2023 consultation paper, Health Canada also introduced a detailed proposal outlining sodium restrictions for conventional infant foods. As well, a commitment was made to update the current fortification requirements for infant cereal and to consider introducing restrictions on sugars, which are detailed in the current consultation.

3.1.2 Proposal

a) Sugars

Health Canada is proposing to introduce a restriction on sugars in certain categories of conventional infant foods. It is proposed that for the following food categories, a food which contains sugars-based ingredients^{Footnote 21} would be required to contain no more than 5 g of total sugars per reference amount and per serving of stated size, and per 50 g if the reference amount is 30 g or 30 mL or less:

• desserts
• beverages
• snacks, for example rusks and puffs

b) Sodium

In the 2023 consultation paper, Health Canada proposed to maintain the prohibition of added sodium chloride to any infant food that contains strained fruit, fruit juice, fruit drink or cereal, and proposed to add desserts to the list. For other foods, the following sodium limits were proposed:

• 200 mg sodium per 100 g for rusks, biscuits and dehydrated snacks
• 100 mg sodium per 100 g for all other ready to eat conventional infant foods

No further changes are proposed at this time.

c) Fortification of infant cereal

In the 2023 consultation paper, Health Canada committed to review the current list of vitamins and mineral nutrients that may be added to infant cereal and to set out minimum and maximum amounts for all added nutrients.

Health Canada is proposing that the addition of iron to infant cereal be mandatory. The addition of calcium, iodine, phosphorus, niacin, riboflavin and/or thiamine would remain voluntary and it is proposed to permit the addition of vitamin D.

The proposed minimum and maximum amounts for vitamins and mineral nutrients added to infant cereal are set out in Column II and III of Table 4. These levels apply to the total amount in the product from all added and naturally occurring sources.

3.1.3 Rationale

a) Sugars and sodium restrictions

Sugars, sodium and saturated fat are nutrients of public health concern in Canada. To help reduce health risks posed by excess consumption of sugars, sodium and saturated fat, Health Canada requires a front-of-package nutrition symbol on prepackaged foods that are high in one or more of these nutrients. A food is considered high in a nutrient if the content meets or exceeds a specific percentage of its daily value. However, foods intended solely for infants 6 months of age or older but less than one year of age are prohibited from displaying the front-of-package nutrition symbol, since there are no daily values applicable to this age group for these nutrients. The WHO Guideline for complementary feeding of infants and young children 6-23 months of age^{Footnote 22} recommends that foods high in sugar and salt should not be consumed by infants and young children.

To address this, Health Canada is proposing to introduce a restriction on sugars in certain categories of conventional infant foods that contain sugars-based ingredients. The proposed restriction on sugars applies the criteria for the "low in sugar" nutrient content claim which uses a threshold that is sensitive to small serving sizes and reference amounts, as is the case for many conventional infant foods, particularly snacks. Implementation of this proposal would help ensure that conventional infant foods do not contribute to excess intake of added sugars. Other jurisdictions also restrict sugars in conventional infant foods. For example, the EU restricts the amount of added sugars that can be included in certain categories of conventional infant food^{Footnote 23}.

In the 2023 consultation paper, Health Canada proposed changes that would strengthen and simplify the current approach to restricting sodium in conventional infant foods. The FDR currently prohibits certain types of conventional infant foods from containing added salt and sets out multiple sodium limits for a range of similar types of infant foods. In the 2023 consultation paper, two sodium limits were proposed to cover all ready-to-eat conventional infant foods not prohibited from containing added salt. The first limit (100 mg/100g of food) is the lowest of the applicable sodium limits set out in the current regulations and was proposed to apply to almost all ready-to-eat conventional infant foods; this limit is also applied by FSANZ. For rusks, biscuits and dehydrated snacks, the proposed limit was set higher (200 mg/100g food) with consideration for the typically small serving size (by weight) of these foods. Together with the proposal to prohibit certain types of foods from containing added salt, the proposal to set sodium limits for all ready-to-eat conventional infant foods would eliminate gaps in the current regulations resulting from the closed list of foods.

This proposal would help complement Health Canada's guidance recommending that complementary foods for infants be prepared and served with little or no added salt or sugar. Given that dietary fat restriction is not recommended for children younger than 2 years, saturated fat limits are not proposed.

b) Fortification of infant cereal

Iron

At around 6 months of age, an infant's iron reserves acquired in utero are depleted. The risk of iron deficiency increases from 6 to 12 months of age. This is because rapid growth during this time dictates higher iron needs^{Footnote 24}. Timely introduction and regular consumption of iron-rich complementary foods can reduce the risk of iron deficiency^{Footnote 25Footnote 26Footnote 27}. Health Canada recommends introduction of iron-rich foods as an infant's first complementary foods.

Infant cereal is the first food for approximately two-thirds of infants in Canada^{Footnote 28} whereas other iron-rich foods such as meat or meat alternatives are not typically first foods and often introduced later in infancy^{Footnote 29}. At present, nearly all infant cereals marketed in Canada are fortified with iron; however, given the importance of infant cereal as an iron source in infant diets, Health Canada is proposing to mandate the addition of iron to ensure universal uptake.

Iron fortification of infant cereal remains voluntary in the EU; however, FSANZ has implemented mandatory iron fortification of infant cereal^{Footnote 30}.

Vitamin D

Vitamin D is an essential vitamin that helps to build and maintain strong bones and teeth. Insufficient vitamin D can lead to rickets in infants and young children. As such, Health Canada recommends a daily vitamin D supplement for all breastfed infants, regardless of any dietary vitamin D intake from infant formula or other foods. Adherence to the vitamin D supplement recommendation is relatively high. However, in a 2022 survey of mothers who had had a baby in the previous 5 years, approximately one quarter of those who had breastfed reported not providing their infant with a vitamin D supplement daily or almost every day^{Footnote 31}.

