CODEX STAN 192-1995 Page 1 of 271 CODEX GENERAL STANDARD FOR FOOD ADDITIVES CODEX STAN 192-1995 PREAMBLE 1. SCOPE 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. 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/ag/agn/jecfa-additives/search.html?lang=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://www.who.int/ipcs/food/jecfa/en/ Adopted in 1995. Revision 1997, 1999, 2001, 2003, 2004, 2005, 2006, 2007, 2008, 2009, 2010, 2011. CODEX STAN 192-1995 Page 2 of 271 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 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 4 Codex Alimentarius Procedural Manual. 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. CODEX STAN 192-1995 Page 3 of 271 intake7 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; 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; and, 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 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. 8 For additional information, see the Codex Alimentarius Commission Procedural Manual. Relations Between Commodity Committees and General Committees- Food Additives and Contaminants. CODEX STAN 192-1995 Page 4 of 271 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 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. 4.3 FOODS FOR WHICH THE CARRY-OVER OF FOOD ADDITIVES IS UNACCEPTABLE Carry-over of a food additive from a raw material or ingredient is unacceptable for foods belonging to the following food categories, unless a food additive provision in the specified category is listed in Tables 1 and 2 of this standard. a） 13.1 - Infant formulae, follow-up formulae, and formulae for special medical purposes for infants. b） 13.2 - Complementary foods for infants and young children. 5. FOOD CATEGORY SYSTEM10 The food category system is a tool for assigning food additive uses in this Standard. The food category system applies to all foodstuffs. The food category descriptors are not to be legal product designations nor are they intended for labelling purposes. The food category system is based on the following principles: a） The food category system is hierarchical, meaning that when an additive is recognized for use in a general category, it is recognized for use in all its sub-categories, unless otherwise stated. 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.net). 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/ag/agn/jecfa-additives/search.html?lang=en). Although specifications for flavouring agents are not included in the printed compendium, with the exception of those few which have an additional non-flavour technological function, they are included in an online searchable database at the JECFA website at FAO. http://apps3.fao.org/jecfa/flav_agents/flavag-q.jsp?language=en. 10 Annex B to this Standard. CODEX STAN 192-1995 Page 5 of 271 Similarly, when an additive is recognized for use in a sub-category, its use is recognized in any further sub-categories 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. By doing so, the food category system does not need to specifically mention compound foodstuffs (e.g., prepared meals, such as pizza, because they may contain, pro rata, all the additives endorsed for use in their components), unless the compound foodstuff needs an additive that is not endorsed for use in any of its components. d） The food category system is used to simplify the reporting of food additive uses for assembling and constructing this Standard. 6. DESCRIPTION OF THE STANDARD This Standard consists of three main components: a） Preamble b） Annexes i. Annex A is a guideline for considering maximum use levels for additives with numerical JECFA ADIs. ii. Annex B is a listing of the food category system used to develop and organize Tables 1, 2, and 3 of the standard. Descriptors for each food category and sub-category are also provided. iii. Annex C is a cross-reference of the food category system and Codex commodity standards. c） Food Additive Provisions i. Table 1 specifies, for each food additive or food additive group (in alphabetical order) with a numerical JECFA ADI, the food categories (or foods) in which the additive is recognized for use, the maximum use levels for each food or food category, and its technological function. Table 1 also includes the uses of those additives with non- numerical ADIs for which a maximum use level is specified. ii. Table 2 contains the same information as Table 1, but the information is arranged by food category number. iii. Table 3 lists additives with Not Specified or Not Limited 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 excluded from the general conditions of Table 3. The provisions in Tables 1 and 2 govern the use of additives in the food categories listed in the Annex to Table 3. Unless otherwise specified, maximum use levels for additives in Tables 1 and 2 are set on the final product as consumed. Tables 1, 2, and 3 do not include references to the use of substances as processing aids.11 11 Processing Aid means any substance or material, not including apparatus or