Health Canada's Proposed Changes to the Daily Values (DVs) for Use in Nutrition Labelling

July 14, 2014

Table of Contents

• List of Abbreviations
• 1. Executive Summary
• 2. Purpose
• 3. Current Context
• 4. Background
  • 4.1 Nutrition Labelling in Canada
  • 4.2 Origins of the Daily Values
• 5. Proposed Changes to the Daily Values for Use in Nutrition Labelling
  • 5.1 Proposed Approach and Rationale for Vitamins and Mineral Nutrients
  • 5.2 Specific Changes Proposed for Daily Values for Vitamins and Mineral Nutrients
  • 5.3 Proposed Approach and Rationale for Macronutrients and Sodium
  • 5.4 Specific Changes Proposed for Nutrients of Public Health Concern Related to Excessive Intake
• 6. Submitting Comments to Health Canada
• Appendix A: Lexicon
• Appendix B: History of Nutrition Labelling in Canada
• Appendix C: Recommendations from the Institute of Medicine on Setting Reference Values for Nutrition Labelling
• Appendix D: Recommendations from Codex Alimentarius on Setting Reference Values for Nutrition Labelling
• Appendix E: Examples of Changes in Declared Percent Daily Value for Vitamins and Mineral Nutrients for Sample Food Products
• Appendix F: Daily Values for Macronutrients and Sodium in Canada and the US for Children Aged 1-3 Years
• References

List of Abbreviations

AI

Adequate Intake

AMDR

Acceptable Macronutrient Distribution Range

CFG

Canada's Food Guide

CFR

Code of Federal Regulations

CHD

Coronary Heart Disease

DFE

Dietary Folate Equivalents

DRI

Dietary Reference Intake

DV

Daily Value

% DV

percent Daily Value

EAR

Estimated Average Requirement

EER

Estimated Energy Requirement

ESADDIs

Estimated Safe and Adequate Dietary Intakes

FAO

Food and Agriculture Organization of the United Nations

FDR

Food and Drug Regulations

GNL

Guidelines on Nutrition Labelling

IOM

Institute of Medicine

IU

International Unit

NAS

National Academy of Sciences

NE

Niacin Equivalents

NFt

Nutrition Facts table

NRV

Nutrient Reference Value

NRVs-NCD

Nutrient Reference Values for nutrients associated with risk of diet-related non-communicable diseases

NRVs-R

Nutrient Reference Values for Nutrient Requirements

RAE

Retinal Activity Equivalents

RDA

Recommended Dietary Allowance

RDI

Recommended Daily Intake

RNI

Recommended Nutrient Intake

WHO

World Health Organization

UL

Tolerable Upper Intake Level

US FDA

Unites States Food and Drug Administration

1. Executive Summary

In response to a commitment identified in the 2013  Speech from the Throne to consult with Canadian parents and consumers on ways to improve nutritional information on food labels, Health Canada is undertaking a broad review of the nutrition labelling regulations. This review has led to proposed revisions to the reference values, commonly referred to as Daily Values (DVs), which are used to calculate the percent DV (% DV) declared beside specific nutrients within the Nutrition Facts table (NFt).

Health Canada is proposing the following:

1. To maintain the use of a population coverage approach based on the Recommended Dietary Allowance (RDA) or, when an RDA is unavailable, the Adequate Intake (AI), as the DV for vitamins and mineral nutrients;
2. To use upper limit values as the DV for nutrients where intake should be limited such as fat, saturated fat, trans fat, cholesterol and sodium; and
3. For macronutrients, to limit the requirement to declare the % DV to those of public health concern related to excessive intake.

In most cases, Health Canada's proposed changes are consistent with those being proposed by the United States Food and Drug Administration (US FDA) as part of the  Proposed Changes to the Nutrition Facts label consultation.

2. Purpose

The purpose of this document is to outline the rationale for Health Canada's proposed changes to the DVs and their subsequent impact on the % DV declaration on the NFt and to solicit feedback on the proposed changes from interested stakeholders and consumers.

