Characteristics of a Fortification Program

Food fortification can be mandatory (required by government regulations) or voluntary (permitted by government regulations and policies). Some characteristics of both types of fortification programs are presented in Table 2. As with any intervention, each of these has certain advantages and limitations that have to be considered to determine the regulatory course that is most appropriate for the country and for the public health concern at hand. For example, it is reported that voluntary fortification of foods with folic acid in Australia and New Zealand, while demonstrating benefits, has not reached the target population to the extent intended. Therefore, policymakers are considering mandatory fortification as an option to ensure sufficient folate intake among all women in Australia and New Zealand.

At the international level, the Codex Alimentarius Commission has adopted a set of criteria which allow for the rational addition of nutrients to improve the nutritional quality of the overall food supply and prevent indiscriminate fortification of foods, while acknowledging that the need for, and appropriateness of, addition of nutrients to foods will depend on the nutritional problems of a country, the characteristics of the target populations, and

Table 2 Characteristics of mandatory and voluntary food fortification

Mandatory fortification

Voluntary fortification

Initiated by government

Regulations require addition of nutrients

Food vehicle(s) are staple foods consumed in significant and relatively stable amounts

Driven primarily by a documented need for a public health intervention

Resource-intensive, coordinated multi-sector effort Targeted to reach populations at risk of deficiency Excessive intakes of fortified nutrients are minimized Adverse effects on other nutrient intakes or health conditions due to fortification are curtailed Fortification levels and food vehicles are tightly controlled A cost-effective nutrition intervention for governments Proven to be an effective strategy to eliminate micronutrient deficiencies in the general population

May be initiated by government or by industry Regulations provide for optional addition of nutrients Both staple and nonstaple foods are used as food vehicles Driven primarily by consumer demand and market forces Relatively fewer resources are needed, particularly from the public sector

Can be introduced quickly

In the case of breakfast cereals, proven to make substantial contributions to nutrient intakes

Random fortification and overfortification of the food supply is a potential concern although this can be minimized by appropriate regulatory restrictions aWhile government-initiated fortification is usually mandatory, it can be 'voluntary' in that food companies have the option of selling unfortified versions of the food provided they are appropriately labeled. For example, in Canada, 'flour' or 'enriched flour' is required to contain specified amounts of thiamin, riboflavin, niacin, folic acid, and iron (B.13.001, Food and Drug Regulations) and 'milk' is required to be fortified with vitamin D (B.08.003, Food and Drug Regulations). In the US, however, 'enriched flour' is required to contain these nutrients, but 'flour' is not (Title 21 of the Code of Federal Regulations, sections 137.105 and 137.165) and 'milk, vitamins A and D added' is required to contain specified amounts of these vitamins, but 'milk' is not (21 CFR 131.110).

their food consumption patterns. The Codex general principles for the addition of essential nutrients to foods (CAC/GL 09-1987) state the following:

• The nutrient should be present at a level that will not result in an excessive or an insignificant intake of the added nutrient considering the amounts from other sources in the diet.

• The nutrient should not result in an adverse effect on the metabolism of any other nutrient.

• The nutrient should be sufficiently stable in the food during packaging, storage, distribution, and use.

• The nutrient should be biologically available from the food.

• The nutrient should not impart undesirable characteristics to the food, or unduly shorten shelf-life.

• The additional cost should be reasonable for the intended consumers, and the addition of nutrients should not be used to mislead the consumer concerning the nutritional quality of the food.

• Adequate technology and processing facilities should be available, as well as methods of measuring and/or enforcing the levels of added nutrients.

The Codex principles mirror the criteria proposed in the US (in 1974) as conditions to be met to support food fortification, including the following:

• There should be a demonstrated need for increasing the intake of an essential nutrient in one or more population groups.

• The food selected as a vehicle should be consumed by the population at risk and intake of this food should be stable and uniform.

• The amount of nutrient added should be sufficient to correct or prevent the deficiency when the food is consumed in normal amounts by the population at risk.

• The addition of the nutrient should not result in excessive intakes.

Many developed countries have adopted various regulations to either require or permit manufacturers to fortify their food products in a safe and appropriate manner, and to market such products in a manner that is truthful and not misleading to consumers. In some countries, such as Norway, Finland, and Denmark, voluntary fortification has been considered unnecessary and potentially harmful and, therefore, is generally restricted. However, in many other countries, such as the US, UK, Canada, Switzerland, and Belgium, regulations are less restrictive allowing foods to be fortified voluntarily as long as fortification is safe and harmful levels of nutrients are avoided.

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