Health Canada's policy review on the addition of vitamins and minerals to foods which was initiated in January 1998 is now completed. The purpose of this document is to inform all interested parties of the proposed policy, as well as plans for implementation. This document proposes more flexible requirements for special purpose foods such as meal replacements and nutritional supplements and also addresses outstanding requests for regulatory amendments from the food industry related to certain substitute foods, breakfast cereals, certain staple grain products.

Consultations have been held throughout the review process providing Health Canada with valuable information highlighting areas of agreement, as well as areas of concern. There has been consistent agreement on the need to continue fortification to address public health concerns (through mandatory and optional fortification of selected and targeted food vehicles), and to maintain the nutritional quality of the food supply (through restoration of nutrient¹ losses due to processing, and ensuring the nutritional adequacy of substitute foods). Stakeholders have held differing views on the proposed policy on discretionary fortification: views differed on the need for a nutritional rationale, on the criteria for foods that would qualify for fortification, on the nutrients to be permitted for addition, and on proposed levels of addition. Consumers have expressed a mildly positive attitude toward greater choice of fortified foods provided that there remain choices of unfortified foods, and that there is clear information on the label identifying fortified foods.

Health Canada is required to respond to the food industry submission for discretionary fortification in order to protect the safety of Canadians from excessive nutrient intakes. Health Canada has set an overarching policy on discretionary fortification to ensure safety by controlling the limits and parameters on discretionary vitamin and mineral nutrient additions to foods.

Over the period of the policy review, the Dietary Reference Intakes reports of the Institute of Medicine (IOM) of the U. S. National Academies have become available. The reports from the IOM have been invaluable to this review as they provided updated estimates of nutrient requirements and a new reference value, the Tolerable Upper Intake Level (UL) which have been key in assessing various options for discretionary fortification. In addition the Institute of Medicine was contracted to provide guidance on the use of the Dietary Reference Intakes in nutrition labelling and most relevant here, in discretionary fortification. Where feasible this guidance has been taken into account in the proposed policy.

The final decisions on discretionary fortification were arrived at after an analysis of several options for discretionary fortification based on input from stakeholders as well as statistical modelling of scenarios which were conducted during the safety assessments. The statistical modelling included various scenarios. These ranged from maximum possible exposure to nutrient intakes from foods if all foods that could be fortified were fortified, to simulations in which estimated intakes were based on a fraction of the market being fortified, even if all could be fortified. These latter simulations also assumed that only a fraction of the population would choose a fortified product over an unfortified one if such choices were available. The purpose of regulation for discretionary fortification is consumer protection from exposure to excessive intakes. In addition to safety, the option analysis assessed how well each option addressed criteria related to availability and choice/ innovation, trade and competitiveness, regulatory burden and ease of enforcement. The proposed policy on discretionary fortification is the result of the option analysis.

The Codex General Principles for the Addition of Essential Nutrients to Foods will continue to be retained as the reference. Nevertheless, the proposed conditions for discretionary fortification is a more modern approach which will protect Canadians from consuming excessive amounts of vitamins and minerals from foods, and at the same time provide consumers with a choice of a variety of fortified foods.

In proposing these significant changes to the current policy on the addition of vitamins and minerals to foods, Health Canada has adhered to the original guiding principles established at the start of the policy review. The purposes of the proposed policy are to protect consumers from health hazards due to nutrient excess, deficits or imbalance; prevent practices that may mislead, deceive or confuse the consumer; maintain and improve the nutritional quality of the food supply. The policy is based on the best available evidence while being feasible and practical, and sensitive to trade and competitiveness issues. It is recognized that there is a need for appropriate education and communication to guide consumers to enable them to make good choices of food.

Proposed policy

Vitamin and mineral addition to foods is permitted under the following broad categories, to help protect consumers from nutrient inadequacies and from excessive nutrient intakes:

Vitamin and mineral addition is permitted to maintain and improve the nutritional quality of the food supply through (i) restoration and (ii) nutritional equivalence of substitute foods.
Food fortification programs will continue to be employed to correct and/or prevent nutritional problems of public health significance.
Discretionary fortification, the optional addition of any nutrient from a defined list of vitamins and minerals over defined ranges at the discretion of manufacturers, is expanded to allow for a wider range of fortified products which would provide for more food sources of nutrients without increased risk to health.
The category of special purpose foods is broadened to allow the formulation of a greater variety of products designed for people who may require them for special nutritional purposes.

Implementation

In implementing the policy, it is proposed that additional regulations would be developed to permit vitamin and mineral addition to foods as follows:

Discretionary fortification: The implementation of discretionary fortification would be governed as described below.
1. Eligible foods: All foods are eligible to be fortified at the discretion of manufacturers except: flours, breads, pasta (dry, fresh, frozen, single ingredient), rice, milks, butter, suet, lard, varietal cheeses, sugar and sugar syrups, maple syrup, honey, artificial sweeteners, salt, herbs, spices, dry seasonings, vinegar, flavouring preparations, leavening agents, alcoholic beverages, fresh produce, fresh unprocessed meat, poultry and fish, eggs, nuts, legumes, simulated and extended meat and poultry products, coffee beans, leaf tea, infant foods, formulated liquid diets, breakfast cereals, meal replacements and nutritional supplements.
2. Nutrient Risk Categories:
  Risk Category A nutrients: Those vitamin and mineral nutrients for which no UL was set because of no reports of adverse effects, and no concern expressed; and those nutrients for which a UL was set but with a wide margin of safe intake; and those nutrients with a narrow margin of safety, but non-serious critical adverse effects: thiamin, riboflavin, pantothenate, biotin, vitamin B₁₂, ß-carotene, vitamin C, vitamin B₆, vitamin E, niacin.
  
  Risk Category B nutrients: Those nutrients with serious adverse effects, but with low risk of excessive intake at the proposed level of addition for discretionary fortification: calcium, folic acid, magnesium, vitamin D, potassium.
  
  Risk Category C nutrients (to be excluded from discretionary fortification): Those nutrients with a narrow margin of safety, and with serious adverse effects, and/or with current levels of exposure to intakes above the UL by vulnerable subgroups: vitamin A as retinol, zinc, iron, copper, selenium, manganese, iodine, fluoride. Nutrients in this category are currently permitted or required to be added to a range of foods for purposes of restoration, mandatory fortification, nutritional equivalence of substitute foods or to make a special purpose food such as a meal replacement. New or further additions for these purposes would continue to be subject to regulatory requirements.
  