3. Current Context

On January 28, 2014, the Minister of Health announced the launch of a consultation with Canadian parents and consumers on ways to improve nutritional information on food labels, in response to a commitment identified in the 2013  Speech from the Throne. The initial phase of the consultation consisted of an online questionnaire and face-to-face roundtable discussions with Canadian parents and consumers in selected locations across Canada. This phase of the consultation closed on April 30, 2014. A What We Heard report has been prepared to provide an overview of the feedback received.

Health Canada is now entering into consultations with the broader stakeholder community on various technical aspects of nutrition labelling, including the proposed changes to the DVs described in this document. Separate consultation documents have been prepared on other aspects of the NFt, specifically serving size, reference amounts, the list of core nutrients, and format. Input from these consultations and the earlier feedback from Canadian parents and consumers will be used in conjunction with other data sources in the development of proposed amendments to the nutrition labelling regulations.

4. Background

4.1 Nutrition Labelling in Canada

On December 12, 2002, the Government of Canada promulgated regulatory amendments to the Food and Drug Regulations (FDR) requiring most prepackaged foods to carry an NFt in a consistent format. The regulations on nutrition labelling aim at preventing injury to the health of Canadians, including those with special dietary needs, by providing product-specific nutrient information to assist in making informed food choices (see Appendix B: History of nutrition labelling in Canada for more information). Nutrition labelling requirements include the declaration of the energy value and nutrient content, the manner of their declaration, as well as specifications with regard to the format of the NFt (see Figure 1).

4.2 Origins of the Daily Values

The amount of many of the nutrients in the NFt is conveyed using the % Daily Value (% DV). The current DVs in Canada are based on two sets of reference values: 1) the Recommended Daily Intakes (RDIs) for vitamins and minerals in  Table 1 in Division 1 of Part D and in  Table 1 in Division 2 of Part D of the FDR; and 2) the reference standards for total fat, the sum of saturated fatty acids and trans fatty acids, cholesterol, total carbohydrate, dietary fibre, potassium and sodium in Section  B.01.001.1 of the FDR. Throughout this paper, for ease of reference we will call both sets of reference values the DVs.

Upon commissioning the Institute of Medicine (IOM) to create a common set of Dietary Recommended Intakes (DRIs) for Canada and the US, both countries committed to using these values as the scientific underpinning of the DV for nutrition labelling (see Appendix A: Lexicon for more information on the DRIs). However, when the current nutrition labelling regulations were promulgated in 2002, the DRIs had not yet been established for all nutrients and thus were not used as the basis for the DVs.

5. Proposed Changes to the Daily Values for Use in Nutrition Labelling

Health Canada is proposing to update the DVs for use in nutrition labelling, specifically for foods intended for the general population. In developing the proposed changes to the DVs, Health Canada considered two main sets of recommendations for setting reference values for nutrition labelling: 1) the IOM's Guiding Principles for Nutrition Labelling and Fortification (see Appendix C: Recommendations from the Institute of Medicine on setting reference values for nutrition labelling); and 2) the Codex Alimentarius Commission General Principles for Establishing Nutrient Reference Values for the General Population (see Appendix D: Recommendations from Codex Alimentarius on setting reference values for nutrition labelling). In March 2014, the US FDA announced proposed updates to the requirements for their Nutrition Facts label ( 79 FR 11879). The proposal includes updates to the DVs, and the establishment of DVs for foods represented for children under the age of 4 years and for pregnant and lactating women. The US proposed changes were also taken into consideration.

To update the DVs for vitamin and mineral nutrients (except sodium), the population coverage approach using the Recommended Dietary Allowance (RDA), or when an RDA is unavailable, the Adequate Intake (AI), would be maintained (Section 5.1 Proposed approach and rationale for vitamins and mineral nutrients and Section 5.2 Specific changes proposed for Daily Values for vitamins and mineral nutrients). To update the DVs for nutrients of public health concern related to excessive intakes (sodium, fats, and sugars), an approach based on upper limit values is being proposed (Section 5.3 Proposed approach and rationale for macronutrients and sodium and Section 5.4 Specific changes proposed for nutrients of public health concern related to excessive intake).

5.1 Proposed Approach and Rationale for Vitamins and Mineral Nutrients

The current DVs for vitamins and mineral nutrients are derived based on the "population coverage" principle of choosing the highest recommended intake values for ages 2 years and above (a separate set of DVs was established for infants and young children under 2 years of age), and omitting supplemental needs for pregnancy and lactation.

