Appendix B - Options Analysis

Introduction

For discretionary fortification, there are three main questions which need to be answered regarding implementation. 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.

The options for eligible foods range from no exclusions, through exclusion of certain standardized and staple foods that are widely consumed, to exclusion of foods which contain important amounts of constituents associated with risk to health, such as saturated and trans fats. These options (see Table One) have been evaluated on the basis of criteria reflecting the key issues of concern identified by the External Advisory Panel and stakeholders during the earliest phase of the policy review:

1. consumer protection;
2. availability and choice / innovation;
3. trade and competitiveness.

Furthermore, the implications of each option based on stakeholder comments have been considered in terms of education / information / risk communication; monitoring; regulations and enforcement.

Table One: Options for Eligibility Criteria for foods which may be fortified at the discretion of manufacturers

Methods:

A. The Issues and Decision-Making Criteria

The key issues of concern in developing the revised policy were population health; consumer protection; safety and effectiveness; availability and choice; trade and competitiveness. These were identified during stakeholder consultations in the earliest phase of the policy review. These were developed into decision-making criteria to evaluate the policy options proposed in 1999. These criteria have been retained and further elaborated in the present evaluation of discretionary fortification, and are described as follows.

1. Consumer protection

   This criterion is a measure of the extent to which the options are consistent with Health Canada’s primary role in protecting the health and safety of Canadians. This criterion addresses the impact of ad libitum consumption of foods, if fortified at the discretion of manufacturers, on risk of excessive or imbalanced intake. Further, this criterion addresses the issue of potential promotion of foods containing constituents well recognised as increasing risk to health, on the basis that they are fortified.

   For discretionary fortification, the potential for health benefit for individuals exists, if the individual with an inadequate intake chooses a food fortified with the nutrient lacking in his or her diet. However, benefit on a population basis cannot be addressed, nor can it be statistically modelled, because it is not known who will select a fortified product, given the choice, or his or her nutritional status. In general, the Canadian population has a low prevalence of inadequacy for most nutrients, except for magnesium, and for adults, vitamin C, and for older adults vitamin B₁₂ and vitamin B₆. Some groups also have median intakes of calcium below the Adequate Intake suggesting some potential for inadequacy. Thus it is expected that on a population-wide basis, benefit from discretionary fortification would be quite low. Therefore the issue of discretionary fortification is not one of establishing benefit, but one of managing risks, primarily risk of excessive intake.

   1.1 Safety Assessment of Discretionary Fortification Options
   
   1.1.1 Risk Assessment Methodology

   1.1.1.1 Risk Categorization of Nutrients
   The safety assessment of the options for discretionary fortification is assisted in part through the use of the risk categories of nutrients, which were proposed by the Food Directorate, using the new DRIs. The categorization was based on the margin between the highest adult RDA or AI and the UL for children or the most exposed group. It 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. The highest adult RDA was selected as the lower boundary because of the practice in the U. S. of fortifying foods to a per cent of the Daily Value which is based on the highest adult RDA. Thus a food that is fortified to 100 % of the RDA for certain nutrients (e.g. zinc, folic acid , retinol-vitamin A, niacin) would provide an intake over the UL to a child in a single serving of the food. Three risk categories of nutrients were proposed and discussed with stakeholders in November 2002.

   The Risk Categories below were used between 2002 and 2003 for statistical modelling and consultation purposes. The response to the initial categorization, together with the modelling, helped in the development of the final risk categories which are presented in Health Canada’s Proposed Final Policy and Proposed Implementation, p 11.
   Risk Category A: thiamin, riboflavin, vitamin B₁₂, pantothenic acid, biotin.
   Risk Category B: vitamin B₆, vitamin E, vitamin C, niacin.
   Risk Category C: calcium, folic acid, vitamin A as retinol, zinc, vitamin D, iodine, iron, copper, selenium, manganese, magnesium (UL for supplementary magnesium only).
   Other nutrients for which an RDA or AI has been established, but for which a risk category has not been assigned, include choline, chromium, fluoride, molybdenum, phosphorus and vitamin K. For a variety of reasons which are briefly described here, these nutrients are proposed to be excluded from discretionary fortification. Choline has very limited evidence available to set an AI and a UL and has a 2-fold range of safety. Data for chromium are too limited to set a UL. Molybdenum has limited animal data used to set a UL. Phosphorus has a narrow range of safety and is increasingly used as a food additive and vitamin K has insufficient data to set a UL, but is used in supplements (by prescription only) due to its role in blood coagulation.