  Other nutrients for which a risk category has not been assigned include choline, chromium, molybdenum, phosphorus, vitamin K. These nutrients are proposed to be excluded from discretionary fortification for a variety of reasons (see Appendix B).
3. Level of addition:
  Nutrients in Risk Category A may be added such that the total amount (naturally occurring and added) of the nutrient in the food is up to 20% of the Daily Value per reference amount of the food. If the food contains 20% of the Daily Value, the food will qualify for an "excellent source" claim. For Risk Category B nutrients, the total amount (naturally occurring and added) of the nutrient permitted in the food is up to 10% of the Daily Value. If the food contains 10% of the Daily Value the food will qualify for a "good source" claim.
4. If a nutrient is added, the minimum level of the total amount of the nutrient in the food must be 5% of the Daily Value per reference amount of the food. If the food contains at least 5% of the Daily Value, the food will qualify for a "source" claim.
5. For those vitamins and minerals which have been added, the total amounts of those vitamins and minerals in the food must be declared in the Nutrition Facts table as part of the mandatory nutrition labelling requirements.
6. Foods with added vitamins and mineral nutrients will be required to indicate on the principal display panel that the food contains an added vitamin(s) or mineral(s).
Special purpose foods are foods which have been designed to perform a specific function, such as replacing a meal. They necessitate a content of essential nutrients which can be achieved only by the addition of one or more nutrients. Expansion of the options for meal replacements and nutritional supplements is proposed to include foods targeted to consumers with lower or higher energy needs, and to target better the needs for different age groups. The proposed nutrient levels are based on the new Dietary Reference Intakes.
The proposed regulations will include a list of acceptable vitamin compounds and mineral salts which may be used for fortification.
It is proposed that requirements for analytical testing and record keeping be established for vitamin and mineral addition to foods. Manufacturers would be required to establish procedures for measuring the content of vitamins and minerals in the final product, and to conduct tests to determine the uniformity of distribution of the vitamin or mineral in the food; the stability of the vitamin or mineral nutrient in the food throughout its shelf life; and the expiration date of the food except in the case of foods with best before dates. Manufacturers and importers would be required to keep records of these tests.

In addition to the proposed policy, this document describes regulatory changes to implement the proposed policy as well as to amend the regulations to make provisions for vitamin and mineral additions that have been permitted through Interim Marketing Authorizations (IMAs) (for fortified plant-based beverages, enriched corn meal, vegetable based or vegetable and milk protein-based products which resemble cheese), and to address requests for fortification or restoration, such as the addition of an expanded list of nutrients and higher levels for some nutrients currently added to breakfast cereals, the enrichment of rice and a reduction in the level of potassium relative to protein content of simulated meat products.

A. Introduction

Health Canada initiated a comprehensive policy review on the addition of vitamins and minerals to foods in January 1998. During the earliest phase of the policy review, stakeholders indicated that the major issues regarding fortification were those in the areas of public health, safety, consumer choice and availability, and trade and competitiveness.

Consultations were held throughout the review process providing Health Canada with valuable information highlighting areas of agreement, as well as areas of concern. There has been consistent agreement on the need to continue fortification to address public health concerns (through mandatory and optional fortification of selected and targeted food vehicles), and to maintain the nutritional quality of the food supply (through restoration of nutrient losses due to processing, and nutritional adequacy of substitute foods). Stakeholders have held differing views on the proposed policy on discretionary fortification: views differed on the need for a nutritional rationale, on the criteria for foods that would qualify for fortification, on the nutrients to be permitted for addition, and on proposed levels of addition. Consumers indicated a mildly positive interest in more choices of foods fortified at the discretion of manufacturers providing that unfortified choices remain available, and providing that Health Canada sets limits to ensure the safety of the levels permitted to be added to the food supply, and requires clear identification of foods with added nutrients.

This document responds to concerns that have been raised during the consultations and indicates how they have been addressed; it sets out the process used in a clear and transparent manner in advance of publication of the regulatory proposals. This document provides an indication of the regulatory framework which is intended to be the basis for regulatory proposals to be published in Canada Gazette Part I.

This Phase

This last policy review phase has involved the following steps.

Stakeholder Consultations
Throughout the policy review process, several consultations were held and stakeholders were able to provide valuable input at critical stages (see Appendix A for milestones in the review process).
Statistical Modelling
Health Canada conducted statistical modelling of the impact of discretionary fortification under mature market scenarios based on information provided by the food industry (see Appendix B).
Institute of Medicine (IOM) Reports and their role in the Proposed Policy
The Dietary Reference Intakes (DRI) review process was conducted under the auspices of the IOM of the U.S. National Academies to evaluate the scientific basis for nutrient requirements for the healthy population in Canada and the United States. The results were published in a series of reports over the period 1997 to 2004. The review was initiated in 1995 by the Food and Nutrition Board, IOM and supported by Health Canada and the U. S. government.

Health Canada will be applying the new DRIs in the development of standards and policies in several areas including the Nutrition Recommendations for Canadians, and the policy review on vitamin and mineral nutrient additions to foods

The DRIs are a useful new tool in evaluating the adequacy of nutrient intakes of population groups, and in assessing exposure to excessive intakes, applications that Health Canada has used in developing the revised policy on discretionary fortification.

An additional IOM report, prepared by an expert panel, and published in 2003 (IOM 2003), provides guidance on the application of the DRIs in discretionary food fortification in the North American context. The report details 6 guiding principles (numbered 11-16) towards this application which were considered in developing the proposed policy. One principle² recommended that a documented public health need was required for discretionary fortification. In Canada there is a longstanding and widely endorsed policy that government intervene to protect the health of Canadians; as such, numerous mandatory fortification programs have been employed as warranted, to address demonstrated nutritional inadequacies. Discretionary fortification in the Canadian context is aimed to set controls and limits to protect the safety of Canadians against exposure to excessive vitamin and mineral nutrient intakes while allowing the food industry to offer more choices of fortified foods.
Application of the ULs
The DRI review process led to the replacement, over the period 1997 - 2004, of the Recommended Nutrient Intakes (RNIs) in Canada and the Recommended Dietary Allowances (RDAs) in the United States with a common set of reference values, the Dietary Reference Intakes (IOM 1997; 1998; 2000; 2002; 2003; 2004). The DRI review process evaluated data on the requirements to prevent nutrient deficiencies and maintain a defined level of nutrient stores. It also examined evidence relating nutrient intakes to the reduction in the risk of chronic diseases. The resulting reference values are the Estimated Average Requirement (EAR)³, the Recommended Dietary Allowance (RDA)⁴, the Adequate Intake (AI)⁵ and a new value, the Tolerable Upper Level of Intake (UL) (IOM, 1997). The UL is the highest average daily intake level that is likely to pose no risk of adverse health effect to almost all individuals in the general population. As intake above the UL increases, the risk of adverse effects increases.

Health Canada applied the UL to develop risk categories for nutrients, as detailed below, and to benchmark exposure to excessive intakes in the modelling scenarios.

Development of Risk Categories

The IOM report advises the use of a 3-step process for using intake data together with the Tolerable Upper Intake Level (UL) in a careful modelling approach to explain how current exposure to the nutrient would be altered by discretionary fortification (Guiding Principle 12).

The first step would be determination of dietary inadequacy. The advice is that if there is no inadequacy, then no discretionary fortification is justified.
In the second step proposed by the IOM committee, if an inadequacy has been identified and a UL has not been set for the nutrient(s) involved because there are no reports of adverse effects, then discretionary fortification to address the inadequacy would be scientifically justified.

