1. SCOPE
1.1 Permitted Food Additives
Only the food additives listed herein are permitted for use in foods in conformance with the provisions of this Standard1. Only food additives which have been evaluated by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and found acceptable for use in foods are included in this Standard.
1.2 Foods in Which Additives May Be Used
This Standard sets forth the conditions under which permitted food additives may be used in all foods, whether or not they have previously been standardized by Codex. The food additive provisions of Codex Commodity Standards shall be included in and superseded by the provisions of this Standard. These provisions also comply with the other requirements of the Preamble.
1.3 Foods in Which Additives May Not Be Used
Food categories or individual food items where the use of food additives are not allowed or are restricted are defined by this Standard.
1.4 The Permitted Levels of Use for Food Additives
The primary objective of establishing permitted levels of use of food additives in various food groups is to ensure that the intake of additives does not exceed the acceptable daily intake.
The food additives covered by this standard and their maximum levels of use are based in part on the food additive provisions of previously established Codex commodity standards, or upon the request of governments after subjecting the requested maximum levels to an appropriate method which would verify the compatibility of a proposed maximum level with the ADI.
The Danish budget method may be used as a first step in this regard2. The submission of actual food consumption data is also encouraged.
2. DEFINITIONS OF TERMS USED IN THIS STANDARD
Food additive means any substance not normally consumed as a food by itself and not normally used as a typical ingredient of the food, whether or not it has nutritive value, the intentional addition of which to food for a technological (including organoleptic) purpose in the manufacture, processing, preparation, treatment, packing, packaging, transport or holding of such food results, or may be reasonably expected to result (directly or indirectly), in it or its by-products becoming a component of or otherwise affecting the characteristics of such foods. The term does not include contaminants or substances added to food for maintaining or improving nutritional qualities.3
Acceptable Daily Intake (ADI) is an estimate by JECFA of the amount of a food additive, expressed on a body weight basis, that can be ingested daily over a lifetime without appreciable health risk (standard man = 60 kg).4
Acceptable Daily Intake “Not Specified” (NS)5 is a term applicable to a food substance of very low toxicity which, on the basis of the available data (chemical, biochemical, toxicological, and other), the total dietary intake of the substance arising from its use at the levels necessary to achieve the desired effect and from its acceptable background in food does not, in the opinion of JECFA, represent a hazard to health. For that reason, and for reasons stated in individual JECFA evaluations, establishment of an acceptable daily intake expressed in numerical form is not deemed necessary by JECFA. An additive meeting this criterion must be used within the bounds of good manufacturing practice as defined in sub-paragraph 3.3 below.
3. GENERAL PRINCIPLES FOR THE USE OF FOOD ADDITIVES6
Only those food additives shall be endorsed and included in this Standard which, so far as can be judged on the evidence presently available from JECFA, present no risk to the health of the consumer at the levels of use proposed.
The inclusion of a food additive in this Standard shall have taken into account any Acceptable Daily Intake, or equivalent assessment, established for the additive and its probable daily intake7 from all sources. Where the food additive is to be used in foods eaten by special groups of consumers, account shall be taken of the probable daily intake of the food additive by consumers in those groups.
3 Codex Alimentarius, Second Edition (Revised 1995), Volume 1A (General Requirements), p. 11.
4 Principles for the Safety Assessment of Food Additives and Contaminants in Food, World Health
Organization, (WHO Environmental Health Criteria, No. 70), P. 111 (1987).
5 For purposes of this Standard, the phrase acceptable daily intake (ADI) “not limited” (NL) has the same
meaning as ADI “not specified”. The phrase “acceptable ADI” refers to an ADI which is more appropriately
limited by the level of treatment of the food, rather than on a mg additive per kg body weight per day basis
(see, Summary of Evaluations Performed by the Joint FAO/WHO Expert Committee on Food Additives
(JECFA), FAO/WHO, ILSI Press, 1994, Part 1, p. 3).
6 General Principles for the Use of Food Additives were originally adopted by the Ninth Session of the Codex
Alimentarius as a Codex Advisory Text (para. 295, ALINORM 72/35) and were reprinted in the Second
Edition of the Codex Alimentarius, Vol. 1A, (General Requirements) pp. 45–47 (Revised 1995). Pertinent
portions of the Text have now been incorporated as an integral part of this Standard, suitable modifications
having been made as necessary with respect to the present context.
7 “Guidelines for Simple Evaluation of Food Additive Intake”, CAC/VOL. XIV Ed. 1, Supplement 2 (1989),
gives procedures for calculating the theoretical maximum daily intake (TMDI) and the estimated daily intake
(EDI) of food additives; other appropriate procedures may be used to calculate the TMDI and EDI.
3.2 The use of food additives is justified only when such use has an advantage, does not present a hazard to health of and does not mislead the consumer, and serves one or more of the technological functions set out by Codex and needs set out from (a) through (b) below, and only where these objectives cannot be achieved by other means which are economically and technologically practicable:
to preserve the nutritional quality of the food; an intentional reduction in the nutritional quality of a food would be justified in the circumstances dealt with in sub-paragraph (b) and also in other circumstances where the food does not constitute a significant item in a normal diet;
to provide necessary ingredients or constituents for foods manufactured for groups of consumers having special dietary needs;
to enhance the keeping quality or stability of a food or to improve its organoleptic properties, provided that this does not change the nature, substance or quality of the food so as to deceive the consumer;
to provide aids in the manufacture, processing, preparation, treatment, packing, transport or storage of food, provided that the additive is not used to disguise the effects of the use of faulty raw materials or of undesirable (including unhygienic) practices of techniques during the course of any of these activities.