• Health Canada is proposing to continue using a population coverage approach to set the DVs for vitamins and mineral nutrients

Health Canada is proposing to continue to use the population coverage approach, however, instead of setting them for a population group of 2 years and older, the DVs would be set for the population group 4 years and older. In addition, two separate sets of DVs are proposed to be established for infants (6-12 months) and for toddlers (1-3) because their eating patterns and requirements generally differ markedly from those of the general population. These would be based on the RDAs for each of the respective groups. The DVs for the group 4 years and older would be based on the highest RDA or, where there is no RDA, the highest AI, excluding pregnant and lactating women. The exclusion of pregnant and lactating women reflects the recognition that their requirements differ markedly from those of the general population. Sodium, which is a nutrient of public health concern related to excessive intake, is discussed in Section 5.3 Proposed approach and rationale for macronutrients and sodium.

The population coverage approach means setting the DV at a level that covers the nutrient requirements of most of the people in the population group. The use of the RDA (or the AI) is consistent with the Codex General Principles, which recommend using the daily intake reference value that is estimated to meet the requirements of 98% of the apparently healthy individuals in a specific life stage and sex group. The RDA is that reference value in Canada and the US and is considered to be the best available reference value to estimate an intake that would meet the requirements of practically all who would be using the label in the population (Yates, 2006; Murphy and Barr, 2006). When determining the DVs for labelling targeted to the population 4 years and older, Health Canada proposes to select the highest RDA or AI within that population, similar to the current DVs. For example, the DV for vitamin C for the population group 4 years and over would be the RDA for males 19 years and older, and for calcium, it would be the RDA for males and females 9-18 years.

Health Canada's opinion is that by using a population coverage approach, more individuals who use the % DV information to select or compare foods would have the assurance that their nutrient needs are being taken into account. Also, this approach is consistent with the one recently proposed by the US FDA, thereby leading to more harmonized DV values for nutrition labelling of products that are sold in both Canada and the US.

5.2 Specific Changes Proposed for Daily Values for Vitamins and Mineral Nutrients

Table 1 describes the current and proposed DVs for vitamins and mineral nutrients (except sodium). By proposing to use the most recent RDA (or AI) for setting these DVs, the DVs for the following nutrients would increase: vitamin A, vitamin C, vitamin D, vitamin E, vitamin K, folate, vitamin B₁₂, calcium, potassium, iron, phosphorus, magnesium, manganese, zinc, and selenium. On the other hand, the DVs for the following nutrients would decrease: thiamin, riboflavin, vitamin B₆, iodide, copper, chromium and molybdenum. Finally, the DV for biotin would not change and there would now be a DV for choline. All of the proposed values are the same as the proposed US FDA values with the exception of Vitamin D. Health Canada is soliciting feedback on whether the exception should be made for vitamin D, as explained in more detail below.

In deciding which approach to use for setting the DVs for vitamins and mineral nutrients, Health Canada also considered taking a "population-weighted" approach. However, the requirements of a large group within the population would not be reflected if a population-weighted RDA was used as the basis for the DV. Similarly, if a population-weighted Estimated Average Requirement (EAR) was chosen, as recommended in the IOM's  Dietary Reference Intakes: Guiding Principles for Nutrition Labelling and Fortification report, the requirements of an even greater number of individuals in the population would not be considered.

It has also been argued that basing the DV on a value in excess of the nutrient requirements of most members of the population may lead to excessive nutrient intakes for individuals with lower requirements (Tarasuk, 2006). Health Canada has considered this issue for two nutrients. In particular, Health Canada has considered the possibility of proposing a population-weighted RDA value as the DV for vitamin D and iron.