For nutrients with a UL, or with no UL but concerns expressed about safety e.g. chromium, the third step is to model the impact of fortification of those nutrients for exposure analysis on the appropriate populations. Such analysis would consider the severity of the adverse effect (Guiding Principle 15) and whether the adverse effect is observed with intakes from foods, or supplements or all sources. If the evidence from the exposure analysis indicates that the fortification poses a significant risk of adverse effects to at least one segment of the population, then discretionary fortification at the proposed level would not be justified.

IOM Guiding Principle 12:
In situations where discretionary fortification is scientifically justified, intake data should be used with the Tolerable Upper Intake Level (UL) to provide evidence, using a careful modelling approach, to explain how current exposure to the nutrient in question would be altered by discretionary fortification.

IOM Guiding Principle 15:
The severity of the adverse effect on which the Tolerable Upper Intake Level (UL) is based should be reviewed when considering discretionary fortification with a nutrient using the IOM's conceptual design approach.

Because Health Canada's approach to addressing dietary inadequacy is through other means (e.g. mandatory fortification) than discretionary fortification, Health Canada's alternative to the three step process, was to define risk categories, using the new DRIs, considered the margin between the highest adult RDA or AI and the UL for children, or the most exposed group. Health Canada also took into account the seriousness of the adverse effects due to excessive intakes, and whether the UL was set for total intakes or for supplements only.

Modelling
Health Canada modelled how current intakes of nutrients would be affected by discretionary fortification. The intakes of Canadian adults and children provided the basis for such modelling. Key elements in the assessment were to assign nutrients to risk categories and to identify the levels of exposure to excessive intakes by the most vulnerable segments of the population (see Appendix B).

The IOM 2003 report confirmed the need for a modelling approach to explain how current exposure to the nutrient would be altered by discretionary fortification (Guiding Principle 12).
Levels of Addition
As recommended in the IOM 2003 report, Health Canada proposes that the levels of addition permitted for discretionary fortification would result in a total nutrient content that would meet either 'good source' and 'excellent source' claims for the relevant nutrients according to their risk classification, based on the options analysis (see Appendix B), and the IOM 2003 advice articulated in Guiding Principle 13.

B. Proposed Policy

The Codex General Principles for the Addition of Essential Nutrients to Foods will continue to be retained as the reference. Nevertheless, the proposed conditions for discretionary fortification is a more modern approach which will protect Canadians from consuming excessive amounts of vitamins and minerals, and at the same time provide consumers with a choice of a variety of fortified foods.

Vitamin and mineral addition is permitted under the following broad categories

Vitamin and mineral addition is permitted to maintain and improve the nutritional quality of the food supply through (i) restoration and (ii) nutritional equivalence of substitute foods.

Restoration of vitamins and minerals lost during processing will be permitted if the amount originally present provided at least 5% of the Weighted Recommended Nutrient Intake (WRNI)⁶ per reasonable daily intake of the food (RDI) (see Appendix H) or per reference amount where there is no reasonable daily intake. The amount added should compensate for the loss in processing.

Establishing the nutritional equivalence of substitute foods in terms of vitamin and mineral content, will be permitted provided that the traditional food provides at least 5% of the WRNI per reasonable daily intake (RDI) of the food. The amount added to the substitute food will be the amount required to bring the level of the nutrient to that in the food for which it is a substitute.
Food fortification programs will continue to be employed to correct and/or prevent nutritional problems of public health significance.

Health Canada continues to keep abreast of nutritional problems of public health significance. The Canadian Community Health Survey 2.2 (the Nutrition Focus Survey), a nationally representative survey on food consumption and other questions related to healthy living began in January 2004 and results will be available in 2005. These will provide food and nutrient intake data for a large number of Canadians including children. A second survey scheduled to go into the field in January 2006 (the Canadian Health Measures Survey) will look at a number of biochemical as well as physical measures of nutritional status. Based on new information that may emerge from these surveys and other studies, the nutrients and/or levels permitted to be added to foods, as well as the foods that are used as vehicles for fortification may need revision in the future.
Discretionary fortification, the optional addition of any nutrient from a defined list of vitamins and minerals over defined ranges at the discretion of manufacturers, is expanded to allow for a wider range of fortified products which would provide for more food sources of nutrients without increased risk to health.

Analysis of a full range of options regarding eligibility of foods for discretionary fortification and various levels of addition indicates that permitting levels of discretionary fortification of all foods (excluding a defined list of standardized and staple foods, alcoholic beverages, fresh produce and fresh unprocessed meat, fish, poultry, eggs and pulses) without setting additional eligibility criteria satisfies more of the evaluation criteria than other options. The evaluation is presented in Appendix B. Limits are set based on placement of nutrients in risk categories, and on the levels that can be safely permitted within each risk category.
The category of special purpose foods is broadened to allow the formulation of a greater variety of products designed for people who may require them for nutritional purposes.

The increased flexibility in discretionary fortification proposed for (c) will allow a broader range of fortified products available to the general population. Policy recommendation (d) is intended for products fortified beyond that permitted under (c) and which are targeted towards specific groups and/or specific nutritional uses. Fortification of these products will require a nutritional rationale and appropriate labelling to ensure that the indications for appropriate and safe use can be given to consumers. Proposals for handling these issues are presented in the section on special purpose foods.

C. Implementation Plans

Because the major changes relate to discretionary fortification, and the special purpose foods category, these are presented first.

Discretionary Fortification

Introduction
For discretionary fortification, there are three main questions which need to be answered regarding implementation which, when addressed together, ensure that foods that are fortified under this global policy are safe. The first is which foods are eligible. The second is which vitamins and minerals may be added and the third is to what level may they be added.

Methodology
Proposed options for food eligibility for discretionary fortification were considered ranging from no exclusions, through exclusion of certain standardized and staple foods that are widely consumed, to exclusion of foods of low nutritional value and foods containing important amounts of constituents associated with risk to health, such as saturated and trans fats.

Three risk categories of nutrients were proposed. Assessing the safety of the options for discretionary fortification was done through the use of modelling scenarios of exposure of the Canadian population to nutrients in each of the risk categories, under the conditions tested (see Appendix B).

Under each scenario, all qualifying foods were fortified to bring nutrient content to the level evaluated per reference amount. In addition, to evaluate scenarios that more closely reflect actual market practices, a Monte Carlo simulation was subsequently applied. In this case, 33% of foods, chosen randomly from the qualifying foods were fortified, to reflect a mature market in which, according to available data, about one third of consumers indicated that they would buy a fortified product if there was a choice.

It should be noted that in the modelling, no allowance was made for overages of added nutrients. In practice, these overages range from 20 to 200% of the declared value depending on the stability of the nutrient.

Results and Conclusions
1. Which foods may be fortified?
  All options for food eligibility have been evaluated assessing the advantages and disadvantages. The key issues of concern in developing the revised policy were safety and consumer protection; availability and choice; and trade and competitiveness.
  
  As more eligibility criteria are applied to foods, consumer choice of fortified foods is limited, the potential for trade is curtailed and, regulatory burden increases. However the ability to manage risks of excessive and imbalanced intakes becomes easier, because fewer foods would be fortified.
  