3.3 Good Manufacturing Practice (GMP)8
All food additives subject to the provisions of this Standard shall be used under conditions of good manufacturing practice, which include the following:
the quantity of the additive added to food shall be limited to the lowest possible level necessary to accomplish its desired effect;
the quantity of the additive that becomes a component of food as a result of its use in the manufacturing, processing or packaging of a food and which is not intended to accomplish any physical, or other technical effect in the food itself, is reduced to the extent reasonably possible; and,
the additive is prepared and handled in the same way as a food ingredient.
3.4 Specifications for the Identity and Purity of Food Additives
Food additives used in accordance with this Standard should be of appropriate food grade quality and should at all times conform with the applicable Specifications of Identity and Purity recommended by the Codex Alimentarius Commission9 or, in the absence of such specifications, with appropriate specifications developed by responsible national or international bodies. In terms of safety, food grade quality is achieved by compliance with the specifications as a whole and not merely with individual criteria.
8 For additional information, see Codex Alimentarius Commission, Procedural Manual, Ninth Edition (1995),
pp. 116–117.
9 Food additive specifications endorsed by the Codex Alimentarius Commission are included in the JECFA
“Compendium of Food Additive Specifications”, Volumes 1 and 2 (1992), and in addenda thereto, published
by FAO.
4. CARRY-OVER OF FOOD ADDITIVES INTO FOODS10
4.1 Compliance with the Carry-Over Principle
Other than by direct addition, an additive may be present in a food as a result of carry-over from a food ingredient, subject to the following conditions:
the additives is permitted in the raw materials or other ingredients (including food additives) according to this General Standard;
the amount of the additive in the raw materials or other ingredients (including food additives) does not exceed the maximum amount so permitted.
the food into which the additive is carried over does not contain the food additive in greater quantity than would be introduced by the use of the ingredients under proper technological conditions or manufacturing practice.
4.2 Ingredients and Raw Materials as Carriers for Additives11
An additive is permitted in a raw material or other ingredient if the raw material or ingredient is used exclusively in the preparation of a food which is in conformity with the provisions of the standard.
5. FOOD CATEGORY SYSTEM12
The food category system is a tool for the allocation of food additive uses authorized by this Standard. The food category system applies to all foodstuffs including those in which no additives are permitted.
The food descriptors are not to be legal product designations nor are they intended for labelling purposes.
The food category system is based on the following principales:
The food category system is hierarchical, meaning that when the use of an additive is permitted in a general category, it is automatically permitted in all its sub-categories, unless otherwise stated. Similarly, when an additive is permitted in a sub-category, its use is also allowed in any further sub-categories and in descriptors or individual foodstuffs mentioned in a sub-category.
The food category system is based on product descriptors of foodstuffs as marketed, unless otherwise stated.
The food category system takes into consideration the carry-over principle. By doing so, the food category system does not need to specifically mention compound foodstuffs, e.g., prepared meals, because they may contain, pro rata, all the additives allowed in their components, except when the compound foodstuff needs and additive which is not authorized in its components.
The food category system is used to simplify the reporting of food additive uses for assembling and constructing this Standard.
10 The principle relating to the carry-over of food additives into foods (the “Carry-Over Principle”) addresses the
presence of additives in food as a result of the use of raw materials or other ingredients in which these
additives are used. The Codex Alimentarius Commission at its 17th Session (1987) adopted a revised
statement of the principle as a Codex Advisory Text. The Text is printed in its entirety in Codex Alimentarius,
Second Edition, Vol. 1A (General Requirements), pp. 94–95, 1992. The Carry-Over Principle applies to all
foods covered by Codex Standards, unless otherwise specified in such standards.
11 See ALINORM 97/12, para. 44.
12 Each Codex Commodity Standard has been initially assigned to one of the food categories or sub-categories of
the food category based on the system developed by the Confédération des Industries Agro-Alimentaires de la
CEE (CIAA). It is expected that the food category system for the Standard (CL 1996/14-FAC) will form the
basis of a new food classification scheme that will be eventually proposed for adoption by the CAC. Codex
Standard Numbers (CXSNs), together with the corresponding names of the Codex Commodity Standards and
the food categories and sub-categories to which the CXSNs have been classified, are listed in ANNEX B.
6. FORMAT OF THE STANDARD
The food additives listed herein have been grouped into the 23 major functional classes of the Codex International Numbering System (INS) for Food Additives.13 Schedule 1 of this Standard specifies, for each food additive (or food additive group) within each major functional class, the foods in which the additives may be used, together with their maximum levels of use.
Schedule 2 of this Standard contains essentially the same information as that provided in Schedule 1 but is arranged by food category and specifies which food additives may be used in foods covered by each category, as well as the maximum levels and conditions of use for each.
Unless otherwise specified, maximum levels for food additives are set on the final product as consumed.
7. REVIEW AND REVISION OF THE STANDARD
7.1 Review of the Standard
The food additive provisions for this Standard shall be reviewed on a regular basis and revised as necessary in light of revisions of Acceptable Daily Intakes by JECFA or of changing technological need and justification for use.
7.2 Revision of the Standard
The food additive provisions of this Standard shall be amended necessary. Proposed revisions of this Standard may be initiated by recommendations by Codex Committees, Codex member States, or the Codex Commission. Information to support amendment of the Standard shall be provided by the proposing body. Supporting information that shall be provided to the Codex Committee on Food Additives and Contaminants may include, as appropriate:
Specifications for the food additive;
intended food category or sub-category, and use level for the food additive;
summary of JECFA safety evaluation of the food additive; and
technological justification and need for the additive.
The Codex Committee for Food Additives and Contaminants shall consider all proposed amendments to this Standard.