Vitamin D

The highest RDA for vitamin D for the population 4 years and older is 20 µg (800 IU), the RDA for adults over 70 years of age, whereas the RDA for the rest of the population 4-70 years old is 15 µg (600 IU). The highest RDA value would be four times the current DV for vitamin D (5 µg or 200 IU), and would represent a more significant change in comparison to the change being proposed by the US FDA, which is only two times  their current DV (400 IU or 10 µg). Health Canada is proposing to use the population-weighted RDA of 15 µg (600 IU) as the DV. According to the IOM report, estimates of inadequate intakes of vitamin D should be interpreted with caution, and should be considered in the context of blood status (IOM, 2010). While there appears to be a high prevalence of inadequate vitamin D intake, available blood status measures do not suggest wide-spread vitamin D deficiency in the Canadian population. Also, Canadian Health Measures Survey data showed that adults over the age of 60 years, like young children, have higher average vitamin D blood levels compared to the rest of the population (Statistics Canada, 2013). Older adults also tend to be higher vitamin D supplement users (Statistics Canada, 2013). The proposed value would allow Health Canada to monitor vitamin D status of Canadians and decide at a later stage whether further increasing the DV to 20 µg (800 IU) is warranted.

Please refer to Appendix E: Examples of changes in declared percent Daily Value for vitamins and mineral nutrients for sample food products, to see the impact selecting this value would have on the % DV declaration in the NFt.

Iron

Health Canada is proposing to increase the DV for iron from 14 mg to 18 mg. This value is based on the highest RDA, which is for females aged 19 years to 50 years (excluding pregnant and lactating women). However, it is significantly higher than the RDA for males in the same age group (8 mg). If a population-weighted RDA value of 11 mg were to be chosen instead, it would fall below the requirements of a substantial proportion of women of child-bearing age.

Based on data from the Canadian Community Health Survey (CCHS) 2.2, iron intakes of Canadians from food are substantially below the ULs for that nutrient (Health Canada and Statistics Canada, 2004). Also, Health Canada intends to maintain restrictions on the addition of iron to foods given that it can be a hazard for those with undiagnosed hemochromatosis^{Footnote 1}. For all the above reasons, Health Canada's opinion is that the use of the highest RDA value of 18 mg as the proposed new DV for iron would not pose additional risk to the Canadian population.

5.3 Proposed Approach and Rationale for Macronutrients and Sodium

The current reference standards used as DVs for fat, cholesterol, carbohydrate, fibre, and sodium in Canada were adopted from the US Daily Reference Values established in 1993 under the Nutrition Labeling and Education Act. For energy-producing nutrients, DVs are based on a 2,000-Calorie daily diet. For example, the current DV for total fat is based on 30% of energy, which equates to 65 g of fat for the 2,000-Calorie reference level. Retaining the 2,000-Calorie reference level would provide continuity. As before, it should not be interpreted as a mandatory daily intake level for good health.

In the case of macronutrients and sodium, Health Canada is proposing to require the use of DVs only for fat, saturated fat, trans fat, and sodium because they are nutrients that are of public health concern related to excessive intakes. Therefore, the DV for carbohydrates would be removed, and instead, Health Canada is proposing to require the use of a DV for sugars. This DV, along with other proposed approaches to enhance the information of sugars on food labels, is discussed in Health Canada's Technical Consultation on Proposed Changes to the Core Nutrients Declared in the Canadian Nutrition Facts Table.

In the case of fibre, the IOM has established an AI at 14 g/1000 Calories. This was primarily based on the intake level that was associated with the greatest reduction in the risk of coronary heart disease (CHD) (IOM, 2005). Health Canada is proposing to update the DV accordingly, to 28 g (based on the 2000-Calorie reference level). This DV is high and could encourage the consumption of foods with added fibre; in many cases, the contribution of these added fibres to reducing CHD risk has not been established. Thus, Health Canada is proposing to eliminate the requirement for the declaration of % DV for fibre.

These changes are summarized in Figure 2, at the end of this section.

• Health Canada is proposing to base the Daily Value of nutrients of public health concern related to excessive intakes on upper limit values

Excessive intake of any one of these nutrients (fat, saturated fat, trans fat, sodium, sugars) is linked directly or indirectly to increased risk of chronic diseases, which makes them nutrients of public health concern (see Appendix A: Lexicon for definition). In particular, overconsumption of saturated and trans fats and sodium has been linked to adverse public health outcomes, such as cardiovascular disease and stroke. With respect to sugars and fat, the majority of scientific evidence in humans suggests that excess consumption leads to excess calorie intake, and this in turn can lead to obesity and related health problems, such as diabetes and heart disease. As well, diets that are too high in these components may be poor in vitamins, minerals and other nutrients that the body requires.

