E Agenda Item 4 (a) CX/FA 15/47/5 December 2014 JOINT FAO/WHO FOOD STANDARDS PROGRAMME CODEX COMMITTEE ON FOOD ADDITIVES Forty-seventh Session Xi an, China, 23-27 March 2015 ENDORSEMENT AND/OR REVISION OF MAXIMUM LEVELS FOR FOOD ADDITIVES AND PROCESSING AIDS IN CODEX STANDARDS BACKGROUND 1. In accordance with the section concerning Relations between Commodity Committees and General Committees of the Codex Alimentarius Commission Procedural Manual, All provisions in respect of food additives (including processing aids) contained in Codex commodity standards should be referred to the Committee on Food Additives, preferably before the Standards have been advanced to Step 5 of the Procedure for the Elaboration of Codex Standards or before they are considered by the commodity committee concerned at Step 7, though such referral should not be allowed to delay the progress of the Standard to the subsequent Steps of the Procedure.. 2. The following food additive and processing aids provisions of Codex standards have been submitted for endorsement since the 46 th Session of the Codex Committee on Food Additives and are listed by: (i) (ii) (iii) (iv) Technological function, INS number and food additive name; Proposed level; (mg additive/kg body weight per day); and s. 3. The following abbreviations have been used in the preparation of this paper: INS International Numbering System for food additives. The INS (INS) is intended as a harmonised naming system for food additives as an alternative to the use of the specific name, which may be lengthy 1. Acceptable Daily Intake. An estimate of the amount of a substance in food or drinking-water, expressed on a body-weight basis, that can be ingested daily over a lifetime without appreciable risk (standard human = 60 kg) 2. The is listed in units of mg per kg of body weight. Not Specified. A term applicable to a food substance of very low toxicity 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 in food does not, in the opinion of JECFA, represent a hazard to health. For that reason, and for reasons stated in individual evaluations, the establishment of an acceptable daily intake expressed in numerical form is not deemed necessary. An additive meeting this criterion must be used within the bounds of good manufacturing practice, i.e., it should be technologically efficacious and should be used at the lowest level necessary to achieve this effect, it should not conceal inferior food quality or adulteration, and it should not create a nutritional imbalance 2. Not Limited. A term no longer used by JECFA that has the same meaning as "not specified" 2. 1 Class Names and the International Numbering System for Food Additives (CAC/GL 36-1989) 2 JECFA Glossary of Terms: http://www.who.int/ipcs/food/jecfa/en/index.html.
CX/FA 15/47/5 2 Temporary. Used by JECFA when data are sufficient to conclude that use of the substance is safe over the relatively short period of time required to generate and evaluate further safety data, but are insufficient to conclude that use of the substance is safe over a lifetime. A higher-than-normal safety factor is used when establishing a temporary and an expiration date is established by which time appropriate data to resolve the safety issue should be submitted to JECFA. The temporary is listed in units of mg per kg of body weight 2. Conditional. A term no longer used by JECFA to signify a range above the "unconditional " which may signify an acceptable intake when special problems, different patterns of dietary intake, and special groups of the population that may require consideration are taken into account 2. No allocated. There are various reasons for not allocating an, ranging from a lack of information to data on adverse effects that call for advice that a food additive or veterinary drug should not be used at all. The report should be consulted to learn the reasons that an was not allocated 2. Acceptable 2. Flavouring agents: Used to describe flavouring agents that are of no safety concern at current levels of intake and subsequent reports of meetings on food additives. If an has been allocated to the agent, it is maintained unless otherwise indicated. Enzyme preparations: Used to describe enzymes that are obtained from edible tissues of animals or plants commonly used as foods or are derived from microorganisms that are traditionally accepted as constituents of foods or are normally used in