  The preferred option for implementing discretionary fortification based on the above-noted analysis, and detailed in Appendix B, is one that would see no food exclusions except for:
  - a defined list of foods, primarily standardized foods that are pervasive in the food supply (flours, breads, pasta, rice, milk, butter, suet, lard, varietal cheeses, sugars and sugar syrups, maple syrup, honey, artificial sweeteners, salt, herbs, spices, dry seasonings, vinegar, flavouring preparations, leavening agents);
  - alcoholic beverages;
  - fresh produce, meats, fish, poultry, eggs, pulses, nuts, simulated and extended meat and poultry products, fresh brewed coffee and fresh brewed tea; and,
  - infant foods, formulated liquid diets, meal replacements and nutritional supplements (which have defined levels of addition under separate regulations).
  The standardized and staple foods listed above are so pervasive in the food supply, that if fortified at the discretion of manufacturers, there is no safe level of addition that could be permitted for many nutrients. Some of the above standardized foods are already fortified under other regulatory provisions.
2. Which nutrients may be added?
  The nutrient Risk Categories are being proposed on the basis of exposure considerations under mature market scenarios and take into account the advice of the IOM. The latter includes using the information provided during the development of the ULs for each nutrient, applying the DRIs in dietary assessment (IOM, 2000), as well as the IOM guidance regarding the application of the DRIs to discretionary fortification (IOM, 2003).
  
  The vitamins and minerals which may be added (or excluded) under discretionary fortification have been categorized as follows:
  
  Risk Category A nutrients: Those nutrients for which no UL was set because of no reports of adverse effects, and no concern expressed; and those nutrients for which a UL was set but with a wide margin of safe intake; and those nutrients with a narrow margin of safety, but non-serious critical adverse effects: thiamin, riboflavin, pantothenate, biotin, vitamin B₁₂, ß-carotene, vitamin C, vitamin B₆, vitamin E, niacin.
  
  Risk Category B nutrients: Those nutrients with serious adverse effects, but with low risk of excessive intake at the proposed level of addition for discretionary fortification: calcium, folic acid, magnesium, vitamin D, potassium.
  
  Risk Category C nutrients (to be excluded from discretionary fortification): Those nutrients with a narrow margin of safety, and with serious adverse effects, and /or with current levels of exposure to intakes above the UL by vulnerable subgroups: vitamin A as retinol, zinc, iron, copper, selenium, manganese, iodine, fluoride.
  
  Nutrients in this category are currently permitted or required to be added to a range of foods for either purposes of restoration, mandatory fortification, nutritional equivalence of substitute foods or to make a special purpose food such as a meal replacement. New or further additions for these purposes would continue to be subject to the applicable regulatory requirements.
  
  Other nutrients for which a risk category has not been assigned include choline, chromium, molybdenum, phosphorus, vitamin K. These nutrients are proposed to be excluded from discretionary fortification for a variety of reasons (see Appendix B).
3. Levels of Addition
  Note: The statistical modelling and the levels of addition were determined using the new Dietary Reference Intakes as described in Appendix B. However, the final levels are expressed in terms of the current labelling reference value in Canada, the Recommended Daily Intake, expressed on the label as Daily Value. Until the common set of labelling reference values are developed for use in both Canada and the U. S., the reference standard for discretionary fortification is the Recommended Daily Intakes set out in Table 1 to Divisions 1 and 2 of Part D of the Food and Drug Regulations.
  
  Levels of addition for discretionary fortification are shown in Appendix C. If a nutrient is added, the minimum level of total nutrient (naturally occurring and added) in the food must be 5% of the Daily Value per reference amount of the food (i.e. the food will qualify for a "source" claim). Nutrients in Risk Category A may be added such that the total amount of the nutrient (naturally occurring and added) in the food is up to 20% of the Daily Value per reference amount of the food. If the food contains 20% of the Daily Value the food will qualify for an "excellent source" claim. For Risk Category B nutrients, the total amount of the nutrient (naturally occurring and added) permitted in the food after addition is up to 10% of the Daily Value per reference amount of the food. If the food contains 10% of the Daily Value the food will qualify for a "good source" claim.
  
  For those vitamins and minerals which have been added, the total amounts of those vitamins and minerals in the food must be declared in the Nutrition Facts table as part of the mandatory nutrition labelling requirements. In addition, foods with added vitamins and mineral nutrients will be required to indicate on the principle display panel that the food contains an added vitamin(s) or mineral(s).
4. Reference Values for Discretionary Fortification
  A reference value or reference standard is required for describing the levels of nutrients permitted for discretionary fortification. The new DRIs and the IOM guiding principles regarding nutrition labelling are an important first step in a process aimed at developing a common set of reference values for nutrition labelling for both Canada and the U. S. Until the common set of reference values are developed, the reference standard for discretionary fortification is the Recommended Daily Intakes set out in Table 1 to Divisions 1 and 2 of Part D of the Food and Drug Regulations. These tables were updated in 2002 and are primarily based on the highest RNIs for adults excluding pregnancy and lactation contained in the 1983 Recommended Nutrient Intakes for Canadians.
5. Nutrient Content Claims
  Nutrient content claims with respect to vitamins and minerals are regulated in Part D of the Food and Drug Regulations. Sections D.01.004 and D.02 .002 prohibit any statements or claims for a vitamin or mineral other than a statement of quantity unless the food contains at least 5% of the Daily Value (Recommended Daily Intake) in serving of stated size.
  
  The Canadian Food Inspection Agency (CFIA) has criteria for specific claims in the Guide to Food Labelling and Advertising. The claims are as follows: "source": 5% RDI; "good source": =15% RDI except =30% for vitamin C; "excellent source": =25% RDI, except =50% for vitamin C.
  
  In view of the proposed levels of vitamin and mineral nutrient additions it is appropriate to revise the nutrient content claims and that these be the subject of regulations under the Food and Drug Regulations as follows:
  
  Claim % Daily Value*
  
  Source 5
  
  Good Source 10
  
  Excellent Source 20
  
  *per reference amount and serving of stated size.

Special Purpose Foods

What is a special purpose food?
The Codex definition of special purpose foods is retained: i.e., "foods that have been designed to perform a specific function, such as to replace a meal which necessitates a content of essential nutrients which cannot be achieved except by the addition of one or more of these nutrients. These foods include but are not limited to foods for special dietary use." The Codex General Principles for the Addition of Essential Nutrients to Foods state that "Nutrients may be added to special purpose foods, including foods for special dietary uses, to ensure an appropriate and adequate nutrient content. Where appropriate, such addition should be made with due regard to the nutrient density⁷ of such foods."