   While stakeholders indicated some agreement with the above risk categorization in response to the October 2002 consultation document, many stakeholder groups recommended waiting for the report of the IOM on the application of the DRIs to nutrition labelling and discretionary fortification, which was to become available in late 2003. Nonetheless, risk categorization has demonstrated its utility in assessing the safety of defined levels of nutrient addition under a range of scenarios. The IOM report became available in December 2003. This report set out a series of Guiding Principles. With reference to applying the ULs, Guiding Principle #15 states that “The severity of the adverse effect on which the UL is based should be reviewed when considering discretionary fortification with a nutrient using the conceptual decision approach presented” (in the report). An important consideration in using the ULs is the heterogeneity of the severity of adverse effect of excessive nutrient intakes, and in the case of some nutrients, the limited data available to set the UL. Other considerations in interpreting the risk of adverse effects due to high exposure are the sources of nutrient on which the adverse effects were identified in setting the ULs. This is a practical recommendation which Health Canada has taken into account in setting out the final risk categories of nutrients.

   1.1.1.2 Exposure Assessment
   The exposure assessments are key elements of the risk assessment. Assessing the safety of the options for discretionary fortification was through the use of modelling scenarios of exposure of the Canadian population to nutrients in each of the risk categories, under the conditions tested.
   
   The data from three Federal/ Provincial surveys (British Columbia, Manitoba and Ontario) were pooled to provide a sample of 4489 to generate the adult results, and the data from the Quebec survey of children and youth (n= 1932) were used to generate the children’s results. All participants in these surveys provided a 24 hour recall and about one third of participants provided a second recall, permitting adjustment to reflect usual intakes. All intakes were calculated based on the 1999 Canadian Nutrient File.
   
   Under each scenario, all qualifying foods were fortified to bring nutrient content to the level evaluated per reference amount. However, to evaluate scenarios that more closely reflect actual market practices, a Monte Carlo simulation was applied. In this case 33% of foods chosen randomly from the qualifying foods were fortified, to reflect a mature market in which, according to data provided by an industry group, about one third of consumers indicated that they would buy a fortified product (e.g. beverages, cereals, bread, bars) if there was a choice. Under the mature market simulations, all ready-to-eat cereals were fixed to the stated level of nutrient addition because of consumer brand loyalty to one or a limited number of cereals.
   It should be noted that in the modelling, no allowance was made for overages of added nutrients. In practice, these range from 20 to 200% of the declared value depending upon the stability of the nutrient.
   
   The fortification scenarios listed in Table One (Options 1, 2, 3, 4 for the June 2003 consultation and Option 1- mature market scenarios afterwards) were tested.

2. Availability and choice/ innovation

   This criterion speaks to the extent to which the option would allow more food choices and wider distribution of nutrients in the food supply. Innovation is addressed through the extent to which the development of new fortified products potentially filling niche markets is fostered.

3. Adherence to /Application of Codex General Principles and the new Dietary Reference Intakes

   Early in the policy review process, stakeholders supported Health Canada’s recognition of the Codex General Principles for the Addition of Essential Nutrients to Foods. However, there was also recognition that these principles do not include discretionary fortification, i.e. fortification without a defined nutritional rationale. Consequently, the Codex General Principles will apply to all purposes for addition except discretionary fortification.

   However, the appropriate application of the new Dietary Reference Intakes in both risk assessment (IOM 2000, 2003), in setting levels of addition (IOM, 2003) and eventually, in the longer term, in labelling is applicable to all discretionary fortification options.