the preparation of foods. Such enzyme preparations are considered to be acceptable provided that satisfactory chemical and microbiological specifications can be established. Food additives: Used on some occasions when present uses are not of toxicological concern or when intake is self-limiting for technological or organoleptic reasons. Acceptable Level of Treatment. s are expressed in terms of mg per kg of body weight per day. In certain cases, however, food additives are more appropriately limited by their levels of treatment. This situation occurs most frequently with flour treatment agents. It should be noted that the acceptable level of treatment is expressed as mg/kg of the commodity. This should not be confused with an 2. Good Manufacturing Practice (GMP) in the Use of Food Additives 3 means that: the quantity of the additive added to food does not exceed the amount reasonably required to accomplish its intended physical nutritional or other technical effect in food; 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 technological effect in the food itself, is reduced to the extent reasonably possible; the additive is of appropriate food grade quality and is prepared and handled in the same way as a food ingredient. Food grade quality is achieved by compliance with the specifications as a whole and not merely with individual criteria in terms of safety. 3 Procedural Manual of the Codex Alimentarius Commission (Definitions)
CX/FA 15/47/5 3 ENDORSEMENT AND/OR REVISION OF MAXIMUM LEVELS FOR FOOD ADDITIVES IN CODEX COMMODITY STANDARDS The Committee is invited to consider for endorsement the food additive provisions (see Annex 1) forwarded by: (a) (b) (c) 27 th Session of the Committee on Processed Fruits and Vegetables (REP15/PFV): - Amendments to the Standard for Certain Canned Vegetables (Annex on Mushrooms) (CODEX STAN 297-2009); - Amendments to the Standard for Pickled Fruits and Vegetables (CODEX STAN 260-2007); - Draft Standard for Quick Frozen Vegetables (at Step 8) and Annexes on Carrots, Corn-on-the- Cob, on Leek, and Whole Kernel Corn (at Step 5/8); - Draft Standard for Certain Canned Fruits (at Step 8) and annexes on Mangoes (at Step 8) and Pears (at Step 5/8); - Draft Standard for Ginseng Products (at Step 5/8). 19 th Session of the FAO/WHO Coordinating Committee for Asia (REP15/ASIA): - Draft Regional Standard for Non-Fermented Soybean Products (at Step 8). 36 th Session of the Committee for Nutrition and Food for Special Dietary Uses (REP15/NFSDU): - Amendments to the Standard for Infant Formula and Formulas For Special Medical Purposes Intended For Infants (CODEX STAN 72 1981) (at Step 5/8).
CX/FA 15/47/5 4 COMMITTEE ON PROCESSED FRUITS AND VEGETABLES (CCPFV) 3. FOOD ADDITIVES Please : deleted provisions are presented in strikethrough font. STANDARD FOR CERTAIN CANNED VEGETABLES - ANNEX ON MUSHROOMS (CODEX STAN 297-2009) 4 3.2. Colours 150a Caramel I plain caramel GMP 150c Caramel III ammonia caramel 50,000 mg/kg Not Specified (29 th JECFA,1985) 0-200 mg/kg bw (0-150 mg/kg bw on solids basis) (29 th JECFA,1985) 3.3 Only the flavour enhancer listed below is permitted for use, under the conditions of good manufacturing practices, in the products covered by this Annex. 3.3.Flavour enhancers used in accordance with Table 3 of the General Standard for Food Additives (CODEX STAN 192-1995) for Food Category 04.2.2.4 are acceptable for use in canned mushrooms. Caramel I plain caramel is included in GFSA Table 3. Food category 04.2.2.4 Canned or bottled (pasteurized) or retort pouch vegetables (including mushrooms and fungi, roots and tubers, pulses and legumes, and aloe vera), and seaweeds is not listed in the Annex to Table 3. In GSFA food category 04.2.2.4: ML 50,000 mg/kg. (Format for Codex Commodity Standards AMENDMENTS TO THE STANDARD FOR PICKLED FRUITS AND VEGETABLES (CODEX STAN 260-2007) 5 4. FOOD ADDITIVES Acidity regulators, antifoaming agents, antioxidants, colours, firming agents, flavour enhancers, preservatives, sequestrants and sweeteners used in accordance with Tables 1 and 2 of the General Standard of Food Additives in the food category in which the individual pickled fruit or vegetable fall into (i.e., one of the following categories: 04.1.2.3, 04.1.2.10, 04.2.2.3, and 04.2.2.7) or listed in Table 3 of the General Standard are acceptable for use in foods conforming to this Standard. 4 REP15/PFV, App. V. 5 REP15/PFV, App. VI.