Special purpose foods currently encompass a wide range of products including foods for special dietary uses. These latter are defined in Section B.24.001 of the Food and Drug Regulations as follows:

"food for special dietary use" means food that has been specially processed or formulated to meet the particular requirements of a person:
1. in whom a physical or physiological condition exists as a result of a disease, disorder or injury; or
2. for whom a particular effect, including but not limited to weight loss, is to be obtained by a controlled intake of foods;
Examples of foods for special dietary uses include:
- formulated liquid diets⁸ (B.24.102)
- meal replacements⁹ (B.24.200)
- nutritional supplements¹⁰ (B.24.201)
- gluten-free foods (B.24.018)
- sodium-reduced foods for sodium-restricted diets (B.24.008)
  
  The current regulations contain detailed nutrient compositional requirements for formulated liquid diets, meal replacements and nutritional supplements.
Revisions to current regulations pertaining to special purpose foods
Reference value for compositional requirements for special purpose foods.
The new DRIs will be applied to establish the nutrient compositional requirements for special purpose foods, since one purpose for updating the compositional requirements is to reflect the new nutrient recommendations. The meal replacements and nutritional supplements are formulated based on a defined nutrient contribution to the total daily intake, for example to provide 25% of the recommended daily intake in a serving of the food. The new RDA/AIs are the appropriate reference values for developing such products for targeted individuals. This approach was used in the current regulations for meal replacements and nutritional supplements promulgated in 1995. The nutrient composition was based on the 1990 Nutrition Recommendations and the 1990 Recommended Nutrient Intakes (RNIs).
1. Meal replacements
  The current regulatory requirements for meal replacements were established for products which were primarily intended to be used in weight reduction diets. It is for this reason that the minimum energy requirement for meal replacements was set at 225 kcal per serving and nutrient levels providing approximately 25% to 50% (including overages) of the RNI so that four servings (900 kcal) could provide from 100% to as much as 200% of the recommended nutrient intake.
  
  The current Regulations do not impose a maximum energy value on meal replacements thus there is flexibility for the formulation of meal replacements with varying nutrient to energy density. This allows meal replacements to be targeted for different purposes such as weight reduction or for specific population subgroups, such as individuals with low energy requirements.
  
  There is concern, however, that the nutrient density of meal replacements as currently regulated and targeted to individuals with average or high energy requirements is too high. Consumption of several meal replacements to achieve a energy intake of 1800 kcal could provide 400% of the recommended nutrient intake. For some nutrients, this would result in intakes over the UL. It is therefore proposed that the Regulations for meal replacements would allow for two categories as follows:
  1. meal replacements with the current minimum of 225 kcal per serving targeted by appropriate indications on the label to individuals on weight loss diets or to those with limited energy intakes for other reasons, e.g. age, infirmity, or disease as described in paragraph (a) of the definition for food for special dietary use.
    
    Consistent with their role as meal replacements, it is proposed that nutrient content be based on a daily intake of 900 kcal; the minimum protein level will be retained at 20% of energy and the upper level will be set at 35% of energy consistent with the IOM Acceptable Macronutrient Distribution Range (AMDR); the total fat will be retained at a maximum of 35% of energy; linoleic acid at a minimum of 3% of energy, a-linolenic acid at a minimum of 0.5% of energy and the ratio of linoleic to a-linolenic between 4:1 to 10:1; and vitamins and minerals at 25% of the adult male RDA/AI per 225 kcal (see Appendix D).
  2. meal replacements with a minimum of 350 kcal per serving targeted by appropriate indications on the label to individuals with average or higher energy requirements (2000+ kcal).
    
    It is proposed that the nutrient content be based on a daily minimum of 2000 kcal; the protein level be set at 10-35% of energy consistent with the IOM AMDR for protein; the total fat will be retained at a maximum of 35% of energy; linoleic acid at a minimum of 3% of energy and a-linolenic acid at a minimum of 0.5% of energy and the ratio of linoleic to a-linolenic between 4:1 to 10:1; and vitamins and minerals at 12.5% of the adult male RDA/AI per 225 kcal (see Appendix D).
  It is proposed that Section B.01.053 which sets minimum levels for protein, 5 vitamins and one mineral for a food represented as an instant or ready breakfast be revoked because these nutritional requirements are inadequate for a meal replacement.
Prepackaged meals
The Food and Drug Regulations define a "prepackaged meal" (B.01.001) as "a prepackaged selection of foods for one individual that requires no preparation other than heating and that contains at least one serving, as described in Canada's Food Guide to Healthy Eating, of a) meat, fish, poultry, legumes, nuts, seeds, eggs or milk or milk products other than butter, cream, sour cream, ice-cream, ice milk and sherbet, and b) vegetables, fruit or grain products". There are no nutrient compositional requirements set out in the Regulations for prepackaged meals. Specific labelling requirements exist for prepackaged meals that are represented for use in a weight reduction diet.

Interest has been expressed in the fortification of prepackaged meals to ensure that these provide, in a serving, nutrients balanced to their energy value, when such prepackaged meals are represented for the use by a particular population subgroup. This is particularly important for subgroups of the population who may rely on these types of products to provide a major portion of their daily energy and nutrient intake. Examples of such groups include the elderly or others living alone who find prepackaged meals to be convenient and easy to use and organoleptically more acceptable than meal replacements.

It is proposed to make provision in the Regulations for the addition of vitamins and mineral nutrients to prepackaged meals that are positioned as special purpose foods, i.e. targeted to specific groups and appropriately labelled. It is proposed that the nutrient compositional requirements of the meal replacements apply to these foods.

As for meal replacements, it is proposed to require that prepackaged meals targeted by appropriate indications on the label to individuals with low energy requirements provide a minimum of 225 kcal per serving with a serving providing 25% of the adult male RDA/AI (Appendix D). It is proposed that protein level for prepackaged meals intended for individuals with low energy requirements be set at 20% to 35% of energy; the total fat at a maximum of 35% of energy; linoleic acid at a minimum of 3% of energy and a-linolenic acid at a minimum of 0.5% of energy.

Prepackaged meals targeted by appropriate indications on the label to individuals with higher energy intakes would be required to provide a minimum of 350 kcal per serving. A serving would be required to provide 25% of the adult male RDA/AI; 10%-35% of energy from protein; total fat at a maximum of 35% of energy; linoleic acid at a minimum of 3% of energy and a-linolenic acid at a minimum of 0.5% of energy.
Nutritional supplements
Nutritional supplements are defined by the Food and Drug Regulations as products that are a supplement to a diet that may be inadequate in energy and essential nutrients. The energy value of a "nutritional supplement", as provided by protein, fat and carbohydrates, differentiates these foods from vitamin/mineral supplements which provide virtually no energy.
The current regulatory nutrient requirements for nutritional supplements are expressed on an energy basis. The range between the minimum and maximum levels for vitamins and minerals provided for nutritional supplements was intended to allow flexibility in the formulation of products targeted for different needs.

Vitamin and mineral nutrient specifications for nutritional supplements were based on the 1990 Nutrition Recommendations and provide one third to one half of the recommended nutrient intake in 150 kcalories. These supplements were originally intended to be consumed once per day to supplement an inadequate diet. In practice, however, there is a wide variety of nutritional supplements on the markets targeted as snacks, supplements for athletes and supplements for active living. Multiple servings may be consumed in a day. Because the regulations require a high nutrient density, this may result in intakes over the UL from these foods alone.