utensils, and not consumed as a food ingredient by itself, intentionally used in the processing of raw materials, foods or its ingredients to fulfill a certain technological purpose during treatment or processing and which may result in the non-intentional but unavoidable presence of residues or derivatives in the final product: Codex Alimentarius Commission Procedural Manual. CODEX STAN 192-1995 Page 6 of 271 ANNEX A GUIDELINES FOR THE DEVELOPMENT OF MAXIMUM LEVELS FOR THE USE OF FOOD ADDITIVES WITH NUMERICAL ACCEPTABLE DAILY INTAKES This annex is intended as a guidance to screen proposals for use of additives based on consideration of their maximum use level and the physiological upper limit to the amount of food and drink that can be consumed each day. The Annex is not intended for allocating provisions for the use of an additive and cannot be used for calculating accurate additive intakes. FOOD ADDITIVES - BASIC PRINCIPLES FOR CALCULATION OF USE LEVELS Guideline 1 The levels and quantities of food additives used in the Budget Method calculations should be expressed on the same basis as the substances on which the ADI was allocated (e.g., an acid or its salts). For foods sold as concentrates or powders intended for reconstitution before consumption, the Budget calculation on the food additive use levels should be performed on the ready-to-eat product. ESTIMATION OF THE SAFETY ASPECTS OF USE LEVELS - FOOD ADDITIVES WITH NO NUMERICAL ADI Guideline 2 FOOD ADDITIVES WITH AN ADI OF “NOT SPECIFIED” When an additive has been allocated an ADI "not specified"12 it could in principle, be allowed for use in foods in general with no limitation other than in accordance with Good Manufacturing Practices (GMP). It should, however, be born in mind that ADI not specified does not mean that unlimited intake is acceptable. The term is used by JECFA in case where "on the basis of the available data (chemical, biochemical, toxicological, and other) the total daily 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 the Committee, represent a hazard to health"1 If, therefore, a substance is used in larger amounts and/or in a wider range of foods than originally envisaged by JECFA it may be necessary to consult JECFA to ensure that the new uses fall within the evaluation. For example a substance may have been evaluated as a humectant without including a later use as a bulk sweetener, which could give considerable higher intake. Guideline 3 FOOD ADDITIVES EVALUATED AS “ACCEPTABLE” FOR CERTAIN PURPOSES In some cases, JECFA has been unable to allocate an ADI but nevertheless found a specific use of a substance acceptable. In such cases, the additive in question should only be authorized in accordance with the conditions specified. In case of any other reported uses CCFA should request JECFA to re-evaluate the additive in question in light of the new information on uses. ESTIMATION OF THE SAFETY ASPECTS OF USE LEVELS - FOOD ADDITIVES WITH NUMERICAL ADI Guideline 4 FRACTIONS OF THE ADI TO BE USED FOR SOLID FOOD AND BEVERAGES, RESPECTIVELY If an additive is proposed for use in both solid food and in beverages the full ADI cannot be used for both for uses in solid food and uses in beverages. It is therefore necessary to allocate a fraction of the ADI to each of the applications. As a first approach, it may be appropriate to assume that one-half of the ADI is allocated to 12 Principles for the Safety Assessment of Food Additives and Contaminants in Food. Geneva, World Health Organization, 1987 (Environmental Health Criteria, No. 70), p.83. CODEX STAN 192-1995 Page 7 of 271 each solid and liquid foods. However, in special cases other fractions may be more appropriate as long as the sum of the fractions does not exceed the figure for the ADI (e.g. FS=1/4 and FB=3/4 ; FS=1/6 and FB=5/6), where FS is the fraction for use in solid food and FB is the fraction for use in beverages). If the additive is used only in solid food, then FS =1 and FB=0 and if the additive is used only in beverages, then FS=0 and FB=1. III(a) FOOD ADDITIVE USES IN SOLID FOOD (FS) Guideline 5 USE LEVELS BELOW FS X ADI X 40 If the proposed use levels are below FS x ADI x 40, these food additive provisions could be suitable in food in general. Guideline 6 USE LEVELS BELOW FS X ADI X 80 If the proposed use levels are below FS x ADI x 80 they are acceptable provided the daily consumption of the foods containing the additive will usually not exceed half of the assumed maximum total solid food intake (i.e., 12.5 g/kg bw/day). Guideline 7 USE LEVELS BELOW FS X ADI X 160 If the proposed use levels are below FS x ADI x 160 they are acceptable provided the daily consumption of the foods containing the additive will usually not exceed one fourth of the assumed maximum total solid food intake (i.e., 6.25 g/kg bw/day). Guideline 8 USE LEVELS BELOW FS X ADI X 320 If the proposed use levels are below FS x ADI x 320 they could be accepted provided the daily consumption of the foods containing the additive will usually not exceed one eighth of the assumed maximum