CX/FA 15/47/5 5 DRAFT STANDARD FOR QUICK FROZEN VEGETABLES (At Step 8) 6 4. FOOD ADDITIVES Only those food additive classes listed in the corresponding Annexes are technologically justified and may be used in products covered by this Standard. Within each additive class only those food additives listed in the corresponding Annexes, or referred to, may be used and only for the functions, and within limits, specified. 5. PROCESSING AIDS The processing aids used for products covered by this Standard shall comply with the Guidelines on Substances Used as Processing Aids (CAC/GL 75-2010). 3. FOOD ADDITIVES None permitted. ANNEXES THE DRAFT STANDARD FOR QUICK FROZEN VEGETABLES ANNEX ON CARROTS (At Step 5/8) For info only. ANNEX ON CORN-ON-THE-COB (At Step 5/8) 3. FOOD ADDITIVES None permitted. For info only. ANNEX ON LEEK (At Step 5/8) 3. FOOD ADDITIVES None permitted. For info only. 6 REP15/PFV, App. III.
CX/FA 15/47/5 6 ANNEX ON WHOLE KERNEL CORN (At Step 5/8) 3. FOOD ADDITIVES None permitted. For info only. DRAFT STANDARD FOR CERTAIN CANNED FRUITS (At Step 8) 7 4. FOOD ADDITIVES 4.1 Only those food additive classes listed below and in the corresponding Annexes are technologically justified and may be used in products covered by this Standard. Within each additive class only those food additives listed in the corresponding Annexes, or referred to, may be used and only for the functions, and within limits, specified. 4.2 Acidity regulators used in accordance with Tables 1 and 2 of the General Standard for Food Additives (CODEX STAN 192-1995) in food category 04.1.2.4 (Canned or bottled (pasteurized) fruit) or listed in Table 3 of the General Standard are acceptable for use in foods conforming to this Standard. ANNEXES THE DRAFT STANDARD FOR CERTAIN CANNED FRUITS ANNEX ON MANGOES (At Step 8) 3. FOOD ADDITIVES 3.1 Antioxidants, and firming agents used in accordance with Tables 1 and 2 of the General Standard for Food Additives (CODEX STAN 192-1995) in Food Category 04.1.2.4 (Canned or bottled (pasteurized) fruit) or listed in Table 3 of the General Standard are acceptable for use for foods conforming to this Annex. 3.2 Colours Only the colours listed below are permitted for use in canned mushroom in sauce. 7 REP15/PFV, App. II.