4. Trade and Competitiveness

   This criterion addresses the extent to which the options would facilitate fortified food and beverage products to be marketed with our major trading partners. The extent to which Canadian manufacturers would develop fortified products for export, and Canada would be able to import more products from our major trading partners is considered.

   4.1 Situation in the US.

   In the United States, all fortification is at the discretion of the manufacturer. Mandatory fortification is not required for any food product. Every standard of identity for an enriched food is coupled with a standard of identity for an unenriched version of the same food.

   The US Code of Federal Regulations contains a Fortification Policy (21CFR§104.20) which sets out situations and conditions in which fortification of foods is considered appropriate: correction of inadequate intakes of nutrients; restoration of nutrient losses; balancing nutrient content in proportion to caloric value (nutrient density); and prevention of nutritional inferiority of substitute foods. The FDA’s Fortification Policy is expressed as a series of guidelines which manufacturers are urged to follow if they elect to add nutrients to a manufactured or processed food. With the exception of the requirements for nutrients classified as food additives, and those linked to nutrient content claims and related label statements, the FDA does not regulate discretionary fortification of unstandardized foods and is not involved in decisions taken by companies to fortify these.

   4.2 Situation in the European Union

   In Europe, responsibility for regulating fortified foods rests with the Member States. As of 1998, regulatory or legislative controls varied widely ranging from virtually unrestricted addition as long as no health hazards existed (e. g. Austria, U. K.) to addition allowed only if approved by the Ministry of Health (e. g. Italy).

   The White Paper on Food Safety, adopted by the Commission of the European Communities on January 12, 2000, proposed in its Action Plan on Food Safety “to lay down provisions for marketing foods to which nutrients such as vitamins and minerals have been added”. It was intended for the provisions to be adopted by the Commission in September 2000 and by the Council/Parliament in September 2001. Adoption of a proposal has been delayed and the Commission has released a Proposal for a Regulation for the European Parliament and of the Council on the addition of vitamins and minerals and of certain other substances to food, November 10, 2003, for comment. The document focuses on voluntary (discretionary) addition. The proposal includes a positive list of vitamins and minerals that may be added. The Commission also proposes to set maximum safe levels that can be added to foods, taking into account intakes from other dietary sources, and the upper safe levels (ULs) established by the Scientific Committee on Food of the European Commission. The only foods excluded are fresh produce including fruits, vegetables, fish and meats, and beverages containing alcohol greater than 1.2% by volume. To address concerns that products that do not have a “desirable” nutrient profile such as candies, high salt and high fat snacks should not be allowed to be fortified, it is proposed that the nutrient profile of a food be a criterion for allowing a fortified food to carry claims (nutrition or health claims).

   4.3 Situation in Australia and New Zealand

   Food Standards Australia and New Zealand (FSANZ) has a specific standard (Standard 1.3.2-Vitamins and Minerals) which prohibits the addition of vitamins and minerals to general purpose foods unless the addition of that vitamin or mineral is specifically permitted (levels of addition are also defined). Regulatory Principles were derived from the Codex General Principles for the Addition of Essential Nutrients to Foods.

B. Implications of Each Option

Stakeholders commented on the advantages and disadvantages of each option at a consultation in June 2003. Taking this input into account, the implications of each option for discretionary fortification were also considered from the additional perspectives of :

• Education / Information / Risk Communication - The issues include the type and characteristics or nature of public health messages required to decrease potential risk of the option.
  
  
• Monitoring - The issues include the type of monitoring required to assess the impact of the implementation of the option as well as the responsibility for monitoring.
  
  
• Regulations and enforcement - The issues include the regulatory burden on Health Canada associated with the option, the ease of enforcement.

C. Evaluating the Options for Discretionary Fortification

Four major options, plus mature market scenarios under Option 1, presented in the table below, were weighed against the decision-making criteria. A mature market scenario assumed that only certain product categories would be fortified based on data provided by industry and that one third of choices were assumed to be fortified. Representative nutrients from risk categories B and C presented on p 3 of this Appendix were modelled. The levels were based on the new IOM Recommended Dietary Allowances (RDA) and Adequate Intakes (AI).