Health Canada is proposing to permit the addition of vitamin D to infant cereal to help reduce the risk of inadequate vitamin D intakes and promote adequate bone health in infants. This proposal is intended to offer a source of vitamin D from a widely consumed conventional infant food. The proposal to permit addition of vitamin D to infant cereal aligns with Codex Standard for Processed Cereal-Based Foods for Infants and Young Children (Codex Standard 74-1981)^{Footnote 32}, and with the EU regulations, which permits or requires vitamin D in infant cereal.

Minimum and maximum amounts for vitamins and mineral nutrients

The current nutrient amounts prescribed in the FDR are outdated, published decades prior to the introduction of NASEM's DRIs. Several of the minimum levels prescribed are higher than recommended intakes and no maximum amounts are set out for mineral nutrients.

The current proposal upholds the principles of Canada's food fortification policy which permits or requires the addition of nutrients to foods to maintain or improve the nutritional quality of the food supply without posing a risk of excess nutrient consumption. Under the policy, the addition of nutrients is only permitted for specific reasons, for example, to restore nutrients lost during processing or to respond to a public health need where the risk of nutrient deficiency has been identified.

To this end, the proposed maximum amounts in Column III of Table 4 for calcium, iodine, iron, phosphorus, niacin, riboflavin and thiamine were set to ensure that DRI recommendations would be met in breastfed infants. The values were derived by taking the intake recommendations for infants 7 to 12 months and subtracting the average nutrient contribution from human milk.

For mineral nutrients, the proposed minimum amounts in Column II of Table 4 were set at half of the maximum value, with the exception of iron, where the amount was adjusted upward so that current levels in infant cereal would not be reduced. For niacin, riboflavin and thiamine, the proposed minimum amounts were set on the basis of nutrient restoration. In other words, the proposed amounts were set to replace nutrient losses that occur during processing of the grains from which infant cereals are made.

The proposed range of vitamin D amounts set out would provide a source of the nutrient while ensuring that safe levels of intake are not exceeded. The range aligns with certain breakfast cereals that have been issued temporary marketing authorization in Canada and overlaps with ranges set out in Codex Standard 74-1981, and in the EU.

3.1.4 Consultation

Eleven stakeholders provided comments on the proposed compositional requirements for conventional infant foods. A range of stakeholders provided feedback, including four regional health authority representatives, three health professionals, one health professional organization, one industry association, one consultant and one academic stakeholder.

Comments on the proposed restrictions on sugars and sodium

Few comments were received specifically about the proposal for restrictions on sugars and sodium. Of these comments, some stakeholders expressed support while others recommended more stringent restrictions. For example, some stakeholders suggested prohibiting addition of sugars or sodium to all conventional infant foods, or prohibiting foods not recommended for infants, such as fruit juice, from representing as infant foods.

One stakeholder from academia provided an analysis of label data for conventional infant foods, which showed that high levels of sugars are present in many products. They highlighted that a high proportion of strained infant dishes met or exceeded the front-of-package labelling thresholds (using thresholds for foods intended solely for children one year of age or older, but less than four years of age), and that a quarter of these foods had fruit puree or juice, defined as sugars-based ingredients by Health Canada, as the main ingredient. This stakeholder recommended that restrictions on the amounts and sources of added nutrients of concern be considered for these foods.

Health Canada's response

Health Canada does not have evidence to support that it is necessary from a public health standpoint to prohibit the addition of sodium chloride or sugars to all conventional infant foods. To mitigate the risk of excess sodium and sugars consumption in infants, Health Canada recommends that complementary foods be prepared and served with little or no added sugar or salt. Similarly, the WHO Guideline for complementary feeding of infants and young children 6-23 months of age includes a recommendation that foods high in sugar and salt (and trans fats) should not be consumed, that sugar-sweetened beverages should not be consumed, and that consumption of fruit juice should be limited.

Notably, a market scan completed by Health Canada did not identify any fruit drinks, fruit juices, or other sugary drinks represented for infants in the Canadian marketplace. However, to ensure that foods represented for infants do not provide excess sugars in the diet, Health Canada has proposed a restriction on sugars in these beverages and certain other categories of conventional infant foods, such as infant desserts. Although many strained infant foods identified in the scan contained fruit and/or vegetable purees, these foods present an appropriate food texture for infants starting at about 6 months of age. Very few strained infant foods contained other sugars-based ingredients, such as fruit juice.

Regarding sodium, Health Canada has proposed more stringent restrictions than is currently in the FDR for certain types of conventional infant foods.

Comments on fortification of infant cereal

Only two comments were received specific to the fortification of infant cereal. A regional health authority representative and an industry association indicated support for setting minimum and maximum vitamin and mineral nutrient amounts. The regional health authority representative recommended mandatory iron fortification for cereal represented for consumption by infants.

Health Canada's response

Health Canada has proposed minimum and maximum levels for the vitamin and mineral nutrients that can be added to infant cereal. Given the importance of infant cereal as an iron source during the complementary feeding period, Health Canada is proposing to mandate the addition of iron to ensure universal uptake.

3.1.5 Questions for stakeholders

• Do you support the proposals for restrictions on sugars and sodium in conventional infant foods?
• Do you support the following aspects of the proposal for infant cereal fortification:
  1. Making the addition of iron mandatory
  2. Introducing the voluntary addition of vitamin D
  3. Proposed minimum and maximum levels for added nutrients

In answering these questions, please provide supporting rationale.