CX/FA 15/47/5 7 160a(i), a(iii), e, f Carotenoids 200 mg/kg 160a(ii) Carotene beta - vegetable 1,000 mg/kg 120 Carmines 200 mg/kg Group of 0-5 mg/kg bw for beta carotene (synthetic) and beta carotene from Blakeslea trispora (57 th JECFA, 2001) Group expressed as the sum of the carotenoids: betacarotene, beta-apo-8'- carotenal and beta-apo-8'- carotenoic acid, methyl and ethyl esters (18 th JECFA, 1974) "Acceptable", provided the level of use does not exceed the level normally found in vegetables (41 st JECFA, 1993) Group of 0-5 mg/kg bw for carmines, as ammonium carmine or the equivalent of Ca, K and Na salts (26 th JECFA, 1982 established and maintained at 55 th JECFA, 2000) In GSFA food category 04.1.2.4 Canned or bottled (pasteurized) fruit : ML 200 mg/kg In GSFA food category 04.1.2.4: ML 1,000mg/kg In GSFA food category 04.1.2.4: ML 200mg/kg 3. FOOD ADDITIVES ANNEX ON PEARS (At Step 5/8) 3.2 Colours (permitted only in special holiday packs) used in accordance with Tables 1 and 2 of the General Standard for Food Additives (CODEX STAN 192-1995) in Food Category 04.1.2.4 (Canned or bottled (pasteurized) fruit) or listed in Table 3 of the General Standard are acceptable for use for foods conforming to this Annex. 3.2 Flavourings used in products covered by this Annex should comply with the Guidelines for the Use of Flavourings (CAC/GL 66-2008).
CX/FA 15/47/5 8 PROPOSED DRAFT STANDARD FOR GINGSENG PRODUCTS (At Step 5/8) 8 4. FOOD ADDITIVES No additives are permitted in the products covered by this Standard. For info only. 8 REP15/PFV, App. III.
CX/FA 15/47/5 9 FAO/WHO COORDINATING COMMITTEE FOR ASIA (CCASIA) FOOD ADDITIVES 4.1 General Requirements DRAFT REGIONAL STANDARD FOR NON-FERMENTED SOYBEAN PRODUCTS (at Step 8) Only those additive functional classes indicated as technologically justified in Table 2 may be used for the product categories specified. Within each additive class, and where permitted according to the table, only those food additives listed may be used and only within the functions and limits specified. In accordance with Section 4.1 of the Preamble to the General Standard for Food Additives (CODEX STAN 192-1995), additional additives may be present in non-fermented soybean products as a result of carry-over from soybean ingredients. Food additive/ functional class Soybean beverages and related products (2.2.1) Plain Soybean beverage (2.2.1.1) Composite/ flavoured soybean beverages (2.2.1.2) Soybean-based beverages (2.2.1.3) Soybean curd and related products (2.2.2) Semisolid soybean curd (2.2.2.1) Soybean curd (2.2.2.2) Compressed soybean curd (2.2.3) Acidity regulators - X X X X X - Antioxidants - X X - - - - Dehydrated soybean curd film (2.2.4) Colours - X X - - - - Emulsifiers - X X - - - - Firming Agents - - - X X X - Flavour enhancer - X X - - - - Preservatives - - - - - X X Stabilizers - X X - X - - Sweeteners - X X - - - - X= The use of food additives belonging to the functional class is technologically justified. -= The use of food additives belonging to the functional class is not technologically justified. 4.2 Specific Food Additive Provisions 4.2.1 Plain Soybean Beverage None permitted. For info.
CX/FA 15/47/5 10 4.2.2 Composite/ flavoured Soybean Beverages and Soybean-based Beverages (mg/kg bw) Acidity regulators, antioxidants, colours, emulsifiers, flavor enhancer, stabilizers and sweeteners used in accordance with Tables 1, Table 2 and Table 3 of the General Standard for Food Additives (CODEX STAN 192-1995) in Food Category 06.8.1 are acceptable for use in this product. In addition, the following food additives may be used. Antioxidant 304 Ascorbyl palmitate 500 mg/kg 307a,b,c Tocopherols 20,000 mg/kg Colour 100(i) Curcumin 1 mg/kg 102 Tartarzine 300 mg/kg 110 Sunset yellow FCF 300 mg/kg 132 Indigotine 150 mg/kg 133 Brilliant blue FCF 100 mg/kg 141(i),(ii) Chlorophylls and chlorophyllins, copper complexes 30 mg/kg, as copper 150b Caramel II-sulfite caramel 20,000 mg/kg 0-1.25 mg/kg bw (17 th JECFA, 1973) A group of 0.15-2 mg/kg bw for dl-α-tocopherol and d- α-tocopherol, concentrate, singly or in combination (30 th JECFA, 1986). 0-3 mg/kg bw (61 st JECFA,2003) 0-7.5 mg/kg bw (8 th JECFA, 1964) 0-4 mg/kg bw (74 th JECFA, 2011) 0-5mg/kg bw (18 th JECFA, 1974) 0-12.5 mg/kg bw (13 th JECFA,1969). 0-15 mg/kg bw for chlorophylls (INS 141(i) (13 th JECFA, 1969) 0-15 mg/kg bw for chlorophyllins copper complexes (INS 141(Ii) (22 nd JECFA, 1978). 0-160 mg/kg bw (55 th JECFA, 2000) Currently there is no provision in GSFA food category 06.8.1 Soybean-based beverages Name of the additive is misspelled; should be tartrazine.