Health Canada is proposing to base the DV for nutrients of public health concern related to excessive intakes on upper limit values. This is consistent with the Codex Alimentarius' General Principles for Establishing Nutrient Reference Values for the General Population for labelling purposes, which are set out in the annex to the Guidelines on Nutrition Labelling(GNL) (see Appendix D: Recommendations from Codex Alimentarius on setting reference values for nutrition labelling). These General Principles specify that the establishment of general population nutrient reference values for nutrients associated with increased risk of diet-related non-communicable diseases (NRVs-NCDs) should take into account daily intake reference values for upper levels established by recognized authoritative scientific bodies, where applicable, such as the UL and the upper level of Acceptable Macronutrient Distribution Ranges (AMDRs) (see Appendix A: Lexicon for definitions). As well, the IOM's Committee on the Use of Dietary Reference Intakes in Nutrition Labelling recommended that the basis of the DVs for saturated fat, trans fat and dietary cholesterol should be set at a level that is as low as possible in keeping with an achievable health-promoting diet. In the absence of such levels set by the IOM, Health Canada considered those set by other authoritative bodies, where applicable.

5.4 Specific changes proposed for nutrients of public health concern related to excessive intake

Fat

Excessive addition of fat during food processing, food preparation, and at the table contributes to excess calorie intake, which in turn could lead to obesity and associated chronic diseases. A DV for fat helps consumers identify foods that are high in fat. However, the current DV does not reflect the upper level of the AMDR for fat (35% of total calories) based on a 2000-Calorie diet. For this reason, Health Canada is ready to consider slightly increasing the DV for fat from 65 g to 75 g if supported by stakeholders. This would be consistent with the general proposed approach for setting the DV for other nutrients of public health concern related to excessive intakes.

Saturated Fat and Trans Fat

In Canada, saturated and trans fat are currently combined in the same % DV declaration, with the DV for the sum of saturated and trans fat being 20 g based on a limit of 10% of energy for the 2,000-Calorie dietary energy reference value. At the time the nutrition labelling regulations were being revised, there was no reference value for trans fat established by any authoritative body and hence, it was not possible to have a separate DV for trans fat. Health Canada has indications that the combined % DV declaration for saturated and trans fat is confusing to consumers and is proposing to have two separate DVs for saturated and trans fat. This approach would be partly consistent with that of the US FDA, which proposes to continue to have a DV for saturated fat, whereas they do not propose to set one for trans fat. For saturated fats, Health Canada is proposing to maintain the current DV of 20 g for saturated fat (the same as the US and the same as the NRV-NCD for saturated fat recently adopted by Codex for nutrition labelling purposes). The DV that Health Canada is proposing for trans fat is based on the WHO intake recommendation of 1% of total energy which translates to 2 g based on the 2,000-Calorie reference value.

Sodium

The current DV for sodium in both Canada and the US is 2400 mg. The DRIs for sodium, published in 2005 after the promulgation of the nutrition labelling regulations, indicate an AI amount of 1500 mg/day for most of the population, and a UL of 2300 mg/day. More recently (2012), the WHO published a guideline on  Sodium intake for adults and children, which recommends that adults reduce sodium intake to below 2000 mg/day to reduce blood pressure and risk of cardiovascular disease (WHO, 2012).

Health Canada analyzed the AI and UL values recommended by the IOM and the WHO guideline as options for updating the DV for sodium in the NFt (Health Canada, 2014) and is herein proposing to adopt the UL value of 2300 mg. This decision was made taking into consideration an analysis of the above three options and was based on the following defined principles. Specifically, Health Canada determined that the DV should be interpreted and used in a manner similar to the DVs for other nutrients to limit and should be consistent with the long term public health goal of minimizing risk to the health of Canadians. Sodium is similar to other nutrients to limit (for example, saturated and trans fat) in that there is overconsumption by the population and this is linked to adverse public health outcomes. The value of 2300 mg in particular was set as a threshold above which higher sodium intakes are associated with high blood pressure and consequently a higher risk of stroke and cardiovascular disease. Health Canada also determined that the new reference value should allow for consistency in educational approaches for nutrients to limit in the diet, encourage reformulation of processed foods to be lower in sodium, especially in the context of high sodium levels in the food supply, and should be compatible with labelling schemes of major trading partners, particularly the US.