3.2 Gluten-free food

3.2.1 Background

Individuals with celiac disease and gluten-related disorders rely on specialty gluten-free foods as substitutes for a large number of gluten-containing foods. Currently, the only dietary management for these conditions is to maintain a gluten-free diet. However, following such a diet increases the risk of nutrient deficiencies especially for certain vitamins and minerals that are required to be added to white flour^{Footnote 33Footnote 34}. Therefore, it is important that individuals following a gluten-free diet have access to fortified gluten-free foods.

Gluten-free foods are currently regulated as FSDU under Division 24 of the FDR. An exemption exists in Part D of the FDR^{Footnote 35}, which governs the addition of vitamins, mineral nutrients, and amino acids to foods. This exemption permits the fortification of specially formulated or processed gluten-free foods as long as no specific standard is prescribed in the FDR, and they are not advertised to the general public.

In the proposed modernized framework, gluten-free foods would no longer be considered FSDU and would be regulated under the general food framework. Health Canada has proposed to remove the current advertising restriction for these products to promote awareness and accessibility to fortified gluten-free foods. To maintain the policy intent to ensure nutritional equivalence of substitute foods and to help avoid over-fortification of the food supply, it is necessary to specify the types of gluten-free foods that can be fortified as well as the nutrients and levels that can be added.

3.2.2 Proposal

It is proposed that the following gluten-free foods be permitted to be fortified on a voluntary basis:

• gluten-free flours
• gluten-free foods containing gluten-free flours, for example:
  • baking mixes, baked goods, breads and bread products including rolls, bagels, pita bread, croutons, bread sticks, tortillas, baguettes, bagel thins, etc.

If fortified, Table 5 outlines the proposal for the nutrients and levels that would be required or permitted in gluten-free flours. These levels apply to the total amount in the product from all added and naturally occurring sources. In the case of the fortification of gluten-free foods containing gluten-free flour, it is proposed that the nutrients in Column I and levels in Column II listed in Table 5 would be permitted in amounts corresponding to the amount of gluten-free flour used in the recipe. It is also proposed that manufacturers be given the flexibility to fortify either the gluten-free flour ingredient or the gluten-free food as sold to the consumer in a manner that meets the requirements outlined in Table 5.

3.2.3 Rationale

Health Canada is proposing to maintain a voluntary approach for the fortification of gluten-free foods. Although a mandatory approach was explored, the drawbacks outweighed the benefits. For example, many gluten-free foods are imported from jurisdictions where there are no mandatory fortification requirements. Introducing mandatory fortification provisions could discourage importation of gluten-free foods from other countries since manufacturers might not want to reformulate for the Canadian market. Also, introducing mandatory fortification could increase the cost of manufacturing these foods which are already more expensive than their gluten-containing counterparts. In contrast, a voluntary fortification approach would provide industry with flexibility and would be less burdensome.

Under the proposed policy, Health Canada is limiting fortification to gluten-free flours and gluten-free foods containing gluten-free flours. Limiting fortification to these two categories would prevent the overfortification of the food supply which could result if any gluten-free food were permitted to be fortified. Health Canada would permit fortification to ensure that these foods contain the important nutrients provided by their gluten-containing counterparts. This approach aligns with the Codex general principle for fortification of substitute foods^{Footnote 36}, which Canada has adopted. The Codex principle supports the fortification of substitute foods which are significant contributors to the intake of essential nutrients in the population to ensure that they are nutritionally equivalent to the foods they are meant to replace.

Currently, the FDR does not specify fortification levels, nor specific nutrients that may be added to gluten-free foods. The current proposal was guided by the fortification requirements for white flour, under the FDR^{Footnote 37}, and its natural nutrient content. In alignment with current requirements for the fortification of white flour under the FDR, it is proposed that if fortified, gluten-free flours must contain iron, folic acid, thiamine, niacin and riboflavin while the addition of vitamin B₆, pantothenic acid, magnesium and calcium would be voluntary. The addition of selenium to gluten-free flour would be permitted in quantities similar to what is naturally present in white flour. Selenium is lacking in gluten-free flour alternatives and there is some evidence that people with celiac disease following a gluten-free diet may be deficient^{Footnote 34}.

3.2.4 Consultation

In response to the 2023 consultation paper, nine responses were received on the fortification of gluten-free foods. A range of stakeholders provided feedback including two industry associations, one health professional, two health professional organizations, two stakeholders representing provincial and/or territorial governments and two NGOs. Overall, most stakeholders supported the proposal.

Comments on voluntary vs mandatory fortification of gluten-free foods

Some stakeholders recommended that Health Canada explore mandating fortification of gluten-free foods to improve their nutritional quality and decrease the prevalence of nutritional deficiencies in individuals with celiac disease. However, one NGO raised concerns that mandating fortification would be associated with increased manufacturing costs and therefore increased retail costs for medically necessary foods that are already more expensive than comparable gluten-containing products. This stakeholder recommended that Health Canada conduct a market analysis to assess the cost of fortifying gluten-free foods.

Health Canada's response

Health Canada considered mandating the fortification of gluten-free foods to meet the nutritional needs of individuals with celiac disease. However, as described in the rationale section above, the drawbacks outweighed the benefits. Following the 2023 consultation, Health Canada met with an NGO to discuss their recommendation to mandate the fortification of gluten-free foods. After discussions, the NGO revised their recommendation, acknowledging the burden of mandatory fortification on industry and the impact on products imported from jurisdictions where fortification is not mandatory. They indicated support for the voluntary fortification of certain gluten-free foods since this approach, coupled with removing the advertising restriction, should help to increase options for fortified gluten-free foods in the marketplace. The NGO agreed to support Health Canada by exploring industry's interest in fortifying gluten-free foods.

