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1、CODEX STAN 192 - PREAMBLE Page 1 of 78 GENERAL STANDARD FOR FOOD ADDITIVES CODEX STAN 192-1995, Rev. 4-2003 PREAMBLE 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 wh
2、ich 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,
3、 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 The food additive provisions of Codex Commodity Standards shall be included in and superseded by the provisions of this Standard.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 MA
4、Y 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 gr
5、oups 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 govern
6、ments 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. DEFI
7、NITIONS OF TERMS USED IN THIS STANDARD a) 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 organolepti
8、c) 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 food
9、s. The term does not include contaminants or substances added to food for maintaining or improving nutritional qualities.3 1 Notwithstanding the provisions of this Section of the General Standard, the lack of reference to a particular additive or to a particular use of an additive in a food in the G
10、eneral Standard as currently drafted, does not imply that the additive is unsafe or unsuitable for use in food. The Commission shall review the necessity for maintaining this footnote on a regular basis, with a view to its deletion once the General Standard is substantially complete. 2 “Consensus Do
11、cument on the Danish Budget Method”, Nordic Working Group on Food Toxicology and Risks Evaluation, Report No. 4/90. 3 Codex Alimentarius, Second Edition (Revised 1995), Volume 1A (General Requirements), p. 11. CODEX STAN 192 - PREAMBLE Page 2 of 78 b) Acceptable Daily Intake (ADI) is an estimate by
12、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 c) Acceptable Daily Intake “Not Specified“ (NS)5 is a term applicable to a food substance of very low toxicity which, on the b
13、asis 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 healt
14、h. 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-par
15、agraph 3.3 below. 3. GENERAL PRINCIPLES FOR THE USE OF FOOD ADDITIVES 6 3.1 a) 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 p
16、roposed. b) 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 c
17、onsumers, account shall be taken of the probable daily intake of the food additive by consumers in those groups. 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 tec
18、hnological functions set out by Codex and needs set out from (a) through (d) below, and only where these objectives cannot be achieved by other means which are economically and technologically practicable: a) to preserve the nutritional quality of the food; an intentional reduction in the nutritiona
19、l 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; 4 Principles for the Safety Assessment of Food Additives and Contaminants in Food, World Health Organiza
20、tion, (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
21、 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 ad
22、opted 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 integ
23、ral 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
24、 the estimated daily intake (EDI) of food additives; other appropriate procedures may be used to calculate the TMDI and EDI. CODEX STAN 192 - PREAMBLE Page 3 of 78 b) to provide necessary ingredients or constituents for foods manufactured for groups of consumers having special dietary needs; c) to e
25、nhance 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; d) to provide aids in the manufacture, processing, preparation, treatment, packing, transport or
26、 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
27、provisions of this Standard shall be used under conditions of good manufacturing practice, which include the following: a) the quantity of the additive added to food shall be limited to the lowest possible level necessary to accomplish its desired effect; b) the quantity of the additive that becomes
28、 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, c) the additive is prepared and handled in the sa
29、me 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
30、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 crit
31、eria. 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: a) the additive is permitted in the raw materials
32、 or other ingredients (including food additives) according to this General Standard; 8 For additional information, see Codex Alimentarius Commission Procedural Manual, Tenth Edition (1997), p. 78. 9 Food additive specifications endorsed by the Codex Alimentarius Commission are included in the JECFA
33、“Compendium of Food Additive Specifications“, Volumes 1 and 2 (1992), and in addenda thereto, published by FAO. 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
34、 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-
35、 95, 1992. The Carry-Over Principle applies to all foods covered by Codex Standards, unless otherwise specified in such standards. CODEX STAN 192 - PREAMBLE Page 4 of 78 b) the amount of the additive in the raw materials or other ingredients (including food additives) does not exceed the maximum amo
36、unt so permitted. c) 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 ADDIT
37、IVES11 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
38、 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 fol
39、lowing principles: a) 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 a
40、llowed in any further sub-categories and in descriptors or individual foodstuffs mentioned in a sub-category. b) The food category system is based on product descriptors of foodstuffs as marketed, unless otherwise stated. c) The food category system takes into consideration the carry-over principle.
41、 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.
42、d) The food category system is used to simplify the reporting of food additive uses for assembling and constructing this Standard. 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 F
43、ood Additives.13 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 Confdration des Industries Agro-Alimentaires de la CEE (CIAA). It is expected that t
44、he 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 a
45、nd sub-categories to which the CXSNs have been classified, are listed in ANNEX B. 13 Although the General Standard as currently drafted covers only antioxidants and preservatives, the complete Standard will eventually cover the uses of food additives in all 23 INS functional classes; see Codex Alime
46、ntarius Vol. 1A, Second Edition (Revised 1995), Section 5.2, pp. 57-92. CODEX STAN 192 - PREAMBLE Page 5 of 78 Table 1 of this Standard specifies, for each food additive or food additive group (in alphabetical order), the foods in which the additive is acceptable for use, together with the acceptabl
47、e maximum use levels. Table 1 also includes the uses of those additives with non-numerical ADIs for which a maximum use level is specified. Table 2 of this Standard contains the same information as Table 1, but the information is arranged by food category number. Table 3 of this Standard lists addit
48、ives with non-numerical JECFA ADIs that are acceptable for use in foods in general when used at quantum satis levels and in accordance with the principles of good manufacturing practice described in Section 3.3 of this preamble. The Annex to Table 3 lists food categories and individual food items ex
49、cluded from the general conditions of Table 3. The provisions in Table 1 and 2 govern the use of additives in the food categories listed in the Annex to Table 3. Table 1, 2 and 3 do not include reference to the uses of substances as processing aids. 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 JEC