General principles for addition of nutrients to foods
Consideration of additional requirements
Nutrients are increasingly being added to foods for a number of reasons and this tendency raises the issue of the regulation of such practices. Discussion on the impact of legislation was based on the working paper entitled 'Impact of Legislation on Food Fortification Practices' (CONFORT 3).
It should be stressed here that there is a substantial body of legislation at the national level, as well as Codex international recommended standards which are applicable to all food products. The Consultation stressed that these same requirements must in general apply also to foods to which nutrients are added. However, some specific issues related to the practice of addition of nutrients to foods may require additional legal provisions. Such provisions, however, should cover the subject of the addition of nutrients horizontally across a range of foods. Vertical (product specific) legislation should be discouraged unless strictly necessary.
At the present stage of world trade development, the existence of international provisions pertaining to the addition of nutrients to foods are necessary in order to facilitate trade in such products. Within the FAO/WHO Food Standards Programme, the Codex Alimentarius Commission has adopted "General Principles for the Addition of Essential Nutrients to Foods".
According to these General Principles, essential nutrients may be added to food in order to achieve any of the following: restoration of nutrients lost during processing; nutritional equivalence of substitute foods; fortification; and ensuring the appropriate nutrient composition for a special purpose food. The basic principles for the addition of essential nutrients to foods, as stated by the Codex Alimentarius Commission are:
1. The essential nutrient should be present at a level which will not result in either an excessive or an insignificant intake of the added essential nutrient considering amounts from other sources in the diet;
2. The addition of an essential nutrient to a food should not result in an adverse effect on the metabolism of any other nutrient;
3. The essential nutrient should be sufficiently stable in the food under customary conditions of packaging, storage, distribution and use;
4. The essential nutrient should be biologically available from the food;
5. The essential nutrient should not impart undesirable characteristics to the food and should not unduly shorten the food shelf life;
6. Technology and processing facilities should be available to permit the addition of the essential nutrient in a satisfactory manner;
7. Addition of essential nutrients to foods should not be used to mislead or deceive the consumer as to the nutritional merit of the food;
8. The additional cost should be reasonable for the intended consumer;
9. Methods of measuring, controlling and/or enforcing the levels of added essential nutrients in the foods should be available;
10. When provision is made in food standards, regulations or guidelines, for the addition of essential nutrients to foods, specific provisions should be included identifying the essential nutrients which are to be considered or be required and the levels at which they should be present in the food to achieve their intended purposes.
As stated previously, the Codex definition of fortification is, "...the addition of one or more essential nutrients to a food whether or not it is normally contained in the food, for the purpose of preventing or correcting a demonstrated deficiency of one or more nutrients in the population or specific population groups...". Within the above General Principles outlined by the Codex, nutrient addition for purposes of fortification should be the responsibility of national authorities since the kinds and amounts of essential nutrients to be added and foods to be fortified will depend upon the particular nutritional problems to be corrected, the characteristics of the target populations and the food consumption patterns in the area. Any fortification programme should meet the following conditions:
- There should be a demonstrated need for increasing the intake of an essential nutrient in one or more target groups. This may be in the form of actual clinical or sub-clinical evidence of deficiency, estimates indicating low levels of intake of nutrients or possible deficiency likely to develop because of changes taking place in food habits;
- The food selected as a vehicle for the essential nutrients should be consumed by the population at risk;
- The food selected as a vehicle for the essential nutrient(s) should be stable and uniform and the lower and upper levels of intake should be known;
- The amount of the essential nutrient added to the food should be sufficient to correct or prevent the deficiency when the food is consumed in normal amounts by the population at risk;
- The amount of the essential nutrient added should not result in excessive intakes by individuals with a high intake of a fortified food.
The Consultation felt that there were a number of issues related to food fortification which should be additionally considered:
Compulsory addition of nutrients
Such rules would be the responsibility of national authorities and respond to specific regional, national or even local situations. Specific provisions may address:
- Specific food vehicles to be chosen on the basis of the recommendations given above;
- Specific nutrients that may be added to these foods;
- Specific levels which would be appropriate for the situation.
Existing legislation currently pertaining to nutrient addition to selected food products in many countries are included in Annex 7.
The establishment of an advisory list of nutrients
The establishment of an advisory list of nutrients and nutrient compounds to be used in food fortification should be encouraged. The Consultation felt that the Advisory lists of mineral salts and vitamin compounds for use in foods for infants and young children detailed in the Codex Alimentarius Volume 4-1994, would be an excellent starting point. Such a list should be regularly updated taking into account new scientific and technological developments and data on safety, bioavailability, stability and other relevant data.
Foods to which nutrients may be added
The Consultation felt that a list of foods to which nutrients may be added should not be drawn. However, the selection of such foods should be guided by the principles set out in the appropriate Codex guidelines referred to above.
Levels of nutrients
The Consultation believed that minimum levels for the addition of nutrients should be set, in international recommended standards, according to the purpose of the addition. The setting of maximum levels, it was felt, should be considered for those nutrients for which there is evidence that excessive intakes would result in undesirable effects.
It has already been stated that general labelling rules and specific rules on nutrition labelling should apply. A particular issue of interest is that of nutrition claims and health claims to be made for foods to which nutrients are added.
Experience has shown that the success of food fortification programmes can be enhanced by permitting the manufacturers to make relevant claims. Commercial realities would also advocate that such permission also be granted when nutrients are added voluntarily to foods. However, care should be taken that use of claims does not result in practices that could mislead or deceive the consumer or distort the true value of the fortification.
Given that the subject of health and nutrition claims on food labelling is currently being discussed within the Codex Alimentarius programme, the Consultation did not deem it appropriate to discuss it further. However, the Consultation recommended that Codex accelerate the resolution of this important matter.
Finally, the Consultation suggested that the extent of legislative measures to be developed should not be such as to make fortification practices cumbersome nor restrict communication on the availability of the fortified food. The legislative development process should involve extensive consultation with the scientific community, industry, consumers and other relevant, interested parties.