CODEX STAN 192-1995 GENERAL STANDARD FOR FOOD ADDITIVES.pdf
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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 The food additive provisions of Codex Commodity Standards shall be included in and superseded by the provisions of this Standard.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
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