CX/FA 15/47/5 11 150d Caramel IV-sulfite ammonia caramel 20,000 mg/kg 160a(i),a(iii),e,f Carotenoids 500 mg/kg 160a(ii) Carotenes, beta-, vegetable 2,000 mg/kg 160b(i) Annatto extracts, bixin based 5 mg/kg as bixin 160b(ii) Annatto extracts, norbixin based 100 mg/kg as norbixin (mg/kg bw) 0-200 mg/kg bw (0-150mg/kg bw on solids basis) (29 th JECFA, 1985). Group of 0-5 mg/kg bw for beta carotene (synthetic) and beta carotene from Blakeslea trispora (57 th JECFA, 2001) Group expressed as the sum of the carotenoids: betacarotene, beta-apo-8'- carotenal and beta-apo-8'- carotenoic acid, methyl and ethyl esters (18 th JECFA, 1974) "Acceptable", provided the level of use does not exceed the level normally found in vegetables (59 th JECFA, 2002). An for bixin of 0 12 mg/kg bw and a group for norbixin and its disodium and dipotassium salts of 0 0.6 mg/kg bw expressed as norbixin (67 th JECFA, 2006) An for bixin of 0 12 mg/kg bw and a group for norbixin and its disodium and dipotassium salts of 0 0.6 mg/kg bw expressed as norbixin (67 th JECFA, 2006)
CX/FA 15/47/5 12 Emulsifier 432-436 Polysorbates 2,000 mg/kg 472e Diacetyltartaric and fatty acid esters glycerol 473 Sucrose esters of fatty acids 473a 474 Sucroglycerides Sucrose oligoesters, type I and type II 2,000 mg/kg 20,000 mg/kg, singly or in combination 475 Polyglycerol esters of fatty acids 20,000 mg/kg 491-495 Sorbitan esters of fattey acids 20,000 mg/kg (mg/kg bw) 0-25 mg/kg bw (17 th JECFA, 1973) 0-50 mg/kg bw (61 st JECFA, 2003). 0-30 mg/kg bw for this substance together with sucroglycerides, sucrose oligoesters type I and type II and sucrose monoesters of lauric, palmitic or stearic acid (73 rd JECFA, 2010) 0-30 mg/kg bw for this substance together with sucrose esters of fatty acids, sucroglycerides, sucrose oligoesters type II and sucrose monoesters of lauric, palmitic or stearic acid (73 rd JECFA, 2010). Group of 0-30 mg/kg bw for this substance and sucrose esters of fatty acids, sucrose oligoesters type I and type II and sucrose monoesters of lauric, palmitic or stearic acid (73 rd JECFA,2010) of 0-25 mg/kg bw (35 th JECFA, 1989) Group of 0-25 mg/kg bw as the sum of sorbitan esters of lauric, oleic, palmitic and stearic acids (26 th JECFA, 1982)
CX/FA 15/47/5 13 Stabilizer 405 Propylene glycol alginate 10,000 mg/kg Sweetener 950 Acesulfame potassium 500 mg/kg 951 Aspartame 1,300 mg/kg Flavour enhancer 508 Potassium chloride 1,000 mg/kg (mg/kg bw) 0-70 mg/kg bw (41 st JECFA,1993) 0-15 mg/kg bw (37 th JECFA, 1990). 0-40 mg/kg bw (25 th JECFA,1981) Group 'not limited' for hydrochloric acid and its ammonium, Mg, K salts (23 rd JECFA,1979) Potassium chloride is included in GFSA Table 3. Food category 06.8 is not listed in the Annex to Table 3 4.2.3 Soybean Curd Acidity regulator, firming agent and stabilizers used in accordance with Tables 1,Table 2 and Table 3 of the General Standard for Food Additives (CODEX STAN 192-1995) in Food Category 06.8.3 are acceptable for use in this product. 