Comments on foods proposed to be allowed to be fortified

Stakeholders supported fortification of gluten-free flours. One stakeholder also recommended that Health Canada allow the fortification of gluten-free baking mixes, baked products, cereals and pastas.

Health Canada's response

Health Canada proposes to limit fortification to gluten-free flours and gluten-free foods containing gluten-free flour including, baking mixes and baked products. Breakfast cereals and pasta are already permitted to be fortified under Division 13 of the FDR.

3.2.5 Questions for stakeholders

• Do you support the proposed types of gluten-free foods that would be permitted to be fortified?
• Do you support the nutrients and levels that are proposed for addition to gluten-free foods?

In answering these questions, please provide supporting rationale.

3.3 Formulated nutritional foods

3.3.1 Background

The proposed category of formulated nutritional foods (FNF) would capture products currently regulated as meal replacements (MR) and nutritional supplements (NS) under Division 24 of the FDR, including MR that are represented for use in weight reduction diets.

In the 2023 consultation paper, the following definitions were proposed:

• Formulated nutritional food for children means a formulated food sold or represented for children 1 to 13 years old to be consumed in addition to their diet when it may be inadequate in energy and essential nutrients.
• Formulated nutritional food for ages 14 or more means a formulated food sold or represented for individuals aged 14 or more to be consumed in addition to their diet when it may be inadequate in energy and essential nutrients or as a replacement for one or more daily meals, but not for all daily meals.

It is important to note that the proposed category of FNF would be distinct from supplemented foods, which may contain one or more supplemental ingredient(s) (for example, vitamin, mineral, amino acid) added for purposes other than nutrition. With supplemented foods, a risk-based approach was taken to determine permitted supplemental ingredient levels and associated conditions of use (for example, cautionary statements) to protect the health and safety of consumers. In contrast, the approach applied for setting the proposed compositional requirements for FNF upholds the principles of Canada's food fortification policy which permits or requires the addition of nutrients to foods to mitigate the risk of nutrient inadequacy without posing a risk of excess nutrient consumption.

3.3.2 Proposal

Two categories of FNF are proposed, which are further divided into subcategories. The subcategories have been updated since the 2023 consultation paper.

1. FNF for children:
   • 1 to 3 years
   • 4 to 13 years
2. FNF for ages 14 or more:
   • Providing 150 to 349 kcal per serving
   • Providing 350 kcal or more per serving
   • Represented as a replacement for a meal, including those represented for use in weight reduction diets

Distinct compositional requirements are proposed for all subcategories of FNF. Since the DRIs differ significantly for the different age groups, the proposed compositional requirements do not accommodate products targeted to multiple FNF subcategories based on age. This is because, in some cases, the proposed minimum amounts for one subcategory are higher than the proposed maximum amounts for another subcategory. For instance, for magnesium, the minimum amount for products intended for children 4 to 13 years (35 mg) is higher than the maximum amount for products intended for those 1 to 3 years (25 mg).

The proposed requirements, set out in Table 6, are on a "per serving" basis. These requirements apply to the total level in the product, from all added and naturally occurring sources, when prepared. Nutrients with no minimum level are proposed to be voluntary.

Protein is the only macronutrient where compositional requirements are proposed. This is more flexible than the current regulatory approach, where, in addition to protein, requirements are set out for total fat and certain fatty acids.

The proposed maximum amounts for micronutrients would not include overage. This is more flexible than the current regulatory approach for MR and NS where overages are included in the maximum micronutrient amounts for almost all nutrients.

3.3.3 Rationale

a) Energy requirements

The proposal that most FNF subcategories provide a minimum of 150 kcal per serving aligns with the current minimum energy requirements for NS in the FDR. For FNF for ages 14 or more, the caloric level dividing the subcategories has been increased from the 200 kcal level proposed in the 2023 consultation paper to 350 kcal. The level of 350 kcal corresponds to 25% of the lowest median energy intake for individuals 14 years or older from CCHS 2015. For FNF represented as an MR, the proposed minimum energy requirement of 200 kcal is consistent with other jurisdictions. Under the proposal, it would be optional to represent as an MR, which is consistent with the current regulatory approach.

For FNF for children, maximum energy amounts are proposed to ensure these foods do not displace a significant proportion of healthy foods in the diet. These amounts are approximately 15% of the lowest median energy intake for the target age category from CCHS 2015. This approach considers that FNF for children are intended to be consumed in addition to a diet that may be inadequate in energy and essential nutrients.

b) Mandatory and voluntary nutrient requirements

To ensure consumers' needs are met when using FNF to replace foods usually consumed in the diet, it is proposed that most nutrients with an RDA be mandatory. For flexibility in product composition, an exception is proposed for carbohydrates for which addition would be voluntary. This is consistent with the current regulatory approach for MR and NS which has not posed a concern, as well as approaches followed by other jurisdictions.

For most nutrients with an AI, it is proposed that their addition be voluntary. An AI is based on much less data and incorporates substantially more judgment than is used in establishing an RDA. Furthermore, deficiencies are rarely seen for these nutrients and FNF are not intended as a sole source of nutrition. One exception being proposed is that potassium be required in FNF targeted to those ages 14 years or more. This proposal is supported by evidence of a relationship between increased potassium intake and decreased blood pressure in adults^{Footnote 38}. For FNF targeted to children, addition of potassium is proposed to be voluntary, as the scientific literature on the relationship between dietary intake and blood pressure is limited in this population.