General exclusions

All modelling scenarios and options excluded fresh unprocessed meat, poultry, fish, eggs, fruits and vegetables, coffee beans, leaf tea. Infant foods were also excluded. All modelling scenarios and options also excluded certain standardized and staple foods from discretionary fortification because of their pervasiveness in the food supply and the potential for widespread exposure to excessive or imbalanced intakes if these were to be fortified at the discretion of manufacturers. The list of excluded standardized foods for November 2002 modelling was flours, breads, pasta, rice, milk, margarine. The list of standardized and staple foods was expanded for the June 2003 modelling to also exclude varietal cheeses, sugar, honey, maple syrup, molasses, salt, pepper, other spices, leavening agents and artificial sweeteners. It is proposed that alcoholic beverages also be excluded. In further explorations of Option 1, under mature market scenarios, milk as a beverage and margarine were included in the modelling to assess the impact of an industry proposal that these two standardized staple foods be allowed discretionary fortification.

The options for food vehicles for discretionary fortification were the subject of a consultation workshop on June 23, 2003. The further analysis of the application of mature market conditions to Option 1 were completed in December 2003 and are now being shared with stakeholders.

Rationale for Exclusion criteria:
The increasing market for fortified foods suggests that fortification does lead to increased consumption of the fortified vehicles. Restricting discretionary fortification to foods that meet nutritional criteria was suggested for options which would increase the availability of fortified foods while preventing promotion of fortified foods with components associated with risk to health or foods of low nutritional value. Under Option 2, the first criterion is intended to be the same as for the “low in saturated fatty acids” claim. According to the DRI report (IOM 2002), “any incremental increase in saturated fatty acid [and trans fatty acid ] intake increases CHD risk”.

Establishing a level of sodium >480 mg remains consistent with Health Canada’s Nutrition Recommendations... A Call for Action (1990) to lower sodium intake. This level also meets the requirement for foods which may bear the sodium and hypertension health claim.

Under Option 3, the 10% WRNI criterion was included to ensure that foods to be fortified would have an inherent nutritional value and to exclude those foods composed mainly of sugars. It should be noted that no UL was set for sugars intake in the DRI report, however, the report recommended that added sugars should not make up greater than 25% of energy.

As proposed by the industry sector, options with no exclusion criteria were also considered. Under Option 1, all product categories are treated similarly. Under Option 4, each product category would have specific allowable levels of nutrient addition. An underlying assumption regarding the implementation of both Options 1 and 4 is that not all product categories would be fortified, and also that of those product categories that may be fortified, only a segment would be fortified.

Results

1. Consumer Protection

Of all the options, Option 3 offers maximal consumer protection under discretionary fortification, both with regard to the foods that could be fortified, and potential for exposure to excessive intakes if all qualifying foods were fortified. The exposure to excessive intakes from foods is limited because the number and types of foods that may be fortified are restricted. However, individuals who already follow healthy eating recommendations are those most likely to be at risk of excessive intakes under Option 3.

Option 2 ranks second in terms of consumer protection and is consistent with Health Canada’s role in health protection, as this option would reduce the potential for promotion of fortified foods with constituents recognized to be associated with increased risk to health. The levels of Risk Category A and B nutrients that could be added without risk are similar to the levels under Option 3, but only low levels of Risk C nutrients could be added, and only with an assumption that not all foods that could be fortified would be fortified.

Under Option 4, consumer protection would be difficult to ensure because of the continually changing exposure to nutrients from Defined Voluntary Fortification (DVF) as more product categories were approved. An alternative would be to define all possible DVF categories at the outset with maximum levels of addition. This alternative would be a highly burdensome exercise to complete, involving many possible permutations and combinations of fortification on a product category- by- product category basis, and with stakeholder involvement at each step. The danger in taking this approach would be in setting an absolute mechanism which would be unable to adapt to changes in scientific knowledge and the food supply. Based on the levels of nutrient addition proposed by industry, to date, DVF has the potential for the greatest exposure to excessive intakes. This is because of the widespread consumption of the DVF categories of beverages and breakfast cereals, and the requested levels of Risk Category C nutrients. If only a fraction of food products were to be fortified, as the industry has proposed, then the exposure to intakes over the UL may be reduced but the potential would always be there for a high proportion of a category to be fortified as is the case with breakfast cereals.