Sugars

Sugars^{Footnote 2} are one of the core nutrients that must be declared in absolute amounts (grams) in the NFt. Consistent with the approach in the US, Health Canada did not set a DV for sugars in the NFt when nutrition labelling was introduced in Canada. This is because the evidence for setting an upper intake level based on a relationship between sugar intake and a chronic disease endpoint was insufficient. Similar to sodium and fat, Health Canada considers sugars to be a nutrient of public health concern related to excessive intakes. We are considering two approaches for improving the labelling of sugars in the NFt. These approaches are discussed in the Health Canada's Technical Consultation on Proposed Changes to the Core Nutrients Declared in the Canadian Nutrition Facts Table.

Calories

The energy value of a prepackaged food in Canada is only permitted to be expressed in Calories per serving of stated size on the NFt. Health Canada is not proposing to set a DV for Calories  due to large variations in estimated energy requirements based on age, gender, height, weight and physical activity levels. This approach is consistent with the US FDA proposal.

Cholesterol

Currently, the declaration of the % DV for cholesterol is optional and is based on 300 mg. Limitation on the intake of dietary cholesterol may apply to Canadian subgroups for medical reasons. However, Health Canada has determined that the current requirement to declare the absolute amount of cholesterol on food labels meets the information needs of these individuals, and therefore is not proposing to make any changes to the DV for cholesterol or its condition of use.

The proposed changes for macronutrients and sodium DVs for populations of 4 years and older are summarized in Table 2. The proposed DVs for macronutrients and sodium for children aged 1-3 years are presented in Appendix F: Proposed Daily Values for macronutrients and sodium in Canada and the US for children aged 1-3 years.

6. Submitting Comments to Health Canada

Comments on the proposed changes to the Daily Values for use in nutrition labelling as outlined in this technical consultation document may be submitted in writing by regular mail or electronically at the address indicated below.

Please include your comments or suggestions, along with your rationale and any relevant supporting data, on the proposed changes to the Daily Values. All feedback would be greatly appreciated.

If you are submitting your comments electronically, please use the title "Proposed Changes to the DVs" in the subject box of your email.

Bureau of Nutritional Sciences
Food Directorate
251 promenade Sir Frederick Banting Driveway
Tunney's Pasture
Ottawa, Ontario
K1A 0K9

Email: nut.labelling-etiquetage@hc-sc.gc.ca
Fax: 613-941-6636

Submissions must be received by 11:59 p.m. EST on September 12, 2014.

Appendix A: Lexicon

Acceptable Macronutrient Distribution Range:
The Acceptable Macronutrient Distribution Range (AMDR) is defined as a range of intake for a particular energy source (protein, fat or carbohydrate), expressed as a percentage of total energy (kcal), that is associated with reduced risk of chronic disease while providing adequate intakes of essential nutrients.

Codex Alimentarius:
The  Codex Alimentarius is a collection of internationally recognized standards, codes of practice, guidelines and other recommendations relating to foods, food production and food safety. While being recommendations for voluntary application by members, Codex standards serve in many cases as a basis for national legislation.

Dietary Reference Intakes
The Dietary Reference Intakes (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 Institute of Medicine (IOM), which is an independent, non-governmental body in the US. The US and Canadian governments jointly sponsored the development of the DRIs since 1994.

The DRIs 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), and the Tolerable Upper Intake Level (UL).

• 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.
• 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.

Estimated Energy Requirement:
The Estimated Energy Requirement (EER) is defined as the average dietary energy intake that is predicted to maintain energy balance in a healthy adult of a defined age, gender, weight, height and level of physical activity consistent with good health.

Nutrient of public health concern:
Nutrients are considered to be of public health concern related to excessive intakes if there is an indication that, despite current interventions such as education and reformulation of food products, the intakes of a significant proportion of the general population are linked to 1) the prevalence of a chronic disease or 2) excessive intakes of Calories.