Although fluoride has an AI, it is proposed that its addition not be permitted to FNF. Fluoridated water is the primary source of dietary fluoride with only trace amounts naturally present in most foods^{Footnote 39}. Since consumers of FNF likely drink water or use it to prepare FNF in powdered format, the addition of fluoride does not align with the intent of this product category: to supplement a diet that may be inadequate in energy or essential nutrients.

c) Minimum requirements

The minimum amounts for protein are proposed to be based on a percentage of the RDA. Since RDAs are set on a body weight basis (grams per kilogram), median body weights obtained from CCHS 2015 were used to calculate absolute amounts. For each FNF subcategory, the highest calculated RDA was used to set the proposed minimum amount. For example, for 4 to 13 year olds, the RDA of 0.95 g/kg was multiplied by the median body weights for 4 to 8 year olds and 9 to 13 year olds. The highest calculated RDA of the two groups was used to set the minimum amount for FNF for ages 4 to 13 years.

For FNF for children and FNF targeted to those ≥ 14 years that provide 150 to 349 kcal, the proposed minimum levels for protein are based on 15% of the highest calculated RDA per serving for the respective target age category. This is consistent with the proposed approach described below for setting minimum micronutrients amounts for these product subcategories. For FNF providing ≥ 350 kcal, the same approach based on 15% of the highest calculated RDA for protein is proposed even though it does not align with the proposed approach for setting micronutrient requirements at 25% of the RDA for this subcategory. Requiring a protein minimum of 25% RDA cannot be justified since the protein RDAs are based on body weight and are therefore variable.

A minimum protein level of 25% of the highest calculated RDA is proposed for MRs represented for use in weight reduction diets since sufficient intakes of protein are especially important during weight loss to minimize the risk of muscle wasting^{Footnote 40Footnote 41}. Requiring a higher protein content for products intended for use in weight reduction diets is consistent with the current approach in the FDR for MR used for this purpose.

Protein quality requirements are proposed to ensure that if the quality is not equivalent to casein, the protein amount would be increased to compensate. This is similar to the current protein quality requirements for NS and MR in the FDR.

For mandatory micronutrients, for most FNF categories, the minimum amounts are proposed to be set at 15% of the highest RDA per serving for the respective target age group. This level corresponds to the amount necessary for making a "good source" claim for most nutrients.

However, for FNF for ages 14 or more, it is proposed that a minimum of 25% of the highest RDA be required for products providing a minimum of 350 kcal. Setting higher minimum micronutrient levels for FNF providing 350 kcal or more ensures that higher calorie products provide proportionally more micronutrients. As well, it is proposed that all FNF represented as MRs (regardless of calorie level), provide a minimum micronutrient level of 25% RDA to ensure that one serving could replace the micronutrients for at least one of four daily eating occasions.

For potassium, an exception is proposed since there is no established RDA. It is proposed that the minimum amount be set at 15% of the highest potassium AI for FNFs targeted to those 14 years of age and older, including those represented as MRs. A minimum of 15% AI ensures all products could make a "good source" claim.

Note that no minimum amounts are proposed for micronutrients that can be voluntarily added to FNF.

d) Maximum requirements

In the case of saturated fat, sugars and sodium, Health Canada introduced a mandatory front-of-package nutrition symbol on conventional prepackaged foods in 2022. The symbol is intended to help people in Canada quickly and easily identify foods high in these nutrients. Since the 2023 consultation paper proposed to extend nutrition symbol labelling to FNF, maximum compositional requirements for these nutrients are not being proposed at this time.

No maximum amounts are proposed for protein, carbohydrates, total fat, linoleic acid or alpha-linolenic acid as there are no upper limits set by NASEM or other authoritative body for these. For amino acids, it is proposed that they may be added to FNF only to meet protein quality requirements.

With the exception of sodium, maximum amounts are proposed for all micronutrients that can or must be added to FNF. Maximum amounts are proposed based on a percentage of either the highest RDA/AI or the lowest UL, for the respective target age group. Where there was no UL established by NASEM or where other information was determined to be more appropriate, alternate scientific sources were used as an upper limit (see Appendix 2 for more details). Since these ULs and upper limits do not include overage, it is proposed that the maximum amounts would not include overage.

For most micronutrients, Health Canada is proposing to set the maximum amount at 50% of the highest RDA/AI for the respective target age group per serving. This approach assumes that it would not be expected for consumers to exceed two servings per day (in other words,100% RDA/AI). For most healthy people, it is not necessary to exceed the RDA/AI. However, for some micronutrients there is a narrow margin of safety between the RDA/AI and UL. In cases where the maximum amount calculated as 50% of the highest RDA/AI exceeds 25% of the lowest UL within the target age group, Health Canada is proposing to cap the maximum amount at 25% UL to help mitigate the risk of excess nutrient intakes. The threshold of 25% UL was chosen based on the assumption that an FNF could replace up to a quarter of the diet. This approach was applied to all micronutrients, except niacin, magnesium and potassium.

For niacin, setting the maximum amount at 50% of the highest RDA would result in levels exceeding 25% of the lowest NASEM UL^{Footnote 42}, which applies to both forms of niacin: niacinamide and nicotinic acid. Given that the adverse effect upon which the NASEM UL is based (flushing) is only attributed to supplemental nicotinic acid, Health Canada considered recommendations of the EFSA Scientific Committee on Food, who set out a separate higher UL for niacinamide, distinct from their nicotinic acid UL^{Footnote 43}. It is proposed to set the maximum amount for total niacin at 50% of the highest RDA because this does not exceed 25% of the lowest EFSA UL for niacinamide; however, the proportion contributed by nicotinic acid is proposed to be limited to 25% of the lowest EFSA UL for nicotinic acid.