It is proposed that the regulations for nutritional supplements be amended to bring them in line with the new RDAs/AIs. In addition, in view of the ULs established by the IOM, and, particularly, since in the case of a number of nutrients there is overlap between the RDAs/AIs for some age groups and the ULs for others, e.g. children, for some micronutrients, it is proposed to amend the Regulations for nutritional supplements as indicated below (and tabled in Appendix E).

It is proposed that:
- Specific labelling regarding indications for use and targeting be required for informed and appropriate safe use of the special purpose food.
- Specific vitamin and mineral levels would be established for nutritional supplements targeted to different population subgroups (see Appendix E). The DRI report of 2002 provided estimated energy requirements (EERs) for the various age and sex groups; the RDAs/AIs for the respective age and sex groups were considered in establishing the proposed vitamin and mineral levels which are expressed per 100 kcal.
- The minimum energy requirement for nutritional supplements would be decreased from 150 kcal per serving to 100 kcal per serving for products targeted to children.
- The current requirements for protein, fat and fatty acids remain unchanged.
- All 8 B vitamins be required; the remaining micronutrients would be optional: i.e., vitamins A, D, C, E and calcium, phosphorus, iron, iodide, copper, zinc, manganese, selenium, chromium and molybdenum.
- Non-targeted nutritional supplements would provide vitamins and minerals in relation to energy based on the recently established RDAs/AIs for adult males aged 19-30, except for calcium which is based on RDA/AI for males aged 14-18 years. Non-targeted nutritional supplements would provide the RDAs/AIs for micronutrients in 1500 kcal; the regulatory requirements for vitamin and minerals for non-targeted nutritional supplements would be expressed on a per 100 kcal basis (Appendix E-Adults, adolescents and children). Nutritional supplements formulated to these requirements would also be appropriate for supplements targeted to active individuals/athletes.
- Nutritional supplements targeted to young children (1 to 3 years of age) would provide levels of vitamins and minerals based on an intake of 1000 kcal providing the IOM RDA/AI for this age group and expressed on a per 100 kcal basis (Appendix E-Toddlers).
- Nutritional supplements targeted to women of childbearing years would be required to provide iron, folate, calcium and vitamin D, in addition to nutrients required for energy utilization, the B vitamins, at minimum levels consistent with the new IOM RDAs/AIs; levels are established based on 1) 900 kcal providing the RDA/AI for women 19-30 years for those on energy restricted diets and requiring a higher nutrient density (Appendix E-Women of child bearing years on energy restricted diet) ; 2) 1500 kcal providing the RDA/AI for women 19-30 years (Appendix E-Women of child bearing years); and would be expressed on the basis of 100 kcal. Provision is made for additional formulations for nutritional supplements containing higher levels of calcium, vitamin D, folic acid, vitamin B12 and iron (see Appendix E).
- Nutritional supplements targeted to adults over 50 would provide levels of vitamins D, B₆ and B₁₂ and of iron, and nutrients required for energy utilization, consistent with the IOM RDAs/AIs for men aged 51-70 years, except for vitamin D which is based on the AI for adults over 70 years (Appendix E-Older adults).
For special purpose foods not included in the provisions above
Requests for regulatory amendments to make provision for special purpose foods that are not in the provisions above must be accompanied by information to support the nutritional composition of special purpose food. A rationale for the nutrient additions would be required in the case of these foods. Information supporting the rationale for targeting a special purpose food to a specific group would include:
1. evidence that the nutrition needs for the target group(s) are different from the general population, how and to what extent; this may require demonstration of inadequate intake or evidence of increased requirements. Intake data and /or requirement data for the target group would provide the necessary evidence for nutrition needs;
2. evidence supporting that the proposed levels of fortification contribute to meeting the identified needs. Modelling data to show how the product, when used as intended, contributes to intakes in the context of the total diet would be appropriate evidence; and
3. evidence that the proposed levels of fortification are safe and do not exceed the UL in the context of the total diet for the target group. This condition is an extension of the item b) above in which upper levels of the intake distribution would be identified.
4. specific labelling regarding indications for use and targeting for informed and appropriate use of the special purpose food.
Substitute Foods

The following are modifications to the current Regulations.
1. Fruit Flavoured Drinks
  Sections B.11.150 and B.11.151 currently permit the addition of vitamin C, thiamine, folic acid iron and potassium to drinks that are sold as a substitute for a fruit juice or as a breakfast drink provided that they are not carbonated or represented or commonly known as a soft drink or thirst-quenching or refreshment drink. The nutrient levels were based on those contained by apple juice and orange juice.
  
  It is proposed that Sections B.11.150 and B.11.151 be revoked, however, that provision be made for the addition of vitamin C to fruit-flavoured drinks to provide a minimum of 60 mg per reference amount and a maximum level of 130 mg per reference amount (the level present in raw orange juice). In addition, these fruit drinks would be eligible for discretionary fortification with the B vitamins, vitamin D, vitamin E, beta-carotene, calcium, magnesium and potassium.
2. Simulated meat products
  The current requirements for addition of vitamin and minerals nutrients for simulated meat products are set out in the Table to Division 14. These requirements are proportional to protein content of the product, i.e. the amount of vitamin and mineral nutrients per gram of protein. As the protein content increases, the levels of vitamins and minerals increase. Minimum protein levels are set for various simulated meat products in Sections B.14.085 - 14.090 and range from 9 to 25%. The higher protein content of some simulated meat products results in vitamin and mineral levels including potassium that are higher than in the corresponding meat product. In the case of potassium, this results in unacceptable texture and flavour.
  
  It is proposed that Division 14 be amended to require that the amount of potassium contained by a simulated meat product be 20.0 mg potassium per gram of protein up to the amount corresponding to the minimum amount of protein for that simulated meat product, with no further addition of potassium required for products containing more than the minimum amount of protein. This proposal is consistent with the Codex Alimentarius General Principles for the Addition of Essential Nutrients to Foods.
  
  The following items are products that were allowed for sale under an Interim Marketing Authorization (IMA) and which we propose to incorporate as new regulations.
3. Plant-based beverages
  An IMA was issued on November 20, 1997 to authorize the sale of soy and other plant-based beverages as an alternative to milk. (Appendix F). This IMA sets out the requirements for manufacturers who want to voluntarily fortify their products. If fortified, these beverages must contain specified amounts of calcium, zinc, vitamins A, D, B₁₂, and riboflavin. As well, one or more of the following nutrients are permitted at defined levels: vitamin B₆, vitamin C, thiamin, niacin, folacin, pantothenic acid, phosphorus, potassium, and magnesium. Such beverages must contain not less than 2.5 g protein of a nutritional quality equivalent to not less than 75% casein per 100mL; not more than 3.3 g of fat per 100 mL of which not more than 65% shall be saturated fatty acids, not more than 5% trans fatty acids and not less than 2.5% linoleic acid, as indicated in the IMA.
4. Vegetable-based or vegetable-and milk-protein based product which resemble cheese
  An IMA was issued on March 29, 2001 to authorize the sale of fortified vegetable based or vegetable and milk protein based products, which resemble cheese so that these products may contain the important nutrients provided by cheese (Appendix G). This IMA sets out the requirements for manufacturers who want to voluntarily fortify their products. If fortified, these products must contain vitamin A, vitamin B₁₂, riboflavin, niacin, calcium, phosphorus, magnesium and zinc in the amounts listed in Appendix G. Other requirements regarding protein quality and content, fat and sodium content are detailed in Appendix G. The amendment resulting from this IMA is consistent with the Codex Alimentarius General Principles for the Addition of Essential Nutrients to Foods.
Restoration of nutrients

