GENERAL STANDARD FOR FOOD ADDITIVES

1 CODEX STAN 192 Page 1 GENERAL STANDARD FOR food ADDITIVESCODEX STAN 192-1995, Rev. 3-20011. PERMITTED food ADDITIVESOnly the food ADDITIVES listed herein are permitted for use in foods in conformance with theprovisions of this Standard1. Only food ADDITIVES which have been evaluated by the Joint FAO/WHO ExpertCommittee on food ADDITIVES (JECFA) and found acceptable for use in foods are included in this FOODS IN WHICH ADDITIVES MAY BE USEDThis 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.

2 The food additive provisions of CodexCommodity standards shall be included in and superseded by the provisions of this STANDARD . Theseprovisions also comply with the other requirements of the FOODS IN WHICH ADDITIVES MAY NOT BE USEDFood categories or individual food items where the use of food ADDITIVES are not allowed or arerestricted are defined by this THE PERMITTED LEVELS OF USE FOR food ADDITIVESThe primary objective of establishing permitted levels of use of food ADDITIVES in various food groupsis to ensure that the intake of ADDITIVES does not exceed the acceptable daily food ADDITIVES covered by this

3 STANDARD and their maximum levels of use are based in part on thefood additive provisions of previously established Codex commodity standards , or upon the request ofgovernments after subjecting the requested maximum levels to an appropriate method which would verify thecompatibility of a proposed maximum level with the Danish budget method may be used as a first step in this regard2. The submission of actual foodconsumption data is also DEFINITIONS OF TERMS USED IN THIS STANDARDa) food additive means any substance not normally consumed as a food by itself and not normally used asa typical ingredient of the food , whether or not it has nutritive value, the intentional addition of which tofood for a technological (including organoleptic)

4 Purpose in the manufacture, processing, preparation,treatment, packing, packaging, transport or holding of such food results, or may be reasonably expectedto result (directly or indirectly), in it or its by-products becoming a component of or otherwise affectingthe characteristics of such foods. The term does not include contaminants or substances added to foodfor maintaining or improving nutritional 1 Notwithstanding the provisions of this Section of the GENERAL STANDARD , the lack of reference to a particular additive or to aparticular use of an additive in a food in the GENERAL STANDARD as currently drafted, does not imply that the additive isunsafe or unsuitable for use in food .

5 The Commission shall review the necessity for maintaining this footnote on a regularbasis, with a view to its deletion once the GENERAL STANDARD is substantially Consensus Document on the Danish Budget Method , Nordic Working Group on food Toxicology and Risks Evaluation,Report No. 4 Alimentarius, Second Edition (Revised 1995), Volume 1A ( GENERAL Requirements), p. STAN 192 Page 2b) Acceptable Daily Intake (ADI) is an estimate by JECFA of the amount of a food additive, expressedon a body weight basis, that can be ingested daily over a lifetime without appreciable health risk( STANDARD man = 60 kg).

6 4c) Acceptable Daily Intake "Not Specified" (NS)5 is a term applicable to a food substance of very lowtoxicity which, on the basis of the available data (chemical, biochemical, toxicological, and other), the totaldietary intake of the substance arising from its use at the levels necessary to achieve the desired effectand from its acceptable background in food does not, in the opinion of JECFA, represent a hazard tohealth. For that reason, and for reasons stated in individual JECFA evaluations, establishment of anacceptable daily intake expressed in numerical form is not deemed necessary by JECFA.

7 An additivemeeting this criterion must be used within the bounds of good manufacturing practice as defined in sub-paragraph GENERAL PRINCIPLES FOR THE USE OF food ADDITIVES a) Only those food ADDITIVES shall be endorsed and included in this STANDARD which, so far as can bejudged on the evidence presently available from JECFA, present no risk to the health of theconsumer at the levels of use ) The inclusion of a food additive in this STANDARD shall have taken into account any AcceptableDaily Intake, or equivalent assessment, established for the additive and its probable daily intake7from all sources.

8 Where the food additive is to be used in foods eaten by special groups ofconsumers, account shall be taken of the probable daily intake of the food additive by consumersin those The use of food ADDITIVES is justified only when such use has an advantage, does not present a hazardto health of and does not mislead the consumer, and serves one or more of the technological functions set outby Codex and needs set out from (a) through (d) below, and only where these objectives cannot be achievedby other means which are economically and technologically practicable:a) to preserve the nutritional quality of the food ; an intentional reduction in the nutritional quality ofa food would be justified in the circumstances dealt with in sub-paragraph (b) and also in othercircumstances where the food does not constitute a significant item in a normal diet.

9 4 Principles for the Safety Assessment of food ADDITIVES and Contaminants in food , World Health Organization, (WHOE nvironmental 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 oftreatment of the food , rather than on a mg additive per kg body weight per day basis (see, Summary of EvaluationsPerformed by the Joint FAO/WHO Expert Committee on food ADDITIVES (JECFA), FAO/WHO, ILSI Press, 1994, Part 1, ).

10 6 GENERAL Principles for the Use of food ADDITIVES were originally adopted by the Ninth Session of the Codex Alimentariusas a Codex Advisory Text (para. 295, ALINORM 72/35) and were reprinted in the Second Edition of the CodexAlimentarius, Vol. 1A, ( GENERAL Requirements) pp. 45-47 (Revised 1995). Pertinent portions of the Text have now beenincorporated as an integral part of this STANDARD , suitable modifications having been made as necessary with respect to thepresent "Guidelines for Simple Evaluation of food Additive Intake", CAC/VOL.