For magnesium, setting the maximum amount at 50% of the highest RDA would result in levels exceeding 25% of the lowest NASEM UL^{Footnote 39}. However, limiting the maximum amount to 25% of the lowest UL would result in either a very narrow range between the proposed minimum and maximum amounts, or maximum amounts that are lower than the minimum amounts, which is not feasible. Therefore, it is proposed to limit the maximum amount to 40% of the lowest UL to allow an appropriate range of addition. Although the proposed approach for magnesium would allow a higher proportion of the UL, it is deemed not to be a safety concern. Even though one serving of an FNF could replace up to a quarter of the diet, these products are not expected to be consumed more than twice a day. Moreover, the UL for magnesium applies to pharmacological sources only since naturally occurring magnesium from the background diet does not contribute to adverse effects. Furthermore, it should be noted that the adverse effect upon which the UL is based is diarrhea, which is reversible, and self-limiting.

For potassium, a UL has not been established by NASEM or other authoritative bodies since a specific indicator of a toxicological effect could not be established. However, NASEM concluded that short term potassium supplementation of approximately 2,500 mg/day on the background of a usual diet appears to be safe for generally healthy individuals. Health Canada applied this upper limit in lieu of a UL for determining a proposed maximum level. Maximum amounts set on the basis of 50% of the highest AI would result in levels exceeding 25% of the upper limit. Limiting the maximum amount in this manner is likely overly restrictive given there is currently no maximum for potassium set out in the FDR for MR or NS and this upper limit applies to supplemental sources of potassium only. Moreover, even though one serving of an FNF could replace up to a quarter of the diet, these products are not expected to be consumed more than twice a day. Therefore, it is proposed to limit the maximum amount to 40% of the upper limit.

3.3.4 Consultation

Health Canada received comments from 12 stakeholders on the proposed compositional requirements and subcategories for FNF. A range of stakeholders provided feedback including two provincial and/or territorial government representatives, two NGOs, one health professional, one health professional organization, two industry associations, one consultant, one academic (supported by multiple colleagues), one expert, and one industry stakeholder.

A summary of the comments received from the previous consultation regarding compositional requirements for FNF are as follows.

Comments on FNF for children - Proposed subcategories

Although some stakeholders supported the previously proposed FNF subcategories for children (1 to 3 and 1 to 13 years), other stakeholders recommended that two distinct categories for children be established (1 to 3 and 4 to 13 years), noting the vulnerability of children between 1 to 3 years and alignment with the World Health Organization International Code of Marketing of Breast-milk Substitutes.

Health Canada's response

In consideration of this feedback, Health Canada has proposed to set out two distinct sets of requirements for FNF for children (ages 1 to 3 and 4 to 13 years) as explained in Section 3.3.2. Under the proposed approach, FNF for children could be represented for any age group within a subcategory.

Comments on addition of other substances

An expert asked whether Health Canada will establish regulations or guidance on the addition of other substances such as docosahexaenoic acid and probiotics to FNF for children.

Health Canada's response

Policy work on these substances is ongoing. Further information will be provided as part of the pre-publication of the proposed regulations in the Canada Gazette, Part I in spring 2026.

Comments on energy requirements

One industry association recommended that the minimum energy requirement for FNF for children be based on a minimum caloric density (for example, 1.0 kcal/mL or g) instead of an absolute amount per serving because serving sizes for children may be smaller. They noted that the common serving size of 125 mL would not meet the proposed minimum energy requirement of 150 kcal considering the caloric density of products currently available in Canada. They recommended that Health Canada establish a maximum energy requirement for FNF intended for children to prevent displacement of other foods and to align with their intended purpose.

Health Canada's response

Based on an internal scan of products targeted to children that are found on the Canadian market, the serving sizes range from 200 to 235 mL (when prepared according to the directions for use). Furthermore, most products meet the proposed minimum energy requirement for FNF for children. Therefore, no changes have been made to the proposal for minimum energy requirements. However, Health Canada has proposed a maximum energy requirement for FNF for children in the present consultation, as described in the Section 3.3.3 a).

Comments on macronutrient requirements: Protein and total fat

An industry association recommended that minimum and maximum requirements be established for protein in FNF for children to align with applicable Acceptable Macronutrient Distribution Ranges, with flexibility to further adapt. They also recommended that FNF for ages 14 or more should not have a maximum amount for protein to support innovation in the high protein/active nutrition category for adults. This association also proposed deviations to macronutrient limits and appropriate label requirements to support high protein or low fat FNF.

Health Canada's response

As described above in Sections 3.3.3 c) and d), Health Canada has proposed no minimum or maximum requirements for fat and no maximum requirements for protein, which allows flexibility to adapt the macronutrient formulation of FNF to support innovation. Minimum requirements for protein are being proposed based on a percentage of the RDA. The Acceptable Macronutrient Distribution Ranges have not been used to set these requirements as they apply to total daily intake and not one food or meal.

Comments on macronutrient requirements: Linoleic and alpha-linolenic acid

An industry association recommended no minimum limits for linoleic and alpha-linolenic fatty acids for FNF for children unless a certain caloric threshold is met. They also suggested that FNF for ages 14 or more with 150 to199 kcal per serving should not have minimum limits for these fatty acids to provide flexibly in product development and to align with the current regulatory framework for NS. An industry stakeholder noted that mandatory requirements for these fatty acids pose a burden to industry and that linoleic fatty acid is not warranted for products only replacing a part of the diet.

Health Canada's response

As described in Section 3.3.3 b), linoleic and alpha-linolenic acid are proposed to be voluntary nutrients as they do not have RDAs established by NASEM. In addition, no maximum amounts are proposed for these nutrients as there are no upper limits set by NASEM or other authoritative body, as noted in Section 3.3.3 d).