As with the statistical modelling of the other options, where exposure was assessed under the assumption that all qualifying foods would be fortified if they were permitted, the same approach was also initially taken with Option 1. Results under this scenario indicated no risk of exposure with amounts of Risk Category A nutrients of up to 100% RDA (because no UL has been set for

these nutrients, and no concern expressed) and amounts of Risk B nutrients of up to 25% RDA with no risk of exposure to intakes over the UL from foods . However, with the same assumption, there was no safe level of addition of Risk Category C nutrients.

Industry stakeholders have advised us that modelling based on the assumption that all foods would be fortified, if permitted by the regulations, overestimates exposure because the assumption is unrealistic. An industry stakeholder group provided data to Health Canada indicating that in a mature market in which discretionary fortification predominates, such as seen in the U. S., only a fraction of product categories are fortified, and even within those categories, not all products are fortified, and not all to the maximum permitted level. Further, data were provided indicating that about one third of consumers would be interested in buying a fortified product i.e. “with added functional components” (beverage- 32% of consumers would consider buying; cereals- 47% would consider buying; bars-20% would consider buying) if available.

Thus additional modelling was undertaken under Option 1 to simulate “mature market” scenarios (referred to here as Fixed Market Penetration (FMP)) to explore up to what levels of Risk Category C nutrients could be added with low exposure to excessive intakes. As indicated by the industry group, the main commodities that would be voluntarily fortified in a mature market would include breakfast cereals, instant breakfast powders, ‘bars’ (cereal bars, power bars, including confectionary), beverages including milk, fruit and vegetable juices and drinks, carbonated beverages and water, soy beverages and products, ketchup, wieners and processed meats and frozen dinners. Snack foods such as potato chips were also included. Only a very small per cent of other categories such as 8% of baked goods, 2% of soups would be expected to be fortified (data provided by an industry group). Under the mature market simulations, all ready-to-eat cereals were fixed to the stated level of nutrient addition because of consumer brand loyalty to one or a limited number of cereals.

Figure 1 Option 1: Percent of boys aged 14-16 years with intakes over the UL for calcium under mature market conditions, with 100% of choices fortified (solidline) or with 33% of choices fortified (dashed line). Current baseline is shown at left of scenario "FMP - Cooked cereals + milk" fortified to levels of 5%, 10% or 25% of AI for calcium, but all RTEs fixed at 110mg calcium.

Figure 2 Option 1: Per cent of children aged 6-8 years with intakes over the UL for folic acid under mature market conditions with 100% of choices fortified (solid line) and with 33% of choices fortified (dashed line). Current baseline is shown at left of scenario “FMP-Cooked cereals + milk” fortified to levels of 5%, 10% or 25% of RDA for folic acid, but 200 μg folic acid to all RTE cereals.

Figure 3 Option 1: Percent of children aged 6 - 8 years with intakes over the UL for zinc under mature market conditions with 100% of choices fortified (solid line) and with 33% of choices fortified (dashed line). Current baseline is shown to left of scenario "FMP-Cooked Cereals + Milk" fortified to levels of 5%, 10% or 25% of RDA for zinc, but 1.5mg zinc to all RTE cereals.

In summary, under all options, there is no risk of excessive intake of the nutrients in Risk Category A (p3 of this Appendix) from foods because there is no UL, and no concern expressed by the IOM expert panels. Under all options except Option 4, there is no exposure to excessive intakes of Risk Category B nutrients (p3 of this Appendix) from foods, even if all foods were to be fortified at 25% of RDA or AI; however fortification of all qualifying foods to 50% of RDA or AI results in intakes over the UL. For Risk Category C nutrients (p3 of this Appendix), Option 3 was the only option that resulted in a small exposure (<10%) to intakes over the UL (except for nutrients where intakes are currently over the UL, e. g. zinc), if all qualifying foods were fortified to a level of 10% RDA or AI.

