General Standard For Food Additives Codex Stan 192 1995-Free PDF

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CODEX STAN 192 1995 2,1 1 Food Additives Included in this Standard. Only the food additives listed herein are recognized as suitable for use in foods in conformance with the. provisions of this Standard 1 Only food additives that have been assigned an Acceptable Daily Intake ADI. or determined on the basis of other criteria to be safe2 by the Joint FAO WHO Expert Committee on Food. Additives JECFA 3 and an International Numbering System INS designation by Codex will be considered. for inclusion in this Standard The use of additives in conformance with this Standard is considered to be. technologically justified,1 2 Foods in Which Additives May Be Used. This Standard sets forth the conditions under which food additives may be used in all foods whether or not. they have previously been standardized by Codex The use of additives in foods standardized by Codex is. subject to the conditions of use established by the Codex commodity standards and this Standard The. General Standard for Food Additives GSFA should be the single authoritative reference point for food. additives Codex commodity committees have the responsibility and expertise to appraise and justify the. technological need for the use of additives in foods subject to a commodity standard The information given. by the commodity committees may also be taken into account by the Codex Committee on Food Additives. CCFA when considering food additive provisions in similar non standardized foods When a food is not. covered by a commodity committee CCFA will appraise the technological need. 1 3 Foods in Which Additives May Not Be Used, Food categories or individual food items in which the use of food additives is not acceptable or where use. should be restricted are defined by this Standard,1 4 Maximum Use Levels for Food Additives. The primary objective of establishing maximum use levels for food additives in various food groups is to. ensure that the intake of an additive from all its uses does not exceed its ADI. The food additives covered by this Standard and their maximum use levels 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 use levels to an appropriate method for verifying the. compatibility of a proposed maximum level with the ADI. Annex A of this Standard may be used as a first step in this regard The evaluation of actual food. consumption data is also encouraged,2 DEFINITIONS, 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 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 4. 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 General 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 For the purpose of this standard determined on the basis of other criteria to be safe means that the use of a food. additive does not pose a safety concern under conditions of use described by JECFA as being of no toxicological. concern e g use levels defined circumstances, 3 A data base of food additive specifications with their current ADI status the year of their most recent JECFA. evaluation their assigned INS numbers etc are available in English at the JECFA website at FAO. http www fao org food food safety quality scientific advice jecfa jecfa additives en The database has a query page. and background information in English French Spanish Arabic and Chinese The reports of JECFA are available at. the JECFA website at WHO http apps who int food additives contaminants jecfa database search aspx. 4 Codex Alimentarius Procedural Manual,CODEX STAN 192 1995 3. b 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 5. c Acceptable Daily Intake Not Specified NS 6 is a term applicable to a food substance of very low. toxicity for 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 levels in food does not in the opinion of JECFA. represent a hazard to health, For the above 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 the above criterion must be used within the bounds of good manufacturing practice as defined. in section 3 3 below, d Maximum Use Level of an additive is the highest concentration of the additive determined to be. functionally effective in a food or food category and agreed to be safe by the Codex Alimentarius. Commission It is generally expressed as mg additive kg of food. The maximum use level will not usually correspond to the optimum recommended or typical level of. use Under GMP the optimum recommended or typical use level will differ for each application of an. additive and is dependent on the intended technical effect and the specific food in which the additive. would be used taking into account the type of raw material food processing and post manufacture. storage transport and handling by distributors retailers and consumers. 3 GENERAL PRINCIPLES FOR THE USE OF FOOD ADDITIVES. The use of food additives in conformance with this Standard requires adherence to all the principles set forth. in Sections 3 1 3 4,3 1 Food Additive Safety, a Only those food additives shall be endorsed and included in this Standard that so far as can be.