Current regulatory provisions for the restoration of vitamins and minerals in specific foods will be retained, e. g. corn meal. It is proposed that a general provision would allow restoration of vitamins and minerals lost in processing, storage and handling if the amount originally present provided at least 5% of the Weighted Recommended Nutrient Intake of the nutrient in a reasonable daily intake of the food or ther reference amount where there is no reasonable daily intake. The amount of vitamins and minerals added should compensate for that lost due to processing, storage and handling. It is proposed that Schedule K to the Food and Drug Regulations will be revised to eliminate duplication with the reference amounts (in Schedule M) where the reasonable daily intake is the same (see Appendix H).

Specific Cases

The following foods may be fortified to achieve one or more objectives of this proposed policy.

Breakfast Cereals
It is proposed that Section B.13.060 of the Food and Drug Regulations be amended to provide for the addition to breakfast cereals of more vitamin and mineral nutrients and at higher levels. The proposals for breakfast cereals listed below are based in part on an effort to allow greater trade harmonization in this product category while ensuring safety. The proposals also recognize the traditional role of breakfast cereals as a significant source of nutrients in the Canadian diet which has long been recognized through regulations specific to this product category (B.13.060).

In assessing breakfast cereals, the following nutrients were modelled: calcium, folic acid, zinc, retinol, iron. For further details see Appendix B. The risk assessment indicated that the levels proposed below would result in minimal exposure of the population to intakes over the UL. In the case of folic acid, to mitigate any risk of masking vitamin B₁₂ deficiency, any breakfast cereal fortified at 200 µg folic acid, which may result in a small percent of children and adults with intakes over the UL, will be required to be fortified with vitamin B₁₂ at 2.4 µg. In the case of zinc, about 12% of Canadian boys aged 6-8 years, the youngest age group for which data are available, have intakes over the UL, but do not approach the level at which copper-deficiency anemia was seen in infants.

Nutrient	Minimum per reference amount	Maximum per reference amount
Vitamin A/retinol (µg)	50	155
Vitamin D (µg)	0.25	1.0
Vitamin C (mg)	3	6
Thiamin ( mg)	0.6	0.6
Riboflavin (mg)	0.08	0.4
Niacin (mg)	1.4	5
Vitamin B₆ (mg)	0.2	0.5
Folate µg	20	200 *
Vitamin B₁₂ (µg)	0.4	2.4 (*2.4 is required if folic acid is 200)
Calcium ( mg)	55	110
Phosphorus (mg)	55	200
Magnesium (mg)	50	60
Iron (mg)	4	9
Zinc (mg)	1.0	1.5

Enriched rice
The enrichment of rice recognizes its importance as a staple food by many Canadians. Several nutrients are lost in milling, and at the present time in Canada, if pre-cooked rice is represented as enriched, it must contain added thiamin, niacin and iron; the addition of vitamin B₆, folic acid and pantothenic acid is optional. In the United States, thiamin, riboflavin, niacin, folic acid and iron must be added to enriched rice; the addition of calcium and vitamin D is optional. In line with the Canadian policy to harmonize the mandatory nutrients in enriched grains, it is proposed to expand the ranges of the permitted nutrient levels (see Appendix I), and to make provision for the addition of calcium. The enrichment of rice with calcium is consistent with the permitted fortification of flour with calcium in Canada. The maximum levels for nutrients in the U.S. standard are twice the minimum to allow for variability in the enrichment process, and it is proposed that these ranges be adopted.
Enriched corn meal
The enrichment of corn meal with certain vitamins and minerals at levels harmonized with those in the U. S. has been permitted since 1997 under an IMA). The Regulations will be amended in accordance with the IMA and as seen in Appendix J. It is further proposed that corn meal may not be presented as "enriched" unless it contains added thiamin, riboflavin, niacin, folic acid and iron.
Processed cheese products and cottage cheese
Provision will be made to permit the addition of calcium to processed cheese products to a level of 30 mg calcium per g protein; this ratio is within the range found in varietal cheeses. Provision will also be made for cottage cheese permitting calcium addition up to the level of 300 mg per reference amount (Schedule M to the Food and Drug Regulations), equivalent to the amount of calcium in the reference amount of milk.

Milks

Vitamin D is a mandatory ingredient in all standardized milks. It is added to provide 300- 400 IU (7.5 - 10 µg) in a reasonable daily intake of 852 mL or 35 - 47 IU (0.9 - 1.2 µg) per 100 mL. Canada's Food Guide to Healthy Eating recommends children consume 2 - 3 servings of milk products daily. A Food Guide serving of milk is 250 mL. It is proposed that the reasonable daily intake for milk be changed to 750 mL ( Schedule K, Appendix H) and the levels of vitamin D be changed to 1.0 - 1.3 µg (40 IU - 53 IU) per 100 mL It is proposed that the level of vitamin D in goat's milk also be increased to 1.0 - 1.3 µg per 100 mL.

The levels of vitamin A and folic acid (amounts per 100 mL), where added, will not be affected by the change in the reasonable daily intake.
Schedule K to the Food and Drug Regulations

Proposed Revisions to Schedule K (see Appendix H)

Schedule K to the Food and Drug Regulations lists the reasonable daily intake (RDI) of a variety of foods. RDIs have been used:
- to determine the nutritional contribution/significance of a food for purposes of restoration of vitamin and mineral losses due to processing, packaging or storage, or for purposes of determining the need to add nutrients to a substitute food.
- as the basis for protein claims
- as the basis for determining the significant nutrients in a novel food.
As in the past, it is proposed that for restoration of processing losses, the original unprocessed food must contain at least 5% of the Weighted Recommended Nutrient Intake per reasonable daily intake of the food as set out in Schedule K. Where there is no reasonable daily intake then the reference amount (Schedule M of the Food and Drug Regulations) will apply. The vitamin(s) and mineral(s) which have been lost due to processing may be added to the level in the original unprocessed food. Similarly, where consideration is being given to the addition of vitamins and mineral nutrients to substitute foods, the original food must contain at least 5% of the Weighted Recommended Nutrient Intake per reasonable daily intake of the food or per reference amount where there is no reasonable daily intake listed. The vitamin(s) and mineral(s) which may be added to the substitute food must be added to the level in the food for which it is substituting.

Schedule M to the Food and Drug Regulations contains reference amounts for foods which were derived from the average quantities of foods consumed at a single eating occasion. It is proposed that Schedule K be amended to include only those foods which are likely to be consumed more than once per day, for example, bread. The reference amount for bread is 50 g (estimated as one to two slices). The reasonable daily intake is 150 g which is about 3 to 5 slices. In the case of fruits and vegetables, these are consumed several times per day but it is unlikely that the same fruit or vegetable is consumed more frequently than once per day.

