(and for establishing permitted lists)
Draft standard considered by the Codex Alimentarius Commission
in first reading * and now referred to Governments for detailed comments
Text prepared by the Secretariat from Reports of the Joint FAO/WHO Expert Committee on Food Additives
* with editorial revisions by the Secretariat.
For the purposes of these general principles, the term “food additive” is understood to cover non-nutritive substances added intentionally to food, generally in small quantities, to prevent spoilage, to stablize or improve its keeping qualities, texture, flavour and appearance and to provide aids in processing. This use of the term is not intended to restrict any wider coverage which may later be agreed on for use under the Codex.
The use of food additives is justified only when it serves the following purposes:
the maintenance of the nutritional quality of a food;
the enhancement of keeping quality or stability with resulting reduction in food wastage;
making foods attractive to the consumer in a manner which does not lead to deception
providing essential aids in food processing.
If food additives at present in use have not already been subjected to adequate examination to ensure minimum risk in use, this should be done, unless existing knowledge indicates that it is unnecessary.
All food additives proposed in the future should be subjected to toxicological examination to minimize risk before being accepted for use.
Food additives accepted for use should be subjected to continuing observation for possible deleterious effects under changing conditions of use and should be reappraised whenever indicated by advances in knowledge.
The food additives to be included in the permitted lists to be published in the Codex Alimentarius have been considered by the Joint FAO/WHO Expert Committee on Food Additives which has evaluated the available toxicological data, and established acceptable daily intake levels together with specifications for their identity and purity.
Food additives may under special circumstances be included on a provisional basis in the permitted lists, and remain provisionally on such lists until the Joint FAO/WHO Expert Committee has been able to evaluate the available toxicological data and drawn up specifications for their identity and purity.
When it is desired to include other additions in the permitted lists, requests should be sent to FAO/WHO detailing the additional substances suggested, together with published and unpublished data on specifications for identity and purity as well as detailed reports of toxicological and related studies. All documents should be submitted in duplicate.
In the permitted lists of food additives in the Codex Alimentarius acceptable daily intake zones are indicated. The acceptable zones represent the limits of intake that can be regarded as presenting no signficant hazard to health on the basis of the evidence available. However, the problems that may arise from the introduction of a food additive into the diet may be complex and may sometimes require further study by experts in nutrition or other related fields. This is more likely to occur when high levels of dosage are used or if the food additive is to be used in foods mainly consumed by some special group in the community, such as children.
Expert opinion will be required whenever higher dosage levels of certain food additives are to be used or when special circumstances arise. The zone of acceptability has therefore been split into two parts in selected cases. The first part has been termed the unconditional zone of acceptability and this represents a level of use that is effective technologically at least for some purposes, and can be safely employed without further expert advice. The second part consists of a conditional zone which is equally acceptable and represente levels of use that can be employed safely but at these levels it is thought desirable that some degree of expert supervision and advice should be readily available. It is, therefore, intended that the unconditional zones of acceptability should be regarded as a guide to developing countries that may not be able to call upon appropriate experts to guide them in the handling of particular problems in this field. The conditional zones of acceptability on the other hand are more likely to be of interest to those countries that have a more elaborate organization for dealing with food policy and the health hazard of the consumer. It must be emphasized that the whole zone of acceptability may be safely employed. It provides for an adequate margin of safety after careful consideration of the evidence available. Added precautions in the unconditional zone of acceptability are only necessary in the special circumstances described.
It cannot be too strongly emphasized that food additives should only be used when necessary and that the level of use should not exceed the lowest level that can achieve the desired technological effect under good manufacturing practices.
The acceptable daily intake zones indicated in the permitted lists of the Codex Alimentarius should not be used out of their context. Before using them, the relevant report of the Joint FAO/WHO Expert Committee should be consulted.
The following procedure illustrates how the information available from daily intake zone figures may be effectively used:
Decide upon the effective level of the food additive under consideration that would be needed in good technological practice.
Examine the possible uses and list all the foods in which the food additive might be used.
Calculate the daily intake level that might occur if the food additive was used in all the foods for which it might be a useful additive, working on the basis of the average intake of the food materials containing the additive. This average intake for appropriate population groups is obtained from national food consumption surveys. For certain kinds of food, consideration should be given to relatively large variations in consumption between individuals or between special groups of the population. Such individuals or groups might be exposed to excessive amounts of the additive if the calcualtion is based on average levels derived from food consumption surveys. Examples of this are beverages and sweets, which may be consumed by children in much larger quantities than the average.
Obtain the necessary information from which to calculate the average body weight of the population group concerned (usually between 50 and 70 kgs.).
From this information calculate the intake of the additive in mg. per kg. of body weight per day.
Check this figure against the acceptable intakes given for the substance in the table. If it falls within the unconditional zone, the situation is satisfactory and the level proposed may be accepted. If it falls within the conditional intake zone, further scientific advice is required before the level of use proposed is accepted.
Example
A substance X is proposed as a food additive in several foods at a level of treatment of 100 p.p.m. of the food as it is eaten.
The foods in which it might occur are listed and the amounts of these foods that would be eaten daily on the basis of national food consumption survey are calculated.
The total average intake of treated food of an average man is found to be 500 gs. a day. The daily intake of X is therefore estimated at 50 mgs.
The body weight of an average man in the population under consideration is 70 kgs.
Therefore the intake of X would be 0.7 mg/kg body weight per day.
From examination of the table on Appendix A the acceptable daily intakes for substance X are:
| unconditional zone: | 0–1 mg/kg body weight |
| conditional zone: | 1–7.5 mg/kg body weight |
Thus, the suggested use of substance X gives an intake in the unconditional zone. It is therefore acceptable without further advice. (Substance X is an imaginary substance and the figures given here are only illustrative.)