Appendix B: History of Nutrition Labelling in Canada

In Canada, the  Food and Drugs Act (R.S. 1985, c. F27) is the principal federal statute governing the labelling of food. The Act applies to all food sold in Canada at all levels of commerce. Regulations made under the Act cover ingredient listing, nutrition labelling and all types of claims.

Nutrition labelling guidelines were introduced in Canada in 1988, along with amendments to the  FDR, concluding a process that was started in 1983. Application of the system, in whole or in part, was voluntary, with a few exceptions. The Guidelines on Nutrition Labelling (Canada, 1989) governed format, nutrient content information (core list and optional nutrients) and a declaration of serving size. Once applied, the nutrient declaration had to comply with the amended regulations (Canada, 1988), which stipulated nomenclature, units of measurement and expression on a per serving basis. Under the overall heading of "Nutrition Information," amounts of vitamins and minerals were required to be expressed in terms of a percentage of a single set of nutrient reference values, RDIs, per serving of stated size (Canada, 1986). Amounts of macronutrients were expressed in terms of weight; no percentage information was provided.

The process that began in 1983 had proposed criteria for rating the nutrient content of food based on two reference standards: a nutrient density index and the percentage of a composite RNI derived from the Recommended Nutrient Intakes for Canadians (Canada, 1983a, 1983b). A reference set of RNIs expressed per megajoule was derived by dividing the RNI for each age and gender group by the average energy requirements of that group. When the RNIs were not based on energy and the nutrient to energy ratios were not constant among groups, the highest RNI/megajoule was selected. Relating all the RNIs to energy was criticized however, and the proposal was not pursued.

In 1986, Health Canada decided to set RDIs for nutrition labelling using the highest RNI from 1983 for each nutrient for each age and gender group, omitting supplemental needs for pregnancy and lactation (Canada, 1986). Thus the values chosen were those for 19- to 24-year-old males (except for iron, for which the value was that of women of childbearing age). RDIs were established for 11 vitamins (vitamin A, vitamin D, vitamin E, vitamin C, thiamin, riboflavin, niacin, vitamin B6, folacin, vitamin B12, and pantothenic acid) and 6 minerals (calcium, iron, phosphorus, iodide, magnesium, and zinc). The list of RDIs was reviewed again in 2002 and updated to include two vitamins (biotin and vitamin K) and 6 minerals (selenium, chloride, copper, manganese, chromium and molybdenum). The Guidelines on Nutrition Labelling (Canada, 1989) specified the minimum nutrient content information, the label format and the serving size information that would constitute nutrition labelling for food sold in Canada.

In 1996, Canada's national action plan on nutrition, Nutrition for Health: An Agenda for Action (Joint Steering Committee, 1996), identified key strategies to reduce health risks to Canadians. The report supported the need for improving the usefulness of nutrition labelling, increasing its availability, and broadening public education on its use. In June 2001, Health Canada undertook a final consultation on proposals to improve nutrition information on prepackaged food labels, including nutrition labelling.

On December 12, 2002, the Canadian government issued "Regulations Amending the Food and Drug Regulations (Nutrition Labelling, Nutrient Content Claims and Health Claims" (Canada, 2003). The new regulations mandate nutrition labelling on most prepackaged food, update and consolidate permitted nutrient content claims, and introduce a new regulatory framework and process for diet related health claims.

The new regulations on nutrition labelling aim at preventing injury to the health of Canadians, including those with special dietary needs, by providing product-specific nutrient information to assist in making informed food choices. The Regulatory Impact Assessment Statement in  Canada Gazette Part II stated the following objectives for the nutrition labelling regulations:

1. To enable consumers to make appropriate food choices in relation to reducing the risk of developing chronic diseases and permitting dietary management of chronic diseases of public health significance;
2. To encourage the availability of foods with compositional characteristics that contribute to diets that reduce the risk of developing chronic diseases;
3. To advance compatibility with the US system and further work towards mutual acceptance by Canada and the US of their respective nutrition labelling requirements; and
4. To provide a system for conveying information about the nutrient content of food in a standardized format which allows for comparison among foods and prevents consumers' confusion in respect of the nutrient value and composition of a food at point of purchase.