Thus consumer protection is best addressed through Options 2 and 3, with regard to the risk of excessive intakes and the potential for promotion of fortified foods with components associated with risk to health. The former is particularly relevant to Risk Category C nutrients which could be added at moderate levels. The modelling under Option 1 with assumptions of mature market conditions indicates that for some nutrients in Risk Category C (page 3 of this appendix), such as calcium and folic acid, but not zinc, addition up to 10% of RDA or AI could be permitted with minimal risk of excessive intake.

2. Availability and choice/ innovation

Option 1 allows for the greatest number of fortified food choices and wider distribution of nutrients in the food supply because any and all foods, with the exception of a list of standardized and staple foods, and fresh, unprocessed meats, fish, eggs and produce, and infant foods, may be fortified. This option also has the highest potential for innovation. The extent of the potential for innovation will be influenced by decisions on the levels of Risk Category C nutrients permitted.

Option 2 would result in some restrictions on choice of fortified foods, based on saturated and trans fat content and sodium content. As well, innovation would be limited to those foods that meet these criteria. A number of commonly consumed foods, e.g. peanut butter, processed cheese products, soups and vegetable juices, luncheon meats, wieners, would be excluded from fortification. Stakeholders have objected to this exclusion as these foods are widely consumed and can contribute to a healthy diet.

Option 3 is the most restrictive in that it limits fortified food choices to those that are already healthy choices. It would not result in a wider distribution of nutrients in the food supply. Innovation would be hampered because the marketing options for the food industry would be limited.

Option 4 would see wider distribution of nutrients within product categories, and innovation within the approved categories. However, as more DVF categories use up the safe levels of Risk Category B and C nutrients, choices of fortified foods or other foods as sources of nutrients in the rest of the food supply would be limited.

3. Trade and Competitiveness

Option 1 would allow the greatest potential for flexibility in trade. Of all of the options, this allows for much greater trade flexibility because this option does not exclude any foods from potential fortification (except a list standardized and staple foods, alcoholic beverages, infant foods and fresh produce, see p 7 this Appendix).

Options 2 and 3 would result in fairly extensive curtailment of trade due to the exclusion of certain products from fortification. Option 3 in particular results in very few eligible food vehicles for fortification.

Option 4 would see lower concerns about trade in the approved product categories, however, the levels of Risk Category C nutrients permitted would be a limitation to trade. The nutrients and the levels permitted would be influenced by the number of product categories manufacturers wish to fortify with a given nutrient. There is potential for a “first in the door” approach to obtain all of the nutrients of marketing interest, creating an unlevel playing field and limit any future innovation or changes.

Implications

1. Education / Information / Risk Communication

The risk communication may be most challenging under Option 1 since it does not require eligibility criteria for foods permitted fortification, and promotion of fortified foods may result in consumers switching to fortified foods containing constituents with recognized risk to health or with little or no nutritional benefit as opposed to any unfortified but otherwise healthy food choice. To date there is no evidence that such switching of food choices occurs, but neither has this been systematically investigated. To prevent this switching of choices, consumers need to be aware of healthy eating guidelines, and have increased knowledge about the composition of foods. As well, the food industry would need to fortify responsibly and would need to develop appropriate messaging to inform and educate consumers of the risks.

Under Option 2, Health Canada would retain credibility through consistency in public health messaging about saturated and trans fat and sodium. The fortification of foods with little nutritional value (foods mainly sugars, carbonated beverages) would be permitted under this option, a situation that is not supported by the public health sector. However, the potential risk to health under this option would be mainly from excessive nutrient intakes, which can be controlled by the levels permitted.

Under Option 3, risk communication would be simplest, since messages about healthy eating would be consistent with other Health Canada nutrition promotion activities. However, messages will still remain difficult regarding explanation of why already healthy food choices are being fortified. Of all of the options for discretionary fortification, this is the one that the public health sector supports, if discretionary fortification must be implemented.