total food intake (i.e., 3.13 g/kg bw/day). Guideline 9 USE LEVELS ABOVE FS X ADI X 320 If the proposed levels are higher than FS x ADI x 320 they should only be accepted for products where calculation of potential intake from all proposed uses will show that exceeding the ADI is unlikely, or if estimation of the intake of the additive based on more exact intake estimates methods show that the use levels are acceptable (e.g., food consumption surveys) III(b) FOOD ADDITIVE USES IN BEVERAGES (FL) Guideline 10 USE LEVELS BELOW FL X ADI X 10 If the proposed levels are below FL x ADI x 10 , the additive could be accepted for use in all beverages in general. Guideline 11 USE LEVELS BELOW FL X ADI X 20 If the proposed use levels are below FL x ADI x 20 they could be accepted provided the daily consumption of beverages containing the additive will usually not exceed half of the assumed maximum total intake of beverage (i.e., 50 ml/kg bw/day). CODEX STAN 192-1995 Page 8 of 271 Guideline 12 USE LEVELS BELOW FS X ADI X 40 If the proposed use levels are below FL x ADI x 40 they could be accepted provided the daily consumption of beverages containing the additive will usually not exceed a fourth of the assumed maximum total intake of beverage (i.e., 25 ml/kg bw/day). Guideline 13 USE LEVELS BELOW FL X ADI X 80 If the proposed use levels are below FL x ADI x 80 they could be accepted provided the daily consumption of beverages containing the additive will usually not exceed an eighth of the assumed maximum total intake of beverage (i.e., 12.5 ml/kg bw/day). Guideline 14 USE LEVELS ABOVE FL X ADI X 80 Levels above FL x ADI x 80 should only be accepted for products where calculation of potential intake will show that exceeding the ADI is unlikely (e.g., strong alcoholic beverages). CODEX STAN 192-1995 Page 9 of 271 ANNEX B FOOD CATEGORY SYSTEM PART I: Food Category System 01.0 Dairy products and analogues, excluding products of food category 02.0 01.1 Milk and dairy-based drinks 01.1.1 Milk and buttermilk (plain) 01.1.1.1 Milk (plain) 01.1.1.2 Buttermilk (plain) 01.1.2 Dairy-based drinks, flavoured and/or fermented (e.g., chocolate milk, cocoa, eggnog, drinking yoghurt, whey-based drinks) 01.2 Fermented and renneted milk products (plain), excluding food category 01.1.2 (dairy-based drinks) 01.2.1 Fermented milks (plain) 01.2.1.1 Fermented milks (plain), not heat-treated after fermentation 01.2.1.2 Fermented milks (plain), heat-treated after fermentation 01.2.2 Renneted milk (plain) 01.3 Condensed milk and analogues (plain) 01.3.1 Condensed milk (plain) 01.3.2 Beverage whiteners 01.4 Cream (plain) and the like 01.4.1 Pasteurized cream (plain) 01.4.2 Sterilized and UHT creams, whipping and whipped creams, and reduced fat creams (plain) 01.4.3 Clotted cream (plain) 01.4.4 Cream analogues 01.5 Milk powder and cream powder and powder analogues (plain) 01.5.1 Milk powder and cream powder (plain) 01.5.2 Milk and cream powder analogues 01.6 Cheese and analogues 01.6.1 Unripened cheese 01.6.2 Ripened cheese 01.6.2.1 Ripened cheese, includes rind 01.6.2.2 Rind of ripened cheese 01.6.2.3 Cheese powder (for reconstitution; e.g., for cheese sauces) 01.6.3 Whey cheese 01.6.4 Processed cheese 01.6.4.1 Plain processed cheese 01.6.4.2 Flavoured processed cheese, including containing fruit, vegetables, meat, etc. CODEX STAN 192-1995 Page 10 of 271 01.6.5 Cheese analogues 01.6.6 Whey protein cheese 01.7 Dairy-based desserts (e.g., pudding, fruit or flavoured yoghurt) 01.8 Whey and whey products, excluding whey cheeses 01.8.1 Liquid whey and whey products, excluding whey cheeses 01.8.2 Dried whey and whey products, excluding whey cheeses 02.0 Fats and oils, and fat emulsions 02.1 Fats and oils essentially free from water 02.1.1 Butter oil, anhydrous milkfat, ghee 02.1.2 Vegetable oils and fats 02.1.3 Lard, tallow, fish oil, and other animal fats 02.2 Fat emulsions mainly of type water-in-oil 02.2.1 Butter 02.2.2 Fat spreads, dairy fat spreads and blended spreads 02.3 Fat emulsions mainly of type oil-in-water, including mixed and/or flavoured products based on fat emulsions 02.4 Fat-based desserts excluding dairy-based dessert products of food category 01.7 03.0 Edible ices, including sherbet and sorbet 04.0 Fruits and vegetables (including mushrooms and fungi, roots and tubers, pulses and legumes, and aloe vera), seaweeds, and nuts and seeds 04.1 Fruit 04.1.1 Fresh fruit 04.1.1.1 Untreated fresh fruit 04.1.1.2 Surface-treated fresh fruit 04.1.1.3 Peeled or cut fresh fruit 04.1.2 Processed fruit 04.1.2.1 Frozen fruit 04.1.2.2 Dried fruit 04.1.2.3 Fruit in vinegar, oil, or brine 04.1.2.4 Canned or bottled (pasteurized) fruit 04.1.2.5 Jams, jellies, marmalades 04.1.2.6 Fruit-based spreads (e.g., chutney) excluding products of food category 04.1.2.5 04.1.2.7 Candied fruit 04.1.2.8 Fruit preparations, including pulp, purees, fruit toppings and coconut milk 04.1.2.9 Fruit-based desserts, incl. fruit-flavoured water-based desserts 04.1.2.10 Fermented fruit products 04.1.2.11 Fruit fillings for pastries 04.1.2.12 Cooked fruit