The declaration of the amounts of nutrients associated with risk of developing chronic diseases and the use of DVs to interpret the amounts present met the first and second objectives. The adoption of the term Daily Value and use of the US Daily Reference Values for all nutrients except vitamins and minerals met the third objective and the development of a rigidly standardized format of the NFt that included the DVs met the fourth.

Appendix C: Recommendations from the Institute of Medicine on Setting Reference Values for Nutrition Labelling

In 2002, Health Canada and the US FDA requested specific guidance from the IOM on how to apply the DRIs to food labels. The Committee on Use of Dietary Reference Intakes in Nutrition Labelling issued its report entitled  Dietary Reference Intakes: Guiding Principles for Nutrition Labelling and Fortification in November 2003 (IOM, 2003).

DVs for Vitamins and Mineral Nutrients
The committee recommended continuing to express nutrition information for vitamins and minerals as a % DV on the nutrition label. It also recommended basing the % DV on a population-weighted Estimated Average Requirement (EAR), when an EAR has been set for a nutrient. Where an EAR has not been set, the committee recommended basing the % DV using a population-weighted Adequate Intake (AI). The Committee did generally acknowledge that the derivation of the AI was by no means uniform and that the AI estimates exceed mean requirements.

The committee also recommended basing the population-weighted EARs or AIs for vitamins and mineral nutrients on a population of individuals 4 years of age and older (excluding pregnant and lactating women). Younger children would be excluded on the assumption that their eating patterns typically differ from those of older children and adults. The exclusion of pregnant and lactating women reflected the recognition that their requirements differ markedly from those of the general population. In addition to a set of DVs for foods made for the general population 4 years of age and older, the IOM committee recommended separate DVs for food made for four distinctive life stage groups: infants (< 1 y); toddlers (1-3 y); pregnant and lactating women.

DVs for Protein, Carbohydrates, Cholesterol and Fats
The Committee also recommended that the Acceptable Macronutrient Distribution Ranges (AMDRs) established by the IOM in the Dietary Reference Intake Report on Macronutrients should be the basis of the DVs for protein, total carbohydrates and total fat, and these should be based on a 2,000-Calorie reference level. In addition, the committee supported the labelling of % DVs for saturated fat, trans fat, and cholesterol and recommended that the basis of the DVs for these nutrients should be set at a level that is as low as possible in keeping with an achievable health-promoting diet.

Appendix D: Recommendations from Codex Alimentarius on Setting Reference Values for Nutrition Labelling

The international food standards setting body, Codex Alimentarius Commission (Codex), has published  Guidelines on Nutrition Labelling(GNL)[Guidelines on Nutrition Labelling - CAC/GL 2-1985] (Codex, 2013). The GNL state that Nutrient Reference Values (NRVs) should be used for labelling purposes to help consumers make choices that contribute to an overall healthful dietary intake.

Codex recently updated the GNL to provide General Principles for establishing Nutrient Reference Values (NRVs) for the general population for labelling purposes [Annex to GNL]. As a result of this work, there are now two categories of reference values:

• NRVs-R (Requirements)^{Footnote 3}: based on levels of nutrients associated with nutrient requirements. In accordance with the recently adopted General Principles, an NRV-R value should be based on the daily intake reference value estimated to meet the requirement of 98% of the apparently healthy individuals in a life-stage group (in other words, RDA-type value) or appropriate alternative. This category of NRV would apply to NRVs for most vitamins and minerals as well as protein.
• NRVs-NCD^{Footnote 4}: for nutrients associated with risk of diet-related Noncommunicable Diseases (NCDs), other than nutrient deficiency diseases or disorders. This value is aimed at reducing NCD risk.

In both cases, the General Principles recommend that relevant daily intake reference values provided by FAO/WHO that are based on a recent review of the science or relevant daily intake reference values that reflect recent independent review of the science from other recognized authoritative scientific bodies be taken into consideration as primary sources in establishing NRVs and that these should reflect intake recommendations for the general population.  The general population is identified as individuals older than 36 months. When setting NRVs-R for the general population, Codex recommends excluding values for pregnant and lactating women.

Appendix E: Examples of Changes in Declared Percent Daily Value for Vitamins and Mineral Nutrients for Sample Food Products

Appendix F: Daily Values for Macronutrients and Sodium in Canada and the US for Children Aged 1-3 Years

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