The implications of DVF are the same as for Option 1, but the issue of risk communication/messaging is the most complex. In addition to the issue of mixed messages/ confusion regarding the consumption of foods with components recognized to be associated with risk to health, of greater concern is the potential exposure of subgroups to high levels of Risk C nutrients, i.e. the risk of excessive intakes is potentially much greater than under Option 1 because as more food categories are approved, each with its defined levels of Risk Category C nutrients the chance of exposure to these nutrients increases. Safe implementation of this option would require consumer knowledge of ULs and the contribution of foods to those levels.

2. Monitoring Impact

Monitoring needs depend on the foods that are fortified, the extent of fortification of the food supply, and the nutrients and levels of addition. The monitoring needs are greatest under Option 1, since the entire food supply would be affected. There is a potential increased health risk of consumption of foods with components of known risk to health which will need to be monitored, as well as exposure to excessive nutrient intakes. At a minimum, consumption patterns across the entire food supply will need to be assessed. The Canadian Community Health Survey 2.2 (the Nutrition Focus Survey), a nationally representative survey on food consumption and healthy living initiated in January 2004 may help provide a good baseline. A second survey scheduled to go into the field in January 2006, during which blood and urine samples will be collected to look at a number of biochemical measures as well as physical measures of nutritional status will provide an important addition to the baseline assessment.

Monitoring under Option 1 particularly will also require the industry participation to coordinate effective and efficient means of collecting and analysing pertinent data. Access to marketing data, consumption patterns and other market trend information by government would significantly aid in this process. If the implementation of Option 1 differs from what the industry has stated they would reasonably do, then changes to the regulations can be made to ensure that the risks to health are minimized.

Under Option 2, although monitoring requirements are similar to those of the other options, the urgency of implementation is less because there is lower risk of consuming foods with risk to health and therefore, no potential increase in coronary heart disease, hypertension, etc. due to this option.

Under Option 3, the urgency for monitoring the impact is the lowest of any option due to the fact that potential increases in chronic diseases (hypertension, heart disease, etc.) are not expected because foods with constituents associated with risk to health would not be fortified. As well, risks of excessive intake are minimal as the number of allowable fortified foods is very limited.
Requirements for establishing monitoring mechanisms are also lessened under this option, as the segment of the food supply which would include fortified products would be small. Industry’s and government’s roles in monitoring the impact of the fortified foods allowed under this option would be more manageable due to the smaller scale of discretionary fortification.

Monitoring needs under Option 4, DVF, or with DVF in combination with any other option would be similar to those in Option 1. The monitoring would have the added complexity of a constantly shifting market place as more DVF categories would be approved over time. This option has the potential to affect the entire food supply over time.

3. Regulations and Enforcement

Regulatory burden under Option 1 is the lowest amongst all of the options. Requirements involve specifying ranges for nutrients in the different risk categories.

Effective enforcement of acceptable levels of nutrients will require significant resources, both in terms of manpower and technical and analytical capacity. Cooperation between the industry and government would be required to share enforcement mechanisms needed for this option.

Under Options 2 and 3, the regulatory burden increases for Health Canada in setting out eligibility criteria for food vehicles as well as the ranges of addition. However, the major burden is that of enforcement which would require the assessment of saturated and trans fat content and sodium content, as well as assessing the total nutrient content of the products for compliance under Option 3. This in itself would require considerable resources to establish and maintain. Essentially, without a practical enforcement plan, industry will become self-regulating under this option.

The regulatory burden of DVF is greater than for the other options as each new product category and its levels of addition would be approved on a sequential basis in discussion with relevant stakeholders. Because the product categories would be defined over time, Health Canada would be unable to plan for safe levels of addition in future applications, and could be seen as inefficient and unprepared. Although CFIA may be better able to enforce compliance with defined product categories and defined levels of addition, the changing market place as new products are approved would be an increasing burden over time.

Table 1: Options and Fortification Levels Nov 27 03