Comments on macronutrient requirements: Protein quality

Some stakeholders noted their support for the proposal to allow the addition of amino acids to FNF to meet protein quality requirements. An expert suggested that protein quality requirements for FNF for children should include Protein Digestibility Corrected Amino Acid Score (PDCAAS) as the preferred method as per the 2017 Food and Agriculture Organization of the United Nations Expert Group recommendations and questioned whether it is necessary to maintain the protein quality requirement for FNF for ages 14 or more.

Health Canada's response

Health Canada has proposed that protein quality can be measured by PER or PDCAAS. These products are intended to supplement a diet that may be inadequate in energy or essential nutrients; this includes inadequate intakes of high-quality protein. Therefore, protein quality requirements are proposed for all categories of FNF, including FNF for ages 14 or more.

Comments on macronutrient requirements: Nutrients of concern

An academic recommended that restrictions on the amount and sources of added nutrients of concern be considered for FNF for children (for example, sugars, sodium, and trans fat).

Health Canada's response

There is strong evidence linking excess consumption of these nutrients to increased risk of obesity, hypertension and chronic diseases such as heart disease and type 2 diabetes. Health Canada introduced a mandatory front-of-package nutrition symbol on conventional prepackaged foods in 2022. The symbol is intended to help reduce risks to health by providing consumers with quick and easy-to-use information on foods high in saturated fat, sugars and/or sodium. Furthermore, Health Canada's ban on partially hydrogenated oils, the main source of industrially produced trans fat, came into effect on September 17, 2018.

Since the 2023 consultation paper proposed to extend nutrition symbol labelling to FNF, compositional requirements for sugars, sodium and saturated fat are not being proposed at this time. Comments related to the 2023 proposal continue to be under review.

Comments on micronutrient requirements: Minimum and maximum amounts

An industry association requested that the minimum amount for micronutrients that are typically consumed in sufficient quantities correspond to the amount needed to make a "source of" claim (5% daily value), except for FNF represented for use in weight reduction diets. This industry association also requested maximum amounts be set using a risk-based approach, allowing up to 100% RDA per serving for certain nutrients; noting that limits should take into consideration typical dietary patterns and allow for flexibility.

Health Canada's response

Health Canada is proposing to set minimum amounts based on 15 to 25% RDA and maximum amounts based on 50% RDA/AI or 25% of the UL. Setting minimum micronutrients amounts based on 5% daily value would not provide adequate micronutrients since, based on median energy intakes from CCHS 2015, these products provide more than 5% of total energy intake. Setting maximum amounts for micronutrients using a risk-based approach would not align with Canada's food fortification policy as noted in Section 3.3.1. Typical dietary patterns were not considered when developing the proposed maximum amounts because these products are intended to replace a portion of the typical diet by either supplementing inadequate intakes of energy and nutrients or replacing a meal.

Comments on micronutrient requirements: Approach for potassium

A consultant supported Health Canada's proposal for a lower minimum amount for potassium. However, an expert questioned the rationale for proposing the current regulatory minimums in the FDR for NS and MR for potassium, noting that these values are based on outdated adult nutrient requirements. Further, the expert questioned the rationale for the mandatory addition of potassium to FNF for children.

Health Canada's response

Considering these comments, it is proposed to set a minimum of 15% of the highest AI per serving, as described in Section 3.3.3 c). Furthermore, acknowledging that the scientific literature on the relationship between potassium intake and blood pressure is limited in children, it is proposed that potassium be voluntary for FNF for children.

Comments on micronutrient requirements: Request to deviate from proposed requirements

One industry association requested that the micronutrient requirements for FNF for children allow for deviations based on scientific evidence or sharing the formulation with other markets. They flagged that the supplemented foods framework is not an adequate avenue for fortified products for children less than 14 years as there are restrictions on vitamins and minerals for this age group.

Health Canada's response

Unlike supplemented foods, the addition of nutrients to FNF must align with the principles of Canada's food fortification policy, which aims to mitigate the risk of inadequacy and minimize the risk of nutrient excess. Allowing deviations from the proposed compositional requirements for FNF to share formulations with other markets does not align with this intent. Of note, the compositional requirements for FNF would be incorporated by reference into the FDR to enable administrative amendments to reflect the latest nutritional science.

3.3.5 Questions for stakeholders

• Do you support the proposed subcategories for FNF for children and FNF for ages 14 or more?
• Do you support the proposed approach for setting minimum and maximum amounts for macronutrients and micronutrients?
• Do you have concerns with the proposed maximum energy ranges for FNF for children?
• Do you have concerns with having no compositional requirements for carbohydrate, fat, or linoleic and alpha linolenic fatty acids?
• Do you have concerns with FNF not being able to target multiple FNF subcategories based on age given the distinct compositional requirements proposed?
• If applicable, how would the proposed nutrient composition for FNF impact your clinical practice?

In answering these questions, please provide supporting rationale.

4.0 Conclusion

The proposal set forth ensures that the composition of infant foods and foods currently regulated as FSDU would be safe and nutritionally adequate. This is achieved by anchoring the proposal in the most recent scientific evidence on recommended intakes while also considering relevant Codex standards as well as regulations applied in other jurisdictions. To ensure flexibility and that product formulation can meet the specific dietary needs of individuals with medical conditions, exemptions from meeting compositional requirements have been proposed when medically justified. In addition, the final requirements are proposed to be incorporated by reference in the FDR to enable administrative amendments to align with new scientific evidence.

Health Canada values input on its proposed policies and regulations. Comments on the proposed compositional requirements for infant foods and foods currently regulated as FSDU are welcome and will be assessed in conjunction with those received in response to the 2023 consultation paper regarding the broader regulatory modernization of Divisions 24 and 25. The information received will help shape the final regulatory modernization proposal to be published in the Canada Gazette, Part I.