With the proposed revisions to Schedule K, nutrient content claims for protein (in the table following Section B.01.513, items 8-10 of the Regulations) will continue to be based on the reasonable daily intake, or where there is no reasonable daily intake listed, on the reference amount in Schedule M.
Requirements for Analytical Testing and Record Keeping

The addition of vitamins and mineral nutrients to foods must be carefully controlled, because vitamins and minerals are biologically active compounds that are required in small amounts, and are added to foods in very small quantities. In addition to the control of the amounts added, the vitamins and minerals must be uniformly dispersed throughout the food. Vitamins are also unstable and are subject to destruction by heat, oxidation, light, etc. Reasonable overages of vitamins and mineral, within the limits of good manufacturing practice, must be present to ensure that the required levels of the vitamins and minerals are maintained throughout the shelf-life of the food under customary conditions of distribution and storage. Since excessive overages could lead to inadvertent excesses, overages for most minerals need only be sufficient to compensate for variations in dispersion.

Since vitamins and minerals are usually sold as premixes, these should come with certificates of analysis, and if stored, should be re-analysed at intervals to verify their potency.

It is proposed that manufacturers will be required to establish procedures for verifying the content of the vitamins and mineral nutrients in the final product. To accomplish this, it is proposed that the manufacturer be required to conduct tests to determine:
1. the uniformity of distribution of the vitamin or mineral in the food;
2. the stability of the vitamin or mineral in the food;
3. the minimum amount of overage required to maintain the level of the vitamin or mineral in the food throughout its shelf-life ;
4. for foods with a durable life of more than 90 days, the date after which the manufacturer does not recommend that the food be consumed because the declared levels of vitamins and minerals may no longer be present. This date must be shown on the label.
Manufacturers and importers would be required to keep records of the tests.
Regulated List of Vitamin Compounds and Mineral Salts

To ensure that the source of vitamins and minerals added to foods meet appropriate specifications for identity and purity of vitamins and minerals, a proposed list of permitted vitamin compounds and mineral salts is presented in Appendix K. A vitamin compound or mineral salt must comply with specifications in a relevant monograph in:

the fifth edition of the Food Chemicals Codex published by the National Academy of Sciences and the National Research Council of the United States of America in Washington, D. C. (2003) including supplements; or

If not in the Food Chemical Codex, then in the Food and Nutrition Paper 52 Compendium of Food Additive Specifications Volumes 1 and 2, as amended from time to time, published by the Food and Agriculture Organization of the United Nations in Rome (1992); or

If there is no monograph applying to a substance under 9. a) and 9. b), the substance must comply with a relevant monograph published in one of the following secondary sources:
1. the British Pharmacopoeia, 2003. The Stationery Office, Norwich; or
2. The United States Pharmacopeia, 27^th Revision and The National Formulary, 22^nd Edition. Official from January 1, 2004. United States Pharmocopeial Convention Inc. Rockville Md. (2004); or
3. The Pharmaceutical Codex, 12^th Edition, Council of the Pharmaceutical Society of Great Britain. The Pharmaceutical Press, London (1994); or
4. Martindale The Extra Pharmacopoeia, 31^st Edition, JEF Reynolds (Ed) The Royal Pharmaceutical Society of Great Britain. London (1996); or
5. the European Pharmacopoeia 4^th Edition, Council of Europe, Strasbourg Cedex, France (2001) and supplements; or
6. the International Pharmacopoeia 3^rd Edition, Volumes 1, 2, 3, 4, and 5. World Health Organization, Geneva (2003); or

References

Institute of Medicine. 1997 Dietary Reference Intake for Calcium, Phosphorus, Magnesium, Vitamin D and Fluoride. National Academy Press, Washington, D. C.

Institute of Medicine. 1998. Dietary Reference Intakes: Folate, Other B Vitamins, and Choline. National Academy Press, Washington, D. C.

Institute of Medicine. 2000. Dietary Reference Intakes for Vitamin C, Vitamin E, Selenium and Carotenoids. National Academy Press, Washington, D. C.

Institute of Medicine, 2000. Dietary Reference Intakes. Applications in Dietary Assessment. National Academy Press, Washington, D. C.

Institute of Medicine. 2001. Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium and Zinc. National Academy Press, Washington, DC.

Institute of Medicine, 2002. Dietary Reference Intakes. Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein and Amino Acids. National Academy Press, Washington, D. C. (Prepublication Copy)

Institute of Medicine, 2003. Dietary Reference Intakes. Guiding Principles for Nutrition Labelling and Fortification. National Academy Press, Washington, D. C.

Institute of Medicine, 2003. Food Chemical Codex, Fifth Edition. National Academy Press, Washington, D. C.

Institute of Medicine, 2004. Dietary Reference Intakes. Water, Potassium, Sodium, Chloride and Sulfate, National Academy Press, Washington, D. C. (Prepublication Copy)

Footnotes

Nutrients refer to vitamin and mineral nutrients for the purpose of this policy.
IOM Guiding Principle 11: The scientific justification for discretionary fortification of food should be based on documented public health needs, particularly on dietary inadequacy that is determined by assessing the prevalence of nutrient inadequacy in the population.
Estimated Average Requirement: the average daily nutrient intake level estimated to meet the requirements of half of the healthy individuals in a particular life stage and gender group.
Recommended Dietary Allowance: the average daily dietary nutrients intake level sufficient to meet the nutrient requirements of nearly all (97 to 98 percent ) healthy individuals in a particular life stage and gender group.
Adequate Intake: the recommended average daily intake level based on observed of experimentally determined approximations of estimates of nutrient intake by a group of apparently healthy people that are assumed to be adequate-used when an RDA cannot be determined.
WRNIs became part of the Regulations in 1996. They were calculated by determining the proportion of the population made by each age/sex group using the census data of either 1986 or 1991 and multiplying these percentages by the respective 1990 Nutrition Recommendations. The results for each nutrient were summed to give the WRNI values.
Nutrient density means the amount of nutrients (in metric units) per stated unit of energy (MJ or kcal).
"formulated liquid diet" means a food that (a) is sold for consumption in liquid form, and (b) is sold or represented as a nutritionally complete diet for oral or tube feeding of a person described in paragraph (a) of the definition "food for special dietary use";
"meal replacement" means a formulated food that, by itself, can replace one or more daily meals;
"nutritional supplement" means a food sold or represented as a supplement to a diet that may be inadequate in energy and essential nutrients";
"Overage" means the amount of a vitamin and mineral nutrient that is, within the limits of good manufacturing practice, added to a food in excess of the amount declared on the label, in order to ensure that the amount of the vitamin or mineral nutrients declared on the label is maintained throughout the durable life of the food (Division 1 to Part B).


	Last Updated: 2005-07-26		Important Notices

Addition of Vitamins and Minerals to Foods, 2005

Health Canada's Proposed Policy and Implementation Plans

Table of Contents

Executive Summary