4.2.4 Compressed Soybean Curd (mg/kg bw) Acidity regulator, firming agents, preservatives, listed in Table 3 of the General Standard for Food Additives (CODEX STAN 192-1995) are acceptable for use in this product. In addition, the following food additives may be used. Preservatives 262ii Sodium diacetate 1,000 mg/kg 0-15 mg/kg bw (17 th JECFA,1973) Currently there is no ML in GSFA food category 06.8.4 Semi-dehydrated soybean curd
CX/FA 15/47/5 14 4.2.5 Dehydrated Soybean Curd Film (mg/kg bw) Preservatives listed in Table 3 of the General Standard for Food Additives (CODEX STAN 192-1995) are acceptable for use in this product. In addition, the following food additives may be used. Preservatives 220-225,227-228, 539 4.3 Flavourings Sulfites 200 mg/kg, as residual SO 2 Group 0-0.7 mg/kg bw as SO 2 for sulfites (51 st JECFA, 1998) The flavourings used in products covered by this standard shall comply with the Guidelines for the Use of Flavourings (CAC/GL 66-2008). 4.4 Processing Aids Processing aids with antifoaming, controlling acidity for coagulant and for extracting soybean beverages and carrier functions can be used in the products covered by this standard. Processing aid used in products covered by this standard shall comply with the Guidelines on substances used as processing aids (CAC/GL 75-2010). Currently there is no ML in GSFA food category 06.8.2 Soybean-based beverage film
CX/FA 15/47/5 15 COMMITTEE ON NUTRITION AND FOOD FOR SPECIAL DIETARY USES (CCNFSDU) AMENDMENTS TO THE STANDARD FOR INFANT FORMULA AND FORMULAS FOR SPECIAL MEDICAL PURPOSES INTENDED FOR INFANTS (CODEX STAN 72 1981) (at Step 5/8) New provisions for inclusion in part 4 Section A INS No. Name of the Food Additive Maximum level in 100 ml of the product ready for consumption 4.1 Thickener 1450 Starch sodium octenyl succinate 2 g in hydrolysed protein and/or amino acid based infant formula only 4.2 Emulsifier 472c Citric and fatty acid esters of glycerol 0.9 g in all types of liquid infant formula 0.75 g in all types of powder infant formula (mg/kg bw) Not specified (26 th JECFA,1982) The 79 th JECFA (2014) concluded that the consumption of OSAmodified starch in infant formula or formula for special medical purposes intended for infants is not of concern at use levels up to 20 g/l. Not limited' (17 th JECFA,1973) The 79 th JECFA (2014) concluded that there are no toxicological concerns about the use of CITREM in infant formula and formula for special medical purposes at concentrations up to 9 g/l. Starch sodium octenyl succinate is included in GFSA Table 3. Food categories 13.1.1 Infant formulae and 13.1.3 Formulae for special medical purposes for infants are listed of Annex to Table 3 Citric and fatty acid esters of glycerol is included in GFSA Table 3. Food categories 13.1.1 Infant formulae and 13.1.3 Formulae for special medical purposes for infants are listed of Annex to Table 3