judged on the evidence presently available from JECFA present no appreciable health risk to. consumers at the use levels proposed, b The inclusion of a food additive in this Standard shall have taken into account any ADI or equivalent. safety assessment established for the additive by JECFA and its probable daily intake 7 from all food. sources Where the food additive is to be used in foods eaten by special groups of consumers e g. diabetics those on special medical diets sick individuals on formulated liquid diets account shall be. taken of the probable daily intake of the food additive by those consumers. c The quantity of an additive added to food is at or below the maximum use level and is the lowest level. necessary to achieve the intended technical effect The maximum use level may be based on the. application of the procedures of Annex A the intake assessment of Codex members or upon a request. by the CCFA to JECFA for an independent evaluation of national intake assessments. 3 2 Justification for the Use of Additives, The use of food additives is justified only when such use has an advantage does not present an appreciable. health risk to consumers does not mislead the consumer and serves one or more of the technological. functions set out by Codex and the needs set out from a through d below and only where these. objectives cannot be achieved by other means that are economically and technologically practicable. a 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. 5 Principles for the Safety Assessment of Food Additives and Contaminants in Food World Health Organization WHO. Environmental Health Criteria No 70 p 111 1987 For the purposes of this Standard the phrase without. appreciable health risk means that there is a reasonable certainty of no harm to consumers if an additive is used at. levels that do not exceed those in this Standard The provisions of this Standard do not sanction the use of an. additive in a manner that would adversely affect consumer health. 6 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 evaluation by JECFA which established safety on the. basis of an acceptable level of treatment of food limited numerically or by GMP rather than on a toxicologically. established ADI, 7 Codex members may provide the CCFA with intake information that may be used by the Committee in establishing. maximum use levels Additionally the JECFA at the request of the CCFA will evaluate intakes of additives based on. intake assessments submitted by Codex members responding to a call for data The CCFA will consider the JECFA. evaluations when establishing the maximum use levels for additives. CODEX STAN 192 1995 4, b To provide necessary ingredients or constituents for foods manufactured for groups of consumers. having special dietary needs, c 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. d 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 or 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. 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 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. c The additive is of appropriate food grade quality and 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 Commission 9 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 conformance of additives to their specifications as a whole not merely with individual criteria and through. their production storage transport and handling in accordance with GMP. 4 CARRY OVER OF FOOD ADDITIVES INTO FOODS, 4 1 Conditions Applying to Carry Over of Food Additives from ingredients and raw materials into foods. Other than by direct addition an additive may be present in a food as a result of carry over from a raw. material or ingredient used to produce the food provided that. a The additive is acceptable for use in the raw materials or other ingredients including food additives. according to this Standard, b The amount of the additive in the raw materials or other ingredients including food additives does not.
exceed the maximum use level specified in this Standard. c The food into which the additive is carried over does not contain the additive in greater quantity than. would be introduced by the use of raw materials or ingredients under proper technological conditions. or manufacturing practice consistent with the provisions of this standard. 4 2 Special conditions applying to the use of food additives not directly authorised in food ingredients. and raw materials, An additive may be used in or added to a raw material or other ingredient if the raw material or ingredient is. used exclusively in the preparation of a food that is in conformity with the provisions of this standard. including that any maximum level applying to the food is not exceeded. 8 For additional information see the Codex Alimentarius Commission Procedural Manual Relations Between. Commodity Committees and General Committees Food Additives and Contaminants. 9 An index CAC MISC 6 of all specifications adopted by the Codex Alimentarius Commission as well as the year of. adoption is available at the Codex website http www codexalimentarius org standards en These specifications. prepared by the JECFA are also being published in 2006 in the Combined Compendium of Food Additive. Specifications FAO JECFA Monographs No 1 which consists of four volumes and in subsequent JECFA. Monographs The specifications are also available at the JECFA website http www fao org food food safety. General Standard for Food Additives GSFA should be the single authoritative reference point for food additives Codex commodity committees have the responsibility and expertise to appraise and justify the technological need for the use of additives in foods subject to a commodity standard The information given by the commodity committees may also be taken into account by the Codex Committee

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