Appendix 1: Dietary Reference Intakes

The DRIs are a set of scientifically based nutrient reference values for healthy populations. They were established by Canadian and American scientists through a review process overseen by the NASEM which is an independent, non-governmental body in the United States (US). The US and Canadian governments jointly sponsor the development of the DRIs since 1994.

The DRI are an important part of the evidence underpinning government activities such as the development of regulatory standards, assessment of dietary intakes, food product safety assessment, and the development of dietary guidance for the general population and for specific life stage groups.

The main types of DRI reference values are the Estimated Average Requirement (EAR), the Recommended Dietary Allowance (RDA), the Adequate Intake (AI), the Tolerable Upper Intake Level (UL), and the Chronic Disease Risk Reduction Intake (CDRR).

• An EAR is the average daily nutrient intake that is estimated to meet the requirement of half the healthy individuals in a life-stage and gender group. A specific indicator of adequacy is used to determine the EAR. The EAR is used to calculate the RDA.
• An RDA is an estimate of the minimum daily average dietary intake level that is sufficient to meet the nutrient requirement of nearly all (97 to 98 percent) healthy individuals in a particular life-stage and gender group. The main use of the RDA is as a goal for usual intake of individuals. Since the RDA is calculated based on the EAR, an RDA can only be set for a particular nutrient if there is sufficient scientific evidence to establish an EAR for that nutrient.
• The AI is the recommended average daily nutrient intake level based on observed or experimentally determined approximations or estimates of nutrient intake by a group (or groups) of apparently healthy people who are assumed to be maintaining an adequate nutritional state. If sufficient scientific evidence is not available to establish an EAR and to subsequently set an RDA, an AI is derived for the nutrient instead. An AI is based on much less data and incorporates substantially more judgment than is used in establishing an EAR and subsequently the RDA. The issuance of an AI indicates that more research is needed to determine, with some degree of confidence, the mean and distribution of requirements for that specific nutrient. The AI is expected to meet or exceed the needs of most individuals in a specific life-stage and gender group. The AI can be used as the goal for an individual's intake when an RDA is not available for a nutrient.
• A UL is the highest level of continuing daily nutrient intake that is likely to pose no risk of adverse health effects in almost all individuals in the life-stage group for which it has been designed. The term "tolerable" intake was chosen to avoid implying a possible beneficial effect. Instead, the term is intended to specify a level of intake with a high probability of being tolerated biologically. The UL is not intended to be a recommended level of intake. As intake increases above the UL, the potential risk of adverse effects increases.
• A CDRR is the lowest level of intake expected to reduce chronic disease risk. CDRR values were established for sodium.

Appendix 2: References from authoritative bodies other than NASEM

List of references from authoritative bodies other than NASEM that were used for assessing upper limits for certain micronutrients in FNF, medical foods for ages one or more and TDR for weight reduction

• Vitamin E
  • EFSA. 2015. "Scientific Opinion on Dietary Reference Values for vitamin E as α-tocopherol." EFSA Journal 13(7). https://doi.org/10.2903/j.efsa.2015.4149
  • EFSA Scientific Committee on Food. 2006. "Tolerable Upper Intake Levels for Vitamins and Minerals." https://www.efsa.europa.eu/sites/default/files/efsa_rep/blobserver_assets/ndatolerableuil.pdf
• Niacin (including niacinamide and nicotinic acid)
  • EFSA Scientific Committee on Food. 2006. "Tolerable Upper Intake Levels for Vitamins and Minerals." https://www.efsa.europa.eu/sites/default/files/efsa_rep/blobserver_assets/ndatolerableuil.pdf
• Vitamin B₆
  • EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA). 2023. "Scientific opinion on the tolerable upper intake level for vitamin B6." EFSA Journal 21(5). https://www.efsa.europa.eu/en/efsajournal/pub/8006
• Selenium
  • EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA). 2023. "Scientific opinion on the tolerable upper intake level for selenium." EFSA Journal 21(1). https://www.efsa.europa.eu/en/efsajournal/pub/7704
• Vitamin K*
  • Health Canada. 2023. The Prescription Drug List. https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/prescription-drug-list.html
• Chromium*
  • EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS). 2010. "Scientific Opinion on the safety of trivalent chromium as a nutrient added for nutritional purposes to foodstuffs for particular nutritional uses and foods intended for the general population (including food supplements)." EFSA Journal 8(12), 1882. https://doi.org/10.2903/j.efsa.2010.1882
  • World Health Organization (WHO). 1996. "Trace elements in human nutrition and health." https://www.who.int/publications/i/item/9241561734

*Not applicable to medical foods for ages one or more and TDR for weight reduction

Appendix 3: List of micronutrients for which a maximum requirement was not established and supporting rationale

The list pertains to medical foods for ages one or more and TDR for weight reduction. A rationale is provided when a UL exists, but a maximum requirement was not established. Unless otherwise specified, references to the ULs below refer to those set by NASEM.

• Vitamin C
  • UL is based on diarrhea which is an acute and reversible adverse effect^{Footnote 44}
• Folate
  • UL is based on masking vitamin B₁₂ deficiency^{Footnote 42} and nutritionally complete medical foods are proposed to contain vitamin B₁₂
• Niacin^{Footnote 43}
  • Niacinamide: EFSA UL is based on a no-observed-adverse-effect level
  • Nicotinic acid: EFSA UL is based on flushing which is an acute and reversible adverse effect
• Phosphorous
  • UL is based on diarrhea which is an acute and reversible adverse effect^{Footnote 39}
• Iron
  • UL is based on gastrointestinal effects including constipation, nausea, vomiting and diarrhea which are acute and reversible adverse effects^{Footnote 24}
• Magnesium
  • UL is based on diarrhea which is an acute and reversible adverse effect^{Footnote 39}